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DewDiligence

07/25/17 12:32 PM

#212631 RE: DewDiligence #212627

Housekeeping note: iHub has a bug whereby the “≥” symbol shows up in the title bar as “=” even though it displays correctly in the message body. See #msg-133276416, for instance.

Moreover, if a message is edited one or more times, the “≥” symbol is erroneously displayed as “=”.
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biomaven0

07/25/17 2:52 PM

#212637 RE: DewDiligence #212627

>>observed imbalance in thromboembolic events

Out of some 3,100 patients there were apparently five events:

Thromboembolic events – diagnosed as deep venous thrombosis (DVT) and pulmonary embolism (PE) – were reported in five patients receiving baricitinib during the controlled period of two of seven completed Phase 2 or Phase 3 trials in RA. Although an imbalance was observed during the placebo controlled period of the RA clinical trials, the rate of these events in the overall baricitinib clinical program was consistent with that seen among the general population of treated RA patients.



Pretty hard to prove for sure that isn't an issue - would need a really big trial. Paradoxically, the harder you look for these events the more you see, so the rate would go up some (in both placebo and drug arms) if they specifically look for this.

Peter