Table 2. Drug-related AEs ⩾grade 3a.
| Related adverse event (preferred term) (no. of events) | MK1200+ GEM800 (n=6) Dose level 1 | MK1200+ GEM1000 (n=3) Dose level 2a | MK1500+ GEM800 (n=3) Dose level 2b | MK1500+ GEM1000 (n=4) Dose level 3a | MK1800+ GEM800 (n=3) Dose level 3b | MK1800+ GEM1000 (n=7) Dose level 4a | MK2100+ GEM800 (n=3) Dose level 4b | MK2400 (n=1) Dose level 5b |
|---|---|---|---|---|---|---|---|---|
| Any ⩾G3 AE | 8 | 6 | 2 | 2 | 11 | 11 | 10 | 1 |
| Anaemia | 2 | 1 | 1 | 1 | 1 | 2 | 2 | |
| Lymphocytes decreased | 1 | 1 | ||||||
| Neutropenia | 1 | 4 | 1 | |||||
| Thrombocytopenia | 1 | |||||||
| WBC decreased | 1 | |||||||
| Diarrhoea | 1 | |||||||
| Dysphagia | 1 | |||||||
| Nausea | 1 | 1 | ||||||
| Vomiting | 2 | |||||||
| Fatigue | 1 | 1 | ||||||
| ALT increased | 3 | 1 | ||||||
| AST increased | 1 | 1 | ||||||
| Alk Phos increased | 1 | |||||||
| Bilirubin increased | 2 | 1 | ||||||
| Hypokalaemia | 1 | 2 | 1 | |||||
| Hypophosphatemia | 3 | 1 | 1 | 1 | ||||
| DIC | 1 | |||||||
| Intracranial haemorrhage | 1 | |||||||
| Debility | 1 |
Abbreviations: AE=adverse events; Alk Phos=Alkaline Phosphatase; ALT=alanine amino-transferase; AST=aspartate amino-transferase; DIC=disseminated intravascular coagulation; WBC=white blood cells.
a
Only patients that experienced a ⩾grade 3 adverse event are recorded in this table (n=30 out of 44 patients).