SS P08 08Oct2014 Standard Scripts Project 08 Meeting

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Meeting Record

When: 08 October 2014
Place: Teleconference
Facilitator: Mary Nilsson
Scribe: Mary Nilsson
Attendance: Mohammad, Christos, Frank, Terry, Mercy, Aiming, Simin, Nancy, Ann, Wei

  1. Hepatotoxicity white paper


  • We might want more on central vs local labs - We believe medical opinion is to keep separate.
  • If observe a value >x, a CRF is turned on and local follow-up data is collected.
  • Table 7.1 - Keep p-values on each row
  • Wording of "haptotoxicity signal" - to Hepatic-related
  • Keep total column off (only in demographics)
  • Figure 7.1 Wei will send latest figure to Terry
  • Table 7.3 SMQ table - make consistent with AE white paper. Figure instead? We don't think so.
  • Figure 7.2 (patient profile) Wei will send her version of hepatic patient profile
  • We should expect a debate on individual study versus integrated
  • Time to event - concerns with this for scheduled things like labs (different than AEs)

  • Last revision by Jmbodart,10/13/2015