Table 3.
Treatment-related adverse events.
| Part A (N = 14) | Part B (N = 22) | |||||
|---|---|---|---|---|---|---|
| All grades 1–4** (no. patients, %) | Grades 3–4** (no. patients, %) | All grades 1–4** (PEM-related; no. patients, %) | Grades 3–4** (PEM-related; no. patients, %) | All grades 1–4** (chemotherapy-related; no. patients, %) | Grades 3–4** (chemotherapy-related; no. patients, %) | |
| Total subjects with treatment-related adverse events* | ||||||
| Laboratory investigations | ||||||
| Increased AST/ALT | 2 (14%) | 4 (18%) | 1 (5%) | 5 (23%) | 1 (5%) | |
| Increased alkaline phosphatase | 1 (7%) | 1 (5%) | 1 (5%) | |||
| Hyponatremia | 1 (5%) | 1 (5%) | ||||
| Increased creatinine | 2 (14%) | |||||
| Decreased white blood cell count | 1 (5%) | 3 (14%) | 1 (5%) | |||
| Lymphopenia | 1 (7%) | 1 (7%) | ||||
| Neutropenia | 3 (14%) | 1 (5%) | 9 (41%) | 4 (18%) | ||
| Anaemia | 2 (9%) | 4 (18%) | ||||
| Thrombocytopenia | 2 (9%) | |||||
| General disorders | ||||||
| Fatigue | 2 (14%) | 9 (41%) | 3 (14%) | 9 (41%) | 2 (9%) | |
| Chills | 1 (5%) | 1 (5%) | ||||
| Pain/arthralgias | 6 (27%) | 1 (5%) | 8 (36%) | 1 (5%) | ||
| Fever | 2 (9%) | 1 (5%) | 1 (5%) | |||
| Hoarseness | 1 (7%) | |||||
| Weight loss | 2 (9%) | 2 (9%) | ||||
| Muscle weakness | 2 (9%) | 2 (9%) | ||||
| Dehydration | 2 (9%) | |||||
| Gastrointestinal disorders | ||||||
| Nausea | 1 (7%) | 3 (14%) | 1 (5%) | 6 (27%) | 2 (9%) | |
| Anorexia | 2 (9%) | 3 (14%) | ||||
| Vomiting | 1 (7%) | 2(9%) | 3 (14%) | |||
| Constipation | 1 (7%) | 1 (5%) | 1 (5%) | |||
| Diarrhoea | 1 (7%) | 5 (23%) | 12 (55%) | 1 (5%) | ||
| Abdominal bloating/gas | 1 (7%) | 1 (5%) | 2 (9%) | |||
| Reflux/heartburn | 2 (9%) | |||||
| Gastrointestinal bleeding | 2 (9%) | 1 (5%) | ||||
| Skin and eye disorders | ||||||
| Pruritus | 1 (7%) | 1 (5%) | ||||
| Rash | 2 (14%) | 2 (9%) | ||||
| Dry skin | 1 (5%) | 1 (5%) | ||||
| Nose bleeding | 1 (5%) | |||||
| Dry eyes | 1 (5%) | 1 (5%) | ||||
| Central nervous system disorders | ||||||
| Headache | 1 (5%) | 1 (5%) | ||||
| Memory impairment | 1 (5%) | 1 (5%) | ||||
| Sensory neuropathy | 1 (5%) | 1 (5%) | ||||
| Respiratory disorders | ||||||
| Pneumonitis | 1 (5%) | 1 (5%) | ||||
| Infusion | ||||||
| Infusion reaction | 1 (5%) | 2 (9%) | ||||
no. number.
*Treatment-related adverse events were defined as any adverse event possibly, probably, or definitely related to treatment with pembrolizumab (Part A) or pembrolizumab plus chemotherapy (Part B).
**A subject that experienced multiple occurrences of an adverse event was counted once at the maximum recorded grade.