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 |
| Â | Parodontitis, tooth infection, fever | Â | Moderate | No | Â |
B | Oral candidiasis | 6 | Moderate | Probably | Hospitalization |
| Â | Fever | Â | Moderate | Probably | Hospitalization |
| Â | Fever | Â | Mild | Possibly | Study termination |
| Â | myalgia | Â | Mild | Unlikely (during follow-up) | Â |
| Â | Headache | Â | Mild | Unlikely (during follow-up) | Hospitalization |
C | Angina pectoris | 4 | Moderate | No | Hospitalization |
| Â | Pneumonia | Â | 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 |
| Â | Increased lupus activity with increased proteinuria and pain | Â | Severe | No (during follow-up) | Hospitalization |
| Â | Cyclophosphamide induced leukopenia | Â | Severe | No (during follow-up) | Hospitalization |
| Â | Hospitalization for a second cyclophosphamide pulse | Â | 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 |