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Vertex Pharmaceuticals Incorporated Message Board

  • tom_b1shop tom_b1shop Aug 18, 2008 5:33 PM Flag

    LMAO, the 16 pnts were fm low-riba control arm

    you guys were full of it!!!!

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    • The reduced Riba arm, which received full dose of Boc and IFN, is compared against all other arms in the trial. There is no separate arm other than shown in the following link.
      If you click the following webpage:

      http://clinicaltrials.gov/ct/show/NCT00423670?order=2,

      you’ll find all SCH trial regimens and no arm distinct from below:
      Arm 1____PegIntron and ribavirin for 48 weeks (Control)
      Arm 2____ PegIntron, ribavirin, and SCH 503034 for 28 weeks
      Arm 3____ 4 weeks lead-in followed by PegIntron, ribavirin and SCH 503034 for 24 weeks
      Arm 4____ PegIntron, ribavirin and SCH 503034 for 48 weeks
      Arm 5____ 4 weeks lead-in followed by PegIntron, ribavirin and SCH 503034 for 44 weeks
      Arm6_____ PegIntron, Reduced ribavirin and SCH 503034 for 48 weeks

      Arms ____No. of patients__SVRed pts___% SVR___% Dropout
      Control_________104________39________38%_______14%
      No lead-in 28wk__107________59________55%_______28%
      Lead-in 28 wk____103________58________56%_______26%
      No lead-in 48wk__103________68________66%____not reported
      Lead-in 48wk_____103________76_______73%____not reported
      Reduced Riba______59

      Documented # of patients___579
      # of patients enrolled _______595
      Undocumented # of pts______16

      What one should notice is that % dropouts for the lead-in 48 wk arm (Arm 5 above) should have at the minimum 26% (more like the double the number because this arm received Boc for 44 wks, in comparison to 24 wks for Arm 3)).
      Let us be very very generous and say the dropout rate at EOT was only 26%. Then 73% SVRed +26% dropouts = 99%. This means that the sum of the relapsed and discontinued make up only the remaining one % of 103 patients in the arm. This says that only one patient relapsed or discontinued in the period between the end of treatment and at the 12th wk post-treatment at which point the SVR12 was determined. This is highly unlikely.

      • 2 Replies to thirdmeinvestor
      • The table was too long and folded and unintelligible. Try again:

        Arms __No. of patients_SVRed pts_% SVR_% Dropout
        Control_______104_____39___38%__14%
        No lead-in 28wk_107____59___55%__28%
        Lead-in 28 wk___103____58___56%__26%
        No lead-in 48wk_103____68___66%_not reported
        Lead-in 48wk___103____76___73%_not reported
        Reduced Riba____59

        Documented # of patients___579
        # of patients enrolled _______595
        Undocumented # of pts______16



        What one should notice is that % dropouts for the lead-in 48 wk arm (Arm 5 above) should have at the minimum 26% (more like the double the number because this arm received Boc for 44 wks, in comparison to 24 wks for Arm 3)).
        Let us be very very generous and say the dropout rate at EOT was only 26%. Then 73% SVRed +26% dropouts = 99%. This means that the sum of the relapsed and discontinued make up only the remaining one % of 103 patients in the arm. This says that only one patient relapsed or discontinued in the period between the end of treatment and at the 12th wk post-treatment at which point the SVR12 was determined. This is highly unlikely.

      • very nice research. Here is the quote from the purpose of the trial, note it says 5 arms plus the comparator:

        "This is a Phase 2, randomized, 5-arm, comparative, open-label safety and efficacy study comparing treatment with PegIntron (1.5 µg/kg QW) plus ribavirin (800-1400 mg/day) to treatment with SCH 503034 800 mg TID plus PegIntron (1.5 µg/kg QW) and ribavirin (800-1400 mg/day) in adult treatment-naïve subjects with genotype 1 CHC infection. The 5 arms of the study will compare: PegIntron and ribavirin for 4 weeks followed by PegIntron, ribavirin and SCH 503034 for 44 weeks (Arm 5) versus PegIntron, ribavirin and SCH 503034 for 48 weeks (Arm 4) versus PegIntron and ribavirin for 4 weeks followed by PegIntron, ribavirin and SCH 503034 for 24 weeks (Arm 3) versus PegIntron, ribavirin, and SCH 503034 for 28 weeks (Arm 2) versus PegIntron and ribavirin for 48 weeks (control, Arm 1). Follow-up is for up to 72 weeks after randomization. Efficacy (HCV-RNA), safety (physical examinations, vital signs, recording of adverse events, and clinical laboratory tests) assessments will be made."

        In the table below that quote, 4 and 6 are the same.

    • No, actually it proves we were right. There WERE 16 missing patients, all it shows now is, where they apparently were.

      For those who said there were NOT 16 missing patients, well 16 showed up today posted on another board (although we haven't seen links on it yet).

      I KNEW that some would spin this.

 
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