Table 2.
Adverse events occurring in ≥5% of patients, including all G3+ adverse events
| Organ system | Any Grade, N (%) | Grade 3 +, N (%) |
|---|---|---|
| Haematological | ||
| Anemia | 2 (6) | |
| Reduced platelets | 3 (9) | |
| Gastrointestinal | ||
| Abdominal pain/ bloating | 2 (6) | |
| Constipation | 9 (28) | |
| Diarrhoea | 2 (6) | |
| Dry mouth | 5 (16) | |
| Dyspepsia/ GORD | 5 (16) | |
| Mucositis/ lip pain | 2 (6) | |
| Nausea | 11 (34) | |
| Vomiting | 4 (13) | |
| Respiratory | ||
| Bronchopulmonary haemorrhage | 1 (3) | 1 (3) |
| Cough | 3 (9) | |
| Pneumonitis | 2a(6) | |
| Musculoskeletal | ||
| Pain – back | 4 (13) | |
| Pain - chest wall | 3 (9) | |
| Neurological | ||
| Blurred vision | 2 (6) | |
| Headache | 2 (3) | |
| Intracranial haemorrhage | 1 (3) | 1 (3) |
| Peripheral sensory neuropathy | 3 (9) | |
| General | ||
| Anorexia | 4 (13) | |
| Fall | 1 (3) | 1 (3) |
| Fatigue/ lethargy | 12 (38) | |
| Fever | 3 (9) | 1 (3)a |
| Insomnia | 3 (9) | |
| Rash | 4 (13) | |
| Weight loss | 2 (6) | |
| Infections | ||
| Flu-like symptoms | 2 (6) | |
| Sepsis | 1 (3) | 1 (3) |
| URTI | 2 (6) | |
| Investigations | ||
| Elevated ALT | 9 (28) | 1 (3) |
| Elevated AST | 9 (28) | 1 (3) |
| Elevated ALP | 3 (9) | 1 (3) |
| Elevated GGT | 2 (6) | 1 (3) |
| Elevated bilirubin | 4 (13) | 1 (3) |
| Elevated lipase | 1 (3) | 1 (3) |
| Hypercalcemia | 2(6) | |
| TOTAL | 80 | 12 |
ENT ear nose throat, GORD gastroesophageal reflux disease, LDH lactate dehydrogenase, URTI upper respiratory tract infection.
aCentrally adjudicated as a T-DM1 related serious adverse events.