Person who experienced the adverse event (patient)
| Event ID | CASEID | CASEVERSION | I F COD | EVENT DT | MFR DT | INIT FDA DT | FDA DT | REPT COD | AUTH NUM | MFR NUM | MFR SNDR | LIT REF | AGE | AGE COD | AGE GRP | GNDR COD | E SUB | WT | WT COD | REPT DT | TO MFR | OCCP COD | REPORTER COUNTRY | OCCR COUNTRY |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 97465373 | 9746537 | 3 | F | 2014 | 20160630 | 20131211 | 20160707 | EXP | PHHY2013BR143932 | NOVARTIS | 0.00 | F | Y | 74.00000 | KG | 20160707 | MD | BR | BR |
Drug(s) used by person
| Event ID | CASEID | DRUG SEQ | ROLE COD | DRUGNAME | PROD AI | VAL VBM | ROUTE | DOSE VBM | CUM DOSE CHR | CUM DOSE UNIT | DECHAL | RECHAL | LOT NUM | EXP DT | NDA NUM | DOSE AMT | DOSE UNIT | DOSE FORM | DOSE FREQ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 97465373 | 9746537 | 1 | PS | GILENYA | FINGOLIMOD HYDROCHLORIDE | 1 | Oral | 0.5 MG, QD | S0035, S0060 | 22527 | .5 | MG | CAPSULE | QD | |||||
| 97465373 | 9746537 | 2 | SS | GILENYA | FINGOLIMOD HYDROCHLORIDE | 1 | Oral | 0.5 MG, QD | 22527 | .5 | MG | CAPSULE | QD | ||||||
| 97465373 | 9746537 | 3 | SS | VITAMIN D | CHOLECALCIFEROL | 1 | Unknown | Y | 0 | ||||||||||
| 97465373 | 9746537 | 4 | C | TOPIRAMATE. | TOPIRAMATE | 1 | Unknown | UNK | 0 | ||||||||||
| 97465373 | 9746537 | 5 | C | PANTOPRAZOLE | PANTOPRAZOLE SODIUM | 1 | Unknown | UNK | 0 | ||||||||||
| 97465373 | 9746537 | 6 | C | IRON | IRON | 1 | Unknown | UNK | 0 | ||||||||||
| 97465373 | 9746537 | 7 | C | MINERALS | MINERALS | 1 | Unknown | UNK | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 97465373 | 9746537 | 1 | Multiple sclerosis |
| 97465373 | 9746537 | 3 | Multiple sclerosis |
| 97465373 | 9746537 | 4 | Product used for unknown indication |
| 97465373 | 9746537 | 5 | Product used for unknown indication |
| 97465373 | 9746537 | 6 | Product used for unknown indication |
| 97465373 | 9746537 | 7 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 97465373 | 9746537 | OT |
| 97465373 | 9746537 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 97465373 | 9746537 | Blood pressure decreased | |
| 97465373 | 9746537 | Blood pressure fluctuation | |
| 97465373 | 9746537 | Central nervous system lesion | |
| 97465373 | 9746537 | Headache | |
| 97465373 | 9746537 | Hemiplegia | |
| 97465373 | 9746537 | Hypoaesthesia | |
| 97465373 | 9746537 | Loss of consciousness | |
| 97465373 | 9746537 | Malaise | |
| 97465373 | 9746537 | Migraine | |
| 97465373 | 9746537 | Multiple sclerosis relapse | |
| 97465373 | 9746537 | Paraesthesia | |
| 97465373 | 9746537 | Road traffic accident | |
| 97465373 | 9746537 | Somnolence |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| Event ID | CASEID | DSG DRUG SEQ | START DT | END DT | DUR | DUR COD |
|---|---|---|---|---|---|---|
| 97465373 | 9746537 | 1 | 20131018 | 0 |