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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126267892 | 12626789 | 2 | F | 20160809 | 20160805 | 20160812 | EXP | US-AMGEN-USASP2016100741 | AMGEN | HAYES D. SWOC 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;1-11 | 0.00 | F | Y | 0.00000 | 20160812 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126267892 | 12626789 | 1 | PS | pegfilgrastim | PEGFILGRASTIM | 1 | Subcutaneous | FOR SIX CYCLES (6 MG, Q2WK) | U | 125031 | 6 | MG | UNKNOWN FORMULATION | QOW | |||||
| 126267892 | 12626789 | 2 | SS | pegfilgrastim | PEGFILGRASTIM | 1 | U | 125031 | UNKNOWN FORMULATION | ||||||||||
| 126267892 | 12626789 | 3 | SS | BEVACIZUMAB | BEVACIZUMAB | 1 | Intravenous (not otherwise specified) | SIX DOSES (10 MG/KG, Q2WK) | 0 | 10 | MG/KG | QOW | |||||||
| 126267892 | 12626789 | 4 | SS | BEVACIZUMAB | BEVACIZUMAB | 1 | 0 | ||||||||||||
| 126267892 | 12626789 | 5 | SS | PACLITAXEL ALBUMIN | PACLITAXEL | 1 | Intravenous (not otherwise specified) | FOR 12 WEEKS (100 MG/M2, QWK) | 0 | 100 | MG/M**2 | /wk | |||||||
| 126267892 | 12626789 | 6 | SS | PACLITAXEL ALBUMIN | PACLITAXEL | 1 | 0 | ||||||||||||
| 126267892 | 12626789 | 7 | SS | DOXORUBICIN | DOXORUBICIN | 1 | Intravenous (not otherwise specified) | 60 MG/M2, UNK | 0 | 60 | MG/M**2 | ||||||||
| 126267892 | 12626789 | 8 | SS | DOXORUBICIN | DOXORUBICIN | 1 | 0 | ||||||||||||
| 126267892 | 12626789 | 9 | SS | CYCLOPHOSPHAMIDE. | CYCLOPHOSPHAMIDE | 1 | Intravenous (not otherwise specified) | 600 MG/M2, UNK | 0 | 600 | MG/M**2 | ||||||||
| 126267892 | 12626789 | 10 | SS | CYCLOPHOSPHAMIDE. | CYCLOPHOSPHAMIDE | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126267892 | 12626789 | 1 | Breast cancer |
| 126267892 | 12626789 | 2 | Inflammatory carcinoma of the breast |
| 126267892 | 12626789 | 3 | Breast cancer |
| 126267892 | 12626789 | 4 | Inflammatory carcinoma of the breast |
| 126267892 | 12626789 | 5 | Breast cancer |
| 126267892 | 12626789 | 6 | Inflammatory carcinoma of the breast |
| 126267892 | 12626789 | 7 | Breast cancer |
| 126267892 | 12626789 | 8 | Inflammatory carcinoma of the breast |
| 126267892 | 12626789 | 9 | Breast cancer |
| 126267892 | 12626789 | 10 | Inflammatory carcinoma of the breast |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126267892 | 12626789 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126267892 | 12626789 | Acute respiratory distress syndrome | |
| 126267892 | 12626789 | Anaemia | |
| 126267892 | 12626789 | Diarrhoea | |
| 126267892 | 12626789 | Dyspnoea | |
| 126267892 | 12626789 | Embolism | |
| 126267892 | 12626789 | Febrile neutropenia | |
| 126267892 | 12626789 | Hypertension | |
| 126267892 | 12626789 | Nausea | |
| 126267892 | 12626789 | Pain | |
| 126267892 | 12626789 | Palmar-plantar erythrodysaesthesia syndrome | |
| 126267892 | 12626789 | Respiratory failure | |
| 126267892 | 12626789 | Sepsis | |
| 126267892 | 12626789 | Thrombocytopenia |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |