Table 9 Adverse events following bronchial provocation and those not related to challenge in the safety population.
System Organ Class | Preferred Term | 1st Exc# | 2nd Exc | Mann# | Meth# | NCR# |
|---|---|---|---|---|---|---|
n | 435 | 429 | 419 | 420 | 436 | |
1.1 All | 25 (8%) | 21 (7%) | 130 (41%) | 89 (28%) | 49 (16%) | |
Cardiac Disorders | Class Totals | 1 (5%) | 0 | 6 (27%) | 13 (59%) | 2 (9%) |
Dizziness | 1 | 5 | 13 | 0 | ||
Gastrointestinal disorders | Class Totals | 1 (5%) | 1 (5%) | 14 (70%) | 0 | 4 (20%) |
Nausea | 1 | 5 | 1 | |||
Retching | 1 | 4 | ||||
General disorders and administration site concerns | Class Totals | 1 (4%) | 0 | 24 (86%) | 3 (11%) | 0 |
Burning sensation mucosal | 9 | |||||
Feeling jittery | 6 | 2 | ||||
Nervous system disorders | Class Totals | 4 (20%) | 2 (10%) | 6 (30%) | 4 (20%) | 4 (20%) |
Headache | 2 | 1 | 5 | 4 | 4 | |
Respiratory, thoracic and mediastinal disorders | Class Totals | 12 (6%) | 11 (6%) | 73 (39%) | 66 (36%) | 23 (12%) |
Chest discomfort | 3 | 1 | 13 | 18 | 1 | |
Cough | 2 | 1 | 9 | 8 | 4 | |
Dyspnoea | 4 | 3 | 12 | 22 | 1 | |
Nasal congestion | 1 | 4 | 3 | |||
Pharyngolaryngeal pain | 1 | 11 | 1 | 1 | ||
Reversible airways obstruction | 1 | 3 | 2 | |||
Rhinitis | 3 | 1 | 1 | |||
Rhinorrhea | 2 | 8 | 1 | |||
Wheezing | 1 | 6 | 7 | 1 |