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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 112481433 | 11248143 | 3 | F | 20140813 | 20160725 | 20150708 | 20160729 | PER | PHHY2014US135149 | NOVARTIS | 52.01 | YR | M | Y | 0.00000 | 20160729 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 112481433 | 11248143 | 1 | PS | GILENYA | FINGOLIMOD HYDROCHLORIDE | 1 | Oral | UNK | 22527 | CAPSULE | |||||||||
| 112481433 | 11248143 | 2 | C | NICOTINE. | NICOTINE | 1 | UNK | U | 0 | PATCH |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 112481433 | 11248143 | 1 | Relapsing-remitting multiple sclerosis |
| 112481433 | 11248143 | 2 | Smoking cessation therapy |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 112481433 | 11248143 | Arthropod bite | |
| 112481433 | 11248143 | CD4 lymphocytes decreased | |
| 112481433 | 11248143 | Fall | |
| 112481433 | 11248143 | Fatigue | |
| 112481433 | 11248143 | Lymphocyte count decreased | |
| 112481433 | 11248143 | Metatarsalgia | |
| 112481433 | 11248143 | Palmoplantar keratoderma | |
| 112481433 | 11248143 | Rash | |
| 112481433 | 11248143 | Urinary tract infection |
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 |
|---|---|---|---|---|---|---|
| 112481433 | 11248143 | 2 | 20150915 | 0 |