TriangleNCT01492088 · OUTCOME
Overall Response Rate (ORR) (Phase 1 and 2)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- percentage of participants
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Cycles 2, 4, 7, 10, 13 and 16 (21-day cycles) until disease progression, death or end of treatment (EOT) (Up to 15 months)
What was measured
Overall response rate is defined as the percentage of participants with complete remission (CR) or partial remission (PR) as assessed by an independent review facility (IRF) using International Working Group (IWG) Revised Response Criteria for Malignant Lymphoma. CR is defined as the disappearance of all evidence of disease and PR is defined as regression of measurable disease and no new sites.
Analysis population: Response-evaluable population included participants who received at least 1 dose of study drug, have measurable disease at baseline, and 1 postbaseline disease assessment. Data was summarized together for Phase 1 and 2 participants in brentuximab 1.8 mg/kg arm group.
Groups in this outcome
Brentuximab Vedotin 1.4 mg/kg: Phase 1
Brentuximab vedotin 1.4 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle, until there was evidence of disease progression or unacceptable toxicity.
Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r HL Only
Participants with r/r Hodgkin Lymphoma (HL) received brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.
Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r sALCL Only
Participants with r/r systemic anaplastic large-cell lymphoma (sALCL) received brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.
| Group | Source count |
|---|---|
| Brentuximab Vedotin 1.4 mg/kg: Phase 1 | 3 |
| Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r HL Only | 15 |
| Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r sALCL Only | 17 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Brentuximab Vedotin 1.4 mg/kg: Phase 1 | 0 | Not reported | 0 | 71 | Not reported |
| Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r HL Only | 47 | Not reported | 21 | 73 | Not reported |
| Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r sALCL Only | 53 | Not reported | 28 | 77 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0
- upper Limit
- 71
- value
- 0
- group Id
- OG001
- lower Limit
- 21
- upper Limit
- 73
- value
- 47
- group Id
- OG002
- lower Limit
- 28
- upper Limit
- 77
- value
- 53
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 15
- group Id
- OG002
- value
- 17
- units
- Participants
- description
- Overall response rate is defined as the percentage of participants with complete remission (CR) or partial remission (PR) as assessed by an independent review facility (IRF) using International Working Group (IWG) Revised Response Criteria for Malignant Lymphoma. CR is defined as the disappearance of all evidence of disease and PR is defined as regression of measurable disease and no new sites.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Brentuximab vedotin 1.4 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle, until there was evidence of disease progression or unacceptable toxicity.
- id
- OG000
- title
- Brentuximab Vedotin 1.4 mg/kg: Phase 1
- description
- Participants with r/r Hodgkin Lymphoma (HL) received brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.
- id
- OG001
- title
- Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r HL Only
- description
- Participants with r/r systemic anaplastic large-cell lymphoma (sALCL) received brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.
- id
- OG002
- title
- Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r sALCL Only
- param Type
- NUMBER
- population Description
- Response-evaluable population included participants who received at least 1 dose of study drug, have measurable disease at baseline, and 1 postbaseline disease assessment. Data was summarized together for Phase 1 and 2 participants in brentuximab 1.8 mg/kg arm group.
- reporting Status
- POSTED
- time Frame
- Cycles 2, 4, 7, 10, 13 and 16 (21-day cycles) until disease progression, death or end of treatment (EOT) (Up to 15 months)
- title
- Overall Response Rate (ORR) (Phase 1 and 2)
- type
- PRIMARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice