TABLE 2.

Adverse events after randomization and after randomization by attribution

Time to randomization and system organ class	Preferred term	Severity level	No. of events (no. of subjects)
			Group 1	Group 2	Group 3	Total
After randomization
Blood and lymphatic system disorders	Thrombocytopenia	4		1 (1)
Gastrointestinal disorders	Constipation	1	1 (1)
	Flatulence	1		1 (1)
	Nausea	1	1 (1)	4 (3)
	Vomiting	1		2 (1)	1 (1)
General disorders and administration site conditions	Chest pain	1	1 (1)
	Fever	1	1 (1)
Infections and infestations	Upper respiratory infection	1	1 (1)
Investigations	Creatinine level increase	1		1 (1)
	Elevated liver enzyme levels	1		1 (1)	1 (1)
	Urinalysis abnormal	1	1 (1)
	Leukocyte level decrease	1	1 (1)	1 (1)	1 (1)
Metabolism and nutrition disorders	Hyperkalemia	1			1 (1)
Musculoskeletal and connective tissue disorders	Neck pain	2	1 (1)
Renal and urinary disorders	Hematuria	1		3 (2)	2 (2)
	Microscopic hematuria	1	1 (1)	4 (2)	5 (2)
	Proteinuria	1	1 (1)
Respiratory, thoracic, and mediastinal disorders	Runny nose	1		1 (1)
Vascular disorders	Blood pressure fluctuation	1	1 (1)
	Hypertension	1		1 (1)	1 (1)
	Hypotension	2	1 (1)
	Phlebitis	1		1 (1)
After randomization subtotal			11 (7)	22 (10)	12 (7)	45 (24)
After randomization by attribution
Possibly attributable
Gastrointestinal disorders	Constipation	1	1 (1)			1 (1)
	Flatulence	1		1 (1)		1 (1)
	Nausea	1	1 (1)	2 (2)		3 (3)
	Vomiting	1			1 (1)	1 (1)
General disorders and administration site conditions	Chest pain	1	1 (1)			1 (1)
	Fever	1	1 (1)	1 (1)
Investigations	Creatinine level increase	1		1 (1)		1 (1)
	Leukocyte level decrease	1	1 (1)		1 (1)	2 (2)
Renal and urinary disorders	Hematuria	1			1 (1)	1 (1)
	Microscopic hematuria	1	1 (1)	2 (2)	1 (1)	4 (4)
Possibly attributable total			5	7	4	16 (10)
Positively attributable
Blood and lymphatic system disorders	Thrombocytopenia	4		1 (1)		1 (1)
Gastrointestinal disorders	Nausea	1		2 (1)		2 (1)
	Vomiting	1		2 (1)		2 (1)
Positively attributable total				5 (2)		5 (2)
Total			11 (7)	22 (10)	12 (7)	45 (24)