Table 3:
All-grade treatment-emergent adverse events in ≥10% of patients and grade ≥3 events in all patients
| N=85 | Grade 1–2, n (%) | Grade 3, n (%) | Grade 4, n (%) | Grade 5, n (%) |
|---|---|---|---|---|
| Haematologic | ||||
| Decreased platelet count | 36 (42%) | 23 (27%) | 4 (5%) | 0 |
| Decreased lymphocyte count | 2 (2%) | 11 (13%) | 40 (47%) | 0 |
| Decreased neutrophil count | 23 (27%) | 12 (14%) | 18 (21%) | 0 |
| Decreased WBC count | 28 (33%) | 18 (21%) | 4 (5%) | 0 |
| Anaemia | 32 (38%) | 9 (11%) | 0 | 0 |
| Increased lymphocyte count | 4 (5%) | 16 (19%) | 0 | 0 |
| Leukocytosis | 1 (1%) | 17 (20%) | 0 | 0 |
| Febrile neutropaenia | 0 | 7 (8%) | 1 (1%) | 0 |
| Non-haematologic | ||||
| Nausea | 60 (71%) | 1 (1%) | 0 | 0 |
| Hyperglycaemia | 48 (56%) | 6 (7%) | 0 | 0 |
| Fatigue | 50 (59%) | 0 | 0 | 0 |
| Bruising | 44 (52%) | 0 | 0 | 0 |
| Diarrhoea | 30 (35%) | 2 (2%) | 0 | 0 |
| Constipation | 29 (31%) | 0 | 0 | 0 |
| Arthralgia | 27 (32%) | 0 | 0 | 0 |
| Cough | 27 (32%) | 0 | 0 | 0 |
| Hypocalcaemia | 27 (32%) | 0 | 0 | 0 |
| Acneiform rash | 26 (31%) | 0 | 0 | 0 |
| Increased AST | 21 (25%) | 2 (2%) | 2 (2%) | 0 |
| Hyponatremia | 22 (26%) | 1 (1%) | 0 | 0 |
| Fain in extremity* | 23 (27%) | 0 | 0 | 0 |
| Headache | 21 (25%) | 0 | 0 | 0 |
| Other skin/subcutaneous tissue disorder | 20 (24%) | 1 (1%) | 0 | 0 |
| Myalgia | 20 (24%) | 0 | 0 | 0 |
| Increased ALT | 14 (16%) | 2 (2%) | 2 (2%) | 0 |
| Fever | 18 (21%) | 0 | 0 | 0 |
| Upper respiratory infection | 17 (20%) | 1 (1%) | 0 | 0 |
| Vomiting | 17 (20%) | 1 (1%) | 0 | 0 |
| Hyperkalaemia | 15 (18%) | 2 (2%) | 0 | 0 |
| Insomnia | 17 (20%) | 0 | 0 | 0 |
| Increased blood bilirubin | 14 (17%) | 2 (2%) | 0 | 0 |
| Gastroesophageal reflux disease | 15 (18%) | 0 | 0 | 0 |
| Hypokalaemia | 14 (17%) | 1 (1%) | 0 | 0 |
| Nasal congestion | 15 (18%) | 0 | 0 | 0 |
| Hypophosphatemia | 11 (13%) | 3 (4%) | 0 | 0 |
| Back pain | 13 (15%) | 0 | 0 | 0 |
| Dry Skin | 13 (15%) | 0 | 0 | 0 |
| Hypoglycaemia | 12 (14%) | 0 | 1 (1%) | 0 |
| Hypomagnesaemia | 13 (15%) | 0 | 0 | 0 |
| Anxiety | 12 (14%) | 0 | 0 | 0 |
| Dizziness | 12 (14%) | 0 | 0 | 0 |
| Edema in limbs | 12 (14%) | 0 | 0 | 0 |
| Palpitations | 12 (14%) | 0 | 0 | 0 |
| Bone Pain | 11 (13%) | 0 | 0 | 0 |
| Lung infection | 7 (8%) | 3 (4%) | 1 (1%) | 0 |
| Maculopapular rash | 10 (12%) | 1 (1%) | 0 | 0 |
| Dyspepsia | 10 (12%) | 0 | 0 | 0 |
| Pruritus | 9 (11%) | 1 (1%) | 0 | 0 |
| Creatinine increased | 9 (11%) | 0 | 0 | 0 |
| Hypoalbuminemia | 9 (11%) | 0 | 0 | 0 |
| Musculoskeletal disorder | 9 (11%) | 0 | 0 | 0 |
| Pain | 9 (11%) | 0 | 0 | 0 |
| Abdominal pain | 6 (7%) | 2 (2%) | 0 | 0 |
| GI disorders, other | 7 (8%) | 1 (1%) | 0 | 0 |
| Hypertension | 5 (6%) | 1 (1%) | 0 | 0 |
| Atrial fibrillation | 2 (2%) | 3 (4%) | 0 | 0 |
| Depression | 3 (4%) | 1 (1%) | 1 (1%) | 0 |
| Other infections and infestations | 3 (4%) | 2 (2%) | 0 | 0 |
| Infusion-related reaction | 3 (4%) | 2 (2%) | 0 | 0 |
| Skin infection | 2 (2%) | 2 (2%) | 0 | 0 |
| Syncope | 1 (1%) | 3 (3%) | 0 | 0 |
| Urinary tract infection | 3 (4%) | 1 (1%) | 0 | 0 |
| Dehydration | 2 (2%) | 1 (1%) | 0 | 0 |
| Immune system disorders, other | 2 (2%) | 1 (1%) | 0 | 0 |
| Papulopustular rash | 2 (2%) | 1 (1%) | 0 | 0 |
| Cholecystitis | 1 (1%) | 0 | 1 (1%) | 0 |
| Lipase increased | 1 (1%) | 0 | 1 (1%) | 0 |
| Pneumonitis | 1 (1%) | 1 (1%) | 0 | 0 |
| Sleep apnea | 1 (1%) | 1 (1%) | 0 | 0 |
| Appendicitis | 0 | 1 (1%) | 0 | 0 |
| Arthritis | 0 | 1 (1%) | 0 | 0 |
| Sudden cardiac death | 0 | 0 | 0 | 1 (1%) |
| Gallbladder obstruction | 0 | 1 (1%) | 0 | 0 |
| Pharyngitis | 0 | 1 (1%) | 0 | 0 |
ALT=alanine aminotransferase. AST=aspartate aminotransferase. GI=gastrointestinal. NOS=not otherwise specified. WBC=white blood cell.
*
*Includes pain due to musculoskeletal injuries deemed unrelated to study treatment, muscle cramping, tenderness, or stiffness.