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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 105253939 | 10525393 | 9 | F | 20130628 | 20160901 | 20141017 | 20160908 | EXP | PHHY2014IT060309 | NOVARTIS | 47.98 | YR | F | Y | 67.00000 | KG | 20160908 | OT | IT | IT |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 105253939 | 10525393 | 1 | PS | GILENYA | FINGOLIMOD HYDROCHLORIDE | 1 | Oral | 0.5 MG, QD | 15 | MG | Y | U | 22527 | .5 | MG | CAPSULE | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 105253939 | 10525393 | 1 | Multiple sclerosis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 105253939 | 10525393 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 105253939 | 10525393 | Alanine aminotransferase increased | |
| 105253939 | 10525393 | Aspartate aminotransferase increased | |
| 105253939 | 10525393 | Blood alkaline phosphatase increased | |
| 105253939 | 10525393 | Central nervous system lesion | |
| 105253939 | 10525393 | Gamma-glutamyltransferase increased | |
| 105253939 | 10525393 | White blood cell count 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 |
|---|---|---|---|---|---|---|
| 105253939 | 10525393 | 1 | 20130530 | 20130904 | 0 |