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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 class

TIS (N = 5), n (%)

TIP (N = 12), n (%)

Overall (N = 17), n (%)

Any MedDRA system organ class

2 (40.0)

3 (25.0)

5 (29.4)

Injury, poisoning and procedural complications

1 (20.0)

0 (0.0)

1 (5.9)

Sunburn

1 (20.0)

0 (0.0)

1 (5.9)

Investigations

1 (8.3)

0 (0.0)

1 (5.9)

Forced expiratory volume decreased

1 (8.3)

0 (0.0)

1 (5.9)

Respiratory, thoracic and mediastinal disorders

2 (16.7)

1 (20.0)

3 (17.6)

Cough

1 (8.3)

0 (0.0)

1 (5.9)

Haemoptysis

0 (0.0)

1 (20.0)

1 (5.9)

Obstructive airways disorder

1 (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
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BMC Pulmonary Medicine

ISSN: 1471-2466

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