TriangleNCT03370276 · OUTCOME
Number of Study Treatment Related Adverse Events
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- events
- Interval / dispersion
- Not reported
- Time frame
- Up to 48 months
What was measured
Related adverse events according to Common Terminology Criteria for Adverse Events (CTCAE) V4.1. An adverse event (AE) is defined as any untoward medical occurrence, including an exacerbation of a pre-existing condition, in a patient in a clinical investigation who received a pharmaceutical product. A serious adverse event (SAE) is defined as any AE that results in death, is immediately life-threatening, results in persistent or significant disability/incapacity, requires or prolongs patient hospitalization, is a congenital anomaly/birth defect, or is to be deemed serious for any other reason if it is an important medical event when based on appropriate medical judgement that may jeopardize the patient and may require medical or surgical intervention to prevent one of the other outcomes listed in the above definitions.
Analysis population: Evaluable participants
Groups in this outcome
Phase I Lead in + Phase II: Cohort A
Patients who had progressed on at least one prior line of treatment for their recurrent and/or metastatic HNSCC Participants were treated with Nivolumab and Cetuximab at recommended Phase II dose (RP2D). Nivolumab: Nivolumab intravenously (IV) at 240 mg as outlined in the treatment arms. Cetuximab: Cetuximab intravenously (IV) at 500 mg/m\^2 or 250 mg/m\^2 as outlined in the treatment arms.
Phase II - Cohort B
Patients who have not had any prior treatment for their recurrent and/or metastatic HNSCC Participants were treated with Nivolumab and Cetuximab at recommended Phase II dose (RP2D). Nivolumab: Nivolumab intravenously (IV) at 240 mg as outlined in the treatment arms. Cetuximab: Cetuximab intravenously (IV) at 500 mg/m\^2 or 250 mg/m\^2 as outlined in the treatment arms.
| Group | Source count |
|---|---|
| Phase I Lead in + Phase II: Cohort A | 45 |
| Phase II - Cohort B | 43 |
Reported measurements
Grade 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase I Lead in + Phase II: Cohort A | 115 | Not reported | Not reported | Not reported | Not reported |
| Phase II - Cohort B | 228 | Not reported | Not reported | Not reported | Not reported |
Grade 2
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase I Lead in + Phase II: Cohort A | 105 | Not reported | Not reported | Not reported | Not reported |
| Phase II - Cohort B | 142 | Not reported | Not reported | Not reported | Not reported |
Grade 3
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase I Lead in + Phase II: Cohort A | 23 | Not reported | Not reported | Not reported | Not reported |
| Phase II - Cohort B | 27 | Not reported | Not reported | Not reported | Not reported |
Grade 4
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase I Lead in + Phase II: Cohort A | 1 | Not reported | Not reported | Not reported | Not reported |
| Phase II - Cohort B | 1 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 115
- group Id
- OG001
- value
- 228
- title
- Grade 1
- categories
- measurements
- group Id
- OG000
- value
- 105
- group Id
- OG001
- value
- 142
- title
- Grade 2
- categories
- measurements
- group Id
- OG000
- value
- 23
- group Id
- OG001
- value
- 27
- title
- Grade 3
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 1
- title
- Grade 4
- denoms
- counts
- group Id
- OG000
- value
- 45
- group Id
- OG001
- value
- 43
- units
- Participants
- description
- Related adverse events according to Common Terminology Criteria for Adverse Events (CTCAE) V4.1. An adverse event (AE) is defined as any untoward medical occurrence, including an exacerbation of a pre-existing condition, in a patient in a clinical investigation who received a pharmaceutical product. A serious adverse event (SAE) is defined as any AE that results in death, is immediately life-threatening, results in persistent or significant disability/incapacity, requires or prolongs patient hospitalization, is a congenital anomaly/birth defect, or is to be deemed serious for any other reason if it is an important medical event when based on appropriate medical judgement that may jeopardize the patient and may require medical or surgical intervention to prevent one of the other outcomes listed in the above definitions.
- groups
- description
- Patients who had progressed on at least one prior line of treatment for their recurrent and/or metastatic HNSCC Participants were treated with Nivolumab and Cetuximab at recommended Phase II dose (RP2D). Nivolumab: Nivolumab intravenously (IV) at 240 mg as outlined in the treatment arms. Cetuximab: Cetuximab intravenously (IV) at 500 mg/m\^2 or 250 mg/m\^2 as outlined in the treatment arms.
- id
- OG000
- title
- Phase I Lead in + Phase II: Cohort A
- description
- Patients who have not had any prior treatment for their recurrent and/or metastatic HNSCC Participants were treated with Nivolumab and Cetuximab at recommended Phase II dose (RP2D). Nivolumab: Nivolumab intravenously (IV) at 240 mg as outlined in the treatment arms. Cetuximab: Cetuximab intravenously (IV) at 500 mg/m\^2 or 250 mg/m\^2 as outlined in the treatment arms.
- id
- OG001
- title
- Phase II - Cohort B
- param Type
- NUMBER
- population Description
- Evaluable participants
- reporting Status
- POSTED
- time Frame
- Up to 48 months
- title
- Number of Study Treatment Related Adverse Events
- type
- SECONDARY
- unit Of Measure
- events
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice