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) |