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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 114455535 | 11445553 | 5 | F | 20150219 | 20160725 | 20150902 | 20160727 | PER | PHHY2015US067626 | NOVARTIS | 64.37 | YR | F | Y | 0.00000 | 20160727 | MD | US | US |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 114455535 | 11445553 | 1 | PS | GILENYA | FINGOLIMOD HYDROCHLORIDE | 1 | Oral | UNK | 22527 | CAPSULE | |||||||||
| 114455535 | 11445553 | 2 | C | B-COMPLEX (B50) | 2 | Unknown | UNK | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 114455535 | 11445553 | 1 | Multiple sclerosis |
| 114455535 | 11445553 | 2 | Supplementation therapy |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 114455535 | 11445553 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 114455535 | 11445553 | Alanine aminotransferase increased | |
| 114455535 | 11445553 | Ataxia | |
| 114455535 | 11445553 | Blood glucose increased | |
| 114455535 | 11445553 | Bone pain | |
| 114455535 | 11445553 | Dizziness | |
| 114455535 | 11445553 | Eye pain | |
| 114455535 | 11445553 | Fall | |
| 114455535 | 11445553 | Fatigue | |
| 114455535 | 11445553 | Foot fracture | |
| 114455535 | 11445553 | Hemiparesis | |
| 114455535 | 11445553 | Hypoaesthesia | |
| 114455535 | 11445553 | Neutrophil count increased | |
| 114455535 | 11445553 | Non-cardiac chest pain | |
| 114455535 | 11445553 | Protein total decreased | |
| 114455535 | 11445553 | Urinary tract infection | |
| 114455535 | 11445553 | Vertigo |
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 |
|---|---|---|---|---|---|---|
| 114455535 | 11445553 | 2 | 20150801 | 0 |