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)

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)