Trial · NCT03646123
Outcomes22
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 22
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Febrile Neutropenia (FN) Rate (Part A) | 7.5 months | For Part A, the full analysis set included all participants who received at least 1 dose of A+AVD (any of the study drugs in the regimen). | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Complete Response (CR) Rate at EOT (Parts B and C) | 7.8 months | For Parts B and C, the full analysis set included all participants who enrolled and received any amount of the combination therapy in the study. | Percentage of participants | NUMBER |
| SECONDARY | Number of Participants With Adverse Events of Clinical Interest (AECI) (Part A) | Approximately up to 7.5 months | For Part A, the full analysis set included all participants who received at least 1 dose of A+AVD (any of the study drugs in the regimen). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Primary Refractory Disease Rate (Part A) | 10.2 months | For Part A, the full analysis set includes all participants who received at least 1 dose of A+AVD (any of the study drugs in the regimen). | percentage of participants | NUMBER |
| SECONDARY | Complete Response Rate (Part A) | 7.2 months | For Part A, the full analysis set includes all participants who received at least 1 dose of A+AVD (any of the study drugs in the regimen). | percentage of participants | NUMBER |
| SECONDARY | Physician-reported Progression Free Survival (PFS) (Part A) | 24 months | For Part A, the full analysis set includes all participants who received at least 1 dose of A+AVD (any of the study drugs in the regimen). | percentage of participants | NUMBER |
| SECONDARY | Number of Participants With Subsequent Anticancer Therapy Utilization (Part A) | 33.8 months | For Part A, the full analysis set includes all participants who received at least 1 dose of A+AVD (any of the study drugs in the regimen). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Actual Dose Intensity: Brentuximab Vedotin (Part A) | 6.5 months | For Part A, the full analysis set includes all participants who received at least 1 dose of A+AVD (any of the study drugs in the regimen). | mg/kg/week | MEAN |
| SECONDARY | Actual Dose Intensity: Doxorubicin, Vinblastine, Dacarbazine (Part A) | 6.5 months | For Part A, the full analysis set includes all participants who received at least 1 dose of A+AVD (any of the study drugs in the regimen). | mg/m2/week | MEAN |
| SECONDARY | Relative Dose Intensity (Part A) | 6.5 months | For Part A, the full analysis set includes all participants who received at least 1 dose of A+AVD (any of the study drugs in the regimen). | percentage of intended dose | MEAN |
| SECONDARY | Rate of Dose Reduction and Delays: Brentuximab Vedotin (Part A) | 6.5 months | For Part A, the full analysis set includes all participants who received at least 1 dose of A+AVD (any of the study drugs in the regimen). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Rate of Dose Reduction and Delays: Doxorubicin (Part A) | 6.5 months | For Part A, the full analysis set includes all participants who received at least 1 dose of A+AVD (any of the study drugs in the regimen). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Rate of Dose Reduction and Delays: Vinblastine (Part A) | 6.5 months | For Part A, the full analysis set includes all participants who received at least 1 dose of A+AVD (any of the study drugs in the regimen). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Rate of Dose Reduction and Delays: Dacarbazine (Part A) | 6.5 months | For Part A, the full analysis set includes all participants who received at least 1 dose of A+AVD (any of the study drugs in the regimen). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Incidence of Adverse Events (Parts B and C) | 8.9 months | For Parts B and C, the full analysis set includes all participants who enrolled and received any amount of the combination therapy in the study. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Incidence of Laboratory Abnormalities (Parts B and C) | 8.9 months | For Parts B and C, the full analysis set included all participants who enrolled and received any amount of the combination therapy in the study. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Overall Response Rate (ORR) at EOT (Parts B and C) | Up to 7.8 months | For Parts B and C, the full analysis set included all participants who were enrolled and received any amount of the combination therapy in the study. | Percentage of participants | NUMBER |
| SECONDARY | Duration of Response (DOR) at End of Study (Parts B and C) | Up to 51.1 months | For Parts B and C, the full analysis set includes all participants who were enrolled and received any amount of the combination therapy in the study. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure. | Months | MEDIAN |
| SECONDARY | Duration of Complete Response (DOCR) (Parts B and C) | Up to 51.1 months | For Parts B and C, the full analysis set includes all participants who were enrolled and received any amount of the combination therapy in the study. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure. | Months | MEDIAN |
| SECONDARY | Event Free Survival (EFS) Rate (Parts B and C) | Months 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42 | For Parts B and C, the full analysis set includes all participants who were enrolled and received any amount of the combination therapy in the study. | Percentage of participants | NUMBER |
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
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GET https://conductscience.org/api/trials/v1/NCT03646123/outcomes