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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 105862013 | 10586201 | 3 | F | 20160927 | 20141116 | 20160930 | EXP | PHEH2014US022054 | NOVARTIS | 0.00 | F | Y | 0.00000 | 20160930 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 105862013 | 10586201 | 1 | PS | GILENYA | FINGOLIMOD HYDROCHLORIDE | 1 | Unknown | U | 22527 | CAPSULE |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 105862013 | 10586201 | 1 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 105862013 | 10586201 | OT |
| 105862013 | 10586201 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 105862013 | 10586201 | Abdominal pain | |
| 105862013 | 10586201 | Abdominal pain upper | |
| 105862013 | 10586201 | Biliary dilatation | |
| 105862013 | 10586201 | Lymphocyte count decreased |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |