Comparison · NCT03584516-0787a1dc
Part 1: Itacitinib 200 mg QD + CS vs Part 1: Itacitinib 300 mg QD + CS: Part 1: Number of Participants With Dose-limiting Toxicities (DLTs)
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. Part 1: Itacitinib 200 mg QD + CS vs Part 1: Itacitinib 300 mg QD + CS: Part 1: Number of Participants With Dose-limiting Toxicities (DLTs). Trial comparisons, record NCT03584516-0787a1dc. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03584516-0787a1dc
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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 | 0 | 0.259 | wilson | |
| Risk in group 2 | 0.1 | 0.0179 | 0.404 | wilson | |
| Risk difference, group 1 minus group 2 | -0.1 | -0.404 | 0.172 | 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 fewer participant with the outcome on Part 1: Itacitinib 200 mg QD + CS than on Part 1: Itacitinib 300 mg QD + CS | 10 | 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 | Part 1: Itacitinib 200 mg QD + CS | Participants were treated with oral itacitinib 200 milligrams (mg) once daily (QD) + corticosteroids (CS) for a maximum of 36 months. CS were given at a starting dose of 0.5 to 1.0 mg/kilogram (kg) QD (prednisone or methylprednisolone equivalent to prednisone dose). Itacitinib treatment was to continue until treatment failure (chronic graft-versus-host disease \[cGVHD\] progression, death, or initiation of new systemic cGVHD therapy), unacceptable toxicity, or withdrawal of consent, for a maximum of 36 months. | 0 | 11 | OG000 |
| Group 2 | Part 1: Itacitinib 300 mg QD + CS | Participants were treated with oral itacitinib 300 mg QD + CS for a maximum of 36 months. CS were given at a starting dose of 0.5 to 1.0 mg/kg QD (prednisone or methylprednisolone equivalent to prednisone dose). Itacitinib treatment was to continue until treatment failure (cGVHD progression, death, or initiation of new systemic cGVHD therapy), unacceptable toxicity, or withdrawal of consent, for a maximum of 36 months. | 1 | 10 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Part 1: Number of Participants With Dose-limiting Toxicities (DLTs)
- Description
A DLT was defined as the occurrence of any protocol-defined toxicity with onset up to and including Day 28, except those with a clear alternative explanation. Participants who received at least 21 of 28 doses of study drug at the level assigned or had a DLT were considered evaluable for determining tolerability of the dose. Participants who did not achieve this duration of exposure and did not have a DLT were to be replaced for purposes of toxicity identification.
- Time frame
- up to Day 28
- Population
Safety Analysis Set: all enrolled/randomized participants who received at least 1 dose of study drug and/or reference therapy. Treatment groups for this population were determined according to the actual treatment the participant received regardless of assigned study drug treatment.
Source ClinicalTrials.gov
Trial
- Title
- GRAVITAS-309: Itacitinib and Corticosteroids as Initial Treatment for Chronic Graft-Versus-Host Disease
- NCT number
- NCT03584516
- Phases
- PHASE2, PHASE3
- Conditions
- Chronic Graft-versus-host Disease
- Interventions
- Itacitinib, Placebo, Methylprednisolone, Prednisone
- Lead sponsor
- Incyte Corporation
- Results first posted
- 2025-01-27
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03584516?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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