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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126141271 | 12614127 | 1 | I | 2016 | 20160724 | 20160802 | 20160802 | EXP | US-JNJFOC-20160720296 | JANSSEN | 56.80 | YR | A | F | Y | 47.63000 | KG | 20160802 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126141271 | 12614127 | 1 | SS | GALANTAMINE HBR | GALANTAMINE HYDROBROMIDE | 1 | Oral | OFF THE MEDICATION FOR 6 DAYS | Y | U | 0 | 12 | MG | TABLETS | BID | ||||
| 126141271 | 12614127 | 2 | SS | GALANTAMINE HBR | GALANTAMINE HYDROBROMIDE | 1 | Oral | Y | U | 0 | 12 | MG | TABLETS | QD | |||||
| 126141271 | 12614127 | 3 | SS | GALANTAMINE HBR | GALANTAMINE HYDROBROMIDE | 1 | Oral | Y | U | 0 | 12 | MG | TABLETS | ||||||
| 126141271 | 12614127 | 4 | SS | GALANTAMINE HBR | GALANTAMINE HYDROBROMIDE | 1 | Oral | Y | U | 0 | 12 | MG | TABLETS | QD | |||||
| 126141271 | 12614127 | 5 | SS | GALANTAMINE HBR | GALANTAMINE HYDROBROMIDE | 1 | Oral | FOR 2 DAYS | Y | U | 0 | 12 | MG | TABLETS | |||||
| 126141271 | 12614127 | 6 | SS | GALANTAMINE HBR | GALANTAMINE HYDROBROMIDE | 1 | Oral | Y | U | 0 | 12 | MG | TABLETS | QD | |||||
| 126141271 | 12614127 | 7 | SS | GALANTAMINE HBR | GALANTAMINE HYDROBROMIDE | 1 | Oral | DAY AND A HALF | Y | U | 0 | 6 | MG | TABLETS | BID | ||||
| 126141271 | 12614127 | 8 | PS | GALANTAMINE HBR | GALANTAMINE HYDROBROMIDE | 1 | Oral | Y | U | 21169 | 12 | MG | TABLETS | BID | |||||
| 126141271 | 12614127 | 9 | I | DIPHENHYDRAMINE. | DIPHENHYDRAMINE | 1 | Unknown | U | U | 999999 | UNSPECIFIED | ||||||||
| 126141271 | 12614127 | 10 | SS | LEVETIRACETAM. | LEVETIRACETAM | 1 | Unknown | U | 0 | 7 | MMOL | UNSPECIFIED | |||||||
| 126141271 | 12614127 | 11 | SS | LEVETIRACETAM. | LEVETIRACETAM | 1 | Unknown | U | 0 | 8 | ML | UNSPECIFIED |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126141271 | 12614127 | 1 | Dementia Alzheimer's type |
| 126141271 | 12614127 | 2 | Dementia Alzheimer's type |
| 126141271 | 12614127 | 3 | Dementia Alzheimer's type |
| 126141271 | 12614127 | 4 | Dementia Alzheimer's type |
| 126141271 | 12614127 | 5 | Dementia Alzheimer's type |
| 126141271 | 12614127 | 6 | Dementia Alzheimer's type |
| 126141271 | 12614127 | 7 | Dementia Alzheimer's type |
| 126141271 | 12614127 | 8 | Dementia Alzheimer's type |
| 126141271 | 12614127 | 9 | Insomnia |
| 126141271 | 12614127 | 10 | Product used for unknown indication |
| 126141271 | 12614127 | 11 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126141271 | 12614127 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126141271 | 12614127 | Confusional state | |
| 126141271 | 12614127 | Drug interaction | |
| 126141271 | 12614127 | Drug intolerance | |
| 126141271 | 12614127 | Inappropriate schedule of drug administration | |
| 126141271 | 12614127 | Insomnia | |
| 126141271 | 12614127 | Seizure | |
| 126141271 | 12614127 | Somnolence | |
| 126141271 | 12614127 | Weight decreased | |
| 126141271 | 12614127 | Wrong technique in product usage process |
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 |
|---|---|---|---|---|---|---|
| 126141271 | 12614127 | 1 | 201605 | 0 | ||
| 126141271 | 12614127 | 2 | 20160722 | 20160722 | 0 | |
| 126141271 | 12614127 | 3 | 20160720 | 20160721 | 0 | |
| 126141271 | 12614127 | 4 | 20160723 | 20160723 | 0 | |
| 126141271 | 12614127 | 5 | 2016 | 2016 | 0 | |
| 126141271 | 12614127 | 6 | 2016 | 2016 | 0 | |
| 126141271 | 12614127 | 7 | 2016 | 2016 | 0 | |
| 126141271 | 12614127 | 8 | 2016 | 2016 | 0 | |
| 126141271 | 12614127 | 9 | 201605 | 0 |