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Table 4 Adverse events (AE) starting on the same day & between 1 & 7 days after challenge by MedDRA System Organ Class & Preferred Term (Safety population)

From: The safety and efficacy of inhaled dry powder mannitol as a bronchial provocation test for airway hyperresponsiveness: a phase 3 comparison study with hypertonic (4.5%) saline

System Organ Class Preferred Term AE starting on same day as AE starting between 1 & 7 days after
   Mannitol challenge Hypertonic Saline challenge Mannitol challenge Hypertonic Saline challenge
n   627 (%) 636 (%) 627 (%) 636 (%)
Any   102 (16.3) 84 (13.2) 217 (34.6) 228 (35.8)
Eye disorders   3 (0.5) 1 (0.2) 8 (1.3) 5 (0.8)
Gastrointestinal disorders   15 (2.4) 15 (2.4) 46 (7.3) 29 (4.6)
  Abdominal pain upper 1 (0.2) 3 (0.5) 11 (1.8) 6 (0.9)
  Diarrhoea NOS 1 (0.2) 1 (0.2) 7 (1.1) 3 (0.5)
  Nausea 7 (1.1) 9 (1.4) 20 (3.2) 9 (1.4)
General disorders and administration   10 (1.6) 6 (0.9) 22 (3.5) 13 (2.0)
Infections and infestations   2 (0.3) 4 (0.6) 26 (4.1) 40 (6.3)
  Nasopharyngitis 1 (0.2) 3 (0.5) 8 (1.3) 16 (2.5)
  Upper respiratory tract infect 1 (0.2)   6 (1.0) 11 (1.7)
Injury, poisoning and procedural complications    3 (0.5) 14 (2.2) 11 (1.7)
Investigations   4 (0.6) 4 (0.6) 1 (0.2) 2 (0.3)
Metabolism and nutrition disorders    1 (0.2) 2 (0.3)  
Musculoskeletal and connective tissue disorders   1 (0.2) 3 (0.5) 24 (3.8) 14 (2.2)
  Back pain   1 (0.2) 6 (1.0) 3 (0.5)
Nervous system disorders   46 (7.3) 38 (6.0) 87 (13.9) 101 (15.9)
  Headache NOS 38 (6.1) 32 (5.0) 78 (12.4) 92 (14.5)
Respiratory, thoracic and mediastinal disorders   40 (6.4) 21 (3.3) 48 (7.7) 61 (9.6)
  Asthma aggravated 1 (0.2) 3 (0.5) 6 (1.0) 5 (0.8)
  Cough 8 (1.3) 6 (0.9) 6 (1.0) 8 (1.3)
  Pharyngolaryngeal pain 16 (2.6) 5 (0.8) 16 (2.6) 13 (2.0)
  Rhinorrhoea 4 (0.6)   9 (1.4) 9 (1.4)
  Throat irritation 7 (1.1)   1 (0.2) 1 (0.2)
Skin and subcutaneous tissue disorders   1 (0.2) 4 (0.6) 10 (1.6) 11 (1.7)