TriangleNCT01492088 · OUTCOME
Event Free Survival (EFS) (Phase 1 and 2)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- months
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Cycles 2, 4, 7, 10, 13 and 16 (21-day cycles) until disease progression, death or EOT and then every 12 weeks for 12 months after EOT, until disease progression, or death (Up to 27 months)
What was measured
EFS is defined as the time in months from first dose until any cause of treatment failure: disease progression, premature discontinuation of treatment for any reason, or death due to any cause, whichever occurs first. PD is defined as any new lesion or increase by \>50% of previously involved sites from nadir.
Analysis population: Safety population is defined as all participants who received at least 1 dose of study drug. EFS was censored on the last follow-up date if none of the above events occur during the study.
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 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 | 16 |
| 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 | 2.7 | Not reported | 1.4 | 2.8 | Not reported |
| Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r HL Only | 2.1 | Not reported | 1.2 | 4.8 | Not reported |
| Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r sALCL Only | 4.8 | Not reported | 2.8 | 7.4 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 1.4
- upper Limit
- 2.8
- value
- 2.7
- group Id
- OG001
- lower Limit
- 1.2
- upper Limit
- 4.8
- value
- 2.1
- group Id
- OG002
- lower Limit
- 2.8
- upper Limit
- 7.4
- value
- 4.8
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 16
- group Id
- OG002
- value
- 17
- units
- Participants
- description
- EFS is defined as the time in months from first dose until any cause of treatment failure: disease progression, premature discontinuation of treatment for any reason, or death due to any cause, whichever occurs first. PD is defined as any new lesion or increase by \>50% of previously involved sites from nadir.
- 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 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
- MEDIAN
- population Description
- Safety population is defined as all participants who received at least 1 dose of study drug. EFS was censored on the last follow-up date if none of the above events occur during the study.
- reporting Status
- POSTED
- time Frame
- Cycles 2, 4, 7, 10, 13 and 16 (21-day cycles) until disease progression, death or EOT and then every 12 weeks for 12 months after EOT, until disease progression, or death (Up to 27 months)
- title
- Event Free Survival (EFS) (Phase 1 and 2)
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice