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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 82899432 | 8289943 | 2 | F | 20110707 | 20120123 | 20111122 | 20120426 | PER | PHHY2011US63752 | NOVARTIS | 40.00 | YR | F | N | 85.30000 | KG | 20120306 | MD | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 82899432 | 8289943 | 1 | PS | GILENYA | 1 | ORAL | 0.5 MG,. DAILY, ORAL | 22527 | |||||||||||
| 82899432 | 8289943 | 2 | C | PROZAC (FLUOXETINE HYDROCHLORIDE) | 1 | 0 | |||||||||||||
| 82899432 | 8289943 | 4 | C | BACLOFEN | 1 | 0 | |||||||||||||
| 82899432 | 8289943 | 6 | C | LISINOPRIL | 1 | 0 | |||||||||||||
| 82899432 | 8289943 | 8 | C | VITAMIN D (ERGOCALCIFEROL) | 1 | 0 | |||||||||||||
| 82899432 | 8289943 | 10 | C | ORAL CONTRACEPTIVE NOS | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 82899432 | 8289943 | 1 | MULTIPLE SCLEROSIS |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 82899432 | 8289943 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 82899432 | 8289943 | Alanine aminotransferase increased | |
| 82899432 | 8289943 | Aspartate aminotransferase increased | |
| 82899432 | 8289943 | Enzyme abnormality | |
| 82899432 | 8289943 | Liver function test abnormal | |
| 82899432 | 8289943 | Lymphopenia |
Reporting Sources (this data is often not reported and may therefore be missing here)
| Event ID | CASEID | RPSR COD |
|---|---|---|
| 82899432 | 8289943 | HP |
Therapies reported
| Event ID | CASEID | DSG DRUG SEQ | START DT | END DT | DUR | DUR COD |
|---|---|---|---|---|---|---|
| 82899432 | 8289943 | 1 | 20110329 | 0 |