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Medical information request
Medical information request

EXPAND

Safety

EXPAND population: Overall safety profile1-3

Table - EXPAND population Over all-v
**Deaths in the siponimod group were due to metastatic gastrointestinal melanoma within 4 months of commencing siponimod; septic shock in a patient with terminal colon cancer; urosepsis more than 10 weeks after discontinuation of siponimod and after two doses of rituximab; and suicide. One additional patient with metastatic lung carcinoma withdrew consent from the study after having been on siponimod for 11 months; this patient died (unspecified reason) about 5 months after discontinuing the study medication. Deaths in the placebo group were due to haemorrhagic stroke, lung cancer, gastric cancer, and for an unknown reason
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EXPAND population: Most common AEs (≥5% of patients in either group)2

Table - EXPAND population Most common-v
^AEs were coded according to the MedDRA, version 19·0
Data presented from the EXPAND placebo-controlled Phase 3 study
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EXPAND population: SAEs (≥0.5% of patients in either group)2

Table - EXPAND population-v
Data are presented from the EXPAND placebo-controlled Phase 3 study
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AEs of special interest

  • AEs of special interest include well known pharmacodynamic effects of the S1P modulators, risks associated with immunosuppression, and some events that occurred with S1Ps but for which the mechanism remains unclear
Table - AEs of special interest-v
#Include 'central nervous system hemorrhages and cerebrovascular conditions (SMQ broad)', 'embolic and thrombotic events, arterial (SMQ)', and 'ischemic heart disease (SMQ broad)'
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Abbreviations
AE, adverse event; HLT, high-level term; MedDRA, medical dictionary for regulatory activities; MS, multiple sclerosis; n, number of patients; NMQ, Novartis MedDRA Query; PT, preferred term; SAE, serious adverse event; SOC, system organ class; SMQ, Standardised MedDRA Query
References
1. Data on File, PSUR 2, cutoff date 25-Sep-2020, Novartis Pharma AG.
2. Kappos L, et al. Lancet. 2018;391:1263–1273.
3. Kappos L, et al. Oral presentation at AAN. 2017;CT.02.
* Indication varies in different countries. Current website is a global information resource. Local Prescribing Information/ Summary of Product Characteristics approved by individual country’s regulatory authority is the primary source of information for the indication of siponimod in the individual country.

The Pregnancy outcome Intensive Monitoring (PRIM) program is based on enhanced pharmacovigilance of the Novartis spontaneous reporting system. PRIM is an adverse event outcomes intensive monitoring program to collect information (targeted follow-up checklists) about pregnancy in patients exposed to siponimod immediately before or during pregnancy and infant outcomes 12 months after delivery.