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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
88763923 | 8876392 | 3 | F | 2011 | 20120913 | 20120426 | 20130107 | PER | PHEH2012US004599 | NOVARTIS | 42.00 | YR | F | N | 0.00000 | 20121205 | CN | 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
88763923 | 8876392 | 1 | PS | GILENYA | 1 | ORAL | 22527 | 0.5 | MG | QD |
Indications of drugs used
Event ID | CASEID | INDI DRUG SEQ | INDI PT |
---|---|---|---|
88763923 | 8876392 | 1 | Multiple sclerosis |
Outcome of event
Event ID | CASEID | OUTC COD |
---|---|---|
88763923 | 8876392 | OT |
Reactions reported
Event ID | CASEID | DRUG REC ACT | PT |
---|---|---|---|
88763923 | 8876392 | Exaggerated startle response | |
88763923 | 8876392 | Malaise |
Reporting Sources (this data is often not reported and may therefore be missing here)
Event ID | CASEID | RPSR COD |
---|---|---|
88763923 | 8876392 | CSM |
Therapies reported
Event ID | CASEID | DSG DRUG SEQ | START DT | END DT | DUR | DUR COD |
---|---|---|---|---|---|---|
88763923 | 8876392 | 1 | 201112 | 0 |