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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126251631 | 12625163 | 1 | I | 20160802 | 20160805 | 20160805 | EXP | US-JNJFOC-20160802940 | JANSSEN | NAHLEH ZA, BARLOW WE, HAYES DF, SCHOTT AF, GRALOW JR, SIKOV WM, ET AL. 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 RESEARCH + TREATMENT 2016;158(3):485-495. | 0.00 | F | Y | 0.00000 | 20160805 | MD | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126251631 | 12625163 | 1 | PS | DOXORUBICIN HYDROCHLORIDE. | DOXORUBICIN HYDROCHLORIDE | 1 | Intravenous (not otherwise specified) | U | U | 50718 | 60 | MG/M**2 | LIPOSOME INJECTION | ||||||
| 126251631 | 12625163 | 2 | SS | CYCLOPHOSPHAMIDE. | CYCLOPHOSPHAMIDE | 1 | Unknown | 6 CYCLES | U | 0 | 600 | MG/M**2 | UNSPECIFIED | QOW | |||||
| 126251631 | 12625163 | 3 | SS | PACLITAXEL. | PACLITAXEL | 1 | Intravenous (not otherwise specified) | FOR 12 WEEKS. | U | 0 | 100 | MG/M**2 | UNSPECIFIED | /wk | |||||
| 126251631 | 12625163 | 4 | SS | BEVACIZUMAB | BEVACIZUMAB | 1 | Intravenous (not otherwise specified) | 6 DOSES | U | 0 | 10 | MG/KG | UNSPECIFIED | QOW | |||||
| 126251631 | 12625163 | 5 | SS | PEGFILGRASTIM | PEGFILGRASTIM | 1 | Subcutaneous | 6 CYCLES | U | 0 | 6 | MG | UNSPECIFIED | QOW |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126251631 | 12625163 | 1 | Breast cancer |
| 126251631 | 12625163 | 2 | Breast cancer |
| 126251631 | 12625163 | 3 | Breast cancer |
| 126251631 | 12625163 | 4 | Breast cancer |
| 126251631 | 12625163 | 5 | Breast cancer |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126251631 | 12625163 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126251631 | 12625163 | Acute respiratory distress syndrome | |
| 126251631 | 12625163 | Adverse event | |
| 126251631 | 12625163 | Anaemia | |
| 126251631 | 12625163 | Cardiac failure | |
| 126251631 | 12625163 | Deep vein thrombosis | |
| 126251631 | 12625163 | Diarrhoea | |
| 126251631 | 12625163 | Dyspnoea | |
| 126251631 | 12625163 | Enterocolitis | |
| 126251631 | 12625163 | Febrile neutropenia | |
| 126251631 | 12625163 | Hypercalcaemia | |
| 126251631 | 12625163 | Hypertension | |
| 126251631 | 12625163 | Nausea | |
| 126251631 | 12625163 | Pain | |
| 126251631 | 12625163 | Palmar-plantar erythrodysaesthesia syndrome | |
| 126251631 | 12625163 | Pulmonary embolism | |
| 126251631 | 12625163 | Respiratory failure | |
| 126251631 | 12625163 | Sepsis | |
| 126251631 | 12625163 | Thrombocytopenia |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |