No, I never said all reqs were exactly the same, j
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Posted On: 01/01/2021 1:50:45 PM
No, I never said all reqs were exactly the same, just the part about vasopressors. Both CD12 & eIND exclude vasopressors > 48 hours. However, eIND differs from CD12 by excluding intubated patients with moderate ARDS (mechanically ventilated with PEEP <15 cmH20 with Pa02/FiO2 >150 mmHg). This criteria is included in CD12. The other part was about m/m population but we already knew that.
eIND (from PR)
"The agency specified certain subgroups of patients will be excluded from the eIND authorization process: ...mechanically ventilated with PEEP <15 cmH20 with Pa02/FiO2 >150 mmHg..."
CD12 (from clinicaltrials.gov)
"Inclusion Criteria:
3. Subject, if intubated, positive endexpiratory pressure (PEEP) <15 cmH2O with PaO2/FiO2 >150 mmHg."
eIND (from PR)
"The agency specified certain subgroups of patients will be excluded from the eIND authorization process: ...mechanically ventilated with PEEP <15 cmH20 with Pa02/FiO2 >150 mmHg..."
CD12 (from clinicaltrials.gov)
"Inclusion Criteria:
3. Subject, if intubated, positive endexpiratory pressure (PEEP) <15 cmH2O with PaO2/FiO2 >150 mmHg."
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