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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127950411 | 12795041 | 1 | I | 20160605 | 20160921 | 20160929 | 20160929 | EXP | IT-GLAXOSMITHKLINE-IT2016GSK138758 | GLAXOSMITHKLINE | 38.46 | YR | F | Y | 0.00000 | 20160929 | MD | IT | IT |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127950411 | 12795041 | 1 | PS | WELLBUTRIN | BUPROPION HYDROCHLORIDE | 1 | Oral | 30 UNK, SINGLE | U | 20358 | 30 | DF | PROLONGED-RELEASE TABLET | ||||||
| 127950411 | 12795041 | 2 | SS | FLUOXETINE | FLUOXETINE HYDROCHLORIDE | 1 | Oral | 20 UNK, SINGLE | U | 0 | 20 | DF | TABLET | ||||||
| 127950411 | 12795041 | 3 | SS | LORAZEPAM. | LORAZEPAM | 1 | Oral | 50 MG, SINGLE | U | 0 | 50 | MG | TABLET | ||||||
| 127950411 | 12795041 | 4 | C | TRITTICO | TRAZODONE HYDROCHLORIDE | 1 | 40 UNK, UNK | 0 | 40 | DF | ORAL DROPS |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127950411 | 12795041 | 1 | Bipolar disorder |
| 127950411 | 12795041 | 2 | Product used for unknown indication |
| 127950411 | 12795041 | 3 | Product used for unknown indication |
| 127950411 | 12795041 | 4 | Bulimia nervosa |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127950411 | 12795041 | OT |
| 127950411 | 12795041 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127950411 | 12795041 | Drug abuse | |
| 127950411 | 12795041 | Oppositional defiant disorder | |
| 127950411 | 12795041 | Somnolence | |
| 127950411 | 12795041 | Speech disorder | |
| 127950411 | 12795041 | Suicide attempt |
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 |
|---|---|---|---|---|---|---|
| 127950411 | 12795041 | 1 | 20160605 | 20160605 | 0 | |
| 127950411 | 12795041 | 2 | 20160605 | 20160605 | 0 | |
| 127950411 | 12795041 | 3 | 20160605 | 20160605 | 0 |