NCT02314169 · OUTCOME
Incidence of Treatment-related Grade 3/4/5 Adverse Events (Part B)
Nivolumab With or Without Ipilimumab in Treating Patients With Refractory Metastatic Anal Canal Cancer · Source last updated 2026-07-31
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
- Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
What was measured
Toxicities were assessed by CTCAE version 5.0. The highest grade that occurred for a participant was recorded per toxicity.
Groups in this outcome
Part B1 (Nivolumab)
This outcome measure includes data from participants enrolled to Part B1 and received nivolumab monotherapy.
Part B2 (Nivolumab + Ipilimumab)
This outcome measure includes data from participants enrolled to Part B2 and received the doublet therapy.
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 |
|---|
| Part B1 (Nivolumab) | 52 |
|---|
| Part B2 (Nivolumab + Ipilimumab) | 48 |
|---|
Reported measurements
Abdominal distension
Grade 3
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part B1 (Nivolumab) | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part B2 (Nivolumab + Ipilimumab) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Grade 4
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part B1 (Nivolumab) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part B2 (Nivolumab + Ipilimumab) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Grade 5
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part B1 (Nivolumab) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part B2 (Nivolumab + Ipilimumab) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Did not experience a Grade 3, 4, or 5 event
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part B1 (Nivolumab) | 51 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part B2 (Nivolumab + Ipilimumab) | 48 | Not reported | Not reported | Not reported | Not reported |
|---|
Abdominal pain
Grade 3
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part B1 (Nivolumab) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part B2 (Nivolumab + Ipilimumab) | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
Grade 4
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part B1 (Nivolumab) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part B2 (Nivolumab + Ipilimumab) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Grade 5
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part B1 (Nivolumab) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part B2 (Nivolumab + Ipilimumab) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Did not experience a Grade 3, 4, or 5 event
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part B1 (Nivolumab) | 52 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part B2 (Nivolumab + Ipilimumab) | 47 | Not reported | Not reported | Not reported | Not reported |
|---|
Adrenal insufficiency
Grade 3
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part B1 (Nivolumab) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part B2 (Nivolumab + Ipilimumab) | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
Grade 4
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part B1 (Nivolumab) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part B2 (Nivolumab + Ipilimumab) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Grade 5
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part B1 (Nivolumab) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part B2 (Nivolumab + Ipilimumab) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Did not experience a Grade 3, 4, or 5 event
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part B1 (Nivolumab) | 52 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part B2 (Nivolumab + Ipilimumab) | 47 | Not reported | Not reported | Not reported | Not reported |
|---|
Elevated Alanine Aminotransferase
Grade 3
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part B1 (Nivolumab) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part B2 (Nivolumab + Ipilimumab) | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
Grade 4
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part B1 (Nivolumab) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part B2 (Nivolumab + Ipilimumab) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Grade 5
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part B1 (Nivolumab) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part B2 (Nivolumab + Ipilimumab) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Did not experience a Grade 3, 4, or 5 event
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part B1 (Nivolumab) | 52 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part B2 (Nivolumab + Ipilimumab) | 46 | Not reported | Not reported | Not reported | Not reported |
|---|
Anemia
Grade 3
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part B1 (Nivolumab) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part B2 (Nivolumab + Ipilimumab) | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
Grade 4
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part B1 (Nivolumab) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part B2 (Nivolumab + Ipilimumab) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Grade 5
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part B1 (Nivolumab) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part B2 (Nivolumab + Ipilimumab) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Did not experience a Grade 3, 4, or 5 event
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part B1 (Nivolumab) | 52 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part B2 (Nivolumab + Ipilimumab) | 47 | Not reported | Not reported | Not reported | Not reported |
|---|
Elevated Aspartate Aminotransferase
Grade 3
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part B1 (Nivolumab) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part B2 (Nivolumab + Ipilimumab) | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
Grade 4
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part B1 (Nivolumab) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part B2 (Nivolumab + Ipilimumab) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Grade 5
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part B1 (Nivolumab) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part B2 (Nivolumab + Ipilimumab) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Did not experience a Grade 3, 4, or 5 event
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part B1 (Nivolumab) | 52 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part B2 (Nivolumab + Ipilimumab) | 47 | Not reported | Not reported | Not reported | Not reported |
|---|
Elevated blood bilirubin
Grade 3
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part B1 (Nivolumab) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part B2 (Nivolumab + Ipilimumab) | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
Grade 4
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part B1 (Nivolumab) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part B2 (Nivolumab + Ipilimumab) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Grade 5
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part B1 (Nivolumab) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part B2 (Nivolumab + Ipilimumab) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Did not experience a Grade 3, 4, or 5 event
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part B1 (Nivolumab) | 52 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part B2 (Nivolumab + Ipilimumab) | 47 | Not reported | Not reported | Not reported | Not reported |
|---|
COVID-19 infection
Grade 3
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part B1 (Nivolumab) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part B2 (Nivolumab + Ipilimumab) | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
Grade 4
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part B1 (Nivolumab) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part B2 (Nivolumab + Ipilimumab) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Grade 5
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part B1 (Nivolumab) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part B2 (Nivolumab + Ipilimumab) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Did not experience a Grade 3, 4, or 5 event
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part B1 (Nivolumab) | 52 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part B2 (Nivolumab + Ipilimumab) | 47 | Not reported | Not reported | Not reported | Not reported |
|---|
Fatigue
Grade 3
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part B1 (Nivolumab) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part B2 (Nivolumab + Ipilimumab) | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
Grade 4
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part B1 (Nivolumab) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part B2 (Nivolumab + Ipilimumab) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Grade 5
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part B1 (Nivolumab) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part B2 (Nivolumab + Ipilimumab) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Did not experience a Grade 3, 4, or 5 event
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part B1 (Nivolumab) | 52 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part B2 (Nivolumab + Ipilimumab) | 47 | Not reported | Not reported | Not reported | Not reported |
|---|
Hyperglycemia
Grade 3
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part B1 (Nivolumab) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part B2 (Nivolumab + Ipilimumab) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Grade 4
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part B1 (Nivolumab) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part B2 (Nivolumab + Ipilimumab) | 3 | Not reported | Not reported | Not reported | Not reported |
|---|
Grade 5
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part B1 (Nivolumab) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part B2 (Nivolumab + Ipilimumab) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Did not experience a Grade 3, 4, or 5 event
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part B1 (Nivolumab) | 52 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part B2 (Nivolumab + Ipilimumab) | 45 | Not reported | Not reported | Not reported | Not reported |
|---|
Hypokalemia
Grade 3
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part B1 (Nivolumab) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part B2 (Nivolumab + Ipilimumab) | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
Grade 4
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part B1 (Nivolumab) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part B2 (Nivolumab + Ipilimumab) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Grade 5
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part B1 (Nivolumab) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part B2 (Nivolumab + Ipilimumab) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Did not experience a Grade 3, 4, or 5 event
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part B1 (Nivolumab) | 52 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part B2 (Nivolumab + Ipilimumab) | 47 | Not reported | Not reported | Not reported | Not reported |
|---|
Hyponatremia
Grade 3
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part B1 (Nivolumab) | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part B2 (Nivolumab + Ipilimumab) | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
Grade 4
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part B1 (Nivolumab) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part B2 (Nivolumab + Ipilimumab) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Grade 5
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part B1 (Nivolumab) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part B2 (Nivolumab + Ipilimumab) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Did not experience a Grade 3, 4, or 5 event
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part B1 (Nivolumab) | 50 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part B2 (Nivolumab + Ipilimumab) | 47 | Not reported | Not reported | Not reported | Not reported |
|---|
Hypophosphatemia
Grade 3
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part B1 (Nivolumab) | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part B2 (Nivolumab + Ipilimumab) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Grade 4
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part B1 (Nivolumab) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part B2 (Nivolumab + Ipilimumab) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Grade 5
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part B1 (Nivolumab) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part B2 (Nivolumab + Ipilimumab) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Did not experience a Grade 3, 4, or 5 event
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part B1 (Nivolumab) | 51 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part B2 (Nivolumab + Ipilimumab) | 48 | Not reported | Not reported | Not reported | Not reported |
|---|
Hypophysitis
Grade 3
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part B1 (Nivolumab) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part B2 (Nivolumab + Ipilimumab) | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
Grade 4
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part B1 (Nivolumab) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part B2 (Nivolumab + Ipilimumab) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Grade 5
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part B1 (Nivolumab) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part B2 (Nivolumab + Ipilimumab) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Did not experience a Grade 3, 4, or 5 event
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part B1 (Nivolumab) | 52 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part B2 (Nivolumab + Ipilimumab) | 47 | Not reported | Not reported | Not reported | Not reported |
|---|
Lymphocyte count decreased
Grade 3
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part B1 (Nivolumab) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part B2 (Nivolumab + Ipilimumab) | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
Grade 4
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part B1 (Nivolumab) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part B2 (Nivolumab + Ipilimumab) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Grade 5
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part B1 (Nivolumab) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part B2 (Nivolumab + Ipilimumab) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Did not experience a Grade 3, 4, or 5 event
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part B1 (Nivolumab) | 52 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part B2 (Nivolumab + Ipilimumab) | 47 | Not reported | Not reported | Not reported | Not reported |
|---|
Malaise
Grade 3
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part B1 (Nivolumab) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part B2 (Nivolumab + Ipilimumab) | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
Grade 4
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part B1 (Nivolumab) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part B2 (Nivolumab + Ipilimumab) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Grade 5
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part B1 (Nivolumab) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part B2 (Nivolumab + Ipilimumab) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Did not experience a Grade 3, 4, or 5 event
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part B1 (Nivolumab) | 52 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part B2 (Nivolumab + Ipilimumab) | 47 | Not reported | Not reported | Not reported | Not reported |
|---|
Minimal change disease nephrotic syndrome
Grade 3
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part B1 (Nivolumab) | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part B2 (Nivolumab + Ipilimumab) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Grade 4
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part B1 (Nivolumab) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part B2 (Nivolumab + Ipilimumab) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Grade 5
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part B1 (Nivolumab) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part B2 (Nivolumab + Ipilimumab) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Did not experience a Grade 3, 4, or 5 event
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part B1 (Nivolumab) | 51 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part B2 (Nivolumab + Ipilimumab) | 48 | Not reported | Not reported | Not reported | Not reported |
|---|
Pneumonitis
Grade 3
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part B1 (Nivolumab) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part B2 (Nivolumab + Ipilimumab) | 3 | Not reported | Not reported | Not reported | Not reported |
|---|
Grade 4
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part B1 (Nivolumab) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part B2 (Nivolumab + Ipilimumab) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Grade 5
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part B1 (Nivolumab) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part B2 (Nivolumab + Ipilimumab) | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
Did not experience a Grade 3, 4, or 5 event
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part B1 (Nivolumab) | 52 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part B2 (Nivolumab + Ipilimumab) | 44 | Not reported | Not reported | Not reported | Not reported |
|---|
Rash macula-papular
Grade 3
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part B1 (Nivolumab) | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part B2 (Nivolumab + Ipilimumab) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Grade 4
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part B1 (Nivolumab) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part B2 (Nivolumab + Ipilimumab) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Grade 5
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part B1 (Nivolumab) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part B2 (Nivolumab + Ipilimumab) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Did not experience a Grade 3, 4, or 5 event
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part B1 (Nivolumab) | 51 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part B2 (Nivolumab + Ipilimumab) | 48 | Not reported | Not reported | Not reported | Not reported |
|---|
Vomiting
Grade 3
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part B1 (Nivolumab) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part B2 (Nivolumab + Ipilimumab) | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
Grade 4
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part B1 (Nivolumab) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part B2 (Nivolumab + Ipilimumab) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Grade 5
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part B1 (Nivolumab) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part B2 (Nivolumab + Ipilimumab) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Did not experience a Grade 3, 4, or 5 event
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part B1 (Nivolumab) | 52 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part B2 (Nivolumab + Ipilimumab) | 47 | Not reported | Not reported | Not reported | Not reported |
|---|
Lung Infection
Grade 3
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part B1 (Nivolumab) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part B2 (Nivolumab + Ipilimumab) | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
Grade 4
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part B1 (Nivolumab) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part B2 (Nivolumab + Ipilimumab) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Grade 5
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part B1 (Nivolumab) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part B2 (Nivolumab + Ipilimumab) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Did not experience a Grade 3, 4, or 5 event
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part B1 (Nivolumab) | 52 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part B2 (Nivolumab + Ipilimumab) | 47 | Not reported | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 0
- title
- Grade 3
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- title
- Grade 4
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- title
- Grade 5
- measurements
- group Id
- OG000
- value
- 51
- group Id
- OG001
- value
- 48
- title
- Did not experience a Grade 3, 4, or 5 event
- title
- Abdominal distension
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 1
- title
- Grade 3
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- title
- Grade 4
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- title
- Grade 5
- measurements
- group Id
- OG000
- value
- 52
- group Id
- OG001
- value
- 47
- title
- Did not experience a Grade 3, 4, or 5 event
- title
- Abdominal pain
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 1
- title
- Grade 3
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- title
- Grade 4
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- title
- Grade 5
- measurements
- group Id
- OG000
- value
- 52
- group Id
- OG001
- value
- 47
- title
- Did not experience a Grade 3, 4, or 5 event
- title
- Adrenal insufficiency
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 2
- title
- Grade 3
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- title
- Grade 4
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- title
- Grade 5
- measurements
- group Id
- OG000
- value
- 52
- group Id
- OG001
- value
- 46
- title
- Did not experience a Grade 3, 4, or 5 event
- title
- Elevated Alanine Aminotransferase
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 1
- title
- Grade 3
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- title
- Grade 4
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- title
- Grade 5
- measurements
- group Id
- OG000
- value
- 52
- group Id
- OG001
- value
- 47
- title
- Did not experience a Grade 3, 4, or 5 event
- title
- Anemia
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 1
- title
- Grade 3
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- title
- Grade 4
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- title
- Grade 5
- measurements
- group Id
- OG000
- value
- 52
- group Id
- OG001
- value
- 47
- title
- Did not experience a Grade 3, 4, or 5 event
- title
- Elevated Aspartate Aminotransferase
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 1
- title
- Grade 3
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- title
- Grade 4
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- title
- Grade 5
- measurements
- group Id
- OG000
- value
- 52
- group Id
- OG001
- value
- 47
- title
- Did not experience a Grade 3, 4, or 5 event
- title
- Elevated blood bilirubin
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 1
- title
- Grade 3
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- title
- Grade 4
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- title
- Grade 5
- measurements
- group Id
- OG000
- value
- 52
- group Id
- OG001
- value
- 47
- title
- Did not experience a Grade 3, 4, or 5 event
- title
- COVID-19 infection
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 1
- title
- Grade 3
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- title
- Grade 4
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- title
- Grade 5
- measurements
- group Id
- OG000
- value
- 52
- group Id
- OG001
- value
- 47
- title
- Did not experience a Grade 3, 4, or 5 event
- title
- Fatigue
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- title
- Grade 3
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 3
- title
- Grade 4
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- title
- Grade 5
- measurements
- group Id
- OG000
- value
- 52
- group Id
- OG001
- value
- 45
- title
- Did not experience a Grade 3, 4, or 5 event
- title
- Hyperglycemia
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 1
- title
- Grade 3
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- title
- Grade 4
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- title
- Grade 5
- measurements
- group Id
- OG000
- value
- 52
- group Id
- OG001
- value
- 47
- title
- Did not experience a Grade 3, 4, or 5 event
- title
- Hypokalemia
- categories
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 1
- title
- Grade 3
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- title
- Grade 4
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- title
- Grade 5
- measurements
- group Id
- OG000
- value
- 50
- group Id
- OG001
- value
- 47
- title
- Did not experience a Grade 3, 4, or 5 event
- title
- Hyponatremia
- denoms
- counts
- group Id
- OG000
- value
- 52
- group Id
- OG001
- value
- 48
- units
- Participants
- description
- Toxicities were assessed by CTCAE version 5.0. The highest grade that occurred for a participant was recorded per toxicity.
- groups
- description
- This outcome measure includes data from participants enrolled to Part B1 and received nivolumab monotherapy.
- id
- OG000
- title
- Part B1 (Nivolumab)
- description
- This outcome measure includes data from participants enrolled to Part B2 and received the doublet therapy.
- id
- OG001
- title
- Part B2 (Nivolumab + Ipilimumab)
- param Type
- COUNT_OF_PARTICIPANTS
- reporting Status
- POSTED
- time Frame
- Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
- title
- Incidence of Treatment-related Grade 3/4/5 Adverse Events (Part B)
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice
Triangle