Table 6

Overview of the SAEs during the study or the post-study observation period

Patient

Description of the event

No

DSG

cycles

Intensity

Relationship to DSG

Action taken

A

Renal failure (Severe proteinuria)

9

Moderate

No (cycle 9, incompliance)

Hospitalization

Study termination

Parodontitis, tooth infection, fever

Moderate

No

B

Oral candidiasis

6

Moderate

Probably

Hospitalization

Fever

Moderate

Probably

Hospitalization

Fever

Mild

Possibly

Study termination

myalgia

Mild

Unlikely (during follow-up)

Headache

Mild

Unlikely (during follow-up)

Hospitalization

C

Angina pectoris

4

Moderate

No

Hospitalization

Pneumonia

Severe

Probably

Hospitalization

Study termination

D

Increase in serum creatinine

(renal failure)

0

Severe

No (drop-out after first dose in cycle 1)

Additional therapy

Study termination

E

Excision of an uterine myoma

9

Not applicable

No (during follow-up)

Hospitalization

F

Leukopenia (two SAEs)

5

Severe

Possibly

Hospitalization

Study termination

Increased lupus activity with

increased proteinuria and pain

Severe

No (during follow-up)

Hospitalization

Cyclophosphamide

induced leukopenia

Severe

No (during follow-up)

Hospitalization

Hospitalization for a

second cyclophosphamide pulse

Not applicable

No (during follow-up)

Hospitalization

G

Herpes zoster

9

Moderate

Possibly

Hospitalization

Study termination

H

Lupus flare (arthritis,

myalgia, skin rash)

9

Moderate

Unlikely

Hospitalization

DSG, deoxyspergualin; SAE, serious adverse event.

Lorenz et al. Arthritis Research & Therapy 2011 13:R36   doi:10.1186/ar3268