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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 116024864 | 11602486 | 4 | F | 20150715 | 20160718 | 20151006 | 20160725 | EXP | US-AMGEN-USASP2015070546 | AMGEN | 74.00 | YR | E | F | Y | 73.00000 | KG | 20160725 | CN | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 116024864 | 11602486 | 1 | PS | PROLIA | DENOSUMAB | 1 | Subcutaneous | 60 MG, Q6MO | U | 1053088 | 125320 | 60 | MG | SOLUTION FOR INJECTION | |||||
| 116024864 | 11602486 | 2 | C | SYNTHROID | LEVOTHYROXINE SODIUM | 1 | Oral | 25 MG, QD | 0 | 25 | MG | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 116024864 | 11602486 | 1 | Osteoporosis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 116024864 | 11602486 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 116024864 | 11602486 | Activities of daily living impaired | |
| 116024864 | 11602486 | Arthralgia | |
| 116024864 | 11602486 | Arthropathy | |
| 116024864 | 11602486 | Asthenia | |
| 116024864 | 11602486 | Balance disorder | |
| 116024864 | 11602486 | Feeling abnormal | |
| 116024864 | 11602486 | Gait disturbance | |
| 116024864 | 11602486 | Impaired driving ability | |
| 116024864 | 11602486 | Impaired work ability | |
| 116024864 | 11602486 | Jaw disorder | |
| 116024864 | 11602486 | Joint stiffness | |
| 116024864 | 11602486 | Mobility decreased | |
| 116024864 | 11602486 | Muscle disorder | |
| 116024864 | 11602486 | Muscular weakness | |
| 116024864 | 11602486 | Musculoskeletal disorder | |
| 116024864 | 11602486 | Musculoskeletal pain | |
| 116024864 | 11602486 | Myalgia | |
| 116024864 | 11602486 | Pain | |
| 116024864 | 11602486 | Renal disorder | |
| 116024864 | 11602486 | Suicidal ideation | |
| 116024864 | 11602486 | Tooth 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 |
|---|---|---|---|---|---|---|
| 116024864 | 11602486 | 1 | 20130916 | 20150327 | 0 |