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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 91880553 | 9188055 | 3 | F | 20120226 | 20160815 | 20130325 | 20160822 | EXP | JP-GLAXOSMITHKLINE-B0863036A | GLAXOSMITHKLINE | 59.87 | YR | M | Y | 0.00000 | 20160822 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 91880553 | 9188055 | 1 | SS | PAROXETINE HYDROCHLORIDE. | PAROXETINE HYDROCHLORIDE | 1 | Oral | 0 | 20 | MG | TABLET | QD | |||||||
| 91880553 | 9188055 | 2 | PS | LAMOTRIGINE. | LAMOTRIGINE | 1 | Oral | Y | U | 20241 | 25 | MG | TABLET | QD | |||||
| 91880553 | 9188055 | 3 | C | Rohypnol | FLUNITRAZEPAM | 1 | Oral | U | 0 | 2 | MG | TABLET | QD | ||||||
| 91880553 | 9188055 | 4 | C | RISPERDAL | RISPERIDONE | 1 | Intramuscular | U | 0 | 25 | MG | INJECTION | |||||||
| 91880553 | 9188055 | 5 | C | PREDONINE | PREDNISOLONEPREDNISOLONE ACETATEPREDNISOLONE SODIUM SUCCINATE | 1 | Oral | U | 0 | 45 | MG | TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 91880553 | 9188055 | 1 | Schizoaffective disorder depressive type |
| 91880553 | 9188055 | 2 | Schizoaffective disorder depressive type |
| 91880553 | 9188055 | 3 | Insomnia |
| 91880553 | 9188055 | 4 | Hallucination, auditory |
| 91880553 | 9188055 | 5 | Rash |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 91880553 | 9188055 | OT |
| 91880553 | 9188055 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 91880553 | 9188055 | Autism | |
| 91880553 | 9188055 | Blunted affect | |
| 91880553 | 9188055 | Dependent personality disorder | |
| 91880553 | 9188055 | Diabetes mellitus | |
| 91880553 | 9188055 | Diet noncompliance | |
| 91880553 | 9188055 | Disinhibition | |
| 91880553 | 9188055 | Erythema of eyelid | |
| 91880553 | 9188055 | Genital lesion | |
| 91880553 | 9188055 | Lip erosion | |
| 91880553 | 9188055 | Listless | |
| 91880553 | 9188055 | Ocular hyperaemia | |
| 91880553 | 9188055 | Oral mucosa erosion | |
| 91880553 | 9188055 | Pyrexia | |
| 91880553 | 9188055 | Pyromania | |
| 91880553 | 9188055 | Rash | |
| 91880553 | 9188055 | Rash maculo-papular | |
| 91880553 | 9188055 | Stevens-Johnson syndrome | |
| 91880553 | 9188055 | Suicide attempt | |
| 91880553 | 9188055 | Thinking abnormal |
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 |
|---|---|---|---|---|---|---|
| 91880553 | 9188055 | 1 | 201202 | 0 | ||
| 91880553 | 9188055 | 2 | 20130115 | 20130120 | 0 | |
| 91880553 | 9188055 | 3 | 201202 | 0 | ||
| 91880553 | 9188055 | 4 | 201202 | 0 | ||
| 91880553 | 9188055 | 5 | 201301 | 0 |