TriangleNCT04025879 · OUTCOME
The Number of Participants With Select Adverse Events (AEs)
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
- From first treatment to 30 days after last treatment of study therapy including definitive surgery and radiotherapy (up to approximately 28 months)
What was measured
An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. Select AEs include endocrinopathies, diarrhea/colitis, hepatitis, pneumonitis, interstitial nephritis, and rash. Multiple event terms that may describe each of these were grouped into endocrine, GI, hepatic, pulmonary, renal, and skin select AE categories, respectively. Hypersensitivity/infusion reactions were analyzed along with the select AE categories.
Analysis population: All participants who received at least one dose of study medication in neoadjuvant or adjuvant setting.
Groups in this outcome
Nivolumab + SOC Chemotherapy
Nivolumab 360 mg Q3W + SOC platinum-based doublet chemotherapy Q3W x 4 cycles as neoadjuvant treatment followed by surgery; then post surgery nivolumab 480 mg Q4W adjuvant treatment for up to 13 cycles (approximately 1 year)
Placebo + SOC Chemotherapy
Placebo Q3W + SOC platinum-based doublet chemotherapy Q3W x 4 cycles as neoadjuvant treatment followed by surgery, then post-surgery placebo Q4W for up to 13 cycles (approximately 1 year).
| Group | Source count |
|---|---|
| Nivolumab + SOC Chemotherapy | 228 |
| Placebo + SOC Chemotherapy | 230 |
Reported measurements
Gastrointestinal Event
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Nivolumab + SOC Chemotherapy | 37 | Not reported | Not reported | Not reported | Not reported |
| Placebo + SOC Chemotherapy | 37 | Not reported | Not reported | Not reported | Not reported |
Hepatic Event
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Nivolumab + SOC Chemotherapy | 46 | Not reported | Not reported | Not reported | Not reported |
| Placebo + SOC Chemotherapy | 31 | Not reported | Not reported | Not reported | Not reported |
Pulmonary Event
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Nivolumab + SOC Chemotherapy | 17 | Not reported | Not reported | Not reported | Not reported |
| Placebo + SOC Chemotherapy | 8 | Not reported | Not reported | Not reported | Not reported |
Renal Event
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Nivolumab + SOC Chemotherapy | 34 | Not reported | Not reported | Not reported | Not reported |
| Placebo + SOC Chemotherapy | 18 | Not reported | Not reported | Not reported | Not reported |
Skin Event
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Nivolumab + SOC Chemotherapy | 71 | Not reported | Not reported | Not reported | Not reported |
| Placebo + SOC Chemotherapy | 53 | Not reported | Not reported | Not reported | Not reported |
Hypersensitivity/Infusion Reaction Event
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Nivolumab + SOC Chemotherapy | 15 | Not reported | Not reported | Not reported | Not reported |
| Placebo + SOC Chemotherapy | 14 | Not reported | Not reported | Not reported | Not reported |
Endocrine Event
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Nivolumab + SOC Chemotherapy | 42 | Not reported | Not reported | Not reported | Not reported |
| Placebo + SOC Chemotherapy | 13 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 37
- group Id
- OG001
- value
- 37
- title
- Gastrointestinal Event
- categories
- measurements
- group Id
- OG000
- value
- 46
- group Id
- OG001
- value
- 31
- title
- Hepatic Event
- categories
- measurements
- group Id
- OG000
- value
- 17
- group Id
- OG001
- value
- 8
- title
- Pulmonary Event
- categories
- measurements
- group Id
- OG000
- value
- 34
- group Id
- OG001
- value
- 18
- title
- Renal Event
- categories
- measurements
- group Id
- OG000
- value
- 71
- group Id
- OG001
- value
- 53
- title
- Skin Event
- categories
- measurements
- group Id
- OG000
- value
- 15
- group Id
- OG001
- value
- 14
- title
- Hypersensitivity/Infusion Reaction Event
- categories
- measurements
- group Id
- OG000
- value
- 42
- group Id
- OG001
- value
- 13
- title
- Endocrine Event
- denoms
- counts
- group Id
- OG000
- value
- 228
- group Id
- OG001
- value
- 230
- units
- Participants
- description
- An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. Select AEs include endocrinopathies, diarrhea/colitis, hepatitis, pneumonitis, interstitial nephritis, and rash. Multiple event terms that may describe each of these were grouped into endocrine, GI, hepatic, pulmonary, renal, and skin select AE categories, respectively. Hypersensitivity/infusion reactions were analyzed along with the select AE categories.
- groups
- description
- Nivolumab 360 mg Q3W + SOC platinum-based doublet chemotherapy Q3W x 4 cycles as neoadjuvant treatment followed by surgery; then post surgery nivolumab 480 mg Q4W adjuvant treatment for up to 13 cycles (approximately 1 year)
- id
- OG000
- title
- Nivolumab + SOC Chemotherapy
- description
- Placebo Q3W + SOC platinum-based doublet chemotherapy Q3W x 4 cycles as neoadjuvant treatment followed by surgery, then post-surgery placebo Q4W for up to 13 cycles (approximately 1 year).
- id
- OG001
- title
- Placebo + SOC Chemotherapy
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- All participants who received at least one dose of study medication in neoadjuvant or adjuvant setting.
- reporting Status
- POSTED
- time Frame
- From first treatment to 30 days after last treatment of study therapy including definitive surgery and radiotherapy (up to approximately 28 months)
- title
- The Number of Participants With Select Adverse Events (AEs)
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice