Question 1: How to treat subjects who died of prostate cancer but did not have any post baseline biopsy ?

*Subjects who do not have a post-baseline biopsy but are indicated as experiencing death due to prostate cancer will not be counted as prostate cancer events for the primary analyses. The rationale here is that it is desired to have all prostate cancers confirmed by the Central Pathology Lab to ensure a consistent approach. Such a situation should be rare but could come about if a local diagnosis is made but the tissue does not, for whatever reason, get reviewed centrally. These subjects will be included in the risk set for years 1-2 for the crude rate approach but not for the modified crude rate approach. Note that these subjects would count as events in Table E34 (summary of PCa based on Central and Local Pathology results).

These deaths will be summarized in Table E104 (overall survival and PCa-related deaths), and also will be included in Table E30 (time to death or prostate cancer).

Question 2: This question is related to items (A) Crude Rate Approach in the second two-year period (years 3-4). (B) Modified Crude Rate Approach in the first two-year period (years 1-2).

Does "after month 18" mean after month 18, but before month 24 for both (A) and (B) ?

*Yes that is correct - that is, it means occurring during the first 2-year period after month 18.
Topic revision: r2 - 19 Dec 2014, JoAnnAlvarez

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