AEs
| AE . | Grade 1∗ (%) . | Grade 2∗ (%) . | Grade 3 (%) . | Grade 4 (%) . | Total . |
|---|---|---|---|---|---|
| Any AEs† | 37 (95) | 35 (90) | 18 (46) | 5 (13) | 39 (100) |
| Infection | 12 (31) | 16 (41) | 4 (10) | 32 (82) | |
| Fatigue/lethargy | 21 (54) | 3 (8) | 24 (62) | ||
| Musculoskeletal‡ | 13 (33) | 9 (23) | 2 (5) | 24 (62) | |
| Rash‡ | 14 (36) | 8 (21) | 1 (3) | 23 (60) | |
| Elevated liver enzymes‡ | 6 (15) | 7 (18) | 3 (8) | 1 (3) | 17 (44) |
| Abdominal pain | 10 (26) | 6 (15) | 16 (41) | ||
| Nausea/vomiting | 11 (28) | 4 (10) | 1 (3) | 16 (41) | |
| Diarrhea‡ | 8 (21) | 5 (13) | 13 (34) | ||
| Rituximab infusion–related reaction | 5 (13) | 7 (18) | 12 (31) | ||
| Headache | 5 (13) | 6 (15) | 11 (28) | ||
| Dyspnea | 8 (21) | 1 (3) | 9 (23) | ||
| Nivolumab infusion–related reaction | 3 (8) | 4 (10) | 2 (5) | 9 (23) | |
| Anorexia/weight loss | 5 (13) | 2 (5) | 2 (5) | 9 (23) | |
| Amylase/lipase increased‡ | 1 (3) | 1 (3) | 4 (10) | 2 (5) | 8 (21) |
| Insomnia | 5 (13) | 3 (8) | 8 (21) | ||
| Mood disturbance | 5 (13) | 3 (8) | 8 (21) | ||
| Gastroesophageal reflux disease | 4 (10) | 3 (8) | 7 (18) | ||
| Hyperglycemia | 4 (10) | 1 (3) | 2 (5) | 7 (18) | |
| Cough | 6 (15) | 1 (3) | 7 (18) | ||
| Pruritus‡ | 4 (10) | 3 (8) | 7 (18) | ||
| Neutrophil count decreased | 4 (10) | 1 (3) | 1 (3) | 6 (15) | |
| Limb edema | 6 (15) | 6 (15) | |||
| Fever | 4 (10) | 2 (5) | 6 (15) | ||
| Dry mouth‡ | 4 (10) | 1 (3) | 5 (13) | ||
| Iron deficiency | 3 (8) | 2 (5) | 5 (13) | ||
| Hypotension | 2 (5) | 1 (3) | 2 (5) | 5 (13) | |
| Hyperhidrosis | 3 (8) | 1 (3) | 4 (10) | ||
| Anemia | 3 (8) | 1 (3) | 4 (10) | ||
| Constipation | 3 (8) | 1 (3) | 4 (10) | ||
| Bruising | 3 (8) | 1 (3) | 4 (10) | ||
| Acute kidney injury‡ | 2 (5) | 1 (3) | 1 (3) | 4 (10) | |
| Thrush | 4 (10) | 4 (10) | |||
| Pancreatitis‡ | 1 (3) | 2 (5) | 3 (8) | ||
| Autoimmune hepatitis‡ | 1 (3) | 1 (3) | 2 (6) | ||
| Febrile neutropenia | 1 (3) | 1 (3) | |||
| Adrenal insufficiency‡ | 1 (3) | 1 (3) | |||
| Bile duct obstruction | 1 (3) | 1 (3) |
| AE . | Grade 1∗ (%) . | Grade 2∗ (%) . | Grade 3 (%) . | Grade 4 (%) . | Total . |
|---|---|---|---|---|---|
| Any AEs† | 37 (95) | 35 (90) | 18 (46) | 5 (13) | 39 (100) |
| Infection | 12 (31) | 16 (41) | 4 (10) | 32 (82) | |
| Fatigue/lethargy | 21 (54) | 3 (8) | 24 (62) | ||
| Musculoskeletal‡ | 13 (33) | 9 (23) | 2 (5) | 24 (62) | |
| Rash‡ | 14 (36) | 8 (21) | 1 (3) | 23 (60) | |
| Elevated liver enzymes‡ | 6 (15) | 7 (18) | 3 (8) | 1 (3) | 17 (44) |
| Abdominal pain | 10 (26) | 6 (15) | 16 (41) | ||
| Nausea/vomiting | 11 (28) | 4 (10) | 1 (3) | 16 (41) | |
| Diarrhea‡ | 8 (21) | 5 (13) | 13 (34) | ||
| Rituximab infusion–related reaction | 5 (13) | 7 (18) | 12 (31) | ||
| Headache | 5 (13) | 6 (15) | 11 (28) | ||
| Dyspnea | 8 (21) | 1 (3) | 9 (23) | ||
| Nivolumab infusion–related reaction | 3 (8) | 4 (10) | 2 (5) | 9 (23) | |
| Anorexia/weight loss | 5 (13) | 2 (5) | 2 (5) | 9 (23) | |
| Amylase/lipase increased‡ | 1 (3) | 1 (3) | 4 (10) | 2 (5) | 8 (21) |
| Insomnia | 5 (13) | 3 (8) | 8 (21) | ||
| Mood disturbance | 5 (13) | 3 (8) | 8 (21) | ||
| Gastroesophageal reflux disease | 4 (10) | 3 (8) | 7 (18) | ||
| Hyperglycemia | 4 (10) | 1 (3) | 2 (5) | 7 (18) | |
| Cough | 6 (15) | 1 (3) | 7 (18) | ||
| Pruritus‡ | 4 (10) | 3 (8) | 7 (18) | ||
| Neutrophil count decreased | 4 (10) | 1 (3) | 1 (3) | 6 (15) | |
| Limb edema | 6 (15) | 6 (15) | |||
| Fever | 4 (10) | 2 (5) | 6 (15) | ||
| Dry mouth‡ | 4 (10) | 1 (3) | 5 (13) | ||
| Iron deficiency | 3 (8) | 2 (5) | 5 (13) | ||
| Hypotension | 2 (5) | 1 (3) | 2 (5) | 5 (13) | |
| Hyperhidrosis | 3 (8) | 1 (3) | 4 (10) | ||
| Anemia | 3 (8) | 1 (3) | 4 (10) | ||
| Constipation | 3 (8) | 1 (3) | 4 (10) | ||
| Bruising | 3 (8) | 1 (3) | 4 (10) | ||
| Acute kidney injury‡ | 2 (5) | 1 (3) | 1 (3) | 4 (10) | |
| Thrush | 4 (10) | 4 (10) | |||
| Pancreatitis‡ | 1 (3) | 2 (5) | 3 (8) | ||
| Autoimmune hepatitis‡ | 1 (3) | 1 (3) | 2 (6) | ||
| Febrile neutropenia | 1 (3) | 1 (3) | |||
| Adrenal insufficiency‡ | 1 (3) | 1 (3) | |||
| Bile duct obstruction | 1 (3) | 1 (3) |
ALT, alanine aminotransferase; ALP, alkaline phosphatase; AST aspartate aminotransferase; GGT, γ-glutamyltransferase.
AEs observed in ≥10% patients and all grade ≥3 AEs reported.
Total AEs includes all patients. Musculoskeletal AEs include arthralgia, myalgia, bone pain, and joint effusion; liver enzymes include ALP, GGT, ALT, and AST.
Possible irAEs.