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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126848321 | 12684832 | 1 | I | 20160722 | 20160817 | 20160825 | 20160825 | EXP | FR-AFSSAPS-PA20160738 | FR-GLAXOSMITHKLINE-FR2016GSK119781 | GLAXOSMITHKLINE | 44.25 | YR | F | Y | 0.00000 | 20160825 | OT | FR | FR |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126848321 | 12684832 | 1 | PS | LAMICTAL | LAMOTRIGINE | 1 | Oral | 2100 MG, SINGLE | 20241 | 2100 | MG | ||||||||
| 126848321 | 12684832 | 2 | SS | ATARAX | HYDROXYZINEHYDROXYZINE HYDROCHLORIDE | 1 | Oral | 750 MG, SINGLE | 0 | 750 | MG | TABLET | |||||||
| 126848321 | 12684832 | 3 | SS | Laroxyl | AMITRIPTYLINE | 1 | Oral | 1500 MG, SINGLE | 0 | 1500 | MG | ||||||||
| 126848321 | 12684832 | 4 | SS | IMOVANE | ZOPICLONE | 1 | Oral | 210 MG, SINGLE | 0 | 210 | MG | FILM-COATED TABLET | |||||||
| 126848321 | 12684832 | 5 | SS | PREDNISOLONE. | PREDNISOLONE | 1 | Oral | 280 MG, SINGLE | 0 | 280 | MG | ||||||||
| 126848321 | 12684832 | 6 | SS | Levocetirizine | LEVOCETIRIZINE | 1 | Oral | Y | 0 | ||||||||||
| 126848321 | 12684832 | 7 | SS | DOSULEPIN HYDROCHLORIDE | DOTHIEPIN HYDROCHLORIDE | 1 | Oral | UNK | Y | 0 | |||||||||
| 126848321 | 12684832 | 8 | SS | XEROQUEL | QUETIAPINE FUMARATE | 1 | Oral | 3300 MG, SINGLE | 0 | 3300 | MG | PROLONGED-RELEASE TABLET | |||||||
| 126848321 | 12684832 | 9 | SS | VENLAFAXINE | VENLAFAXINE HYDROCHLORIDE | 1 | Oral | 4500 MG, SINGLE | 0 | 4500 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126848321 | 12684832 | 1 | Product used for unknown indication |
| 126848321 | 12684832 | 2 | Product used for unknown indication |
| 126848321 | 12684832 | 3 | Product used for unknown indication |
| 126848321 | 12684832 | 4 | Product used for unknown indication |
| 126848321 | 12684832 | 5 | Product used for unknown indication |
| 126848321 | 12684832 | 6 | Product used for unknown indication |
| 126848321 | 12684832 | 7 | Product used for unknown indication |
| 126848321 | 12684832 | 8 | Product used for unknown indication |
| 126848321 | 12684832 | 9 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126848321 | 12684832 | OT |
| 126848321 | 12684832 | HO |
| 126848321 | 12684832 | LT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126848321 | 12684832 | Bradypnoea | |
| 126848321 | 12684832 | Bundle branch block | |
| 126848321 | 12684832 | Coma | |
| 126848321 | 12684832 | Electrocardiogram QRS complex prolonged | |
| 126848321 | 12684832 | Electrocardiogram QT prolonged | |
| 126848321 | 12684832 | Hypotension | |
| 126848321 | 12684832 | Hypothermia | |
| 126848321 | 12684832 | Hypotonia | |
| 126848321 | 12684832 | Intentional overdose | |
| 126848321 | 12684832 | Mydriasis | |
| 126848321 | 12684832 | 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 |
|---|---|---|---|---|---|---|
| 126848321 | 12684832 | 1 | 20160722 | 20160722 | 0 | |
| 126848321 | 12684832 | 2 | 20160722 | 20160722 | 0 | |
| 126848321 | 12684832 | 3 | 20160722 | 20160722 | 0 | |
| 126848321 | 12684832 | 4 | 20160722 | 20160722 | 0 | |
| 126848321 | 12684832 | 5 | 20160722 | 20160722 | 0 | |
| 126848321 | 12684832 | 7 | 20160722 | 20160722 | 0 | |
| 126848321 | 12684832 | 8 | 20160722 | 20160722 | 0 | |
| 126848321 | 12684832 | 9 | 20160722 | 20160722 | 0 |