Table 2.
Adverse events for the entire cohort (N=43) compared to the KEYNOTE-775 cohort.
| Toxicity | Grade <3, N (%) | KEYNOTE-775, Grade ≥3, N (%) | Grade ≥3, N (%) | KEYNOTE-775, All grades, N (%) | All grades, N (%) |
|---|---|---|---|---|---|
|
| |||||
| Any adverse event | 6 (14) | 316 (77.8) | 36 (84) | 395 (97.3) | 42 (98) |
| Hypertension | 20 (47) | 154 (37.9) | 21 (49) | 260 (64.0) | 41 (95) |
| Weight loss | 33 (77) | 42 (10.3) | 2 (5) | 138 (34.0) | 35 (81) |
| Anemia | 18 (42) | 25 (6.2) | 11 (26) | 106 (26.1) | 29 (67) |
| Fatigue | 22 (51) | 21 (5.2) | 6 (14) | 134 (33.0) | 28 (65) |
| Thrombocytopenia | 19 (44) | 7 (1.7) | 5 (12) | 43 (10.6) | 24 (56) |
| Anorexia | 22 (51) | 32 (7.9) | 0 | 182 (44.8) | 22 (51) |
| Neutropenia | 18 (42) | 7 (1.7) | 1 (2) | 30 (7.4) | 19 (44) |
| Hypothyroidism | 17 (40) | 5 (1.2) | 0 | 233 (57.4) | 17 (40) |
| Nausea | 15 (35) | 14 (3.4) | 1 (2) | 201 (49.5) | 16 (37) |
| Creatinine elevation | 9 (21) | - | 5 (12) | - | 14 (33) |
| Diarrhea | 9 (21) | 31 (7.6) | 3 (7) | 220 (54.2) | 12 (28) |
| Hypomagnesemia | 12 (28) | - | 0 | - | 12 (28) |
| Oral mucositis | 7 (16) | 6 (1.5) | 3 (7) | 45 (11.1) | 10 (23) |
| Hyponatremia | 7 (16) | - | 1 (2) | - | 8 (19) |
| Constipation | 7 (16) | 3 (0.7) | 0 | 105 (25.9) | 7 (16) |
| Arthralgia | 4 (9) | 7 (1.7) | 2 (5) | 124 (30.5) | 6 (14) |
| Hyperkalemia | 6 (14) | - | 0 | - | 6 (14) |
| Hypokalemia | 1 (2) | - | 4 (9) | - | 5 (12) |
| Colitis | 3 (7) | - | 2 (5) | - | 5 (12) |
| PPE | 4 (9) | 11 (2.7) | 1 (2) | 84 (20.7) | 5 (12) |
| Hypernatremia | 5 (12) | - | 0 | - | 5 (12) |
| Vomiting | 4 (9) | 11 (2.7) | 0 | 149 (36.7) | 4 (9) |
| Dry skin | 4 (9) | - | 0 | - | 4 (9) |
| Rash | 2 (5) | 2 (0.5) | 1 (2) | 47 (11.6) | 3 (7) |
| Myalgia | 2 (5) | 3 (0.7) | 1 (2) | 54 (13.3) | 3 (7) |
| Dry mouth | 3 (7) | - | 0 | - | 3 (7) |
| Epistaxis | 3 (7) | - | 0 | - | 3 (7) |
| Weakness | 3 (7) | 17 (4.2) | 0 | 75 (18.5) | 3 (7) |
| Liver function test elevation | 3 (7) | 13 (3.2) | 0 | 63 (15.5) | 3 (7) |
| Immune hepatitis | 1 (2) | - | 1 (2) | - | 2 (5) |
| Thromboembolic event | 1 (2) | - | 1 (2) | - | 2 (5) |
| Cough | 1 (2) | - | 1 (2) | - | 2 (5) |
| Pain in extremity | 2 (5) | - | 0 | - | 2 (5) |
| Wound dehiscence | 2 (5) | - | 0 | - | 2 (5) |
| Headache | 2 (5) | 1 (0.2) | 0 | 53 (13.1) | 2 (5) |
| Hoarseness | 2 (5) | 0 | 0 | 76 (18.7) | 2 (5) |
| Hypophosphatemia | 2 (5) | - | 0 | - | 2 (5) |
| Gum infection abscess | 0 | - | 1 (2) | - | 1 (2) |
| Pneumonitis | 0 | - | 1 (2) | - | 1 (2) |
| Pruritus | 0 | - | 1 (2) | - | 1 (2) |
| Dehydration | 0 | - | 1 (2) | - | 1 (2) |
| Vasculitis | 0 | - | 1 (2) | - | 1 (2) |
| PRES | 0 | - | 1 (2) | - | 1 (2) |
| Pancreatitis | 0 | - | 1 (2) | - | 1 (2) |
| Encephalitis | 0 | - | 1 (2) | - | 1 (2) |
| Cellulitis | 0 | - | 1 (2) | - | 1 (2) |
| Intracranial hemorrhage | 0 | - | 1 (2) | - | 1 (2) |
| CKD | 0 | - | 1 (2) | - | 1 (2) |
| Appendicitis | 0 | - | 1 (2) | - | 1 (2) |
| Lower gastrointestinal hemorrhage | 1 (2) | - | 0 | - | 1 (2) |
| Abdominal pain | 1 (2) | - | 0 | - | 1 (2) |
| Neuropathy | 1 (2) | - | 0 | - | 1 (2) |
| Weight gain | 1 (2) | - | 0 | - | 1 (2) |
| Colonic perforation | 1 (2) | - | 0 | - | 1 (2) |
| Hyperglycemia | 1 (2) | - | 0 | - | 1 (2) |
| Blurred vision | 1 (2) | - | 0 | - | 1 (2) |
| Dyspepsia | 1 (2) | - | 0 | - | 1 (2) |
| Dizziness | 1 (2) | - | 0 | - | 1 (2) |
| Bronchopulmonary hemorrhage | 1 (2) | - | 0 | - | 1 (2) |
| Dyspnea | 1 (2) | - | 0 | - | 1 (2) |
| Hypermagnesemia | 1 (2) | - | 0 | - | 1 (2) |
Adverse events graded by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. PPE=Palmar-plantar erythrodysesthesia; PRES=Posterior reversible leukoencephalopathy syndrome; CKD=chronic kidney disease.