Table 1.
Treatment-Related Adverse Events of Special Interest That Occurred in at Least 1% of All Treated Patients.
| Event | Anti-PD-1 Antibody, 0.1 mg/kg N = 18) | Anti-PD-1 Antibody, 0.3 mg/kg (N = 19) | Anti-PD-1 Antibody, 1.0mg/ kg(N = 79) | Anti-PD-1 Antibody, 3.0 mg/kg (N = 50) | Anti-PD-1 Antibody, 10.0 mg/kg (N = 130) | Anti-PD-1 Antibody, Total (N = 296) | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| All Events | Grade 3 or 4 Events | All Events | Grade 3 or 4 Events | All Events | Grade 3 or 4 Events | All Events | Grade 3 or 4 Events | All Events | Grade 3 or 4 Events | All Events | Grade 3 or 4 Events | |
| number of patients (percent) | ||||||||||||
| Any adverse event of special interest* | 8 (44) | 0 | 6 (32) | 0 | 39 (49) | 5 (6) | 19 (38) | 2 (4) | 50 (38) | 11 (8) | 122 (41) | 18 (6) |
| Pulmonary disorders | ||||||||||||
| Pneumonitis | 0 | 0 | 0 | 0 | 3 (4) | 2 (3) | 1 (2) | 0 | 5 (4) | 1 (1) | 9 (3) | 3 (1) |
| Allergic rhinitis | 1 (6) | 0 | 0 | 0 | 2 (3) | 0 | 0 | 0 | 1 (1) | 0 | 4 (1) | 0 |
| Diarrhea | 1 (6) | 0 | 2 (11) | 0 | 15 (19) | 0 | 3 (6) | 0 | 12 (9) | 3 (2) | 33 (11) | 3 (1) |
| Skin events | ||||||||||||
| Rash | 3 (17) | 0 | 2 (11) | 0 | 16 (20) | 0 | 4 (8) | 0 | 11 (8) | 0 | 36 (12) | 0 |
| Pruritus | 0 | 0 | 2 (11) | 0 | 13 (16) | 0 | 4 (8) | 0 | 9 (7) | 1 (1) | 28 (9) | 1 (<1) |
| Vitiligo | 3 (17) | 0 | 0 | 0 | 3 (4) | 0 | 2 (4) | 0 | 0 | 0 | 8 (3) | 0 |
| Pruritic rash | 0 | 0 | 0 | 0 | 1 (1) | 0 | 1 (2) | 0 | 4 (3) | 0 | 6 (2) | 0 |
| Urticaria | 0 | 0 | 0 | 0 | 0 | 0 | 3 (6) | 0 | 2 (2) | 0 | 5 (2) | 0 |
| Macular rash | 0 | 0 | 0 | 0 | 0 | 0 | 1 (2) | 0 | 3 (2) | 1 (1) | 4 (1) | 1 (<1) |
| Alopecia | 0 | 0 | 0 | 0 | 2 (3) | 0 | 0 | 0 | 1 (1) | 0 | 3 (1) | 0 |
| Hypopigmentation | 0 | 0 | 0 | 0 | 2 (3) | 0 | 0 | 0 | 1 (1) | 0 | 3 (1) | 0 |
| Laboratory investigations† | ||||||||||||
| Alanine aminotransferase increased | 0 | 0 | 1 (5) | 0 | 4 (5) | 0 | 2 (4) | 0 | 4 (3) | 2 (2) | 11 (4) | 2 (1) |
| Thyroid-stimulating hormone increased | 2 (11) | 0 | 0 | 0 | 2 (3) | 0 | 2 (4) | 0 | 3 (2) | 1 (1) | 9 (3) | 1 (<1) |
| Aspartate aminotransferase increasec | 0 | 0 | 1 (5) | 0 | 2 (3) | 0 | 2 (4) | 1 (2) | 3 (2) | 1 (1) | 8 (3) | 2 (1) |
| Endocrine disorders | ||||||||||||
| Hypothyroidism | 0 | 0 | 1 (5) | 0 | 2 (3) | 0 | 1 (2) | 0 | 3 (2) | 1 (1) | 7 (2) | 1 (<1) |
| Hyperthyroidism | 1 (6) | 0 | 0 | 0 | 0 | 0 | 1 (2) | 0 | 1 (1) | 1 (1) | 3 (1) | 1 (<1) |
| Infusion-related reaction or hypersensitivty | 0 | 0 | 0 | 0 | 2 (3) | 0 | 3 (6) | 0 | 4 (3) | 1 (1) | 9 (3) | 1 (<1) |
The numbers reported within a column may not add up to the total number reported for “any adverse event of special interest” because patients who had more than one adverse event were counted for each event but were counted only once for “any adverse event of special interest” and because data for only those events that were reported in at least 1% of all treated patients are shown. Colitis, hepatitis, hypophysitis, and thyroiditis were among the adverse events of special interest that were reported in less than 1% of patients. PD-1 denotes programmed death 1.
Levels of alanine aminotransferase, thyroid-stimulating hormone, and aspartate aminotransferase were considered to be increased if they exceeded the upper limit of the normal range for the local laboratory.