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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126692471 | 12669247 | 1 | I | 20160722 | 20160816 | 20160820 | 20160820 | EXP | FR-ASTRAZENECA-2016SE88898 | ASTRAZENECA | 2308.00 | WK | F | Y | 0.00000 | 20160820 | MD | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126692471 | 12669247 | 1 | PS | XEROQUEL | QUETIAPINE FUMARATE | 1 | Oral | 11.0DF ONCE/SINGLE ADMINISTRATION | 11 | DF | Y | 22047 | 11 | DF | PROLONGED-RELEASE TABLET | ||||
| 126692471 | 12669247 | 2 | SS | VENLAFAXINE | VENLAFAXINE HYDROCHLORIDE | 1 | Oral | 60.0DF ONCE/SINGLE ADMINISTRATION | 60 | DF | Y | 0 | 60 | DF | PROLONGED-RELEASE TABLET | ||||
| 126692471 | 12669247 | 3 | SS | LEVOCETIRIZINE | LEVOCETIRIZINE | 1 | Oral | Y | 0 | ||||||||||
| 126692471 | 12669247 | 4 | SS | LAMICTAL | LAMOTRIGINE | 1 | Oral | 84.0DF ONCE/SINGLE ADMINISTRATION | 84 | DF | Y | 0 | 84 | DF | TABLET | ||||
| 126692471 | 12669247 | 5 | SS | ATARAX | HYDROXYZINEHYDROXYZINE HYDROCHLORIDE | 1 | Oral | 30.0DF ONCE/SINGLE ADMINISTRATION | 30 | DF | Y | 0 | 30 | DF | TABLET | ||||
| 126692471 | 12669247 | 6 | SS | LAROXYL | AMITRIPTYLINE | 1 | Oral | 60.0DF ONCE/SINGLE ADMINISTRATION | 60 | DF | Y | 0 | 60 | DF | TABLET | ||||
| 126692471 | 12669247 | 7 | SS | IMOVANE | ZOPICLONE | 1 | Oral | 28.0DF ONCE/SINGLE ADMINISTRATION | 28 | DF | Y | 0 | 28 | DF | TABLET | ||||
| 126692471 | 12669247 | 8 | SS | PREDNISOLONE. | PREDNISOLONE | 1 | Oral | 14.0DF ONCE/SINGLE ADMINISTRATION | 14 | DF | Y | 0 | 14 | DF | TABLET | ||||
| 126692471 | 12669247 | 9 | SS | DOSULEPIN HYDROCHLORIDE | DOTHIEPIN HYDROCHLORIDE | 1 | Oral | Y | 0 |
Indications of drugs used
| no results found |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126692471 | 12669247 | HO |
| 126692471 | 12669247 | OT |
| 126692471 | 12669247 | LT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126692471 | 12669247 | Bradypnoea | |
| 126692471 | 12669247 | Bundle branch block | |
| 126692471 | 12669247 | Coma | |
| 126692471 | 12669247 | Electrocardiogram QRS complex prolonged | |
| 126692471 | 12669247 | Electrocardiogram QT prolonged | |
| 126692471 | 12669247 | Hypokalaemia | |
| 126692471 | 12669247 | Hypotension | |
| 126692471 | 12669247 | Hypothermia | |
| 126692471 | 12669247 | Hypotonia | |
| 126692471 | 12669247 | Intentional overdose | |
| 126692471 | 12669247 | Lactic acidosis | |
| 126692471 | 12669247 | Mydriasis | |
| 126692471 | 12669247 | Pneumonia aspiration | |
| 126692471 | 12669247 | Staphylococcal infection | |
| 126692471 | 12669247 | 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 |
|---|---|---|---|---|---|---|
| 126692471 | 12669247 | 1 | 20160722 | 20160722 | 0 | |
| 126692471 | 12669247 | 2 | 20160722 | 20160722 | 0 | |
| 126692471 | 12669247 | 4 | 20160722 | 20160722 | 0 | |
| 126692471 | 12669247 | 5 | 20160722 | 20160722 | 0 | |
| 126692471 | 12669247 | 6 | 20160722 | 20160722 | 0 | |
| 126692471 | 12669247 | 7 | 20160722 | 20160722 | 0 | |
| 126692471 | 12669247 | 8 | 20160722 | 20160722 | 0 |