Cohort 1 | Cohort 2 | Total n (%) | |
TEAEs reported in >10% of subjects | 45 | 33 | 78 (87.6) |
Cough | 19 | 9 | 28 (31.5) |
Fatigue | 8 | 10 | 18 (20.2) |
Dyspnoea | 11 | 5 | 16 (18.0) |
Upper respiratory tract infection | 9 | 5 | 14 (15.7) |
Nasopharyngitis | 7 | 6 | 13 (14.6) |
Bronchitis | 6 | 6 | 12 (13.5) |
Headache | 8 | 3 | 11 (12.4) |
Peripheral oedema | 4 | 6 | 10 (11.2) |
Diarrhoea | 7 | 3 | 9 (10.1) |
Dizziness | 5 | 4 | 10 (11.2) |
Nausea | 6 | 4 | 10 (11.2) |
Urinary tract infection | 5 | 4 | 9 (10.1) |
Pneumonia | 6 | 2 | 8 (9.0) |
Idiopathic pulmonary fibrosis exacerbation | 3 | 5 | 8 (9.0) |
Nasal congestion | 1 | 7 | 8 (9.0) |
Treatment-emergent serious adverse events# | 13 | 11 | 24 (27.0) |
Cardiac disorders | 0 | 4 | 4 (4.5) |
Gastrointestinal disorders | 1 | 0 | 1 (1.1) |
Infections and infestations | 7 | 3 | 10 (11.2) |
Pneumonia | 6 | 2 | 8 (9.0) |
Influenza | 0 | 1 | 1 (1.1) |
Neoplasms¶ | 0 | 1 | 1 (1.1) |
Nervous system disorders | 2 | 0 | 2 (2.2) |
Psychiatric disorders | 1 | 0 | 1 (1.1) |
Renal and urinary disorders | 0 | 1 | 1 (1.1) |
Respiratory, thoracic and mediastinal disorders | 5 | 6 | 11 (12.4) |
Idiopathic pulmonary fibrosis | 2 | 4 | 6 (6.7) |
Acute respiratory failure | 2 | 0 | 2 (2.2) |
Dyspnoea | 0 | 1 | 1 (1.1) |
Epistaxis | 0 | 1 | 1 (1.1) |
Hypoxia | 0 | 1 | 1 (1.1) |
Pulmonary hypertension | 0 | 1 | 1 (1.1) |
Respiratory arrest | 1 | 0 | 1 (1.1) |
Respiratory failure | 0 | 1 | 1 (1.1) |
Vascular disorders | 2 | 0 | 2 (2.2) |
TEAEs included medical conditions, signs and symptoms not previously observed in the subject that emerged during the protocol-specified adverse event reporting period. A serious adverse event was defined as any adverse event or suspected adverse reaction that resulted in death, a life-threatening adverse event, inpatient hospitalisation or prolongation of existing hospitalisation, persistent or significant incapacity, or substantial disruption of the ability to conduct normal life functions. #: 24 subjects with serious adverse events; some subjects experienced more than one serious adverse events. ¶: benign, malignant and unspecified, including cysts and polyps.