Trial · NCT03721965
Registered outcomes29
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 29
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Phase 1: Number of Participants With Treatment-emergent Adverse Events (TEAEs) | up to 45 days | A TEAE was defined as an AE that began or worsened from Baseline after the first administration of study drug. |
| Primary | Phase 1: Cmax of Itacitinib When Administered With Corticosteroids | Day 1: 1, 2, 4, and 6 hours post-dose. Day 7: predose; 1, 2, 4, and 6 hours post-dose | Cmax was defined as the maximum observed plasma concentration. |
| Primary | Phase 1: Cmin of Itacitinib When Administered With Corticosteroids | Day 1: 1, 2, 4, and 6 hours post-dose. Day 7: predose; 1, 2, 4, and 6 hours post-dose | Cmin was defined as the minimum observed plasma concentration. |
| Primary | Phase 1: Tmax of Itacitinib When Administered With Corticosteroids | Day 1: 1, 2, 4, and 6 hours post-dose. Day 7: predose; 1, 2, 4, and 6 hours post-dose | Tmax was defined as the time to the maximum concentration. |
| Primary | Phase 1: AUC of Itacitinib When Administered With Corticosteroids | Day 1: 1, 2, 4, and 6 hours post-dose. Day 7: predose; 1, 2, 4, and 6 hours post-dose | AUC was defined as the area under the plasma concentration-time curve. |
| Primary | Phase 1: Cl/F of Itacitinib When Administered With Corticosteroids | Day 1: 1, 2, 4, and 6 hours post-dose. Day 7: predose; 1, 2, 4, and 6 hours post-dose | Cl/F was defined as the apparent oral dose clearance. |
| Primary | Phase 2: Overall Response Rate up to Day 28 | up to Day 28 | Overall response rate was defined as the number of participants demonstrating a complete response (CR), a very good partial response (VGPR), or a partial response (PR). |
| Secondary | Phase 2: Number of Participants With TEAEs | up to 12 months | A TEAE was defined as an AE that began or worsened from Baseline after the first administration of study drug. |
| Secondary | Phase 2: Cmax of Itacitinib When Administered With Corticosteroids | Day 7: predose; 1, 2, and 4 hours post-dose | Cmax was defined as the maximum observed plasma concentration. |
| Secondary | Phase 2: Cmin of Itacitinib When Administered With Corticosteroids | Day 7: predose; 1, 2, and 4 hours post-dose | Cmin was defined as the minimum observed plasma concentration. |
| Secondary | Phase 2: Tmax of Itacitinib When Administered With Corticosteroids | Day 7: predose; 1, 2, and 4 hours post-dose | Tmax was defined as the time to the maximum concentration. |
| Secondary | Phase 2: AUC of Itacitinib When Administered With Corticosteroids | Day 7: predose; 1, 2, and 4 hours post-dose | AUC was defined as the area under the plasma concentration-time curve. |
| Secondary | Phase 2: Cl/F of Itacitinib When Administered With Corticosteroids | Day 7: predose; 1, 2, and 4 hours post-dose | Cl/F was defined as the apparent oral dose clearance. |
| Secondary | Phase 2: Overall Response Rate up to 100 Days | up to 100 days | Overall response rate was defined as the number of participants demonstrating a CR, a VGPR, or a PR. |
| Secondary | Phase 1: Overall Response Rate | up to Day 28 | Overall response rate was defined as the number of participants demonstrating a CR, a VGPR, or a PR. |
| Secondary | Phase 2: Non Relapse Mortality | up to 24 months | Non relapse mortality was defined as the number of participants who died due to causes other than underlying hematologic disorders relapse. |
| Secondary | Phase 2: Duration of Response | up to approximately 12 months | Duration of response was defined as the time of the onset of response to the loss of response. |
| Secondary | Phase 2: Time to Response | up to approximately 12 months | Time to response was defined as the interval from treatment initiation to the first response. |
| Secondary | Phase 2: Relapse Rate of Malignant and Nonmalignant Disorders | up to approximately 12 months | Relapse rate was defined as the number of participants whose underlying disease relapsed. |
| Secondary | Phase 2: Malignant and Nonmalignant Disorders Relapse-related Mortality Rate | up to approximately 12 months | Mortality rate was defined as the number of participants whose underlying hematologic disorder relapsed and had a fatal outcome. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
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
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this list from software.
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GET https://conductscience.org/api/trials/v1/NCT03721965/registered