NCT01716806 · OUTCOME
Complete Response Rate
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 81 months
What was measured
Complete response rate is defined as the percentage of patients with CR
Analysis population: All subjects who received at least one dose of study drug
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 | 27 |
| Part B | 22 |
| Part C | 20 |
| Part D | 21 |
| Part E | 30 |
| Part F | 7 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part A | 70 | Not reported | 49.8 | 86.2 | Not reported |
| Part B | 64 | Not reported | 40.7 | 82.8 | Not reported |
| Part C | 75 | Not reported | 50.9 | 91.3 | Not reported |
| Part D | 67 | Not reported | 43.0 | 85.4 | Not reported |
| Part E | 30 | Not reported | 14.7 | 49.4 | Not reported |
| Part F | 43 | Not reported | 9.9 | 81.6 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 49.8
- upper Limit
- 86.2
- value
- 70
- group Id
- OG001
- lower Limit
- 40.7
- upper Limit
- 82.8
- value
- 64
- group Id
- OG002
- lower Limit
- 50.9
- upper Limit
- 91.3
- value
- 75
- group Id
- OG003
- lower Limit
- 43.0
- upper Limit
- 85.4
- value
- 67
- group Id
- OG004
- lower Limit
- 14.7
- upper Limit
- 49.4
- value
- 30
- group Id
- OG005
- lower Limit
- 9.9
- upper Limit
- 81.6
- value
- 43
- denoms
- counts
- group Id
- OG000
- value
- 27
- group Id
- OG001
- value
- 22
- group Id
- OG002
- value
- 20
- group Id
- OG003
- value
- 21
- group Id
- OG004
- value
- 30
- group Id
- OG005
- value
- 7
- units
- Participants
- description
- Complete response rate is defined as the percentage of patients with CR
- 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
- NUMBER
- population Description
- All subjects who received at least one dose of study drug
- reporting Status
- POSTED
- time Frame
- Up to 81 months
- title
- Complete Response Rate
- type
- SECONDARY
- unit Of Measure
- Percentage of participants
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Preserved source evidence · Not medical advice
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