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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125283732 | 12528373 | 2 | F | 20130604 | 20160726 | 20160705 | 20160803 | EXP | US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2016-BI-41658BP | BOEHRINGER INGELHEIM | 92.09 | YR | F | Y | 61.23000 | KG | 20160803 | MD | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125283732 | 12528373 | 1 | PS | PRADAXA | DABIGATRAN ETEXILATE MESYLATE | 1 | Oral | 300 MG | 22512 | 150 | MG | CAPSULE | BID | ||||||
| 125283732 | 12528373 | 2 | C | LEVOTHYROXINE. | LEVOTHYROXINE | 1 | Oral | 0.115 MCG | 0 | .115 | UG | QD | |||||||
| 125283732 | 12528373 | 3 | C | ATENOLOL. | ATENOLOL | 1 | Oral | 50 MG | 0 | 50 | MG | QD | |||||||
| 125283732 | 12528373 | 4 | C | LISINOPRIL. | LISINOPRIL | 1 | Oral | 10 MG | 0 | 10 | MG | QD | |||||||
| 125283732 | 12528373 | 5 | C | DIGOXIN. | DIGOXIN | 1 | Oral | 0.125 MG | 0 | .125 | MG | QD | |||||||
| 125283732 | 12528373 | 6 | C | DULOXETINE. | DULOXETINE | 1 | Oral | 60 MG | 0 | 60 | MG | QD | |||||||
| 125283732 | 12528373 | 7 | C | DONEPEZIL. | DONEPEZIL | 1 | Oral | 10 MG | 0 | 10 | MG | QD | |||||||
| 125283732 | 12528373 | 8 | C | Oxycodone | OXYCODONE | 1 | Oral | DOSE PER APPLICATION AND DAILY DOSE: 5MG/325MG | 0 | QD | |||||||||
| 125283732 | 12528373 | 9 | C | TRAZODONE | TRAZODONE HYDROCHLORIDE | 1 | Oral | 50 MG | 0 | 50 | MG | QD | |||||||
| 125283732 | 12528373 | 10 | C | QUETIAPINE FUMARATE. | QUETIAPINE FUMARATE | 1 | Oral | 50 MG | 0 | 50 | MG | QD | |||||||
| 125283732 | 12528373 | 11 | C | CENTRUM | VITAMINS | 1 | Unknown | 0 | QD | ||||||||||
| 125283732 | 12528373 | 12 | C | VITAMIN D3 | CHOLECALCIFEROL | 1 | Oral | 0 | QD | ||||||||||
| 125283732 | 12528373 | 13 | C | Calcium with Zinc | 2 | Oral | 0 | QD | |||||||||||
| 125283732 | 12528373 | 14 | C | SENEKOT | 2 | Oral | 17.2 MG | 0 | 8.6 | MG | BID |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125283732 | 12528373 | 1 | Atrial fibrillation |
| 125283732 | 12528373 | 2 | Hypothyroidism |
| 125283732 | 12528373 | 3 | Hypertension |
| 125283732 | 12528373 | 4 | Hypertension |
| 125283732 | 12528373 | 5 | Product used for unknown indication |
| 125283732 | 12528373 | 6 | Fibromyalgia |
| 125283732 | 12528373 | 7 | Amnesia |
| 125283732 | 12528373 | 8 | Pain in extremity |
| 125283732 | 12528373 | 9 | Sleep disorder |
| 125283732 | 12528373 | 10 | Agitation |
| 125283732 | 12528373 | 11 | Product used for unknown indication |
| 125283732 | 12528373 | 12 | Product used for unknown indication |
| 125283732 | 12528373 | 13 | Product used for unknown indication |
| 125283732 | 12528373 | 14 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125283732 | 12528373 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125283732 | 12528373 | Aphasia | |
| 125283732 | 12528373 | Asthenia | |
| 125283732 | 12528373 | Dementia Alzheimer's type | |
| 125283732 | 12528373 | Partial seizures | |
| 125283732 | 12528373 | Senile dementia | |
| 125283732 | 12528373 | Transient ischaemic attack |
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 |
|---|---|---|---|---|---|---|
| 125283732 | 12528373 | 1 | 20110527 | 0 |