Table 4.

Nonserious versus serious adverse events by MedDRA primary system organ class.

	Nonserious		Serious
	n	%	n	%
Blood and lymphatic-system disorders	9	1.3	4	1.8
Cardiac disorders	1	0.2	8	3.7
Ear and labyrinth disorders	5	0.7	0	0.0
Endocrine disorders	1	0.2	1	0.5
Eye disorders	9	1.3	0	0.0
Gastrointestinal disorders	100	14.8	18	8.3
General disorders and administration-site conditions	83	12.3	5	2.3
Hepatobiliary disorders	1	0.2	3	1.4
Immune-system disorders	2	0.3	0	0.0
Infections and infestations	151	22.4	59	27.1
Injury, poisoning and procedural complications	19	2.8	8	3.7
Investigations	49	7.3	3	1.4
Metabolism and nutrition disorders	6	0. 9	1	0.5
Musculoskeletal and connective tissue disorders	28	4.2	10	4.6
Neoplasms benign, malignant, and unspecified (including cysts and polyps)	1	0.2	4	1.8
Nervous-system disorders	71	10.5	63	28.9
Psychiatric disorders	17	2.5	5	2.3
Renal and urinary disorders	9	1.3	4	1.8
Reproductive system and breast disorders	4	0.6	2	0.9
Respiratory, thoracic, and mediastinal disorders	17	2.5	5	2.3
Skin and subcutaneous-tissue disorders	73	10.8	2	0.9
Social circumstances	3	0.4	0	0.0
Surgical and medical procedures	0	0.0	6	2.8
Vascular disorders	16	2.4	7	3.2
Total	675	100.0	218	100.0

MedDRA = Medical Dictionary for Regulatory Activities.