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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
123813553 | 12381355 | 3 | F | 201503 | 20160808 | 20160518 | 20160817 | EXP | US-AMGEN-USASL2016060968 | AMGEN | 53.00 | YR | A | F | Y | 0.00000 | 20160817 | 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
123813553 | 12381355 | 1 | PS | PROLIA | DENOSUMAB | 1 | Unknown | UNK | U | 125320 | SOLUTION FOR INJECTION | ||||||||
123813553 | 12381355 | 2 | C | VITAMIN D | CHOLECALCIFEROL | 1 | Unknown | UNK | 0 | ||||||||||
123813553 | 12381355 | 3 | C | CALCIUM | CALCIUM | 1 | Unknown | UNK | 0 |
Indications of drugs used
Event ID | CASEID | INDI DRUG SEQ | INDI PT |
---|---|---|---|
123813553 | 12381355 | 1 | Osteoporosis |
Outcome of event
Event ID | CASEID | OUTC COD |
---|---|---|
123813553 | 12381355 | OT |
Reactions reported
Event ID | CASEID | DRUG REC ACT | PT |
---|---|---|---|
123813553 | 12381355 | Arthralgia | |
123813553 | 12381355 | Blood cholesterol increased | |
123813553 | 12381355 | Diabetes mellitus | |
123813553 | 12381355 | Ligament sprain | |
123813553 | 12381355 | Menstrual disorder | |
123813553 | 12381355 | Pain | |
123813553 | 12381355 | Pain in extremity | |
123813553 | 12381355 | Shoulder operation | |
123813553 | 12381355 | Skin exfoliation | |
123813553 | 12381355 | Therapy non-responder | |
123813553 | 12381355 | Uterine leiomyoma | |
123813553 | 12381355 | Weight decreased |
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 |
---|---|---|---|---|---|---|
123813553 | 12381355 | 1 | 2014 | 0 |