TriangleNCT01668784 · OUTCOME
Number of Participants With Serious Adverse Events, Death, Discontinuation Due to 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
- Day of first dose to 30 days post study completion (approximately 106 months)
What was measured
Adverse event (AE) defined: any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. Serious adverse event (SAE) defined: a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization.
Analysis population: All treated participants; all participants who received at least one dose of nivolumab or everolimus
Groups in this outcome
Nivolumab
Nivolumab at 3 mg/kg solution provided intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.
Everolimus
Everolimus provided in 10 mg tablets by mouth daily until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.
| Group | Source count |
|---|---|
| Nivolumab | 406 |
| Everolimus | 397 |
Reported measurements
Deaths
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Nivolumab | 324 | Not reported | Not reported | Not reported | Not reported |
| Everolimus | 342 | Not reported | Not reported | Not reported | Not reported |
SAEs
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Nivolumab | 211 | Not reported | Not reported | Not reported | Not reported |
| Everolimus | 177 | Not reported | Not reported | Not reported | Not reported |
Drug related SAEs
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Nivolumab | 51 | Not reported | Not reported | Not reported | Not reported |
| Everolimus | 55 | Not reported | Not reported | Not reported | Not reported |
Drug related AEs
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Nivolumab | 327 | Not reported | Not reported | Not reported | Not reported |
| Everolimus | 353 | Not reported | Not reported | Not reported | Not reported |
Discontinued due to Drug-related AEs
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Nivolumab | 40 | Not reported | Not reported | Not reported | Not reported |
| Everolimus | 51 | Not reported | Not reported | Not reported | Not reported |
Discontinued due to AEs
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Nivolumab | 85 | Not reported | Not reported | Not reported | Not reported |
| Everolimus | 82 | Not reported | Not reported | Not reported | Not reported |
Adverse Events
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Nivolumab | 398 | Not reported | Not reported | Not reported | Not reported |
| Everolimus | 387 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 324
- group Id
- OG001
- value
- 342
- title
- Deaths
- categories
- measurements
- group Id
- OG000
- value
- 211
- group Id
- OG001
- value
- 177
- title
- SAEs
- categories
- measurements
- group Id
- OG000
- value
- 51
- group Id
- OG001
- value
- 55
- title
- Drug related SAEs
- categories
- measurements
- group Id
- OG000
- value
- 327
- group Id
- OG001
- value
- 353
- title
- Drug related AEs
- categories
- measurements
- group Id
- OG000
- value
- 40
- group Id
- OG001
- value
- 51
- title
- Discontinued due to Drug-related AEs
- categories
- measurements
- group Id
- OG000
- value
- 85
- group Id
- OG001
- value
- 82
- title
- Discontinued due to AEs
- categories
- measurements
- group Id
- OG000
- value
- 398
- group Id
- OG001
- value
- 387
- title
- Adverse Events
- denoms
- counts
- group Id
- OG000
- value
- 406
- group Id
- OG001
- value
- 397
- units
- Participants
- description
- Adverse event (AE) defined: any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. Serious adverse event (SAE) defined: a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization.
- groups
- description
- Nivolumab at 3 mg/kg solution provided intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.
- id
- OG000
- title
- Nivolumab
- description
- Everolimus provided in 10 mg tablets by mouth daily until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.
- id
- OG001
- title
- Everolimus
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- All treated participants; all participants who received at least one dose of nivolumab or everolimus
- reporting Status
- POSTED
- time Frame
- Day of first dose to 30 days post study completion (approximately 106 months)
- title
- Number of Participants With Serious Adverse Events, Death, Discontinuation Due to Adverse Events
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice