Trial · NCT04939701
Registered outcomes39
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 39
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Dose Limiting Toxicities (DLTs) | Cycle 1 Day 1 (C1D1) up to C1D28 | DLT was defined as any event occurring within 28 days of first dose on C1D1 and graded as: * Grade (GR) ≥2 autoimmune reaction * GR 3 Immune related AEs (irAEs) that did not resolve to GR ≤1 in 3 to 5 days, febrile neutropenia with or without infection, thrombocytopenia with bleeding requiring transfusion, anemia requiring transfusion * GR 4 irAEs, neutropenia, thrombocytopenia, anemia * GR ≥3 non-hematological AE that did not resolve to GR ≤2 within 72 hours of onset, liver function test abnormality lasting ≥7 days Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \>5 × upper limit of normal (ULN; GR≥3) without liver metastases and 8 × ULN in participants with liver metastases, AST or ALT \>3 × ULN and total bilirubin (TBL) \>2 × ULN (in participants with, Gilbert syndrome: AST or ALT \>3 × ULN and direct bilirubin \>1.5) (confirmed Hy's Law) * GR 5 toxicity, Prolonged delay (\>2 weeks) in initiating cycle 2 due to treatment-related toxicity. |
| Primary | Number of Participants With Treatment Emergent Adverse Events (TEAEs) & Serious Adverse Events (SAEs) | From first dose up to 198 days | An AE was defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE could therefore be any unfavorable \& unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An AE was considered "serious" if, it resulted in any of the following outcomes: results in death; is life-threatening; results in persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions; results in congenital anomaly, or birth defect; requires inpatient hospitalization; or leads to prolongation of hospitalization; other medically important events. A treatment-emergent adverse event (TEAE) was defined as an AE observed after the date of first dose until 30 days after the last dose. |
| Primary | Number of Participants With ECOG Performance Status at C1D2 | At C1D2 | The ECOG Scale was used to assess performance status. Grade Description: 0 - Fully active, able to carry on all pre disease performance without restriction. 1. \- Restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work. 2. \- Ambulatory and capable of all self-care, but unable to carry out any work activities. Up and about more than 50% of waking hours. 3. \- Capable of only limited self-care, confined to bed or chair more than 50% of waking hours. 4. \- Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair. 5. -Dead. |
| Primary | Number of Participants With ECOG Performance Status at C1D8 | At C1D8 | The ECOG Scale was used to assess performance status. Grade Description: 0 - Fully active, able to carry on all pre disease performance without restriction. 1. \- Restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work. 2. \- Ambulatory and capable of all self-care, but unable to carry out any work activities. Up and about more than 50% of waking hours. 3. \- Capable of only limited self-care, confined to bed or chair more than 50% of waking hours. 4. \- Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair. 5. -Dead. |
| Primary | Number of Participants With ECOG Performance Status at CID15 | At CID15 | The ECOG Scale was used to assess performance status. Grade Description: 0 - Fully active, able to carry on all pre disease performance without restriction. 1. \- Restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work. 2. \- Ambulatory and capable of all self-care, but unable to carry out any work activities. Up and about more than 50% of waking hours. 3. \- Capable of only limited self-care, confined to bed or chair more than 50% of waking hours. 4. \- Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair. 5. -Dead. |
| Primary | Number of Participants With ECOG Performance Status at CID22 | At CID22 | The ECOG Scale was used to assess performance status. Grade Description: 0 - Fully active, able to carry on all pre disease performance without restriction. 1. \- Restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work. 2. \- Ambulatory and capable of all self-care, but unable to carry out any work activities. Up and about more than 50% of waking hours. 3. \- Capable of only limited self-care, confined to bed or chair more than 50% of waking hours. 4. \- Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair. 5. -Dead. |
| Primary | Number of Participants With ECOG Performance Status at C2D1 | At C2D1 | The ECOG Scale was used to assess performance status. Grade Description: 0 - Fully active, able to carry on all pre disease performance without restriction. 1. \- Restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work. 2. \- Ambulatory and capable of all self-care, but unable to carry out any work activities. Up and about more than 50% of waking hours. 3. \- Capable of only limited self-care, confined to bed or chair more than 50% of waking hours. 4. \- Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair. 5. -Dead. |
| Primary | Number of Participants With ECOG Performance Status at C2D2 | At C2D2 | The ECOG Scale was used to assess performance status. Grade Description: 0 - Fully active, able to carry on all pre disease performance without restriction. 1. \- Restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work. 2. \- Ambulatory and capable of all self-care, but unable to carry out any work activities. Up and about more than 50% of waking hours. 3. \- Capable of only limited self-care, confined to bed or chair more than 50% of waking hours. 4. \- Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair. 5. -Dead. |
| Primary | Number of Participants With ECOG Performance Status at C2D8 | At C2D8 | The ECOG Scale was used to assess performance status. Grade Description: 0 - Fully active, able to carry on all pre disease performance without restriction. 1. \- Restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work. 2. \- Ambulatory and capable of all self-care, but unable to carry out any work activities. Up and about more than 50% of waking hours. 3. \- Capable of only limited self-care, confined to bed or chair more than 50% of waking hours. 4. \- Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair. 5. -Dead. |
| Primary | Number of Participants With ECOG Performance Status at C2D15 | At C2D15 | The ECOG Scale was used to assess performance status. Grade Description: 0 - Fully active, able to carry on all pre disease performance without restriction. 1. \- Restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work. 2. \- Ambulatory and capable of all self-care, but unable to carry out any work activities. Up and about more than 50% of waking hours. 3. \- Capable of only limited self-care, confined to bed or chair more than 50% of waking hours. 4. \- Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair. 5. -Dead. |
| Primary | Number of Participants With ECOG Performance Status at C2D22 | At C2D22 | The ECOG Scale was used to assess performance status. Grade Description: 0 - Fully active, able to carry on all pre disease performance without restriction. 1. \- Restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work. 2. \- Ambulatory and capable of all self-care, but unable to carry out any work activities. Up and about more than 50% of waking hours. 3. \- Capable of only limited self-care, confined to bed or chair more than 50% of waking hours. 4. \- Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair. 5. -Dead. |
| Primary | Number of Participants With ECOG Performance Status at C3D1 | At C3D1 | The ECOG Scale was used to assess performance status. Grade Description: 0 - Fully active, able to carry on all pre disease performance without restriction. 1. \- Restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work. 2. \- Ambulatory and capable of all self-care, but unable to carry out any work activities. Up and about more than 50% of waking hours. 3. \- Capable of only limited self-care, confined to bed or chair more than 50% of waking hours. 4. \- Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair. 5. -Dead. |
| Primary | Number of Participants With ECOG Performance Status at C3D8 | At C3D8 | The ECOG Scale was used to assess performance status. Grade Description: 0 - Fully active, able to carry on all pre disease performance without restriction. 1. \- Restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work. 2. \- Ambulatory and capable of all self-care, but unable to carry out any work activities. Up and about more than 50% of waking hours. 3. \- Capable of only limited self-care, confined to bed or chair more than 50% of waking hours. 4. \- Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair. 5. -Dead. |
| Primary | Number of Participants With ECOG Performance Status at C3D15 | At C3D15 | The ECOG Scale was used to assess performance status. Grade Description: 0 - Fully active, able to carry on all pre disease performance without restriction. 1. \- Restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work. 2. \- Ambulatory and capable of all self-care, but unable to carry out any work activities. Up and about more than 50% of waking hours. 3. \- Capable of only limited self-care, confined to bed or chair more than 50% of waking hours. 4. \- Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair. 5. -Dead. |
| Primary | Number of Participants With ECOG Performance Status at C3D22 | At C3D22 | The ECOG Scale was used to assess performance status. Grade Description: 0 - Fully active, able to carry on all pre disease performance without restriction. 1. \- Restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work. 2. \- Ambulatory and capable of all self-care, but unable to carry out any work activities. Up and about more than 50% of waking hours. 3. \- Capable of only limited self-care, confined to bed or chair more than 50% of waking hours. 4. \- Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair. 5. -Dead. |
| Primary | Number of Participants With ECOG Performance Status at C4D1 | At C4D1 | The ECOG Scale was used to assess performance status. Grade Description: 0 - Fully active, able to carry on all pre disease performance without restriction. 1. \- Restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work. 2. \- Ambulatory and capable of all self-care, but unable to carry out any work activities. Up and about more than 50% of waking hours. 3. \- Capable of only limited self-care, confined to bed or chair more than 50% of waking hours. 4. \- Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair. 5. -Dead. |
| Primary | Number of Participants With ECOG Performance Status at C4D8 | At C4D8 | The ECOG Scale was used to assess performance status. Grade Description: 0 - Fully active, able to carry on all pre disease performance without restriction. 1. \- Restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work. 2. \- Ambulatory and capable of all self-care, but unable to carry out any work activities. Up and about more than 50% of waking hours. 3. \- Capable of only limited self-care, confined to bed or chair more than 50% of waking hours. 4. \- Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair. 5. -Dead. |
| Primary | Number of Participants With ECOG Performance Status at C4D15 | At C4D15 | The ECOG Scale was used to assess performance status. Grade Description: 0 - Fully active, able to carry on all pre disease performance without restriction. 1. \- Restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work. 2. \- Ambulatory and capable of all self-care, but unable to carry out any work activities. Up and about more than 50% of waking hours. 3. \- Capable of only limited self-care, confined to bed or chair more than 50% of waking hours. 4. \- Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair. 5. -Dead. |
| Primary | Number of Participants With ECOG Performance Status at C4D22 | At C4D22 | The ECOG Scale was used to assess performance status. Grade Description: 0 - Fully active, able to carry on all pre disease performance without restriction. 1. \- Restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work. 2. \- Ambulatory and capable of all self-care, but unable to carry out any work activities. Up and about more than 50% of waking hours. 3. \- Capable of only limited self-care, confined to bed or chair more than 50% of waking hours. 4. \- Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair. 5. -Dead. |
| Primary | Number of Participants With ECOG Performance Status at C5D1 | At C5D1 | The ECOG Scale was used to assess performance status. Grade Description: 0 - Fully active, able to carry on all pre disease performance without restriction. 1. \- Restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work. 2. \- Ambulatory and capable of all self-care, but unable to carry out any work activities. Up and about more than 50% of waking hours. 3. \- Capable of only limited self-care, confined to bed or chair more than 50% of waking hours. 4. \- Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair. 5. -Dead. |
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.
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