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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125116783 | 12511678 | 3 | F | 20160322 | 20160812 | 20160630 | 20160819 | EXP | DE-AMGEN-DEUSP2016081219 | AMGEN | 78.00 | YR | E | F | Y | 0.00000 | 20160819 | OT | DE | DE |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125116783 | 12511678 | 1 | PS | PROLIA | DENOSUMAB | 1 | Subcutaneous | 60 MG, UNK | N | 125320 | 60 | MG | SOLUTION FOR INJECTION | ||||||
| 125116783 | 12511678 | 2 | C | FLUVASTATIN | FLUVASTATIN SODIUM | 1 | Oral | 40 MG, UNK | 0 | 40 | MG | ||||||||
| 125116783 | 12511678 | 3 | C | DEKRISTOL | CHOLECALCIFEROL | 1 | 20000 IU, BID (1 0 1/2) | 0 | 20000 | IU | BID | ||||||||
| 125116783 | 12511678 | 4 | C | DELIX | RAMIPRIL | 1 | 5 MG, QD MORNING | 0 | 5 | MG | QD | ||||||||
| 125116783 | 12511678 | 5 | C | ASPIRIN. | ASPIRIN | 1 | 100 MG, QD MORNING | 0 | 100 | MG | QD | ||||||||
| 125116783 | 12511678 | 6 | C | PANTOPRAZOLE | PANTOPRAZOLE SODIUM | 1 | Oral | 20 MG, UNK | 0 | 20 | MG | ||||||||
| 125116783 | 12511678 | 7 | C | ACC | ACETYLCYSTEINE | 1 | 600 UNK, UNK | 0 | |||||||||||
| 125116783 | 12511678 | 8 | C | CARVEDILOL. | CARVEDILOL | 1 | 25 MG, QD MORINING | 0 | 25 | MG | QD | ||||||||
| 125116783 | 12511678 | 9 | C | CALCILAC | CALCIUM CARBONATE | 1 | 500 MG/ 400 IU | 0 | |||||||||||
| 125116783 | 12511678 | 10 | C | MOVICOL | POLYETHYLENE GLYCOL 3350POTASSIUM CHLORIDESODIUM BICARBONATESODIUM CHLORIDE | 1 | UNK UNK, Q6MO | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125116783 | 12511678 | 1 | Osteoporosis |
| 125116783 | 12511678 | 2 | Hyperlipidaemia |
| 125116783 | 12511678 | 4 | Hypertension |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125116783 | 12511678 | OT |
| 125116783 | 12511678 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125116783 | 12511678 | Arterial stenosis | |
| 125116783 | 12511678 | Body temperature increased | |
| 125116783 | 12511678 | Malaise | |
| 125116783 | 12511678 | Red blood cell sedimentation rate increased | |
| 125116783 | 12511678 | Vasculitis |
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 |
|---|---|---|---|---|---|---|
| 125116783 | 12511678 | 1 | 2015 | 0 | ||
| 125116783 | 12511678 | 2 | 2012 | 0 | ||
| 125116783 | 12511678 | 4 | 2012 | 0 |