TriangleNCT01492088 · OUTCOME
Progression Free Survival (PFS) (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 or end of study (Up to 72 months)
What was measured
PFS is defined as time in months from start of study treatment to first documentation of objective tumor progression per IRF assessment or up to 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. PFS was censored on the day following the date of last radiological assessment of measured lesions documenting absence of PD for participants who did not have tumor progression.
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 | 3.8 | Not reported | 1.2 | NA | Upper limit of CI was not reached due to low number of participants with events. |
| Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r sALCL Only | 6.2 | Not reported | 2.8 | 31.5 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 1.4
- upper Limit
- 2.8
- value
- 2.7
- comment
- Upper limit of CI was not reached due to low number of participants with events.
- group Id
- OG001
- lower Limit
- 1.2
- upper Limit
- NA
- value
- 3.8
- group Id
- OG002
- lower Limit
- 2.8
- upper Limit
- 31.5
- value
- 6.2
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 16
- group Id
- OG002
- value
- 17
- units
- Participants
- description
- PFS is defined as time in months from start of study treatment to first documentation of objective tumor progression per IRF assessment or up to 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. PFS was censored on the day following the date of last radiological assessment of measured lesions documenting absence of PD for participants who did not have tumor progression.
- 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 or end of study (Up to 72 months)
- title
- Progression Free Survival (PFS) (Phase 1 and 2)
- type
- SECONDARY
- unit Of Measure
- months
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Preserved source evidence · Not medical advice