Table 2 Adverse Events (AE)
Adverse Event | Grade | |||
|---|---|---|---|---|
1 | 2 | 3 | ||
System Organ Class | Specific Term | Â | Â | Â |
Cardiac disorders | Palpitations | 1 | 0 | 0 |
Gastrointestinal disorders | Any AE - Maximum | 3 | 2 | 0 |
Dyspepsia | 1 | 0 | 0 | |
Dysphagia | 1 | 2 | 0 | |
Nausea | 1 | 0 | 0 | |
Esophagitis | 1 | 0 | 0 | |
General disorders and administration site conditions | Any AE - Maximum | 2 | 3 | 0 |
Asthenia | 0 | 1 | 0 | |
Fatigue | 1 | 2 | 0 | |
Non-cardiac chest pain | 1 | 0 | 0 | |
Sensation of foreign body | 0 | 1 | 0 | |
Respiratory, thoracic and mediastinal disorders | Any AE - Maximum | 1 | 5 | 2 |
Aspiration | 0 | 1 | 0 | |
Atelectasis | 0 | 1 | 0 | |
Cough | 1 | 2 | 1 | |
Dyspnea | 2 | 2 | 1 | |
Haemoptysis | 1 | 0 | 0 | |
Pneumonitis | 0 | 1 | 0 | |
Pneumonia | 0 | 1 | 0 | |
Pneumothorax | 0 | 1 | 0 | |
Productive cough | 1 | 0 | 0 | |
Respiratory tract inflammation | 1 | 0 | 0 | |
Metabolism and nutrition disorders | Any AE - Maximum | 4 | 2 | 0 |
Decreased appetite | 3 | 0 | 0 | |
Hypercalcemia | 0 | 1 | 0 | |
Hyperkalemia | 0 | 1 | 0 | |
Hypocalcaemia | 2 | 0 | 0 | |
Hypomagnesaemia | 0 | 1 | 0 | |
Nervous system disorders | Dizziness | 1 | 0 | 0 |
Syncope | 0 | 0 | 1 | |
Musculoskeletal and connective tissue disorders | Chest Pain | 0 | 1 | 0 |
Blood and lymphatic system disorders | Anemia | 1 | 1 | 0 |
Metabolism and nutrition disorders | Any AE - Maximum Grade | 2 | 1 | 0 |
Skin | Pruritis | 0 | 1 | 0 |
Discoloration | 1 | 0 | 0 | |
Investigations | Decreased Lymphocyte Count | 0 | 0 | 2 |
Blood creatine phosphokinase increased | 0 | 0 | 1 | |
Injury, poisoning and procedural complications | Incision Site Pain | 0 | 1 | 0 |
ANY AE - Maximum Grade Seen | Â | 1 | 3 | 6 |