Table 2 Treatment emergent adverse events occurring in ≥5% of patients
Adverse event term | All Grades | Grade 1 or 2 | Grade 3 or 4 | |||||||
|---|---|---|---|---|---|---|---|---|---|---|
Patients | % patients (N = 47) | Patients | % patients (N = 47) | Number of cycles | % cycles (N = 194) | Patients | % patients (N = 47) | Number of cycles | % cycles (N = 194) | |
Blood and lymphatic system | ||||||||||
 Anaemia | 21 | 45% | 15 | 32% | 38 | 20% | 6 | 13% | 11 | 6% |
 Febrile Neutropenia | 4 | 9% | 0 | 0% | 0 | 0% | 4 | 9% | 5 | 3% |
Gastrointestinal disorders | ||||||||||
 Abdominal Pain | 10 | 21% | 10 | 21% | 15 | 8% | 0 | 0% | 0 | 0% |
 Diarrhoea | 10 | 21% | 8 | 17% | 21 | 11% | 2 | 4% | 2 | 1% |
 Dyspepsia | 3 | 6% | 3 | 6% | 3 | 2% | 0 | 0% | 0 | 0% |
 Mouth ulcer | 3 | 6% | 3 | 6% | 4 | 2% | 0 | 0% | 0 | 0% |
 Nausea | 24 | 51% | 24 | 51% | 42 | 22% | 0 | 0% | 0 | 0% |
 Vomiting | 14 | 30% | 14 | 30% | 26 | 13% | 0 | 0% | 0 | 0% |
General disorders | ||||||||||
 Fatigue | 22 | 47% | 18 | 38% | 53 | 27% | 4 | 9% | 4 | 2% |
 Fever | 4 | 9% | 4 | 9% | 4 | 2% | 0 | 0% | 0 | 0% |
 Flu-like Symptoms | 6 | 13% | 6 | 13% | 9 | 5% | 0 | 0% | 0 | 0% |
Infections and infestations | ||||||||||
 Bronchial Infection | 4 | 9% | 2 | 4% | 7 | 4% | 2 | 4% | 2 | 1% |
 Lung infection | 7 | 15% | 4 | 9% | 6 | 3% | 3 | 6% | 3 | 2% |
 Rhinitis infective | 5 | 11% | 5 | 11% | 6 | 3% | 0 | 0% | 0 | 0% |
 UTI | 7 | 15% | 6 | 13% | 7 | 4% | 1 | 2% | 1 | 1% |
Investigations | ||||||||||
 ECG QTc interval prolonged | 16 | 34% | 14 | 30% | 26 | 13% | 2 | 4% | 2 | 1% |
 Neutropenia | 22 | 47% | 7 | 15% | 37 | 19% | 15 | 32% | 28 | 14% |
 Thrombocytopenia | 18 | 38% | 10 | 21% | 53 | 27% | 8 | 17% | 20 | 10% |
Metabolism and nutritional disorders | ||||||||||
 Anorexia | 13 | 48% | 13 | 28% | 24 | 12% | 0 | 0% | 0 | 0% |
 Hypoalbuminemia | 4 | 9% | 4 | 9% | 5 | 3% | 0 | 0% | 0 | 0% |
 Hypokalaemia | 5 | 11% | 5 | 11% | 5 | 3% | 1 | 2% | 1 | 1% |
 Hypophosphatemia | 3 | 6% | 3 | 6% | 4 | 2% | 0 | 0% | 0 | 0% |
MSK and connective tissue | ||||||||||
 Back Pain | 3 | 6% | 3 | 6% | 3 | 2% | 0 | 0% | 0 | 0% |
 Muscle cramps | 3 | 6% | 3 | 6% | 3 | 2% | 0 | 0% | 0 | 0% |
 Pain in extremity | 4 | 9% | 4 | 9% | 4 | 2% | 0 | 0% | 0 | 0% |
Nervous system disorders | ||||||||||
 Headache | 10 | 21% | 8 | 17% | 12 | 6% | 0 | 0% | 0 | 0% |
Psychiatric disorders | ||||||||||
 Depression | 3 | 6% | 2 | 4% | 2 | 1% | 0 | 0% | 0 | 0% |
Respiratory and thoracic disorders | ||||||||||
 Cough | 3 | 6% | 3 | 6% | 3 | 2% | 0 | 0% | 0 | 0% |
 Dyspnoea | 4 | 9% | 4 | 9% | 6 | 3% | 0 | 0% | 0 | 0% |