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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 116013054 | 11601305 | 4 | F | 201412 | 20160407 | 20151006 | 20160715 | EXP | US-AMGEN-USASP2015015912 | AMGEN | 60.00 | YR | A | F | Y | 0.00000 | 20160714 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 116013054 | 11601305 | 1 | PS | PROLIA | DENOSUMAB | 1 | Unknown | UNK | U | 125320 | SOLUTION FOR INJECTION | ||||||||
| 116013054 | 11601305 | 2 | C | CALCIUM | CALCIUM | 1 | 2500 MG, UNK | 0 | 2500 | MG | |||||||||
| 116013054 | 11601305 | 3 | C | VITAMIN D | CHOLECALCIFEROL | 1 | 2400 UNK, UNK | 0 | |||||||||||
| 116013054 | 11601305 | 4 | C | MULTIVITAMIN | VITAMINS | 1 | UNK UNK, QD | 0 | QD | ||||||||||
| 116013054 | 11601305 | 5 | C | SYNTHROID | LEVOTHYROXINE SODIUM | 1 | 0 | ||||||||||||
| 116013054 | 11601305 | 6 | C | TEMAZEPAM ACTAVIS | 2 | 30 MG, UNK | 0 | 30 | MG | CAPSULE |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 116013054 | 11601305 | 1 | Osteoporosis |
| 116013054 | 11601305 | 5 | Thyroid disorder |
| 116013054 | 11601305 | 6 | Sleep terror |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 116013054 | 11601305 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 116013054 | 11601305 | Agitation | |
| 116013054 | 11601305 | Anxiety | |
| 116013054 | 11601305 | Clostridium difficile infection | |
| 116013054 | 11601305 | Dizziness | |
| 116013054 | 11601305 | Infection | |
| 116013054 | 11601305 | Nightmare | |
| 116013054 | 11601305 | Osteonecrosis of jaw | |
| 116013054 | 11601305 | Short-bowel syndrome | |
| 116013054 | 11601305 | Weight decreased | |
| 116013054 | 11601305 | Wound |
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 |
|---|---|---|---|---|---|---|
| 116013054 | 11601305 | 1 | 20140918 | 0 | ||
| 116013054 | 11601305 | 6 | 20130118 | 0 |