Table 2

Adverse events in 91 treated patients over 48 weeks

	50 mg once per day	100 mg two times per day	Total
Patients, n	46	45	91
AEs reported in ≥10% of patients in either dose group, n (%)*
Cough	11 (23.9)	14 (31.1)	25 (27.5)
Rash†	6 (13.0)	8 (17.8)	14 (15.4)
Dyspnoea	6 (13.0)	7 (15.6)	13 (14.3)
Nausea	5 (10.9)	5 (11.1)	10 (11.0)
Idiopathic pulmonary fibrosis‡	6 (13.0)	3 (6.7)	9 (9.9)
Fatigue	3 (6.5)	5 (11.1)	8 (8.8)
Lower respiratory tract infection	2 (4.3)	6 (13.3)	8 (8.8)
Upper respiratory tract infection	1 (2.2)	7 (15.6)	8 (8.8)
SAEs, n (%)*
Idiopathic pulmonary fibrosis‡	1 (2.2)	2 (4.4)	3 (3.3)
Dyspnoea	1 (2.2)	0	1 (1.1)
Haemoptysis	1 (2.2)	0	1 (1.1)
Cardiac failure	1 (2.2)	0	1 (1.1)
Pneumothorax	0	1 (2.2)	1 (1.1)
Pulmonary embolism	0	1 (2.2)	1 (1.1)
Pneumonia	1 (2.2)	1 (2.2)	2 (2.2)
Bacteraemia	1 (2.2)	0	1 (1.1)
Campylobacter infection	1 (2.2)	0	1 (1.1)
Cellulitis	1 (2.2)	0	1 (1.1)
Infectious pleural effusion	0	1 (2.2)	1 (1.1)
Lower respiratory tract infection	0	1 (2.2)	1 (1.1)
Lower respiratory tract infection viral	0	1 (2.2)	1 (1.1)
Parainfluenzae virus infection	0	1 (2.2)	1 (1.1)
Septic embolus	1 (2.2)	0	1 (1.1)
Lung adenocarcinoma stage I	0	1 (2.2)	1 (1.1)
Prostate cancer	0	1 (2.2)	1 (1.1)
Cerebral infarction	1 (2.2)	0	1 (1.1)
Embolic stroke	1 (2.2)	0	1 (1.1)
Chest discomfort	1 (2.2)	0	1 (1.1)
Musculoskeletal chest pain	1 (2.2)	0	1 (1.1)

*n (%) for AEs and SAEs are frequency (percentage) of patients with the event reported.
†Rash includes the following preferred terms: rash, rash macular, rash papular, rash erythematous and rash pruritic.
‡The idiopathic pulmonary fibrosis (IPF) preferred term includes progression, deterioration, exacerbation and worsening of IPF.
AEs, adverse events; SAEs, serious adverse events.