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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123657093 | 12365709 | 3 | F | 20151120 | 20160810 | 20160513 | 20160815 | EXP | JP-GLAXOSMITHKLINE-JP2016JPN065616 | GLAXOSMITHKLINE | 54.00 | YR | F | Y | 45.00000 | KG | 20160815 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123657093 | 12365709 | 1 | PS | LAMICTAL | LAMOTRIGINE | 1 | Oral | 25 MG, QD | 175 | MG | Y | 20241 | 25 | MG | TABLET | QD | |||
| 123657093 | 12365709 | 2 | SS | LAMICTAL | LAMOTRIGINE | 1 | Oral | 50 MG, QD | 175 | MG | Y | 20241 | 50 | MG | TABLET | QD | |||
| 123657093 | 12365709 | 3 | SS | BENZALIN (NITRAZEPAM) | NITRAZEPAM | 1 | Oral | 2.5 MG, QD | U | 0 | 2.5 | MG | QD | ||||||
| 123657093 | 12365709 | 4 | SS | DEPAS | ETIZOLAM | 1 | Oral | 0.5 MG, QD | U | 0 | .5 | MG | QD | ||||||
| 123657093 | 12365709 | 5 | SS | LITHIUM CARBONATE. | LITHIUM CARBONATE | 1 | Oral | 200 MG, QD | U | 0 | 200 | MG | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 123657093 | 12365709 | 1 | Bipolar disorder |
| 123657093 | 12365709 | 3 | Insomnia |
| 123657093 | 12365709 | 4 | Insomnia |
| 123657093 | 12365709 | 5 | Affective disorder |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 123657093 | 12365709 | OT |
| 123657093 | 12365709 | LT |
| 123657093 | 12365709 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 123657093 | 12365709 | Erythema of eyelid | |
| 123657093 | 12365709 | Generalised erythema | |
| 123657093 | 12365709 | Lip erosion | |
| 123657093 | 12365709 | Ocular hyperaemia | |
| 123657093 | 12365709 | Perivascular dermatitis | |
| 123657093 | 12365709 | Purpura | |
| 123657093 | 12365709 | Pyrexia | |
| 123657093 | 12365709 | Rash | |
| 123657093 | 12365709 | Stevens-Johnson syndrome |
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 |
|---|---|---|---|---|---|---|
| 123657093 | 12365709 | 1 | 20151113 | 20151126 | 0 | |
| 123657093 | 12365709 | 2 | 20151126 | 20151126 | 0 |