TABLE 4

Treatment-emergent adverse events (TEAEs) in 89 treated patients

Cohort 1Cohort 2Total n (%)
TEAEs reported in >10% of subjects453378 (87.6)
 Cough19928 (31.5)
 Fatigue81018 (20.2)
 Dyspnoea11516 (18.0)
 Upper respiratory tract infection9514 (15.7)
 Nasopharyngitis7613 (14.6)
 Bronchitis6612 (13.5)
 Headache8311 (12.4)
 Peripheral oedema4610 (11.2)
 Diarrhoea739 (10.1)
 Dizziness5410 (11.2)
 Nausea6410 (11.2)
 Urinary tract infection549 (10.1)
 Pneumonia628 (9.0)
 Idiopathic pulmonary fibrosis exacerbation358 (9.0)
 Nasal congestion178 (9.0)
Treatment-emergent serious adverse events#131124 (27.0)
 Cardiac disorders044 (4.5)
 Gastrointestinal disorders101 (1.1)
 Infections and infestations7310 (11.2)
  Pneumonia628 (9.0)
  Influenza011 (1.1)
 Neoplasms011 (1.1)
 Nervous system disorders202 (2.2)
 Psychiatric disorders101 (1.1)
 Renal and urinary disorders011 (1.1)
 Respiratory, thoracic and mediastinal disorders5611 (12.4)
  Idiopathic pulmonary fibrosis246 (6.7)
   Acute respiratory failure202 (2.2)
   Dyspnoea011 (1.1)
   Epistaxis011 (1.1)
   Hypoxia011 (1.1)
   Pulmonary hypertension011 (1.1)
   Respiratory arrest101 (1.1)
   Respiratory failure011 (1.1)
  Vascular disorders202 (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.