Table 2.
Adverse events
| SOC and PTa | N = 15a | ||||
|---|---|---|---|---|---|
| No. of patients with at least one AEb | n = 15 (100%)a | ||||
| Grade 1 | Grade 2 | Grade 3 | Grade 4 | Grade 5 | |
| n (%)a | n (%)a | n (%)a | n (%)a | n (%)a | |
| Blood and lymphatic system disorders | |||||
| Anemia | 5 (33.3) | 2 (13.3) | 1 (6.7) | ||
| Neutropenia | 2 (13.3) | 5 (33.3) | |||
| Thrombopenia | 1 (6.7) | ||||
| Cardiac disorders | |||||
| Ejection fraction decreased | 1 (6.7) | ||||
| Ear and labyrinth disorders | |||||
| Tinnitus | 2 (13.3) | ||||
| Vertigo | 1 (6.7) | ||||
| Eye disorders | |||||
| Extraocular muscle paresis | 2 (13.3) | ||||
| Gastrointestinal disorders | |||||
| Abdominal pain | 1 (6.7) | ||||
| Constipation | 4 (26.7) | 2 (13.3) | |||
| Diarrhea | 1 (6.7) | 4 (26.7) | 1 (6.7) | ||
| Esophageal obstruction | 1 (6.7) | ||||
| Gastritis | 1 (6.7) | ||||
| Gastroesophageal reflux disease | 1 (6.7) | ||||
| Hemorrhoidal hemorrhage | 1 (6.7) | ||||
| Nausea | 7 (46.7) | ||||
| Oral dysesthesia | 1 (6.7) | ||||
| Vomiting | 3 (20%) | ||||
| General disorders and administration site conditions | |||||
| Edema of limbs | 1 (6.7) | ||||
| Fatigue | 3 (20) | 7 (46.7) | 2 (13.3) | ||
| Fever | 1 (6.7) | ||||
| Infections and infestations | |||||
| Lung infection | 1 (6.7) | ||||
| Laryngitis | 1 (6.7) | ||||
| Mucosal infection | 2 (13.3) | ||||
| Sepsis | 1 (6.7) | ||||
| Shingles | 1 (6.7) | ||||
| Thrush | 1 (6.7) | 1 (6.7) | |||
| Urinary tract infection | 3 (20) | 1 (6.7) | |||
| Injury, poisoning and procedural complications | |||||
| Fall | 2 (13.3) | 1 (6.7) | |||
| Investigations | |||||
| Blood bilirubin increased | 2 (13.3) | ||||
| Weight gain | 1 (6.7) | ||||
| Metabolism and nutrition disorders | |||||
| Anorexia | 2 (13.3) | ||||
| Hypokalemia | 6 (40) | ||||
| Musculoskeletal and connective tissue disorders | |||||
| Bone pain | 2 (13.3) | 2 (13.3) | |||
| Nervous system disorders | |||||
| Dysgeusia | 1 (6.7) | ||||
| Headache | 1 (6.7) | ||||
| Peripheral sensory neuropathy | 1 (6.7) | 1 (6.7) | |||
| Seizure | 1 (6.7) | ||||
| Psychiatric disorders | |||||
| Depression | 1 (6.7) | ||||
| Insomnia | 1 (6.7) | ||||
| Respiratory, thoracic and mediastinal disorders | |||||
| Cough | 1 (6.7) | 1 (6.7) | |||
| Dyspnea | 3 (20) | 1 (6.7) | |||
| Epistaxis | 1 (6.7) | ||||
| Pneumonitis | 1 (6.7) | ||||
| Skin and subcutaneous tissue disorders | |||||
| Alopecia | 6 (40) | ||||
| Palmar–plantar erythrodysesthesia syndrome | 1 (6.7) | ||||
| Abscess | 2 (13.3) | ||||
| Maculopapular rash | 1 (6.7) | ||||
| Vascular disorders | |||||
| Thromboembolic event | 1 (6.7) | 1 (6.7) | |||
aSOC, system organ class; PT, preferred term; N, number of patients in the safety analysis set; n, number of patients.
bIf a patient experienced >1 for a given AE, the patient was counted only once for the most severe grade.