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Home > Key safety topics > Fatalities

Fatalities in Clinical Trials

Controlled period1,a
  • During the controlled period, no deaths were reported in the ofatumumab group, and one death (attributed to aortic dissection) was reported in teriflunomide group during the post treatment follow-up period
OMB overall pool2,b
  • In the OMB overall pool, as of 25-Sep-2022, 9 deaths were reported. Preferred term for these 9 cases include: sudden death (n=1), completed suicide (n=1), COVID-19 and COVID-19 pneumonia (n=2), COVID-19 pneumonia and pneumothorax (n=1); COVID-19 (n=2), intestinal metastasis (n=1), pneumonia and septic shock (n=1). (See COVID-19 section for more details)
  • There was no pattern (related to COVID-19) observed in the causes of fatalities in ofatumumab-treated patients in the clinical studies.​
aincludes data of patients pooled from ASCLEPIOS I and ASCLEPIOS II trials during controlled treatment period.

bOpen-label extension includes cumulative data of all patients (N=1969) who were randomized to ofatumumab 20 mg in ASCLEPIOS I, ASCLEPIOS II, APLIOS and APOLITOS studies, completed the core period of the study, and continued to be treated with ofatumumab 20 mg in open-label ALITHIOS or either completed or discontinued the core period of the study and continued with safety follow-up epoch of the core study and newly switched group (who were randomized to teriflunomide 14 mg in ASCLEPIOS I and ASCLEPIOS II, completed the core period of the study, and switched to ofatumumab 20 mg in open-label ALITHIOS).

 


References

1. Data on file. OMB157 Summary of clinical safety in RMS. Novartis Pharma AG. 
2. Cohen JA, et al. Presented at AAN 2023.P8.004