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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124012502 | 12401250 | 2 | F | 2016 | 20160630 | 20160525 | 20160706 | EXP | JP-GLAXOSMITHKLINE-JP2016JPN055122 | GLAXOSMITHKLINE | 46.12 | YR | F | Y | 0.00000 | 20160706 | CN | JP | JP |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124012502 | 12401250 | 1 | PS | LAMICTAL | LAMOTRIGINE | 1 | Oral | 50 MG, QD | Y | 20241 | 50 | MG | TABLET | QD | |||||
| 124012502 | 12401250 | 2 | SS | LAMICTAL | LAMOTRIGINE | 1 | Oral | 100 MG, 1D | Y | 20241 | 100 | MG | TABLET | QD | |||||
| 124012502 | 12401250 | 3 | SS | LAMICTAL | LAMOTRIGINE | 1 | Oral | 25 MG, BID | Y | 20241 | 25 | MG | TABLET | BID | |||||
| 124012502 | 12401250 | 4 | C | PHENOBAL | PHENOBARBITAL | 1 | UNK | 0 | |||||||||||
| 124012502 | 12401250 | 5 | C | PHENOBAL | PHENOBARBITAL | 1 | 100 MG, 1D | 0 | 100 | MG | QD | ||||||||
| 124012502 | 12401250 | 6 | C | CARBAMAZEPINE. | CARBAMAZEPINE | 1 | 300 UNK, UNK | 0 | |||||||||||
| 124012502 | 12401250 | 7 | C | CARBAMAZEPINE. | CARBAMAZEPINE | 1 | 300 MG, 1D | 0 | 300 | MG | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124012502 | 12401250 | 1 | Epilepsy |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 124012502 | 12401250 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124012502 | 12401250 | Haemorrhage subcutaneous | |
| 124012502 | 12401250 | Hyperkinesia | |
| 124012502 | 12401250 | Hypophagia | |
| 124012502 | 12401250 | Insomnia | |
| 124012502 | 12401250 | Mania | |
| 124012502 | 12401250 | Screaming |
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 |
|---|---|---|---|---|---|---|
| 124012502 | 12401250 | 1 | 20151201 | 0 | ||
| 124012502 | 12401250 | 2 | 20151218 | 0 | ||
| 124012502 | 12401250 | 3 | 20160404 | 20160410 | 0 | |
| 124012502 | 12401250 | 5 | 20140801 | 0 | ||
| 124012502 | 12401250 | 7 | 20140801 | 0 |