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Vaccines, Blood & Biologics

Survival Analysis Program for Study 9901 - Provenge, November 28, 2006

(System Info - 126781 Kim Helen 04/22/2010 19:05:34 TULL)

From: Zhen, Boguang (CBER)
Sent: Tuesday, November 28, 2006 8:36 AM
To: 'Harmon, Matt'
Cc: 'Yuh, Lianng'; 'Smith, Liz'; Tull Lori; Liu, Ke
Subject: survival analysis program for study 9901


Dear Matt,

I have the following questions while I was running some additional survival
analyses for Study 9901.

  1. In the attached SAS program, I tried to duplicate the results presented in
    Figure 8 of your study report (p79) and to repeat the same analysis using all
    available follow-up data (not just cut-off at 36 months as in Figure 8). Could
    you check the program to make sure that I used the right variables/datasets?
  2. In Figure 3 of your study report, it shows that one patient lost to follow-up.
    However, from the results of the above survival analysis program and Figure 8,
    we could not see a censored patient before 36 months. Could you tell us this
    patient?s ID and how you dealt with this patient in survival analysis?
  3. Patient 9124_152 had death date, but the cause of death (DCUASEDC in DEATH.XPT)
    for this patient is missing. Does it mean the cause of death for this patient
    is unknown?
  4. Do you have more follow-up data beyond 36 months for the 25 patients who were
    still alive based on the last contact information, especially the five in the
    placebo control?
  5. I also tried to start running Cox regression model. It would be very helpful if
    you could tell me the datasets you used to obtain all covariates for the
    analysis. I tried to look at your SAS program, but it seems not quite easy for
    me to understand the program due to many macro procedures (though fully
    understandable why you were using macros).

Thanks in advance for your help.



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