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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 84049297 | 8404929 | 7 | F | 201109 | 20160908 | 20120214 | 20160914 | EXP | PHHY2011CA70041 | NOVARTIS | 46.48 | YR | F | Y | 0.00000 | 20160914 | PH | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 84049297 | 8404929 | 1 | PS | GILENYA | FINGOLIMOD HYDROCHLORIDE | 1 | Oral | 0.5 MG, DAILY | U | 22527 | .5 | MG | CAPSULE | QD | |||||
| 84049297 | 8404929 | 2 | SS | GILENYA | FINGOLIMOD HYDROCHLORIDE | 1 | Oral | 0.5 MG, QD | U | 22527 | .5 | MG | CAPSULE | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 84049297 | 8404929 | 1 | Relapsing-remitting multiple sclerosis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 84049297 | 8404929 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 84049297 | 8404929 | Abdominal pain upper | |
| 84049297 | 8404929 | Alopecia | |
| 84049297 | 8404929 | Anaemia vitamin B12 deficiency | |
| 84049297 | 8404929 | Dyspepsia | |
| 84049297 | 8404929 | Headache | |
| 84049297 | 8404929 | Hypoaesthesia | |
| 84049297 | 8404929 | Nausea | |
| 84049297 | 8404929 | Sinusitis | |
| 84049297 | 8404929 | Uterine leiomyoma | |
| 84049297 | 8404929 | Visual impairment |
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 |
|---|---|---|---|---|---|---|
| 84049297 | 8404929 | 1 | 20110727 | 20121214 | 0 | |
| 84049297 | 8404929 | 2 | 20130315 | 0 |