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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 88795263 | 8879526 | 3 | F | 20110612 | 20121119 | 20120426 | 20130107 | PER | PHEH2012US004378 | NOVARTIS | 61.00 | YR | F | N | 77.00000 | KG | 20121205 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 88795263 | 8879526 | 1 | PS | GILENYA | 1 | ORAL | D | S0012 | 20130331 | 22527 | 0.5 | MG | QD | ||||||
| 88795263 | 8879526 | 3 | C | QUINAPRIL (QUINAPRIL) | 2 | 0 | |||||||||||||
| 88795263 | 8879526 | 5 | C | OMEPRAZOLE (OMEPRAZOLE) | 1 | 0 | |||||||||||||
| 88795263 | 8879526 | 7 | C | TIZANIDINE (TIZANIDINE) | 2 | 0 | |||||||||||||
| 88795263 | 8879526 | 9 | C | METOPROLOL (METOPROLOL) | 1 | 0 | |||||||||||||
| 88795263 | 8879526 | 11 | C | PROVIGIL (MODAFINIL) | 1 | 0 | |||||||||||||
| 88795263 | 8879526 | 13 | C | ASPIRIN, 81 MG | 2 | 0 | |||||||||||||
| 88795263 | 8879526 | 15 | C | FLUOXETINE (FLUOXETINE) | 1 | 0 | |||||||||||||
| 88795263 | 8879526 | 17 | C | DILTIAZEM | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 88795263 | 8879526 | 1 | Multiple sclerosis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 88795263 | 8879526 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 88795263 | 8879526 | Eosinophil count increased | |
| 88795263 | 8879526 | Lymphocyte count decreased | |
| 88795263 | 8879526 | Macular oedema | |
| 88795263 | 8879526 | Vision blurred | |
| 88795263 | 8879526 | Visual acuity reduced |
Reporting Sources (this data is often not reported and may therefore be missing here)
| Event ID | CASEID | RPSR COD |
|---|---|---|
| 88795263 | 8879526 | HP |
Therapies reported
| Event ID | CASEID | DSG DRUG SEQ | START DT | END DT | DUR | DUR COD |
|---|---|---|---|---|---|---|
| 88795263 | 8879526 | 1 | 20110516 | 20120217 | 0 |