Summary of TRAEs (all treated patients)
| . | Patients, n (%) (N = 92) . | |
|---|---|---|
| AE . | Any grade . | Grade 3-4 . |
| Patients with ≥1 TRAE | 50 (54) | 14 (15) |
| TRAE occurring in >3% of patients at any grade or in at least 1 patient at grade 3-4 | ||
| Fatigue | 12 (13) | 0 |
| Diarrhea | 10 (11) | 2 (2) |
| Pruritis | 5 (5) | 0 |
| Myalgia | 5 (5) | 0 |
| Rash | 4 (4) | 1 (1) |
| Cough | 4 (4) | 0 |
| Pyrexia | 4 (4) | 0 |
| Neutropenia | 3 (3) | 2 (2) |
| Anemia | 3 (3) | 1 (1) |
| Vomiting | 3 (3) | 0 |
| Decreased appetite | 3 (3) | 0 |
| Colitis | 2 (2) | 1 (1) |
| Increased lipase | 2 (2) | 1 (1) |
| Mucosal inflammation | 2 (2) | 1 (1) |
| Decreased neutrophil count | 2 (2) | 1 (1) |
| Autoimmune hemolytic anemia | 1 (1) | 1 (1) |
| Herpes zoster | 1 (1) | 1 (1) |
| Klebsiella infection | 1 (1) | 1 (1) |
| Lung infection | 1 (1) | 1 (1) |
| Acute respiratory failure | 1 (1) | 1 (1) |
| Pleural effusion | 1 (1) | 1 (1) |
| Pneumonia | 1 (1) | 1 (1) |
| Pneumonitis | 1 (1) | 1 (1) |
| Portal vein thrombosis | 1 (1) | 1 (1) |
| Toxic epidermal necrolysis | 1 (1) | 1 (1) |
| . | Patients, n (%) (N = 92) . | |
|---|---|---|
| AE . | Any grade . | Grade 3-4 . |
| Patients with ≥1 TRAE | 50 (54) | 14 (15) |
| TRAE occurring in >3% of patients at any grade or in at least 1 patient at grade 3-4 | ||
| Fatigue | 12 (13) | 0 |
| Diarrhea | 10 (11) | 2 (2) |
| Pruritis | 5 (5) | 0 |
| Myalgia | 5 (5) | 0 |
| Rash | 4 (4) | 1 (1) |
| Cough | 4 (4) | 0 |
| Pyrexia | 4 (4) | 0 |
| Neutropenia | 3 (3) | 2 (2) |
| Anemia | 3 (3) | 1 (1) |
| Vomiting | 3 (3) | 0 |
| Decreased appetite | 3 (3) | 0 |
| Colitis | 2 (2) | 1 (1) |
| Increased lipase | 2 (2) | 1 (1) |
| Mucosal inflammation | 2 (2) | 1 (1) |
| Decreased neutrophil count | 2 (2) | 1 (1) |
| Autoimmune hemolytic anemia | 1 (1) | 1 (1) |
| Herpes zoster | 1 (1) | 1 (1) |
| Klebsiella infection | 1 (1) | 1 (1) |
| Lung infection | 1 (1) | 1 (1) |
| Acute respiratory failure | 1 (1) | 1 (1) |
| Pleural effusion | 1 (1) | 1 (1) |
| Pneumonia | 1 (1) | 1 (1) |
| Pneumonitis | 1 (1) | 1 (1) |
| Portal vein thrombosis | 1 (1) | 1 (1) |
| Toxic epidermal necrolysis | 1 (1) | 1 (1) |
Includes AEs reported between first dose and 30 d after last dose of nivolumab.