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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 116783315 | 11678331 | 5 | F | 20150605 | 20160620 | 20151028 | 20160705 | EXP | PHHY2015FR138054 | NOVARTIS | 57.77 | YR | F | Y | 0.00000 | 20160705 | MD | COUNTRY NOT SPECIFIED | FR |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 116783315 | 11678331 | 1 | PS | GILENYA | FINGOLIMOD HYDROCHLORIDE | 1 | Oral | 0.5 MG, QD | 16 | MG | N | 22527 | .5 | MG | CAPSULE | QD | |||
| 116783315 | 11678331 | 2 | SS | GILENYA | FINGOLIMOD HYDROCHLORIDE | 1 | Oral | 0.5 MG, QOD | 16 | MG | N | 22527 | .5 | MG | CAPSULE | ||||
| 116783315 | 11678331 | 3 | C | MICARDIS | TELMISARTAN | 1 | Oral | 40 MG, QD | U | 0 | 40 | MG | QD | ||||||
| 116783315 | 11678331 | 4 | C | PARACETAMOL | ACETAMINOPHEN | 1 | Unknown | 2 G, QD (PRN) | U | 0 | 2 | G | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 116783315 | 11678331 | 1 | Relapsing-remitting multiple sclerosis |
| 116783315 | 11678331 | 3 | Hypertension |
| 116783315 | 11678331 | 4 | Pain |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 116783315 | 11678331 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 116783315 | 11678331 | Diarrhoea | |
| 116783315 | 11678331 | Hepatic steatosis | |
| 116783315 | 11678331 | Lymphopenia | |
| 116783315 | 11678331 | Nausea | |
| 116783315 | 11678331 | Prescribed underdose |
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 |
|---|---|---|---|---|---|---|
| 116783315 | 11678331 | 1 | 20150505 | 20150613 | 0 | |
| 116783315 | 11678331 | 2 | 20150615 | 20151016 | 0 |