Trial · NCT04307134
Registered outcomes34
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 34
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) | An AE was any untoward medical occurrence in a participant administered a medicinal product. The event need not necessarily had a causal relationship with the product treatment or usage. AEs included both SAEs and all non-SAEs. An SAE was any untoward medical occurrence in a participant administered a medicinal or nutritional product at any dose that: resulted in death; was life-threatening; required inpatient hospitalization or prolongation of hospitalization; resulted in persistent or significant disability/incapacity; resulted in congenital anomaly/birth defect or was an important medical event. |
| Primary | Number of Participants With Adverse Drug Reactions (ADRs) and Serious ADRs (SADRs) | From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) | An ADR was any untoward medical occurrence attributed to medicinal product in participant who had received that product. SADR was an ADR that resulted in any of the following: death; was life-threatening; required inpatient hospitalization or prolongation of hospitalization; resulted in persistent or significant disability/incapacity; resulted in congenital anomaly/birth defect; or was an important medical event. |
| Primary | Number of Participants With Unexpected AEs and SAEs | From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) | An AE was any untoward medical occurrence in a participant administered a medicinal product. The event need not necessarily had a causal relationship with the product treatment or usage. An SAE was any untoward medical occurrence in a participant administered a medicinal or nutritional product at any dose that: resulted in death; is life-threatening; required inpatient hospitalization or prolongation of hospitalization; resulted in persistent or significant disability/incapacity; resulted in congenital anomaly/birth defect or was an important medical event. An AE was considered expected if the reported event and its specificity or severity were consistent with as pre-specified in the protocol, other than these all AEs were unexpected. |
| Primary | Number of Participants With Unexpected ADRs and SADRs | From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) | An ADR was any untoward medical occurrence attributed to medicinal product in participant who had received that product. SADR was an ADR that resulted in any of the following: death; was life-threatening; required inpatient hospitalization/prolongation of hospitalization; resulted in persistent or significant disability/incapacity; resulted in congenital anomaly/birth defect; or was important medical event. In this outcome measure, number of participants with unexpected ADRs and SADRs are reported. An ADR was considered expected if the reported event and its specificity or severity were consistent with as pre-specified in the protocol, other than these all ADRs were unexpected. |
| Primary | Number of AEs According to Severity | From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) | An AE was any untoward medical occurrence in a participant administered a medicinal product. The event need not necessarily had a causal relationship with the product treatment or usage. AEs' severity was graded using common terminology criteria for AEs (CTCAE) version 4.0; grade 1= mild AE; grade 2= moderate AE; grade 3= severe AE; grade 4= life-threatening AE and grade 5= death. |
| Primary | Number of AEs According to Action Taken | From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) | An AE was any untoward medical occurrence in a participant administered a medicinal product. The event need not necessarily had a causal relationship with the product treatment or usage. Number of AEs were classified as per action taken for AEs (withdrawn \[temporarily or permanently or delayed\]; dose reduced; dose increased; dose not changed; unknown, and not applicable) in this outcome measure. Not applicable per protocol referred to situations if participant died or if the treatment was completed prior to the reaction/event or if drug was not administered. |
| Primary | Number of AEs According to SAEs' Category | From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) | An AE was any untoward medical occurrence in a participant administered a medicinal product. The event need not necessarily had a causal relationship with the product treatment or usage. Number of AEs were classified as per SAEs category (resulted in death; is life-threatening; required inpatient hospitalization or prolongation of hospitalization; resulted in persistent or significant disability/incapacity; resulted in congenital anomaly/birth defect and is an important medical event) in this outcome measure. One SAE could have more than 1 outcome/characteristic and have been counted in more than one category. |
| Primary | Number of AEs According to Their Outcomes | From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) | An AE was any untoward medical occurrence in a participant administered a medicinal product. The event need not necessarily had a causal relationship with the product treatment or usage. Number of AEs were classified as per their outcomes (recovered, recovered with sequelae, recovering, not recovered, and unknown) in this outcome measure. |
| Primary | Number of AEs Based on Causality of AEs to the Study Drug | From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) | AE: any untoward medical occurrence in participant administered medicinal product. Number of AEs per causality of AE to study drug (certain, probable/likely, possible, unlikely, conditional/unclassified, and not-assessable/unclassifiable) were reported. Certain: couldn't be explained by other drugs, had clinically reasonable reaction on cessation of drug and pharmacological/phenomenological reaction to drug re-administration. Probable/likely: couldn't be explained by other drugs, had clinically reasonable reaction on drug cessation. Possible: could also be explained by other drugs, lacked information/unclear information on drug discontinuation. Unlikely: not likely to have causal relationship from drug administration, could also be explained by other drugs. Conditional/unclassified: needed more data to make appropriate assessment/additional of data being reviewed. Not-assessable: lacked sufficient information/conflicting information hampering accurate causality assessment. |
| Primary | Number of AEs Based on Other Causality of AEs | From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) | An AE was any untoward medical occurrence in a participant administered a medicinal product. The event need not necessarily have a causal relationship with the product treatment or usage. Number of AEs were classified as per other causality of AE to the study drug (disease under the study, other disease, concomitant treatment drug or non-drug, and others) in this outcome measure. |
| Primary | Number of Participants With AEs Classified According to Their Age at Baseline | From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) | An AE was any untoward medical occurrence in a participant administered a medicinal product. The event need not necessarily had a causal relationship with the product treatment or usage. Number of participants with AEs were classified according to their baseline demographic characteristics of age (less than \[\<\] 65 years and more than or equal to \[\>=\] 65 years) in this outcome measure. |
| Primary | Number of Participants With AEs Classified According to Their Sex at Baseline | From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) | An AE was any untoward medical occurrence in a participant administered a medicinal product. The event need not necessarily had a causal relationship with the product treatment or usage. Number of participants with AEs were classified according to their baseline demographic characteristics of sex (female and male) in this outcome measure. |
| Primary | Number of Participants With AEs Classified According to Their Diagnosis at Baseline | From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) | An AE was any untoward medical occurrence in a participant administered a medicinal product. The event need not necessarily had a causal relationship with the product treatment or usage. Number of participants with AEs were classified according to their baseline demographic characteristics of diagnosis (Philadelphia \[+\] B-cell Acute Lymphoblastic Leukemia \[ALL\], Philadelphia \[-\] B-cell ALL, and unknown) in this outcome measure. |
| Primary | Number of Participants With AEs Classified According to Their Disease Status at Baseline | From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) | An AE was any untoward medical occurrence in a participant administered a medicinal product. The event need not necessarily had a causal relationship with the product treatment or usage. Refractory Disease: failure to achieve complete response (CR) at the end of induction. Relapsed disease: Reappearance of blasts in the blood or bone marrow (\>5%) or in any extramedullary site after a CR. CR: No circulating blasts or extramedullary disease, trilineage hematopoiesis and \< 5% blasts, absolute neutrophil count (ANC) \> 1000/microliter, platelets \>100000/microliter and no recurrence for 4 weeks. Number of participants with AEs were classified according to their baseline demographic characteristics of disease status (refractory, first relapsed, second relapsed and third or more relapsed) in this outcome measure. |
| Primary | Number of Participants With AEs Classified According to Their Renal Disorder Status at Baseline | From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) | An AE was any untoward medical occurrence in a participant administered a medicinal product. The event need not necessarily have a causal relationship with the product treatment or usage. Number of participants with AEs were classified according to their baseline demographic characteristics of renal disorder status (yes or no) in this outcome measure. |
| Primary | Number of Participants With AEs Classified According to Their Hepatic Disorder Status at Baseline | From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) | An AE was any untoward medical occurrence in a participant administered a medicinal product. The event need not necessarily have a causal relationship with the product treatment or usage. Number of participants with AEs were classified according to their baseline demographic characteristics of hepatic disorder status (yes or no) in this outcome measure. |
| Primary | Number of Participants With AEs Classified According to Their Allergic History Status at Baseline | From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) | An AE was any untoward medical occurrence in a participant administered a medicinal product. The event need not necessarily have a causal relationship with the product treatment or usage. Number of participants with AEs were classified according to their baseline demographic characteristics of allergic history (yes or no) in this outcome measure. |
| Primary | Number of Participants With AEs Classified According to Their Veno-occlusive Liver Disease/ Sinusoidal Obstruction Syndrome (VOD /SOS) Status at Baseline | From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) | An AE was any untoward medical occurrence in a participant administered a medicinal product. The event need not necessarily have a causal relationship with the product treatment or usage. VOD also known as SOS is a potentially life-threatening condition in which the small veins in the liver are blocked. This obstruction impairs blood flow through the liver and can lead to liver damage and failure. Number of participants with AEs were classified according to their baseline demographic characteristics of VOD/SOS (yes or no) in this outcome measure. |
| Primary | Number of Participants With AEs Classified According to Their Previous Systemic Therapy Status at Baseline | From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) | An AE was any untoward medical occurrence in a participant administered a medicinal product. The event need not necessarily have a causal relationship with the product treatment or usage. Number of participants with AEs were classified according to their baseline demographic characteristics of previous systemic therapy status (yes, no, and unknown) in this outcome measure. |
| Primary | Number of Participants With AEs Classified According to Their Previous Hematopoietic Cell Transplant Status at Baseline | From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days) | An AE was any untoward medical occurrence in a participant administered a medicinal product. The event need not necessarily have a causal relationship with the product treatment or usage. Number of participants with AEs were classified according to their baseline demographic characteristics of previous hematopoietic cell transplant status (yes, no, and unknown) in this outcome measure. |
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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