TriangleNCT01010126 · OUTCOME
Incidence of 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
- Every cycle of treatment, up to 3 years
What was measured
Adverse events are defined as events that are classified as either possibly, probably, or definitely related to study treatment, graded per National Cancer Institute Common Terminology Criteria for Adverse Events Version 3.0. The number of patients reporting grade 3 or higher adverse events at least possibly related to treatment are reported here. For a complete list of all reported adverse events, please see the adverse events section of this report.
Analysis population: All patients that received protocol treatment and were evaluated for adverse events are reported in this analysis.
Groups in this outcome
Endometrial Cohort
Patients receive 25 mg temsirolimus IV on days 1, 8, 15, and 22, and 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Ovarian Cohort
Patients receive 25 mg temsirolimus IV on days 1, 8, 15, and 22, and 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Hepatocellular Cohort
Patients receive 25 mg temsirolimus IV on days 1, 8, 15, and 22, and 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Carcinoid Cohort
Patients receive 25 mg temsirolimus IV on days 1, 8, 15, and 22, and 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Islet Cell (Double Agent) Cohort
Patients receive 25 mg temsirolimus IV on days 1, 8, 15, and 22, and 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Islet Cell (Bevacizumab-only) Cohort
Patients receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
| Group | Source count |
|---|---|
| Endometrial Cohort | 26 |
| Ovarian Cohort | 58 |
| Hepatocellular Cohort | 27 |
| Carcinoid Cohort | 57 |
| Islet Cell (Double Agent) Cohort | 55 |
| Islet Cell (Bevacizumab-only) Cohort | 24 |
Reported measurements
Grade 3 Adverse Event
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Endometrial Cohort | 17 | Not reported | Not reported | Not reported | Not reported |
| Ovarian Cohort | 32 | Not reported | Not reported | Not reported | Not reported |
| Hepatocellular Cohort | 24 | Not reported | Not reported | Not reported | Not reported |
| Carcinoid Cohort | 32 | Not reported | Not reported | Not reported | Not reported |
| Islet Cell (Double Agent) Cohort | 36 | Not reported | Not reported | Not reported | Not reported |
| Islet Cell (Bevacizumab-only) Cohort | 13 | Not reported | Not reported | Not reported | Not reported |
Grade 4 Adverse Event
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Endometrial Cohort | 1 | Not reported | Not reported | Not reported | Not reported |
| Ovarian Cohort | 6 | Not reported | Not reported | Not reported | Not reported |
| Hepatocellular Cohort | 0 | Not reported | Not reported | Not reported | Not reported |
| Carcinoid Cohort | 6 | Not reported | Not reported | Not reported | Not reported |
| Islet Cell (Double Agent) Cohort | 8 | Not reported | Not reported | Not reported | Not reported |
| Islet Cell (Bevacizumab-only) Cohort | 0 | Not reported | Not reported | Not reported | Not reported |
Grade 5 Adverse Event
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Endometrial Cohort | 1 | Not reported | Not reported | Not reported | Not reported |
| Ovarian Cohort | 0 | Not reported | Not reported | Not reported | Not reported |
| Hepatocellular Cohort | 1 | Not reported | Not reported | Not reported | Not reported |
| Carcinoid Cohort | 2 | Not reported | Not reported | Not reported | Not reported |
| Islet Cell (Double Agent) Cohort | 0 | Not reported | Not reported | Not reported | Not reported |
| Islet Cell (Bevacizumab-only) Cohort | 0 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 17
- group Id
- OG001
- value
- 32
- group Id
- OG002
- value
- 24
- group Id
- OG003
- value
- 32
- group Id
- OG004
- value
- 36
- group Id
- OG005
- value
- 13
- title
- Grade 3 Adverse Event
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 6
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 6
- group Id
- OG004
- value
- 8
- group Id
- OG005
- value
- 0
- title
- Grade 4 Adverse Event
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 2
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- title
- Grade 5 Adverse Event
- denoms
- counts
- group Id
- OG000
- value
- 26
- group Id
- OG001
- value
- 58
- group Id
- OG002
- value
- 27
- group Id
- OG003
- value
- 57
- group Id
- OG004
- value
- 55
- group Id
- OG005
- value
- 24
- units
- Participants
- description
- Adverse events are defined as events that are classified as either possibly, probably, or definitely related to study treatment, graded per National Cancer Institute Common Terminology Criteria for Adverse Events Version 3.0. The number of patients reporting grade 3 or higher adverse events at least possibly related to treatment are reported here. For a complete list of all reported adverse events, please see the adverse events section of this report.
- groups
- description
- Patients receive 25 mg temsirolimus IV on days 1, 8, 15, and 22, and 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
- id
- OG000
- title
- Endometrial Cohort
- description
- Patients receive 25 mg temsirolimus IV on days 1, 8, 15, and 22, and 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
- id
- OG001
- title
- Ovarian Cohort
- description
- Patients receive 25 mg temsirolimus IV on days 1, 8, 15, and 22, and 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
- id
- OG002
- title
- Hepatocellular Cohort
- description
- Patients receive 25 mg temsirolimus IV on days 1, 8, 15, and 22, and 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
- id
- OG003
- title
- Carcinoid Cohort
- description
- Patients receive 25 mg temsirolimus IV on days 1, 8, 15, and 22, and 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
- id
- OG004
- title
- Islet Cell (Double Agent) Cohort
- description
- Patients receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
- id
- OG005
- title
- Islet Cell (Bevacizumab-only) Cohort
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- All patients that received protocol treatment and were evaluated for adverse events are reported in this analysis.
- reporting Status
- POSTED
- time Frame
- Every cycle of treatment, up to 3 years
- title
- Incidence of Adverse Events
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice