TriangleNCT01716806 · OUTCOME
ORR According to Modified Lugano Criteria Per Blinded Independent Central Review (BICR) (Parts E and F)
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
- Up to 31 months
What was measured
Objective response rate (ORR) per investigator was defined as the percentage of subjects with CR or PR through the end of study or prior to the start of new anti-cancer treatment (including stem cell transplant, and excluding consolidative radiotherapy) other than the study treatment. For Parts E and F, the response was assessed per blinded independent central review (BICR) using the modified Lugano criteria.
Analysis population: All subjects who received at least one dose of study drug
Groups in this outcome
Part E
BV as frontline monotherapy in patients with cHL who were unsuitable or unfit for combination chemotherapy. BV (1.8 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle.
Part F
BV as frontline monotherapy in patients with CD30-expressing PTCL who were unsuitable or unfit for combination chemotherapy. BV (1.8 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle.
| Group | Source count |
|---|---|
| Part E | 30 |
| Part F | 7 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part E | 60 | Not reported | 40.6 | 77.3 | Not reported |
| Part F | 43 | Not reported | 9.9 | 81.6 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 40.6
- upper Limit
- 77.3
- value
- 60
- group Id
- OG001
- lower Limit
- 9.9
- upper Limit
- 81.6
- value
- 43
- denoms
- counts
- group Id
- OG000
- value
- 30
- group Id
- OG001
- value
- 7
- units
- Participants
- description
- Objective response rate (ORR) per investigator was defined as the percentage of subjects with CR or PR through the end of study or prior to the start of new anti-cancer treatment (including stem cell transplant, and excluding consolidative radiotherapy) other than the study treatment. For Parts E and F, the response was assessed per blinded independent central review (BICR) using the modified Lugano criteria.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- BV as frontline monotherapy in patients with cHL who were unsuitable or unfit for combination chemotherapy. BV (1.8 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle.
- id
- OG000
- title
- Part E
- description
- BV as frontline monotherapy in patients with CD30-expressing PTCL who were unsuitable or unfit for combination chemotherapy. BV (1.8 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle.
- id
- OG001
- title
- Part F
- param Type
- NUMBER
- population Description
- All subjects who received at least one dose of study drug
- reporting Status
- POSTED
- time Frame
- Up to 31 months
- title
- ORR According to Modified Lugano Criteria Per Blinded Independent Central Review (BICR) (Parts E and F)
- type
- PRIMARY
- unit Of Measure
- Percentage of participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice