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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125294923 | 12529492 | 3 | F | 20160630 | 20160730 | 20160706 | 20160802 | PER | PHEH2016US016387 | NOVARTIS | 53.86 | YR | F | Y | 58.96000 | KG | 20160802 | CN | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125294923 | 12529492 | 1 | PS | GILENYA | FINGOLIMOD HYDROCHLORIDE | 1 | Oral | 0.5 MG, QD | 11 | MG | N | 22527 | .5 | MG | CAPSULE | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125294923 | 12529492 | 1 | Multiple sclerosis |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125294923 | 12529492 | Balance disorder | |
| 125294923 | 12529492 | Diarrhoea | |
| 125294923 | 12529492 | Fatigue | |
| 125294923 | 12529492 | Feeling abnormal | |
| 125294923 | 12529492 | Food poisoning | |
| 125294923 | 12529492 | Headache | |
| 125294923 | 12529492 | Migraine | |
| 125294923 | 12529492 | Oropharyngeal pain | |
| 125294923 | 12529492 | Vomiting |
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 |
|---|---|---|---|---|---|---|
| 125294923 | 12529492 | 1 | 20160609 | 20160630 | 0 |