Table 2.
The most common (≥10 % of patients overall) drug-related AEs, overall and within the dose-escalation and expansion cohorts
| AE, n (%) | Dose-escalation cohort (n = 23) | MTD expansion cohorts (n = 93) | Total (N = 116) | ||||
|---|---|---|---|---|---|---|---|
| NSCLC (n = 20) | H&N (n = 22) | STS (n = 20) | PC (n = 11) | TPEC (n = 20) | |||
| Skin and SC tissue disordersa | 7 (30) | 9 (45) | 12 (55) | 12 (60) | 9 (82) | 12 (60) | 61 (53) |
| Fatigue | 8 (35) | 11 (55) | 11 (50) | 8 (40) | 7 (64) | 10 (50) | 55 (47) |
| Thrombocytopenia | 6 (26) | 8 (40) | 11 (50) | 8 (40) | 6 (55) | 13 (65) | 52 (45) |
| Nausea | 7 (30) | 8 (40) | 9 (41) | 4 (20) | 4 (36) | 9 (45) | 41 (35) |
| Decreased appetite | 7 (30) | 6 (30) | 5 (23) | 5 (25) | 4 (36) | 11 (55) | 38 (33) |
| Vomiting | 5 (22) | 8 (40) | 7 (32) | 6 (30) | 2 (18) | 8 (40) | 36 (31) |
| Diarrhoea | 4 (17) | 6 (30) | 7 (32) | 5 (25) | 0 | 5 (25) | 27 (23) |
| Peripheral neuropathies NECb | 2 (9) | 2 (10) | 1 (5) | 5 (25) | 3 (27) | 4 (20) | 17 (15) |
| Pyrexia | 0 | 5 (25) | 2 (9) | 5 (25) | 0 | 4 (20) | 16 (14) |
| Stomatitis | 0 | 3 (15) | 3 (14) | 4 (20) | 2 (18) | 2 (10) | 14 (12) |
| Dehydration | 1 (4) | 4 (20) | 5 (23) | 0 | 0 | 3 (15) | 13 (11) |
aMedDRA System Organ Class – includes rash maculo-papular (n = 20, 17 %), rash macular, rash pruritic (each n = 15, 13 %), rash papular (n = 12, 10 %), rash erythematous (n = 11, 9 %), rash (n = 7, 6 %), pruritus (n = 5, 4 %), dermatitis acneiform, dry skin (each n = 2, 2 %), alopecia, circumoral edema, erythema nodosum, exfoliative rash, night sweats, petechiae, skin exfoliation, skin hyperpigmentation, swelling face, and urticaria (each n = 1, <1 %). Patients could have reported >1 AE
bHigh-level term, Peripheral neuropathies NEC – includes neuropathy peripheral and peripheral sensory neuropathy
AE adverse event, H&N head and neck cancer, MTD maximum tolerated dose, NEC not elsewhere classified, NSCLC non-small cell lung cancer, PC prostate cancer, SC subcutaneous, STS soft tissue sarcoma, TPEC tumor pharmacodynamic expansion cohort