Table 3:
Treatment-related adverse events
| Pembrolizumab 2 mg/kg (n=178) |
Pembrolizumab 10 mg/kg (n=179) |
Chemotherapy control (n=171) |
|||||||
|---|---|---|---|---|---|---|---|---|---|
| Grade 1–2 | Grade 3 | Grade 4 | Grade 1–2 | Grade 3 | Grade 4 | Grade 1–2 | Grade 3 | Grade 4 | |
| Summary | |||||||||
| Any | 101 (57%) | 18 (10%) | 1 (<1%) | 107 (60%) | 23 (13%) | 2 (1%) | 93 (54%) | 34 (20%) | 11 (6%) |
| Serious* | 3 (2%) | 9 (5%) | 1 (<1%) | 3 (2%) | 14 (8%) | 2 (1%) | 3 (2%) | 8 (5%) | 6 (4%) |
| Led to discontinuation† | 0 | 3 (2%) | 1 (<1%) | 2 (1%) | 9 (5%) | 1 (<1%) | 6 (4%) | 2 (1%) | 2 (1%) |
| Observed in 5% or more of patients in any treatment group | |||||||||
| Fatigue | 38 (21%) | 2 (1%) | 0 | 51 (28%) | 1 (<1%) | 0 | 54 (32%) | 8 (5%) | 0 |
| Pruritus | 37 (21%) | 0 | 0 | 42 (23%) | 0 | 0 | 6 (4%) | 0 | 0 |
| Nausea | 8 (4%) | 0 | 0 | 15 (8%) | 1 (<1%) | 0 | 52 (30%) | 3 (2%) | 1 (<1%) |
| Decreased appetite | 8 (4%) | 0 | 0 | 15 (8%) | 2 (1%) | 0 | 26 (15%) | 0 | 0 |
| Anaemia | 4 (2%) | 1 (<1%) | 0 | 7 (4%) | 0 | 0 | 26 (15%) | 9 (5%) | 0 |
| Diarrhoea | 15 (8%) | 0 | 0 | 17 (9%) | 2 (1%) | 0 | 11 (6%) | 3 (2%) | 0 |
| Rash | 21 (12%) | 0 | 0 | 18 (10%) | 0 | 0 | 8 (5%) | 0 | 0 |
| Alopecia | 5 (3%) | 0 | 0 | 1 (<1%) | 0 | 0 | 24 (20%) | 1 (<1%) | 0 |
| Vomiting | 1 (<1%) | 1 (<1%) | 0 | 9 (5%) | 1 (<1%) | 0 | 22 (13%) | 3 (2%) | 1 (<1%) |
| Arthralgia‡ | 12 (7%) | 1 (<1%) | 0 | 10 (6%) | 1 (<1%) | 0 | 8 (5%) | 1 (<1%) | 0 |
| Constipation | 5 (3%) | 0 | 0 | 9 (5%) | 0 | 0 | 14 (8%) | 0 | 0 |
| Myalgia | 7 (4%) | 2 (1%) | 0 | 7 (4%) | 0 | 0 | 9 (5%) | 1 (<1%) | 0 |
| Asthenia | 5 (3%) | 1 (<1%) | 0 | 7 (4%) | 1 (<1%) | 0 | 9 (5%) | 1 (<1%) | 0 |
| Hypothyroidism | 9 (5%) | 0 | 0 | 13 (7%) | 0 | 0 | 0 | 0 | 0 |
| Vitiligo | 10 (6%) | 0 | 0 | 9 (5%) | 0 | 0 | 2 (1%) | 0 | 0 |
| Dry skin | 9 (5%) | 0 | 0 | 9 (5%) | 0 | 0 | 2 (1%) | 0 | 0 |
| Thrombocytopenia | 2 (1%) | 0 | 0 | 0 | 1 (<1%) | 0 | 12 (7%) | 2 (1%) | 2 (1%) |
| Neutropenia | 1 (<1%) | 0 | 0 | 1 (<1%) | 0 | 0 | 8 (5%) | 4 (2%) | 2 (1%) |
| Peripheral neuropathy | 2 (1%) | 0 | 0 | 0 | 0 | 0 | 12 (7%) | 2 (1%) | 0 |
| Maculopapular rash | 4 (2%) | 1 (<1%) | 0 | 9 (5%) | 1 (<1%) | 0 | 0 | 0 | 0 |
| Leucopenia | 0 | 0 | 0 | 0 | 0 | 0 | 8 (5%) | 4 (2%) | 2 (1%) |
| Paraesthesia | 1 (<1%) | 0 | 0 | 2 (1%) | 0 | 0 | 11 (6%) | 0 | 0 |
Adverse events are listed in order of descending frequency in the total study population (patients who had at least one study drug dose).
*
One additional patient treated with pembrolizumab 10 mg/kg had two serious treatment-related adverse events of unspecifi ed severity.
†
One additional patient in the pembrolizumab 2 mg/kg treatment group died because of an adverse events considered to be possibly related to treatment at the time of data cutoff (full details provided in text).
‡
One additional patient treated with pembrolizumab 10 mg/kg had arthralgia of unspecifi ed severity.