Table 4.

Incidence of ARQ 197-related adverse events in initial twice a day dosing cohortsa

AEs occurring in ≥5% of all patients
Intermittent treatmentContinuous treatment
System organ class preferred term10–50 mg (N = 12)70–90 mg (N = 10)120 mg (N = 7)150–180 mg (N = 8)120–240 mg (N = 24)360 mg (N = 18)All patients (N = 79)
Blood and lymphatic system disorders
 Anaemia1 (12.5%)1 (4.2%)4 (22.2%)6 (7.6%)
Gastrointestinal disorders
 Nausea2 (16.7%)1 (10.0%)1 (14.3%)1 (12.5%)3 (12.5%)3 (16.7%)11 (13.9%)
 Vomiting1 (10.0%)3 (12.5%)4 (22.2%)8 (10.1%)
 Diarrhoea2 (16.7%)1 (14.3%)1 (12.5%)1 (5.6%)5 (6.3%)
General disorders and administration site conditions
 Fatigue2 (16.7%)2 (20.0%)2 (28.6%)2 (25.0%)2 (8.3%)1 (5.6%)11 (13.9%)
Grade 3/4 AEs occurring in all patients
Intermittent treatmentContinuous treatment
Blood and lymphatic system disorders
 Anaemia1 (12.5%)1 (4.2%)1 (5.6%)3 (3.8%)
 Neutropenia1 (12.5%)1 (5.6%)2 (2.5%)
 Leukopenia1 (5.6%)1 (1.3%)
 Thrombocytopenia1 (5.6%)1 (1.3%)
Gastrointestinal disorders
 Nausea1 (5.6%)1 (1.3%)
 Vomiting1 (5.6%)1 (1.3%)
General disorders and administration site conditions
 Asthenia1 (5.6%)1 (1.3%)
 Fatigue1 (14.3%)1 (1.3%)
Hepatobiliary disorders
 Hepatic failure1 (4.2%)1 (1.3%)
Investigations
 AST increased1 (5.6%)1 (1.3%)
 Blood ALP increased1 (5.6%)1 (1.3%)
Metabolism and nutrition disorders
 Dehydration1 (5.6%)1 (1.3%)
 Hyperammonaemia1 (4.2%)1 (1.3%)
 Hyponatraemia1 (5.6%)1 (1.3%)
  • aAll values shown represent the number of AEs by severity, type, and dose.