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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 120774442 | 12077444 | 2 | F | 2016 | 20160727 | 20160215 | 20160805 | PER | PHEH2016US003583 | NOVARTIS | 44.15 | YR | F | Y | 0.00000 | 20160805 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 120774442 | 12077444 | 1 | PS | GILENYA | FINGOLIMOD HYDROCHLORIDE | 1 | Unknown | UNK UNK, QD | F0029 | 22527 | CAPSULE | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 120774442 | 12077444 | 1 | Product used for unknown indication |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 120774442 | 12077444 | Cyst | |
| 120774442 | 12077444 | Dizziness | |
| 120774442 | 12077444 | Drug monitoring procedure not performed | |
| 120774442 | 12077444 | Dyspnoea | |
| 120774442 | 12077444 | Fatigue | |
| 120774442 | 12077444 | Feeling hot |
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 |
|---|---|---|---|---|---|---|
| 120774442 | 12077444 | 1 | 201602 | 0 |