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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 113756016 | 11375601 | 6 | F | 20141208 | 20160803 | 20150813 | 20160808 | EXP | PHHY2015DE027340 | NOVARTIS | 28.93 | YR | M | Y | 60.00000 | KG | 20160808 | MD | DE | DE |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 113756016 | 11375601 | 1 | PS | GILENYA | FINGOLIMOD HYDROCHLORIDE | 1 | Oral | 0.5 MG, QD | 35.0390015 | MG | 22527 | .5 | MG | CAPSULE | QD | ||||
| 113756016 | 11375601 | 2 | SS | GILENYA | FINGOLIMOD HYDROCHLORIDE | 1 | Oral | 0.5 MG, QD | 35.0390015 | MG | 22527 | .5 | MG | CAPSULE | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 113756016 | 11375601 | 1 | Multiple sclerosis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 113756016 | 11375601 | OT |
| 113756016 | 11375601 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 113756016 | 11375601 | Alanine aminotransferase increased | |
| 113756016 | 11375601 | Aspartate aminotransferase increased | |
| 113756016 | 11375601 | Back pain | |
| 113756016 | 11375601 | Blood cholesterol increased | |
| 113756016 | 11375601 | Central nervous system lesion | |
| 113756016 | 11375601 | Facial pain | |
| 113756016 | 11375601 | Fatigue | |
| 113756016 | 11375601 | Gamma-glutamyltransferase increased | |
| 113756016 | 11375601 | Hypoaesthesia | |
| 113756016 | 11375601 | Lymphopenia | |
| 113756016 | 11375601 | Monocyte count increased | |
| 113756016 | 11375601 | Multiple sclerosis relapse | |
| 113756016 | 11375601 | Nasopharyngitis | |
| 113756016 | 11375601 | Persistent depressive disorder | |
| 113756016 | 11375601 | 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 |
|---|---|---|---|---|---|---|
| 113756016 | 11375601 | 1 | 20141201 | 20150215 | 0 | |
| 113756016 | 11375601 | 2 | 20150218 | 0 |