Table 2.
AEs in treated patients
| Pembrolizumab (n = 279) | Placebo (n = 134) | |||
|---|---|---|---|---|
| Any grade | Grade 3 or 4 | Any grade | Grade 3 or 4 | |
| Any AE (all-cause) | 270 (96.8) | 149 (53.4) | 122 (91.0) | 62 (46.3) |
| AEs occurring in ≥10% of patients in either treatment arm (all-cause)a | ||||
| Increased aspartate aminotransferase | 67 (24.0) | 38 (13.6) | 22 (16.4) | 10 (7.5) |
| Increased blood bilirubin | 55 (19.7) | 21 (7.5) | 17 (12.7) | 8 (6.0) |
| Fatigue | 54 (19.4) | 7 (2.5)a | 32 (23.9) | 2 (1.5)a |
| Pruritus | 53 (19.0) | 1 (0.4)a | 17 (12.7) | 0 |
| Increased alanine aminotransferase | 51 (18.3) | 19 (6.8) | 13 (9.7) | 4 (3.0) |
| Decreased appetite | 51 (18.3) | 3 (1.1)a | 21 (15.7) | 0 |
| Diarrhea | 51 (18.3) | 4 (1.4)a | 21 (15.7) | 3 (2.2)a |
| Abdominal pain | 42 (15.1) | 4 (1.4)a | 9 (6.7) | 0 |
| Rash | 35 (12.5) | 5 (1.8)a | 7 (5.2) | 0 |
| Nausea | 34 (12.2) | 2 (0.7)a | 21 (15.7) | 1 (0.7)a |
| Peripheral edema | 32 (11.5) | 0 | 17 (12.7) | 0 |
| Ascites | 31 (11.1) | 22 (7.9) | 14 (10.4) | 8 (6.0) |
| Constipation | 30 (10.8) | 1 (0.4)a | 15 (11.2) | 0 |
| Back pain | 29 (10.4) | 5 (1.8)a | 14 (10.4) | 0 |
| Pyrexia | 29 (10.4) | 2 (0.7)a | 15 (11.2) | 0 |
| Anemia | 28 (10.0) | 11 (3.9) | 14 (10.4) | 12 (9.0) |
| Asthenia | 26 (9.3) | 0 | 15 (11.2) | 0 |
| Cough | 24 (8.6) | 0 | 24 (17.9) | 0 |
| Arthralgia | 22 (7.9) | 1 (0.4)a | 14 (10.4) | 1 (0.7)a |
| Dyspnea | 20 (7.2) | 0 | 15 (11.2) | 2 (1.5)a |
| Immune-mediated AEs (all-cause)b,c | ||||
| Any | 50 (17.9) | 20 (7.2) | 11 (8.2) | 1 (0.7) |
| Hypothyroidism | 14 (5.0) | 1 (0.4) | 7 (5.2) | 0 |
| Pneumonitis | 10 (3.6) | 4 (1.4) | 1 (0.7) | 0 |
| Hyperthyroidism | 8 (2.9) | 0 | 0 | 0 |
| Severe skin reaction | 8 (2.9) | 6 (2.2) | 0 | 0 |
| Hepatitis | 5 (1.8) | 4 (1.4) | 0 | 0 |
| Colitis | 4 (1.4) | 2 (0.7) | 2 (1.5) | 0 |
| Infusion reaction | 3 (1.1) | 0 | 0 | 0 |
| Adrenal insufficiency | 2 (0.7) | 0 | 0 | 0 |
| Hypophysitis | 2 (0.7) | 1 (0.4) | 0 | 0 |
| Myositis | 2 (0.7) | 1 (0.4) | 0 | 0 |
| Myasthenic syndrome | 1 (0.4) | 0 | 0 | 0 |
| Thyroiditis | 1 (0.4) | 0 | 0 | 0 |
| Type 1 diabetes mellitus | 1 (0.4) | 1 (0.4) | 1 (0.7) | 1 (0.7) |
AE, adverse event. aGrade 3 AEs only.
bListed in decreasing frequency in the pembrolizumab arm.
cImmune-mediated AEs and infusion reactions were based on a list of terms prepared by the sponsor and included AEs regardless of attribution to study treatment by the investigator.