| Primary | Phase 1: Number of Participants With Treatment-emergent Adverse Events (TEAEs) | A TEAE was defined as an AE that began or worsened from Baseline after the first administration of study drug. | All enrolled participants | Posted | | Count of Participants | | Participants | | up to 45 days | | | | ID | Title | Description |
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| OG000 | Cohort 1 : Itacitinib + Corticosteroids | Itacitinib was administered once a day orally in combination with corticosteroids as per local treatment guidelines. |
| | | Title | Denominators | Categories |
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| Primary | Phase 1: Cmax of Itacitinib When Administered With Corticosteroids | Cmax was defined as the maximum observed plasma concentration. | Due to the small sample size (n=2), data cannot be reported without risking participant re-identification. Data are not being reported in order to protect participants' privacy. | Posted | | | | | | Day 1: 1, 2, 4, and 6 hours post-dose. Day 7: predose; 1, 2, 4, and 6 hours post-dose | | | | ID | Title | Description |
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| OG000 | Cohort 1 : Itacitinib + Corticosteroids | Itacitinib was administered once a day orally in combination with corticosteroids as per local treatment guidelines. |
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| Primary | Phase 1: Cmin of Itacitinib When Administered With Corticosteroids | Cmin was defined as the minimum observed plasma concentration. | Due to the small sample size (n=2), data cannot be reported without risking participant re-identification. Data are not being reported in order to protect participants' privacy. | Posted | | | | | | Day 1: 1, 2, 4, and 6 hours post-dose. Day 7: predose; 1, 2, 4, and 6 hours post-dose | | | | ID | Title | Description |
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| OG000 | Cohort 1 : Itacitinib + Corticosteroids | Itacitinib was administered once a day orally in combination with corticosteroids as per local treatment guidelines. |
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| Primary | Phase 1: Tmax of Itacitinib When Administered With Corticosteroids | Tmax was defined as the time to the maximum concentration. | Due to the small sample size (n=2), data cannot be reported without risking participant re-identification. Data are not being reported in order to protect participants' privacy. | Posted | | | | | | Day 1: 1, 2, 4, and 6 hours post-dose. Day 7: predose; 1, 2, 4, and 6 hours post-dose | | | | ID | Title | Description |
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| OG000 | Cohort 1 : Itacitinib + Corticosteroids | Itacitinib was administered once a day orally in combination with corticosteroids as per local treatment guidelines. |
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| Primary | Phase 1: AUC of Itacitinib When Administered With Corticosteroids | AUC was defined as the area under the plasma concentration-time curve. | Due to the small sample size (n=2), data cannot be reported without risking participant re-identification. Data are not being reported in order to protect participants' privacy. | Posted | | | | | | Day 1: 1, 2, 4, and 6 hours post-dose. Day 7: predose; 1, 2, 4, and 6 hours post-dose | | | | ID | Title | Description |
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| OG000 | Cohort 1 : Itacitinib + Corticosteroids | Itacitinib was administered once a day orally in combination with corticosteroids as per local treatment guidelines. |
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| Primary | Phase 1: Cl/F of Itacitinib When Administered With Corticosteroids | Cl/F was defined as the apparent oral dose clearance. | Due to the small sample size (n=2), data cannot be reported without risking participant re-identification. Data are not being reported in order to protect participants' privacy. | Posted | | | | | | Day 1: 1, 2, 4, and 6 hours post-dose. Day 7: predose; 1, 2, 4, and 6 hours post-dose | | | | ID | Title | Description |
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| OG000 | Cohort 1 : Itacitinib + Corticosteroids | Itacitinib was administered once a day orally in combination with corticosteroids as per local treatment guidelines. |
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| Primary | Phase 2: Overall Response Rate 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). | No participants enrolled in Phase 2 due to early termination of the study. | Posted | | | | | | up to Day 28 | | | | ID | Title | Description |
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| OG000 | Cohort 1 : Itacitinib + Corticosteroids | Itacitinib was administered once a day orally in combination with corticosteroids as per local treatment guidelines. |
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| Secondary | Phase 2: Number of Participants With TEAEs | A TEAE was defined as an AE that began or worsened from Baseline after the first administration of study drug. | No participants enrolled in Phase 2 due to early termination of the study. | Posted | | | | | | up to 12 months | | | | ID | Title | Description |
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| OG000 | Cohort 1 : Itacitinib + Corticosteroids | Itacitinib was administered once a day orally in combination with corticosteroids as per local treatment guidelines. |
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| Secondary | Phase 2: Cmax of Itacitinib When Administered With Corticosteroids | Cmax was defined as the maximum observed plasma concentration. | No participants enrolled in Phase 2 due to early termination of the study. | Posted | | | | | | Day 7: predose; 1, 2, and 4 hours post-dose | | | | ID | Title | Description |
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| OG000 | Cohort 1 : Itacitinib + Corticosteroids | Itacitinib was administered once a day orally in combination with corticosteroids as per local treatment guidelines. |
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| Secondary | Phase 2: Cmin of Itacitinib When Administered With Corticosteroids | Cmin was defined as the minimum observed plasma concentration. | No participants enrolled in Phase 2 due to early termination of the study. | Posted | | | | | | Day 7: predose; 1, 2, and 4 hours post-dose | | | | ID | Title | Description |
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| OG000 | Cohort 1 : Itacitinib + Corticosteroids | Itacitinib was administered once a day orally in combination with corticosteroids as per local treatment guidelines. |
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| Secondary | Phase 2: Tmax of Itacitinib When Administered With Corticosteroids | Tmax was defined as the time to the maximum concentration. | No participants enrolled in Phase 2 due to early termination of the study. | Posted | | | | | | Day 7: predose; 1, 2, and 4 hours post-dose | | | | ID | Title | Description |
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| OG000 | Cohort 1 : Itacitinib + Corticosteroids | Itacitinib was administered once a day orally in combination with corticosteroids as per local treatment guidelines. |
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| Secondary | Phase 2: AUC of Itacitinib When Administered With Corticosteroids | AUC was defined as the area under the plasma concentration-time curve. | No participants enrolled in Phase 2 due to early termination of the study. | Posted | | | | | | Day 7: predose; 1, 2, and 4 hours post-dose | | | | ID | Title | Description |
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| OG000 | Cohort 1 : Itacitinib + Corticosteroids | Itacitinib was administered once a day orally in combination with corticosteroids as per local treatment guidelines. |
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| Secondary | Phase 2: Cl/F of Itacitinib When Administered With Corticosteroids | Cl/F was defined as the apparent oral dose clearance. | No participants enrolled in Phase 2 due to early termination of the study. | Posted | | | | | | Day 7: predose; 1, 2, and 4 hours post-dose | | | | ID | Title | Description |
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| OG000 | Cohort 1 : Itacitinib + Corticosteroids | Itacitinib was administered once a day orally in combination with corticosteroids as per local treatment guidelines. |
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| Secondary | Phase 2: Overall Response Rate up to 100 Days | Overall response rate was defined as the number of participants demonstrating a CR, a VGPR, or a PR. | No participants enrolled in Phase 2 due to early termination of the study. | Posted | | | | | | up to 100 days | | | | ID | Title | Description |
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| OG000 | Cohort 1 : Itacitinib + Corticosteroids | Itacitinib was administered once a day orally in combination with corticosteroids as per local treatment guidelines. |
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| Secondary | Phase 1: Overall Response Rate | Overall response rate was defined as the number of participants demonstrating a CR, a VGPR, or a PR. | The study was terminated before participants reached Day 28, the time point for analysis. | Posted | | | | | | up to Day 28 | | | | ID | Title | Description |
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| OG000 | Cohort 1 : Itacitinib + Corticosteroids | Itacitinib was administered once a day orally in combination with corticosteroids as per local treatment guidelines. |
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| Secondary | Phase 2: Non Relapse Mortality | Non relapse mortality was defined as the number of participants who died due to causes other than underlying hematologic disorders relapse. | No participants enrolled in Phase 2 due to early termination of the study. | Posted | | | | | | up to 24 months | | | | ID | Title | Description |
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| OG000 | Cohort 1 : Itacitinib + Corticosteroids | Itacitinib was administered once a day orally in combination with corticosteroids as per local treatment guidelines. |
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| Secondary | Phase 2: Duration of Response | Duration of response was defined as the time of the onset of response to the loss of response. | No participants enrolled in Phase 2 due to early termination of the study. | Posted | | | | | | up to approximately 12 months | | | | ID | Title | Description |
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| OG000 | Cohort 1 : Itacitinib + Corticosteroids | Itacitinib was administered once a day orally in combination with corticosteroids as per local treatment guidelines. |
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| Secondary | Phase 2: Time to Response | Time to response was defined as the interval from treatment initiation to the first response. | No participants enrolled in Phase 2 due to early termination of the study. | Posted | | | | | | up to approximately 12 months | | | | ID | Title | Description |
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| OG000 | Cohort 1 : Itacitinib + Corticosteroids | Itacitinib was administered once a day orally in combination with corticosteroids as per local treatment guidelines. |
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| Secondary | Phase 2: Relapse Rate of Malignant and Nonmalignant Disorders | Relapse rate was defined as the number of participants whose underlying disease relapsed. | No participants enrolled in Phase 2 due to early termination of the study. | Posted | | | | | | up to approximately 12 months | | | | ID | Title | Description |
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| OG000 | Cohort 1 : Itacitinib + Corticosteroids | Itacitinib was administered once a day orally in combination with corticosteroids as per local treatment guidelines. |
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| Secondary | Phase 2: Malignant and Nonmalignant Disorders Relapse-related Mortality Rate | Mortality rate was defined as the number of participants whose underlying hematologic disorder relapsed and had a fatal outcome. | No participants enrolled in Phase 2 due to early termination of the study. | Posted | | | | | | up to approximately 12 months | | | | ID | Title | Description |
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| OG000 | Cohort 1 : Itacitinib + Corticosteroids | Itacitinib was administered once a day orally in combination with corticosteroids as per local treatment guidelines. |
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| Secondary | Phase 2: Failure-free Survival | Failure-free survival was defined as the number of participants who were still alive, had not relapsed, had not required additional therapy for acute graft-versus-host disease (aGVHD), and had not demonstrated signs or symptoms of chronic GVHD. | No participants enrolled in Phase 2 due to early termination of the study. | Posted | | | | | | up to 6 months | | | | ID | Title | Description |
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| OG000 | Cohort 1 : Itacitinib + Corticosteroids | Itacitinib was administered once a day orally in combination with corticosteroids as per local treatment guidelines. |
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| Secondary | Phase 2: Overall Survival | Overall survival was defined as the interval from study enrollment to death due to any cause. | No participants enrolled in Phase 2 due to early termination of the study. | Posted | | | | | | up to approximately 12 months | | | | ID | Title | Description |
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| OG000 | Cohort 1 : Itacitinib + Corticosteroids | Itacitinib was administered once a day orally in combination with corticosteroids as per local treatment guidelines. |
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| Secondary | Phase 2: Incidence Rate of Secondary Graft Failure | Analysis was to be conducted to assess the number of participants experiencing secondary graft failure. | No participants enrolled in Phase 2 due to early termination of the study. | Posted | | | | | | up to approximately 12 months | | | | ID | Title | Description |
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| OG000 | Cohort 1 : Itacitinib + Corticosteroids | Itacitinib was administered once a day orally in combination with corticosteroids as per local treatment guidelines. |
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| Secondary | Phase 2: Average Corticosteroid Use | The average number of participants who discontinued corticosteroids was to be assessed. | No participants enrolled in Phase 2 due to early termination of the study. | Posted | | | | | | up to 180 days | | | | ID | Title | Description |
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| OG000 | Cohort 1 : Itacitinib + Corticosteroids | Itacitinib was administered once a day orally in combination with corticosteroids as per local treatment guidelines. |
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| Secondary | Phase 2: Cumulative Corticosteroid Dose | The number of participants with various cumulative corticosteroid doses was assessed. | No participants enrolled in Phase 2 due to early termination of the study. | Posted | | | | | | up to 180 days | | | | ID | Title | Description |
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| OG000 | Cohort 1 : Itacitinib + Corticosteroids | Itacitinib was administered once a day orally in combination with corticosteroids as per local treatment guidelines. |
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| Secondary | Phase 2: Number of Participants Who Discontinued Corticosteroids | The number of participants who discontinued corticosteroids was assessed. | No participants enrolled in Phase 2 due to early termination of the study. | Posted | | | | | | up to 100 days | | | | ID | Title | Description |
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| OG000 | Cohort 1 : Itacitinib + Corticosteroids | Itacitinib was administered once a day orally in combination with corticosteroids as per local treatment guidelines. |
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| Secondary | Phase 2: Number of Participants Who Discontinued Immunosuppressive Medication | The number of participants who discontinued immunosuppressive medication was assessed. | No participants enrolled in Phase 2 due to early termination of the study. | Posted | | | | | | up to 100 days | | | | ID | Title | Description |
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| OG000 | Cohort 1 : Itacitinib + Corticosteroids | Itacitinib was administered once a day orally in combination with corticosteroids as per local treatment guidelines. |
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| Secondary | Phase 2: Number of Participants With aGVHD Flares | The number of participants who experienced aGVHD flares requiring treatment was assessed. | No participants enrolled in Phase 2 due to early termination of the study. | Posted | | | | | | up to 100 Days | | | | ID | Title | Description |
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| OG000 | Cohort 1 : Itacitinib + Corticosteroids | Itacitinib was administered once a day orally in combination with corticosteroids as per local treatment guidelines. |
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| Secondary | Phase 2: Number of Participants With Chronic Graft-versus-host Disease (cGVHD) | The number of participants with a diagnosis of any cGVHD, including mild, moderate, severe, was assessed. | No participants enrolled in Phase 2 due to early termination of the study. | Posted | | | | | | up to 365 days | | | | ID | Title | Description |
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| OG000 | Cohort 1 : Itacitinib + Corticosteroids | Itacitinib was administered once a day orally in combination with corticosteroids as per local treatment guidelines. |
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