TriangleNCT03595124 · OUTCOME
Percentage of Patients Experiencing Adverse Events (AEs)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- percentage of participants
- Interval / dispersion
- 70% Confidence Interval
- Time frame
- Up to 2 years from study entry
What was measured
Percentage of patients experiencing grade 3+ non-hematologic and all grade 4-5 AEs occurring during protocol therapy or within 30 days of treatment will be evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. The 70% confidence interval was chosen to match the one-sided significance level of alpha = 0.15 specified in the protocol analysis plan.
Analysis population: The data was analyzed with revised intention-to-treat approach. The following patients were excluded: Three (3) Arm B patients (as of Amendment 2A, the arm permanently closed to accrual and patients were randomly assigned to Arms A and C), One (1) Arm A patient who is ineligible for the study. 11 total patients were analyzed.
Groups in this outcome
Arm A (Axitinib, Nivolumab)
Patients receive axitinib PO BID on days 1-28 and nivolumab intravenously (IV) over 30 minutes, or per institutional guidelines, on days 1 and 15 (if \< 18 years old) or on day 1 (if \>= 18 years old). Treatment repeats every 28 days for up to 26 cycles (2 years) in the absence of disease progression or unacceptable toxicity.
Arm C (Nivolumab)
Patients receive nivolumab IV over 30 minutes, or per institutional guidelines, on days 1 and 15 (if \< 18 years old) or on day 1 (if \>= 18 years old). Treatment repeats every 28 days for up to 26 cycles (2 years) in the absence of disease progression or unacceptable toxicity.
| Group | Source count |
|---|---|
| Arm A (Axitinib, Nivolumab) | 6 |
| Arm C (Nivolumab) | 5 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm A (Axitinib, Nivolumab) | 50 | Not reported | 30.52 | 69.48 | Not reported |
| Arm C (Nivolumab) | 80 | Not reported | 46.87 | 97.39 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 30.52
- upper Limit
- 69.48
- value
- 50
- group Id
- OG001
- lower Limit
- 46.87
- upper Limit
- 97.39
- value
- 80
- denoms
- counts
- group Id
- OG000
- value
- 6
- group Id
- OG001
- value
- 5
- units
- Participants
- description
- Percentage of patients experiencing grade 3+ non-hematologic and all grade 4-5 AEs occurring during protocol therapy or within 30 days of treatment will be evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. The 70% confidence interval was chosen to match the one-sided significance level of alpha = 0.15 specified in the protocol analysis plan.
- dispersion Type
- 70% Confidence Interval
- groups
- description
- Patients receive axitinib PO BID on days 1-28 and nivolumab intravenously (IV) over 30 minutes, or per institutional guidelines, on days 1 and 15 (if \< 18 years old) or on day 1 (if \>= 18 years old). Treatment repeats every 28 days for up to 26 cycles (2 years) in the absence of disease progression or unacceptable toxicity.
- id
- OG000
- title
- Arm A (Axitinib, Nivolumab)
- description
- Patients receive nivolumab IV over 30 minutes, or per institutional guidelines, on days 1 and 15 (if \< 18 years old) or on day 1 (if \>= 18 years old). Treatment repeats every 28 days for up to 26 cycles (2 years) in the absence of disease progression or unacceptable toxicity.
- id
- OG001
- title
- Arm C (Nivolumab)
- param Type
- NUMBER
- population Description
- The data was analyzed with revised intention-to-treat approach. The following patients were excluded: Three (3) Arm B patients (as of Amendment 2A, the arm permanently closed to accrual and patients were randomly assigned to Arms A and C), One (1) Arm A patient who is ineligible for the study. 11 total patients were analyzed.
- reporting Status
- POSTED
- time Frame
- Up to 2 years from study entry
- title
- Percentage of Patients Experiencing Adverse Events (AEs)
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice