NCT04099251 · OUTCOME
Number of Participants Experiencing Laboratory Abnormalities in Selected Liver Parameters
Effectiveness Study of Nivolumab Compared to Placebo in Prevention of Recurrent Melanoma After Complete Resection of Stage IIB/C Melanoma · Source last updated 2026-08-07
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 dose up to 30 days post last dose of the blinded phase (up to 13 months)
What was measured
The number of participants experiencing laboratory abnormalities in the specific pre-determined liver tests.
Analysis population: Participants with at least one on-treatment measurement of the corresponding laboratory parameter
Groups in this outcome
Nivolumab
Participants received 480 mg IV Nivolumab in an approximately 30-minute infusion on Day 1 of each 4-week treatment cycle until unacceptable toxicity, withdrawal of consent, completion of 12 months of treatment (from first dose of study treatment), disease recurrence, or the study ends, whichever occurred first. Participants began study treatment (Cycle 1) within 3 calendar days of randomization. Subsequent cycles were initiated within ± 3 days of the target visit date.
Placebo
Nivolumab matched placebo (0.9% Sodium Chloride for Injection/5% Dextrose for Injection) IV in a 30-minute infusion on Day 1 of each 4-week treatment cycle until unacceptable toxicity, withdrawal of consent, completion of 12 months of treatment (from first dose of study treatment), disease recurrence, or the study ends, whichever occurred first. In the event of disease recurrence, participants on the blinded nivolumab or placebo portion will be offered the option to receive open-label on-protocol nivolumab treatment. Participants received 480 mg IV Nivolumab in a 30-minute infusion on Day 1 of each 4-week treatment cycle until unacceptable toxicity, recurrence/progression, withdrawal of consent, completion of 12 months of treatment from first dose of open-label study treatment, whichever occurred first.
Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
| Group | Source count |
|---|
| Nivolumab | 513 |
|---|
| Placebo | 261 |
|---|
Reported measurements
ALT OR AST > 3XULN
Analysis denominator · Participants
| Group | Source count |
|---|
| Nivolumab | 513 |
|---|
| Placebo | 261 |
|---|
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Nivolumab | 29 | Not reported | Not reported | Not reported | Not reported |
|---|
| Placebo | 5 | Not reported | Not reported | Not reported | Not reported |
|---|
ALT OR AST > 5XULN
Analysis denominator · Participants
| Group | Source count |
|---|
| Nivolumab | 513 |
|---|
| Placebo | 261 |
|---|
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Nivolumab | 16 | Not reported | Not reported | Not reported | Not reported |
|---|
| Placebo | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
ALT OR AST > 10XULN
Analysis denominator · Participants
| Group | Source count |
|---|
| Nivolumab | 513 |
|---|
| Placebo | 261 |
|---|
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Nivolumab | 6 | Not reported | Not reported | Not reported | Not reported |
|---|
| Placebo | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
ALT OR AST > 20XULN
Analysis denominator · Participants
| Group | Source count |
|---|
| Nivolumab | 513 |
|---|
| Placebo | 261 |
|---|
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Nivolumab | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
| Placebo | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
TOTAL BILIRUBIN > 2XULN
Analysis denominator · Participants
| Group | Source count |
|---|
| Nivolumab | 513 |
|---|
| Placebo | 261 |
|---|
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Nivolumab | 3 | Not reported | Not reported | Not reported | Not reported |
|---|
| Placebo | 5 | Not reported | Not reported | Not reported | Not reported |
|---|
ALP > 1.5XULN
Analysis denominator · Participants
| Group | Source count |
|---|
| Nivolumab | 512 |
|---|
| Placebo | 261 |
|---|
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Nivolumab | 20 | Not reported | Not reported | Not reported | Not reported |
|---|
| Placebo | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 29
- group Id
- OG001
- value
- 5
- denoms
- counts
- group Id
- OG000
- value
- 513
- group Id
- OG001
- value
- 261
- units
- Participants
- title
- ALT OR AST > 3XULN
- categories
- measurements
- group Id
- OG000
- value
- 16
- group Id
- OG001
- value
- 2
- denoms
- counts
- group Id
- OG000
- value
- 513
- group Id
- OG001
- value
- 261
- units
- Participants
- title
- ALT OR AST > 5XULN
- categories
- measurements
- group Id
- OG000
- value
- 6
- group Id
- OG001
- value
- 0
- denoms
- counts
- group Id
- OG000
- value
- 513
- group Id
- OG001
- value
- 261
- units
- Participants
- title
- ALT OR AST > 10XULN
- categories
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 0
- denoms
- counts
- group Id
- OG000
- value
- 513
- group Id
- OG001
- value
- 261
- units
- Participants
- title
- ALT OR AST > 20XULN
- categories
- measurements
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 5
- denoms
- counts
- group Id
- OG000
- value
- 513
- group Id
- OG001
- value
- 261
- units
- Participants
- title
- TOTAL BILIRUBIN > 2XULN
- categories
- measurements
- group Id
- OG000
- value
- 20
- group Id
- OG001
- value
- 1
- denoms
- counts
- group Id
- OG000
- value
- 512
- group Id
- OG001
- value
- 261
- units
- Participants
- title
- ALP > 1.5XULN
- denoms
- counts
- group Id
- OG000
- value
- 513
- group Id
- OG001
- value
- 261
- units
- Participants
- description
- The number of participants experiencing laboratory abnormalities in the specific pre-determined liver tests.
- groups
- description
- Participants received 480 mg IV Nivolumab in an approximately 30-minute infusion on Day 1 of each 4-week treatment cycle until unacceptable toxicity, withdrawal of consent, completion of 12 months of treatment (from first dose of study treatment), disease recurrence, or the study ends, whichever occurred first. Participants began study treatment (Cycle 1) within 3 calendar days of randomization. Subsequent cycles were initiated within ± 3 days of the target visit date.
- id
- OG000
- title
- Nivolumab
- description
- Nivolumab matched placebo (0.9% Sodium Chloride for Injection/5% Dextrose for Injection) IV in a 30-minute infusion on Day 1 of each 4-week treatment cycle until unacceptable toxicity, withdrawal of consent, completion of 12 months of treatment (from first dose of study treatment), disease recurrence, or the study ends, whichever occurred first. In the event of disease recurrence, participants on the blinded nivolumab or placebo portion will be offered the option to receive open-label on-protocol nivolumab treatment. Participants received 480 mg IV Nivolumab in a 30-minute infusion on Day 1 of each 4-week treatment cycle until unacceptable toxicity, recurrence/progression, withdrawal of consent, completion of 12 months of treatment from first dose of open-label study treatment, whichever occurred first.
- id
- OG001
- title
- Placebo
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Participants with at least one on-treatment measurement of the corresponding laboratory parameter
- reporting Status
- POSTED
- time Frame
- From first dose up to 30 days post last dose of the blinded phase (up to 13 months)
- title
- Number of Participants Experiencing Laboratory Abnormalities in Selected Liver Parameters
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice
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