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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126790601 | 12679060 | 1 | I | 20160810 | 20160824 | 20160824 | EXP | US-CIPLA LTD.-2016US17529 | CIPLA | AFT RL, NAUGHTON M, TRINKAUS K, WEILBAECHER K.. EFFECT OF (NEO)ADJUVANT ZOLEDRONIC ACID ON DISEASE-FREE AND OVERALL SURVIVAL IN CLINICAL STAGE II/III BREAST CANCER. BRITISH JOURNAL OF CANCER. 2012;107:7 TO 11 | 0.00 | Y | 0.00000 | 20160824 | OT | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126790601 | 12679060 | 1 | PS | Epirubicin | EPIRUBICIN | 1 | Intravenous (not otherwise specified) | 75 MG/M2, EVERY 3 WEEKS | U | U | 65361 | 75 | MG/M**2 | INFUSION | |||||
| 126790601 | 12679060 | 2 | SS | DOCETAXEL. | DOCETAXEL | 1 | Unknown | 75 MG/M2, EVERY 3 WEEKS | U | U | 0 | 75 | MG/M**2 | ||||||
| 126790601 | 12679060 | 3 | SS | Zoledronic acid | ZOLEDRONIC ACID | 1 | 4 MG, EVERY 3 WEEKS | U | U | 0 | 4 | MG | INFUSION | ||||||
| 126790601 | 12679060 | 4 | C | DEXAMETHASONE. | DEXAMETHASONE | 1 | Oral | 20 MG, UNK | U | U | 0 | 20 | MG | ||||||
| 126790601 | 12679060 | 5 | C | Calcium | CALCIUM | 1 | Unknown | 1000 MG, QD | U | U | 0 | 1000 | MG | QD | |||||
| 126790601 | 12679060 | 6 | C | Vitamine D | 2 | Unknown | 800 IU, QD | U | U | 0 | 800 | IU | QD | ||||||
| 126790601 | 12679060 | 7 | C | Granulocyte-stimulating factor | 2 | Unknown | UNK | U | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126790601 | 12679060 | 1 | Breast cancer female |
| 126790601 | 12679060 | 2 | Breast cancer female |
| 126790601 | 12679060 | 3 | Breast cancer female |
| 126790601 | 12679060 | 4 | Premedication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126790601 | 12679060 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126790601 | 12679060 | Osteonecrosis of jaw |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |