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SITUATION:
- Phase III study randomized study comparing 2 drugs (Drug1 and Drug2) following chemotherapy in patients with newly diagnosed FLT3-mutated acute myeloid leukemia
- Randomized study using a 1:1 minimization algorithm based on 6 stratification factors
- Early result review and observation:
- 187 patients randomized (94/drug1 : 93/drug2)
- 27 patients identified with an important biomarker that could potentially impact the outcome
- 10 events were observed among the 27 patients
- Imbalance treatment allocation for those patients (10/drug1 : 17/drug2
SPONSOR’S REQUEST:
Integrate that biomarker as a stratification factor (replace or add stratification factor)
Discover how IDDI supported a Sponsor to reach the overall balance amongst 2 arms by adding a stratification factor.
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