Table 2. Treatment-related Adverse Events (AE).
| CTCAE System Organ Class/Preferred Term (MedDRA) | N (%) Tot. AE | Grade 1 | Grade 2 | Grade 3 |
| Blood/Lymphatic System Disorders: | 1 (0.7) | |||
| Blood/lymphatic disorder | 1 | 1 | ||
| Ear and Labyrinth Disorders: | 2 (1.5) | |||
| Hearing impaired | 1 | 1 | ||
| Middle ear inflammation | 1 | 1 | ||
| Gastrointestinal Disorders: | 15 (10.9) | |||
| Abdominal pain | 5 | 3 | 1 | 1 |
| Constipation | 1 | 1 | ||
| Diarrhea | 1 | 1 | ||
| Vomiting | 6 | 5 | 1 | |
| Other | 2 | 2 | ||
| General Disorders: | 50 (36.5) | |||
| Fatigue | 17 | 14 | 2 | 1 |
| Fever | 2 | 1 | 1 | |
| Flu like symptoms | 4 | 3 | 1 | |
| Irritability | 4 | 3 | 1 | |
| Pain | 5 | 2 | 1 | 2 |
| Other | 18 | 8 | 10 | |
| Immune System Disorders: | 2 (1.5) | |||
| Allergic reaction | 2 | 1 | 1 | |
| Infections and Infestations: | 24 (24.2) | |||
| Eye infection | 1 | 1 | ||
| Otitis media | 4 | 2 | 2 | |
| Rhinitis infective | 3 | 3 | ||
| Sinusitis | 2 | 2 | ||
| Skin infection | 1 | 1 | ||
| Upper respiratory infection | 1 | 1 | ||
| Other | 12 | 12 | ||
| Injury, Poisoning and Procedural Complications: | 5 (3.6) | |||
| Fall | 1 | 1 | ||
| Fracture | 4 | 1 | 3 | |
| Investigations: | 1 (0.7) | |||
| Neutrophil count decreased | 1 | 1 | ||
| Metabolism and nutrition disorders: | 1 (0.7) | |||
| Dehydration | 1 | 1 | ||
| Musculoskeletal and connective tissue disorders: | 2 (1.5) | |||
| Pain in extremity | 1 | 1 | ||
| Other | 1 | 1 | ||
| Nervous System Disorders: | 6 (4.4) | |||
| Headache | 1 | 1 | ||
| Lethargy | 2 | 1 | 1 | |
| Tremor | 3 | 3 | ||
| Psychiatric disorders: | 4 (2.9) | |||
| Mania | 1 | 1 | ||
| Restlessness | 1 | 1 | ||
| Other | 2 | 1 | 1 | |
| Respiratory, thoracic and mediastinal disorders: | 19 (13.9) | |||
| Allergic rhinitis | 1 | 1 | ||
| Cough | 7 | 5 | 2 | |
| Nasal congestion | 4 | 3 | 1 | |
| Pneumonitis | 4 | 4 | ||
| Sore throat | 1 | 1 | ||
| Other | 2 | 1 | 1 | |
| Skin and subcutaneous tissue disorders: | 5 (3.6) | |||
| Rash maculo-papular | 2 | 1 | 1 | |
| Other | 3 | 3 |
Events are listed alphabetically with percentages indicating percent of total AEs. Grading is according to standard Common Terminology Criteria for Adverse Events (CTCAE) grading.