TriangleNCT03038672 · OUTCOME
Proportion of Patients With Grade 3 or Higher Adverse Events
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- proportion of patients
- Interval / dispersion
- Not reported
- Time frame
- 25 months
What was measured
Will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. The overall adverse event rates for grade 3 or higher hematologic and non-hematologic adverse events at least possibly related to treatment will be compared between the two treatment groups using the Chi-square test (or Fisher's exact test if the data in the contingency table is sparse).
Analysis population: All eligible and treated patients.
Groups in this outcome
Group I (Nivolumab)
Patients receive nivolumab IV over 30 minutes every 2 weeks for 4 months and every 4 weeks for a total of up to 2 years in the absence of disease progression or unacceptable toxicity. Patients may cross over to Group II at the time of disease progression.
Group II (Varlilumab, Nivolumab)
Patients receive varlilumab IV over 90 minutes every 4 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity. Patients also receive nivolumab IV over 30 minutes every 2 weeks for 4 months and every 4 weeks for a total of up to 2 years in the absence of disease progression or unacceptable toxicity.
| Group | Source count |
|---|---|
| Group I (Nivolumab) | 25 |
| Group II (Varlilumab, Nivolumab) | 26 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Group I (Nivolumab) | 0.76 | Not reported | Not reported | Not reported | Not reported |
| Group II (Varlilumab, Nivolumab) | 0.84 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 0.76
- group Id
- OG001
- value
- 0.84
- denoms
- counts
- group Id
- OG000
- value
- 25
- group Id
- OG001
- value
- 26
- units
- Participants
- description
- Will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. The overall adverse event rates for grade 3 or higher hematologic and non-hematologic adverse events at least possibly related to treatment will be compared between the two treatment groups using the Chi-square test (or Fisher's exact test if the data in the contingency table is sparse).
- groups
- description
- Patients receive nivolumab IV over 30 minutes every 2 weeks for 4 months and every 4 weeks for a total of up to 2 years in the absence of disease progression or unacceptable toxicity. Patients may cross over to Group II at the time of disease progression.
- id
- OG000
- title
- Group I (Nivolumab)
- description
- Patients receive varlilumab IV over 90 minutes every 4 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity. Patients also receive nivolumab IV over 30 minutes every 2 weeks for 4 months and every 4 weeks for a total of up to 2 years in the absence of disease progression or unacceptable toxicity.
- id
- OG001
- title
- Group II (Varlilumab, Nivolumab)
- param Type
- NUMBER
- population Description
- All eligible and treated patients.
- reporting Status
- POSTED
- time Frame
- 25 months
- title
- Proportion of Patients With Grade 3 or Higher Adverse Events
- type
- SECONDARY
- unit Of Measure
- proportion of patients
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice