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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123974184 | 12397418 | 4 | F | 20160506 | 20160628 | 20160524 | 20160705 | EXP | JP-GLAXOSMITHKLINE-JP2016JPN070289 | GLAXOSMITHKLINE | 34.00 | YR | F | Y | 0.00000 | 20160705 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123974184 | 12397418 | 1 | PS | LAMICTAL | LAMOTRIGINE | 1 | Oral | 25 MG, QD | 275 | MG | Y | 20241 | 25 | MG | TABLET | QD | |||
| 123974184 | 12397418 | 2 | SS | LAMICTAL | LAMOTRIGINE | 1 | 275 | MG | Y | 20241 | TABLET | ||||||||
| 123974184 | 12397418 | 3 | SS | YOKUKANSAN | HERBALS | 1 | Oral | 7.5 G, 1D | Y | 0 | 7.5 | G | QD | ||||||
| 123974184 | 12397418 | 4 | SS | REMERON | MIRTAZAPINE | 1 | Oral | 15 MG, 1D | 45 | MG | Y | 0 | 15 | MG | QD | ||||
| 123974184 | 12397418 | 5 | C | RIVOTRIL | CLONAZEPAM | 1 | 1 MG, 1D | 0 | 1 | MG | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 123974184 | 12397418 | 1 | Bipolar II disorder |
| 123974184 | 12397418 | 2 | Affect lability |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 123974184 | 12397418 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 123974184 | 12397418 | Drug eruption | |
| 123974184 | 12397418 | Oral mucosa erosion | |
| 123974184 | 12397418 | Oral pain | |
| 123974184 | 12397418 | Rash generalised |
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 |
|---|---|---|---|---|---|---|
| 123974184 | 12397418 | 1 | 20160425 | 20160507 | 0 | |
| 123974184 | 12397418 | 3 | 201603 | 20160507 | 0 | |
| 123974184 | 12397418 | 4 | 20160503 | 20160507 | 0 | |
| 123974184 | 12397418 | 5 | 201603 | 20160503 | 0 |