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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 90448863 | 9044886 | 3 | F | 20120823 | 20160815 | 20130130 | 20160818 | EXP | JP-GLAXOSMITHKLINE-B0827238A | GLAXOSMITHKLINE | 62.26 | YR | F | Y | 0.00000 | 20160818 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 90448863 | 9044886 | 1 | PS | LAMOTRIGINE. | LAMOTRIGINE | 1 | Oral | 25 MG, QD | Y | 20241 | 25 | MG | TABLET | QD | |||||
| 90448863 | 9044886 | 2 | SS | LAMOTRIGINE. | LAMOTRIGINE | 1 | Oral | 25 MG, BID | Y | 20241 | 25 | MG | TABLET | BID | |||||
| 90448863 | 9044886 | 3 | SS | LAMOTRIGINE. | LAMOTRIGINE | 1 | Oral | UNK | Y | 20241 | TABLET | ||||||||
| 90448863 | 9044886 | 4 | SS | INVEGA | PALIPERIDONE | 1 | Oral | 3 MG, QD | 108 | MG | Y | 0 | 3 | MG | TABLET | QD | |||
| 90448863 | 9044886 | 5 | SS | INVEGA | PALIPERIDONE | 1 | 108 | MG | Y | 0 | TABLET | ||||||||
| 90448863 | 9044886 | 6 | SS | EURODIN TABLET (JAPAN) | ESTAZOLAM | 1 | Oral | 4 MG, QD | 144 | MG | Y | 0 | 4 | MG | QD | ||||
| 90448863 | 9044886 | 7 | SS | SEROQUEL | QUETIAPINE FUMARATE | 1 | Oral | 125 MG, QD | 4500 | MG | 0 | 125 | MG | QD | |||||
| 90448863 | 9044886 | 8 | SS | SEROQUEL | QUETIAPINE FUMARATE | 1 | 4500 | MG | 0 | ||||||||||
| 90448863 | 9044886 | 9 | SS | MYSLEE | ZOLPIDEM TARTRATE | 1 | Oral | 10 MG, QD | 360 | MG | Y | 0 | 10 | MG | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 90448863 | 9044886 | 1 | Depression |
| 90448863 | 9044886 | 4 | Depression |
| 90448863 | 9044886 | 5 | Delusion |
| 90448863 | 9044886 | 6 | Insomnia |
| 90448863 | 9044886 | 7 | Depressed mood |
| 90448863 | 9044886 | 8 | Insomnia |
| 90448863 | 9044886 | 9 | Insomnia |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 90448863 | 9044886 | OT |
| 90448863 | 9044886 | HO |
| 90448863 | 9044886 | LT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 90448863 | 9044886 | Constipation | |
| 90448863 | 9044886 | Erythema | |
| 90448863 | 9044886 | Erythema of eyelid | |
| 90448863 | 9044886 | Eye discharge | |
| 90448863 | 9044886 | Lip erosion | |
| 90448863 | 9044886 | Lymphadenopathy | |
| 90448863 | 9044886 | Ocular hyperaemia | |
| 90448863 | 9044886 | Oral mucosa erosion | |
| 90448863 | 9044886 | Pigmentation disorder | |
| 90448863 | 9044886 | Pyrexia | |
| 90448863 | 9044886 | Rash generalised | |
| 90448863 | 9044886 | Rash maculo-papular | |
| 90448863 | 9044886 | Toxic epidermal necrolysis |
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 |
|---|---|---|---|---|---|---|
| 90448863 | 9044886 | 1 | 20120719 | 2012 | 0 | |
| 90448863 | 9044886 | 2 | 2012 | 20120823 | 0 | |
| 90448863 | 9044886 | 3 | 20120824 | 20120825 | 0 | |
| 90448863 | 9044886 | 4 | 20120719 | 20120828 | 0 | |
| 90448863 | 9044886 | 6 | 20120719 | 20120828 | 0 | |
| 90448863 | 9044886 | 7 | 20120719 | 20121116 | 0 | |
| 90448863 | 9044886 | 9 | 20120719 | 20120828 | 0 |