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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 122850312 | 12285031 | 2 | F | 20160831 | 20160902 | 20160420 | 20160907 | PER | PHEH2015US007469 | NOVARTIS | 34.31 | YR | M | Y | 90.71000 | KG | 20160907 | CN | US | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 122850312 | 12285031 | 1 | PS | GILENYA | FINGOLIMOD HYDROCHLORIDE | 1 | Oral | 0.5 MG, QD | S0082A | 22527 | .5 | MG | CAPSULE | QD | |||||
| 122850312 | 12285031 | 2 | SS | GILENYA | FINGOLIMOD HYDROCHLORIDE | 1 | Oral | 1 MG (TOOK 2 PILLS), QD | 22527 | 1 | MG | CAPSULE | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 122850312 | 12285031 | 1 | Multiple sclerosis |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 122850312 | 12285031 | Extra dose administered | |
| 122850312 | 12285031 | Feeling abnormal | |
| 122850312 | 12285031 | Headache | |
| 122850312 | 12285031 | Insomnia | |
| 122850312 | 12285031 | Memory impairment |
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 |
|---|---|---|---|---|---|---|
| 122850312 | 12285031 | 1 | 20141222 | 0 | ||
| 122850312 | 12285031 | 2 | 20160831 | 20160831 | 0 |