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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126128551 | 12612855 | 1 | I | 20160725 | 20160802 | 20160802 | EXP | US-ROCHE-1802702 | ROCHE | NAHLEH Z, BARLOW W, HAYES D, SCHOTT A, GRALOW J, SIKOV W, PEREZ E, CHENNURU S, MIRSHAHIDI H, CORSO S, LEW D, PUSZTAI L, LIVINGSTON R AND HORTOBAGYI G SWOG S0800 (NCI CDR0000636131): ADDITION OF BEVACIZUMAB TO NEOADJUVANT NABPACLITAXEL WITH DOSE-DENSE DOXORUBICIN AND CYCLOPHOSPHAMIDE IMPROVES PATHOLOGIC COMPLETE RESPONSE (PCR) RATES IN INFLAMMATORY OR LOCALLY ADVANCED BREAST CANCER . BREAST CANCER RESEARCH AND TREATMENT 2016 JUL 08;:1-11. | 0.00 | Y | 0.00000 | 20160802 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126128551 | 12612855 | 1 | PS | Bevacizumab | BEVACIZUMAB | 1 | Intravenous (not otherwise specified) | SIX DOSES | U | 125085 | 10 | MG/KG | SOLUTION FOR INFUSION | QOW | |||||
| 126128551 | 12612855 | 2 | SS | Bevacizumab | BEVACIZUMAB | 1 | U | 125085 | |||||||||||
| 126128551 | 12612855 | 3 | SS | Pegfilgrastim | PEGFILGRASTIM | 1 | Subcutaneous | FOR SIX CYCLES | U | 0 | 6 | MG | QOW | ||||||
| 126128551 | 12612855 | 4 | SS | Pegfilgrastim | PEGFILGRASTIM | 1 | U | 0 | |||||||||||
| 126128551 | 12612855 | 5 | SS | NAB-PACLITAXEL | PACLITAXEL | 1 | Intravenous (not otherwise specified) | FOR 12 WEEKS | U | 0 | 100 | MG/M**2 | /wk | ||||||
| 126128551 | 12612855 | 6 | SS | NAB-PACLITAXEL | PACLITAXEL | 1 | U | 0 | |||||||||||
| 126128551 | 12612855 | 7 | SS | DOXORUBICIN | DOXORUBICIN | 1 | Intravenous (not otherwise specified) | U | 0 | 60 | MG/M**2 | ||||||||
| 126128551 | 12612855 | 8 | SS | DOXORUBICIN | DOXORUBICIN | 1 | U | 0 | |||||||||||
| 126128551 | 12612855 | 9 | SS | CYCLOPHOSPHAMIDE. | CYCLOPHOSPHAMIDE | 1 | Intravenous (not otherwise specified) | U | 0 | 600 | MG/M**2 | ||||||||
| 126128551 | 12612855 | 10 | SS | CYCLOPHOSPHAMIDE. | CYCLOPHOSPHAMIDE | 1 | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126128551 | 12612855 | 1 | Breast cancer |
| 126128551 | 12612855 | 2 | Inflammatory carcinoma of the breast |
| 126128551 | 12612855 | 3 | Breast cancer |
| 126128551 | 12612855 | 4 | Inflammatory carcinoma of the breast |
| 126128551 | 12612855 | 5 | Breast cancer |
| 126128551 | 12612855 | 6 | Inflammatory carcinoma of the breast |
| 126128551 | 12612855 | 7 | Breast cancer |
| 126128551 | 12612855 | 8 | Inflammatory carcinoma of the breast |
| 126128551 | 12612855 | 9 | Breast cancer |
| 126128551 | 12612855 | 10 | Inflammatory carcinoma of the breast |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126128551 | 12612855 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126128551 | 12612855 | Acute respiratory distress syndrome | |
| 126128551 | 12612855 | Anaemia | |
| 126128551 | 12612855 | Diarrhoea | |
| 126128551 | 12612855 | Dyspnoea | |
| 126128551 | 12612855 | Embolism | |
| 126128551 | 12612855 | Febrile neutropenia | |
| 126128551 | 12612855 | Hypertension | |
| 126128551 | 12612855 | Nausea | |
| 126128551 | 12612855 | Pain | |
| 126128551 | 12612855 | Palmar-plantar erythrodysaesthesia syndrome | |
| 126128551 | 12612855 | Respiratory failure | |
| 126128551 | 12612855 | Sepsis | |
| 126128551 | 12612855 | Thrombocytopenia |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |