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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124889192 | 12488919 | 2 | F | 20160617 | 20160708 | 20160622 | 20160714 | PER | PHEH2016US015398 | NOVARTIS | 30.99 | YR | F | Y | 0.00000 | 20160714 | MD | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124889192 | 12488919 | 1 | PS | GILENYA | FINGOLIMOD HYDROCHLORIDE | 1 | Oral | 0.5 MG, QD | S0123 | 22527 | .5 | MG | CAPSULE | QD | |||||
| 124889192 | 12488919 | 2 | C | GABAPENTIN. | GABAPENTIN | 1 | Unknown | U | 0 | ||||||||||
| 124889192 | 12488919 | 3 | C | CYCLOBENZAPRINE | CYCLOBENZAPRINE | 1 | Unknown | U | 0 | ||||||||||
| 124889192 | 12488919 | 4 | C | OMEPRAZOLE. | OMEPRAZOLE | 1 | Unknown | U | 0 | ||||||||||
| 124889192 | 12488919 | 5 | C | WOMEN'S MULTI /02225001/ | 2 | Unknown | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124889192 | 12488919 | 1 | Multiple sclerosis |
| 124889192 | 12488919 | 2 | Product used for unknown indication |
| 124889192 | 12488919 | 3 | Product used for unknown indication |
| 124889192 | 12488919 | 4 | Product used for unknown indication |
| 124889192 | 12488919 | 5 | Product used for unknown indication |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124889192 | 12488919 | Anxiety | |
| 124889192 | 12488919 | Dizziness | |
| 124889192 | 12488919 | Extrasystoles | |
| 124889192 | 12488919 | Fatigue | |
| 124889192 | 12488919 | Feeling abnormal | |
| 124889192 | 12488919 | Heart rate decreased | |
| 124889192 | 12488919 | Insomnia | |
| 124889192 | 12488919 | Middle insomnia | |
| 124889192 | 12488919 | Nausea | |
| 124889192 | 12488919 | Nervousness | |
| 124889192 | 12488919 | Palpitations |
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 |
|---|---|---|---|---|---|---|
| 124889192 | 12488919 | 1 | 20160617 | 0 |