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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 116030652 | 11603065 | 2 | F | 2015 | 20160818 | 20151006 | 20160825 | EXP | US-AMGEN-USASP2015083594 | AMGEN | 59.00 | YR | A | F | Y | 0.00000 | 20160825 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 116030652 | 11603065 | 1 | PS | PROLIA | DENOSUMAB | 1 | Unknown | UNK | U | 125320 | SOLUTION FOR INJECTION |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 116030652 | 11603065 | 1 | Osteoporosis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 116030652 | 11603065 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 116030652 | 11603065 | Activities of daily living impaired | |
| 116030652 | 11603065 | Asthenia | |
| 116030652 | 11603065 | Back disorder | |
| 116030652 | 11603065 | Bone pain | |
| 116030652 | 11603065 | Depression | |
| 116030652 | 11603065 | Dry throat | |
| 116030652 | 11603065 | Feeling abnormal | |
| 116030652 | 11603065 | Fibromyalgia | |
| 116030652 | 11603065 | Gastrooesophageal reflux disease | |
| 116030652 | 11603065 | Hypersensitivity | |
| 116030652 | 11603065 | Insomnia | |
| 116030652 | 11603065 | Obsessive-compulsive disorder | |
| 116030652 | 11603065 | Pain | |
| 116030652 | 11603065 | Pollakiuria | |
| 116030652 | 11603065 | Spinal fracture | |
| 116030652 | 11603065 | Thyroid disorder |
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 |
|---|---|---|---|---|---|---|
| 116030652 | 11603065 | 1 | 201506 | 0 |