Document x1dzMDX5706bwkkK9M0gkJz7b

ft 9 i' / / LONG TERM HEALTH EFFECTS OF EXPOSURE TO 2 A 5 - T AND/OR ITS CONTAMINANTS 237738 TABLE 0F CONTENTS ' i.A' -JX Page . 1. SomnarJ of Findings ............................................................................................ 1 f- ir 2. Historical Review ..................................................... 5 3. Objectives of Study ....................................... 7 4. Study Design ......................................................... 7 5. Methods and Materials ................................................ 9 6. Subjects of the S t u d y ................................................ 11 7. Results .............................................................. 13 Demographic Information ........................................... 12 Alcohol and Smoking Use ........................................... 13 Family History of Illness .................................... 14 History of Medical Problems ....................................... 14 History of Medical Problems in Populations With and Without Chi or acne ............ AH History of Upper Gastrointestinal Ulcers ..............*.......... 15 Physical Examination Findings ..................................... 18 Clinical Laboratory and Other Test Findings ...................... 20 Lipids ......................................................... 20 Pulmonary Function ............................................. 21 ECG and Chest x-rays Findings ................................. 23 Clinical Laboratory Results .................................... 23 Nerve Conduction Velocity Data ................................ 24 8. Reproduction and Birth Defects ....................................... 25 9. The Trichlorophenol Runaway Group .................................... 26 10. Other Work Exposures of the Study Population ........................ 29 237739 11. Discussion and Conclusins ............. i....... ........... . 31 22. /Refejj|nces ;T.. ____. ......... ............................ 33 13. \Tabl ................................ .............. ....... 34 14. Appendices 237740 Summary' of. Findings1 jA clinical and epidemiologicaT'-jtudy of 436 subjects from a plant making-. 2,4,5-f frn 1948-69 was carried out. The subjects in the data analysis consisted ft '% of 4l8 while maj^es: 204 subjects were defined as exposed, 163 not exposed, and there were 51 subjects whose exposure was questionable. The remaining 18 who were not included in the epidemiological comparisons were 5 black males, 10 white females, 1 male American Indian, 1 male of Hispanic origin, and 1 male not employed at Monsanto but exposed to material of the runaway reaction as a child. Since the number of this group was too small for comparisons they were not included in the statistical analysis. The data on each subject included historical information about illness from childhood to 1979, results of a comprehensive physical examination, clinical laboratory tests, organ function tests and x-rays. The analysis of the data on 418 subjects indicates the following: 1. Chi or acne is the dramatic clinical hallmark which clearly separates the expos^^rom- the pot' exposed or those of questionable exposure; 86% of the -204 exposed developed chloracne and this condition persisted in 52% of the exposed. " *' . V":# "* . There wera no cases ofv.chloracne in the not exposed Jpr those of Questionable exposure. - v 2. Actinic elastosis, a degenerative condition affecting the elastic y? tissues in the d.er\mis is known to be related to the - degree of exp.~.~osure to y- sunlight and is*age ap#$kin coloration dependent. In this study the frequency of actinic elastosis Was 59% in the exposed as compared to 30% in the not exposed.i When corrected for age there was still a significant difference between the-.exposed and not exposed. A biologically significant observation indicates that actinic elastosis in the exposed is found predominantly in subjects with persistent 23774# chloracne largely in and around the site of the chloracne and that the elastosis *i .. is ore $|vere when found with chloracne. 3. f There were 15 cases of hirsutism; 11 cases of malar hirsutism we observed in the exposed group associated with chloracne. 4. An historical finding which deserved critical analysis was the statistically significant relationship between exposure and history of upper gastrointestinal ulcers even when adjusted for age. The innate deficiencies in the data which limit drawing conclusions from these data are: a. The information is based on interview history not medical records or current examination. b. The data provide prevalence information not incidence. No comparisons can be made with incidence of upper gastrointestinal ulcers in the region or the national population for the age groups encountered. The data is therefore suggestive and not conclusive.5. The information assembled about cardiovascular effects indicate that the historical occurrence- of hypertension, coronary artery di-sease and cerebrovastular accidents obtained by interview are age related, not exposure or chloracne related. The blood pressure findings on physical examinations reveals no significant differences between the exposed and the not exposed group when the criteria for abnormal levels were defined by age. The few abnormal findings elicited by ECG examination included statistically significant differences in occurrence of PVC's and PAC's when the exposed were compared to the not exposed. These were found to be age, not exposure related. 6. When the data about pulmonary effects were assembled it was found that there was a greater frequency of pulmonary granulomatous disease on x-ray -2- 237742 examination among both the exposed and the not exposed groups when the >50 year oid i .*t -- ,* were omj>a||d to the <50 year old. The pulmonary function examination revealed consistent differences in all parameters (FEV, FVC, FEV]/FVC, and MMEFR) between 'I the exposed and not exposed groups only if they are present smokers. The ffi confounding factors were that the exposed group was 10 ^ears older than the not* exposed and that 13 of the exposed were coal miners before they started to work for Monsanto. Among current smokers with no coal mining experience however, there were significant differences in FEVi, FVC and MMEFR between the 2,4,5-T process exposed and the not exposed. 7. When clinical laboratory data other than lipids were reviewed no differences were found between the exposed vs. the not exposed, the chloracne vs. no chloracne group. 8. Lipid findings were considered separately and in relation to exposure, " age, and therpresence of chloracne; - When exposure-alone was^considered there-were: no. significant differences in the.freque.ncy of .abnorrna1Jevels in.all parameters . - , : V*' tested. Frequency of abnormal HDL levels-however were;somewhat greater in those , *" ' . % - with persistent chloracne, than those who never had or formerly had^chloracne and >* there was a greater frequency of abnormal LDL levels among those who only had a history of chloracne. Since the total number of abnormal values is small, the biological significance of these statistical differences is uncertain. 9. In the neurobehavioral aspects of the study no differences in neurological examination findings between the exposed and not exposed groups were found that were not age associated or with other known etiologies such as extensive burns, W.W.II injuries, cervical nerve damage, cervical spurs, etc. In full recognition of the inherent problems associated with carrying out and 3 Interpreting nerve conduction velocity tests, a critical analysis of the qualified subjects was made. No significant differences in motor and sensory -3237743 functions were observed between the exposed and not exposed groups, between those whorhad ejlloracne* and'=those who did not, after adjusting for age. / .' \ In tie interview, questions were asked about nervousness, decrease in libido 1 and impotence. Nervousness was reported more frequently among the older exposed A group than the younger exposed group. Recognizing the cultural considerations which influence replies to questions about sexQal. matters, decreased sexual desire was reported more frequently among the exposed than the not exposed. However, it should be noted that there was a 10`year difference in mean age between the exposed and not exposed. When the two groups were compared on the basis of age, the differences in sexual desire and impotence were age related pot exposure related. 10. Reproduction considerations Again recognizing the inherent defects in the method of eliciting clinical information, no significant differences in the frequency of birth defects, stillbirths and miscarriages were found when, the exposed group was compared with the not exposed group. . 11. An unusual problem encountered only among the exposed were three cases of Peyronie's Disease. % This problem is characterized :|by induration and 4r subsequently fibrous scarring of the corpus cavernosum of the penis producing distortion on erection. This problem is not known to have any relationship to toxic exposure. 237744 LONG TERM HEALTH EFFECTS OF EXPOSURE TO 2,4;i-T *A t- ANO/OR ITS;,fONTAMINANTS C tv Historical Review' In 1949, at a plant of the Monsanto Chemical Company, Nitro, West Virginia, a runaway reaction occurred involving one of three autoclaves in Building 41 in which trichloropheno-1 was being prepared. This process accident occurred on March 8, 1949, when under abnormal temperature and pressure conditions the safety valve and pipe connection of this autoclave blew out and the contents scattered throughout the interior of the building as well as the surrounding terrain and structures.* The employees who were asked to clean-up the building and repair the damaged autoclave were the first to develop symptoms. They were chemical operators, pipe fitters and other maintenance personnel. The acute symptoms inc1ude.d,j.tri tation .of- the. respiratory, tract and eyes,.headache, .dizziness, nausea and a severe irritant reaction of the exposed skin. After the initial acute symptoms subsided, within 10 days to 3 weeks, an acneform eruption and other health effects were noted. The clinical findings, at that time, were acneform * lesions, severe muscle pains affecting the upper and lower extremities, thorax and shoulders on exertion, easy fatigue, nervousness and ?r?itability, the com plaint of decreased libido, dyspnea, vertigo, and intolerance to cold. Of the four workers who were hospitalized in Cincinnati in 1949 for study, all had en larged and tender livers, one manifested sensory loss in a foot. Clinical lab oratory findings included severely delayed prothrombin time and a slight increase in total serum lipids. Histological examination of a nerve biopsy in the worker with pedal sensory loss demonstrated myelin degeneration. Follow-up examinations were conducted in April of 1950^ and subsequently, in 1953.2 In April of 1950 the original four and five additional subjects were seen. In 1953 -5- 237745 a tpt?l of ^ subjects were examined, seven of those having been seen in 1949 and 1950. \ Aftigr four years had elapsed, those symptoms and findings observed * initially which were referrable to the nervous system and liver were no longer found. Those with moderate to severe chloracne had improved considerably; there*, was some persistence of the acne in those so affected. In 1977-78 a mortality study^ of the group known to have been exposed to the material of the runaway reaction was conducted. This population consisted of 121 males. The follow-up was 1005S complete for death certificate information. Standard mortality ratios for all causes of death were determined. In 1957, 2,3,7,8 tetrachlorb-dibenzo-p-dioxin (TCDD) was identified as a toxic and acnegenic contaminant of trichlorophenol s y n t h e s i s . S i n c e that time a considerable amount of scientific data has accumulated about the toxi cologic, and cl inica! effects, associa ted,,with.,exposure, to the trOhl orophenol process, to 2,4,5-T synthesis and to the^contaminant TCDD in man, experimental ' - .**'" ' ...... animals, and in vitro researchjjjrodels, ^ahe sub-acute effects which have been repeatedly observed in Humana ^delude chroracne, the most consistent clinical -- *5?;. .*%. marker, liver function impafnitet, peripheral neuropathy, ervosness and irri tability, sensation impairment, personality changes, porphyria cutanea tarda as well as hypertrichosis;and hyperpigmentation; Elevation of serum cholesterol, triglycerides, GGPT and alkaline phosphatase have been reported. Toxicologic examination of TCDD has revealed hepatotoxic effects and teratogenic effects in rodents, suppression of cell-mediated immunity in mice and guinea pigs and the induction of hepatic carcinoma in rats. 6- 237746 Some of the clinical reports appear to have; been concerned with the asso ciate Vascular disease and an increased risk for cancer in populations * expo^edjto Tig)D. OBJECTIVES OF STUDY ** % The objectives of this clinical study were to determine and identify the possible long-term health effects of chemicals associated with the making of 2,4,5-T, including 2,3,7,8 tetrachloro-dibenzo-p-dioxin (TCDD) and to determine the increased risk for those adverse health effects which have been observed in the sub-acute phase or sub-chronic state in man as well as the effects which have been noted to occur in experimental animals including rodents, rabbits and sub human primates. The objectives of the study, as reflected in its design, were to determine increased risks for cutaneous, pulmonary, cardiovascular, gastroin- ,, testinal, hep at i c r e n a l neu rob ehav,ioral, problems, reproductive prob lems, birth, defects, endocrinologic effects, effects on lipid metabolism, susceptibility to infection and the possibility of increased risk for cancer. A most appropriate population for this study consisted of the employees and former employees of Monsanto Industrial Chemicals, Inc., Nitro, West Virginia who were involved in the manufacture of 2,4,5-T from 1948 to 1969. STUDY DE S I G N b The study design originally proposed the following three cohorts on the basis of company medical records. . (1) Current employees, former employees and retirees who were exposed to the 2,4,5-T process during the period 1948 to 1969 and who were kr.own to have chloracne and/or other clinical manifestations attri buted to the process. 237747 -7- (2)' Current employees, former employees or retirees, who were exposed to * %y v - ,5-T. protess during the period 1943-1969, but who were not known tcldevetop chloracne or other clinical manifestations attributable to the "process. v ' (3) Current employees, former employes and retirees who were not exposed to 2,4,5-T process and have no record of chloracne. In the planning stage, it was anticipated that approximately 150 subjects would be available for the study in each of the above cohorts. It was estimated a total of 400-500 employees and former employees would participate in the study. Both management personnel and members of the Medical Department of the Monsanto/ Nitro plant did an excellent job of recruitment of subjects for the study. However, it was recognized during review of questionnaires, including work history interviews as Well^ as 'pt^sician interviews and physical examination, that the participating ,subjects-did- not fulfill-.. some of the criteria- for *these original cohort requirements. Selection bias was a factor in voluntary participation. No subject was excluded from the examination. The number in the exposed cohort ex ceeded the number in the'non-exposed cohort. Subjects, who had never claimed or * * been observed to have had chloracne, were found to have history and/or residual chloracne upon examination. There was disagreement with regard to definition of exposure, i.e., exposure and intermittent exposure. On the basis of information gleaned from:questionnaires and company work records t'*ee cohorts were consti tuted: 1) those who were clearly exposed to the 2,4,5-T process or its components; 2) those who were clearly not exposed and 3) those who were questionably exposed. 237748 -8- METHODS AND MATERIALS '. `: ) V;V : ^ , ;.*'Tfe design of the study and on-site survey were directed by Dr. Raymond R. Suskvid* ThSfinterviews and clinical examination of 436 subjects were conducted during the week, June 11-18, 1979, in the Putnam County Health Center in * Winfield, West Virginia by members of the Departments of Environmental Health and Dermatology of the University of Cincinnati Medical Center. Personnel from the , above departments irttluded physicians, nurses, graduate students in the De- i1 partment of Environmental Health, technicians and interviewers. An average of 60 |, persons were examined per day during the study, with fewer persons seen on Sunday. The questionnaire and study program is found in Appendix I. t --Vi*4 The complete examination included: an interview, clinical laboratory r , examination of blood and urine, pulmonary function tests, ECG, chest x-ray, nerve i! , ' X conduction velocity measurements, and a complete physical examination, including | skin examination by-dermatologists. During the-dermatological examination* .. j' L biopsies, skin_.scrapings, and photographs were taken as deemed appropriate by the ....- " physician and when agreed to by the participating subject. The nerve conduction velocity measurements were obtained for most subjects from two nerves: the *m peroneal nerve for motor function and the sural nerve for sensory function. In a relatively small number of subjects (22) nerve conduction measurements were j made on the ulnar nerve. Clinical laboratory analyses included: blood calcium, phosphorous, BUN, j creatinine, BUN/creatinine ratio, uric acid, glucose (CS), total protein, albumin, globulin, albumin/globulin ratio, total bilirubin, direct bilirubin, r, Transaminase SGO, Transaminase SGP, alkaline phosphatase, LDH, cholesterol, ^ Iron, total lipids, sodium, potassium, chloride, G-glutamyl transpeptidase, triglycerides, CBC and differential, thyroxine R.I.A., thyroxine binding glo- r -9- n * > 7 7 ilA bulins.'Uri*rn7 alysis included routine examination as well a-s coproporphyriIns and uroporphyri^fe.* Blood serum lipid fraction examination completed by the Lipid Research Division of the University of Cincinnati Medical Center included: serum cholesterol," serum triglyceride, serum HDL, and estimated serum LDL. Chest x-rays were read by members of the staff of the Department of Radiology, University of Cincinnati Medical Center, under the supervision of Dr. Jerome Wiot. ECG's were interpreted by Dr. Te-Chuan Chou of the Cardiology Division, Department of Internal Medicine, University of Cincinnati Medical Center. Skin biopsies were prepared and read by Dr. Daniel Richfield, Dermatopathologist. Skin scrapings were cultured at the University of Cincinnati. Dr. A. Blair Smith initiated the examination of the data. Dr. Vicki Hertzberg, of the Biostatistics Division, performed all of the statistical analysis described in this report. Data from the questionnaires were coded in the conventional manner by assigning numerical r values to the responses given. Normal ^and abnormal f indingsnoted by the examining physicians and salient details of each subject's medical -V & ' J t history were coded using the SNOMED system. Chest x-rays were coded by. obser- *. "&' '' .` vations and conclusions, drawn by members of the^Radio'l^gy ^^partment.. ECG findings were entered as?interpreted by members of the Divisidli-of Cardiology, Department of Internal Medicine. ECG findings were reviewed with the subject's history, clinical findings, and chest x-rays in order to determine significant ECG findings. Laboratory data were entered as received. All data were keypunched and verified by the University of Cincinnati Computer Center. The keypunched data were then compared to the original files of the study subjects for accuracy. A computer file containing information from the questionnaires, * Values for urinary coproporphyrin and uroporphyrin were determined from a single void sample rather than the required 10 ml. aliquot of 24 hour volume; hence levels outside of the normal range cannot be regarded as significant. -10- 237750 physical examinations, laboratory findirigs^Was created. All extremely large or small values.for each variable were checked against the original values in the studyisubje^'s files. Following this second edit for accuracy of entered data, *V % analysis of fata began, using statistical programs available through,the Statis tical. "rialysis System (SAS) con^uter package. The statistical procedures used are briefly described in Appendix II. As the analysis progressed, periodic editing continued so as to insure the greatest possible accuracy. THE SUBJECTS OF THE STUDY The total number of subjects in the study is 436. There- are 419 white males, 5 black males, 1 male of Hispanic descent, 1 male of American Indian descent, and 10 white females. One subject among the 419 white males was a 36-year old who was exposed to runaway reaction residue in 1949-at the age of 6;- Since he*was not an employee, he is not included in the data analysis. Since*the number of women and non-white males is too small to be meaningful, they are not included in the remainder of'the analysis." A*brief description of thse subjects, however, is contained in Appendix III. Information about seX., rac, eduta&ton and a r r a n g e is found in Table 1. * > The cohorts designated by exposure are defined as follows?; Group I - no exposure: 163 subjects Group II - exposure, without qualification: 204 subjects These subjects were involved in process and production and include pipefitters, electricians and all other employees working in or around the 2,4,5-T process. Group III - questionable exposure: 51 subjects This group includes laboratory and supervisory personnel not in volved in production, but who occasionally handled 2,4,5-T or were around -11- 237751 the production area for , s short pe*r*+i%io'ds of time; la'boratory personnel who worked^ laboratories where 2,4,5-T was anaTyzerf^tnf^dj^jSBt''actually foand'tffhe material, carpenters who worked in the buildings of 2,4,5-T '' } *f ` - roductfon occasionally, supervisory personnel whose main work efforts ' -were in offices, but occasionally 'toured th buildings where 2,4,5-T was produced, and warehouse employees who described handling all types of finished products, including 2,4,5-T. For a number of the analyses, the clearly exposed group was compared tb the clearly not exposed group. Group III constituted a suspected exposure category. We report comparisons of the latter group with the clearly exposed and not exposed where pertinent. \ v* ji4'L -12- 237752 RESULTS * ^ . Demographic Information \ tomographic data of the 418 white males were examined to determine 'i 1 potentially-confounding variables. Data on all subjects are found in Tables 14. The three groups were found to be'significantly different with respect to employment status (p<0.0001) (Table 2) and the highest education level achieved (p< 0.0001) (Table-3). -34.8% of the exposed were retirees and therefore in an older age group, whereas only 13.5% of the not exposed were retirees; 9.8% of the exposed were terminated, among them, employees who left the company in the era of 1949-1955 because of the health problem attributed to 2,4,5-T,.whereas only 0 .6% of the not exposed group were in the category of terminated. -Tfie mean age of the not exposed and 'questionably exposed groups was ten years younger than the exposed group (Table 4). B. Alcohfil and Smoking Use --- ;}History of alcohol consumption was found not to be "significantly ''* ;*: different in. the three group (Table j>). When smoking status (current, former, ** never) wasjused as the criteria theri^was no difference between the exposed and not exposed group (Table 6). However, when the two groups were compared for pack years smoked, .the exposed group was significantly higher than the not exposed group (Tabled). When present smokers were compared there was an almost 20 pack year difference between the_ exposed and not exposed. There was a difference of 9 pack years between the exposed and not exposed group in the former smokers. This probably reflects the.10 year age difference between the exposed and not exposed group and the heavier consumption of cigarettes in the exposed group. -13- 237753 C. Family History of Illness . J F^gily history of illnesses were compared; the results are given in Table 7. a H of the comparisons are mde usingHFisher's exact test for *2 x 2 \ 5 , tables. Family history of hayfever was foynd to be reported more often in the not exposed group (0.01<p <0.05). A family history .of'heart attack or angina after age 60 was reported significantly more often in the exposed group ( p < 0 .0 1 ). 0. History o r Medical Problems The comparison of `the exposed and not exposed cohorts for illness elicited by medical history is given in Tables 8-9. Chloracne is reported more frequently in the exposed group: 86-27% in the exposed vs. 0.0% in the not exposed and questionable exposure group. In the not exposed.group, acne vulgaris occurred more frequently than in the exposed group. A history of upper, gastro intestinal ulcer occurred almost 4 times more frequently in the''expos'group than J n thejiot expose_d group (p < 0.005). When the medical history of the ex posed and not exposed are compared for two (2) age groups, less than 50 vs. 50 years and older, skin cancer and cerebrovascular- accidents are only related to age not exposure; exposure, not ag, appears to be a factor in the history of upper gastrointestinal ulcer. Hypertension and coronary artery disease occur more frequently in the older age group irrespective of exposure. E. History of Medical Problems in Populations With and Without Chloracne Since chloracne appears to be the prime clinical indicator of, exposure, absorption and biological response, the study subjects were further classified into three sub-groups within the exposed populations; i.e., those who never have developed chloracne, those who had a history of chloracne but which was not observed in the 1979 examination and those whose chloracne persisted and -14- 237754 was noted ,i on V;c`'Jlinical examination - (tables 10-13). Among the 204 clea*vrl*%y exposed, 176 devfelopejjchloracne at some period. Of these, 107. were found 4o have chlor- acne oriexami|atiqn. Among the not exposed and questionably exposed, there were none who presented a history of chloracne nor were they found to have evidence of, chloracne on examination. In both age groups, history of upper G.I. ulcer is more frequent in those who had chloracne than those who did not have chloracne regardless of exposure (Tables 10 and 11). As in the exposed versus not exposed group, the history of hypertension, cerebrovascular accident (CVA) and coronary artery disease are clearly age-related, not chloracne related. When the clinical histories of the exposed population only were examined in relation to the history of and/or presence of chloracne, the same observations are made about angina, hypertension and coronary artery disease in that they are age-related not chloracne related. In the exposed group there is no association between the-history of'upper G; Ft utoer and-chloracne (Table 12 Kr..: - .A 1though there_._appears.to ,,be a j t atlst&ca 11 y sign iftcant re 1 at ionsh ip between exposure and history of upper G;I. ujcer, a closer examination of the temporal sequence of exposurv lhd onset offflh&r revofs six'subjects in the exposed group and one subject 'Tlh^the ques^ioi^ble group :who$e symptoms of ulcer, `-.7 _ . "'-Vi.; * ` ^' occurred prior to exposure. In addition, there are fouh-subjects-among the *T exposed group whose ulcers were related to-, cortisone therapy, ASA therapy or alcoholism. If these 11 subjects are omitted from the analysis there are then 32 of 194 (16.49%) of the exposed group reporting ulcer vs. 9 of 163 (5.52%) among the not exposed subjects. This difference is statistically significant upon age adjustment (p=0.01). However, if the seven subjects reporting history of ulcer before exposure are considered to be not exposed subjects because of the temporal sequence, there are then 32 of 194 (16.49%) of the exposed group reporting ulcer -15- 237755 vs. 16 of l70 (9.4135). This'difference is not statistically significant upon' age adjustment.. Other wftti the following' results; (1) There was no relationship found between exposure category and history of ulcer among never smoking subjects. * * (2) Among formerly smoking subjects, 24.1055 (20 of 83) of the exposed group report history of ulcer compared to 6.8535 (5 of 73) o f the not exposed group (p< 0.005). (3) There was no relationship found between exposure category and history of ulcer among presently smoking subjects. (4) There was no relationship found between exposure category and history of ulcer among the'three categories of alcohol drinking (never, former, and present). -16- 237756 The following is a breakdown of data designating exposure vs. ulcer type and treatment: ; - ; *i**." 1% ' `sT ' *" History of Gastrointestinal B1 ceding Upper G.I. Ulcer Site as Reported Peptic Stomach Duodenal Treatment as Repo rted . Did not Report Tr eatment No Treatment - Treated, with Diet Only Medical Treatment : Ulcer Symptoms- Re lieved with Hiatal Herni a Repair Gastrectomy .| Partial Gastrectomy Surgical Treatment of Ulcer, NOS Problems Now l J Not'Exposed ln=ib3r *X 0 9 5.52 Exposed (n=ZG4) #X 5 42 20.59 39 4 21 2 12 2 * .i.-- 7 -- - 13 3 4 10 __ 2 - -, v 3 1 6 38 Questionable * Exposure (n=51) # X 0 6 11.76 1 -a 2 3 2 1_ . 1 These data haye the ad'ditional problem of being prevalence figures only as opposed to incidence rates. 1 Also, report of upper gastrointestinal ulcer and \ designation of ulcer by site is crude at best since neither examination by gastrointestinal x-ray, nor endoscopy diagnosis was available. Hence, while these data are suggestive, conclusions cannot be drawn due to the equivocal findings and the crude nature of the data. -17- 237757 ` F.:-. Physical Examination. Findings V l* ; : *The physica# e3faminatioi* revea1ed a w ide' range' of findings. The se are cited\in a cyprehensive list in Appendix IV . The significant clinical findings were, those associated with the skin and appendages, connective tissues, and sexual complaints-* . The discernible abnormalities referrable to the cardio vascular, pulmonary, hepatic, hematopoietic systems, and nerve function were largely determined by objective tests in this study. These will be discussed under organ function tests, radiography and clinical laboratory measurements. The significant clinical findings as related to exposure status are found in Table 14 and 15. As was indicated previously 52.4535 of those who were clearly exposed still had chloracne. There is a significant difference in the frequency of acne vulgaris among the not exposed as compared to the exposed, 11.6635 versus 1.9635. Among the exposed 120 or 58.8235 were found to have actinic elastpsis_in contrast to 49 (30.0635) among the not exposed and 39.2255 among the questionably exposed. There is a very significant difference in the occurrence 3of actinic elastosis between the exposed and not exposed in both age groups even I thougS age is a factor in this clinical finding. Theri is a rather unique find- l ing of 3 cases o f Peyronie's Disease among the 204 exposed. All of them had Uchloracne at some time and they were all over 50 years old. .-4 Rosacea and rhinophyma occurred in 4 exposed persons over the age of 50 arid 2 questionably exposed. The complaints of loss of libido occurred more fre quently in the exposed than'the not exposed. When age was considered, the largest number of complaints of loss of libido or impotence occurred in the older age group but there were greater percentages of complaints about these problems in the exposed group as compared to the not exposed. 237758 -18- Tables 16 and 17 identify the clinical findings in the exposed popu^ latien in relation to,,chloracrid status/ In these groups, actinic elastosi* is found predominantly in the subjects with persistent chloracne (74.8%) but it also ri . TjT i occurs significantly in those with a history of chloracne only (46.38%). 11 cases of malar hirsutism were found among t( exposed in the persistent chloracne cases (10.28%). 9 of these 11 cases occur in the group over 50. Table 18 1isjts the sites and severity of chloracne observed on physical examination. The distribution and severity of actinic elastosis is presented- in Table 19. L: Since there appears to be some association of actinic elastosis with chloracne further analysis of this relationship with respect to severity of chloracne and severity of actinic elastosis was carried out. These analyses are \I presented in Table 20 and Table 21. Of the 67 mild cases of residual chloracne, 44 had actinic elastosis. Of the 36 with moderate chloracne 33 had actinic i! elastosis. 33% of the actinic elastosis cases found with chloracne were severe. It would appear that the percentage of persons with severe- act iiifc e! asto sisj*is 3\ 1' related to presence of chloracne (Table l) r In ottofr words, aifinic elastosis \ appears to be oore severe when found with. chi or acn*'' . ^ -9 - ... r r Blood pressure findings at the time of ex^ination in>the-exposed,. questionably exposed and not exposed groups are presented in Table* 22. When the criterion for abnormal systolic and diastolic use different values for the groups <59 (140/90) and 56O (160/95), there appears to be no significant differences between the exposed and not exposed group. These criteria are stricter than that proposed by the National Heart, Lung and Blood Institute.^ 237759 i -19- * G. Clinical Laboratory and Other Test Findings '. i m Lipids * . ^`5 % - * "f Because of the suspected relationship of serum lipids to exposure to 2,4,5-T and its contaminants, serum lipids are analyzed in several ways. Serum cholesterol, triglyceride, LDL, and HDl were classified by age-specific per centiles as determined by the National Lipid Research Project data^ (See Appendix V). Serum cholesterol, triglyceride, and LDL were classified as "abnormal" if they fell above the 90th percentile, and were classified as "normal" otherwise. Serum HDL was classified as "abnormal" if it fell below the 10^^ percentile, and was classified as "normal" otherwise. The frequency of abnormal lipid findings are compared for exposed,, not exposed workers and questionably exposed (Table - 23), and no significant differences are noted in cholesterol, triglycerides, HDL and LDL.levels. These relationships are further investigated within each level - . of smoking.status (present, former.and never) (Table. 24).. $mok.ing..appears:ta.-have-, no effect on the differences, between these groups. Logistic regression was used '*'*w "' " ..............................V ` ' ' I, to detect associations of abnormal serum lipid findings with exposure. After.-, adjusting for pack years smoked, no signifftant differences befcpert exposed- and* . .. ***>, not exposed could be found. * . . v.T W 'Js - Multiple linear regression was also used to detect possible "Shifts" in the mean serum lipids for the two exposure groups after correcting for the effects of age, tobacco, and alcohol. In all cases (cholesterol, triglycerides, HDL, LDL) there are no significant differences between the two exposure groups after adjusting for the effects of age, tobacco and alcohol. When the lipid levels of the exposed group only are examined in relation to the occurrence of chloracne, the HDL levels in those with persistent chloracne are found to be somewhat lower than of the group with a history only of -20- 237760 chloracne or those who never had chloracne (Table 25). Those who had a history ' `- -. i only of chlbracne have somewhat higher LDL* levels than those who had chloracne currently ollnever. Among former smokers in the exposed group there is a greater .I ` -' ' ... . '1 frequency of abnormal triglyceride and HDL levels among those with residual chloracne than those with no history or only history of chloracne (Table 26). Among those who smoke presently there is a higher frequency of abnormal or high LDL levels for those^who have a history only of chloracne. 2) Pulmonary Function Status ( Both FEVj and FVC were considered abnormal if the observed value was less than 80% of the predicted value of Morris. A FEVj/FVC ratio of less than 0.70 (70%) was considered to be abnormal. The ^ 2 5 - 7 5 was considered abnormal if the observed value was less than 70% of the predicted value of Morris. Consistent differences in abnormal pulmonary function values (FEV|, FVC, FEVj/FVC and ^ 2 5 - 7 5 1 are ^ound between the exposed apd not exposed .grdups (Table 27). Among present smokers there was a significant difference iir pulmonary function values between the exposed and not exposed group. There are ^^L-^.ifferences in pulmonary function values, among persons who have formerly jpoked or among persons who have never smoked when the exposed were compared to Jar * the not exposed (Table 28). -.*i Logistic regression was used to detect associations of abnormal pulmonary function parameters with exposure. The model and coefficients are given in Appendix VI. The significance and odds ratios for abnormal pulmonary function for exposed vs. not exposed after adjusting for pack years smoked are -21- 237761 as follows: Pulmon/y Function Parameter FEVi FVC FEVj/FVC FEF Significant of Exposure 0.02 0.05 0.01 0.06 Odds Ratio 2.71 2.10 2.89 1.82 The association of exposure and abnormal pulmonary function among current smokers was investigated further for the confounding by prior coal mining exposure. None of the not exposed subjects who currently smoke had prior coal mining exposure'. Of the exposed subjects who currently smoke, 13 individuals had prior coal mining exposure. Among the current smokers who had no coal mining exposure the exposed were found to have a higher frequency of abnormal F E V p FVC -.and .MMEFR_,th.an vthe..not exposedas_follows: ___ Pulmonary Function Parameter FEV1 FVC FEVj/FVC FEF25-75 N-Mi nefs-Current Smokers Miners Current Smokers Exposed (n-60)- # Abnormal Not Exposed (n=44) 4 ^Abnormal Probability Exposed (fl*13) # '^Abnormal 12 20.00 14 23.33 10 16.67 18 30.00 2 4.55 1 2.27 3 6.82 5 11.36 0.039 0.003 N.S. 0.039 7 53.85 4 30.77 8 61.54 8 61.54 23772 -22- 3) ECG.and X-ray bindings .Tables 29'arid 30 list the occurrence of ECG findings in the e x '% T M : * posed and not exposed aswell* as the differences in occurrence when the exposed and not exposed are "separated into <50 and ^ 5 0 year groups. Number of persons with PVC's and PAC's appear to be only age-related. Tables 31 and 32 list the x- ray findings in the exposed as compared to the not exposed as well as the comparison between the <50 and >50 year old groups. Significant x-ray findings findings appear to be age-related but not exposure related. 4) Clinical Laboratory Findings In Table 33 the relative frequency of out of normal range values is compared in the exposed vs. not exposed group. In Table 34 the relative fre quency of out of normal range values of clinical laboratory findings for the exposed group in relation to chloracne status is presented. : ... . ..Analysis covariance was used to compare.the._laboratory,, finings in the exposed group to the not exposed ^groyp.^ft^lldjusting for the effects of age, smoking status and alcohol status. Jhe-jiame p r o ^ ^ r e was ..used to compare the laboratory findings for three.chioracnfcS^pSv^ for the effects of age, smoking and alcafi$ii)fcatus~ >W Fisher's exact test was used to determine the existence7: of differences between the exposed and not exposed with respect -to the relative frequency of out-of-reference-range laboratory findings. The X 2 test for independence in contingency'or two way tables was used to determine differences in the three (3) chloracne groups with respect to the relative frequency of out- of-reference-range laboratory findings (Appendix VII). 237763 In several other incidents involving the synthesis of trichloro*t * phenol and 2,4,5-T, 'porphyria cutanea tarda was observed with uroporphyrinuria.: Th exposedff.noj exposed and questionably exposed in this study were compared for percentage of abnormal levels of coproporphyrin and uroporphyrins. No signi ficant differences .were found (Table 35). 5) Nerve Conduction Velocity Data Priop to the beginning of the data analysis, all subjects reporting diabetes or reporting a high weekly alcohol intake were eliminated from the analysis (high weekly alcohol intake was defined as greater than or equal to 35 oz. alcohol per week). After these deletions, there were 319 with complete sural examinations and 336 with complete peroneal examinations remaining. The data from the nerve conduction vel*ocity tudy were adjusted according to the, deJesus method (Appendix VIII). Tables 36-38 lists all nerve conduction parameters considered. The following methods of analysis were then used: a) .. Analysis of covariance was used to compare the conduction parameters after adjusting^for age diffrences in the groups. No significant differences were.found .betven ttm.,exii'and riot.ttmsed. . Also within the exposed only* "ho relation tp ch 1 tus^' wfffound after adjusting for age. : b) Using the normal ranges provided by NIOSH (see Appendix IX) the exposed group has a significantly higher proportion with abnormally low peroneal nerve conduction velocities than the not exposed group (7451 vs. A9%y p <0.0001). No differences were found with respect to abnormal sural nerve conduction velocity or peroneal distal latency (not enough ulnars were tested to say anything about them). However, Boyd points out that these ranges are not age- adjusted. Moreover, temperature has a great effect on velocity and latency, and -24- 2377G4 temperatures were not reported with- these rangs. *(Ranges and appropriate re^ ferences are e^tached). Among young men (age-<SO) no difference between e x p o s e d and'not exposed with respect to any of the. parameters was observed. Among the older merii(age ^50) a significantly higher proportion of the exposed group have abnormally low peroneal nerve conduction velocities as compared to the not exposed group (79% vs. 57%, 0.01 < p <0.05)- c) The z-score method (as used by Selikoff) was als.o used to detect differences in the nerve conduction parameters between exposed and not exposed. No significant differences were found using this method. H. Reproduction and Birth Defect Data In presenting this information it should be understood that all of the data depended on personal recall of such information as number of pregnancies, miscarriages, live births, stillbirths, infant mortality, etc. Confounding factors which effect-accuracy are obvious-e.g. interviewed male subject only, ..agi"of subject, and-change in cultural- attitudes aboutreproductive matters. It confounded by the fact that the pregnancies^miscarriages^ stillbirths not designated in a time period related to exposure e.g., pre, during, post exposure. Fisher's exact test was used to compare the reported occurrence of re productive anomalies in the exposed group to the not exposed group. The data on rproductive and birth defect findings are found in Tables 39 and 40. No significant differences were found in miscarriages, in rate of birth defects or stillbirths. 2377G5 The TCP Runaway Reaction `Group' -- * '+ t ^~ '. ^ ,,4 ~ Among ttoj| 204 pesions who were known to be exposed to the.2*4,5-T Synthesis and preparation, there were 55 who were involved in a trichlorophenol process runaway reaction, which occurred on March 8, 1949, described in the historical introduction. There were a total of 122 persons known to have been involved in this accident and with its products. This group of 551was matched as closely as possible in age with an unexposed group and a third group of exposed but not to the accident material. Since the range of the runaway reaction group was 49 years and older, the matched unexposed control group consisted of persons in the same age range, e.g.,^49 years. There were 65 persons in the unexposed group. Because of the percentage of aging re-** tirees in the TCP runaway group there was still a four year age difference between the accident group and controls. There was no difference, in ge between the TCP " 7 'accident group and the other exposed. - In the other-exposed,, group, Jthp.,ge..range was **55. .There _we_re 77 subjects in. that groups Data comparisons were made between the accident group and theunexposed groupes well as the accident group and the other exposed group. The following were the significant findings elicited: * 1) When smoking status was considered, the average number of pack years was significantly greater in the TCP runaway group than the not exposed group by 10 pack years. The difference between the TCP group and other exposed group was 9.5 pack years. . 2) All of the TCP exposed had a history of chloracne; none of the not exposed had chloracne; 83% of the other exposed group had a history of chloracne. In the TCP group examined, 58.2% still had chloracne; in the other exposed 55.8% still had chloracne. -26- 237766 3) There were no significant differences in the current findings of chlor- acne and a c i n i c elastosis between the TCP and the other exposed group. 4) The percentage of persons with actinic elastosis was significantly . larger in the TCP group than the not exposed group (753 vs. 49%)- The difference in the occurrence of actinic elastosis between the TCP and other exposed group (75% vs. 68%) was not significant. s 5) There was a significantly larger number of systolic murmurs found in the TCP as compared to the other exposed group (12.7% vs. 1.3%, 0.01 p 0.05). Although there appears to be a statistical difference between the percentage Of abnormal BUN'S found in the TCP group (9.43% or 5/55) as compared to the other exposed (1/73 or 1.37%) there was no difference between .the TCP group and not exposed group (9.43% vs. 6.35%). 6) The complaints of nervousness were greater in the TCP. runaway group than'the'hot*exposed controls (21.8% vs. 7.7%) . In th other exposed controls the occurrence-of nervousness was 16.9%. ....... --- ` 7) Logistic regression was used to compare TCP runaway group to the not i* exposed and to the other exposed group, for abnormal serum lipid findings, while simultaneously adjusting for pack years smoked. No significant differences were found in either comparison. " ' :'r B) In the pulmonary function tests, the number of persons with abnormal FEVj/FVC test findings in the TCP group was significantly greater than among the m not exposed. This same difference was seen among current smokers in the two groups. There was also a slightly greater percentage of persons with abnormal MMEFR among the TCP group who are currently smoking than the not exposed who are currently smoking. 237767 9) Logistic regression was used to'"Compare*TCP runaway-exposed to not exposed for fbnormal pulmonary functionalle adjusting for;,pack years stroked. No *** relationship was found between TCP runaway exposure and abnormal FEV^f FVC or MMEFR. However, a significant relationship was found between this exposure classification and abnormal FEV^/FVC, with a greater frequency seen in the TCP runaway group (p=0.01). The odds ratio is 4.02 for abnormal FEVj/FVC, given pack years smoked, for TGP runaway exposure vs. not exposed. Logistic regression was used to compare TCP runaway exposed to other exposed for abnormal pulmonary function while adjusting for differences in pack years smoked. No significant differences were found. **. * 2377C8 -28- Other Work Exposures'jof the Study Population '"jttervtKan 2,4,5-f, its intermediates, and/or contaminants, al.of the - . workers in the study were exposed to multiple chemicals and industrial processes under'varying working conditions, at Monsanto/Nitro and/or other industries, in a period roughly between the late 1930's and 1979 (a few subjects were born before 1900). Chemicals identified by the subjects as other Monsanto/Nitro exposures in clude: rubber processing chemicals, i.e., diphenylguanidine; a group of benzo- thiazolesulfenamide accelerators (Santocures); antioxidants, i.e., derivatives of m-cresol; antiozonants (Flectols and Santoflexes), most of the Santoflexes are p phenylenediamine derivatives; vulcanizing agents such as 4,4-dithiodi- morpholine; insecticides, i.e., ethyl and methyl parathion. Additional chem icals named were phthalic anhydride, o and p di chlorobenzene, o and p nitro- phenol ^ :toluene .and mercaptobenzothiazole,^derivatives- o M M T D and-tri methy l-- quinoline components. One of the products, Sopanox* an ^ t i oxidant,, was alleged^ by the study subjects to be associated with the occurrence of kidney stones. The reporting of the H/0 kidney stones is .> ^ , fiere ht.among the t h r e e s groups. '. . One of the chemical hazards to which the study population was'exposed was p aminobiphenyl, a known bladder carcinogen. Ninety-five subjects, or 22.722 of the 418, reported exposure to p aminobiphenyl during the course of their em ployment. To the best of our knowledge these subjects are periodically examined in a monitoring program established by the Medical Department of the Company. Subjects reported the exposure and the monitoring program during the interview and to the examining physician. The data analyses relating to this exposure and -29- 237769 e x p i r e t0 i2 ,Av|i-'i; is at follows; >*< Vf . paminobiphenyl Exposure * H/0 Bladder Tumor * H/0 Bladder Cancer Not Exposed (n=163) % 8 4.91 1 0.81 1 0.61 * Figures are mutually exclusive 2 ,4 ,5 -f exposure" Exposed (n=204) % 71 34.80 7 3.43 2 0.98 .^ Questionable Exposure * .% 16 31.37 0 0.00 2 3.92 The degree to which each subject may have been exposed to other chemicals both at Monsanto/Nitro and other places of employment varied markedly. This fact must be considered in attempting to interpret biological significance to statis tical differences based on small occurrences. * 4 -30- 237770 Discussion and Conclosions .* ^ -The Strengths art^^eaknesses of this study must be considered critically in any appraisal of the medical significance of the data elicited from it. ./Data gleaned from interviews and clinical examinations are useful but have some inherent weaknesses. Medical, work and personal histories depend on memory; findings of physical examinations carried out by different physicians are based on judgments which (iay differ somewhat with the examiner. Nevertheless these. constitute an important data base for making clinical judgments. Since quantitative TCDD levels for any period during the manufacture of 2,4,5-T were not available, it was only possible to relate effects -found, to the b history of definite exposure, no exposure, and questionable exposure to any aspect of 2,4,5-T production. Since chloracne" ls the hallmark of biological activity of TCDD it was possible* in thi s study to* rel*ate al V systemic' and other cutaneous effects'tb* the' * -* -. presence or absence .of chloracne -in the'exposed^group'a^eT-l-to exposure itself. From this study one can conclude;that fpi^phose exposed to TCDD the-idramatic long term effects are:cutaneou%-and/lnvo 1 1 1oslrfriceous apparatus and the '7*^: -'* ` . elastic tissues of the dermis.; ChToracne may persist for* long as,3i^ears after onset and is associated with elastic tissue changes irt/the dermis and some persistence of malar hirsutism. There are suggestive but inconclusive data indicating that for the exposed there was an'increased risk for upper gastrointestinal ulcer; that'among those in whom chloracne persists there is (although numbers are small) an association with low HDL levels and further for those with only a history of chloracne there is an association with higher LDL levels. In those who currently smoke and have been exposed to the 2,4,5-T process -31- 237771 materials there appears to be an association of abnormal pulmonary function findings when compared to those who smoke but who were never exposed. There is no evidence from this study that there are identifiable long term Effects on'"the cardiovascular system, on the liver, on the gastrointestinal tract, on peripheral nerve function. There is no indication, on the basis of histories! Information (recognizing all of its weaknesses) that there was a greater risk for miscarriages, stillbirths, or birth defects among the families in which the male parent was exposed. 2377" 2 -32- Rferences 1 . v -Ashe, VT H a m and Suskind, Raymond R.: Report of the Kettering Laboratory, University"of Cincinnati, Chi oracne Cases of the Monsanto Chemical .ompany7 Nitro, West**-Virginia, October 194*&;* Apri 1 1_950- 2- Suskirfd R.R.: Report of the Kettering Laboratory, University of Cincinnati, A CTimcal ana Environmental Survey, Monsanto Cnemfcal Company, Nitro, West Virginia, July 1953. 3. Zack, J.A. and Suskind, R.R.: The Mortality Experience of Workers Exposed to Tetrachlorodibenzodioxin in a Trichlorophenol Process Accident, Journal of Occupational Medicine, 22:11-14, 1980. 4. Kimmig, J. and Schulz, K.H.: Chlorinated Aromatic Cyclic Ether as a Cause of So-Called Chloracne, Naturwissenschaften, 44:337-338, 1957. 5. Kimmig, J. and Schulz, K.H.: Occupational Acne Caused by Chlorinated Aro matic Cyclic Ethers, Dermatologica, 115:540-546, 1957. 6. Systematized. Nomenclature of Medicine, College of American Pathologists, Second Edition, 2"Volumes, April 1979. 7.' Kurata, J.H., Elashoff, J.D., Grossman, M.I.: Inadequacy of the Literature of the Relationship Between Drugs, Ulcers, and Gastrointestinal Bleeding, Gastroenterology, 82:373-82, 1982._______ _____ _ _ : _ ... 8. Report of Jojnt National Committee on Detection, Evaluation and Treatment of fitgh Blood Pressure,-National-Hearty Lung and Blood -Institute,-1977.-- --- 9. -The Lipid Research Clinics Population Studies Book: Volume I: The Pre valence Study, USDKHS (19SQJ. -33- 237773 y,sw SBi H' T A B L E S i i i 237774 TABLE l ~ DEMOGRAPHIC DATA ALL STUDY SUBJECTS Males Females Total j -T-o-t-a-l 426 10 436 White 419 10 Black 5 0 Other 2 0 HIGHEST EDUCATION LEVEL ACHIEVED 0 - 8*^ Grade 9 - Grade > 1 2 ^ Grade Total. 237775 TABLE 2 s PRESENT EMPLOYMENT STATUS ' Not Exposed Number .... Percent Active 140 85.89 -- Questionable Exposure Number _ Percent - 38 74*51 Exposed Number Percent 113 55.39 Total / 291 Retired . 22 13.50 Terminated 1 0.61 11 21.57 71 34.80 104 2 3.92. 20 9.80 23 Total 16.3 51 204 418 p < -0.0001 237776 -35- TABLE 3 EDUCATION LEVEL 0 - 8th Grad"e . 9 - )2th Grade Not Exposed Number 2 92 Percent *r -:.T, _____ 1.23..... 56.79 > 12 th "Orade .Total 68 41.98 162 - ------ Questionable Exposure Number Percent --- 4 . 7.84 27 52.94 -*...... - -- - 20 39.22 51 Exposed Number V Percent Total .19 9.36 * 25 147 72.41 266 37 18.23 125 203 416 p < O.OOOl -36- 2377T7 TABLE 4 A6E OF POPULATIONS Kean Standard Deviation Exposed (204) v. . :* Questionable Exposure (51) Not Exposed (163) 56.67 10.58 years 53.30 10.63 years 46.23 t 12.86 years -37- 237778 1 0 TABLE 5 EXPOSURE vs. ALCOHOL STATUS* Not Exposed Number Percent Questionable Exposure Number Percent Exposed Number Percent Total Never x. Former 27 17.09 47 29.75 8 15.69 18 9.38 .- 53 17 33.33 74 38;54 138 p N.S. * For definition, see Appendix X. Present 84 53.16 26 50.98 100 52.08 210 Total 158 Vsi 192 401 237779 -38 TABLE 6 EXPOSURE > vs. . SR0K1NG STATUS* Not Exposed Number Percent ^ Questionable Exposure Number Percent Exposed Number Percent Total . Never 47 28.83 18 35.29 46 22.66 111 Former ?2 44.17 Present 44 26.99 .21 41.18 12 23.53 84 41.38 . 177 73 35.96 129 . P N-S * For definition, see Appendix V. EXPOSURE vs. PACK YEARS SMOKED* Exposed (198)' Not Exposed (162) Questionable Exposure (50) Mean Standard Deviation 27.04 28.82 15.73 t 24.01 19.67 + 23.97 * p <0.0001 for comparing Exposed to Not Exposed Total 163 51 203 417 -3L 23770 -39- TABLE 7 *\ FAMILY HISTORY OF ILLNESS * Family History of Asthma 1 1! Hayfever Acne Eczema Hives Upper G.I. Ulcer Colitis . Heart Attack or Angina before Age 60 Heart Attack or Angina after Age 60 i High Blood Pressure Cerebrovascular Accident (CVA) High Cholesterol Diabetes Liver Disease Nervous Disorder Inherited Disorder Cancert Exposed mm ii 29 14.22 11 5.39 21 10.29 16 7.84 18 8.82 34 16.67 22 10.78 63 25.98 ; Not Exposed : In=16J) \ ' vi X i ; 19 11.6 6 120 12.27 ! 20 12.27 ! * 9 5.52 V 22 13.50 : 31 19.02 ! :i; 13 7.98 | 1,36 22.09 64 31.37 | ' si 19.02 73 35.78 59 28.92 ! 1 62 38.04 . :j39 23.93 26 12.75 ; ,\1 21 12.88 48 23.53 \ 35 21.47 13 6- r \ '!t 9 5.52 30 14.7.1,/ 10 !1 28 .*!* 7 17.18 4.29 71 34 ' 1 45 27.78 * Includes Parents and Siblings of Subjects t Nnf ovnncpH nrnun hac naif!? rpnll/lnn frfl this O U G S t l o n '.. Probability V N.S. 0.03 N.S. N.S. N.S. N.S. N.S. N.*5. ' 0.0097 N.S. N.S. N.S. N.S. N.S. N.S. N.S. N.S. Exdbsure-* ln5>) L I' 7 13.73 3 '5`.88 7 13.53 3 5.88 3 .5.88 12 23.53 4 7,84 14" 27.45 4* 13 . 25.49 . 19 37.25 14 2 ^ 4 5 9 17.65- : 10 19.61 5 9.80 9 17.65 . 2 3.92 19 37.25 237781 table b HISTORY OF MEDICAL PROBLEMS: ' i \" History of I 111 H :\* 'V i1 Chloracne* Acne Vulgaris^ Folliculitis Skin Cancer Chronic Obstructive Pulmonary Disease (COPD) Hypertension. , , Arteriosclerosis Angina Coronary Artery Disease Cerebrovascular Accident (CVA) Upper G1 Ulcer^ Bladder Cancer Prostatic Disease Kidney Stones 1 p< 0.0001 2 pcO.OOl . Exposed i TnaWT i 176 ,06.27 ; 20' 9.80 ; 1 1 5(0.49 ! ' 8 ' 3.92 ; ` 3: 1 1.47 i! 60 , 0 'tfidO ; 3 1*47 i ,<,,/.'tAtli' 6' fcS&O 2.94 f ; 42 20 .59 ; 2 . v98 '*? 24 11.76 ' : i* >i1 ii .) 1< >j. ii i;t ! i .t\ 1Jt< J j I i No ttfExposed p-1631 l' * 0 0.00 48. 29.45 2 1.23 4 2.45 2 1.23 36 22.09 1 0.61 2 1.23 10 6.13 2 i.23 9 5.52 1 0.61 6 3.68 16 9.82 V Questionable Exposure l*| l X* 0 0.00 10 19.61. 0 0.00 1 1.96 1 1.96 A* 10 0 2 6 1 6 19.61 0.00* 3.9 11.76 1.96 11.76 2 3.92 2 3.92 5 9.80 * p values for comparing age-adjusted (on basis of age< 5 0 v's. age50) reported occurrence in exposed vs. not exposed i- i 237752  TABLE 9 HISTORY OF MEDICAL PROBLEMS VS. . EXPOSURE STATUS "V * BY A>GE *\ <'. S g `> * ' History of Exposed t n=51 ) I* Age < 50 J Not Exposed {n=100j ; * Chloracne* Acne Vulgaris23 Foil1culitls Skin Cancer Chronic Obstructive Pulmonary Disease (COPD) Hypertension*4 Arteriosclerosis Angina Coronary Artery Disease**3 Cerebrovascular Accident (CVA) Upper GI Ulcer Bladder Cancer Prostatic Disease Kidney Stones 39 9 0 0 0 9 0 2 1 0 7 0 3 7 76.47 17.65 0.00 0.00 0.00 o; 42 2 1 0; ft.oo 42.00 j2.00 .oo |o.00 17.65 14 14.00 0.00 0 : !o.oo 3.92 1 1 96 1tv. v )$, 0.00 13.73 0.00 i jl.00 0 ; jo.oo 01 .00 l * 1 5 , 15.00 0 ;o.oo 5.88 3 3.00 13.73 7 7.00 I'l .r*... .j ' Exposed " IS-TSSl I Age % SO Not Exi^osed (n*6; .' % 1 137 89.54 0 0.00 7.19 11 1 0.65 9.52 6 0 0.00 8 5.23 3 4.76 3 1.96 2 3.17 51 33.33 0 0.00 1 0.65 19 12.42 6 3.92 22 34.92 1 1.59 1 1.59 10 15.87 2 3.17 35 2 2 . 8 8 2 1.31 5 3.27 17 1 1 . 1 1 4 6.35 1 1.59 3 4.76 9 14.29 ^ 0.01 < p < 0.05 In exposed young v$.pj|d i'hU j . 3 : p < 0.0001 In not exposed young vs. old 2 0.05 < p < 0.10 In exposed young vs. old i 4 0.001 < p < 0.01 In not exposed young vs. old 237783 TABLE.10 j HISTO*R'Y OF MEDI,CAL PjROBLEMS . Si- .. HISTORY AND/OR PRESENCE OF CHLORACNE History of Acne Vulgaris* Folliculitis Skin Cancer Chronic Obstructive Pulmonary Disease (COPD) Hypertension2 Arteriosclerosis Angina Coronary Artery Disease Cerebrovascular Accident (CVA) Upper G1 Ulcer2 Bladder Cancer Prostatic Disease Kidney Stones 1 p< 0.0001 0.001 < p < 0 . 01 ` History and/or Presence ; (n=176): # *: i" i / 13 *1 1 7.39! ! 0.57 7 : 3.98 3 ; 1.70 55 31.25 0 0.00 3 . l! 1.70 19 .10.00 6 3.4)1 38 ;21.5j9 2 UM 7 1<i3.9*8 19 410.8t0 I!. *!!i. 'j 1i, :'j1*' i. 1 * : f)t 1 . 1i' ! ,f!; -- \ . * No History or Presence ------- [ T f ----- . vi 1 65 26.86 2 0.83 6 2.48 . ; 3 mr 1.24 51 21.07 1 0.41 4 1.6S 17 7.02 3 1.24 19 7.85 3 1.24 9 3.72 r . *W 26 10.74 , i i t V ;i 2377E4 -44- 2377S5 TABLE 1. HISTORY OF MEDICAL PROBLEMS vs. HISTORY AND/OR PRESENCE OF CHLORACNE BY AGE ` A --- Ocn .aiV History of $ Acne Vulgaris* Folliculitis Skin Cancer Chronic Obstructive Pulmonary Disease (COPO) Hypertension^ Arteriosclerosis Angina Coronary Artery D i s e a s e d Cerebrovascular Accident (CVA) Upper GI Ulcer Bladder Cancer Prostatic Disease Kidney Stones _______ Age Chloracne Ever (h*39) # , :% Chloracne : Never =i3or ft* % 5 12\B2 40 36.92 0 o.oo , ;2 1.54 0 0.00 .. 1 ii 0.77 0 0.00 ; 0 0.00 7 /I7.95 o .. 2 513 1 2.56 * 0 0.00 ; 2 5.13, . 5 iz:.fi2; 16.*12.31 $ .jO-OO ;1 ',v;0;77 ! 0.00 ' !0 0.00 1 7.69 0 0.00 'A 3.08 i z 9.23 * O.OOOl < p < 0.001 0.05 < p < 0.10 p < 0.0001 In chloracne never, young vs. old i . Inch-lorvacn*e '(ever,Itiyoung vs. old In chloracne never, young vs. old ' Chloracne Ever (n =137) #% Aqe l 50 : Chlorine ; Nevi' i (n*' t2:).y/ 8 5.84 1 0.73 7 5.11 3 2.19 17 . 15.1 0 0.00 5 4.46 3 2.68 48 35.04 0 0.00 1 0.73 18 13.14 6 4.38 32 23.36 2 1.46 5 3.65 14 10.22 35 31.25 1 0.89 3 2.68 17 15.18 3 2 .68.'. 9 8.08 ' 3 2.68 5 4.46 14 12.50 a : ^ o 3:1 V*''* 2377S6 ' 1 History of TABLE.12 I HISTORY OF MEDICAL PROBLEMS VSi ^ CHLORACNE STATUS IN EXPOSED ONLY I ! History Only ) 'i ; r 69) *: ; '* ; Current (n=107) v 1 %. Acne Vulgaris Folliculitis Skin Cancer iIn Chronic Obstructive Pulmonary Disease (COPD) Hypertension Arteriosclerosis Angina Coronary Artery Disease Cerebrovascular Accident (CVA) Upper G1 Ulcer Bladder Cancer Prostatic Disease ' Kidney Stones 8.70 0 0.00 4 5.80 * { 2 2.90 | < i, i `J 21 30.43 0 0.00 j 1 1.45 j 1 5 7.25 j 2 2.90 j 11 15.94 i 0 o.qo ' ; 2 2.9 | 10 14.49 ] , * <Jp, iI* 1 1 .3 1 '* 0 2 14 >4 27 2 .5 9 6.54 0.93 2.80 0.93 31.78 0.00 1.87 13.08 3.74 25.23 1.87. 4.67* 8.41 -it****!***,,, 7 , re.oQ 0 . b.oo 1. 3.57 * 0 0.00 5 17.86 0 0.00 0 0.00 1 3..57 0 0.00 4 14.29 0 p.oo 1 3.57 5 *17.86 '* I -46- 237787 TABLE!13 I HISTORY OF MEDICAL PROBLEMS vs. CHLORACNE STATUS IN EXPOSED ONLY BY AGE ; History of Acne Vulgaris Folliculitis Skin Cancer Chronic Obstructive Pul- monary Disease (CPD) Hypertension* Arteriosclerosis Angina? Coronary Artery Disease? Cerebrovascular Accident (CVA) Upper GI Ulcer Bladder Cancer Prostatic Disease Kidney Stones History Only wr X Age < 50 i Current / (11=23)' i . i . vT; 3 18.75 2 8.70 0 0.00 & 0.00 0 0.00 0 o.oo; 0 0.00 , 0 .00, ; No History (n=12 J I %. .i; 33.33 b 0.00 0 0.00 b 0.00 6 1 6.25 26,09 2 , 16.67 ! 0 0.00 0 0 .00' 9 0.00 0 0.00 * i . 8,70 0.00 r 1 6.25. 0 0 .00. : 0.00 0 0.00 * * . o.oo: 0 0.00 , , k1 6.25 ' 5 21.74 8.33 1 0 0.00 0 0.00 0 ' 0>00 0 0.00 2 8.70 !i 8.33. 2 12.50 3 13.04! 2 16.67 1 0.01 < p<0.05 2 0.05* p<0.10 For history only, young vs. old For current, young vs. old \ .A i: V History Only (n=53) X A q & > 50 v, Current (n=84j" # X' ... i # .f T ho / History (n=16j |X 3 5.66 5 5.95 3 18.75 0 0.00 1 i.isi 0 * ;o.oo 4 7.55 3. 3.57 * 1 6.25 2 3.77 1 1.19 0 0.00 20 37.74 28 33.33 0 0.00 o' 0.00 1 1.89 0 0.00 4 7.55 14 16.67 2 3.77 4 4.76 3 18.75 0 0.00 0 0.00 1 6.25 0 0.00 10 18.87 22 26.19 - 3 18.75 P 0.00 2 2.38 0 0.00 2 3.77 3 3.57 0 0.00 8 15.09 6 7.14 3 18.75 F in d in g C h lo ra c n e 1 Acne V u lg a ris 2 A c tln lq E la s to s ls 3 A c tin ic K erato ses^ B asal C e ll E p ith e lio m a S ta s is D e rm a titis P e y ro n ie 's D ise a se ^ F o llic u litis H irs u tis m "N e rv o u s n e s s V A n x Ie ty D e p re s s io n D ecreased L ib id o ( H / O r Im p o te n c e NOS ( H / 0 ) CJ 3 cn. CD TABLE i 1!4 1i Significant Clinical Findings In Relation to Exposure 1[xposed \ 1[ 'jo } 1 ,' % i ; "ii. 107 52 U S 4 1 . 9 6 !: 1* i ' ?' 5882 Vj J; * * 1 . 1Q .29 , 14 6 .8 6 j 2 : ' i j o l 'dS j i 9 A, 1 i i : 5 ,3 9 ; M & ^ V 6 .1 8 " 39 19.12 17 ' 8 . 3 3 :?i Vr , !l. 4- N ot Exposed ( n * l 163) 1% d 19 49 9. 7 5 0 14 3 19 * 0 .0 0 1 1 .6 6 3 0 .0 6 5 .52 4 .2 9 3 .0 7 O'. 00 8 .5 9 1 .8 4 1 1 .6 6 11 '4 6 .7 5 2 .4 5 *-^ ^ * * * * ^ 1 v . , 'VV **' E x p o s u re ln - 5 1 ) f1 0 0 .0 0 2 3 .9 2 20 39.22 5 9 .8 0 0 0 .0 0 0 0 .0 0 1 V .96 3 S .8 8 1 1 .9 6 . 6 11.76 9 17.65 2 3 .9 2 ) TABLE 14 CONTINUED - Key to p Valued..., ^ 1 p < 0.0001' 2 0.01< p < 0.05 3 0.0001 < p < 0.001 * 0.05 < p < 0.10 Age-adjusted comparison of exposed to not exposed Age-adjusted comparison of exposed to not exposed Age-adjusted comparison of exposed to not exposed Age-adjusted comparison of exposed to not exposed -4 8 - 23779 t \ I Finding * Chloracne Acne Vulgaris* Actinic Elastosls3 *^ c Actinic KeratosesJ Basal Cell Epithelioma5 Stasis Dermatitis5 Peyronie's Disease Folliculitis1,6 Hirsutism "NervousnessM/Anx1ety Depression Decreased Libido (H/0)^# Impotence NOS (H/0)5,5 j TABLE 15 Significant Clinical Findings In Relation to Exposure Status by Age .'J.I1tt- * Age < 60 .. Exposed : Not Exposed ( n = 5 1 ) '* # %' *r| i; (N*100) % 23 . 4 5 110; 4 7.84 !o 18 0.00 18.00 19 37.25 18 18.00 2 3 . 9 2 ' ;f 1 1.00 1 1.96 1 1.96 o j - " o.oo 7 ** v 1 3 . 7 3 10 f0 j' o ; 13 0.00 , 0.00 0.00 1 3 .bo 2 .3.92 1 1.00 4 '$J% i . 8 4 r > 4 .7.84 : 15 15.00 T V 1 1.00 r i.96 0 0.00 ______ Age >. 50 , E x p o s e d N o t Exposed (n=l 53) (n'=63) #% % 84 0 101 19 13 1 3 2 9 29 54.90 0.00 1 66.01 12.42 8.50 0.65 1.96 1.31 5.88 18.95 * .0 1 31 8 7 5 0 1 2 . ,*: 0.00 1.59 49.21 12.70 11.11 7.94 0.00 1.59 3.17 '6.35 35 22.88 16 10.46 10 * 15.87 4 6.35 iV i f ! r~ > 237780 TABLE 15'CONTMIEOKey to*p Values 1 .0.001 < p < 0 . 0 1 2 0.001 < p < 0.01 ^ 3 0.0001 <p <0.001 4 p< 0.0001 5 0.001 < p < 0.01 0.01 < p< 0.05 7 0.0001<p <0.001 6 0.05 <p< 0,10 ' 9 0.01 <p< 0.05 In exposed, young vs. old In not exposed, young vs. old In exposed, young vs. old In not exposed, young vs. old In not exposed, young vs. old In not exposed, young vs. old- In not exposed, young vs. old . In exposed", youngvvs. *- In exposed, young vs. old 2377 isSO- a TABLE 1& Significant Clinical Findings In Relation to Chloracne Status in Exposed Only Finding * Acne Vulgaris ^ Actinic Elastosls ^ ^ Actinic Keratoses Basal Cell Epithelioma Stasis Dermatitis Peyronie's Disease Folliculitis Hirsutism2 "Nervousness"/Anx1ety Depression Decreased Libido (H/0) Impotence, NOS (H/0) 1 0.01 < p < 0.05 2 0.001 < p < 0.01 History Only ~ ( n = 6 9 ) --I% jr 1 32 8 4 1 2 6 i* 0 9 1.45 46.38 11.59 5.80 1.45 2.90 8.70 0.00 13.04 13 18.84 6 8.70 1 ; 1 In age < 50 In age 50 Current (n=107) i% 0 80 10 9 .. i ,1 1 11 20 0.00 74.77 9.35 8.41 0.93 0.93 0.93 10.28 18.69 20 18.69 10 9.35 No History W" # "i 3 10.71 8 28.57 3 10.71 1 3.57 0 0.00 0 0.00 2 7.14 0 0.00 4 14.29 6 21.43 1 3.57 Finding Acne Vulgaris Actinic Elastosls ^ Actinic Keratoses Basal Cell Epithelioma Stasis Dermatitis Peyronie's Disease Folliculitis 3 Hirsutism "Nervousness'VAnxIety Depression Decreased Libido (H/0)^ 2 Impotence, NOS (H/0) 1 0.01 < p < 0.05 2 0.05 < p < 0.10 TABLE 17 Significant Clinical Findings In Relation to Chloracne Status 1n Exposed Only by Age v History only n*lb fX Aqe < 50 f Ho Current History n*7j n*lZ 1 .%- f X Aqe 2. 50 History only_____ n=53 Current n*`84 IX IX 1 6.25 0 0.00 3 25.00 0 0.00 0 0.00 5 31.25 13 S6.2S 1 8.33 0 0.00 1 X 4.35 1 8.33 . 1 6.25 0 o.oo 0 0.00 27 50.94 67 79.76 8 15.09 9 10.71 3 5.66 9 10.71 1 6.25 0 *./ o:oo 0 0.00 0 0.00 0 ,,0.00 o! 0.00 0 0.00 1 1.19 2 3.77 1 1.19 4 25.00 0 0.00 1 * 4.35 2 8.70 2, 16.67 0 0.00 2 3.77 0 0.00 0 0.00 9 10.71 1 6.25 2 12.50 0 0.00 13.04. ' 0 0.00 i 2 8.70 0 0.00 1 4.35 0 0.00 8 15.09 17 20.24 11 20.75 18 21.43 6 11.32 9 10.71 \ s No History n-lb* fX 0 0.00 7 43.75 2 12.50 1 6.25 0 0.00 0 0.00 0 0.00 0 . 0.00 4 25.00 6 37.50 1 6.25 In current chloracne, young vs. old In no history chloracne, young vs. old t 3 0.01 < p < 0.05 4 0.01 < p < 0.05 In history only chloracne, young vs. old In no history chlorache, young vs. old i -itjf*-*V TABLE 18 DISTRIBUTION AND SEVERITY OF CHLORACNE Distribution of Chloracne and Chloracne Scars' 'S . irf*Exposed Group by Site (ns204) Site Face * Neck Extremities Trunk l\4.* Genitals ^ Face (only) Neck (only) Face and Neck (only) Face and Trunk (Only) - Face* Trunk and. Genitals (only) Extremities (only) Trunk (only) " "" -- Genitals (only.) S c a n (only) * Residual Chloracne #% 98 48.04 17 8.33 4 1.96 18 8.82 15 7.35 67 32.84 3 1.47 8 3.92 5 2.45 2 0.98 0 0.00 -4 1.96 1 0.49 8 3.92 Chloracne Scars #% 13 6.37 9 4.41 0 0.00 6 2.94 0 0.00 10 4.90 5 2.45 1 0.49 2 .98 0 0.00 0 0.00 1 0.49 .0 0,00 0. 0.00 *' -s AJ vtm i% 67 62.62 Severity of Chloracne (n=107) Moderate #% 36 33.96 Severe % 3.77 53- 237734  TABLE 19 ;, f lSTRJgyLTIGM AND-SEVERNY OF ACTINIC ELASTOSJS Distribution of Actinic Elastpsis by Site i SITE _ r' Face Neck ^ Arms and Hands Trunk Face (only) Neck (only) Face and Neck (only) Face and Trunk (only) Arms and Hands (only) Trunk (only) - EXPOSED #Trv=204) % 113 55.39 57 27.94 9 4.41 1 0.49 62 30.39 7 3.43 , 42 20.59 1 0.49 0 0.00 0 0.00 NOT EXPOSED (n=l63) #X 46 28.22 21 12.88 4 2.45 .0 0.00 27 16.56 3 1.84 .15 9.20 0 0.00 0 0.00 0 0.00 u--n QUESTIONABLE EXPOSURE #(n 18 35.29 8 15.69 3 5.88 0 o.oo 11 21.57 2 3.92 4 7.84 0 0.00 0 0.00 0 0.00 Severity of Actinic Elastosis (n=189) MILD #% 67 35.44 MODERATE #% 81 43.09 SEVERE #% 41 21.81 237795 -54- 'sfe-- V TABtE* 20 :s- ^ SEVERIT. OF CHLORACNE ITI PRESENCE * ' oK a c t i n i c ELASTOSIS Actinic Elastosis and Chloracne Chioracne Only TOTAi - . MILD #% 44 55.00 MODERATE #% 33 41.25 23 85.18 3 11.11 67* ' ,.....3.6 SEVERE #X 3 3.75 TOTAL 80 1 : 3.70 4 7. 27 107 . . 0.01 < p <0.05 237726 .55- TABLE 21. * - : ;$EV|R1TY F ACTIfHC ELA5T0SIS IN PRESENCE - l OF CHLORACHE - Actinic Elastosis and Chioracne Actinic Elastosis Only TOTAL . MILD #% 18 22.50 MODERATE #X 35 43.75 SEVERE #% 27 33.75 TOTAL 80 49 44.95 67 46 42.20 81 14 12.84' 109 41 189 p <0.005 2377S7 /. fg TABLE'22 \ * * * , BLOOD PRESSURE . (Nomal <140/90 for Subjects 59, <160/95 for Subjects *60) Exposure Category Systol ic Normal Abnormal Diastol-ic Normal Abnormal EXPOSED (n=202) #. % 145 71,78 QUESTIONABLY EXPOSED (n=49) # Aet 41 83.67 NOT EXPOSED (n=l61) # % 122 75.78 57 28.22 8 16.33 39 24.22 153 75.74 39 79.59 132 81.99 49 24.26 10 20.41 29 18.01 Systolic. Pressure:" p =" ns for comparison of exposed to not exposed. Diastolic Pressure: p = ns for comparison of exposed^to not exposed. 237728 -57- TABLE 23 EXPOSURE vs SERUM LIP 10$ Serum Lipid Cholesterol [Triglycerides kOL, estimated HDL Exposed n fl(%Abnormal) 200 15( 7.50) 200 29(14.50) 196 15( 7.65) 200 19( 9.50) Not Exposed n #(%Abnormal) 63 17(10.43) i. '< I' f:! 163 31,(19.0)2) 159 10( 6.29) 163 17(10.43) .!: 10 CO f.0 CD 'At!. Probability N.S. N.S. N.S. N.S. i* V Questionable Exposure n #(%AbnormaT) 49 13(26.53) 49 11(22.45) \ 47 9(19.15) 49 4( 8.16) Serum Lipid Smoking Status T A B L E '24 EXPOSURE '' VS.;t *SERUM LIP IDS BY .SMOKING STATUS* V-'* r t ( 1/ Exposed n #(%)Abnprmal V .r * :i! iNot Exposed. n: l(X)Abnormal *../ - 3 * * ^ .--*-, V Probability `1 i ;. '{ ' W '* '1 ./* , Questionable / Exposure n #(%)Abnormal Cholesterol \Ai1* ni> Triglycerides Nevfcr Former Present 45 3 6.67) 83 7 8.43) 71 51 7.04) Never Former Present 45 8(17.78) 83 11(13.25) 71 10(14.08) \ 4?; 5(10.64) 72i 6( 8.33) 1 44f 6(13.64) j; , , ' 47; 8(17.02) 72 14 19.44 44 9(20.45) # N.S. N.S. N.S. N.S. N.S. N.S. 17 3(17.65) 21 . 7(33.33) 11 3(27.27) 17 3(17.65) 21 7(33.33) 11 1( 9.09) LDL, estimated _ Never Former Present 43 3 ( 6.98) 83 6 7.23] 69 6 ( 8.70) 46 1 70 43 3( 6.52) 1( 1.43) 6(13.95) N.S. N.S. N.S. 17 3(17.65) . 19 4(21.05) 11 2(18.18) i HDL *! Never 45 4(8.89] 47' 5(10.64) N.S. 17 3(17.65) Former 83 8 ( 9.64 72 5( 6.94) N.S. 21 1( 4.76) Nr ^ J CD - Present 71 7 s - s e i : .? 7(15.91) i N.S. 11 0( 0.00) * 4*1' P O * When pack years were cons Idered there were no significant.differences in all of the lipid parameters. . , !I .1 D1Jf> .SeruMm" Lirp.i'jd:. *. Cholesterol Triglycerides LDLt estimated* HDL2 1 p < 0.015 2 p < 0.05 00 a .J t ! }` ' :f . 't TABLE 25 * CHLORACNE STATUS IN EXPOSE!) ONLY vs. 'i1 ' SERUM LIPIDS .. , History Only n #( i) Abnormal v i 67 8(11.94) , 67 5( 7.46). . 66 10(15.15) 67 2( 2.99)v ^ " .. -i . ' Current 0 #(%)Abnorma1 i * i 105t 5( 4.76) i 105 20(19.05) 1 `-V : 103 3( 2.91) i 105 15(14.29) ! i T"t 'iJ': ii \ t 'k 1 ih '-St, i( % * 'I \ l \ \ l No History , n 0t%)Abnonnal 28 2( 7.14) 28 4(14.29) 27 2( 7.41) . 28 ' 2( 7.14) * Serum Lipid Smoking Status Cholesterol Never Former Present Triglyceride Never Former * Present LDL* estimated Never Former Present * HDL Never Former * Present 10 to 1 0.05 < p < 0.10 *1 CD 2 O 0.001 < p < 0.01 * * r'" i ** t ;f 1 I 1; TABLE 26 CHCORACNE STATUS IN EXPOSED .ONLY *i : * J VS .'! SERUM LIPIDS :BY SMOKING STATUS < History Only n #(X)Abnormal * ft ) j j ,i I .` ,i i ! *n T * Current TillCIAbnormal 18 . 5 2(11,11) 31 3( 9.68) 18 3(16.67) 18 3(16.67) 31 1( 3.23) 18 1( 5.56) 16 42 47 fi ! 'i ' 15 42 ! 4,i7 0( 0.00). 3( 7.14) 2( 4.26). 4 2(12.50) 9(21.43) 9(19.15) 18 2(11.11) ' |5 31 3( 9.68) h 17 5(29.41) . 4T6 18 0( 0.00) i = : i. j 16 31 1( 3.23) . 42 18 1( 6.66) : 47 0( 0.00) 2( 4.76) 1( 2.17) 2(12.50) 7(16.67) 6(12.77) i, `. %\ ' vNo History n 11 1( 9.09) 10 1 (1 0 .0 0 ) 6 0( 0.00) 11 3(27.27) 10 1(10.0 0 ) 6 0( 0. 00) 10 1( 10.00) 10 1( 10.00) 6 0( 0. 00) 11 2(18.18) 10 0{ 0.00) 6 Oj/OvOO) :f t ! i Pulmonary , `"'Function '1'lparameter > iII | ' 11!! rOskj ''1 ''FEVj/F'VC MHEFR ||i| i' **n.il**l i' .i> I.. .1 HIM 1 O.M'i, * ( n 11> * f| 1 ii i.I TABLE 27 I EXPOSURE >* vs. j . PULMONARY TEST FINDINGS Exposed IK v. (n=20Jf | (IC)Abnormal ' fl- !i *''i;i} . t!' Not Exposed (%)Abnormal 32 15.76 HI II I It 351 I. . 117..Z4 ,, 32., 15.76 II 1 J i 23.151 - 4/ '* . 1 I1 '1 1 ( 11 1t -\ 1 11 II 8 \. 16 4.94 6.79 4.94 11.11 I'l il i* n ( <i l( !I 1I `I .V .1 1 Probability v Vi *J jV ,-. V Questionable Exposure -- i # ;;(%.^Abnormal 0.0001 5 9.80 0.0038 11 21.57 0.0013 3 5.88 0.0038 13 25 49 Pulmonary Function Parameter FEV,i. -- FVC FEV,/FVC MMEFR N CO J cn o ** * j Smoking Status Never Former Present Never Former Present Never Former Present Never Former Present TABLE 281 EXPOSURE ys* ` PULMONARY TEST FINDINGS BY SMOKING STATUS '! Exposed n #(%)Abnormal 45 3( 6.67) 84 10(11.90) > 73 19(26.03) 45 3(6.67) 84 14(16.67) 73 18(24,66) 45 3( 6.67) 84 11(13.10 73 18(24.66) 45 4( 8.89) 84 17(20.24 73 26(35.62) ! i'. n i 47 71 44 '] '*; j*,f Nt Exposed , i{%)Abnormal i ; 3( 6.38) 3( 4.23) 2( 4.55). 47 6(12.77) 71 4( 5.63) 44 1( 2.27) ' 47 71 i 44 ;i j 47 ') 71 ! 44 j 1( 2.13) 4,( 5.63). 3( 6.B2)? 3( 6.58) 10(14.08) 5(11.36) ! Probability N.S. N.S. 0.0044 N.S. 0.0551 0.0015 N.S. N.S. 0.0229 N.S. N.S. 0.0059 j * > i .*****1^ 1 l- ""_ ,1 \?. i. Questionable / Exposure. ./ n #(%)Ab normal 18 0( 0.00) 21 3(14.29) 12 * .92W*.(16.67) 18 2(11.11) 21 6(28.57) 12 3(25.00). 18 0( 0.00). 21 2( 9.52) 12 1( 8.33) 18 1{ 5.56) 21 6(28.57) 12 6(50.00) Finding Normal ECG Negative ECG* Sinus Bradycardia Sinus Tachycardia PVC'S PAC's Atrial Fibrillation Intraventricular Conduction Defect Left Anterior Hemiblock 1 st Degree AV Block Right Bundle Branch Block, complete Left Bundle Branch Block, complete Old Anterior Myocardial Infarct Old Inferior Myocardial Infarct True Posterior Myocardial Infarct Digitalis Effect * Normal or not significant findings TABLE, 29j EXPOSUREI VS. >') ECG FINDINGS Exposed wm j 69 33.82 *80 39.22 * 5.39 % 0.98 17 8-33 5 2.45 1 0.49 5 2.45 11 5.39 4 1.96 J 6 2.94: ' ? 0.98 j 3 1,47 4 7 3.fr)3 -;']j1 ` v i ` 0.98 ! 2 0.98 *r- , v' Not Exposed ( ri* 163) .f , % 71 4 3 .5 6 43 26.38 5 3.07 1 0.61 4 2.45 4 2.45 1 0.61 1 0.61 4 , 2.45 2 1.23 2 1.23 1 0.61 2 1.23 2 1.23 1 0.61 1 ' 0.61 / . .-rV: Questionable Exposure l=tfc ii LT 14 15 . 2 1 0 1 0 1 2 1 0 0 2 3 0 0 27.45 29.41 3.92 1.96 0.00 1.96 0.00 1.96 3.92 1.96 0.00 0.00 3.92 5.88 0.00 0.00 ~n i Finding Left Ventricular Hypertrophy Right Ventricular Hypertrophy Left Atrial Hypertrophy > Non-specific ST-T Wave Changes n Low Voltage QRS ' Abnormal P Wave Left Axis Deviation i TABLE 29 CONTINUED EXPOSURE vs. ; ECG FINDINGS .Exposed wry 1% T~ 6 ^ / 2.94 i : 0.49 K X : 0.98 4 1 * 4.<1 # r 0*49 ? i .t 4.41 0 .4 9 ; j;: ji J; j! , j Not Exposed (n-A&J) % 5 3:07 0 0.00 0 0.00 5 3.07 0 0.00 4 2.45 2 1.23 Questionable Exposure n=! i ' %" 1 1.96 0 0.00 0 0.00 2 3.92 0 0.00 1 1.96 0 0.00 237806 ik>r I /i Finding Normal ECG * iNegative ECG* 2,1 /Sinus Bradycardia ^Sinus Tachycardia PVC's 3 PAC`s 4 Artlal Fibrillation Intraventricular Conduction Defect Left Anterior Hemfblock 1st Degree AV Block Right Bundle Branch Block complete Left Bundle Branch Block complete Old Anterior Myocardial Infarct ^ Old Inferior Myocardial Infarct j True Posterior Myocardial Infarct J Digitalis Effect * Normal or not significant findings r t a b l e 30 - 1V; EXPOSURE, *'{ vs* j; ECG FINDINGS BYrAGE , IV ;r ?/ __________ Age `'i 50__________ Exposed j 'fnS17 j I % ! 22, 43.14 38 74.51 1 J ; 96 1 1.96 1 "i: 1.96 m Not Exposed ,j j ~ f n * IO r " V. # % i! ;t 57 57.00 fif5 88 88.00 r2 2.00 j0 0.00 ;lf 1 1.00 0 0.00 0 0.00 io ; o 0.00 0.00 1 1.96 ] o 0.00 3 5.88 11:! z 2 3.92 0 2.00 0.00 1 1.96 J.C 0 0.00 0.00 j : 1 LOO 0 0.00 o 0.00 0 o.qo .i> 0 'o.oq 1 , 1.96 ! 0 .0.00 0 .0.00 ! , 0 0.00 ' f. \ Exposed l Aqe >, 50 -Not Exposed ' .(n=(53K., 47 30.72 86 56.21 10 6.54 1 0.65 16 10.46 14 22.22 32 50.79 '3 4.76 1 1.59 3 4.76 5 . 3.27 1 0.65 4. 2.61 8 5.23 2 1.31 5 3.27 2 1.31 3 1.96 7 4.58 1 0.65 2 1.31 4 6.35 1 1.59 1 , 1.59 2 3.17 2 3,17 2 3.17 0 0.00 2 . 3.17 2 3.17 1 1.59 * 1 i,59,' * 1 \ vr I Finding jf Left Ventricular Hypertrophy * Right Ventricular Hypertrophy Left Atrial Hypertrophy Non-Specific ST-T Wave Changes Low Voltage QRS Abnormal P Wave ^ Left Axis Deviation p < 0.0001 2 0.01 < p < 0.05 I, J 0.05 < p < 0.10 l 4 0.01 < p < 0.05 5 TABLE 30 CONTINUED . ' M* I ]?. . e x p o s u r*e vI1;1'1' vs. j! ECG FINDINGS B{V AGE T Exposed '1nilT AJ * ! l| ' !' : r t, :.lf, Not Exposed ~(Plotn~ X o o.oo V* 1 1.00 o o.oo ;< p 0.00 1 1.96 i , 0 0.00 l i.96 p 2 JU 0 o.oo S; 0 2.00 0.00 2 3.92 i 0 0.00 0 0.00 t i 1.00 -4-%-'i. *'*tf Age *50 Exposed {n^l"5TJ Not Expoled . (n=63)-- L* t 6 3.92 m\\. * ' i 6.35 1 0.65 0 0.00 1 0.65 0 0.00 8 5.23 3 `4;76 1 0.65 7 4.58 , .,-t>: " 0.00 V> ' 4 6.35 1 0.65 1 1.59 For not expojjpd, young vs. old for exposed .'-Vy'oung vs. old for exposedv|young vs. old } Foir not exposed, young vs. old _J i Finding Normal Chest X-Ray Evidence Old Granulomatous Disease I ' Evidence Arteriosclerosis Evidence Degenerative Bone Disease g Cardiomegaly i Mass Chronic Obstructive Pulmonary Disease (CPD) Aortic Aneurysm Pulmonary Hypertension Blunted Costophrenic Angle Acute Parenchymal Disease Elevated Hemi-diaphragms Pleural Thickening Parenchymal Scarring Possible Mass Aortic Valve Disease Trauma 237809 ; .1 ' t" TABL^ai .1 EXPOSURE ,, t vs!-.I CHESTfX-RAV FINDINGS t*. Exposed J {n=204i i # X ?: 94 46.08 i 60 2?;41; 23 15 7.35 j ; 8 3.92] 5. ,2.45; 9 14.41; ' l ;0.49: 0 ,o.ooi 20 9.8tfi 0 ;o.oo; 5- 2.45 15 ;7.35 13 6.31 6 i 2.94 0 f 0.00 2 0.98. Not Exposed (H=a53) : - X n o ,67.48 23 14.11 12 V 7.36 4 2.45 2 1.23 3 1.84 3 1.84 0 ' 0.00 1 0.61 9 5.52 1 0.61 1 .0.61 5 3.07 9 5.52 .* 7 4.29 1 0.61 3 1.04 I 'i. Questionable Exposure (n=3l)7 >X 36 70.59 9 17.65 1 2 3.92 0 0.00 1 1.96 1 1.96 1 1.96 0 0.00 2 3.92 0 0.00 2 3.92 1 1.96 0 0.00 2 3.92 0 0.00 0 0.00 TABLE.'32 EXPOSURE ^,v * Finding Normal Chest X-Ray 1*2 a4 t Evidence, Old Granulomatous B (f Disease Evidence, Arteriosclerosis ^ lIO Evidence, Degenerative Bone Disease * Cardiomegaly Mass Chronic Obstructive Pulmonary Disease (COPD) Aortic Aneurysm Pulmonary Hypertension Blunted Costophrenic Angle Acute Parenchymal Disease Elevated Hemi-diaphragms 5 Pleural Thickening Parenchymal Scarring * Zl Possible Mass F*. Aortic Valve Disease ' Trauma ^* CHEST X-RAY FIiNDINGS BY AGE [ i' Exposed (n=bTT ** 42 82.35 Age < 5 0I 5 . Not Ex posed ! (n-Tibaj r t>f - fiv fe'2 B2.00 Age >, 50 Exposed (n=153) % Not Exposed (n*63 . `1 V It j TM% * 52 33.99 28 44.44* 1 6 11.76* 9 '| 9.00 54 35.29 14 22.22 * 0 0.00 0 0.00 0 0.00 1 1.96 2 3.92 0 0.00 0 o.oo 3 5.88 0 0.00 0 0.00 0 0.00 1 1.96 0 0.00 0 0.00 0 0.00 0 j 0.00 o !1i 0.00 0 .J( 0.00 2 '1.2.00 0 ? 0.00 0 'r: 0.00 0 ] 0.0f0'V* 3 i 3.00 iO -i 0.00 !o ; 0.00 2 2.00 2 1 2.00 3 J 3.00 1. ;j 1.00 1 Ll.oo i 23 15.03 15 9.80 ' 8 5.23 4 2.61 7 4.58 1 0.65 0 0.00 17 11.11 0 0.00 5 3.27 15 9.80 12 7.84 6 3.92 0 0.00 2 1.31 12 * 19.05 4 6.35 2 3.17 1 1.59 3 4.76 0 0.00 1 1.59 6 9.52 1 1.59 1 1.59. 3 4.76 7 11.11 4 6.35* 0 QiOO k Jt 2 .,, 3 . 1 7 jt ;ig' ^ . * TABLE 3Z CONTINUED V * \ 't . ' - \ . Key to p Values. < 5&'vs. 50 Years 't ^ - p <0.0001 p <0.0001 *' 0.001 < p < 0.01 0.01 < p < 0.05 0.01 <p< 0.05 For exposed, young vs. old For not exposed, young vs. old For exposed, young vs. old For not exposed, .young ys. old Tor exposed, young vs. old 237S11 237812 BLOOD Calcium Phosphorus BUN , Creatinine 7* Uric Acid Glucose (CS) Total Protein Albumin Globulin Albumin/Globulln ratio Total Bilirubin* Direct Bilirubin ^ Transaminase, SGO Transaminase, SGP Alkaline Phosphatase LOH Iron j TABLE.S3 '* CL I(ti*tAL *LAtBlORA1T\ORY FINDINGS * e x p o sf.1u r e Sit a t u s Vi ; 4< 't Exposed |i), Not Exposed n TfSAbnormal) 'j'!**' s I(^Abnormal) * 197 0(0.00) I 161 190 3(1.58) 154 197 V 8(4.06) 161 196 ,f 2(1.02) r i6o 197 12(6.09) 1 160 190 14(7.37) i 154 197 1(0.51) j 160 197 0(0.00) 160 197 0(0.00) 197 2(1.02) 160 I 161 197 2(1.02) V 161 197 . 9(4.57) i 161 190 8(4.21) 190 8(4.21) ii 154 i `154 197 4(2.03) i ; i 161 190 12(6.32) . \ ' l5^ 197 2(1.02) . !# 16.1 A 0(.'0.00) 4( 2.60) 5( 3.11) 1( 0.63) 7( 4.38) 5( 3.25) 1( 0.63) 0( 0.00) 0( 0.00) 0( 0.00) 7( 4.35) 10(11.18) 3( 1.95) 5( 3.25) ^ 3( 1.86) 4( 2.60) 2( 1.24) Questionable . Exposure n V /f(%Abnormal) 49 2( 4.08) 46 2( 4.35) 49 1( 2.04) 49 3( 6.12) . 49 2( 4.08) ' 47 3(' 6.38) 49 1 0( O jOO) 49 0( 0.00) 49 0( O.OOl' 49 0( -9.VOO) 48 - 1( 2.08) 49 6(12.24) 47 1( 2.13) 46 ' 1( 2.17) . 49 1( 2.04) 47 0( 0.00) 48 0( O-.PO) Sodium 1 Potassium ; Chloride t G-glutamyl transpeptidase i Thyroxine binding globulins a CBC WBC RC HGB HCT KCHC3 HCH MCV 1 Differential N Poly CO Lymph O) Mono M CJ Eos Baso TADLE 33 CONTINUED CLINICAL LABORATORY FINDINGS _ ' ' `X EXPOSRE STATUS ; Exposed I Not Exposed n $(%Abnormal) ! .i. n f(%Abnormal) 197 2( 1.02) 190 2( 1.05) 197 1( Ov 51) 197 8(4.06) 198 51(25.76) 197 7( 3.55) 197 0( 0.00) 197 15( 7.61) 197 25(12.69) 197 67(34.01) 197 23(11.68) 197 79(40.10) l * 1 161 \ 154 hi, 160 161 ?1 : - 161 ! i r -i *4* * 1+ f :i 160 'i ti 160 1jl i >. ' :r ' 's'i 160 160 160 ) ' l' '-1 . I 160 160 . 2( 1.24) 0(0.00) 3(1.88) 6( 3.73) 53(32.92) 7( 4.38) 1( 0.63) 10( 6.25) 17(10.63) 30(18.75) 13( 8.13) '49(30.63) QU!xposu?e^^ ^ n HXAbnormal^ 4 9 0( 0.00) >1 47 i( `:i3) 49 0( o.oo) " 49 6(12.24)/ ' 49 16(32.65) *: 49 49 . 49 49 49 49 49 1( 2.04) 0( 0.00) 3( 6.12) 11(22.45) 14(28.57) 7(14.29). 20(40.82) '.i ( 197 4( 2.03) ! jir 160 3( 1.80) 197 5( 2.54) 197 1(0.51) 197 3( 1.52) 160 ' 2( 1.25) j 1; 159 2( 1.26) U f 160 3( 1.88) 197 0( 0.00) j. .j ' 160 1( 0.63) p CM 49 49 o( q.oo). ' . 49 of.o)- 49 0( 0.00) 49 0( 0.00) Urinalysis Acetone ; Albumin Bacteria Blood Clii Epithelial Cells 1 Glucose White Blood Cells { ! TABLE 33 CO^TIMUED CLINI/CAL LABORAt;ORY FINDINGS EXPOSURE STATUS Exposed "jj i i' Not Exposed n "(XPosItlve) : n t #l%Positive) \ ' 196 0( 0,00) 196 2('l,02) 196 11( 561) 196 2( i;02) 196 ; 68(3V,69) 196 2( 1.02) 196 3( 1.53) j i l" .! ! ;1 ;| ! .i 159 159 159 159 159 159 159 1( 0.63) 0( 0.00) 13( 8.18) 2(; 1.26) 54(27.67) 2( 1.26) 4( 2.52) . * 0.05 <p< 0.10 for exposed vs. not exposed oc 0.01 <p<0.05 for exposed vs. not exposed ^ 0.001< p <0.01 for exposed vs. not exposed : i > ji \\ .i i* i ' ( ) u on Questi onobi Exposure n 0(%Po.si tive) V .j 49 ' 0( 0.00) ... 49 0( 0.00) 49 0( 0.00) 49 0( 0.00) 49 12(24.39) ; 49 0( 0.00) 49 2( 4.08) V\ XI i f- ' BLOOD JCalcium Phosphorus BUN Creatinine Uric Acid* Glucose (CS) Total Protein Albumin Globulin Albumin/Globultn ratio Total Bilirubin Direct Bilirubin Transaminase, SCO Transaminase, SGP Alkaline Phosphatase LDH Iron Sodium (J ! TABiLE 34 \ J V CLINICAL LABORATORY FINDINGS i IVS. < CHLORACNE STATU1S' If) EXPOSED. ONLY . , History Only , \ .'ii" '* ,'jJt, Current_ n #l%Abnormal) V n "7C?Ab"normal) i J t1, 69 0( 0.00} 69 0( 0.00) .69 , 4( 5.80) 69 1( 1.45) 69 K 1.45V 66 6( 9.09) 69 H 1.45) .69 0( 0.00) 69 0( 0.00) 69 0( 0.00). 69 2( 2.90) 69 4( 5.80) 66 5 ( ^ 5 8 ) , 66 5( 7.50) 69 . 66 ; 69 I 1( 1.45) 3( 4.55) 0( 0.00) 69 0( 0.00)' 102 0( 0.00) ..-J 98 1( 1.02) 102 4( 3.92) ioi 1( 0.99) w 7( 6.86) ;98 7( 7.14) | 1!02 : 0( 0.00) i 1i02 ' 0( 0.00) 102 0( 0.00) i02 2( 1.96) 102 0( 0.00) 102 51 4.90) :<93. 2( 2.04) | j 90 2{ 2.04) | , 102 3( 2.94) ] 98 8( 8.16) 102 2( 1.96) !102 2(1.96) -- . /V'., 1 No History i f ( t Abnormal) 4m .# ** 9' 26 0( 0.00) 26 2{ 7.69) 26 0( 0.00) 26 0( 0.00) . 26 4(15.38) 26 U 3.85) 26 0( 0.00). 26 0( 0.00) , . , 26 0( 0.00) ... ; ; 26 0(0.00) 26 0{ 0.00) . 26 0( 0.00) 26 1 (. 3.85) 26 1( 3.85) 26 0( 0.00) . 26 1( 3.8S)' - 26 o(o.oo). , 26 0( 0.00) 3 .3M.O 4'' .i.'TW `V-tf ' ` mv,c ' -; - y :1**"/'*' ./.a . , tri* r ;, TABLE 34 -;Vt< -C"LI.N.IC..-A>-L-LVBOiJ.' - li. '|sV.f Potassium Chloride G-glutamyl transpeptidase CHLOMCNE STATUS 'W X P O S D ONLY' i I :y!tji.v t -t- vM-if'*' *. ' 1i a -, r' '* 'f v3*'*/*^' f`S/1' i', J !,v--v r .ij:; - -..*iM.1'l^i; j! rv * ' 5' HlstoryOnlyfift Current: ,t o.otf)A . n; {, 66 ' ^ If( i Abnormal 1( l . & y y );. `i|wirV,|.1rJi ;'y-J'*,-|9!f.8,n** nnr%Abnormal ) '' -f 1 0( 0. 00) 69 b ( *- | y 1 1(0.90) 69 2( 2.90) ' I!'.;;, 5( 4.90) Thyroxine binding globulins CBC 69 16(23.19) '-I 'r. . ,:| u - ' j'-.i i-i `J,r ' ! t\' '' . J, ' 1 27(26.47) UBC RBC H6B HCT MCHC MCH MCV Differential Poly Lymph Mono Eos Baso 69 . K 1.45) j , ' 69 0( 0.00) , i j`iii 69 . ' * 1->:"1=.- 69 10( 14'.49)y . 69 30(43:48) . ' w ! *! t 69 6(8.70)' j i!ioi A . '"69 27(39.13) , j 1 JJ 'il*lfl t*\PV(J t 'w ,' ii-i :: i 6( 5.94') 0( 0. 00) 7( 6*93) 12(11.80) 32(31.66) 14(13.06) 45(44.55) 69 ; 2( 2.90) 69 4( 5.00) 69 0(0.00) i . n; - 699 \ ? J1(( " ; V ^ ^o'. I \ i'#) * 2( >.90) !7 ;i1i-tiQ) . Cioi; 1{ 0.99) 1( 0.99)- * :i 'r 1 : 1 ; . ' .> i'jlj>j4.:i`jtpF--O ^ yk. n t - p . 9 9 ) M i 101> /^ 0 (.0.001 .*y * : ' V f f P ,;$'', .i-jfciV. :*!> .'*'-S*K>3 " .>r..ti.v .sS `M S 1* l ", *j*> -a,n,. !P> to A. - sA : , vi Wo "TBmilliiai ;y - ^ k26 1('3.T85) > r ^ m 26 oi o:oo) 26 1 ( 385F- ;" >-{3 27 0(29.63) *, J;tj Vi1, -A ... {'j- ili.)1 `, 1 '* i * 1 27 o( pip) ; 3 - 27 0(0100) :\b` *'*<% 27 3(lljll) I'f'il;'vj)'f? v 27 3(u|ll). J* 27 5 (18*.52) ^ -p'\ iSi ` 27 3(11.11) .- yiU ' ^, > .W* -.1 27 3(25-93) i \ , .*v, ;*?: ! ' ' H vs 2? 0( .00) :r-`, ; l ' 27 0( 0.00) 27 0(0.00); , - r..^ .>'j#. 11 27 1 ( > 7 0 ) .Li* 27 O(lp.OO) H'SrJi '.*" . > . ;.tliilfjK \ TABLE 34 CONTINUED CLINICAL LABORATORY FINDINGS CHLORACNE STATUS IN EXPOSED ONLY !i r Urinalysis j 1i r! History Only n f(tfPositive) Current n dispositive) t Acetone 68 0( 0.00) ! \ 101 Albumin O"IV)j Bacteria Blood 68 0( 0.00) 68 51 7.35) 68 1(1.47) ' -i 101 j 101 | i'; 101 Epithelial Cells 68 26(38.24) j ; loi Glucose 68 2( 2.94) 1 i 101 White Blood Cells 68 1{ 1.47) j 101 5 *' 1 ' i< * 0.01< p<0.05 for history only vs . current vs. no history 0( 0.00) 1( 0.99) 2( 1.98) 1( 0.99) 36(35.64) 0( 0.00) 2( 1.98) __ * 1 V No History , n l(iPositfve) *** 27 0( 0.00) 27 l l ^ ;7p) 27 4(14.81) 27 0(0.00) 27 6(22.22 V / 27 0( 0.00) 27 0( 0.00) iO cj a '* ' < " V .* ' f* '0''-' *- `||' \ .S. j* '5* \\* EXPOSED (n=l97) QUESTIONABLY EXPOSED (n=49) NOT EXPOSED (n=161) ;TABLE 35 . URINE COPROPORPHYRIA . ^' * - V ' , ' ' Low Normal ; '. High - (<30 mcg/1) (30-240 ificg/V). r (>240 mcg/1) * 1 * # 3! # % *> 6 34>5% 185 *93.91 6 3.05 "0 0.00 48 97.96 _ 1 2.04 1 0.62 154 95.65 6 3.73 p ns for comparison of exposed to not exposed. . URINE UROPORPHYRINS EXPOSED (n=196) QUESTIONABLY EXPOSED (n=49) NOT EXPOSED (n=161) Low (<15 mcg/1 ) m 8 % 4.08 2 4.08 6 3.73 Normal High (15-60'ricg/)* "" ~(>60 mcg/lT # %# X 140 71.43 .48 24.49 42 * 85.71. 5 10.20 122 75.78 33 20.50 p * ns for comparison of exposed to not exposed. * The values for coproporphyrin and uroporphyrin were from a single void sampl -77- 237619 NERVE PARAMETER Ulnar Nerve Conduction Velocity Latency * Amplitude Ratio Peroneal Nerve Conduction Velocity Latency Amplitude Ratio Sural Nerve Conduction Velocity Latency Ampi1tude ThBLE 136 ` MEAN NERVE CONDUCTION PARAMETER VALUES FOR THE THREE EXPOSURE CATEGORIES (Not Adjusted-for Age) EXPOSED ' x + 5 (n) `1i S' 1 , 1' 56*90 +_ 7.43 0 ) 1 NOT EXPOSED X + S (n) i; 3 i '! 60.07 + 8.44 (10) 3.30 + .1.08 (9) j 3.07 + 0 . 6 8 ( 9) 1.04 + 0 . 1 8 41.08 + 5.63 4.07 + 1 . 2 1 (9) .'j I* I" ` .i i ' ,1 (T60) 1 i 'i (160) j 0.91 + 0,19 43.45 + 5 . 9 6 4.12 + 1.04 (10) (134) (134) 0.86 + 0,23 (160) ; 0.92 +_ 0.16 (134) QUESTIONABLE EXPOSURE x + 5 (n) v '* * ** . ' % 52.12 + 1 . 5 3 (2) 2.55 + 0.1 (2) ; 1.01 + 0 . 1 2 (2) 42.55 + 5.16 (42) . 4.31f+ *1,18 (42) 0.93 + 0.16 (42) , *41 41.27 + 6.50 (50) J 4.84 + 0 . 5 9 oso) r it 1.91 + 1.07 (150) ? 42.42 + 4.97 (128) 4.62 + 0 . 6 8 (128) 2.51 +1.31 (128) 40.90 + 4.41 (41) 4.63 + 0.59 (41) . 2.07 + 1.06 (41) r .1: !*f. V\ t NERVE Ulnar J i * tIo Peroneal PARAMETER Nerve Conduction Velocity Latency- Amplitude Ratio Nerve Conduction Velocity Latency Amplitude Ratio Sural Nerve Conduction Velocity Latency Amplitude r fiABLE ;37 KEAN NERVE CONDUCTION PARAMETER VALUES FOR THE TWO EXPOSURE CATEGORIES (Adjustedfor Age) EXPOSED > > ..;; x + s (nj ' 1 i- ; -Sr .'1 -0.14 i 0 . 9 2 ;: (9)1i olzp 1.18; (9)1 *,! 0.35 i 0.95* (9)( ii * 1 " ). 1 f -0.06 + 0.9 0 6 0 ) - 0 . 0 9 + 1 . 0 5 (16if0) -0.10 + 1.15 (160) l. 't |1. ' 0.06 + 1.17 (15) 0 J 1 + 0.9^ (jj0) 0.07 + 0 . 9 3 (ISO) * NOT EXPOSED x + s (n) 0.26 + 1.13 do) 0.13 + 0.94 (9) 0.35 + 1.05 (10) v 0.04 + 1.07 (134) 0.06 + 0.92 (134) 0.05 + 0.83 (134) -0.04 + 0 . 8 5 (128) -0.06 + 1 . 0 7 (128) 0.09 + 1.09 (128) *!,- )** I'. '? i 1 p. . '-. * .%! ns ii;` ; 1 , !* ns ns v--* ns ns ns ns ns ; ns TABLE 38 , EXPOSURE VS. OUT-OF-RANGE NERVE CONDUCTION PAtR,AMETER VALUES (Not Adjusted for Age) NERVE PARAMETER Ulnar NCV Latency Peroneal NCV Latency Sural NCV EXPOSED (n)_ _ Low Normal (%) w a (9) i 7' (li.ii) (77.78) (9) 0 6 (66.67) (160) (160) 119 (74.38) 98 (61.25) 41 (25.63) SIO I .88) (150) l 105 35 (70.00) (23.33) High (sq .i (11.11) ' 3 iti (33.33) ' t!' i 0 !i ! 11 1: (6.83) j 1 ; 10: ( (6.67) 'NOT EXPOSED (n) Low Normal __ High (%) (%) v (*) (10) 1 i (10.00) (9) 0 7 (70.00) 7 (77.78) 2 (20.00) 2 (22.22) (134) ' 65 (48.51) (134) 78 (5.21) 68 (50.75) 49 (36.57) 1 (0.75) 7 (5.22) (128) 76 44 (59,38) (34.38) 8 (6.25) v'f*s ns 0.0001 ns A\S. 1 Exposed group has a higher percentage with low Peroneal Nerve Conduction Velocity than the Not Exposed group. This may, however, be an artifact of age, since' NCV slows with age and the Exposed group Is older than'the Not Exposed group. # Z28CZ Pregnancies TA 39 i ;;i EXPOSURE 9 ' VS*]' REPRODUCTIV^F INOINGS i ,'! <i it Exposed (ri^TMT Hot Exposed (n-lb5) 1p i Probability 663 Mi 42y; ! ' > i Live Births f Dead 1n 4 Weeks i Rate (/1000 live births) 00 573 5 ' , 16 27.92 : 3731 i, !t ; 18.767 i* r i.s . # Miscarriages Rate (/1000 pregnancies) 72 108.597 Children with Birth Defects* Rate (/1000 live births) .V 1 Stillbirths Rate (/10G0 Fetuses to term) 23 40.14Q 14 23.850 51 ,118.881 ij i 20 1 53.61`J 1 !i 13.228 i ; i- N.S. * * N.S. . .. S*:- N.S. * These are further detailed I n the Summary of Birth Defects which follow 'i JiU i I.-J f M! Questionably ExpbSisrt^l'^'; I P --- > 139 128 3 23.4375 7 50.360 46.875 . 4 30.303 1 EWSURETATEGORY': * TAB. AO SUMMARY OF BIRTH DEFECTS AS ; REPORTED .ir b:*|jly' SUBJECTt*S ' EXPOSED 1 : ( QUESTIONABLY EXPOSED /* 1 4U-r * NOT EXPOSEfT'" -.-'TOTAL- PREGNANCY BEFORE OR AFTER SUBJECTS' EXPOSURE: LIKELY BIRTH DEFECTS: POSSIBLE BIRTH DEFECTS:9 (Insufficient data to determine severity or cause) Before 8a I After 6b ' .5 Unable *to Determine : ii . , :ii i. 1 t , oC i z1 !! *''i ;1 -f 1 ;) roo. Before 1 Unable to After Determine 3e -- V 9* 32 9 17 UNLIKELY BIRTH DEFECTS:h t CD iIS> 1 1. i 1 1m m }( i 1 ---- 69 -*i Subjects' descriptions of Birth Defects were reviewed with faculty at the Cincinnati Center for Developmental Disorders and categorized as Likely Birth Defects Possible Birth Defects and Unlikely Birth Defects. ^Includes: ^Includes: c lnc1udes: d Includes: includes: ^Includes: ^Includes: ^Includes: Congenital cyanotic cardiac anomaly hydrocpele hernia undescended testicle angioma congenital short leg, club foot, anomaly of sternum. Pectus carlnatum, obstructive defects pf urinary tract, Down's Syndrome* congenital hydrocoele* spina bifida. Unspecified cardiac anomaly, pyloric stenosis. Hydrocephalus, congenital anomaly of eye. j Ventricular-septal defect, atrial-septal defect, club foot. Spina bifida, club foot, Down's Syndrome, obstructive .defects of urinary tract, hernia, antral web, congenital anomalies of eye, absence of fingers, cystic hygroma, polycystic kidney disease (auto Vsomal dominant with positive family history), congenital dislocation of hips (two of two children in one family; one male, one female). Epilepsy, retardation, slow learner, deafness, incomplete ossification of vertebra. Muscle problems, one eye larger than other,^tongue-tied, speech defect, punctured lungs, inherited arthritis, blood problem, floating kidney, j ' 237823 ..If1 J ACKNOWLEDGEMENT The study which is reported here received support from: THE MONSANTO COMPANY THE NATIONAL INSTITUTE OF ENVIRONMENTAL HEALTH SCIENCES, U.S. PUBLIC HEALTH SERVICE THE INSTITUTE OF.ENVIRONMENTAL HEALTH, UNIVERSITY 'OF CINCINNATI "" 237S24 \ UNIVERSITY of CINCINNATI DEPARTMENT OF' ENVIRONMiAL HEALTH * 2,4,5-T WORKERS' STUDY INFORMED CONSENT STATEMENT Before agreeing to^gtoticipate in this study, it is important that you understand1;th%oi#pose*'of the examination, its benefits and possible, discomforts.~ The objective of this thorough examination is to determine the health status of the employees and former employees of the Monsanto Industrial Chemical Company in Nitro, West Virginia and to identify health problems which may be related to the occupational environment. The examination will focus on possible health effects over a long period of time of chemicals associated with the making of 2,4,5-T such as dioxin. If __________________________________________________, agree to* participate in the medical research study conducted by the University of Cincinnati under the direction of Dr. Raymond Ri -Suskind- I understand that-'l^will be interviewed and asked a series of questions about myself and the health of my family. In addition to a physical examination I shall permit chest X-rays and an EKG to be done; shall.permit pulmonary function a n d j nerve conduction tests to be performed; shall have blood drawn and furnish urine for laboratory examination. If indicated by the physician's examination, skin biopsies and skin scrapings for laboratory diagnosis will 1>e done.-;--The~d iscomfort o f t h e biopsy will *be the same, as.witha ,,skin..v;; injection. The University of Cincinnati Medical Center follows*a policy of making all decisions concerning compensation and medical treatment for injuries occurring during or caused by participation in biomedical or behavioral research on an individual basis. If I believe I have been injured as a result of research, I will contact Dr. Suskind. Any question*--that I may have concerning this study will be answered by Dr. Raymond R. SusMnd, phone (513) 872-5701, or his associates. I am free to withdraw frofethis study at any ti/ne. i Subject __ Investigator Witness ____ Date 237825 ^HEALTH STATUS RESEAP.CH PROGRAM mm** ' UNIVERSITY O'F'CINCINNATI LOYES OF THE MONSANTO INDUSTRIAL CHEMICAL COMPANY QUESTIONNAIRE Name; Last First Address :__________ Street City State 'Telephone Number:________ / area code Social Security Number: / / .. 15) Present Status^ / / Active (1) (check one) / , _ j Ref1red (2) l __/ Terminated(3) '6-10) Current Department: '*%> i n - 1 4 ) Job Title: -f| [15-17) Clock Number: / / / / Middle Apt. # Zip Code -- #/ / / / / / #/ / / / 237S26 -19) Interviewer Number: b f t t ^ ) 2. Sex: / / male (3") / / female (2) ) 3. Race: /__ / White, not of Hispanic Origin (l) L J B1 ack, not.of Hispanic Origin (2) l __ / Hispanic (3) /__ f American Indian or Alaskan Native (4) l __ f Asian or Pacific Islander (5) / 7 Other______________________ ` (6) ) 4. `Marital Status: /__/ single (1) /__/ married (2) /__/ divorced (3) ----- r ....... / / separ.ated,,C4).V_.,,/^widowed.I 5 L ___ ____ _________________________ s , 5. Numaer of Marriages: /__/ >-37) 6. Education: HighesCjpade completed I I I * Elementary = 0 1 - 0 8 !_ j Secondary = 0 9 - 1 2 - College = 13 (1 year) 14 (2 years) J1 15 (3 years) ! 16 (4 years) j 17 (5 years) i 18 (6 years | 19 (7 or more years) 237g;p, A r rX T 'D l'A ^ B. OCCUPATIQfJAMlSTORY ' ' - . . I 3) 1. Ar you nowje gyed # Monsanto, Nitro? /__/ yes (1) f ~ < 'o f ,ret irement / / / t i l I J mo. day yr. of termination / W / I I I I I I mo. day yr. ; /__/"no (2) I 1-54) i 5-59) If presently~mployed at Monsanto What is your job title: Name of department:____ What is your main job or work:(describe^ code/ / / / code/ / / / / / (60-65) When did you start this job:* / / / / / / I I I 9-80)/ 0 / 1 / mo. day yr. 3. Beginning with your first job at Monsanto, give the following information: Department ) 1. s': - Job Title 7 / f 7 7 / it / i i / / / / / / i i / ./ 39-55) 3.j. Dates (from/to) roo/Jir/mo/yr What you did (work description) 7 7 7-/7" 'T` ^-- ..... -- --- - -- -- /_ / /-/_ / / * ///-// / //////i / // i'v. I 80) 0/ 2/ / / / / / 4/ i i7 7 \ i!-21) 51,. L J_ / / / / 1 1 / / -38) 6.* / / _z-/ / / 7 7 /-/ / / ///-// / i / / / / / / I -L.J -- -55) 7.* /- / /-/ / / lilil lili -80) 0 / 3 / If terminated or retired, list same information above. 237628 C21). > Department */ 8* / I '/i *.', Job Title " ^^ fc/^ /7 / / / ; Dates . . (from/to} - mo/yr/mo/yr / / /-/ 7 \ \ ' * *- / Wha.t you did(work'description) 2-38) 9. V' 7 / / -/ / / '___ >' ' % / / % - . r*rv / / '"S3) 10. // / / /-/ / / _ / / / / / / /. / / 72) 11. r9-f#8Q)// /# / / / / t i l l 1) 12. l ./ / / / IllI - :<-38) 13. / / / / /-/ 1 / / A /-/ J ! . --1 / / J-l / / / / / / fill / 19-53) 14. / / /-/ / / z_ / / --- // -- II I f - -- - - / -- 72) 15." / / /-7 " / / ..................... ... z_ / / / l i l t / -60) // 237629 APPENDIX' i 4. If retired' inated, what work have you done since leaving Monsanto? ...zal i- ~ Employ %* K / f^ Dates (from/to) mo/yr/mo/yr / - ... /- Work description / / '_______ S..C. ///// //'/// -401 / / - / - _ _ i t i l i 41-52) / -* ______ / / / //// 1-64) / // ///// :"-76) 3-S0)/0/4/ lb-16) / / // / ____ / ititi lini 7-28) . / / / Itili (29-40) / // Ititi 11-52) / / - ./ ititi ' 113-64) ------------------- ....../ L(6s -/6) 79-80)///" " " " / // Ititi / - . / ....'' '`T " ' 77 777 -- ; --... 5. Previous work history^ before Monsanto i Employer Job Title Dates (from/to) ^mo/yr/mo/yr / 7--2d) [29-40) // // HmCiM jp3-64) Rs5-76) ,79-80)/ 0 7 T 7 P-16) is) / / / / / / / / / / Work description s.x.c. / itili / Itili / ititi / ititi / fitti / ititi / itti! / ___ L L L . l . I 237830 Employer / ' Job TltH * 9o._4anl ------ ji ZI I 7-641' -- r-r-- **"*Ly>,,. / :y " 76) ^ V / . 9-80)/ / / 61 / " ' 7-26) /s Dates (from/to).\ mo/yr/mo/yr1 Work description _/ . *i V*. * / /. // // // // S.I.G. ///// . ///// tft.fi ///// tttft fitti 6- While working at Monsanto were you engaged in other employment? | a. mechanical work / / yes (1) i / no (2) 0) b. farming /__/ yes (1) / / no (2) _j c. other/__ / "yesflj /_____ / no(2) (describe)__________________________ ._______ *) . . -~I n previous-.ernployment.were-ypu expo s e d t o dus t , spi vents, pesticides, wel d inq or soldering fumes, fertilizer, weed 'kit 1ers, etc . / / y es (1 ) ' ' 7 / no (2 ) -,- - ifjyesr-specify ____ \ ... ...... 7...... - " ........... ~ 237C31 g. WORK ,HYGIENE AT MONSANTO ' 1-i*P '?42 ) l* Do otr.Sfcld ,you smoke at worksite? /__/ yes(1) __ / no(2) A ) 2. Do jSu c|Piid yo** eat at worksite? /__/ yes(l) /__/ no(2) ) or drjftik Beverages ^uch as- coffee or soft drinks at worksite? / / yes(I) / / r 3. Do you or d$d^yd?fwear any of the following roost of the time at work? .) /___ / yes(l) /__/ no(2) Short sleeves - V / / yes(l) /__/ no(2) Long sleeves 4) /___ / yes(l) /__/ no(2) Gloves If yes, on what job?_____________________________ What kind (cotton, rubber;, leather, plastic, lined, etc)? f) )) 1 ),. l) (43) 4) p'5) ^. 6) 17) i^S) i ~ /__/ yes(l) /__/ no(2) Protective sleeves If yes on what job?________________ _______ What kind (cotton, rubber, etc.)?______________________ __f yes{1) /__/ no(2) Apron If yes, on what job?_____________________________ v , What kind? . yes(!)_/, _no(2) Special Shoes or Boots If yes, do you or did you change out ci them before going home? /__/ yes 7 7 no' __/ yes(l) /__/ no(2) Respirator If yes, on what~job? ~ ..... ..... - : -- __( yes(l) /__/ no(2) Eye Protection If yes, on what job? ________________________. __/ yes(l) /__/ no(2j Mask * If yes, on what job?__________________________ . /__/ yes(l) /__f no(2) Protective clothing If yes, on what job?______._______________ _ _ What kind?_________ ;_____________________ ;______________________ ` v / / yesfl) /__/ nofi^Other (specify)________________________________________________ > If yes, on what job?_________ .____________________ 4. Do you or did you use a'barrier or protective creams at work? / / yes(l) / / n If yes, /__/ often(l) /__ / occasionally(2) /__/ seldom(3) If yes, what brand?__________________________ 5. Do you or did you change out of your work clothes regularly before going home? __/ yes(l) __/ no(2 ) 6. Do you or did you change out of your work shoes regularly before going home? / / yes(l) / / no(2) 237832 7_. Where ar^Q^iiias^tiut work clothes laundered? , t\ htaifl} . /__/ conmercial laund*y{2) /. / .company(3) Z) u S d i d you shower before going home? / / yes(l) / n_/ no(2 ) 3) 54} y or^di.d you use waterless hand cleaner? / / yesll) / , / no(2) 5) 10. Was soap siJpplrfSiff by the company? /__/ yes(l) / ,,/ no{2) What type?_________ Was soap supplied by self? /__/ yes(l) /__/ no(2) What type?_________________ 56) 11. Did you ever develop an illness which you believed to be related to your work at Monsanto? I __/ yes(l) /__/ no(2) If yes, describe briefly_______________________________ What job were you engaged in at the time? ,*7-61) Department Code / / i f f 2-651 Type of work Code / / 66-69) 1!9-ao)- / Date of onset / / / / / / mo*.... y iv... . I 237833 D. NUTRITION . 1. How many days a week.do-you eat; (fill in) : s) r t 1 s) -day.mal ?\_ lerving meal? g the evening or night? 2, Hov^orai^tim e s c e r .week do you eat the following? y v '' Heat aridiHeait^iSBstitutes (fill-in) 9) -.10) (ID 12) 13) (14) '15) 16) il7) '18) 19) .20) (2 1) 22) 23) (24) .-'25 1f 1 a. Bacon ______ b. Tongue______ _ c. Sausage _____ , d. Luncheon meat e. Hot dogs f . Liver-chicken 9- Liver-other -- h. Poultry _ ____ i. Salt pork J* Pork or ham.______ k. Bones, (neck or otner) 1. v Ilia Beef or veal n. Other meat _ 0. F i s h _____ _ P- Eggs .........qv.. Dri ed beans or pea di shes r. Peanut butter or nuts |>3 (27).. ,| - 3. r' j_i Do 3you use*any of the following? (circle) ... a. vitamin supplement . (1 ) b. mineral supplement (2 ) c. both vitamins and mi'neral supplements (3) d. none of.the above (4) j"i 4. How Fru ;[2B) 129) (30) (31) 132) a. b. c. da e. Other cooked vegetables ______ r ''(33) (34) (35) (36) '") wd) 33) (40) 5. How many times per week do you eat the following? . a. b. c. d. e. fa g. Wine h. Whiskey, vodka, rum, scotch, gin 237834 appendix'i- E. 0NSUMPTI0N ^- -- 1 ) 1. Do jfdu presentT^stnoke cigarettes? /__/ yes(l) /__/.no(2) (4<!.43) (44^45) If yes: 'ff^wfiat age did you start? I l l total years smoking? I l l packs smoked per day? /__/<!( 1) /__ /l-2(2) /__/2-3(3) / />3(4) 2, If you do not now^*smoke cigarettes, have you smoked them in the past? 147) (48-49) (50-51) (52) /__/ yes(l) /__/ no(2) If yes: at what age did you start? I l l total years smoked? I l l packs smoked a day? /__/<!(!) / /l-2(2) f _ j 2-3(3) /__/>3(4) 3. Have you smoked as many as 5 packs of cigarettes during your life? (53) L J yes(l) l _ l no(2) ___ __ II j 237835 F. 'ALCOHOt COMSUMPTfitt ' - , * " / av .` * ' * . \ . >4) 2. po|yQu g ^ ^ mtjjv'a1cohfolic beverages? / /yes(l) / no{2j ^ 1# n o M d you ever drink alcoholic beverages*? /__/.yes(l) /__/ na(2) $6-57) -ttololiper? you'when you gave up drinking? I l l 58-9) 2. HowVld were you^wfien you first started drinking? I l l - * fc* * ' ' :' 60) 3. About how often do you drink some kind of alcoholic beverage? (check one) /___/almost every day --^ (1) /___/three or four time aweek J (2) l ___/once or twice a week (3) /___ f once or twice a month (4) L J less, than once a month (5) When you drink beer, about how many cans or bottles of beer do you usually drink? ) 4_/0(l) /l--2(2) / /3-4(3) I /5-6(4) / _ / > 6(5) 5. When you drink wine, about how many glasses of wine do you usually drink? r ' ...... 1__70(1) 7 I I -2(2) - "7 " 7T-4(3) " / 75-6(4) / 7>6(5) ;' '-- *___6. When, you drink-highballs, mixed-drinks, or.other kinds, of-- liquor, about how. ipany drinks do you usually have? . 4_/0(l). _/l-2(2) / /3-4(3) _/5-6(4) / />6(5) 64J 7. Have your drinking habits changed over time? /__/ yes(l) /__/ no(2) -5S-P&) I* If. you reduced yoyr alcohol intake, indicate year? 19/ / / Vfhen you drank beerV about how many cans or bottles did you usually drink? 4 7 1 - 2 ( 1 ) /_73-4(2) ' /5-6(3) /_/>6(4) When-yon^rank wine, about how many glasses did you usually drink? fift). 4 7 1 - 2 (1 )- / 73- 4(2) / /5-6(3) ! _ b 6(4) ljj When you drank highballs, mixed drinks, or other kinds of liquor, how many *<yd you usually have? 4_/l-2(l) L /3--4 (2) /S'-6(3} / />6 (4) 237836 APPENDIX I G. '-FA*/MILY Have mthegjjjiQur. father; your mother, or any of your brothers or sisters . (inclwin^BIf-brothers and half-sisters) had any of the following problems? PROBLEM. CHECK A "YES" OR "-NO" RESPONSE.. IF "YES", CHECK "*THE'APPROPRIATE REtATIQNSHIP(S). IF'"YES" FOR A BROTHER OR SISTER, ASX: Howmanyof your brother(s) or sister(s) have (had) this problem? AND ENTER APPROPRIATE RESPONSE. HOW MANY SIBLINGS PROBLEM ________RESPONSE__________ RELATIONSHIP__________ HAVE (HAD) THIS PR03LEM (5) (6-9) [ 10- 11} 1. Asthma L J Y es / / no /__/ Father __/ Mother __/ Brother __/ Sister LJ LJ - t U ) 2. Hayfever .13-16) ,,. , p'p.prm_t_ ^ -18) `-- / / yes . . L J TM -- ..... /__/ Father __( Mother / / Brother / / Sister ...' L J .......... . . _ L J . ____ ___ (19) (20-23) (24-25) 3. Acne .(pimples) - (6) 4. Eczema (27-30) (31-32) L J yes /, / no* * L J yes L J m. (33) (34-37) (38-39) 5. Hives L J yes L J no / / Father /__f .Mother __/ Brother __/ Sister # __/ Father __f Mother __/ Brother __/ Sister LJ LJ , ,1- // LJ __/ Father __f Mother __/ Brother __/ Sister LJ LJ 237837 PROBLEM_________ RESPONSE . - RELATIONSHIP /__f Father . . l __ / Mother . / / Et.rother L _ J Sister' * (47) 7. Colitis 18-51) 152-53) yes l / no ,, / / Father' / Mother l _ J Brother / / Sister '54) 55-58) f59-60) 8. Heart attack or angina before age 60 /__/ yes /__/ no /__/ Father ^__/ Mother /__/ Brother /__/ Sister 61) 9. Heart attack L J yes (62-65) or angina after age 60 /__/ no 66-67).. .. * - --.. -- ---5.i.'' - ^ -7--- -- (68) 10. (69-72) (73-74) <79-801 /0/8/ High blood pressure (5) 11. (6-9) (10-11) Stroke :^/ / yes L J no. 7- / yes L J,TM " /__/ Father l __/ Mather l __f Brother / / Sister /__/ Father /__/ Mother / / Brother / / Sister /__/ Father /__/ Mother / / Brother ^__/ Sister (12) 12. (13-16) (17-18) High cholesterol, high L J yes i __/ no triglycerides. or high blood fat /__/ Father / / Mother /__/ Brother /, / Sister _ ......... . HOW MANY SIBLINGS HAVE' (HAD) THIS. PROBLEM `Y lf _J /__/ !_J // z_> z_/ 0 ... -..... .... ....... ' LJ LJ LJ U LJ LJ 237838 PROBLEM--- * RESPONSE' %* t. (26) 14. (27-30) (31-32) L i W disease _/* / yes (such / no cirrhosis, --- hepatitis, etc.) y RELATIONSHIP __/ Father __/ MotherL J Brother L J Sister 1 ' f Father l __/"pother __j Brother __1 Sister 1 HOW MANY SIBLINGS HAVE (HAD) THIS PROBLEM LJ U LJ _f (33) 15. (34-37) (3H-39) Nervous disorder or mental "j disorder /__1 yes ,, --' 1 no L__I Father __f Mother __1 Brother __/ Sister LJ // l40) - 16. (41-44) (45-46) Inherited disorder or disorders they were born with --- - /__f yes , L-- 1 no / / Father __/ Mother __/ Brother ___/ Sister- .. LJ L J -- - - (47) 17. Cancer" 7__1 yes __1 Father ..... - TYPE: _ / / (4-51) (52-53) LJ # __/ Mother __1 Brother 154-65) __/ Sister IF YES TO "CANCER", SPECIFY TYPE AND SITE: // LJ L // L /J f / / / /. - 0 1= lymphoma 02= hodgkin's disease, 03= leukemia W = throat 05= esophagus 06= stomach 07= rectum 08= bowel 09= kidney 0= brain 11= breast 12= cervix 13= uterus 14= lung 15= skin* 16= prostate 17= bone 18= other cancer (specify) (66-67) IS. How many brothers or half brothers do you or did you have? I l l \ (67-68) 19. How many sisters or half sisters do you or did you have? I l l (79-80) 70/9/ 237839. n rr - -4-- V H. --'PERSONAL MEDICAL HISTORY (5-3) ( 9-1 2 ) (13-16) (17-20) (21-24) (25-28) (29-32) (33-36) (37-40) (41-44) (45-48) (4^-52) (53-56) (67-60) (61-64) (65-68) (69-72) (73-76) (5-U) (SL-12) . '13-16) (17-20) (21-24) (25-28) (29-32) (33-35) (37-40) (41-44) 45-48) (49-52) ever had any. of the following? : If yes, in what year? was it confirmed or? CONFIRMED BY DOCTOR AREA OF 30DY (TYPE)' Y E $ [l)N C r(2 )Y E A E Acne (blackheads Ju.cysts)--- Tv Skin abscesses 2, Dermatitis......... *........3. 19/ t J 19/ i A 097/1r Liver disorder.... .......... 4. a* hepatitis.....^.....,a, 09/ / / 09/ / / b. cirrhosis............. b. 09/ / k c. enlarged 1iver........ c, .19/ / h . ^ d. other d. 0 . 9 / / / Muscle pains (area)..........5. Nerve injury.................6. _ 19/ _/ / _ .19/ / K ............Nervousness............. Stomach ulcer .....87,. - 1 9 / / A __ 557/1 Bowel trouble or colitis.... 9, 09/ / : Kidney trouble (type)..... .;1Q, a 9/ / a _ . Bladder trouble.............11Thyroid disease.............12. _ __ . 1 9 / / 09U A -- Other hormone problems..... 13, 1 19/ / r _ Bone problems (type, where) .14- ! 1 9 / / Arthritis (type)(79-8Q)/l/0/15. 1 9 / / /, Hypertension......... ........16, 09/ / r ~ i Heart attack ....... ."17; Angina........ ..../.. ......18, Bronchitis ..... ......19; Recurrent infections (type) .20. Emphysema......... ,1...____21, Bronchial Asthma/...___ ..y ;22, 19/` / 19/7 / 1 9 /-/-7 597 / 1 .09/ / \ r 0 .9 /.'/ h " .A . -, 'i -- a * . . : -^ 1 - * Pulmonary edema-___ > ..... .*..23. " 097/7 Pneumonia.............. 24, * . . 0 9 / 7 7 Pleurisy....................25, /il 9 / / / 1 * " \- Stroke......................26, 19/ / / 27. Have you ever beeru-told by a doctor that you had (or have) any type of cancer? (53) / _ / y e s ( l ) /__/ noC2) ) (54-55) If yes, what kind of cancer? Specify type: / / / / / / (56-57) 01s lymphoma 06= stomach 11= breast 02= hodgkin's disease 07= rectum 12= cervix 03= leukemia 08= bowel 13= uterus 04= throat 09= kidney 14= lung 05= esophagus 10= brain 15= skin .* 16= prostate 17= bone . 18= other cancer (specify) *n what year were you first told about this (these) condition(s)? 19/ / / 19/__L (60-61) r 237840 2) 28. H a v ^ y o u e v e r b e e ri'- ^ o s p ita liz e d ? i / y e s ( l) ^ ___/ n o ( 2 ) IF/YI _ [you h o s p ita liz e d ? In^hat^ear were you hospitalized? WhaVwas^the name of the hospital? W here is . t h e h o f p i t a l ( in w hat c i t y and s t a t e ) ? ` 3-64) 165-66) {67-68) ' S3-70) .-1-7?) - 4) 179-80)/ 1 / 1 / EFtafS" 19/ / / 19/ / / 19/ / / 19/ / / - 19/ / / ' " 19/ / / .............. .. -:- - ` ~- ------^ ---- 9/ 237841 nrrcnuAA * GASTROINTESTINAL,-(STOMACHS INTESTINES) ' _ 29; ' Ha|l youS^fr* llS^lnore than. 10 pounds without dieting / /yesfl) /__/ l) J f f c e s ^ f e u n t lost? / / ;/ lbs. over what time period? / ,/ /"weeks :l?) * ' If ^ s . ^ v e year(s): . 19/ J I 19/ / 7 19/ / / 19/ / / ;*- `y ) ' 30. Have you ever, losTyour appetite? /__/ yes(l) /__/ fto(2) - .22) _24j If yes, when did this happen? f t ] y mo. III yr. Ho w long did this condition last: I I I weeks i) 31. Have you ever had a peculiar taste in your mouth: /__/ yes{l) /__/ no(2) If yes, what kind of taste(specify)? ______________ ;________________ 5-33) If yes, give year(s): 19/ / / 19/ / / 19/ / / 19/ / / ;} 32. Have you experienced nausea frequently? /__/ yes(l) /__/ no(2) i-42) If yes, give year(s): 19/ / / 19/ / / 19/ / / 19/ / / 3} 33. Have.you ever had abdominal pains: ^__/ yes(l) // no(2) _ _ 1-- - "If yesv'indicate location (check only-one of the .fol lowing) :. ______ _ 4)------ / / diffused) / / epigastric(2) / / periumbilical(3) / / other(4) i) If yes, is/was the pain related to meals? /__f yes(l) /__/ no(2) .5-53) If yes, give year(s): 1$/ / / 19/ I I 19/ / / 19/ / / 34. Have you ever experienced episodes of crampy, abdominal pain associated with >?) constipation, lasting several days? // yes(l) /__I no(2) J5) ;6-63) If yes, have their.3e.,, been more than: /__/ 2 such incidents(l) /__f 5 incidents(2) If yes, give year(s): 19 / \ / / 19/ / / 19/ / / 19/ / /v - NEUROLOGICAL^, * - *) 35. Do you often have headaches: /__/ yes(l) /__/ no(2) 55) i.lf yes how often? /__/ daily(l) /__/ weekly(2) /__/ less frequently than weeklyf 9-80)/1/2/?*? ^ 6 . Have you ever had any of the following conditions? WHEN? 5-8) Sleeplessness current / / yes(l) / / no(2) past / / yes(l) / / no(2) 19/ / 1 M2) Nightmares, current / / yes{l) / / no(2) past / / yes(l) / / no(2) 19/ / / _ 16) Muscle pain current / / yes{l) / / no(2) past / / yes(l) / / no(2) 19/ / / 17-20) Joint pain current /__/ y e s d ) /__/ no(2) past / / yes(l.) _ / no(2) 19/ / / 237842 APPENDI* i 121*24) ' Muscle weakness % in limbs ^ ^ ^ v current / ./ yes(l) /__/ no(2) -28} Paresthesia^ current /__f yes(l}-/__/ no(2) (29-32) D i z m n e s 1 current /__/ yes(l) /__/ no(2) (33-36) Depr^sil|? . current / / yes(l) / / no(2) Hemorjlrpoor*, or change in... (37-40)' memory ' current /__/ yes(l) / / no(2) (41-44) Always tired, general fatigue current / / yes(l) /__/ no(2) (45-48) Nervousness current /__/ yes(l) /__/ no(2) (49-52) Sleepiness current /__/ yes(l) /__/ no(2) past / /yes(l) / / no(2) 19/ past.2__/ yestl)/. / no(.2) 19/ past / / yes(l) /; / no(2) 19/ past /:-;/ yes(l) /.' / no(2) 19/ * . past /___ /yestl) /__/ no(2) 19/ past /___ /yes(l) /__/ no(2) 19/ past / /yes(l) /__/ no(2J 19/ past /___ /yes(l) /__/ no(2) 19/ // // // // // // // // SEXUAL HISTORY (53) 37. Have you noticed any change in your sexual life? /___/ yes(l) /_/ noU) (54-59) If yes, give year(s): 19/ / / 19/ / / 19/ / / If yes, what was the change? f60-62) ": Decreased sexual-desire? ^/- / yes(1 nc(2)1f yes,..when?- 1 9/ /.../__ (63-65) Increjtsed sexual desire? /__ / yes(l) / / nc(2 JUf yes, when? 19/ / / ( 66- 68) Decreased ability to achieve & maintain erection? /__/ yes(l) /__/ no(2) If yes, when? 19/ / / (69-71) Increased ability to achieve & maintain erection? /__/ yes(l') / / no{2)\ * If yes, when? 19/ / / aw(79-80) M rf'L T iU iA 1 5-'!' -14). ],- REPRODUCTIVE HISTOR>v- How m&rtf ti^|niave^8ff been marriedT /__/__/ Time(s) Datelsiof gfrjagetjs): 19/ / t ' 19/ / 7 19/ / / 19/ / / ASK FOR^fcL wivES'(HUSSAuOS): tRecord answers in table below) V . .. ] 'Do you have `(have you had) trouble having a family with your wife (husband) despite a desire to have one? 2, How many children? born alive, do you have or have you had with your (present, previous, last previous, etc.) wife (husband)? 3, How many children, born alive, died within 4 weeks of birth? 4, How many miscarriages or spontaneous abortions did your wife (did you) have? 5, How many stillbirths did your wife (did you) have? How many children, born alive, were born with a birth defect? mc_ QUESTION_______ PRESENT SPOUSE PREVIOUS SPOUSE LAST PREVIOUS SPOUSE 1 Problems having ........ a.family / " / yes / / no ( 1 ) .. ~ ( 2 ) / -- / yes / . (1) . -- / no (2)-. / / yes / / no ( 1 ) . ,, ~ . ( 2 ) , ,, .... 18-23) 2,,,Children born alive / -/ -/children-- /- / -/children / / children..____ Birthdates (mo./day/yr.) *. * * \ * 24-29) 3, Children dead within 4.weeks / / /children / / /children / / /children r-an 4, Number of (30-35) miscarriages 5* Number of [35-41) stillbirths /// /// /. / j I. / / /// / -/ / (42-47) -Children.with birth defects" State type of birth defects / / /children / / /children / / /children 237S44 L4S; (49) (51) APPENDIX I \. 0. 1. vofl^eqularly dse health aids such as. those for constipation, idi'gieSion, arthritis, or headache (far example aspirin, laxatives, diet pills, lf~y..wfeat'^k4id or brand: 2. Do you regularly use salves or liniments such>as those for itchy skin,,;burns, s-. abrasions, etc.?^ * /__/ yes(l) /__/ no(2) If yes, what kind or brand:_______ 3. . Do you have or have you ever had acne? /__/ yes(l) / / no(2) If yes, how was it treated?___________________;___________ ______________________ 4. Are you now taking medication(s) prescribed by a doctor? / / yes(l) / / no(2) If yes specify the name{s) of the medications and the iUness(es) being treated:______________________________ ;__________________ ________ ________ (52) 5. Do you have any known allergic reactions^to drugs? ~ / / yes"(l) { __/ no("2) IT yes, to what drugs, (be specific)?__________________________________ ^7845 K. REVIEW OP SYSTEMSAND PHYSICAL EXAMINATION VitalfSig VaJ-54) Nursi I D i * */ ' (55-60) Date I I I I I I I I I mo. day yr. (6K66) BP 7 /p- / / (67-69) Pulse I I I /miff. (70-71) Resp. / / /min. (72-73) * Height / / /lHchgj^ \ (74-76) Weight./- / / /pounds (79-8Q) 0/4/ ' ,** (6) Unusual appearance l __I yes(l) /__I no(2) Temp. /_/_/./ /F (77-78) IS) If yes, describe ________________________________________ __ (7-8) Physician__________________________ ___ Physician ID# I I I Additional History - Review of Systems Physical Examination (Indicate Problems and/or Abnormal Findings) Skin - active or residue of acne, i other skin abnormalities, na'iisrhair~ (9-10) : / _ / yes(l) _ / no(2) Nose, mouth, throat, mucous membranes / / yes(l) ! _ _ ! no(2) <! ii w- * * (11-12) l _ J yes(l) / / no(2) Dental status / / yes(1) /__/ no(2) -V 4. (13-14) /__/ yes(l) /__f no(2) L J yes(l) / _ / no(2) 237846 Add itionaV^tffsgry,v Rev fewvdJf Sys tems --- r---{ '. -- 1-- - ^ ^"vV-" i? ..; ^ i"' 1 ' ' l ~ I1 16) / _ ? yes(l) / / no(2) Lymph nodes -A Physical Examination t,' " il,*./ * XI, * , , . \-*1, - V1 . / V** *',"m. s ** . * 'v* *'4'*. i ' / / yes(l) r _ l no(2) ; >18) /__/ yes(1) /__/ no(2) Thorax, Pulmonary, Cardiac ;) , 1 1 >-T- / / yes (1) ' .* V?m- / / no(2) ' ~T20)' lJ ! ! _ j yes(1j ~ T ~ / Gastrointestinal_ no(2)... + y ' / / yes(l) *> 7 / no(2) 1 t i -22) /__/ yes(l) Liver l _ J no(2) r L J yes(l) l _ J no(2) " :-24) l _ j yes(l) / _ / no(2) /__/ y_es(l) / _ / no(2) 237847 Additjenat^HsJtory --Rev--i-e-w--o-f-- Systems., \ Sexual^- Physical E:xamination' [25-26) /__/ yes(l) ^ 'Skeletal. ; /__/ no(2) ^ f (27-28) /__/ yes(l) Kidney ! J . no(2) -0 ^ /__! yes(l) /__/ no(-2) 1" 1 J .. ; / / yes(l) V / / no(2) (29-30) / _ / yes(l) Bladder / _ / no(2) * /__/ yes(l) /__/ no(2) * (31-32) _ J yes(l) /__/ no(2) Genitalia, "including additional reproductive review . /__/ yes(l) /__/ no(2) (33-34) / _ / yes(lj / TM/. n*a(2) *.. / L J yes(l) / 7 no{2) 237S48 Add-ftiona1 Hi? tory Rev iew.of-Sys tems s, V Vsul|r- *t** . fr, 1 .v*0' [3St 36) ! _ J yes(l) / / no(2) Neuropsychiatrie Phsical Examination /__/ yes(l) /__/ no(2) * * *% (37-38) ! _ J yes(l) oMO^ons j _ J no(2) ' " mr (,3a-40j. l _ J y.es(l) /___/ no(2) / / yes(l) / / no(2) /__/ yes(l) /__/ no(2) 237849 / U T th U i* i Abnormal Findings Fforr^idory { _ J yes(l) itai !_ _ / no(2) * ^ Tf' w From Physical Examination /__/ yes(l) Retail: /__/ no12) &Uanqs_i.s Impression X, 237850 v43) ,' W ) 15) (46) 7) (46) .45) >50) si) (52) 53) (54) 55) rise)I (57) 58) (59) 160J(61) ' (62) (63) PULl'iOflARY'FUNCTION RECORD 1. . Silice nation or visit t o :the doctor,, have you experienced ai& of ^ p e following: Yes > N o . ajfc Cot b \ Fever c. ^Chills .A' d. Muse leeches e- Shortness of breath f. Chest pains,'ching, tighness or burning . g. Wheezing h. Expectoration (phlegm) i. Stuffy nose j. Eyes burning or watering k. Throat sore or burning l. Loss of appetite m. Weight loss 2* ::Oo^you -smoke..cigarettes,.cigars^or.pipe?..../ / yes (1) /__/ ng(2)____ 3 V ~ Have* you had" any of the foTI owing recently?" " ` -------- * Respiratory infection within two(2) weeks? /__/ yes(l) /__/ no(2) Bronchodilator drug within six (6) hours? __/ yes(l) /__/ no(2) Cigarette within one (1) hour? / / yes(l) / / no(2) Meal within two (2) hours? __/ yes(l) / / no(2) 4. Are you now wearing any tight garments? /__/ yes(l) __( no(2) 5. Have you had this test before? / yes(l) If yes, w h e n ? _ ______ .______________ where?_ under same name? __/ yes(l) __/ no(2) / no(2) 237851 APPENDIX I -r 5) `56) *.167) ' __________________ _________________________ _______ 58-69) TECHNICIAN__________________________________ ID* / _ / _ / (79-80) (5-7) Total FVC Time VOLUME IN L. ATPS VOLUME IN L. BTPS % FEV/FVC PREDICTED* NORMAL l PREDICTED ' l-------------00i --< UU-l FVC ---- - m F (25-75) .(24-27) L/Sec. (12-15) ______(15-17) (18-21) (28-31) L/Sec. (40-43) (32-33) (34-37) -----------------r-(.T4-y4,---4---7--)-- (22-23) (38-39) 237852 ..NERVE 'CONDUCTION 3-49) ID# _ S j jr . ? * (50-53) (54-56K si-'*:v . aterrv / =- Distanc* / / f / ms ^ 7/ mm*. (57-60)' ` N.C.V. / / / . / / m/s (61-63) Stm. Curr. I I (79-80J/1/6/ (5.14) Il U ! t ! mA I I /./ / /// (15-23) ///.// / / // / LJ (24-30) / /./ / 7 /-/ / LJ 2. Peroneal (31.34) Latency l ! l . l ! ms (35.37) (38-41)-- Distance ! I I ! tun NiO.Vi - / -7-,A- A - m/s ---- - - .. v42.44) (45-154) Stm. Curr. I l l /mA * Il U ! I I l.l / /// (55.63). II U t (64-70) / /-/ / (79-80)/l/7/ i. Sural / ' / /./ / / /./ / LJ /_/ (5-8) Latency / A : /./ / ms (S-ll) Distance / / / / ran (12-15) N.C.V. / / / . / / m/s (6-.18) - Stm. Curr. / 7 / / mA (19-28) (29-37) (38-44) / / /./ / / / /./ / I-- //__/ ! II.I / I I l.l / Z Z7 7 /// z_/ LJ 237853 laboratory tests v/ ;.,h / M Pleasgcheig if done:' .145-47) ' / /. no(2) **B--50J / 7 ye*U) / / / no.f2) (51-53) / / y U 7 '' / 7 no(2) [54-56) / / yes(I) /__/ no{2) 157--5?) / / yes(i) /__/ no{2) (60-.62) / / yesU) / _ / no(2). [63-55) /__/ yesU) / _ / no(2) *66->68) (73-80) UM /__/ ye$U) OTHER TESTS: / / no(2) Urine Sample 10#/ j Blood Sample -ID#/ f / Skin Biopsy ID#/ f / Skin Scrapings ID#/ / / Culture ID#/ 1 / Photograph ID#/ / / X-Ray ID#/ f / EKG ID#/ _ L / *. GQWMEftTS: 237854 - ^ APPNQTX II # Statisticaf^Procedure \\ * V; For a discussion of the methods ( x ^ test for independence, age-adjustment) used for contingency table analysis please see Statistical Methods for Rates and Proportions (J.L. Fleiss, Wiley Interscience (1973) New York). Fisher's t exact test is presented in Testing Statistical Hypotheses (E.L. Lehmann, John Wiley & Sons (1959) New York). A fine discussion of multiple linear regression analysis and analysis of covariance is .contained in Applied Regression Analysis and Other Multivariable Methods (D.G. Kleinbaum and L.L. Kupper, Duxbury Press (1978) North Scituate, Massachusetts-)-.... . .........-. -- .. .. .. ------- - 237855 appendix h i f/ *si \&X 1 : /** Limited Motion H/0 "Nervousness" ^ H/0 Depression Clinical Findings OTHERS Not Exposed: (n=W 1 1 1 Arcus Senilis Cataracts 1 1 Retinal Nicking H/0 Thrombosed Deep Vessels H/0 Angina H/0 Hypertension 1 1 2 Rhonchi . Asthma, ,, . . ....- 1 ... ... - : * 1 .. - Poor Dental Hygeine . ....... __1. H/0 Duodenal Ul'cer H/0 Stomach Ulcer 1 - .H/0Cholecystectomy ' 1 H/0 Prostatitis H/0 Renal Surgery 1 " H/0Thyroid Disease, H/0 Tumors(Breast, Uterus,one) 1 Arthritis(Heberden's Nodes) H/0 Chloracne Chloracne Actinic Elastosis H/0 Acne Vulgaris Acne Vulgaris Hirsutism Seborrheic Dermatitis 2 4 3 1 '.Exposed *'*(n=5) 1 1 1 1 1 1 1 1 1 4 3 4 1 23785S OTHERS Hot Exposed "Dishydrotic-Dermatitis1' Lichen Planus Hypopigmentation, post infl arrmatory Seborrheic Keratoses Actinic Keratoses Dermatophytosis Onychomycosis Baker's Cyst Decreased Growth of Hair -? Nevi Dermatofibroma 1 1 1 2 1 1 2 1 "T n F tr.Exposed 1 1 1 3 1 1 237857 y. . ^ .v / -JP*" i. * ..VJ V V-k . J , ... APPENDIX IV CLINICAL.FINDINGS NOT EXPOSED . (n=163) EXPOSED r (n=2Q4) QUESTIONABLE EXPOSURE (n=51) NEUROLOGIC . s Clonus Hyporeflexia and Hyperreflexia Positive Babinski/Romberg Loss of Yibratory Sensation, Light Touch, and Proprioception Paresthesia;Numbness Resting Tremor Head, Hand Speech'Dysfunction H/0 Multiple Sclerosis H/O Cerebrovascul ar Accident H/0 Epilepsy PSYCHOSOCIAL---------- "--------- H/0 "Nervousness" H/O Depression H/0 Anxiety H/0 Decreased Libido H/0 Increased Libido H/0 Impotence, NOS EYE Pterygium Macular Degeneration Arcus Senilis^ Cataract Diabetic Retinopathy Exotropia, NOS H/0 Cataract Surgery H/0 Glaucoma #% #% #% a 5 3-07 - 1 0.49 5 2.45 2 0.98 - 9 5.52 14 6:86 - 1 0-61 6 2.94 - 3 1.84 4 1.96 1 1.96 1 0.61 - 1 0.61 -. 4 . 2 3 - ~ -- 6-, .2^94_; 1 0.61 - . 1.95 -------- -- -- - ~ - - -........ 16 9.82 - 27 13.24 3 1.84 6 2.94 - -1 0.49 12 7.36 38 18.63 2 1.23 . - 4 2.45 17 . 8.33 5 9.80 1 1.96 - 9 17.55 - 2 3.92 -2 1.23 4 2.45 2 1.23 1 0.61 1 0.61 2 0.98 1 0.49 6 2.94 3 1.47 1 0.49 2 0.98 3 1.47 1 1.96 1 1.96 1 1.96 " 2 3.92 237858 4K 1 '3 jW ' CARS. HOSE ^AjdKlHROArT v "Otitls-vi Hearing iss , H/0-Perotfv Tumor k * ..t . x^ j./r*' HOT . EXPOSED v ' 7"n*l63) #% ',1 v 2 . - 1.23 3 i.4 - CARWVASCULAR' TrRetinal Nicking Varicosities Localized Edema Pitting Edema Venous Stasis ^ 6 3.68 10 6.13 1 0.61 1 0.61 - Diminished Pulses in Lower Extremities 5 3.07 Cardiac Murmur, NOS 1 0.61 Diastolic Murmur 1 0.61 Systolic Murmur 5 3.07 Bruit - * ' EXPOSED. . Tn*2047 i' % - "V. 2 0**98 1 0.49 6 2.94 30 14.71 2 0.98 5 2.45 10 4.90 -_ 9 4.41 1 0.49 '-Hypertension (see B.P. findings) H/0 Aortic 'Aneurysm "" : H/0 Arteriosclerosis H/0 Anemia --- -- -- --- H/0 Coronary Artery Disease H/0 Raynaud's Phenomenon H/0 Angina H/O Hypertension . , ~7 ---- - . 1 - 0.61 10 6.13 1 0.61 2 1.23 36 22.09 1 -- 0.49 ;-- - 1_ 0.49 20 9.80 - 3 1.47 60 29.41 PULMONARY '' Increased AP Diameter, Chest 1 0.61 1 0.49 Kasai Polyp 1 0.61 - Chronic Obstructive Pulmonary Disease (CQPD) 1 0.61 3 1.47 Rales 3 1.84 10 4.90 Breath Sounds, Vesicular -- tallness to Percussion - 1 0.49 Crepitation 1 0.61 Decreased Breath Sounds 3 1.84 9 4.41 QUESTIONABLE __ EXPOSURE T n=51^ X. 1 1.96.' 2 3.92 - 2 3.92 2 3.92 1 1.96 1 1.96 1 1.96 1 1.96 1 1.96 V 1.96 - 6 11.76 - 2 3.92 10 19.61 1 1.96 - 1 1.96 1 1.96 - 237859* not EXPOSED' Tn=V637 ' ' QUESTIONABLE EXPOSED. Tn*2WT : EXPOSURE " TriVsiT v, ^ 'tfioncM . .H/O Black Lunij Benefits H/O Chronic Obtruetive"Pulmonary Disease (COPD) X 2.45 "C;. -- , . . * * a . 2 1-23 * I . * > ; # IQ ' 4;% r ' ' 1 1 .. 0 . 4 * * ' . - 1 i 0.49' 1 0.49 - m - 1 3 '&1.47 1 X 1.96 1-36 1.96 ORAL, Leukoplakia Poor Dental Hygiene and Caries Periodontal Disease 1 0.61 - 14 8.59 22 10.78 4 2.45 5 2.45 4 7.84 2 3.92 GASTROINTESTINAL H/O Colitis .2 H/O Diverticulitis - H/O Colon Tumor H/O Cecal Tumor - H/O Esophageal Tumor - H/O Colon Cancer. H/O Colostomy H/O GI Bleeding - * Ji/0 Upper.1.,Ulcer-- ... 9- . Site As Reported: Peptic -- Stomach"... ... " 3 4-- Duodenal Surgical Treatment as Reported: 2 H/O Gastrectomy H/O Partial Gastrectomy - H/O Surgical Treatment of Ulcer, NOS - 1.23 1 2 1 1 1 2 1 5 5.52__ ,Jl2 1.84 2.45 1.23 9 21 12 3 1 6 0.49 0.98 0.49 * 0.49 0.49 0.98 0.49 2.45 .:.2Q-5SL.- 4.41 -10*29-- -- 5.88 3 5.88 - - - .J6-- 4U.76, 1 1,96 -3---- 5.88 2 3.92 - - LIVER AND GALLBLADDER .Enlarged Liver Tender Liver 4 2.45 2 1.23 8 3.92 2 0.98 1 1.96 - H/O Hepatitis H/O Cholecystectomy H/O Cirrhosis H/O Factor IX Deficiency -UROGENITAL . . 1 0.61 1 0.61 2 1.23 1 0.49 5 2.45 2 3.92 1 1.96 - Enlarged Prostate Enlarged Testis Testicular Atrophy Inguinal Hernia 3 1.84 - m 5 2.45 1 0.49 2 0.98 2 0.98 1 1.96 1 1.96 1 1.96 _ 237860  HOT EXPOSED TnM637 EXPOSED IP24T .QUESTIONABLE' EXPOSURE ~ T n = 517T-. #% #% #5 Hypospadias Hydrocoffle Spernatotele^Bi lateral 1 0.61 - -4 1.96 1 0.49 1 t-95 - Phimosis \\ - Balanitis 1 0.61 H/0 Kidney Stones H/0 Hydronephrosis 16 9.82 . H/0 Hematuria 2 1.23 H/0 Nephritis 3 1.84 H/0 Pyelonephritis - H/0 Prostatitis 4 2.45 H/0 Prostatectomy H/0 Renal Abscess 2 1.23 H/0 Bladder Tumor 1 0.61 H/0 Prostate Cancer - H/0 Venereal Disease (Gonorrhea, Syphil ;) - H/0 Infertility H/0 Bladder Carcinoma 1 0.61 H/0 Renal Surgery - 1 0.49 " 1 0.49 1 1.96 24 11.76 1 0.49 5 9.80 - 5 2.45 1 1.96 3 1.47 1 0.49 1 1.96 - 6 2.94 - 2 0.93 2 3.92 1 0.49 7 3.43 -* 1 0.49 2 0.98 1 0.49 - 2 0.98 . ' 2 3.92 6 2.94 " LYMPHATIC 1 Enlarged Lymph Nodes 2 1.23 2 0.98 2 3.92 Enlarg&Tdnsils f 0.61 *" 1 49 .ENDOCRINE___ ... ... Enlarged Thyroid Gland Exophthalmos H/0 Gynecomastia H/0 Diabetes H/0 Thyroid Oisease 1 0.`61 - 1 3 1 0.49 9 4.41 3 1.47 2 3.92 1 1.96 . SKIN Cutis Marmorata ' Polymorphous Light Eruption; 1 0.49 - 1 0.49 - Nodular Elastc&is of Favre-Racouchot Radiation Dermatitis 1 0.61 m 1 0.49 1 1.96 > Comedones, NOS" [ Miliaria 14 8.5.9 1 0.61 4 1.96 . 8 15.69 1 237861 [ HOT EXPOSED Tn^lW EXPOSED Xn*205T QUESTIONABLE EXPOSURE JFs'VJ i . 1 _ 7; . Cysts (intlud^l Sebaceous artd'vKeratin) Acne VuT Chloracne^. Rosacea Folliculitis Irritant Dermatitis Stasis Dermatitis ** Humnular Dermatitis "Dishidrotic Dermatitis" ID Reaction Xerosis Lichen Simplex Chronicus Prurigo Nodularis Intertrigo Drug Eruption Seborrheic Dermatitis Psoriasis--v .... . ` ^ Actinic Elastosis .... Xanthoma Dystrophic Toenails Hirsutism Universal Hirsutism Pigmentation, NOS Hypopigmentation, Chemically Induced Hypopigmentation', Post" Inflammatory Leukoderma and Vitiligo ^7 Hyperpigmentation, NOS Hyperpigmentation, Post Inflammatory Lentigo, Cafe au'Lait Spots, Poikilodenna of Civatte Hemosiderosis - Idiopathic Guttate Hypomelanosis # %8 4.91 19 11.66 14 8.59 2 1.23 5 3.07 2 1.23 1 0.61 1 0.61 1 0.61 15 9.20 2 1.23 49 30.06 2 1.23 3 1.84 . 1 0.61 1 0.61 1 0.61 2 1.23 - 4 2.45 #% 3 . 1-47 4 1.96 107 52.45 3 ; 1.47 9 4-41* 2 0.98 1 0.49 - 1 0.49 4 1.96 1 0.49 1 0.49 1 0.49 n 5.39 2 " ' 0.98 120 58.82 i 0.49 5 2.45 n 5.39 - i 0.49 i 0.49 3 1.47 3 1.47 4 1.96 1 0.49 3 1.47 3 1.47 i 0.49 fz 1 . 1.96 2 3.92 * ji 1 .1.96 3 5.88 - - - 2 3.92 2 3.92 3 5.88 20 39.22 1 1.96 I 1.96 - 237862 y* '-'S- NOT EXPOSED Xn=163j EXPOSED .. ln2Q4) r ^ ** Lihen St^ertfjjFet Atrophicus . Hyperplasia SeHceous Gland Alopecia, i reiser ibed Keratoses, w$' ' * ' .^'' Seborrheic Keratoses#' Actinic Keratoses Acanthoma ^ Keratoses Pilaris function, Dermal, and Compound Nevi #% - 1 0.61 2 1.23 10 6.13 9 5.52 1 0.67 15 9.20 1% 2 0.98 2 0.98 1 ... 0.49 ia 8.82 * 21 10.29 2 0.98 13 6.37 Blue Nevi 1 0.61 Peyronie's Disease - Dupuytren1s Contracture - Telangiectasis 6 3.63 Spider Angiomata 2 1.23 Yerruca, Verruca Vulgaris, Molluscum Contagiosum 5 3.07 .Fibropithlial Polyps. ,, Squamous Cell Carcinoma .... ..5 ...3.07.. - Bowen's Disease * --- - Basal Cell Epithelioma Trichoepithelioma 7 4.29 1 0.61 HeHnoima/1npressi on 1 0.61 Dermatofibroma 2 1.23 Lipoma 2 1.23 Angiomas `^ 4 2.45 Keurofibroma/Multiple Neurofibroma 1 0.61 Herpes I 1 0.61 3 1.47 1 0.49 7 3.43 1 0.49 4 . 1.96 _ 0.98 1 0.49 1 ---0^49 14 6.86 - L '* -* 2 0.98 5 2.45 3 1.47 1 0.49 - QUESTIONABLE EXPOSURE (n=5f) iX 1 1.96 1 1.96 1 1.96 6 11.76 5 9.80 - 1 1.96 3 5.88 - 1 1.96 1 1.96 - 1 1.96 ... 2. .... 3.92 - " - 1 1.96 1 1.96 - - 237863 /r * . Ji ' & * * * * ' '~ r Dermat o ^ y t d H . *V . OnychomySjsiw -. ." Trichomycosis X4T1 'iJinea Vers'icol ^ Dermagraphic Urticaria Ichthyosis Vulgaris v H/0 Dermatitis, NOS H/0 Pilonidal Cyst H/0 Acne Vulgaris H/O Chloracne H/0 Folliculitis H/0 Dishidrotic Dennatitis H/0 Xerosis H/O Skin Cancer, NOS H/ Skjn Tumor, NOS H/0 Melanoma, Surgical Excision H/Q. Eiasal Cell Epithelioma INFECTIONS Malaria _____ H/0 Dengue "Fever K/Q Rheumatic Fever NOT .EXPOSED Tn7i63T . EXPOSED ' - Tn?204T QUESTIONABLE EXPOSURE Cn=5T) # ;% I% #X 45 27.61 16 9.82 - 1 0.61 1 0.61 - 16 9.82 1 0.61 48 29.45 - 2 1.23 1 0.61 1 0.61 4 2.45 1 0.61 1 0.61 62 30.39 * . -14 27.45 22 10.78 * 6 11.76 1 0.49 - 0.49 1 1.96 -- 3 1.47 n 5.39 i 0.49 20 9.80 176 86.27 1 0.49 - - 8 3.92 - 2 0.98 10 19.61 - 10 19.61 - - 1 1.96 - - - V . 0.61... .. , .0.49 1 0.49 1 0.61 - _~ - 237864 APPENDIX V Tafiie 20, P l g s m a Total C h o l e s t e r o l (mg/dl) * .White^Males - Vilit g.flandom Sample. Study (North America). r^pWHF W -J ! N OVERALL I-, ... M eant *j ** s , t *. * V - 0-4TM ~ 2 0 T ^ w * CLINIC R A N G E Mean s .e . 5 *-- PERCENTILES 10 25 50 75 90 . 35 -- -- *-- -- 5.9- % 1 4 6 155.2 1.8 151.0 3.4 157.1 2.3 125 131 141 153 168 183 189 10-14 294 s 160.6 1.5 152.0 3.3 168.1 4.3 124 131 144 160 173 188 202 15-19 298 153.0 1.4 150.6 2.6 155.5 2.5 116 123 136 152 168 183 191 20-24 118 162.2 2.5 - 163.0 5.6 163.5 3.2 118 126 142 159 179 197 2 12 25-29 253 178.7 2.1 171.3 4.1 187.8 4.7 130 137 154 176 199 223 234 30-34 403 193.1 1.8 185.6 4.6 204.1 5.9 142 152 171 190 213 237 253 35-39 371 200.6 1.9 186.6 4.5 214.8 6.6 147 157 176 195 222 248 267 40-44,;- 383- - -20S.2'-1.9 "-197-.8 4.7-- 15(h ioa 179" 204 229 251 260 210.3 5.8 -45-49-- 326-- -213.4- 1.9 ---- 201.0 3.9 -- -163 171 188 210 235 "258 275 237.4 7.1 50-54 340 213.2 1.9 201.4 7.4 225.4 4.4 156 168 189 2 11 237 263 274 55-59 261 215.0 22. 206.8 4.7 227.1 7.2 161 172 168 214 236 260 280 60-64 131 216.6 3.3 216.4 7.4 234.9 7.2 163 170 191 215 237 262 287 65-69 105 ' 221.0 3.6 211.8 6.6 225.7 5.1 166 174 192 213 250 275 288 7 0 4 - s 119 210.3 3.4 210.4 4.1 210.4 4.1 144 160 185 214 236 253 265 N ot' Mean not given it N < 25. 5lh and 35tn percenMes not given rf N < 100; 10th and 90th oercentifes not given ( N < 75. 25th and 75th perceni.'es not given rf N < 50; 50th perce ntiie-not given it N < 40. Chrvc range indicates the range among UtxJ Research Cimics (ine lowest l RC mean value and the highest IR C mean value) ana as respective SE. * The Lipid Research Clinics Population Studies Book: Volume I: The Prevalence Study, USDHHS, Public Health Service, National Institutes of Health, (1980), 237865 AKHtNUiA V T a b ! g . 2 4 ^ Ia s m a T rig ly c e rid e (m g / d l) * ,White.M l e s - ^ ; 2, R a n d o m Sample. The L B C ^ P r e x a j e ^ S t u d y (North America).' H CLINIC R A N G E W v`l r Me~yan S.E. M e a n >.t. . 6 10 >-- ; Vvit9 " r<8_ -51.9 1.7 r**.jr * 50.2 3.5 53.2 2.1 28 34 25 50 39 48 75 9Q 95. ^rr ._ t J2E5 70 85 j 10-14 299 63.4 1.6 53.9 5.2 67.2 4.5 33 37 46 58 74 94 15-19 299 78.2 2.4 74.1 4.3 .38 43 53 68 88 125 143 80.1 4.1 20-24 113 89.3 3.7 87.9 5.2 98.5 9.4 44 50 61 78 107 146 165 25-29 2S3 104.2 4.2 , 1 80.2 5.4 45 51 67 88 120 171 204 125.3 14.1 30-34 403 122.1 3.7 95.4 4.6 48 57 76 102 142 `214 253 148.0 22.3 35-39 372 140.8 5.5 ` 115.8 12.5 52 58 80 109 167 250 316 160.8 19.4 40-44 335 152.4 6.9 117.5 9.6 56 69 89 123 174 252 318 197.3 41.6 45-49 327 143.4 5.9 124.4 8.7 56 65 88 119 165 218 279 184.7 34.1 50-54 340 153.4 5.5 122.8 9.0 63 75 94 128 178 244 313 161.4 12.0 t 55-59 60-64 261 * 134.3 4:2 'h 131 130.6 8.7 129.8 10.4 146.9 12.1 125.8 10.1 148.4 30.9 60 70 85 117 \67 210 261 56 65 84 1 1 1 150 193 240 65-69 ^ 105 , 133.6 11.1 70+ 119 13 6 72 135.9 16.8 144.8 20.5 130.9 8.9 130.9 8.9 54 61 78 108 164 227 256 63 71 87 115 152 202 239 Not: Mean not given rf N < 25: 5ttJ and 95:n percentiles not given rf N c 100: 10m and 9C:n percentiles not given it N < 75; 25m ana 75tn percent.;es not given rf N < 50; 50th percentile not given it N < *0. Clinic rang indicates :n range among LidkJ Research Cim.cs (me lowest l RC mean vama and the highest LRC mean vaiu) and u respect/v SE. * The Lipid Research Clinics Population Studies Book: Volume I: The Prevalence Study, (JSOHHS, Public Health Service, National Institutes of Health, (1980). 237866 n rrtiu / iA Table 32. Plasm a LDL-Cholestero! (m g/dlj * White.MaleS" V isi^2. R a n d o m Sample. T h e LftiWiWiflce'Study (North America). | a9 N W 9% OVERALL Mean s S.E. Av___ '* CLINIC R A N G E Mean S.E. 5 -- *-- PERCENTILES 10 25 50 75 9 0 ^ 9 5 -- -- -- ' . % 6*9 13lT 92.5 1.8 90.9 3.9 92.8 2.1 63 69 80 90 103 117 129* s 1014 284 > 96.5 1.4 15-19 298 94.4 1.3 84.8 3.0 101.5 3.8 92.5 3.4 95.5 2.3 64 72 81 94 109 122 132 62 68 80 93 109 123 130 2 4 118 103.3 2.4 101.6 3.0 108.4 5.2 66 73 85 101 118 138 147 25-29 253 116.7 1.9 109.6 3.5 120.6 4.7 70 75 96 116 138 157 165 30-54 403 126.4 1.6 119.8 4.4 128.7 5.7 78 88 107 124 144 166 185 3 9 371 133.2 1.7 118.4 3.9 146.3 5.8 81 92 110 131 154 176 189 ..4*44 ,.385 . 135.6 1.5 .__ 129.5 4.3 . . 87.,, 98 115 135. .157, 173..186 146.1 4.5 -.4^49... .325 _1.43.9 ..1.8..... .. 132.9 3.6. - 93. 106 120. 141 163 186. 2 0 2 . 155.8 6.6 50-54 340 142.3 1.7 m 137.0 4.2 154.1 4.2 89 102 118 143 162 185 197 5553 261 145.8 2.1 137.0 5.6 160.5 5.9 88 103 123 145 168 191 203 0 4 131 148.3 3.1 148.2 5.1 157.3 7.2 83 106 121 143 165 188 210 105 "150.4 3.5 146.3 5.5 153.4 5.0 98 104 125 146 170 199 2 10 7Qr+Z 119 142.9 2.9 141.5 3.5 141.5 3.5 88 100 119 142 164 182 186 M ot'. Mean not given it N < 25: fen and 35m percentiles not grven rf N < 100; 1QK* nd 90tn pe*cen:rcs PCI given rt N < 75. 35V *nd 75U1 percent.ie* not given if N < 50; percentile not given rf N *. 40. n < range mtkcates r*e range among U od Resea/cn Curves (in# lowest LHC mean vatu apttB ia hignest LRC mean value) and as r& pecove SE. * The Lipid Research Clinics Population Studies Book: Volume I: The Prevalence Studv, USDHHS, Public Health Service, National Institutes W Heal thTTl930-). 2378S7 T a W 6 ' 3 6 ^ p i a s m a . H D L - C 5 i o I e s t e r o I (rhg/dl)* .. , White Males -'V is it 2. Random Sample. ' ' / ThetLB^eyaleoce Study (North America). k g r acn: N to,\ ---- -.i"'If a* .OVERALL . CLINIC RANGE. M ean S.E. M ean S.E. -+* ,_ 55.5 - 1 ;54.8 1.8 55.6 1.1 PERCENTILES - ,'1l0 " 25 -r -- 50 -- 75 -- 90 -- 95 -- * 38 42 49 54 63 70 74: ** 10-14 296 ^ 54.9 0.7 53.9 1.0 58.5 2.3 37 40 46 55 61 71 74 15-19 299 46.1 0.6 42.2 1.2 48.6 1.6 30 34 39 46 52 59 63 20-24 118 45.4 1.0 40.0 1.6 48.2 1.8 30 32 38 45 51 57 63 25-29 253 44.7 0.7 39.6 1.8 45.7 1.2 31 32 37 44 50 58 63 30-34 403 45.5 0.6 39.8 1.6 50.2 2.2 28 32 .38 45 52 59 63 35-39 371 40-44 383 43.4 - 0.6 \ 44.3 0.6 34.6 1.2 48.0 1 .B 29 31 36 43 49 58 62 35.5 1.7 27 31 36 43 51 60 67 r 49.9 2.1 TM 45-49 325 45.4 0.6 40.2 2.0 30 33 38 45 52 60 64 " 49.3 2 J 2 ----- 50-54 340 55-59 261 44.1 0.6 .47.6 0JB - \ 36.5 li 50.1 2.1 41.2 1.6 51.1 3.0 28 31 e3'6 44 51 58 63 28 31 38 46 55 64 71 60-64 131 51.5 1.3 44.8 2.2 54.6 2.3 30 34 41 49 61 69 74 * 65-69-- 105- 51.1 1.5 41.2 2.1 56.7 2.1 30 33 39 49 62 74 78 70+ 119 0.5 1.7 53.2 2.1 53.2 2.1 31 3 3 40 48 5 6 70 75 t Not: Wean no! given H N < 25; 5th and 95th p ercen t not given it N < 100: 10th and 50th percent.. not given it N < 75, 25th and 75th p ercen t not given il N < 50; 50lh percentile riot given if N < 40. Oirwc range indcatea tne range among L o d Research C in c s (the lowest l RC mean value and the hghest LRC mean va n *) and ita respective SE. * The lipid Research Clinics Population Studies Book: Volume I: The Prevalence Study, USDHHS, Public Health Service, National Institutes of Health, (1930). 237868 APPENDIX VI . *%- Logistic Regression frfjBfnary variable (e.g., FEV-j, noridal or abnormal) each subject's probability p^itive response is modeled as a function of one or more predietor variaJhle^fin this example, exposure group and pack years smoked), as follows: Prpb (FEV-j abnormal) - ] + `exp(-(6o + S-j x Pack Years + where Z - 1 if exposed 0 1f not exposed x Z) ) The Newton~Raphsom method is then applied to the entire sample to produce maximum likelihood estimates of the coefficients of pack years smoked and Z%the exposure variable. More details are given in The Analysis of Binary Data (Q,R, Cq x , Chapman aricj Hall (1970) London). The maximum likelihood estimates for the exposed vs. not exposed comparison found are as follows; Pulmonary Function Parameter Coefficient Intercept FEV1 -3.54 FVC -3.10 FEVj/FVC -3.43 MMEFR -2.64 Peck tears exposure G.QZ l.QQ 0.02 0.74 0.02 1.06 0.03 0.60 23786' S --V' * - . . <M W it * A, fai APPENDIX VI $ Clinical L a b o r a t o r y Valued Reference Range \ Calcium 8 0 10.8 Phosphonia. . . . . . . . . . . . . 2.0 4.7 BUN . i ........ .. .. .. .. .a 6 25 Creatinin 0.* 1.7 Glucosa . . . . . . . . . . . . i. . 65 130 Uric Acid . . . . . . . . . . . . . . . 5 8.5 Total P rotein.......... . 62 8.3 Albumin .. .. .. 36 52 Alb.'Glob Ratio 1.0 2.3 G lo b u lin ....... 19 3.7 MG/DL m g /d l MG/DL MG/DL .MG/DL MG/DL ; GM/OL GM/DL GM/DL SG O T............................ SG PT................... ......... LDH ................ . ...... Total B iliru b in . . . . . . Direct B iliru b in ...... ...... Aik. Phosphatase. . . ...... GGTP .................... ......... ......... PoLrjslum . .. C h lo rid e ........... .. ......... Total Lipids . . . . . . . . ...... Triijlyccridos , ......... ......... Cholusterol . . . . . . . . . . . . . Iro n ............... ................ ......... 1 - 70 90 - 250 0-0.3 10 * 50 I f 40 134;- 145 96 1' 110 03 - 1.0 50-200 125-300 45-200 . KJ/L Hi/L UNITS MG/DL MG/DL UNITS/t .. UNITS/L . ,;MMOL/L ^M O L/L WMOL/L GM/DL MG/DL MG/DL MCG/DL A> * THYROXINE-BINDING G LO BULIN (TBQ| 4 Retcronce Range; 12-30 MCG/ML Piognanl womon or women taking Ihe pill: G.T 15 MCG/ML * " U R IN A LY S IS Appoarance pH Specific Gravity Acetone Albumin Gtueoso Blood WBC RBC Cast Badona Epithelial Cells Clear 4 8 -7.5 1.001 1.035 Negative Negative Negative Negative 0-5/HPF 0-2AIPF Negative Nogative Negative i .9 .. ^ 'J(jV- -, : -i : * * i '*! I' !; r'i7 } i Ii X It. ]. i I ` f I *. ! ' .i * i i A `i ' I-1 I i. . ''.ji'; t ' CBC WITH DIFFERENTIAL WBC RBC Male: 6".f'Mi*ior*VM^.,. r m / Female: HEMOGLOBIN HEMATOCRIT MCV MCH MCHC POLYS BANDS LYMPHOCYTES MONOCYTES EOSINOPHILS BASOPHILS Differential Absolute Values NEUTROPHILS^ LYMPHOCYTES MONOCYTES EOSINOPHILS BASOPHILS Male: Fomale: Mala: Female: ,4 CU.MM ' 18.0 GM/DL 16.0 GiMM//DDLL'#rV1 . 54 PERCENNTT Y ' * 49 PERCEaNwT 100 U3 V - if 33 UUG ; * f* ; t7 36 PERCENT 81 PERCENT 5 PERCENT t.U' 47 PERCENT- " v tO PERCENT 1 * 8 PERCENT 2 PERCENT V.. 1650 -8330 Cells/CU.MM 1049 3581 Cdls/CU MM 61- 929 Cells/U.MM 40- 423 Cells/QU.MM . -* 10- 146 Cdls/CU.MM U PORPHYRINS* URINE, Q U AN TITATIVE fVj; U * * Copfoporphyrin 30 240 MCG'24 hrs. h* Uroporphyrin 15 7* r. , ; 1 i ,v '"; * K* : y ' .* , ;,v Ok H :v ' t. - 237870 APPENDIX v i n J* l( t ' , t <m ^ ijti&tnient of Nerve Conduction Velocity Data '- * * ** Fdt^urposes of analysis of the ner.ve conduction findings all cases reporting, consuming*1more than 35 oz. of alcohol jj^r week were eliminated. Also dropped from the analysis were all subjects giving a history of diabetes. ^ To correct for temperature effects a mode temperature was calculated for each limb across all participants in the study. The following data adjustments were then made: Ulnar or Peroneal -v a) NCV's were corrected to the mode of the midpoint nerve temperatures using DeJesus et al.'s (1973) temperature correction equation, Vc = V, .0.0419AT where *VS = standardized NCV to standard^ (mode) temperature Ve = measured velocity at the experimental temperature AT = difference in C .between* standard and experimental temperatures b)- Distal latencies were corrected to the mode of the distal temper atures using DeJesus' temperature correction equation: DL7= DL^: e''507AT _ DLS = corrected distal latencies to standard temperature DLe = measured distal latency at the experimental temperature AT = as above c) Residual latencies were calculated by subtracting from the latency (derived in b above) the terminal distance divided by the standardized NCV (derived in a above). 237871 d) ^'iffstat^Ta^encies derived in b above'were correct to the irigde of the /' ,t nerve terminal distances using the equation below: L**1 Lj+ ^Vj where . Ls* = latency standardized to standard (mode) distance L latency derived in b above Vs = velocity derived in a above S * difference between standard (mode) and experimental terminal distances e) Ratio of amplitudes (proximal divided by distal) was calculated Sural The only standardisations performed on the sural nerve consisted of correcting the velocities to the mode.of the midpoint nerve temperatures as in a above. 237872 APPENDIX IX. Normal Nerve Conduction Velocity, and Distai Latency Conduction Velocity Average & Range Meters/sec Distal Latency msec .Reference Ulnar El bow-Vfist 56.4 S.D.4.8. 57 .'5(49.5-63.6) .. - 2 . & t 2 - 0 - 3 . 4 } (- i r .-1 * ' Peroneal Motor Fibula Head-Ankle ^ 50 S.D.3.5 5.1.5.D.0.5 2 Sural Sensory Lateral Malleolus-Calf (Ortho) 46.2 5 3 1, Trojaborg, W.f Electroenceph. Clin. Neurophysiol., 17:314-321 , 1964. 2, McQuillen, M.P. and Gorin, F.J., J. Neurol. Neurosurg. Psychiat., 32:144-148, 1969. 3, QiBenedetto Temperature effects on nerve conduction velocity: (2 to 2.4) meter per _ _ Second yC_. _ Meaningful conduction velocity of peripheral nerves can be 'wide only if segment, size, age, and'temperature are known. ` .... - Typical peak-to-peak amplitudes-using recording electrodes_at-sites^__ ^ referred to in this manual. Ulnar Motor:. 10 - 20mV Peroneal Motor; 10 - 20mV Sural Sensory: 20 - 28uV ^ ** 2378T3 "x. v. APPENDIX X. ' 1' . i DEFINITI OF ALCOHOL- STATUS JF "DoA jou jd^djgpR' alcoholic beverages?" . = rio AND "If no, did you ever?" / = NO THEN ALCOHOL STATUS = NEVER IF "Do you now drink?" AND "If no, did you ever?" = NO = YES THEN ALCOHOL STATUS = FORMER IF "Do you now drink?" . s YES THEN ALCOHOL STATUS = PRESENT H Si, 237874 APPENDIX X J* DEFINITION OF SMOKING I IF "^^yo^resei*t]}j:sriioke cigarettes?" AND "li" not now^taTc) you ever smoke?" = NO = NO THEN SMOKING STATUS = NEVER IF "Do you smoke now?" AND "If you do not now smoke cigarettes, have you smoked them in the past?" = NO = YES THEN SMOKING STATUS = FORMER IF "Do you smoke now?" YES THEN SMOKING STATUS = PRESENT 2376 y-1 si/ Sr 0EHDGRAPH1C DATA* way. Reaction Subjects vs. Not Exposed AGE Exposed (55) Not Exjposed (65) -.-Mean t Standard Deviation % ** 62.73 + 7.92 59.40 8.83 0.01 < p< 0.05 HIGHEST EDUCATION LEVEL TCP Runaway Exposed Percent 0 - 8 ^ Grade 9 - 1 2 ^ Grade > 12th Grade Total * 7 12.73 41 74.55 7 12.73 55' 0.01 < p< 0.05 Not Exposed 2 45 17 6 t* EMPLOYMENT STATUS V .TCP Runaway ' Exposed Percent Active Retired Terminated Total V -v 13 32 10 55 23.64 58.13 18.18 " p < 0.0001 Not Exposed 42 22 1 65 Percent 3.13 70.31 26.56 Percent 64.62 33.85 1.54 * All subjects white males ** Information not available for one (1) subject 237876 EXPOSURE vs. SMOKING STATUS% TCP Runaway Exposed Percent ilve'3 Farmer Present Total ^ 4 * 13 23.64 24 43.64 18 32.73 55 p N.S Not Exposed 15 ` 35 15 65 Percent 23.08 53.85 23.08 TCP EXPOSURE vs. PACK YEARS SMOKED* TCP Runaway Exposed (55) Not Exposed (65)' Mean t Standard Deviation 36.66 t 36.13 26.01 t 32.42 * 0 . 0 5 < p < 0 . 1 0 for comparing TCP Exposed to Not Exposed EXPOSURE vs. ALCOHOL STATUS* TCP Runaway Exposed Percent Never Former Present -- Total 6 21 25 ":v 52 11.54 40.38 48.08 P X.S. Not Exposed 9 24 31 64 Percent 14.05 37.50 48.44 * For definition, see Appendix V 237877 v * f* iI $ ' ! FAMILY HISTORY OF ILLNESS * Family History of Asthma / Hayfever 1 Acn ' J Eczema -Hives Ulcers Colitis Heart Attack or Angina before. Age- 60 Heart Attack or Angina after Age 60 HlghJBld Pressure Ce>roiiscu1r Accfyent (CVA) High Chpesterol f \ tiiabet ' .J Nehvous Ol^orar* Inherlt^liaftljSP^ii0 ^ Cancer TCP Runaway Exposed (n=bb T % 6 10.91 4 7.27 4 7.27 4 7.27 4 7.27 8 14.55 4 7.27 17 30.91 - 21 38.18 20 36.36 18 32.73 4 7.27 10 18.18 2 3.64 8 14.55 2 3.64 24 >43.64 1 Not Exposed : Vn=G5 ) 1% i8 12.31 5 . 7.69 ;2 3.08 -3' ; 4.62 * 5 | 7.69 9 13.85 !4 G.15 17 26.15 i 17 26.15 \ 23 35. 3 28 43.08=6 i 9.23 15 23.08 S ! 7.69 ;9 113.85 2 ; 3.08 21 32.31 * Includes Parentsand Siblings of Subjects i Probability c.s. N.S. N.S. N.S. N.S. N.S. N.S. N.S. N.S. . N.S*. N.l. N.S. jN.S. N.S. ,! N.S. N.S. N.S. 237878 . History of - Chloracne* Acne Vulgaris . Foil Icul itls - Skin Cancer , j Chronic-Obstructive Pulmonary Disease,(C^D) Hypertension Arten1r;,iosclerosis . ^ 9 a? .& ; a CoriMry. Afterj| Disease Cerervascular Accident (CV) ProsttTOOisa^ .KWnsat^Sstt^' 1 p< O.OOOl HISTORY OF MEDICAL PROBLEMS ys. : EXPOSURE STATUS TCP Runaway Exposed Fn* 5b) ! \` L% ! 55 100.00 j 3 5.^5 ; i . 0 0.00 ; jl 3 5.45 ; i =, 1 1.82 j, i ri 20 36.35 ; I o o.oo Vt * 1 1.82 : 8 14.55 : . 2 3.64 ! | 1 i.82 2 s 3.64 3 5.45 Not Exposed tn-65"jr" L1 0 0.00 6 9.23 0 0.00 3 4.62 2 3.,08 23 35.38 V 1.54 1 l..$4! 10 15.38 2 3.\08 1 1.54 3 4.62 9 13.85 J 237879 f `Finding i / Chloracne* r1 Acne Vulgaris Actinic Elastosls^ Actinic Keratosis Alopecia, circumscribed Acanthoma Basal Cell Epithelioma Depigmentation Dermatitis Irritant lar Seborfrheic3 /Sta^** l/ermatdihytos1s . OnychqmVosIs ' I , , T; DApuytrt .,^rT.T,, f Peyronie's* 1: Foil icufitis Hirsutism Ichthyosis Vulgaris y * Hot 1i jsive CLINICAL FINDINGS* VS. ; , EXPOSURE ! ,itp Runaway Exposed 1nbS ) l% 32 58.18 0 0.00 41 74.55 6 10.91 0 0.00 1 1.02 5 9.09 1 1.02 0 0.00 1 1.82 1 1.82 0 0.00 14 25.45 7 12.73 0 0.00 2 3.64 0 0.00 4 7.27 1 1.02 237890 Not Exposed (nr"6bj 1% 0 0.00 1 1.54 32 49.23 8 12.31 0 0.00 0 0.00 7 10.77 1 1.54 % 1 1.54 1 1.54 8 12.31 5 7.69 26 40.00 13 20.00 0 0.00 0 6.00 1 1.54 2 3.08 0 0.00 *8.-: Key to p Values p ^ O O O l for comparing TCP vs. Not Exposed OiOOl< p < O^QX for comparing TCP vs. Not Exposec 0.05<p<0.10 for comparing TCP vs. Not Exposed * t * .w 237862 - Serum Lipid Cholestrol Triglycerides LDL, estimated HDl i*( EXPOSURE SERUM LIPID;FINDINGS TCP Runaway Exposed n Tl^Abnormal) 54 5( 9.26) 54 8(14.81) 54 5( 9.26) 54 9(16.67) Not Exposed n ^l%Abnormal) i 65 812.31) 65 16(24.62) 63 4( 6.35) 1; 65 6( 9.23) Probability N.S. N.S. N.S. N.S* ,, i jf i Pulmonary Function Parameter FEV1 FVC FEV^FVC MMEFR .'u EXPOSURE ( VS. l PULMONARY TEST FINDINGS TCP Runaway Exposed (ne 55 ) *# (X)Abrtormal . \' Not Exposed t "(n="6i] 1 (X)rtbnormal 11 20.00 6 9.38 12 21.82 7 i 10.94 i i 15 27.27 5 7.01 17 30.91 11 17.19 Probability N.S. N.S. 0.0092 N.S. % ii. :i i 237884 w ./ */**""*' Serum U p l d Smoking Status Cholesterol * Never Former Present Triglycerides ' . \`,v:4 U L ^ estimated Never Former Present ^4 H W % Never * \ ^ormeV f \ Present 4 '; J .' : , j , J i * / ' ' 2Foevremrer Present I EXPOSURE' , ys. i SERUM LIPID FINDINGS BY:SMOKING STATES;. i* f' TCP Runaway Exposed n tf[%)Abnormal i : J li t Not Exposed n f{% ) Abnormal ProbablV 12 1( 8.33) 24 2( 8.33) 18 2(11.11) 15 2(13.33) 35 1 3( 8.57) :15 3(20.00) N.S. N.S. N.S. 12 1( 8.33) 24 4(16.67) 18 3(16.67) 12 1( 8.33) 24 2( 8.33) 18 2(11.11) 12 1( 8.33) 24 4(16:67) 18 4(22.22) 15 5(33.33) 35 6(17.14) 15 5(33.33) % 1; 'i f ;15 I 1( 6.67) >33 1( 3.03) 1 5 2(13.33) 1 5 , 2(13.33) 35 ; 3( 8.57) 1 5 ! 1( 6.67) N.S. N.S. N.S. 9 ^ N.S. x " n .s . N.S. t, '| N.S. N.S. N.S. 237866 ;; -* , ' Pulmonary Function Parameter FEVj * FVC ,* FEVj/FVC- ' ' MMEFR EXPOSURE vs' PULMONARY TEST FINDINGS TCP Runaway Exposed (n*W T 1 (X)Abnormal Not Exposed '(n='64) . ;(X)Mbnormal. Probability 11 20.00 1.6 9.38 12 21.82 i 17 10.94 1 15 27.27 5 7.81 N.S. N.S. 0.0092 17 30.91 ii 17.19 N.S. i-r i. if i I EXPOSURE vs. i PULMONARY TEST -FINDINGS^BY SMOKING STATUS Pulmonary Function Parameter Smoking Status TCP Runaway Exposed n Abnormal FEV1 FVC FEVj/FVC MMEFR Never Former Present.. V"V* Never Former ,*''*%mPresent Never Former,, Present 13 24 18 13 24 18 13 24 10 Nev.er Former Present 13 - 24 ' 18 1( 7.69) 4(16.67) 6(33.33) 1( 7.69) 6(25.00) 5(27.78) 2(15.38) 5(20.03) 8(44.44) 2(15.38) 6(25.00) 9(50.00) Not Exposed n /Abnormal 15 34 15 15 34 . 15 15 34 15 15 34 15 2(13.33) 3( 8.82) 1 ( .6.67) 3(20.00) 3( 8.02) 1( 6.67) i ( 6.67). 4(11.76) 0( 0.00,) 1( 6.67) 8(23.53) 2(13.33) Probability N.S. N.S. N.S. N.S. N.S. N.S. N.S. N.S. 0.0063 N.S. ,,N.S. ,'0.0599 I 237887 i V% EXPOSURE i vs. ECG FINDINGS * f v; i Finding p Normal ECG Negative'.'ECG* Sinus Bradycardia Sinus Tachycardia PVC'S 1 PAC's Atrial Fibrillation Intraventricular Conduction Defect Left Anterior Hemiblock 1st Degree AV Block^ Rigfil Budfcle Branch Sltjack, complete Left BurtRe BranthlocV, complete Ol|d An t e w or Myocardial^ Infarct OltJ 1n ^ Infarct True Posterior Myocardial Infarct D1g1t!rS*#^ TCP Runaway Exposed {n=$5 ) i* 9 16.36 1 i. 25 45.45 1 7 12.73 i 0.00 ;! 10 18.18 i 1 1.82 i 1 1.02 t 2 3.64 [ 5 9.09 1 0 * 0.00 :! ' 1 .* i.82 ; 1 r1.82 ; 1 Jr.82 S 3 5.45 j; 0 0.00 'i 2 3 64 ^ > ^ 0.01 < p <0.05 for comparing TCP vs. Not Expose# * Normal or not significant findings Vr .ii1 Not Exposed '1^657" #% 15 33 3 ;1 3 :4 l i 11 i2 i2 !2 i j0 12 !2 !1 i1 23.08 50.77 4.62 1.54 4.62 6.15 1.54 1.54 . * 3.08 3.08 3.00 0.00 3.08 3.08 1.54 1.54 i 23788a i Finding Left Ventricular Hypertrophy Right Ventricular Hypertrophy Left Atrial Hypertrophy Non-specific ST-T Wave Changes Low Voltage QRS Abnormal P Wave Left Axis Deviation EXPOSURE ; vs. ; ECG FINDINGS TCP Runaway Exposed ln= 557 #% = 3 5.45; 0 0.00 0 0.00;. 2 3.64 1 1.82-, 2 3.64; 0 0.00! i 2378S9 Not Exposed (n S) ? 5 7.69 0 0.00 0 0.00 3 4.62 0 0.00 4 6.15 1 1.54 ff I EXPOSURE vs. PULMONARY TEST FINDINGS BY SMOKING STATUS 237830 Pulmonary' Function Parameter Status TCP Exposed n #^Abnormal FEV, FVC FEV.JL/FVC * ';MfaMEFrt .,* ; / Never Former Present Never Former Present Never Former . ' Present Never Former Priert. M ,. 13 24 18 13 24 18 13 24 18 13 24 % 18 i( 7.69) 4(16.67) 6(33.33) 1( 7.69) 6(25.00) 5(27.78) 2(15.38) 5(20.83) 8(44.44) 2(15.38) 6(25.00) 9(50.00) Not Exposed n t #(X)Abnormal 15 ; 34 15 ! J 15 ! 34 S . 15 2(13.33) 3( 8.82) 1( 6.67) 3(20.00) 3( 8.82) 1( 6*67) 15 1 34 ; 15 t 15 34 15 J( 6.67) 4(1 1 .^) 0( 0.00%) 1( 6.67) 8(23.53) 2(13.33) Probability N.S. N.S. N.S. N.S. N.S. N.S. N.S. N.S. 0.0063 9 N.S. .N.S. r 0.0599 I' ft EXPOSURE vs. ; CHEST X-RAY FINDINGS1 Finding Normal Chest X-Ray * !* 1 f!" Evidence, Old Granulomatous Disease^ Evidence, Arteriosclerosis Evidence, Degenerative Bone Disease Cardiomegaly Mass Chronic Obstructive Pulmonary Disease (COPD) Aortic Aneurysm Pulmonary Hypertension Blunted Costophrenic Angle Acute Parenchymal Disease ' Elevated Hemi-diaphragms Pleural Thickening parenchymal Scarring possible Mass A ortic Valve Disease Sfrauma TCP Runaway Exposed (n=55~y #% 14 25.45 23 4i;.o2 ; 11 20.00 ; 8 14.55 : 5 9.09 ; 2 3:.64 ; 2 3.64- ; 0 0.00 , 0 0.00 ' 6 io.9i :;S 0 0.00 : 4 7.27 ; 6 10.91 ; 6 10.91 1 1.82 : 0 0.00 2 3.64 1 O.Ol < p < 0.05 for comparing TCP vs.. Not Exposed ! Not Exposed f'6 sY ~ l* -29 44.62 21.54 i 14 12 18.46 4 6.15 2 3.08 1 1.54 3 4.62 0 *. 0.00 1 1.54 6 9.23 1 1.54 1 1.54 3 4.62 8 12.31 4 6.15 0 0.00 2 3.08 I M \, BLOOD Calcium Phosphorus BUN Creatinine Uric Acid Glucose (CS) Total Protein Albumin Globulin Albumin/Globulin ratio Total Bilirubin Direct Bilirubin Transaminase. SGO Transaminase. SGP Alkaline Phosphatase g|ron CLINICAL LABORATORY FINDINGS vs. * : EXPOSURJ STATUS.!,. n f fp ''f `53 52 TCP Runaway Exposed Tt^Abnormal) 0(0.DO) 0(0.00) >) Not Exposed i n tf(%Abnormal) !! 63 0(0.00)' 62 3(4.04) 53 5(9.43) 63 4(6.35) 52 1(1.92) 63. 0(0.00) 53 3(5.66) .62 2(3.23) 52 3(5.77) j ;o2 5(8.06) 53 1(1.69) 62 1(1.61) 53 0(0.00) 62 0(0.00) 53 0(0.00) 62 0(0.00) 53 % 53 53 lUjfJ) 0(0/00) 3(5.66) '62 0(0.00) 63 0(0.00) 63 4(6.35) 52 2(3.85) ! ;62 1(1.61) 52 2(3.05) 62- 1(1.61) 53 2(3.77) 63 2(3.17) 52 3(5V77) 62- 2(3.23) 53 1(1.89) 63 0(0.00) ff CLINICAL LABORATORY FINDINGS VS. j . EXPOSURE STATUS; Sodium Potassium Chloride G-glutamyl transpeptidase Thyroxine binding globulins CBC UBC RBC HGB HCT MCIIC1 MCH HCV '. differential CO Poly CO , . CO Lymph ^ Mono Eos j Basa TCP Runaway Exposed n T ( Abnormal) 53 ^ ;i'l2 53 53 53 2( 3.77) 0( 0.00) 1( 1.89) 4( 7.55) 12(22.64) 53 3( 5.66) 53 0( 0.00) 53 6(11.32) 53 7(13.21) 53 20(37.74) 53 6(11.32) 53 28(52.83) 53 1( 1.89) 53 2( 3.77) 53 1( 1.89) 53 0( 0.00) 53 0( 0.00) j Not Exposed r n #(%Abnorma1) ; 63 ; 62 ; 62 , 63 63 o( o.oo) 0( O.QQ) 2( 3.23) 1( 1.59) 16(25.40) ] 63 : 63 i 63 : 63 : 63 ; 63 : 63 3( 4.70) i( 1.59) 6( 9.52) 8(12.70) 13(20.63) 8(12.70) 27(42.86) J. 63 63 : 62 63 i 63 1( 1.59) 1( 1.59) 0( 0.00) 1( 1.59) 1( 1.59) I Urinalysis Acetone Albumin Bacteria Blood Glucose White Blood Cells CLINICAL LABORATORY FINDINGS VS. :I EXPOSURE STATUS :1 r.--n <* ; 52 52 52 52 52 52 TCP Runaway Exposed TfPositive) ' * \i 0(0.00) 1(1.92) 2(3.85) 0(0.00) 0(0.00) 1(1.92) : Not Exposed n f^Positive) ( . 63 63 63 63 63 ! 63 0( 0.00) 0( 0.00) 7(11.11) 1( 1.59) 1( 1.59) 3( 4.76) 1 O.OS <p< 0.10 for comparing TCP Exposed to Not Exposed L \ ^68C2 \ DEMOGRAPHIC DATA* ^ R e a c t i o n vs: Other Exposed AGE Mean t Standard Deviation Exposed (55) Other Exposed (77) 62.73 1 7.92 63.06 + 5.59 p N.S. HIGHEST EDUCATION LEVEL TCP Runaway. Exposed Percent 0 - Grade 9 - 12**1 Grade > 1 2 ^ Grade Total 7 41 _7 55 12.73 74.55 12.73 EMPLOYMENT STATUS P N.S. ... ... . TCP Runaway Exposed Percent Active Retired Terminated" Total - 13 23.64 32 58.18 10 18.18 55 0.01 <p< 0.05 Other Exposed 12 54 10 76** Other Exposed 35 37 5 77 Percent 15.79 71.05 13.16 Percent 45.45 48.05 6.49 * All subjects white males ** Information not available for one (1) subject 237895 FlnaiiSgus. SMOKINg STATUS* %9 TCP Runaway ^Exposed Percent Never Former Present Total 13 24 ^ IB 55 23.64 43.64 32.73 P N.S. Other Exposed 15 36 25 76 Percent 19.74 47.37 32.89 TCP EXPOSURE vs. PACK YEARS SMOKED* TCP Runaway Exposed (55) Other Exposed (73) Mean Standard Devi ation 36.66 t 36.13 27.13 t 26.01 * 0.05 <.p<0.10 for comparing TCP Exposed to Other Exposed EXPOSURE vs., ALCOHOL STATUS* ;. - TCP Runaway Exposed Percent Never...... Former Present Total 6 11.54 21 40.38 25 48.08 52 p N.S. Other Exposed 7 33 30 70 Percent 10.00 47.14 42.86 * For definition, see Appendix V 237896 237897. FAMILY HISTORY OF ILLNESS * Family History of TCP Runaway Exposed fn=T5T l% Asthma Hayfever Acne Eczema Hives Ulcers Colitis Heart Attack or Angina before Age 60 Heart Attack or Angina after Age 60 High Blood Pressure Cerebrovascular Accident {CVA) High Cholesterol Diabetes Liver Disease Nervous Disorder Inherited Disorder Cancer , !1 6 ; 4 4 4 4 8 4 17 21 20 18 4 10 2 8 2 24 10.91 7.27 7.27 7.27 7.27 14.55 7.27 30.91 38.18 36.36 32.73 7.27 18.18 3.64 14.55 3.64 43.64 * Includes Parents and Siblings of Subjects Other Exposed i% 12 15.58 Ii 3 : 3.90 9 * 11.69 6 7.79 8 10.39 12 15.58 7 9.09 19 i 26 24.68 33.77 * 23 25i 6 ;7 12 $ 31 29.87 32.47 7.79 23.38 9.09 15.58 6.49 40.26 Probability NS NS NS NS NS NS NS NS NS NS NS NS NS NS NS NS HISTORY OF MEDICAL PROBLEMS ' VS. EXPOSURE STATUS History of .^ Chloracne* Acne Vulgaris Fol 1iculItis Skin Cancer Chronic Obstructive Pulmonary Disease (COPD) Hypertension Arteriosclerosis Angina n Coronary Artery Disease Cerebrovascular Accident (CVA) Bladder Cancer Prostatic Disease Kidney Stones TCP Runaway Exposed Tn- 55) X ' 55 100.00 3 5.45 0 0.00 3 5.45 1 1.82 20 36.36 0 0.00 1 1.82 8 14.55 2 3.64 1 1.82 2 3.64 3 5.45 . Other Exposed ~ u ^ 7 ir~ * 64 83.12 5 6.49 0 0.00 5 6.49 2 2.60 25 32.47 0 0.00 0 0.00 10 12.99 4 5.19 1 1.30 3 3.90 7 9.09 237898 *0.001 < p < 0.01 for comparing TCP to Other Exposed; 237899 Finding Chloracne Acne Vulgaris Actinic Elastosis Actinic Keratosis Alopecia, circumscribed Acanthoma Basal Cell Epithelioma Depigmentation Dermatitis Irritant Nummular Seborrheic Stasis Dermatophytosis Onychomycosis Dupuytren's Contracture Peyronie's Disease Folliculitis Hirsutism Ichthyosis Vulgaris * Inrluclun CLINICAL FINDINGS* VS. EXPOSURE TCP Runaway Exposed {n= 55) . ?'' i % 32 58.18 0 0.00 41 74.55 6 10.91 0 0.00 1 1.82 5 9.09 1 1.82 0 1 1, 0 14 7 0 2 0 4 1 0.00 1.82 1.82 0.00 25.45 12.73 0.00 3.64 0.00 t7.27 1.82 ..Other Exposed (n^?7) " l% 43 55.84 0 0.00 .1 i 1" 1 52 67.53 l 12 15.58 .. . i. 0 0.00 i i*i 1 u 1.30 u iuj 6 7.79 n 0 0.00 ii * 0 o'.00 i.' 1/ 0 . 0.00 u iiii 5 1 6.49 ` 1..30 ii <*ii 24 ' 31.17 1 i-1 13 16.88 l'i ii iIl 0 0.00 i iii 0 ' 0.00 J in 1 1.30 5 6.49 1 1.30 \ Finding Lichen Simplex Chronicus Lipoma Melanoma, impression Miliaria Neurofibroma, multiple Poikiloderma Psoriasis Rhinophyma/Rosacea Squamous Cell Carcinoma, impression Xerosis Nervousness/Anxlety/ Depression Systolic murmur ** Diastolic murmur Decreased libido (H/0) H/0 Impotence, NOS \ CLINIj4E?''AL FINDINGS* VS. EXPOSURE TCP Runaway Exposed (na 55) .# % rf ~ 1 1.82 2 ' 3.64 0 0.00 0 0.00 1 1.82 0 0.00 1 1.82 0 0.00 0 0.00 0 0.00 12 21.82 7 12.73 . 0 0.00 13 23.64 9 16.36 * Not inclusive ** 0.01 < p < 0.05 for comparing TCP to Other Exposed Other Exposed % 3 3.90 1. 1.30 0 0.00 0 :0.00 0 0 .0 0 , 0, 0 .0 0 , 01 0 .0 0 , 4. 5.19, 1 % 1.30 1 1.30 | 13' 16.88' 1 1.30 Of/- 0.00 1$* 24.68' 7' 9; 09' 1i i9 1 1 -i d 4 \ J *0(4My Serum Lipid Cholesterol Triglycerides LDLt estimated HDL EXPOSURE^ vs. SERUM LIPID FINDINGS TCP Runaway Exposed r: n #(%Abnormal) 54 5 '( 9.26) 54 8 (14.81) 54 5 ( 9.26) 54 9 (16.67) Other Exposed n #(%Abnormal) 75 3 1 ( 4.00) 75 10 (13.33) 75 4 ( 5.33) 75 6 ( 8,00) \. 'M Probability NS NS NS NS 4i Serum Lipid Cholesterol Triglycerides LDL, estimated HOL C$O i\; *." Smoking Status Never Former Present Never Former Present EXPOSURE . vs. 1 SERUM LIPID FINDINGS BY SMOKING STATUS r JCP Runaway "Exposed n 1*r #()Abnomia11 1 Other Exposed n f(X)Abnormal l"I1il 111lt1, Probability li 12 1( 8:33) 24 2( 8.33) 18 2(11.11) 12 1( 8.33) 24 4(16.67) 10 3(16.67) . 15 35 24, j 0( 0.00) I 3( 8.57) 0( 0.00) 15 2(13.33) 35 , 6(17.14) 24 2( 8.33) % N.S. II N.S. N.S. ir. N.S. ... N.S. N.S. Never ' 12 Former \ 24 Present 18 1( 8.33) 2( 8.33) 2(11.11) 15: 0( 0.00) 35 3( 8.57) 24 1( 4.17) N.S. N.S. N.S. Never Former Present 12 1( 8.33) 24 4(16.67) 18 4(22.22) 15 2(13.33) 35 2{ 5.71) 24 ?( 8.33) t1 N.S. N.S. N.S. V. ' 237903 Pulmonary Function Parameter FEV1 FVC FEVj/FVC MMEFR EXPOSURE vs. PULMONARY TEST FINDINGS TCP Runaway Exposed (n= bb ) ,1 (%)Abnormal Other Exposed (n= 1 (t)Abnormal ) .? 11 20.00 : IS : 1 23.68 t 12 21.82 20 . 26.32 i i i 15 27.27 14 18.42 17 ' 30.91 22 . 28j.95 i* % \ 1. I( 1 1 Probability 1 1 1I N.S. li N.S. >1 1, N.S. li ll N.S. h ii u It Ii IJ II . * *, Pulmonary Function Parameter FEV1 FVC FEVX/FVC MMEFR EXPOSURE vs. PULMONARY TEST F1N01NGS BY SMOKING .STATUS Smoking Status Never Former Present Never Former Present Never Former Present Never Former Present TCP Runaway Exposed n rtTTn3TTAb normal " i! f a 1(&.69) 24 4(.67) 18 6(33.33) 13 1( 7.69) 24 6(25.00) 18 5(27.70) 13 24 18 13 24 % 18 2(15.30) 5(20.83) 8(44-44) 1 2(15.38) 6(25.00) 9(50.00) i M Other Exposed n ' #(%)Abnormal 14 2(14.29) 36 .. 6(16.67) '? 10(40.00) ft 36 25 4 2(14.29) 7(19.44) 11(44.00) 14 1( 7.14) 36 6(16.67) 25 7(28.00) 14 2(14.29) .36 9(25.00) 25 11(44.00) / N.S. N.S. N.S. N.S. N.S. N.S. N.S. N.S. N.S. N.S. N.S. N.S. Pit IS o, 8 Finding 1 Normal ECG1 ,1JP Negative ECG* Sinus Bradycardia Sinus Tachycardia PVC'S2 PAC's Atrial Fibrillation Intraventricular Conduction Defect Left Anterior Hemiblock Is* Degree AV Block Right Bundle Branch Block, complete Left Bundle Branch Block, complete Old Anterior Myocardial Infarct Old Inferior Myocardial Infarct True Posterior Myocardial Infarct Digitalis Effect EXPOSURE i' VS. ' ECG FINDINGS'; ii TCP Runaway Exposed 'Other Exposed #% .11 9 16.36 ; 30 38.96 1 25 45.45 ! ; 46 i 59.74 7 12.73 0 0.00 ; 3,:. 1 3.90 1.30 10 18.18 1 . 1.82 1 Si 5 . *i 6.4'9 ) 4 *1 ' 5.19 1 1.82 J 1 0 . 0.00 2 3.64 ; 1 " 1.30 15" 9.09 i, 0 0.00 : i ; 1.82 ii i 1.82 ; i 1.82 i 3 : 3,90 ! 1 1.30 i 4 . H 5-19 ?1 1.30 1 1.30 3 5.45 : : 3 3.90 0 0.00 ? 1 1.30 2 3.64 1 0 0.00 * Normal or not significant findings it 0.001< p <0.01 for comparing TCP to Other Exposed .05 0 ror par T C ~ ~ Q t Exf }1 906P2T Finding Left Ventricular Hypertrophy .,l'r` Right Ventricular Hypertrophy Left Atrial Hypertrophy Non-specific ST-T Wave Changes Low Voltage QRS Abnormal P Wave Left Axis Deviation Y EXPOSURE ys. ECG FINDINGS TCP . Runaway Exposed WW7 ii ' 3 5.45 0 0.00 0 0.00 2 3.64 1 1,82 2 3.64 0 0.00 ! Other Exposed ~ W TTT~ t* 3 3.90 0 0.00 1 1.30 4 5.19 0 0.00 5 6.49 1 1.30 237907 EXPOSURE i vs. CHEST X-RAY FINDINGS - Finding ' /' Normal Chest X-Ray Evidence, Old Granulomatous Disease Evidence, Arteriosclerosis Evidence, Degenerative Bone Disease Cardlomegaly Mass Chronic Obstructive Pulmonary Disease (COPD) Aortic Aneurysm Pulmonary Hypertension Blunted Costophrenic Angle Acute Parenchymal Disease ^ Elevated Hemi-diaphragms Pleural Thickening Parenchymal Scarring Possible Mass CjAortic Valve Disease ^Trauma TCP Runaway Exposed (n* 557 a* V 14 25.45 23 41.02 11 20.00 8 14.55 5 9.09 2 3.64 2 3.64 0 0.00 0 0.00 6 lo.yi 0 0.00 4 7.27 6 10.91 : 6 10.91 1 1.82 0 0.00 2 3.64 Other Exposed In 7) #X 28 36.36 26 33.77 12 15.50 6 7.79 3 3.90 1 1.30 5 6.49 i . 1.30 0 0.00 9 11.69 0 0.00 1 1.30 7 9.09 4 5.19 4 5.19 0 0.00 0 0.00 \mK ' . S) 1J 8064P2 CLINICAL LABORATORY.FINDINGS vs. EXPOSURE STATUS BLOOD ' 1 Calcium Phosphorus BUN* Creatinine Uric Acid Glucose (CS) Total Protein Albumin Globulin Albumin/Globulin ratio Total Bilirubin Direct Bilirubin Transaminase, SGO Transaminase, SGP Alkaline Phosphatase M0I1 ijlron TCP Runaway ixposed Other Exposed -- .J! 'Tf^Abnormal) : n #(%Abnormal) }'> i . 53 0(0.00) 52 0(0.00) 53 . 5(9.43) 52 1(1.92) 53 3(5.66) 52 3(5.77) 53 1(1.09) . 53 0(0.00) 53 0(0.00) 53 1(1.89) 'v 53 0(0.00) 53 3(5.66) 52 2(3.85) 52 2(3.85) 53 2(3.77) 52 3(5.77) 53 1(1.89) 73 ; ,70 73 73 73 70 73 ;73 73 73 73 73 70 70 73 7g - ' 73 0( 0.00) 1( 1.43) 1( 1.37) 1( 1.37) 3( 4.11) 8(11.43) 0( 0.00) 0( 0.00) 0( 0.00) 1( 1.37) 0( 0.00) 2( 2.74) 1( 1.43) 0( 0.00) 0( 0.00) 5( 7.14) 0( 0.00) 0.05 <p< 0.10 for comparing TCP to Other Exposed %* 237909 F Sodium Potassium Chloride G-glutamyl transpeptidase Thyroxine binding globulins CBC WBC RBC HGB HCT KCHC HCH MCV Differential Poly Lymph Mono EoS CLINICAL LABORATORY FINDINGS vs. ; EXPOSURE STATUS TCP Runaway 'V. Exposed Other Exposed T[%Abnormal) n |(%Abnormal) - i #3 2{ 3.77) i : 73 0( 0.00) 52 0( 0.00) : 70 2( 2.86) `53 1( 1.89) 73 0( 0.00) 53 4( 7.55) t 73 1( 1.37) 53 12(22.64)' :74 16(21.62) 53 3( 5.66) i ;73 2( 2.74) 53 0( 0.00) 73 0( 0.00) 53 6(11.32) 53 7(13.21) 73 7( 9.59) ,i 73 9(12.33) 53 20(37.74) 173 28(38.36) 53 6(11.32) :73 13(17.81) 53 28(52.83) 73 30(41.10) 53 1( 1.89) 53 2( 3.77) 53 1( 1.89) 53 0( 0.00) 53 0( 0.Q0) 7 3 3( 4.11) 73 3( 4.11) 73 0( 0.00) 73 2( 2.74} 73 0( 0.00)