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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126948405 | 12694840 | 5 | F | 201108 | 20160926 | 20160829 | 20160929 | EXP | PHJP2016JP022990 | NOVARTIS | OZAKI Y, AMEMIYA T, HIRAMATSU K, GOTO H, SEKI T, FUJIEDA H ET AL.,. A CASE OF ATYPICAL FEMORAL FRACTURE SUGGESTED TO BE DUE TO LONG-TERM ADMINISTRATION OF BISPHOSPHONATE. THE 24TH ANNUAL MEETING OF THE JAPANESE BREAST CANCER SOCIETY : GENERAL SESSION. 2016;456 | 71.00 | YR | F | Y | 0.00000 | 20160929 | OT | JP | JP |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126948405 | 12694840 | 1 | SS | ZOMETA | ZOLEDRONIC ACID | 1 | Intravenous drip | 4 MG, UNK | 0 | 4 | MG | SOLUTION FOR INJECTION | |||||||
| 126948405 | 12694840 | 2 | SS | ZOMETA | ZOLEDRONIC ACID | 1 | 0 | SOLUTION FOR INJECTION | |||||||||||
| 126948405 | 12694840 | 3 | SS | ZOMETA | ZOLEDRONIC ACID | 1 | 0 | SOLUTION FOR INJECTION | |||||||||||
| 126948405 | 12694840 | 4 | PS | LETROZOLE. | LETROZOLE | 1 | Unknown | UNK | U | 20726 | |||||||||
| 126948405 | 12694840 | 5 | SS | 5-FLUOROURACIL | FLUOROURACIL | 1 | Unknown | UNK | U | 0 | |||||||||
| 126948405 | 12694840 | 6 | SS | CYCLOPHOSPHAMIDE. | CYCLOPHOSPHAMIDE | 1 | Unknown | UNK | U | 0 | |||||||||
| 126948405 | 12694840 | 7 | SS | EPIRUBICIN | EPIRUBICIN | 1 | Unknown | UNK | U | 0 | |||||||||
| 126948405 | 12694840 | 8 | C | PACLITAXEL. | PACLITAXEL | 1 | Unknown | 12 CYCLES OF WEEKLY , QW | U | 0 | /wk | ||||||||
| 126948405 | 12694840 | 9 | C | ALENDRONIC ACID | ALENDRONIC ACID | 1 | Unknown | UNK | U | 0 | |||||||||
| 126948405 | 12694840 | 10 | C | CAPECITABINE. | CAPECITABINE | 1 | Unknown | UNK | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126948405 | 12694840 | 1 | Metastases to spine |
| 126948405 | 12694840 | 2 | Metastases to lymph nodes |
| 126948405 | 12694840 | 3 | Invasive ductal breast carcinoma |
| 126948405 | 12694840 | 4 | Invasive ductal breast carcinoma |
| 126948405 | 12694840 | 5 | Invasive ductal breast carcinoma |
| 126948405 | 12694840 | 6 | Invasive ductal breast carcinoma |
| 126948405 | 12694840 | 7 | Invasive ductal breast carcinoma |
| 126948405 | 12694840 | 8 | Invasive ductal breast carcinoma |
| 126948405 | 12694840 | 9 | Invasive ductal breast carcinoma |
| 126948405 | 12694840 | 10 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126948405 | 12694840 | OT |
| 126948405 | 12694840 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126948405 | 12694840 | Atypical femur fracture | |
| 126948405 | 12694840 | Fall | |
| 126948405 | 12694840 | Metastases to lymph nodes | |
| 126948405 | 12694840 | Metastases to spine | |
| 126948405 | 12694840 | Pain in extremity |
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 |
|---|---|---|---|---|---|---|
| 126948405 | 12694840 | 1 | 201108 | 201510 | 0 |