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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125311181 | 12531118 | 1 | I | 201605 | 20160630 | 20160706 | 20160706 | PER | US-EISAI MEDICAL RESEARCH-EC-2016-018213 | EISAI | 74.28 | YR | M | Y | 0.00000 | 20160706 | CN | US | US |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125311181 | 12531118 | 1 | PS | ARICEPT | DONEPEZIL HYDROCHLORIDE | 1 | Oral | Y | 20690 | 5 | MG | TABLET | QD | ||||||
| 125311181 | 12531118 | 2 | SS | ARICEPT | DONEPEZIL HYDROCHLORIDE | 1 | Oral | Y | 20690 | 10 | MG | TABLET | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125311181 | 12531118 | 1 | Cognitive disorder |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125311181 | 12531118 | Decreased appetite | |
| 125311181 | 12531118 | Dizziness | |
| 125311181 | 12531118 | Drug ineffective | |
| 125311181 | 12531118 | Fatigue | |
| 125311181 | 12531118 | Liver function test increased | |
| 125311181 | 12531118 | Muscle spasms | |
| 125311181 | 12531118 | Pruritus generalised | |
| 125311181 | 12531118 | Renal impairment | |
| 125311181 | 12531118 | Somnolence | |
| 125311181 | 12531118 | Weight decreased |
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 |
|---|---|---|---|---|---|---|
| 125311181 | 12531118 | 1 | 201602 | 201602 | 0 | |
| 125311181 | 12531118 | 2 | 201603 | 20160614 | 0 |