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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 121790303 | 12179030 | 3 | F | 20130731 | 20160629 | 20160315 | 20160705 | EXP | PHHY2016IT033412 | NOVARTIS | 41.61 | YR | F | Y | 0.00000 | 20160705 | OT | IT | IT |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 121790303 | 12179030 | 1 | PS | GILENYA | FINGOLIMOD HYDROCHLORIDE | 1 | Oral | 1 DF, QD | 134 | DF | Y | 22527 | 1 | DF | CAPSULE | QD | |||
| 121790303 | 12179030 | 2 | SS | GILENYA | FINGOLIMOD HYDROCHLORIDE | 1 | Oral | 1 DF, QOD | 134 | DF | Y | 22527 | 1 | DF | CAPSULE | ||||
| 121790303 | 12179030 | 3 | SS | GILENYA | FINGOLIMOD HYDROCHLORIDE | 1 | Oral | 1 DF, QD | 134 | DF | Y | 22527 | 1 | DF | CAPSULE | QD | |||
| 121790303 | 12179030 | 4 | C | TOLEP | OXCARBAZEPINE | 1 | Oral | 600 MG, UNK | U | 0 | 600 | MG | |||||||
| 121790303 | 12179030 | 5 | C | LAROXYL | AMITRIPTYLINE | 1 | INTRA-AURAL | 5 DRP, QD | U | 0 | 5 | GTT | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 121790303 | 12179030 | 1 | Multiple sclerosis |
| 121790303 | 12179030 | 4 | Product used for unknown indication |
| 121790303 | 12179030 | 5 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 121790303 | 12179030 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 121790303 | 12179030 | Alopecia | Alopecia |
| 121790303 | 12179030 | Anorectal discomfort | Anorectal discomfort |
| 121790303 | 12179030 | Arthralgia | Arthralgia |
| 121790303 | 12179030 | Conjunctival irritation | Conjunctival irritation |
| 121790303 | 12179030 | Dry mouth | Dry mouth |
| 121790303 | 12179030 | Oral discomfort | Oral discomfort |
| 121790303 | 12179030 | Prescribed underdose | |
| 121790303 | 12179030 | Sjogren^s syndrome | Sjogren's syndrome |
| 121790303 | 12179030 | Vulvovaginal burning sensation | Vulvovaginal burning sensation |
| 121790303 | 12179030 | Vulvovaginal dryness | Vulvovaginal dryness |
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 |
|---|---|---|---|---|---|---|
| 121790303 | 12179030 | 1 | 20130320 | 20140930 | 0 | |
| 121790303 | 12179030 | 2 | 20140930 | 201503 | 0 | |
| 121790303 | 12179030 | 3 | 201503 | 0 |