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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125653661 | 12565366 | 1 | I | 20141218 | 20160718 | 20160718 | EXP | US-CELGENEUS-USA-2014124895 | CELGENE | NAHLEH Z. SWOG S0800 (NCI CDR0000636131): ADDITION OF BEVACIZUMAB TO NEOADJUVANT NAB-PACLITAXEL WITH DOSE-DENSE DOXORUBICIN AND CYCLOPHOSPHAMIDE IMPROVES PATHOLOGIC COMPLETE RESPONSE (PCR) RATES IN INFLAMMATORY OR LOCALLY ADVANCED BREAST CANCER.. BREAST CANCER RES TREAT. 2016 JUL 08;. | 0.00 | Y | 0.00000 | 20160718 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125653661 | 12565366 | 1 | PS | ABRAXANE | PACLITAXEL | 1 | Intravenous drip | U | UNKNOWN | 21660 | 100 | MG/M**2 | INJECTION FOR INFUSION | /wk | |||||
| 125653661 | 12565366 | 2 | SS | ABRAXANE | PACLITAXEL | 1 | Intravenous drip | U | UNKNOWN | 21660 | 125 | MG/M**2 | INJECTION FOR INFUSION | /wk | |||||
| 125653661 | 12565366 | 3 | SS | Doxorubicin | DOXORUBICIN | 1 | Intravenous drip | U | 21660 | 60 | MG/M**2 | INJECTION | QOW | ||||||
| 125653661 | 12565366 | 4 | SS | Doxorubicin | DOXORUBICIN | 1 | U | 21660 | |||||||||||
| 125653661 | 12565366 | 5 | SS | CYCLOPHOSPHAMIDE. | CYCLOPHOSPHAMIDE | 1 | Intravenous drip | U | 21660 | 600 | MG/M**2 | INJECTION | QOW | ||||||
| 125653661 | 12565366 | 6 | SS | CYCLOPHOSPHAMIDE. | CYCLOPHOSPHAMIDE | 1 | U | 21660 | |||||||||||
| 125653661 | 12565366 | 7 | SS | Pegfilgrastim | PEGFILGRASTIM | 1 | Subcutaneous | U | 21660 | 6 | MG | INJECTION | QOW | ||||||
| 125653661 | 12565366 | 8 | SS | Pegfilgrastim | PEGFILGRASTIM | 1 | U | 21660 | |||||||||||
| 125653661 | 12565366 | 9 | SS | Bevacizumab | BEVACIZUMAB | 1 | Intravenous drip | U | 21660 | 10 | MG/KG | INJECTION | QOW | ||||||
| 125653661 | 12565366 | 10 | SS | Bevacizumab | BEVACIZUMAB | 1 | U | 21660 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125653661 | 12565366 | 1 | Breast cancer |
| 125653661 | 12565366 | 2 | Inflammatory carcinoma of the breast |
| 125653661 | 12565366 | 3 | Breast cancer |
| 125653661 | 12565366 | 4 | Inflammatory carcinoma of the breast |
| 125653661 | 12565366 | 5 | Breast cancer |
| 125653661 | 12565366 | 6 | Inflammatory carcinoma of the breast |
| 125653661 | 12565366 | 7 | Breast cancer |
| 125653661 | 12565366 | 8 | Inflammatory carcinoma of the breast |
| 125653661 | 12565366 | 9 | Breast cancer |
| 125653661 | 12565366 | 10 | Inflammatory carcinoma of the breast |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125653661 | 12565366 | DE |
| 125653661 | 12565366 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125653661 | 12565366 | Acute respiratory distress syndrome | |
| 125653661 | 12565366 | Anaemia | |
| 125653661 | 12565366 | Blood disorder | |
| 125653661 | 12565366 | Breast cancer | |
| 125653661 | 12565366 | Cardiac failure | |
| 125653661 | 12565366 | Death | |
| 125653661 | 12565366 | Deep vein thrombosis | |
| 125653661 | 12565366 | Diarrhoea | |
| 125653661 | 12565366 | Dyspnoea | |
| 125653661 | 12565366 | Embolism | |
| 125653661 | 12565366 | Enterocolitis infectious | |
| 125653661 | 12565366 | Febrile neutropenia | |
| 125653661 | 12565366 | Hypercalcaemia | |
| 125653661 | 12565366 | Hypertension | |
| 125653661 | 12565366 | Nausea | |
| 125653661 | 12565366 | Pain | |
| 125653661 | 12565366 | Palmar-plantar erythrodysaesthesia syndrome | |
| 125653661 | 12565366 | Pulmonary embolism | |
| 125653661 | 12565366 | Respiratory failure | |
| 125653661 | 12565366 | Sepsis | |
| 125653661 | 12565366 | Thrombocytopenia |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |