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Table 6 Overview of the SAEs during the study or the post-study observation period

From: Treatment of active lupus nephritis with the novel immunosuppressant 15-deoxyspergualin: an open-label dose escalation study

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
  1. DSG, deoxyspergualin; SAE, serious adverse event.