Table 4. Most common adverse events (≥5% in any group) across the three studies
EAGERCOLO/DPI/02/06COLO/DPI/02/05
Tobramycin DPINebulised tobramycinColistimethate sodium DPINebulised tobramycinColistimethate sodium DPINebulised colistin
Patients#3082091871931615
Cough149 (48.4)65 (31.1)168 (89.8)151 (78.2)13 (81.3)7 (46.7)
Throat irritationAiCAiC141 (75.4)84 (43.5)13 (81.3)3 (20.0)
Productive cough56 (18.2)41 (19.6)38 (20.3)44 (22.8)2 (12.5)1 (6.7)
Dyspnoea48 (15.6)26 (12.4)49 (26.2)52 (26.9)3 (18.8)4 (26.7)
Oropharyngeal pain43 (14.0)21 (10.5)4 (2.1)1 (0.5)2 (12.5)2 (13.3)
Rales22 (7.1)13 (6.2)2 (1.1)5 (2.6)NRNR
Rhinorrhoea22 (7.1)15 (7.2)1 (0.5)2 (1.0)NRNR
Pulmonary function test decreased21 (6.8)17 (8.1)0 (0)3 (1.6)NRNR
Pyrexia48 (15.6)26 (12.4)23 (12.3)19 (9.8)2 (12.5)1 (6.7)
DysgeusiaAiCAiC117 (62.6)53 (27.5)14 (87.5)3 (20.0)
Respiratory disorders21 (6.8)18 (8.6)53 (28.3)57 (29.5)16 (100)7 (46.7)
Wheezing21 (6.8)13 (6.2)31 (16.6)38 (19.7)7 (43.8)5 (33.3)
Chest discomfort20 (6.5)6 (2.9)26 (13.9)34 (17.6)4 (25)2 (13.3)
Sinusitis18 (5.8)15 (7.2)3 (1.6)2 (1.0)NRNR
Pulmonary congestion17 (5.5)9 (4.3)NRNRNRNR
Dysphonia42 (13.6)8 (3.8)22 (11.8)30 (15.5)NRNR
Nasal congestion25 (8.1)15 (7.2)2 (1.1)4 (2.1)NRNR
Vomiting19 (6.2)12 (5.7)6 (3.2)8 (4.1)2 (12.0)0 (0)
Haemoptysis40 (13.0)26 (12.4)20 (10.7)13 (6.7)NRNR
Nausea23 (7.5)20 (9.6)7 (3.7)9 (4.7)NRNR
Headache35 (11.4)25 (12.0)9 (4.8)16 (8.3)1 (6.3)2 (13.3)
Fatigue20 (6.5)10 (4.8)9 (4.8)8 (4.1)NRNR
Serious lung disorderAiCAiCNRNRNRNR
Chest painAiCAiC13 (7.0)16 (8.3)NRNR
Crackles lungNRNR13 (7.0)14 (7.3)NRNR
Increased upper airway secretionNRNR12 (6.4)13 (6.7)NRNR
PharyngitisNRNR10 (5.3)14 (7.3)NRNR
RhonchiNRNR8 (4.3)10 (5.2)NRNR
  • Data are presented as n or n (%). DPI: dry powder inhaler; AiC: academic in confidence; NR: not reported. #: number of patients experiencing the event at least once.