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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 113499275 | 11349927 | 5 | F | 20130626 | 20160627 | 20150807 | 20160702 | PER | PHHY2014US111824 | NOVARTIS | 39.97 | YR | M | Y | 0.00000 | 20160702 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 113499275 | 11349927 | 1 | PS | GILENYA | FINGOLIMOD HYDROCHLORIDE | 1 | Oral | 22527 | CAPSULE | ||||||||||
| 113499275 | 11349927 | 2 | C | TYLENOL | ACETAMINOPHEN | 1 | Unknown | UNK | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 113499275 | 11349927 | 1 | Multiple sclerosis |
| 113499275 | 11349927 | 2 | Headache |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 113499275 | 11349927 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 113499275 | 11349927 | Blood urea increased | |
| 113499275 | 11349927 | Bronchitis | |
| 113499275 | 11349927 | Gastric ulcer haemorrhage | |
| 113499275 | 11349927 | Haemoglobin decreased | |
| 113499275 | 11349927 | Hepatic enzyme increased | |
| 113499275 | 11349927 | Lymphocyte count decreased | |
| 113499275 | 11349927 | Neuropathy peripheral | |
| 113499275 | 11349927 | Paraesthesia | |
| 113499275 | 11349927 | White blood cell count decreased |
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 |
|---|---|---|---|---|---|---|
| 113499275 | 11349927 | 2 | 20141007 | 0 |