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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125411609 | 12541160 | 9 | F | 20160624 | 20160922 | 20160708 | 20160929 | PER | BE-EISAI MEDICAL RESEARCH-EC-2016-018320 | EISAI | 53.00 | YR | F | Y | 60.00000 | KG | 20160929 | MD | BE | BE |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125411609 | 12541160 | 1 | PS | FYCOMPA | PERAMPANEL | 1 | Oral | 202834 | 2 | MG | TABLET | QD | |||||||
| 125411609 | 12541160 | 2 | SS | TEGRETOL | CARBAMAZEPINE | 1 | Oral | 0 | 400 | MG | TABLET | QD | |||||||
| 125411609 | 12541160 | 3 | SS | TEGRETOL | CARBAMAZEPINE | 1 | Oral | 0 | 600 | MG | TABLET | QD | |||||||
| 125411609 | 12541160 | 4 | SS | DIPHANTOINE | PHENYTOIN | 1 | Oral | 0 | 100 | MG | TABLET | TID | |||||||
| 125411609 | 12541160 | 5 | SS | DIPHANTOINE | PHENYTOIN | 1 | Oral | 0 | 100 | MG | TABLET | BID | |||||||
| 125411609 | 12541160 | 6 | SS | DIPHANTOINE | PHENYTOIN | 1 | Oral | 0 | 150 | MG | TABLET | BID | |||||||
| 125411609 | 12541160 | 7 | SS | DIPHANTOINE | PHENYTOIN | 1 | Oral | 8H: 100 MG ?21H: 150 MG | 0 | 250 | MG | TABLET | BID | ||||||
| 125411609 | 12541160 | 8 | C | DEPAKINE CHRONO | VALPROATE SODIUM | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125411609 | 12541160 | 1 | Epilepsy |
| 125411609 | 12541160 | 2 | Epilepsy |
| 125411609 | 12541160 | 4 | Epilepsy |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125411609 | 12541160 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125411609 | 12541160 | Hyponatraemia | |
| 125411609 | 12541160 | Toxicity to various agents |
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 |
|---|---|---|---|---|---|---|
| 125411609 | 12541160 | 1 | 20160603 | 0 | ||
| 125411609 | 12541160 | 2 | 201507 | 201510 | 0 | |
| 125411609 | 12541160 | 3 | 201510 | 0 | ||
| 125411609 | 12541160 | 4 | 201401 | 201404 | 0 | |
| 125411609 | 12541160 | 5 | 201404 | 201507 | 0 | |
| 125411609 | 12541160 | 6 | 201507 | 20160804 | 0 | |
| 125411609 | 12541160 | 7 | 20160808 | 0 |