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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125309451 | 12530945 | 1 | I | 20160425 | 20160628 | 20160706 | 20160706 | PER | FR-EISAI MEDICAL RESEARCH-EC-2016-018151 | EISAI | 89.11 | YR | F | Y | 0.00000 | 20160706 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125309451 | 12530945 | 1 | PS | ARICEPT | DONEPEZIL HYDROCHLORIDE | 1 | Oral | 20690 | 1 | DF | TABLET | QD | |||||||
| 125309451 | 12530945 | 2 | SS | PAROXETINE. | PAROXETINE | 1 | Oral | 0.5 DOSAGE FORM | Y | 0 | UNKNOWN | ||||||||
| 125309451 | 12530945 | 3 | SS | TEMESTA | LORAZEPAM | 1 | Oral | 1.25 MG | Y | 0 | TABLET | ||||||||
| 125309451 | 12530945 | 4 | C | KARDEGIC | ASPIRIN LYSINE | 1 | Unknown | UNKNOWN | 0 | UNKNOWN |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125309451 | 12530945 | 1 | Dementia Alzheimer's type |
| 125309451 | 12530945 | 2 | Depression |
| 125309451 | 12530945 | 3 | Anxiety |
| 125309451 | 12530945 | 4 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125309451 | 12530945 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125309451 | 12530945 | Confusional state | |
| 125309451 | 12530945 | Hallucination, visual |
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 |
|---|---|---|---|---|---|---|
| 125309451 | 12530945 | 1 | 2014 | 0 | ||
| 125309451 | 12530945 | 2 | 201506 | 2016 | 0 | |
| 125309451 | 12530945 | 3 | 2013 | 20160430 | 0 |