Table 11.

Grade 3–4 adverse events other than infusion reactions

Variable		MMF Group (n=39)		Placebo Group (n=39)
		No. of Patients (%)		No. of Patients (%)
System organ class	Preferred term	Grade 3	Grade 4	Grade 3	Grade 4
Gastrointestinal disorders	Diarrhea	1 (2.6)	0	0	0
	Cyclic vomiting syndrome	0	0	1 (2.6)	0
	Pneumatosis intestinalis	0	0	1 (2.6)	0
	Colitis	1 (2.6)	0	1 (2.6)	0
	Vomiting	0	0	1 (2.6)	0
	Dental caries	0	0	1 (2.6)	0
General disorders and administration site conditions	Fever	0	0	1 (2.6)	0
	Edema	0	0	1 (2.6)	0
Infections and infestations	Influenza	3 (7.7)	0	1 (2.6)	0
	Upper respiratory infection	1 (2.6)	0	2 (5.1)	0
	Nasopharyngitis	1 (2.6)	0	1 (2.6)	0
	Tonsillitis	1 (2.6)	0	0	0
	Herpes nose	1 (2.6)	0	0	0
	Oral Herpes	1 (2.6)	0	0	0
	Chickenpox	0	0	1 (2.6)	0
	Pharyngitis	0	0	1 (2.6)	0
	Periodontitis	0	0	1 (2.6)	0
	Otitis media	0	0	1 (2.6)	0
	Cellulitis	0	0	1 (2.6)	0
Injury, poisoning and procedural complications	Skin abrasion	1 (2.6)	0	0	0
	Forearm fracture	0	0	1 (2.6)	0
Renal and urinary disorders	Acute kidney injury	0	0	1 (2.6)	0
Metabolism and nutrition disorders	Hypoalbuminemia	0	0	2 (5.1)	0
	Hyperuricemia	1 (2.6)	0	0	0
	Obesity	1 (2.6)	0	0	0
Skin and subcutaneous tissue disorders	Dermatitis	0	0	1 (2.6)	0
Blood and lymphatic system disorders	Febrile neutropenia	2 (5.1)	0	0	0
	Lymphadenitis	1 (2.6)	0	0	0
Vascular disorders	Secondary hypertension	0	0	1 (2.6)	0
Investigations	Neutropenia	3 (7.7)	2 (5.1)	2 (5.1)	0
	Clostridium test positive	0	0	1 (2.6)	0