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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 86627395 | 8662739 | 5 | F | 20120625 | 20160919 | 20120712 | 20160927 | EXP | PHEH2012US012798 | NOVARTIS | 56.38 | YR | M | Y | 120.18000 | KG | 20160927 | CN | COUNTRY NOT SPECIFIED | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 86627395 | 8662739 | 1 | PS | GILENYA | FINGOLIMOD HYDROCHLORIDE | 1 | Oral | 0.5 MG, QD | S0012B | 22527 | .5 | MG | CAPSULE | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 86627395 | 8662739 | 1 | Multiple sclerosis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 86627395 | 8662739 | HO |
| 86627395 | 8662739 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 86627395 | 8662739 | Balance disorder | |
| 86627395 | 8662739 | Chromaturia | |
| 86627395 | 8662739 | Dehydration | |
| 86627395 | 8662739 | Dizziness | |
| 86627395 | 8662739 | Drug ineffective | |
| 86627395 | 8662739 | Dysuria | |
| 86627395 | 8662739 | Gait disturbance | |
| 86627395 | 8662739 | Headache | |
| 86627395 | 8662739 | Heart rate decreased | |
| 86627395 | 8662739 | Renal impairment | |
| 86627395 | 8662739 | Somnolence | |
| 86627395 | 8662739 | Urine analysis abnormal | |
| 86627395 | 8662739 | Urine output decreased |
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 |
|---|---|---|---|---|---|---|
| 86627395 | 8662739 | 1 | 20120625 | 0 |