TriangleNCT02500797 · OUTCOME
Number of Participants Who Experienced at Least One Grade 3 or Higher Adverse Event Regardless of Attribution
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 4 weeks after completion of study treatment
What was measured
The number of participants who experienced at least one grade 3 or higher adverse event (AE) regardless of attribution. AEs are graded using the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (version 5.0 beginning April 1, 2018).
Analysis population: Randomized patients who received treatment (i.e. exclude cancel patients).
Groups in this outcome
Initial Single
Patients receive 3mg/kg nivolumab IV over 30 minutes once every 2 weeks. Cycles repeat every 42 days for up to 108 weeks in the absence of disease progression or unacceptable toxicity. Patients who progress on single agent nivolumab may elect to cross over to Initial Cohort - Arm II.
Initial Dual
Patients receive 3mg/kg nivolumab IV over 30 minutes and 1mg/kg ipilimumab IV over 90 minutes once every 3 weeks for 12 weeks. Patients then receive 3mg/kg nivolumab IV over 30 minutes every 2 weeks. Cycles repeat every 42 days for up to 108 weeks in the absence of disease progression or unacceptable toxicity.
LPS Single
Dedifferentiated liposarcoma (LPS) Cohort Patients receive 3mg/kg nivolumab IV over 30 minutes once every 2 weeks. Cycles repeat every 42 days for up to 108 weeks in the absence of disease progression or unacceptable toxicity.
LPS Dual
Dedifferentiated liposarcoma (LPS) Cohort Patients receive 3mg/kg nivolumab IV over 30 minutes and 1mg/kg ipilimumab IV over 90 minutes once every 3 weeks for 12 weeks. Patients then receive 3mg/kg nivolumab IV over 30 minutes every 2 weeks. Cycles repeat every 42 days for up to 108 weeks in the absence of disease progression or unacceptable toxicity. Patients who progress by imaging during the first 12 weeks of therapy may continue treatment, at the discretion of the patient and treating investigator.
UPS/MFH Single
Undifferentiated Pleomorphic Sarcoma \& Malignant Fibrous Histiocytoma (UPS/MFH) Cohort Patients receive 3mg/kg nivolumab IV over 30 minutes once every 2 weeks. Cycles repeat every 42 days for up to 108 weeks in the absence of disease progression or unacceptable toxicity.
UPS/MFH Dual
Undifferentiated Pleomorphic Sarcoma \& Malignant Fibrous Histiocytoma (UPS/MFH) Cohort Patients receive 3mg/kg nivolumab IV over 30 minutes and 1mg/kg ipilimumab IV over 90 minutes once every 3 weeks for 12 weeks. Patients then receive 3mg/kg nivolumab IV over 30 minutes every 2 weeks. Cycles repeat every 42 days for up to 108 weeks in the absence of disease progression or unacceptable toxicity. Patients who progress by imaging during the first 12 weeks of therapy may continue treatment, at the discretion of the patient and treating investigator.
GIST Single
Gastrointestinal stromal tumor (GIST) Cohort Patients receive 3mg/kg nivolumab IV over 30 minutes once every 2 weeks. Cycles repeat every 42 days for up to 108 weeks in the absence of disease progression or unacceptable toxicity.
GIST Dual
Gastrointestinal stromal tumor (GIST) Cohort Patients receive 3mg/kg nivolumab IV over 30 minutes and 1mg/kg ipilimumab IV over 90 minutes once every 3 weeks for 12 weeks. Patients then receive 3mg/kg nivolumab IV over 30 minutes every 2 weeks. Cycles repeat every 42 days for up to 108 weeks in the absence of disease progression or unacceptable toxicity. Patients who progress by imaging during the first 12 weeks of therapy may continue treatment, at the discretion of the patient and treating investigator.
| Group | Source count |
|---|---|
| Initial Single | 42 |
| Initial Dual | 42 |
| LPS Single | 15 |
| LPS Dual | 14 |
| UPS/MFH Single | 13 |
| UPS/MFH Dual | 14 |
| GIST Single | 10 |
| GIST Dual | 11 |
Reported measurements
Grade 3 Event
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Initial Single | 19 | Not reported | Not reported | Not reported | Not reported |
| Initial Dual | 25 | Not reported | Not reported | Not reported | Not reported |
| LPS Single | 11 | Not reported | Not reported | Not reported | Not reported |
| LPS Dual | 5 | Not reported | Not reported | Not reported | Not reported |
| UPS/MFH Single | 9 | Not reported | Not reported | Not reported | Not reported |
| UPS/MFH Dual | 6 | Not reported | Not reported | Not reported | Not reported |
| GIST Single | 5 | Not reported | Not reported | Not reported | Not reported |
| GIST Dual | 6 | Not reported | Not reported | Not reported | Not reported |
Grade 4 Event
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Initial Single | 3 | Not reported | Not reported | Not reported | Not reported |
| Initial Dual | 4 | Not reported | Not reported | Not reported | Not reported |
| LPS Single | 0 | Not reported | Not reported | Not reported | Not reported |
| LPS Dual | 0 | Not reported | Not reported | Not reported | Not reported |
| UPS/MFH Single | 1 | Not reported | Not reported | Not reported | Not reported |
| UPS/MFH Dual | 2 | Not reported | Not reported | Not reported | Not reported |
| GIST Single | 1 | Not reported | Not reported | Not reported | Not reported |
| GIST Dual | 1 | Not reported | Not reported | Not reported | Not reported |
Grade 5 Event
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Initial Single | 5 | Not reported | Not reported | Not reported | Not reported |
| Initial Dual | 6 | Not reported | Not reported | Not reported | Not reported |
| LPS Single | 1 | Not reported | Not reported | Not reported | Not reported |
| LPS Dual | 0 | Not reported | Not reported | Not reported | Not reported |
| UPS/MFH Single | 3 | Not reported | Not reported | Not reported | Not reported |
| UPS/MFH Dual | 1 | Not reported | Not reported | Not reported | Not reported |
| GIST Single | 1 | Not reported | Not reported | Not reported | Not reported |
| GIST Dual | 0 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 19
- group Id
- OG001
- value
- 25
- group Id
- OG002
- value
- 11
- group Id
- OG003
- value
- 5
- group Id
- OG004
- value
- 9
- group Id
- OG005
- value
- 6
- group Id
- OG006
- value
- 5
- group Id
- OG007
- value
- 6
- title
- Grade 3 Event
- categories
- measurements
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 4
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 1
- group Id
- OG005
- value
- 2
- group Id
- OG006
- value
- 1
- group Id
- OG007
- value
- 1
- title
- Grade 4 Event
- categories
- measurements
- group Id
- OG000
- value
- 5
- group Id
- OG001
- value
- 6
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 3
- group Id
- OG005
- value
- 1
- group Id
- OG006
- value
- 1
- group Id
- OG007
- value
- 0
- title
- Grade 5 Event
- denoms
- counts
- group Id
- OG000
- value
- 42
- group Id
- OG001
- value
- 42
- group Id
- OG002
- value
- 15
- group Id
- OG003
- value
- 14
- group Id
- OG004
- value
- 13
- group Id
- OG005
- value
- 14
- group Id
- OG006
- value
- 10
- group Id
- OG007
- value
- 11
- units
- Participants
- description
- The number of participants who experienced at least one grade 3 or higher adverse event (AE) regardless of attribution. AEs are graded using the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (version 5.0 beginning April 1, 2018).
- groups
- description
- Patients receive 3mg/kg nivolumab IV over 30 minutes once every 2 weeks. Cycles repeat every 42 days for up to 108 weeks in the absence of disease progression or unacceptable toxicity. Patients who progress on single agent nivolumab may elect to cross over to Initial Cohort - Arm II.
- id
- OG000
- title
- Initial Single
- description
- Patients receive 3mg/kg nivolumab IV over 30 minutes and 1mg/kg ipilimumab IV over 90 minutes once every 3 weeks for 12 weeks. Patients then receive 3mg/kg nivolumab IV over 30 minutes every 2 weeks. Cycles repeat every 42 days for up to 108 weeks in the absence of disease progression or unacceptable toxicity.
- id
- OG001
- title
- Initial Dual
- description
- Dedifferentiated liposarcoma (LPS) Cohort Patients receive 3mg/kg nivolumab IV over 30 minutes once every 2 weeks. Cycles repeat every 42 days for up to 108 weeks in the absence of disease progression or unacceptable toxicity.
- id
- OG002
- title
- LPS Single
- description
- Dedifferentiated liposarcoma (LPS) Cohort Patients receive 3mg/kg nivolumab IV over 30 minutes and 1mg/kg ipilimumab IV over 90 minutes once every 3 weeks for 12 weeks. Patients then receive 3mg/kg nivolumab IV over 30 minutes every 2 weeks. Cycles repeat every 42 days for up to 108 weeks in the absence of disease progression or unacceptable toxicity. Patients who progress by imaging during the first 12 weeks of therapy may continue treatment, at the discretion of the patient and treating investigator.
- id
- OG003
- title
- LPS Dual
- description
- Undifferentiated Pleomorphic Sarcoma \& Malignant Fibrous Histiocytoma (UPS/MFH) Cohort Patients receive 3mg/kg nivolumab IV over 30 minutes once every 2 weeks. Cycles repeat every 42 days for up to 108 weeks in the absence of disease progression or unacceptable toxicity.
- id
- OG004
- title
- UPS/MFH Single
- description
- Undifferentiated Pleomorphic Sarcoma \& Malignant Fibrous Histiocytoma (UPS/MFH) Cohort Patients receive 3mg/kg nivolumab IV over 30 minutes and 1mg/kg ipilimumab IV over 90 minutes once every 3 weeks for 12 weeks. Patients then receive 3mg/kg nivolumab IV over 30 minutes every 2 weeks. Cycles repeat every 42 days for up to 108 weeks in the absence of disease progression or unacceptable toxicity. Patients who progress by imaging during the first 12 weeks of therapy may continue treatment, at the discretion of the patient and treating investigator.
- id
- OG005
- title
- UPS/MFH Dual
- description
- Gastrointestinal stromal tumor (GIST) Cohort Patients receive 3mg/kg nivolumab IV over 30 minutes once every 2 weeks. Cycles repeat every 42 days for up to 108 weeks in the absence of disease progression or unacceptable toxicity.
- id
- OG006
- title
- GIST Single
- description
- Gastrointestinal stromal tumor (GIST) Cohort Patients receive 3mg/kg nivolumab IV over 30 minutes and 1mg/kg ipilimumab IV over 90 minutes once every 3 weeks for 12 weeks. Patients then receive 3mg/kg nivolumab IV over 30 minutes every 2 weeks. Cycles repeat every 42 days for up to 108 weeks in the absence of disease progression or unacceptable toxicity. Patients who progress by imaging during the first 12 weeks of therapy may continue treatment, at the discretion of the patient and treating investigator.
- id
- OG007
- title
- GIST Dual
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Randomized patients who received treatment (i.e. exclude cancel patients).
- reporting Status
- POSTED
- time Frame
- Up to 4 weeks after completion of study treatment
- title
- Number of Participants Who Experienced at Least One Grade 3 or Higher Adverse Event Regardless of Attribution
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice