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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 121922787 | 12192278 | 7 | F | 20160208 | 20160913 | 20160318 | 20160916 | EXP | BG-AMGEN-BGRCT2015132001 | AMGEN | 54.00 | YR | A | M | Y | 89.00000 | KG | 20160915 | MD | BG | BG |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 121922787 | 12192278 | 1 | PS | AMG 145 | EVOLOCUMAB | 1 | Subcutaneous | 140 MG, Q2WK | 3500 | MG | Y | 125522 | 140 | MG | SOLUTION FOR INJECTION | QOW | |||
| 121922787 | 12192278 | 2 | SS | Prefilled Autoinjector/Pen | DEVICE | 1 | Subcutaneous | UNK | Y | 0 | DEVICE | ||||||||
| 121922787 | 12192278 | 3 | SS | ATORVASTATIN | ATORVASTATIN | 1 | Unknown | 40 MG, UNK | 0 | 40 | MG | ||||||||
| 121922787 | 12192278 | 4 | C | TICAGRELOR | TICAGRELOR | 1 | 90 MG, BID | 0 | 90 | MG | BID | ||||||||
| 121922787 | 12192278 | 5 | C | ASA | ASPIRIN | 1 | 100 MG, QD | 0 | 100 | MG | QD | ||||||||
| 121922787 | 12192278 | 6 | C | BISOPROLOL | BISOPROLOL | 1 | 5 MG, QD | 0 | 5 | MG | QD | ||||||||
| 121922787 | 12192278 | 7 | C | IMURAN | AZATHIOPRINE | 1 | 50 MG, UNK | 0 | 50 | MG | FILM-COATED TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 121922787 | 12192278 | 1 | Dyslipidaemia |
| 121922787 | 12192278 | 2 | Dyslipidaemia |
| 121922787 | 12192278 | 3 | Dyslipidaemia |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 121922787 | 12192278 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 121922787 | 12192278 | Blood creatine phosphokinase increased | |
| 121922787 | 12192278 | Polymyositis |
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 |
|---|---|---|---|---|---|---|
| 121922787 | 12192278 | 1 | 20141211 | 20151109 | 0 | |
| 121922787 | 12192278 | 2 | 20141211 | 20151109 | 0 | |
| 121922787 | 12192278 | 3 | 20141111 | 20150821 | 0 |