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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 85651872 | 8565187 | 2 | F | 20110207 | 20120131 | 20120315 | 20120426 | PER | PHHY2011US34948 | NOVARTIS | 30.00 | YR | F | N | 0.00000 | 20120306 | OT | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 85651872 | 8565187 | 1 | PS | GILENYA | 1 | ORAL | 0.5 MG, DAILY, ORAL, 0.5 MG, DAILY, ORAL | 22527 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 85651872 | 8565187 | 1 | MULTIPLE SCLEROSIS |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 85651872 | 8565187 | Balance disorder | |
| 85651872 | 8565187 | Cough | |
| 85651872 | 8565187 | Diarrhoea | |
| 85651872 | 8565187 | Dizziness | |
| 85651872 | 8565187 | Incorrect dose administered | |
| 85651872 | 8565187 | Malaise | |
| 85651872 | 8565187 | Nausea | |
| 85651872 | 8565187 | Vomiting |
Reporting Sources (this data is often not reported and may therefore be missing here)
| Event ID | CASEID | RPSR COD |
|---|---|---|
| 85651872 | 8565187 | HP |
Therapies reported
| Event ID | CASEID | DSG DRUG SEQ | START DT | END DT | DUR | DUR COD |
|---|---|---|---|---|---|---|
| 85651872 | 8565187 | 1 | 20110204 | 0 |