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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 111334326 | 11133432 | 6 | F | 20130409 | 20160829 | 20150522 | 20160901 | EXP | PHHY2015DE059678 | NOVARTIS | 0.00 | A | M | Y | 77.00000 | KG | 20160901 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 111334326 | 11133432 | 1 | PS | GILENYA | FINGOLIMOD HYDROCHLORIDE | 1 | Oral | 0.5 MG, QD | 4 | MG | U | 22527 | .5 | MG | CAPSULE | QD | |||
| 111334326 | 11133432 | 2 | C | IBUPROFEN. | IBUPROFEN | 1 | Unknown | 1600 OT, UNK | Y | 0 | |||||||||
| 111334326 | 11133432 | 3 | C | METAMIZOLE | METAMIZOLE | 1 | Unknown | 100 OT, UNK | Y | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 111334326 | 11133432 | 1 | Multiple sclerosis |
| 111334326 | 11133432 | 2 | Product used for unknown indication |
| 111334326 | 11133432 | 3 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 111334326 | 11133432 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 111334326 | 11133432 | Alanine aminotransferase increased | |
| 111334326 | 11133432 | Blood cholesterol increased | |
| 111334326 | 11133432 | Cerebral haemorrhage | |
| 111334326 | 11133432 | Gamma-glutamyltransferase increased | |
| 111334326 | 11133432 | Lymphopenia | |
| 111334326 | 11133432 | Multiple sclerosis relapse | |
| 111334326 | 11133432 | Muscular weakness |
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 |
|---|---|---|---|---|---|---|
| 111334326 | 11133432 | 1 | 20121122 | 0 | ||
| 111334326 | 11133432 | 2 | 20121017 | 20121020 | 0 | |
| 111334326 | 11133432 | 3 | 20121017 | 20121020 | 0 |