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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
100220262 | 10022026 | 2 | F | 201310 | 20131219 | 20131206 | 20131231 | EXP | AUR-APL-2013-09916 | AUROBINDO | 33.00 | YR | F | N | 190.00000 | KG | 20131227 | N | 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
100220262 | 10022026 | 1 | PS | LEVETIRACETAM | 1 | 2 IN MORNING AND 3 IN NIGHT | Y | 78993 | |||||||||||
100220262 | 10022026 | 3 | C | KEPPRA (LEVETIRACETAM) | 1 | 0 |
Indications of drugs used
Event ID | CASEID | INDI DRUG SEQ | INDI PT |
---|---|---|---|
100220262 | 10022026 | 1 | Epilepsy |
Outcome of event
Event ID | CASEID | OUTC COD |
---|---|---|
100220262 | 10022026 | OT |
Reactions reported
Event ID | CASEID | DRUG REC ACT | PT |
---|---|---|---|
100220262 | 10022026 | Convulsion | |
100220262 | 10022026 | Loss of consciousness | |
100220262 | 10022026 | Petit mal epilepsy | |
100220262 | 10022026 | Product substitution issue |
Reporting Sources (this data is often not reported and may therefore be missing here)
Event ID | CASEID | RPSR COD |
---|---|---|
100220262 | 10022026 | CSM |
Therapies reported
Event ID | CASEID | DSG DRUG SEQ | START DT | END DT | DUR | DUR COD |
---|---|---|---|---|---|---|
100220262 | 10022026 | 1 | 20131020 | 0 |