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Table 3 Adverse event

From: An 8 week open-label interventional multicenter study to explore the lung clearance index as endpoint for clinical trials in cystic fibrosis patients ≥8 years of age, chronically infected with Pseudomonas aeruginosa

System organ classTIS (N = 5), n (%)TIP (N = 12), n (%)Overall (N = 17), n (%)
Any MedDRA system organ class2 (40.0)3 (25.0)5 (29.4)
Injury, poisoning and procedural complications1 (20.0)0 (0.0)1 (5.9)
Sunburn1 (20.0)0 (0.0)1 (5.9)
Investigations1 (8.3)0 (0.0)1 (5.9)
Forced expiratory volume decreased1 (8.3)0 (0.0)1 (5.9)
Respiratory, thoracic and mediastinal disorders2 (16.7)1 (20.0)3 (17.6)
Cough1 (8.3)0 (0.0)1 (5.9)
Haemoptysis0 (0.0)1 (20.0)1 (5.9)
Obstructive airways disorder1 (8.3)0 (0.0)1 (5.9)
  1. TIS Tobramycin inhalation solution, TIP Tobramycin inhalation powder. Percentages are based on N of each group in safety set. A patient with multiple occurrences of an AE is counted only once in the AE category. A patient with multiple adverse events within a primary system organ class is counted only once in each system organ class total row. MedDRA version 20.0 has been used for coding of adverse events