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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 108002458 | 10800245 | 8 | F | 2013 | 20160927 | 20150216 | 20160930 | EXP | PHHY2015BR018264 | NOVARTIS | 68.92 | YR | F | Y | 65.00000 | KG | 20160930 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 108002458 | 10800245 | 1 | PS | ACLASTA | ZOLEDRONIC ACID | 1 | Intravenous (not otherwise specified) | 5 MG, Q12MO (1 VIAL PER YEAR) | D | 21817 | 5 | MG | SOLUTION FOR INJECTION | ||||||
| 108002458 | 10800245 | 2 | SS | ACLASTA | ZOLEDRONIC ACID | 1 | Intravenous (not otherwise specified) | 4 MG, Q12MO | D | 21817 | 4 | MG | SOLUTION FOR INJECTION | ||||||
| 108002458 | 10800245 | 3 | C | CODATEN | CODEINE PHOSPHATEDICLOFENAC SODIUM | 1 | Oral | 2 DF, QD | 0 | 2 | DF | TABLET | QD | ||||||
| 108002458 | 10800245 | 4 | C | CODATEN | CODEINE PHOSPHATEDICLOFENAC SODIUM | 1 | Oral | 1 DF, QD | 0 | 1 | DF | TABLET | QD | ||||||
| 108002458 | 10800245 | 5 | C | CODATEN | CODEINE PHOSPHATEDICLOFENAC SODIUM | 1 | 0 | TABLET | |||||||||||
| 108002458 | 10800245 | 6 | C | MIOCALVEN D | 2 | Oral | 1 DF, QD | 0 | 1 | DF | SACHET | QD | |||||||
| 108002458 | 10800245 | 7 | C | OSTEOFIX | 2 | Unknown | 1 DF, QD | 0 | 1 | DF | QD | ||||||||
| 108002458 | 10800245 | 8 | C | OSTEOFIX | 2 | Oral | 1 DF, QW (1 TABLET A WEEK) (1 MONTH AGO) | 0 | 1 | DF | /wk | ||||||||
| 108002458 | 10800245 | 9 | C | NOEX | BUDESONIDE | 1 | Oral | 50 MG, BID, 4 YEARS AGO | 0 | 50 | MG | SPRAY | BID | ||||||
| 108002458 | 10800245 | 10 | C | GLIFAGE | METFORMIN HYDROCHLORIDE | 1 | Oral | 1 DF, QW (STARTED 1 YEAR AGO) | 0 | 1 | DF | /wk | |||||||
| 108002458 | 10800245 | 11 | C | SINVASTATINA | SIMVASTATIN | 1 | Oral | 1 DF, QW (STARTED 1 YEAR AGO) | 0 | 1 | DF | /wk |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 108002458 | 10800245 | 1 | Osteoporosis |
| 108002458 | 10800245 | 3 | Spinal pain |
| 108002458 | 10800245 | 4 | Upper limb fracture |
| 108002458 | 10800245 | 5 | Pain |
| 108002458 | 10800245 | 6 | Blood calcium abnormal |
| 108002458 | 10800245 | 7 | Mineral supplementation |
| 108002458 | 10800245 | 8 | Osteoporosis |
| 108002458 | 10800245 | 9 | Sinusitis |
| 108002458 | 10800245 | 10 | Diabetes mellitus |
| 108002458 | 10800245 | 11 | Blood cholesterol increased |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 108002458 | 10800245 | HO |
| 108002458 | 10800245 | DS |
| 108002458 | 10800245 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 108002458 | 10800245 | Bone pain | |
| 108002458 | 10800245 | Dry mouth | |
| 108002458 | 10800245 | Eye swelling | |
| 108002458 | 10800245 | Fall | |
| 108002458 | 10800245 | Femur fracture | |
| 108002458 | 10800245 | Gastrointestinal disorder | |
| 108002458 | 10800245 | Glucose tolerance impaired | |
| 108002458 | 10800245 | Hypokinesia | |
| 108002458 | 10800245 | Infusion site extravasation | |
| 108002458 | 10800245 | Intervertebral disc protrusion | |
| 108002458 | 10800245 | Intervertebral disc space narrowing | |
| 108002458 | 10800245 | Irritable bowel syndrome | |
| 108002458 | 10800245 | Lumbar vertebral fracture | |
| 108002458 | 10800245 | Malaise | |
| 108002458 | 10800245 | Peripheral swelling | |
| 108002458 | 10800245 | Pneumonia | |
| 108002458 | 10800245 | Rash macular | |
| 108002458 | 10800245 | Skin exfoliation | |
| 108002458 | 10800245 | Speech disorder | |
| 108002458 | 10800245 | Spinal compression fracture | |
| 108002458 | 10800245 | Spinal deformity | |
| 108002458 | 10800245 | Spinal fracture | |
| 108002458 | 10800245 | Spinal osteoarthritis | |
| 108002458 | 10800245 | Spondylolisthesis | |
| 108002458 | 10800245 | Swelling face | |
| 108002458 | 10800245 | Underdose | |
| 108002458 | 10800245 | Vein rupture | |
| 108002458 | 10800245 | Vertebral osteophyte | |
| 108002458 | 10800245 | Weight decreased | |
| 108002458 | 10800245 | Weight increased | |
| 108002458 | 10800245 | Wrist fracture |
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 |
|---|---|---|---|---|---|---|
| 108002458 | 10800245 | 1 | 201305 | 0 | ||
| 108002458 | 10800245 | 3 | 2012 | 0 | ||
| 108002458 | 10800245 | 4 | 2013 | 0 |