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Table 9 Adverse events following bronchial provocation and those not related to challenge in the safety population.

From: Comparison of mannitol and methacholine to predict exercise-induced bronchoconstriction and a clinical diagnosis of asthma

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
  1. #Exc = Exercise; Mann = Mannitol; Meth = Methacholine; NCR = not challenge related