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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124933033 | 12493303 | 3 | F | 20160615 | 20160906 | 20160623 | 20160908 | EXP | JP-EISAI MEDICAL RESEARCH-EC-2016-017988 | EISAI | 68.00 | YR | M | Y | 51.00000 | KG | 20160908 | MD | JP | JP |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124933033 | 12493303 | 1 | PS | ARICEPT | DONEPEZIL HYDROCHLORIDE | 1 | Oral | Y | 20690 | 5 | MG | ORALLY DISINTEGRATING TABLETS | QD | ||||||
| 124933033 | 12493303 | 2 | C | LIMAS | LITHIUM CARBONATE | 1 | Oral | 0 | 300 | MG | UNKNOWN | BID | |||||||
| 124933033 | 12493303 | 3 | C | TRAZODONE | TRAZODONE HYDROCHLORIDE | 1 | Oral | 0 | 50 | MG | UNKNOWN | QD | |||||||
| 124933033 | 12493303 | 4 | C | GOODMIN | BROTIZOLAM | 1 | Oral | 0 | .25 | MG | UNKNOWN | QD | |||||||
| 124933033 | 12493303 | 5 | C | BENZALIN | NITRAZEPAM | 1 | Oral | 0 | 5 | MG | UNKNOWN | QD | |||||||
| 124933033 | 12493303 | 6 | C | INVEGA | PALIPERIDONE | 1 | Oral | 0 | 3 | MG | UNKNOWN | QD | |||||||
| 124933033 | 12493303 | 7 | C | MICARDIS | TELMISARTAN | 1 | Oral | 0 | 60 | MG | UNKNOWN | QD | |||||||
| 124933033 | 12493303 | 8 | C | AMLODIPINE | AMLODIPINE BESYLATE | 1 | Oral | 0 | 5 | MG | UNKNOWN | QD | |||||||
| 124933033 | 12493303 | 9 | C | JANUVIA | SITAGLIPTIN PHOSPHATE | 1 | Oral | 0 | 100 | MG | UNKNOWN | QD | |||||||
| 124933033 | 12493303 | 10 | C | AMITIZA | LUBIPROSTONE | 1 | Oral | 20690 | .48 | UG | UNKNOWN | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124933033 | 12493303 | 1 | Dementia Alzheimer's type |
| 124933033 | 12493303 | 2 | Bipolar disorder |
| 124933033 | 12493303 | 3 | Sleep disorder |
| 124933033 | 12493303 | 4 | Sleep disorder |
| 124933033 | 12493303 | 5 | Sleep disorder |
| 124933033 | 12493303 | 6 | Bipolar disorder |
| 124933033 | 12493303 | 7 | Hypertension |
| 124933033 | 12493303 | 8 | Hypertension |
| 124933033 | 12493303 | 9 | Diabetes mellitus |
| 124933033 | 12493303 | 10 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 124933033 | 12493303 | HO |
| 124933033 | 12493303 | LT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124933033 | 12493303 | Atrioventricular block complete | |
| 124933033 | 12493303 | Dehydration | |
| 124933033 | 12493303 | Hypoxia | |
| 124933033 | 12493303 | Muscle spasms | |
| 124933033 | 12493303 | Shock |
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 |
|---|---|---|---|---|---|---|
| 124933033 | 12493303 | 1 | 20160405 | 20160619 | 0 | |
| 124933033 | 12493303 | 2 | 20151110 | 20160619 | 0 | |
| 124933033 | 12493303 | 3 | 20151114 | 20160618 | 0 | |
| 124933033 | 12493303 | 4 | 20160324 | 20160618 | 0 | |
| 124933033 | 12493303 | 5 | 20160412 | 20160618 | 0 | |
| 124933033 | 12493303 | 6 | 20160511 | 20160618 | 0 | |
| 124933033 | 12493303 | 7 | 20151111 | 20160619 | 0 | |
| 124933033 | 12493303 | 8 | 20160202 | 20160618 | 0 | |
| 124933033 | 12493303 | 9 | 20151119 | 20160619 | 0 | |
| 124933033 | 12493303 | 10 | 20160205 | 20160619 | 0 |