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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126169071 | 12616907 | 1 | I | 20150701 | 20160129 | 20160802 | 20160802 | PER | IT-LUPIN PHARMACEUTICALS INC.-2016-00628 | LUPIN | 50.54 | YR | M | Y | 0.00000 | 20160729 | MD | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126169071 | 12616907 | 1 | PS | LEVETIRACETAM. | LEVETIRACETAM | 1 | Oral | 500 MG | UNKNOWN | 78154 | |||||||||
| 126169071 | 12616907 | 2 | SS | Tolep | OXCARBAZEPINE | 1 | Oral | UNKNOWN | 0 | 600 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126169071 | 12616907 | 1 | Epilepsy |
| 126169071 | 12616907 | 2 | Epilepsy |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126169071 | 12616907 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126169071 | 12616907 | Epilepsy | |
| 126169071 | 12616907 | Seizure | |
| 126169071 | 12616907 | Therapy non-responder |
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 |
|---|---|---|---|---|---|---|
| 126169071 | 12616907 | 1 | 20150401 | 20150701 | 0 | |
| 126169071 | 12616907 | 2 | 20150401 | 20150701 | 0 |