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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127690351 | 12769035 | 1 | I | 201608 | 20160914 | 20160921 | 20160921 | PER | US-EISAI MEDICAL RESEARCH-EC-2016-020442 | EISAI | 0.00 | F | Y | 0.00000 | 20160921 | OT | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127690351 | 12769035 | 1 | PS | ARICEPT | DONEPEZIL HYDROCHLORIDE | 1 | Oral | UNKNOWN | 20690 | TABLET | |||||||||
| 127690351 | 12769035 | 2 | SS | NUEDEXTA | DEXTROMETHORPHAN HYDROBROMIDEQUINIDINE SULFATE | 1 | Oral | 20690 | 1 | DF | TABLET | QD | |||||||
| 127690351 | 12769035 | 3 | SS | LOXITANE | LOXAPINE SUCCINATE | 1 | Oral | UNKNOWN | 20690 | TABLET | |||||||||
| 127690351 | 12769035 | 4 | SS | NAMENDA | MEMANTINE HYDROCHLORIDE | 1 | Oral | UNKNOWN | 20690 | TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127690351 | 12769035 | 1 | Product used for unknown indication |
| 127690351 | 12769035 | 2 | Affect lability |
| 127690351 | 12769035 | 3 | Product used for unknown indication |
| 127690351 | 12769035 | 4 | Product used for unknown indication |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127690351 | 12769035 | Decreased appetite | |
| 127690351 | 12769035 | Lethargy | |
| 127690351 | 12769035 | Speech disorder |
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 |
|---|---|---|---|---|---|---|
| 127690351 | 12769035 | 1 | 201608 | 0 | ||
| 127690351 | 12769035 | 2 | 201608 | 0 | ||
| 127690351 | 12769035 | 3 | 201608 | 0 | ||
| 127690351 | 12769035 | 4 | 201608 | 0 |