Document 5bMjj9e8zM8kzL6LK7XOr1eOJ

September 29, 2006 Page 3 ATTACHMENT 2 Tables and excerpts from the draft protocols that contain raw data C-8 blood levels . Preliminary analyses were conducted on the pregnancies data including 18,276 women yielding 48,007 pregnancies . Of those pregnancies, 17,263 women repo rted 41,408 pregnancies occurring in 1960 or later . Nearly 40% of the women reported three or more pregnancies, and 23% repo rted only one pregn ancy. Among the reported pregnancies, 11 .0% (4,569) ended in miscarriage and 0 .69 (287) ended in stillbirth. Among live births, 13 .7% (4,824) were reported to be preterm, 5.9% (2,069) were reported to be low bi rth weight, and 1 .7% (598) were term low birth weight . Preeclampsia was reported for 1,528 pregnancies. Birth defects were repo rted among 1,490 pregnancies, with the most common being congenital heart defects (275), club foot (91), eye defect (81), genitourinary defects (75), and oral clefts (52) . Given that these preliminary analyses were based on 52,000 records out of an expected total of 69,000 participants, constituting 75 .4% of the total, we generated the following estimates for the total number available for the analysis by multiplying the numbers by 1 .33 : 55,073 pregnancies after 1960 6,077 miscarriage s 382 stillbirths 48,614 live births 6,416 preterm births 2,752 low birth weight bi rths 795 term low birth weight bi rths 2,032 preeclampsia 1,982 birth defect s 366 congenital heart defects 121 club foot 108 eye defect s 100 genitourinary defects 69 oral clefts 3.8 Power Power is computed for 2 scenarios : comparing exposed to some extent (n=80k) to not exposed (n=420k) compari ng top 20% exposed areas (n=16k) to less exposed (n=64k) W0794491 .1 p. 2 September 29, 2006 Page 4 Power is presented in Table 3 .4 as the chance of being able to detect a significant result for a modest increase in RR (1 .25) in scenario I and a more substantial increase in RR 2 .0 in scenario 2. [With alpha 0 .05, two sided. Calculated with `sampsize' in STATA .] Note that this underestimates power relative to analyses that consider the full range of exposure or ordered categories, but ignores more complex models with multiple covariates which can reduce power somewhat. Nonetheless, these estimates convey a good impression of the magnitudes of association we will be capable of detecting . Table 3 .4 Summary of power calculations % Power to detect RR of: 1 .25 2 .0 80k vs 420k) 16k vs . 64k) Bladder 88 8 8 Breast (fem) 100 100 Kidney 65 94 Liver 25 50 Pancreas 54 87 Testes 30 58 All 89 (RR 1 .05) 100 (RR 1 .25) 3.1 Study population Brookmar are currently nearing completion of the C8 health project . They anticipate completing data collection in May/June 2006, and carrying out some data cleaning and validation over the subsequent months . We can expect a provisional data set from Brookmar shortly after June and a final dataset around December 2006 . We have received and have been able to examine provisional data for the first 30,000 participants and (for fewer variables 50,000) which have been very useful for assessing patterns of available data . C8 has been measured in all participants, and included in the questionnaire were questions on whether they had every been diagnosed with cancer, a list of specific named cancers, and in each case the year of diagnosis was requested . Based on reported diagnoses of cancer in the first 30,000 participants, the reported numbers and prevalence (all ages) of each cancer site is given in table 3 . 1 Of the sites of primary interest liver and pancreas have low survival so self reported cases in survivors will be uninformative. This leaves Bladder, Breast, Kidney, Skin and Testes with 106, 559, 113, 1135 and 59 cases, respectively . W0794491 .1 p. 3 September 29, 200 6 Page 5 Table 3 .1 Numbers and prevalence of participants reporting diagnoses of cancer in first tranche of 30,629 participants in C8 health project and estimated numbers to be expected in complete dataset . Sites with more interest for follow up are highlighted and the typical 5 year % survival is shown, for these sites . Site #/ % #/ % 5 year survival 30,629 prevalence 69,000 ACS 1995-2001) MOW(* 47 0.15 106 82 Btood 27 0.09 61 Bone 17 0.06 38 Brain 13 0.04 29 248 0 .81 559 88 Cervix 319 1 .04 71 9 Colon 110 0.36 248 Esophagus 19 0.06 43 Gall bladder 1 0.01 2 Kd ney 50 0.16 113 65 Larynx 19 0 .06 4 3 Leukemia 27 0 .09 6 1 3 0.01 7 9 Lungs 56 0 .18 12 6 Lymphoma Melanoma 65 0 .21 14 6 142 0 .46 320 92 Mouth 19 0 .06 4 3 Ovarian 71 0 .23 16 0 Pancreas 2 0 .01 5 4 Prostate 174 0.57 392 Rectum 20 0 .07 4 5 Skin 504 1 .65 1135 100 Stomach 8 0 .03 1 8 Testes 26 0 .08 59 Thyroid 34 0 .11 7 7 96 Uterine 94 0 .31 212 Total 2 1 15 6 .91 4765 Figure 3 .1 Distribution of log C8 in blood o s w W0794491 .1