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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 115921244 | 11592124 | 4 | F | 201506 | 20160920 | 20151005 | 20160924 | EXP | PHHY2015CA103521 | SANDOZ | 43.52 | YR | F | Y | 0.00000 | 20160924 | OT | COUNTRY NOT SPECIFIED | CA |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 115921244 | 11592124 | 1 | SS | GILENYA | FINGOLIMOD HYDROCHLORIDE | 1 | Oral | 0.5 MG, UNK | 0 | .5 | MG | CAPSULE | |||||||
| 115921244 | 11592124 | 2 | PS | GABAPENTIN. | GABAPENTIN | 1 | Unknown | U | 75539 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 115921244 | 11592124 | 1 | Relapsing-remitting multiple sclerosis |
| 115921244 | 11592124 | 2 | Cognitive disorder |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 115921244 | 11592124 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 115921244 | 11592124 | Gait disturbance | |
| 115921244 | 11592124 | Liver disorder | |
| 115921244 | 11592124 | Liver function test abnormal | |
| 115921244 | 11592124 | Malaise | |
| 115921244 | 11592124 | Memory impairment | |
| 115921244 | 11592124 | Multiple sclerosis relapse | |
| 115921244 | 11592124 | Nausea |
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 |
|---|---|---|---|---|---|---|
| 115921244 | 11592124 | 1 | 20140417 | 0 |