TriangleNCT01716806 · OUTCOME
Duration of Objective Response
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
- Up to 81 months
What was measured
Duration of response per investigator was defined as the time from start of the first documentation of objective tumor response (CR or PR) to the first documentation of tumor progression (PD) based on radiographic evidence of progression or to death due to any cause, whichever came first. For Parts E and F, the assessment was per BICR.
Analysis population: All subjects with CR/PR
Groups in this outcome
Part A
Brentuximab vedotin (BV) monotherapy in adults age 60 and above with classical Hodgkin Lymphoma (cHL). BV (1.8 mg/kg) was administered as an intravenous (IV) infusion on Day 1 of each 21-day cycle.
Part B
BV in combination with dacarbazine as frontline therapy in adults aged 60 and above with cHL. BV (1.8 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle. Dacarbazine (375 mg/m\^2) was administered as an IV infusion on Day 1 of each 21-day cycle.
Part C
BV in combination with bendamustine as frontline therapy in adults aged 60 and above with cHL. BV (1.8 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle. Bendamustine (70 mg/m\^2) was administered as an IV infusion on Day 1 and Day 2 of each 21-day cycle.
Part D
BV in combination with nivolumab as frontline therapy in adults aged 60 and above with cHL. BV (1.8 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle. Nivolumab (3 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle.
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 A | 25 |
| Part B | 21 |
| Part C | 17 |
| Part D | 18 |
| Part E | 18 |
| Part F | 3 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part A | 7.6 | Not reported | 5.1 | 67.7 | Not reported |
| Part B | 46.0 | Not reported | 8.5 | NA | Follow-up duration too short relative to event accumulation to estimate upper limit. |
| Part C | NA | Not reported | 3.6 | NA | Follow-up duration too short relative to event accumulation to estimate median and upper limit. |
| Part D | NA | Not reported | 12.7 | NA | Follow-up duration too short relative to event accumulation to estimate median and upper limit. |
| Part E | 7.4 | Not reported | 7.4 | NA | Follow-up duration too short relative to event accumulation to estimate upper limit. |
| Part F | NA | Not reported | 11.3 | NA | Follow-up duration too short relative to event accumulation to estimate median and upper limit. |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 5.1
- upper Limit
- 67.7
- value
- 7.6
- comment
- Follow-up duration too short relative to event accumulation to estimate upper limit.
- group Id
- OG001
- lower Limit
- 8.5
- upper Limit
- NA
- value
- 46.0
- comment
- Follow-up duration too short relative to event accumulation to estimate median and upper limit.
- group Id
- OG002
- lower Limit
- 3.6
- upper Limit
- NA
- value
- NA
- comment
- Follow-up duration too short relative to event accumulation to estimate median and upper limit.
- group Id
- OG003
- lower Limit
- 12.7
- upper Limit
- NA
- value
- NA
- comment
- Follow-up duration too short relative to event accumulation to estimate upper limit.
- group Id
- OG004
- lower Limit
- 7.4
- upper Limit
- NA
- value
- 7.4
- comment
- Follow-up duration too short relative to event accumulation to estimate median and upper limit.
- group Id
- OG005
- lower Limit
- 11.3
- upper Limit
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 25
- group Id
- OG001
- value
- 21
- group Id
- OG002
- value
- 17
- group Id
- OG003
- value
- 18
- group Id
- OG004
- value
- 18
- group Id
- OG005
- value
- 3
- units
- Participants
- description
- Duration of response per investigator was defined as the time from start of the first documentation of objective tumor response (CR or PR) to the first documentation of tumor progression (PD) based on radiographic evidence of progression or to death due to any cause, whichever came first. For Parts E and F, the assessment was per BICR.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Brentuximab vedotin (BV) monotherapy in adults age 60 and above with classical Hodgkin Lymphoma (cHL). BV (1.8 mg/kg) was administered as an intravenous (IV) infusion on Day 1 of each 21-day cycle.
- id
- OG000
- title
- Part A
- description
- BV in combination with dacarbazine as frontline therapy in adults aged 60 and above with cHL. BV (1.8 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle. Dacarbazine (375 mg/m\^2) was administered as an IV infusion on Day 1 of each 21-day cycle.
- id
- OG001
- title
- Part B
- description
- BV in combination with bendamustine as frontline therapy in adults aged 60 and above with cHL. BV (1.8 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle. Bendamustine (70 mg/m\^2) was administered as an IV infusion on Day 1 and Day 2 of each 21-day cycle.
- id
- OG002
- title
- Part C
- description
- BV in combination with nivolumab as frontline therapy in adults aged 60 and above with cHL. BV (1.8 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle. Nivolumab (3 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle.
- id
- OG003
- title
- Part D
- 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
- OG004
- 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
- OG005
- title
- Part F
- param Type
- MEDIAN
- population Description
- All subjects with CR/PR
- reporting Status
- POSTED
- time Frame
- Up to 81 months
- title
- Duration of Objective Response
- type
- SECONDARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice