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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)