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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127562261 | 12756226 | 1 | I | 20160623 | 20160630 | 20160916 | 20160916 | EXP | JP-GLAXOSMITHKLINE-JP2016JPN094101 | GLAXOSMITHKLINE | 42.66 | YR | F | Y | 0.00000 | 20160916 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127562261 | 12756226 | 1 | PS | LAMICTAL | LAMOTRIGINE | 1 | 25 MG, QD | 28025 | MG | Y | N | 20241 | 25 | MG | TABLET | QD | |||
| 127562261 | 12756226 | 2 | SS | LAMICTAL | LAMOTRIGINE | 1 | Oral | 50 MG, QD | 28025 | MG | Y | N | 20241 | 50 | MG | TABLET | QD | ||
| 127562261 | 12756226 | 3 | SS | LAMICTAL | LAMOTRIGINE | 1 | Oral | 50 MG, BID | 28025 | MG | Y | N | 20241 | 50 | MG | TABLET | BID | ||
| 127562261 | 12756226 | 4 | SS | LAMICTAL | LAMOTRIGINE | 1 | Oral | 125 MG, 1D | 28025 | MG | Y | N | 20241 | 125 | MG | TABLET | QD | ||
| 127562261 | 12756226 | 5 | SS | LAMICTAL | LAMOTRIGINE | 1 | Oral | 150 MG, 1D | 28025 | MG | Y | N | 20241 | 150 | MG | TABLET | QD | ||
| 127562261 | 12756226 | 6 | SS | LAMICTAL | LAMOTRIGINE | 1 | Oral | 175 MG, 1D | 28025 | MG | Y | N | 20241 | 175 | MG | TABLET | QD | ||
| 127562261 | 12756226 | 7 | SS | LAMICTAL | LAMOTRIGINE | 1 | Oral | 100 MG, BID | 28025 | MG | Y | N | 20241 | 100 | MG | TABLET | BID | ||
| 127562261 | 12756226 | 8 | SS | LAMICTAL | LAMOTRIGINE | 1 | 225 MG, 1D | 28025 | MG | Y | N | 20241 | 225 | MG | TABLET | QD | |||
| 127562261 | 12756226 | 9 | SS | LAMICTAL | LAMOTRIGINE | 1 | Oral | UNK | 28025 | MG | Y | N | 20241 | TABLET | |||||
| 127562261 | 12756226 | 10 | C | CYMBALTA | DULOXETINE HYDROCHLORIDE | 1 | 20 MG, QD | 0 | 20 | MG | QD | ||||||||
| 127562261 | 12756226 | 11 | C | QUETIAPINE. | QUETIAPINE | 1 | 25 MG, QD | 0 | 25 | MG | QD | ||||||||
| 127562261 | 12756226 | 12 | C | REFLEX | MIRTAZAPINE | 1 | 30 MG, QD | 0 | 30 | MG | QD | ||||||||
| 127562261 | 12756226 | 13 | C | ZOPICLONE | ZOPICLONE | 1 | 7.5 MG, QD | 0 | 7.5 | MG | QD | ||||||||
| 127562261 | 12756226 | 14 | C | DIAZEPAM. | DIAZEPAM | 1 | 5 MG, PRN | 0 | 15 | MG | |||||||||
| 127562261 | 12756226 | 15 | C | LOXONIN | LOXOPROFEN SODIUM | 1 | 2 DF, BID | 0 | 2 | DF | BID | ||||||||
| 127562261 | 12756226 | 16 | C | MIDODRINE TABLET | 2 | 2 MG, BID | 0 | 2 | MG | BID |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127562261 | 12756226 | 1 | Bipolar disorder |
| 127562261 | 12756226 | 14 | Anxiety |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127562261 | 12756226 | HO |
| 127562261 | 12756226 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127562261 | 12756226 | Altered state of consciousness | |
| 127562261 | 12756226 | Aura | |
| 127562261 | 12756226 | Disorientation | |
| 127562261 | 12756226 | Headache | |
| 127562261 | 12756226 | Hypokalaemia | |
| 127562261 | 12756226 | Irritability | |
| 127562261 | 12756226 | Muscle rigidity | |
| 127562261 | 12756226 | Overdose | |
| 127562261 | 12756226 | Somnolence | |
| 127562261 | 12756226 | Staring | |
| 127562261 | 12756226 | Status epilepticus | |
| 127562261 | 12756226 | Treatment noncompliance | |
| 127562261 | 12756226 | White blood cell count decreased |
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 |
|---|---|---|---|---|---|---|
| 127562261 | 12756226 | 1 | 20151102 | 20151116 | 0 | |
| 127562261 | 12756226 | 2 | 20151117 | 20151129 | 0 | |
| 127562261 | 12756226 | 3 | 20151130 | 20160111 | 0 | |
| 127562261 | 12756226 | 4 | 20160112 | 20160403 | 0 | |
| 127562261 | 12756226 | 5 | 20160404 | 20160424 | 0 | |
| 127562261 | 12756226 | 6 | 20160425 | 20160619 | 0 | |
| 127562261 | 12756226 | 7 | 20160620 | 0 | ||
| 127562261 | 12756226 | 9 | 20160623 | 20160623 | 0 |