TriangleNCT01716806 · OUTCOME
Duration of Complete 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 CR per investigator was defined as the time from start of the first documentation of CR to the first documentation of tumor 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
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 | 19 |
| Part B | 14 |
| Part C | 15 |
| Part D | 14 |
| Part E | 10 |
| Part F | 2 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part A | 7.4 | Not reported | 5.1 | NA | Follow-up duration too short relative to event accumulation to estimate upper limit. |
| Part B | NA | Not reported | 14.7 | NA | Follow-up duration too short relative to event accumulation to estimate median and upper limit. |
| Part C | NA | Not reported | 2.8 | NA | Follow-up duration too short relative to event accumulation to estimate median and upper limit. |
| Part D | NA | Not reported | 6.6 | NA | Follow-up duration too short relative to event accumulation to estimate median and upper limit. |
| Part E | NA | Not reported | 7.4 | NA | Follow-up duration too short relative to event accumulation to estimate median and upper limit. |
| Part F | NA | Not reported | NA | NA | Follow-up duration too short relative to event accumulation to estimate median, upper limit, and lower limit. |
Complete source fields
- classes
- categories
- measurements
- comment
- Follow-up duration too short relative to event accumulation to estimate upper limit.
- group Id
- OG000
- lower Limit
- 5.1
- upper Limit
- NA
- value
- 7.4
- comment
- Follow-up duration too short relative to event accumulation to estimate median and upper limit.
- group Id
- OG001
- lower Limit
- 14.7
- upper Limit
- NA
- value
- NA
- comment
- Follow-up duration too short relative to event accumulation to estimate median and upper limit.
- group Id
- OG002
- lower Limit
- 2.8
- 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
- 6.6
- upper Limit
- NA
- value
- NA
- comment
- Follow-up duration too short relative to event accumulation to estimate median and upper limit.
- group Id
- OG004
- lower Limit
- 7.4
- upper Limit
- NA
- value
- NA
- comment
- Follow-up duration too short relative to event accumulation to estimate median, upper limit, and lower limit.
- group Id
- OG005
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 19
- group Id
- OG001
- value
- 14
- group Id
- OG002
- value
- 15
- group Id
- OG003
- value
- 14
- group Id
- OG004
- value
- 10
- group Id
- OG005
- value
- 2
- units
- Participants
- description
- Duration of CR per investigator was defined as the time from start of the first documentation of CR to the first documentation of tumor 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
- reporting Status
- POSTED
- time Frame
- Up to 81 months
- title
- Duration of Complete Response
- type
- SECONDARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice