Table 5.
Treatment-related SAEs during RENEW treatment phase
|
SAE |
Treatment phase (n = 509) |
||
|---|---|---|---|
| |
Number of treatment-related events |
||
| Possible | Probable | Total | |
| Decreased ejection fraction |
1 |
10 |
11 |
| Urinary tract infection |
1 |
3 |
4 |
| Cardiomyopathy |
0 |
3 |
3 |
| Febrile neutropenia |
1 |
2 |
3 |
| Leukopenia |
0 |
3 |
3 |
| Pneumonia |
0 |
3 |
3 |
| Congestive heart failure |
0 |
2 |
2 |
| Cellulitis gangrenous |
0 |
1 |
1 |
| Herpes zoster |
0 |
1 |
1 |
| Upper respiratory tract infection |
0 |
1 |
1 |
| Urosepsis |
0 |
1 |
1 |
| Ventricular hypokinesia |
0 |
1 |
1 |
| Myocardial infarction |
2 |
0 |
2 |
| Nausea |
2 |
0 |
2 |
| Sepsis |
2 |
0 |
2 |
| Septic shock |
2 |
0 |
2 |
| Vomiting |
2 |
0 |
2 |
| Abortion incomplete |
1 |
0 |
1 |
| Cellulitis |
1 |
0 |
1 |
| Deep vein thrombosis |
1 |
0 |
1 |
| Dizziness |
1 |
0 |
1 |
| Fungal skin infection |
1 |
0 |
1 |
| Hydronephrosis |
1 |
0 |
1 |
| Localized infection |
1 |
0 |
1 |
| Lung infection |
1 |
0 |
1 |
| Meningitis |
1 |
0 |
1 |
| Pituitary tumor |
1 |
0 |
1 |
| Pulmonary embolism |
1 |
0 |
1 |
| Varicella | 1 | 0 | 1 |
SAE=serious adverse event; RENEW=Registry to Evaluate Novantrone Effects in Worsening Multiple Sclerosis.