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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 86602672 | 8660267 | 2 | F | 201103 | 20160823 | 20120711 | 20160830 | EXP | JP-GLAXOSMITHKLINE-B0801467A | GLAXOSMITHKLINE | 75.22 | YR | M | Y | 0.00000 | 20160830 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 86602672 | 8660267 | 1 | SS | PAROXETINE HYDROCHLORIDE. | PAROXETINE HYDROCHLORIDE | 1 | Oral | 0 | TABLET | ||||||||||
| 86602672 | 8660267 | 2 | PS | LAMOTRIGINE. | LAMOTRIGINE | 1 | Oral | Y | U | 20241 | 50 | MG | TABLET | TID | |||||
| 86602672 | 8660267 | 3 | C | DEPAKENE | VALPROIC ACID | 1 | Oral | U | 0 | 800 | MG | TABLET | BID | ||||||
| 86602672 | 8660267 | 4 | C | DEPAKENE | VALPROIC ACID | 1 | Oral | U | 0 | 600 | MG | TABLET | BID | ||||||
| 86602672 | 8660267 | 5 | C | DEPAKENE | VALPROIC ACID | 1 | Oral | U | 0 | TABLET | |||||||||
| 86602672 | 8660267 | 6 | C | Benzalin | NITRAZEPAM | 1 | Oral | 0 | 5 | MG | TABLET | QD | |||||||
| 86602672 | 8660267 | 7 | C | SEROQUEL | QUETIAPINE FUMARATE | 1 | Oral | U | 0 | 25 | MG | ORAL DRUG UNSPECIFIED FORM | |||||||
| 86602672 | 8660267 | 8 | C | Meilax | ETHYL LOFLAZEPATE | 1 | Oral | U | 0 | ORAL DRUG UNSPECIFIED FORM | |||||||||
| 86602672 | 8660267 | 9 | C | Benzalin | NITRAZEPAM | 1 | Oral | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 86602672 | 8660267 | 1 | Prophylaxis |
| 86602672 | 8660267 | 2 | Depression |
| 86602672 | 8660267 | 3 | Mood swings |
| 86602672 | 8660267 | 4 | Mood swings |
| 86602672 | 8660267 | 5 | Mood swings |
| 86602672 | 8660267 | 6 | Insomnia |
| 86602672 | 8660267 | 7 | Bipolar disorder |
| 86602672 | 8660267 | 8 | Bipolar disorder |
| 86602672 | 8660267 | 9 | Bipolar disorder |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 86602672 | 8660267 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 86602672 | 8660267 | Abdominal discomfort | |
| 86602672 | 8660267 | Anosognosia | |
| 86602672 | 8660267 | Anxiety | |
| 86602672 | 8660267 | Delusion | |
| 86602672 | 8660267 | Depressed mood | |
| 86602672 | 8660267 | Depression | |
| 86602672 | 8660267 | Dizziness | |
| 86602672 | 8660267 | Feeling abnormal | |
| 86602672 | 8660267 | Impulsive behaviour | |
| 86602672 | 8660267 | Incoherent | |
| 86602672 | 8660267 | Irritability | |
| 86602672 | 8660267 | Mania | |
| 86602672 | 8660267 | Mental impairment | |
| 86602672 | 8660267 | Pain | |
| 86602672 | 8660267 | Rash | |
| 86602672 | 8660267 | Sedation | |
| 86602672 | 8660267 | Stomatitis | |
| 86602672 | 8660267 | Tremor |
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 |
|---|---|---|---|---|---|---|
| 86602672 | 8660267 | 1 | 2009 | 20110105 | 0 | |
| 86602672 | 8660267 | 2 | 20110809 | 20120417 | 0 | |
| 86602672 | 8660267 | 3 | 20110510 | 20110720 | 0 | |
| 86602672 | 8660267 | 4 | 20110721 | 20120116 | 0 | |
| 86602672 | 8660267 | 6 | 201104 | 0 | ||
| 86602672 | 8660267 | 7 | 20110415 | 20110721 | 0 |