Table 2.

Adverse events in recent trials for induction treatment of lupus nephritis

Study (Reference)	End Points			Infection			Hematologic Events			Cancer	GI Events			Alopecia	Reproductive Events
ELNT (11)	Treatment failure (%)			Serious		Other	Leukopenia (%)	Toxic anemia (%)		Patients with cancer, % (n)	Patients with event			Patients with event	Menopause (%)	Transient amenorrhea (%)
Low-dose iv CYC (n=44)	16			7 in 5 patients		10 in 5 patients	11	0		3 (1)	NN			NN	4	4
High-dose iv CYC (n=46)	20			17 in 10 patients		10 in 7 patients	11	2		0	NN			NN	2	2
ELNT 10-yr follow-up (12)	Death (%)	SCr doubling (%)	ESRD (%)	Patients with event			Patients with event			Patients with cancer, % (n)	Patients with event			Patients with event	Successful pregnancies
Low-dose iv CYC (n=44)	11	14	5	NN			NN			14 (6)	NN			NN	10 in 9 patients
High-dose iv CYC (n=46)	4	11	9	NN			NN			2 (1)	NN			NN	9 in 6 patients
Ginzler et al. (13)	Cumulative remission (%)			Severe infection (%)	Other infection (%)		Lymphopenia (%)		Anemia (%)	Patients with cancer	Upper GI symptom s (%)	Diarrhea (%)		Patients with event	Menstrual irregularities (%)	Amenorrhea (%)
MMF (n=83)	52			1	7		22		2	NN	28	18		0	10	0
iv CYC (n=75)	30			4	7		37		3	NN	33	3		10	15	3
ALMS Inductiona (14)	Decrease in UProt/Cr and Stable SCr (%)			Patients with ≥1 infection (%)			Anemia (%)			Patients with cancer	Nausea (%)	Vomiting (%)	Diarrhea (%)	Patients with event (%)	Patients with event
MMF (n=185)	56			69			13			NN	15	14	28	11	NN
iv CYC (n=185)	53			62			7			NN	46	38	13	36	NN

Hemorrhagic cystitis was not noted in any patients in these trials. GI, gastrointestinal; ELNT, Euro-Lupus Nephritis Trial; iv CYC, intravenous cyclophosphamide; NN, adverse event not noted to have occurred, but not specifically mentioned in the manuscript; SCr, serum creatinine; MMF, mycophenolate mofetil; ALMS, Aspreva Lupus Management Study; UProt/Cr, urinary protein-to-creatinine ratio.

^aALMS reported events only when the incidence of that event was >10%.