Table 4.
Treatment‐emergent adverse events in ≥10% of patients receiving nivolumab a
| Adverse event | Nivolumab (n = 209) | Chemotherapy pooled (n = 208) | ||
|---|---|---|---|---|
| All grades, n (%) | Grades 3–4, n (%) | All grades, n (%) | Grades 3–4, n (%) | |
| Skin and subcutaneous tissue disorders | ||||
| Rash b | 48 (23) | 4 (2) | 58 (28) | 2 (1) |
| Pruritus | 25 (12) | 0 | 15 (7) | 0 |
| Gastrointestinal disorders | ||||
| Decreased appetite | 45 (22) | 5 (2) | 74 (36) | 12 (6) |
| Diarrhea c | 43 (21) | 5 (2) | 38 (18) | 4 (2) |
| Constipation | 37 (18) | 0 | 40 (19) | 0 |
| Hepatobiliary | 30 (14) | 15 (7) | 14 (7) | 6 (3) |
| Nausea | 23 (11) | 0 | 41 (20) | 1 (0.5) |
| Musculoskeletal and connective tissue disorders | ||||
| Musculoskeletal pain | 36 (17) | 1 (0.5) | 55 (26) | 3 (1) |
| Respiratory, thoracic, and mediastinal disorders | ||||
| Upper respiratory tract infection | 36 (17) | 2 (1) | 29 (14) | 0 |
| Cough | 35 (17) | 0 | 31 (15) | 1 (0.5) |
| Pneumonia d | 33 (15) e | 16 (8) | 49 (24) f | 30 (14) |
| Pneumonitis g | 22 (11) h | 5 (2) | 13 (6) i | 5 (2) |
| General disorders | ||||
| Pyrexia | 35 (17) | 1 (0.5) | 42 (20) | 1 (0.5) |
| Fatigue/asthenia | 26 (12) | 3 (1) | 57 (27) | 10 (5) |
| Blood and lymphatic system disorders | ||||
| Anemia | 29 (14) | 19 (9) | 63 (30) | 26 (13) |
| Endocrine disorders | ||||
| Hypothyroidism j | 23 (11) | 0 | 3 (1) | 0 |
Adverse events were collected between the start date of the first administration of the study drug and 28 days after the end of the treatment phase. Serious adverse events and immune‐mediated adverse events were collected during the treatment period and for 100 days following the last dose of study drug.
Includes urticaria, drug eruption, eczema, palmar‐plantar erythrodysesthesia syndrome, erythema, erythema multiforme, blister, skin exfoliation, Stevens‐Johnson syndrome, toxic skin eruption, dermatitis, dermatitis described as acneiform, bullous, or contact, and rash described as maculo‐papular, generalized, pustular, or pruritic.
Includes colitis and enterocolitis.
Includes pneumonia aspiration, pneumonia bacterial, lung infection, and Pneumocystis jirovecii.
Three patients (1%) died of pneumonia in the nivolumab group.
Seven patients (3%) died of pneumonia in the chemotherapy group during the 100‐day window. Five of the deaths were in the paclitaxel arm, and two deaths were in the docetaxel arm.
Includes interstitial lung disease and radiation pneumonitis.
Three patients (1%) died of pneumonitis in the nivolumab group during the 100‐day window, which is not an increase from the number of patients who died of pneumonitis in the nivolumab group during the 28‐day window.
One patient (0.5%) died of pneumonitis in the chemotherapy group during the 100‐day window, which is not an increase from the number of patients who died of pneumonitis in the chemotherapy group during the 28‐day window. This death occurred in the paclitaxel arm.
Includes blood thyroid‐stimulating hormone increased.