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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 120130184 | 12013018 | 4 | F | 201601 | 20160705 | 20160205 | 20160713 | EXP | FR-ASTRAZENECA-2016SE12367 | ASTRAZENECA | 343.00 | MON | F | Y | 85.50000 | KG | 20160714 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 120130184 | 12013018 | 1 | PS | XEROQUEL | QUETIAPINE FUMARATE | 1 | Oral | 40.0DF ONCE/SINGLE ADMINISTRATION | 40 | DF | 22047 | 40 | DF | PROLONGED-RELEASE TABLET | |||||
| 120130184 | 12013018 | 2 | SS | OMEPRAZOLE. | OMEPRAZOLE | 1 | Oral | 100.0MG ONCE/SINGLE ADMINISTRATION | 100 | MG | 0 | 100 | MG | ||||||
| 120130184 | 12013018 | 3 | SS | ASPIRINE | ASPIRIN | 1 | Oral | 14.0G ONCE/SINGLE ADMINISTRATION | 14 | G | 0 | 14 | G | ||||||
| 120130184 | 12013018 | 4 | SS | VENLAFAXINE | VENLAFAXINE HYDROCHLORIDE | 1 | Oral | 88.0DF ONCE/SINGLE ADMINISTRATION | 88 | DF | 0 | 88 | DF | ||||||
| 120130184 | 12013018 | 5 | SS | THERALENE | TRIMEPRAZINE | 1 | Oral | 43.0DF ONCE/SINGLE ADMINISTRATION | 43 | DF | 0 | 43 | DF | ||||||
| 120130184 | 12013018 | 6 | SS | ALPRAZOLAM. | ALPRAZOLAM | 1 | Oral | 70.0DF ONCE/SINGLE ADMINISTRATION | 70 | DF | 0 | 70 | DF | ||||||
| 120130184 | 12013018 | 7 | SS | BACLOFENE | BACLOFEN | 1 | Oral | 96.0DF ONCE/SINGLE ADMINISTRATION | 96 | DF | 0 | 96 | DF | ||||||
| 120130184 | 12013018 | 8 | SS | ZYRTEC | CETIRIZINE HYDROCHLORIDE | 1 | Oral | 15.0DF ONCE/SINGLE ADMINISTRATION | 15 | DF | 0 | 15 | DF | ||||||
| 120130184 | 12013018 | 9 | SS | VERATRAN | CLOTIAZEPAM | 1 | Oral | 18.0DF ONCE/SINGLE ADMINISTRATION | 18 | DF | 0 | 18 | DF | ||||||
| 120130184 | 12013018 | 10 | SS | ATARAX | HYDROXYZINEHYDROXYZINE HYDROCHLORIDE | 1 | Oral | 32.0DF ONCE/SINGLE ADMINISTRATION | 32 | DF | 0 | 32 | DF | ||||||
| 120130184 | 12013018 | 11 | C | KETUM | KETOPROFEN | 1 | Oral | 17.0DF ONCE/SINGLE ADMINISTRATION | 0 | 17 | DF | ||||||||
| 120130184 | 12013018 | 12 | C | DAFLON | DIOSMINHESPERIDIN | 1 | Oral | 80.0DF ONCE/SINGLE ADMINISTRATION | 0 | 80 | DF | ||||||||
| 120130184 | 12013018 | 13 | C | NALTREXONE | NALTREXONE | 1 | Oral | 40.0DF ONCE/SINGLE ADMINISTRATION | 0 | 40 | DF | ||||||||
| 120130184 | 12013018 | 14 | C | DOLIPRANE | ACETAMINOPHEN | 1 | Oral | 8.0DF ONCE/SINGLE ADMINISTRATION | 0 | 8 | DF | ||||||||
| 120130184 | 12013018 | 15 | C | PYOSTACINE | PRISTINAMYCIN | 1 | Oral | 16.0DF ONCE/SINGLE ADMINISTRATION | 0 | 16 | DF | ||||||||
| 120130184 | 12013018 | 16 | C | SPASFON | PHLOROGLUCINOL | 1 | Oral | 20.0DF ONCE/SINGLE ADMINISTRATION | 0 | 20 | DF | ||||||||
| 120130184 | 12013018 | 17 | C | SULFARLEM | ANETHOLTRITHION | 1 | Oral | 150.0DF ONCE/SINGLE ADMINISTRATION | 0 | 150 | DF |
Indications of drugs used
| no results found |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 120130184 | 12013018 | LT |
| 120130184 | 12013018 | OT |
| 120130184 | 12013018 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 120130184 | 12013018 | Alcohol withdrawal syndrome | |
| 120130184 | 12013018 | Coma | |
| 120130184 | 12013018 | Drug withdrawal convulsions | |
| 120130184 | 12013018 | Electrocardiogram QT prolonged | |
| 120130184 | 12013018 | Electrocardiogram repolarisation abnormality | |
| 120130184 | 12013018 | Haemodynamic instability | |
| 120130184 | 12013018 | Hepatocellular injury | |
| 120130184 | 12013018 | Hypothermia | |
| 120130184 | 12013018 | Intentional overdose | |
| 120130184 | 12013018 | Poisoning deliberate | |
| 120130184 | 12013018 | Status epilepticus | |
| 120130184 | 12013018 | Toxicity to various agents |
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 |
|---|---|---|---|---|---|---|
| 120130184 | 12013018 | 1 | 20160117 | 20160117 | 0 | |
| 120130184 | 12013018 | 2 | 20160117 | 20160117 | 0 | |
| 120130184 | 12013018 | 3 | 20160117 | 20160117 | 0 | |
| 120130184 | 12013018 | 4 | 20160117 | 20160117 | 0 | |
| 120130184 | 12013018 | 5 | 20160117 | 20160117 | 0 | |
| 120130184 | 12013018 | 6 | 20160117 | 20160117 | 0 | |
| 120130184 | 12013018 | 7 | 20160117 | 20160117 | 0 | |
| 120130184 | 12013018 | 8 | 20160117 | 20160117 | 0 | |
| 120130184 | 12013018 | 9 | 20160117 | 20160117 | 0 | |
| 120130184 | 12013018 | 10 | 20160117 | 20160117 | 0 | |
| 120130184 | 12013018 | 11 | 20160117 | 20160117 | 0 | |
| 120130184 | 12013018 | 12 | 20160117 | 20160117 | 0 | |
| 120130184 | 12013018 | 13 | 20160117 | 20160117 | 0 | |
| 120130184 | 12013018 | 14 | 20160117 | 20160117 | 0 | |
| 120130184 | 12013018 | 15 | 20160117 | 20160117 | 0 | |
| 120130184 | 12013018 | 16 | 20160117 | 20160117 | 0 | |
| 120130184 | 12013018 | 17 | 20160117 | 20160117 | 0 |