TriangleNCT01716806 · OUTCOME
Number of Participants With Brentuximab Vedotin Antitherapeutic Antibodies (ATA)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- Up to 30 months
Analysis population: Subjects with a baseline and at least one post-baseline sample.
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 | 26 |
| Part B | 22 |
| Part C | 17 |
| Part D | 18 |
| Part E | 26 |
| Part F | 6 |
Reported measurements
Baseline Negative
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part A | 23 | Not reported | Not reported | Not reported | Not reported |
| Part B | 20 | Not reported | Not reported | Not reported | Not reported |
| Part C | 16 | Not reported | Not reported | Not reported | Not reported |
| Part D | 17 | Not reported | Not reported | Not reported | Not reported |
| Part E | 24 | Not reported | Not reported | Not reported | Not reported |
| Part F | 6 | Not reported | Not reported | Not reported | Not reported |
Baseline Negative - Negative post-baseline
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part A | 14 | Not reported | Not reported | Not reported | Not reported |
| Part B | 12 | Not reported | Not reported | Not reported | Not reported |
| Part C | 5 | Not reported | Not reported | Not reported | Not reported |
| Part D | 12 | Not reported | Not reported | Not reported | Not reported |
| Part E | 17 | Not reported | Not reported | Not reported | Not reported |
| Part F | 6 | Not reported | Not reported | Not reported | Not reported |
Baseline Negative - Positive post-baseline
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part A | 9 | Not reported | Not reported | Not reported | Not reported |
| Part B | 8 | Not reported | Not reported | Not reported | Not reported |
| Part C | 11 | Not reported | Not reported | Not reported | Not reported |
| Part D | 5 | Not reported | Not reported | Not reported | Not reported |
| Part E | 7 | Not reported | Not reported | Not reported | Not reported |
| Part F | 0 | Not reported | Not reported | Not reported | Not reported |
Baseline Positive
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part A | 3 | Not reported | Not reported | Not reported | Not reported |
| Part B | 2 | Not reported | Not reported | Not reported | Not reported |
| Part C | 1 | Not reported | Not reported | Not reported | Not reported |
| Part D | 1 | Not reported | Not reported | Not reported | Not reported |
| Part E | 2 | Not reported | Not reported | Not reported | Not reported |
| Part F | 0 | Not reported | Not reported | Not reported | Not reported |
Baseline Positive - Negative post-baseline
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part A | 3 | Not reported | Not reported | Not reported | Not reported |
| Part B | 2 | Not reported | Not reported | Not reported | Not reported |
| Part C | 1 | Not reported | Not reported | Not reported | Not reported |
| Part D | 1 | Not reported | Not reported | Not reported | Not reported |
| Part E | 2 | Not reported | Not reported | Not reported | Not reported |
| Part F | 0 | Not reported | Not reported | Not reported | Not reported |
Baseline Positive: Treatment-boosted post-baseline
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part A | 0 | Not reported | Not reported | Not reported | Not reported |
| Part B | 0 | Not reported | Not reported | Not reported | Not reported |
| Part C | 0 | Not reported | Not reported | Not reported | Not reported |
| Part D | 0 | Not reported | Not reported | Not reported | Not reported |
| Part E | 0 | Not reported | Not reported | Not reported | Not reported |
| Part F | 0 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 23
- group Id
- OG001
- value
- 20
- group Id
- OG002
- value
- 16
- group Id
- OG003
- value
- 17
- group Id
- OG004
- value
- 24
- group Id
- OG005
- value
- 6
- title
- Baseline Negative
- categories
- measurements
- group Id
- OG000
- value
- 14
- group Id
- OG001
- value
- 12
- group Id
- OG002
- value
- 5
- group Id
- OG003
- value
- 12
- group Id
- OG004
- value
- 17
- group Id
- OG005
- value
- 6
- title
- Baseline Negative - Negative post-baseline
- categories
- measurements
- group Id
- OG000
- value
- 9
- group Id
- OG001
- value
- 8
- group Id
- OG002
- value
- 11
- group Id
- OG003
- value
- 5
- group Id
- OG004
- value
- 7
- group Id
- OG005
- value
- 0
- title
- Baseline Negative - Positive post-baseline
- categories
- measurements
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 1
- group Id
- OG004
- value
- 2
- group Id
- OG005
- value
- 0
- title
- Baseline Positive
- categories
- measurements
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 1
- group Id
- OG004
- value
- 2
- group Id
- OG005
- value
- 0
- title
- Baseline Positive - Negative post-baseline
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- title
- Baseline Positive: Treatment-boosted post-baseline
- denoms
- counts
- group Id
- OG000
- value
- 26
- group Id
- OG001
- value
- 22
- group Id
- OG002
- value
- 17
- group Id
- OG003
- value
- 18
- group Id
- OG004
- value
- 26
- group Id
- OG005
- value
- 6
- units
- Participants
- 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
- COUNT_OF_PARTICIPANTS
- population Description
- Subjects with a baseline and at least one post-baseline sample.
- reporting Status
- POSTED
- time Frame
- Up to 30 months
- title
- Number of Participants With Brentuximab Vedotin Antitherapeutic Antibodies (ATA)
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice