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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123505035 | 12350503 | 5 | F | 201601 | 20160706 | 20160510 | 20160708 | EXP | PHHY2016BR063915 | NOVARTIS | 71.35 | YR | F | Y | 43.00000 | KG | 20160708 | MD | BR | BR |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123505035 | 12350503 | 1 | PS | ACLASTA | ZOLEDRONIC ACID | 1 | Intravenous (not otherwise specified) | 1 DF (5 MG/100 ML), Q12MO | 21817 | 1 | DF | SOLUTION FOR INJECTION | |||||||
| 123505035 | 12350503 | 2 | SS | ACLASTA | ZOLEDRONIC ACID | 1 | Unknown | UNK | 21817 | SOLUTION FOR INJECTION | |||||||||
| 123505035 | 12350503 | 3 | C | OSCAL D | CALCIUM CARBONATECHOLECALCIFEROL | 1 | Oral | 2 DF, QD | 0 | 2 | DF | TABLET | QD | ||||||
| 123505035 | 12350503 | 4 | C | DEPURA | CHOLECALCIFEROL | 1 | Oral | 10 DRP, QD | 0 | 10 | GTT | DROPS | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 123505035 | 12350503 | 1 | Osteoporosis |
| 123505035 | 12350503 | 3 | Mineral supplementation |
| 123505035 | 12350503 | 4 | Mineral supplementation |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 123505035 | 12350503 | DE |
| 123505035 | 12350503 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 123505035 | 12350503 | Anxiety | |
| 123505035 | 12350503 | Body height decreased | |
| 123505035 | 12350503 | Bone pain | |
| 123505035 | 12350503 | Death | |
| 123505035 | 12350503 | Drug ineffective | |
| 123505035 | 12350503 | Fall | |
| 123505035 | 12350503 | Headache | |
| 123505035 | 12350503 | Malaise | |
| 123505035 | 12350503 | Pain in extremity | |
| 123505035 | 12350503 | Rib fracture | |
| 123505035 | 12350503 | Scapula fracture | |
| 123505035 | 12350503 | Upper limb fracture | |
| 123505035 | 12350503 | Visual impairment |
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 |
|---|---|---|---|---|---|---|
| 123505035 | 12350503 | 1 | 20150119 | 0 | ||
| 123505035 | 12350503 | 2 | 20160114 | 20160114 | 0 | |
| 123505035 | 12350503 | 3 | 2014 | 0 | ||
| 123505035 | 12350503 | 4 | 201601 | 0 |