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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125425371 | 12542537 | 1 | I | 20160624 | 20160709 | 20160709 | EXP | GR-CIPLA LTD.-2016GR09003 | CIPLA | POLYZOS SA, SINGHELLAKIS PN, NAOT D, ADAMIDOU F, MALANDRINOU FC, ANASTASILAKIS AD ET AL.,. DENOSUMAB TREATMENT FOR JUVENILE PAGET^S DISEASE: RESULTS FROM TWO ADULT PATIENTS WITH OSTEOPROTEGERIN DEFICIENCY (^BALKAN^ MUTATION IN THE TNFRSF11B GENE). J CLIN ENDOCRINOL METAB. 2014;99(3):703 TO 707 | 0.00 | Y | 0.00000 | 20160709 | OT | GR | GR |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125425371 | 12542537 | 1 | PS | ALENDRONATE | ALENDRONATE SODIUM | 1 | Unknown | UNK | U | U | 76768 | ||||||||
| 125425371 | 12542537 | 2 | SS | Zoledronic acid | ZOLEDRONIC ACID | 1 | Unknown | UNK | U | U | 0 | INFUSION | |||||||
| 125425371 | 12542537 | 3 | SS | Risedronate | RISEDRONATE SODIUM | 1 | Unknown | UNK | U | U | 0 | ||||||||
| 125425371 | 12542537 | 4 | SS | Calcitonin | CALCITONIN | 1 | Unknown | UNK | U | U | 0 | ||||||||
| 125425371 | 12542537 | 5 | SS | Etidronate | ETIDRONATE DISODIUM | 1 | Unknown | UNK | U | U | 0 | ||||||||
| 125425371 | 12542537 | 6 | SS | PAMIDRONATE | PAMIDRONATE DISODIUM | 1 | Unknown | UNK | U | U | 0 | ||||||||
| 125425371 | 12542537 | 7 | SS | Denosumab | DENOSUMAB | 1 | Subcutaneous | 30 MG, QID | U | U | 0 | 30 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125425371 | 12542537 | 1 | Bone disorder |
| 125425371 | 12542537 | 2 | Bone disorder |
| 125425371 | 12542537 | 3 | Bone disorder |
| 125425371 | 12542537 | 4 | Bone disorder |
| 125425371 | 12542537 | 5 | Bone disorder |
| 125425371 | 12542537 | 6 | Bone disorder |
| 125425371 | 12542537 | 7 | Osteitis deformans |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125425371 | 12542537 | OT |
| 125425371 | 12542537 | DS |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125425371 | 12542537 | Blindness | |
| 125425371 | 12542537 | Cataract | |
| 125425371 | 12542537 | Deafness | |
| 125425371 | 12542537 | Gait disturbance | |
| 125425371 | 12542537 | Hypocalcaemia | |
| 125425371 | 12542537 | Retinal disorder |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |