TriangleNCT01716806 · OUTCOME
Number of Participants With Adverse Events
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 122 months
What was measured
A treatment-emergent AE (TEAE) is defined as a newly occurring or worsening AE after the first dose of any study drug component. Treatment-related AEs are defined as treatment-emergent AEs that are determined by the investigator to be related to the treatment on study. TEAEs were graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE version 4.03). The CTCAE displays Grades 1 through 5, where Grade 1: Mild, Grade 2: Moderate, Grade 3: Severe or medically significant but not immediately life-threatening, Grade 4: Life-threatening consequences, Grade 5: Death related to AE.
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
Any TEAE
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part A | 27 | Not reported | Not reported | Not reported | Not reported |
| Part B | 22 | Not reported | Not reported | Not reported | Not reported |
| Part C | 20 | Not reported | Not reported | Not reported | Not reported |
| Part D | 21 | Not reported | Not reported | Not reported | Not reported |
| Part E | 30 | Not reported | Not reported | Not reported | Not reported |
| Part F | 7 | Not reported | Not reported | Not reported | Not reported |
Treatment-related TEAE
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part A | 25 | Not reported | Not reported | Not reported | Not reported |
| Part B | 22 | Not reported | Not reported | Not reported | Not reported |
| Part C | 19 | Not reported | Not reported | Not reported | Not reported |
| Part D | 18 | 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 |
Any grade 3 or higher TEAE
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part A | 17 | Not reported | Not reported | Not reported | Not reported |
| Part B | 10 | Not reported | Not reported | Not reported | Not reported |
| Part C | 18 | Not reported | Not reported | Not reported | Not reported |
| Part D | 16 | Not reported | Not reported | Not reported | Not reported |
| Part E | 18 | Not reported | Not reported | Not reported | Not reported |
| Part F | 7 | Not reported | Not reported | Not reported | Not reported |
Treatment-related grade 3 or higher TEAE
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part A | 13 | Not reported | Not reported | Not reported | Not reported |
| Part B | 9 | Not reported | Not reported | Not reported | Not reported |
| Part C | 16 | Not reported | Not reported | Not reported | Not reported |
| Part D | 12 | Not reported | Not reported | Not reported | Not reported |
| Part E | 8 | Not reported | Not reported | Not reported | Not reported |
| Part F | 4 | Not reported | Not reported | Not reported | Not reported |
Any treatment-emergent (TE) serious adverse event (SAE)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part A | 5 | Not reported | Not reported | Not reported | Not reported |
| Part B | 4 | Not reported | Not reported | Not reported | Not reported |
| Part C | 13 | Not reported | Not reported | Not reported | Not reported |
| Part D | 4 | Not reported | Not reported | Not reported | Not reported |
| Part E | 14 | Not reported | Not reported | Not reported | Not reported |
| Part F | 4 | Not reported | Not reported | Not reported | Not reported |
Treatment-related TE SAE
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part A | 3 | Not reported | Not reported | Not reported | Not reported |
| Part B | 3 | Not reported | Not reported | Not reported | Not reported |
| Part C | 9 | Not reported | Not reported | Not reported | Not reported |
| Part D | 0 | Not reported | Not reported | Not reported | Not reported |
| Part E | 3 | Not reported | Not reported | Not reported | Not reported |
| Part F | 1 | Not reported | Not reported | Not reported | Not reported |
TEAE leading to treatment discontinuation
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part A | 11 | Not reported | Not reported | Not reported | Not reported |
| Part B | 11 | Not reported | Not reported | Not reported | Not reported |
| Part C | 12 | Not reported | Not reported | Not reported | Not reported |
| Part D | 5 | Not reported | Not reported | Not reported | Not reported |
| Part E | 9 | Not reported | Not reported | Not reported | Not reported |
| Part F | 3 | Not reported | Not reported | Not reported | Not reported |
Treatment-related TEAE leading to treatment discontinuation
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part A | 11 | Not reported | Not reported | Not reported | Not reported |
| Part B | 9 | Not reported | Not reported | Not reported | Not reported |
| Part C | 8 | Not reported | Not reported | Not reported | Not reported |
| Part D | 2 | Not reported | Not reported | Not reported | Not reported |
| Part E | 5 | Not reported | Not reported | Not reported | Not reported |
| Part F | 2 | Not reported | Not reported | Not reported | Not reported |
TEAE leading to death
| 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 | 3 | Not reported | Not reported | Not reported | Not reported |
| Part D | 1 | Not reported | Not reported | Not reported | Not reported |
| Part E | 4 | Not reported | Not reported | Not reported | Not reported |
| Part F | 2 | Not reported | Not reported | Not reported | Not reported |
Treatment-related TEAE leading to death
| 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 | 1 | Not reported | Not reported | Not reported | Not reported |
| Part F | 1 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- 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
- title
- Any TEAE
- categories
- measurements
- group Id
- OG000
- value
- 25
- group Id
- OG001
- value
- 22
- group Id
- OG002
- value
- 19
- group Id
- OG003
- value
- 18
- group Id
- OG004
- value
- 24
- group Id
- OG005
- value
- 6
- title
- Treatment-related TEAE
- categories
- measurements
- group Id
- OG000
- value
- 17
- group Id
- OG001
- value
- 10
- group Id
- OG002
- value
- 18
- group Id
- OG003
- value
- 16
- group Id
- OG004
- value
- 18
- group Id
- OG005
- value
- 7
- title
- Any grade 3 or higher TEAE
- categories
- measurements
- group Id
- OG000
- value
- 13
- group Id
- OG001
- value
- 9
- group Id
- OG002
- value
- 16
- group Id
- OG003
- value
- 12
- group Id
- OG004
- value
- 8
- group Id
- OG005
- value
- 4
- title
- Treatment-related grade 3 or higher TEAE
- categories
- measurements
- group Id
- OG000
- value
- 5
- group Id
- OG001
- value
- 4
- group Id
- OG002
- value
- 13
- group Id
- OG003
- value
- 4
- group Id
- OG004
- value
- 14
- group Id
- OG005
- value
- 4
- title
- Any treatment-emergent (TE) serious adverse event (SAE)
- categories
- measurements
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 9
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 3
- group Id
- OG005
- value
- 1
- title
- Treatment-related TE SAE
- categories
- measurements
- group Id
- OG000
- value
- 11
- group Id
- OG001
- value
- 11
- group Id
- OG002
- value
- 12
- group Id
- OG003
- value
- 5
- group Id
- OG004
- value
- 9
- group Id
- OG005
- value
- 3
- title
- TEAE leading to treatment discontinuation
- categories
- measurements
- group Id
- OG000
- value
- 11
- group Id
- OG001
- value
- 9
- group Id
- OG002
- value
- 8
- group Id
- OG003
- value
- 2
- group Id
- OG004
- value
- 5
- group Id
- OG005
- value
- 2
- title
- Treatment-related TEAE leading to treatment discontinuation
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 1
- group Id
- OG004
- value
- 4
- group Id
- OG005
- value
- 2
- title
- TEAE leading to death
- 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
- 1
- group Id
- OG005
- value
- 1
- title
- Treatment-related TEAE leading to death
- 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
- A treatment-emergent AE (TEAE) is defined as a newly occurring or worsening AE after the first dose of any study drug component. Treatment-related AEs are defined as treatment-emergent AEs that are determined by the investigator to be related to the treatment on study. TEAEs were graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE version 4.03). The CTCAE displays Grades 1 through 5, where Grade 1: Mild, Grade 2: Moderate, Grade 3: Severe or medically significant but not immediately life-threatening, Grade 4: Life-threatening consequences, Grade 5: Death related to AE.
- 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
- All subjects who received at least one dose of study drug
- reporting Status
- POSTED
- time Frame
- Up to 122 months
- title
- Number of Participants With Adverse Events
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice