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CONFIDENTIAL DO NOT COPY OR RELEASE Thimerosal VSD study Phase I Update 2/29/00 Thomas Verstraeten, Robert Davis, Frank DeStefano ] CONFIDENTIAL DO NOT COPY OR RELEASE Following is an update on the proceedings and findings so far of the first phase of this Proposed two phased study. Thave used the original protocol as outline for this update Study design: Retrospective cohort study using the Vaccine Safety Datalink (VSD) automated deta to children who meet the following criteria: 1. Bom in 199% or later. ‘gible HNO member since birth (Le, “bom into the MO"). 3. Continuous'y enrolled he first birth ‘The following children were excluded from the analyses: + Premanire and severe premature children. Premawurity was defined as birthweight of 1000-2499 grams or gestational 7 completed w i OF less than 1000 g or less than 28 completed weeks, We children by the ICDS code 765, ildren thar did not receive two polio va ines by the age his condition was set to avoid inciudine children enrolied in the HMO did not use the services. Police was considered ti most commoniy accepted vaccination hhildren that receive hepatitis 5 immunogiobuiin, as these were more li ely to have higher exposure and outcome ieveis © Children that had ti e diagnos’ faich the exposure was assess * Children in whom any majo: ‘genital or perinatal problem occurred (ineluding any ‘unspecified problem involving the cardiac, respiratory or central nervous system). © Children that remain: ‘the birth hospita! or were hospitalized for any periog over 2 29/00 ~ CONFIDENTIAL DO NOT COPY OR RELEASE Case definition: A case was defined as any child that was diagnosed with one of the neurologic or renal conditions, listed in the annex. No distinction was made on whether a diagnosis was made in the clinic or hospital sett Exposure assessment Age-related cumulative exposure levels were derived from the automated data at 1 and 3 months of age. Confounders and Effect Modiffe wnalyses: HMO site, year and moith of proportionel hazards model for all zisk analyses, stratified by site, vear and month of birth and adjusted for gend ‘The startpoint wes the date of dirth or Jan !" 95 for chiidren born into NCK before this date (no OPD data availabie endpoin: was defined as the rs: of the following dates: © the date of firs: diagnosis ig enrolled in the HMO ‘The diagnoses we: jories (neurolo; developmental and renal) and individual! ountered at jeast 5G cases. Because of the low number of of specificity of the ICD9 codes ) we did no: pursue analyses of the “degenerative neurologic” and "other neurologic” categories as ¢ TOUup but only for the foliowing diagnoses: epilepsy. acquired obstructive hyd ‘pha andi