Comparison · NCT03139604-adbd7573
Itacitinib Plus Corticosteroids vs Placebo Plus Corticosteroids: Number of Treatment-emergent Adverse Events With INCB39110
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. Itacitinib Plus Corticosteroids vs Placebo Plus Corticosteroids: Number of Treatment-emergent Adverse Events With INCB39110. Trial comparisons, record NCT03139604-adbd7573. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03139604-adbd7573
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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 | 0.967 | 0.934 | 0.984 | wilson | |
| Risk in group 2 | 0.991 | 0.967 | 0.997 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0233 | -0.0571 | 0.00583 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.976 | 0.95 | 1 | log | |
| Odds ratio, group 1 over group 2 | 0.278 | 0.057 | 1.35 | log | |
| Number needed to treat, for one fewer participant with the outcome on Itacitinib Plus Corticosteroids than on Placebo Plus Corticosteroids | 42.9 | 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. | 208 | 215 | 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. | 214 | 216 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Treatment-emergent Adverse Events With INCB39110
- Description
- Adverse events reported for the first time or worsening of a pre-existing event after the first dose of study treatment
- Time frame
- 30-35 days after end of treatment, approximately 24 months
- Population
- Safety Analysis Set
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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