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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126453872 | 12645387 | 2 | F | 20160805 | 20160819 | 20160811 | 20160825 | EXP | US-AMGEN-USACT2016103091 | AMGEN | 78.00 | YR | E | M | Y | 0.00000 | 20160825 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126453872 | 12645387 | 1 | PS | AMG 145 | EVOLOCUMAB | 1 | Subcutaneous | 420 MG, Q4WK | 15540 | MG | 125522 | 420 | MG | SOLUTION FOR INJECTION | |||||
| 126453872 | 12645387 | 2 | SS | AMG 145 | EVOLOCUMAB | 1 | 15540 | MG | 125522 | SOLUTION FOR INJECTION | |||||||||
| 126453872 | 12645387 | 3 | SS | Prefilled Autoinjector/Pen | DEVICE | 1 | Subcutaneous | UNK UNK, Q2WK | 0 | DEVICE | QOW | ||||||||
| 126453872 | 12645387 | 4 | SS | Prefilled Autoinjector/Pen | DEVICE | 1 | 0 | DEVICE | |||||||||||
| 126453872 | 12645387 | 5 | SS | 3.5 mL Personal Injector | DEVICE | 1 | Subcutaneous | UNK UNK, Q4WK | 0 | DEVICE | |||||||||
| 126453872 | 12645387 | 6 | SS | 3.5 mL Personal Injector | DEVICE | 1 | 0 | DEVICE | |||||||||||
| 126453872 | 12645387 | 7 | SS | PROPAFENONE. | PROPAFENONE | 1 | Oral | 325 MG, BID | 29900 | MG | 0 | 325 | MG | BID | |||||
| 126453872 | 12645387 | 8 | SS | ATENOLOL. | ATENOLOL | 1 | Oral | 50 MG, BID | 0 | 50 | MG | BID | |||||||
| 126453872 | 12645387 | 9 | C | ATORVASTATIN | ATORVASTATIN | 1 | 40 MG, QD | 0 | 40 | MG | QD | ||||||||
| 126453872 | 12645387 | 10 | C | ATORVASTATIN | ATORVASTATIN | 1 | 0 | ||||||||||||
| 126453872 | 12645387 | 11 | C | ASPIRIN. | ASPIRIN | 1 | Oral | 81 MG, QD | 0 | 81 | MG | QD | |||||||
| 126453872 | 12645387 | 12 | C | DABIGATRAN | DABIGATRAN | 1 | Oral | 150 MG, BID | 0 | 150 | MG | BID |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126453872 | 12645387 | 1 | Hyperlipidaemia |
| 126453872 | 12645387 | 2 | Dyslipidaemia |
| 126453872 | 12645387 | 3 | Hyperlipidaemia |
| 126453872 | 12645387 | 4 | Dyslipidaemia |
| 126453872 | 12645387 | 5 | Hyperlipidaemia |
| 126453872 | 12645387 | 6 | Dyslipidaemia |
| 126453872 | 12645387 | 7 | Product used for unknown indication |
| 126453872 | 12645387 | 8 | Product used for unknown indication |
| 126453872 | 12645387 | 9 | Hyperlipidaemia |
| 126453872 | 12645387 | 10 | Dyslipidaemia |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126453872 | 12645387 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126453872 | 12645387 | Bradycardia |
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 |
|---|---|---|---|---|---|---|
| 126453872 | 12645387 | 1 | 20130906 | 20160711 | 0 | |
| 126453872 | 12645387 | 3 | 20130906 | 0 | ||
| 126453872 | 12645387 | 5 | 20151124 | 20160711 | 0 | |
| 126453872 | 12645387 | 7 | 20160621 | 20160805 | 0 | |
| 126453872 | 12645387 | 8 | 2000 | 20160805 | 0 | |
| 126453872 | 12645387 | 11 | 20150104 | 0 | ||
| 126453872 | 12645387 | 12 | 20160302 | 0 |