SAEs of interest—safety population
| Total | ||
|---|---|---|
| Preferred term* | Percent of patients† | Number of SAEs |
| Total | 8.1 | 43 |
| Abdominal pain | 0.3 | 1 |
| Aortic aneurysm | 0.3 | 1 |
| Arthralgia | 0.3 | 1 |
| Arthritis | 0.3 | 1 |
| Atrial fibrillation | 0.3 | 1 |
| Back pain | 0.3 | 1 |
| Breast hyperplasia | 0.3 | 1 |
| Cerebrovascular accident | 0.3 | 1 |
| Chest discomfort | 0.3 | 2 |
| Chest pain | 0.3 | 1 |
| Concussion | 0.3 | 1 |
| Coronary artery bypass | 0.3 | 1 |
| Depression | 0.3 | 1 |
| Dyspnoea | 0.3 | 1 |
| Fall | 0.3 | 1 |
| Gastrointestinal inflammation | 0.3 | 1 |
| Hip arthroplasty | 0.3 | 1 |
| Hot flush | 0.3 | 1 |
| Infusion-related reaction | 0.3 | 1 |
| International normalised ratio increased | 0.3 | 1 |
| Interstitial lung disease | 0.3 | 1 |
| Intestinal obstruction | 0.6 | 2 |
| Kidney infection | 0.3 | 1 |
| Myocardial infarction | 0.3 | 1 |
| Nephrolithiasis | 0.3 | 1 |
| Neuropathy peripheral | 0.3 | 1 |
| Ovarian cyst ruptured | 0.3 | 1 |
| Pleural effusion | 0.3 | 1 |
| Pneumothorax | 0.3 | 1 |
| Pulmonary mass | 0.3 | 1 |
| Fever | 0.3 | 1 |
| Rash | 0.3 | 1 |
| Rash erythematous | 0.3 | 1 |
| Rash pruritic | 0.3 | 1 |
| Rectal haemorrhage | 0.3 | 2 |
| Skin cyst excision | 0.3 | 1 |
| Thrombophlebitis | 0.3 | 1 |
| Urinary tract infection | 0.3 | 1 |
| Uveitis | 0.3 | 1 |
| Vomiting | 0.3 | 1 |
*MedDRA V.13.0.
†Patients experiencing the same AE or SAE multiple times were only counted once for the corresponding preferred term.
AEs, adverse events; MedDRA, Medical Dictionary for Regulatory Activities; SAEs, serious adverse events.