Comparison · NCT03139604-bb7cc004
Itacitinib Plus Corticosteroids vs Placebo Plus Corticosteroids: Incidence Rate of Secondary Graft Failure
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
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ConductScience Library. Itacitinib Plus Corticosteroids vs Placebo Plus Corticosteroids: Incidence Rate of Secondary Graft Failure. Trial comparisons, record NCT03139604-bb7cc004. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03139604-bb7cc004
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.00913 | 0.00251 | 0.0327 | wilson | |
| Risk in group 2 | 0 | 0 | 0.0172 | wilson | |
| Risk difference, group 1 minus group 2 | 0.00913 | -0.00926 | 0.0327 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | log | a group has no participants with the outcome | |||
| Odds ratio, group 1 over group 2 | log | a cell of the two-by-two table is zero | |||
| Number needed to treat, for one more participant with the outcome on Itacitinib Plus Corticosteroids than on Placebo Plus Corticosteroids | 110 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Itacitinib Plus Corticosteroids | Itacitinib was administered at a starting dose of 200 mg orally once daily QD (2 × 100 mg tablets) in combination with steroids i.e. methylprednisolone 2 mg/kg IV daily (or prednisone equivalent) or at a dose that is appropriate for the severity of the disease. | 2 | 219 | OG000 |
| Group 2 | Placebo Plus Corticosteroids | Matching placebo was administered orally once daily QD in combination with steroids i.e. methylprednisolone 2 mg/kg IV daily (or prednisone equivalent) or at a dose that is appropriate for the severity of the disease. | 0 | 220 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Incidence Rate of Secondary Graft Failure
- Description
Defined as \> 95% recipient cells any time after engraftment with no signs of relapse, OR retransplantation because of secondary neutropenia (\< 0.5 × 109/L) and/or thrombocytopenia (\< 20 × 109/L) within 2 months of transplantion
- Time frame
- Randomization through end of Study, study duration expected to average 24 months
- Population
- Full Analysis Set (FAS) Population
Source ClinicalTrials.gov
Trial
- Title
- GRAVITAS-301: A Study of Itacitinib or Placebo in Combination With Corticosteroids for Treatment of Acute Graft-Versus-Host Disease
- NCT number
- NCT03139604
- Phases
- PHASE3
- Conditions
- Graft-versus-host Disease (GVHD)
- Interventions
- Itacitinib, Placebo, Prednisone, Methylprednisolone
- Lead sponsor
- Incyte Corporation
- Results first posted
- 2020-05-15
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03139604?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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