Table 2.
Adverse Events of Any Cause.*
|
Adverse Event |
dMMR Cohort (N = 215) |
pMMR Cohort (N = 550) |
||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Pembrolizumab (N = 109) |
Placebo (N = 106) |
Pembrolizumab (N = 276) |
Placebo (N = 274) |
|||||||||||
| Any Grade | Grade ≥3† | Any Grade | Grade ≥3† | Any Grade | Grade ≥3† | Any Grade | Grade ≥3† | |||||||
| number of patients (percentage) | ||||||||||||||
| Any event | 107 (98.2) | 69 (63.3) | 105 (99.1) | 50 (47.2) | 258 (93.5) | 152 (55.1) | 256 (93.4) | 124 (45.3) | ||||||
| Event leading to death | 1 (0.9) | 1 (0.9) | 2 (1.9) | 2 (1.9) | 6 (2.2) | 6 (2.2) | 2 (0.7) | 2 (0.7) | ||||||
| Adverse event | ||||||||||||||
| Fatigue | 78 (71.6) | 1 (0.9) | 59 (55.7) | 3 (2.8) | 175 (63.4) | 5 (1.8) | 165 (60.2) | 7 (2.6) | ||||||
| Peripheral sensory neuropathy | 71 (65.1) | 4 (3.7) | 66 (62.3) | 0 | 153 (55.4) | 3 (1.1) | 157 (57.3) | 5 (1.8) | ||||||
| Anemia | 63 (57.8) | 21 (19.3) | 58 (54.7) | 11 (10.4) | 152 (55.1) | 38 (13.8) | 144 (52.6) | 25 (9.1) | ||||||
| Nausea | 55 (50.5) | 3 (2.8) | 44 (41.5) | 1 (0.9) | 121 (43.8) | 3 (1.1) | 114 (41.6) | 3 (1.1) | ||||||
| Constipation | 47 (43.1) | 1 (0.9) | 40 (37.7) | 0 | 120 (43.5) | 1 (0.4) | 106 (38.7) | 1 (0.4) | ||||||
| Diarrhea | 46 (42.2) | 5 (4.6) | 36 (34.0) | 1 (0.9) | 99 (35.9) | 4 (1.4) | 88 (32.1) | 3 (1.1) | ||||||
| Thrombocytopenia | 38 (34.9) | 5 (4.6) | 31 (29.2) | 2 (1.9) | 83 (30.1) | 12 (4.3) | 59 (21.5) | 7 (2.6) | ||||||
| Arthralgia | 32 (29.4) | 0 | 31 (29.2) | 1 (0.9) | 62 (22.5) | 3 (1.1) | 75 (27.4) | 2 (0.7) | ||||||
| Dyspnea | 30 (27.5) | 3 (2.8) | 21 (19.8) | 1 (0.9) | 58 (21.0) | 5 (1.8) | 52 (19.0) | 0 | ||||||
| Myalgia | 29 (26.6) | 0 | 19 (17.9) | 1 (0.9) | 45 (16.3) | 2 (0.7) | 46 (16.8) | 4 (1.5) | ||||||
| Neutropenia | 28 (25.7) | 13 (11.9) | 34 (32.1) | 18 (17.0) | 87 (31.5) | 51 (18.5) | 73 (26.6) | 33 (12.0) | ||||||
| Vomiting | 22 (20.2) | 2 (1.8) | 9 (8.5) | 2 (1.9) | 53 (19.2) | 2 (0.7) | 38 (13.9) | 2 (0.7) | ||||||
| Weight loss | 16 (14.7) | 1 (0.9) | 6 (5.7) | 1 (0.9) | 19 (6.9) | 1 (0.4) | 21 (7.7) | 2 (0.7) | ||||||
| Rash | 7 (6.4) | 1 (0.9) | 13 (12.3) | 1 (0.9) | 57 (20.7) | 6 (2.2) | 27 (9.9) | 2 (0.7) | ||||||
*
Listed are adverse events with a rounded incidence of at least 15% in all the patients in either trial group, according to preferred term.
†
In the dMMR cohort, 3 patients (1.4%) — 1 in the pembrolizumab group and 2 in the placebo group — died from grade 5 adverse events: cardiac arrest, sepsis, and lower gastrointestinal hemorrhage in 1 patient each. In the pMMR cohort, 8 patients (1.5%) — 6 in the pembrolizumab group and 2 in the placebo group — died from grade 5 adverse events: sepsis in 4 patients, cardiac arrest in 2 patients, and small intestinal obstruction and sudden death not otherwise specified in 1 patient each.