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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126499731 | 12649973 | 1 | I | 20160801 | 20160813 | 20160813 | EXP | IT-AUROBINDO-AUR-APL-2016-10186 | AUROBINDO | 0.00 | Y | 0.00000 | 20160812 | OT | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126499731 | 12649973 | 1 | PS | LEVETIRACETAM. | LEVETIRACETAM | 1 | Unknown | U | U | 78993 | |||||||||
| 126499731 | 12649973 | 2 | SS | LEVETIRACETAM. | LEVETIRACETAM | 1 | U | U | 78993 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126499731 | 12649973 | 1 | Epilepsy |
| 126499731 | 12649973 | 2 | Cortical dysplasia |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126499731 | 12649973 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126499731 | 12649973 | Condition aggravated | |
| 126499731 | 12649973 | Incorrect dose administered | |
| 126499731 | 12649973 | Seizure |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |