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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127335871 | 12733587 | 1 | I | 20160829 | 20160912 | 20160912 | EXP | US-ROCHE-1826367 | ROCHE | , TANG G, RASTOGI P, GEYER C, LIU Q, ROBIDOUX A, ATKINS J, BAEZ-DIAZ L, AND BRUFSKY A THE EFFECT ON OVERALL AND DISEASE-FREE SURVIVAL (OS + DFS) BY ADDING BEVACIZUMAB AND/OR ANTIMETABOLITES TO STANDARD NEOADJUVANT CHEMOTHERAPY: NSABP PROTOCOL B-40 (ABSPD2-1). CANCER RESEARCH 2015;75:-. | 0.00 | F | Y | 0.00000 | 20160911 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127335871 | 12733587 | 1 | PS | Bevacizumab | BEVACIZUMAB | 1 | Intravenous (not otherwise specified) | U | 125085 | 15 | MG/KG | SOLUTION FOR INFUSION | Q3W | ||||||
| 127335871 | 12733587 | 2 | SS | CAPECITABINE. | CAPECITABINE | 1 | Unknown | DAYS 1 -14 | U | 45305 | 825 | MG/M**2 | BID | ||||||
| 127335871 | 12733587 | 3 | SS | Doxorubicin | DOXORUBICIN | 1 | Unknown | U | 0 | 60 | MG/M**2 | Q3W | |||||||
| 127335871 | 12733587 | 4 | SS | CYCLOPHOSPHAMIDE. | CYCLOPHOSPHAMIDE | 1 | Unknown | 4 CYCLES | U | 0 | 600 | MG/M**2 | Q3W | ||||||
| 127335871 | 12733587 | 5 | SS | GEMCITABINE | GEMCITABINEGEMCITABINE HYDROCHLORIDE | 1 | Unknown | DAYS 1 AND 8 | U | 0 | 1000 | MG/M**2 | |||||||
| 127335871 | 12733587 | 6 | SS | DOCETAXEL. | DOCETAXEL | 1 | Unknown | DAY 1 | U | 0 | 100 | MG/M**2 | |||||||
| 127335871 | 12733587 | 7 | SS | DOCETAXEL. | DOCETAXEL | 1 | Unknown | DAY 1 | U | 0 | 75 | MG/M**2 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127335871 | 12733587 | 1 | Breast cancer |
| 127335871 | 12733587 | 2 | Breast cancer |
| 127335871 | 12733587 | 3 | Breast cancer |
| 127335871 | 12733587 | 4 | Breast cancer |
| 127335871 | 12733587 | 5 | Breast cancer |
| 127335871 | 12733587 | 6 | Breast cancer |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127335871 | 12733587 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127335871 | 12733587 | Abdominal infection | |
| 127335871 | 12733587 | Acute kidney injury | |
| 127335871 | 12733587 | Alkalosis | |
| 127335871 | 12733587 | Anxiety | |
| 127335871 | 12733587 | Arthritis | |
| 127335871 | 12733587 | Back pain | |
| 127335871 | 12733587 | Blood creatinine increased | |
| 127335871 | 12733587 | Breast disorder | |
| 127335871 | 12733587 | Breast pain | |
| 127335871 | 12733587 | Bronchitis | |
| 127335871 | 12733587 | Cholecystitis | |
| 127335871 | 12733587 | Cystitis noninfective | |
| 127335871 | 12733587 | Decreased appetite | |
| 127335871 | 12733587 | Depression | |
| 127335871 | 12733587 | Device related infection | |
| 127335871 | 12733587 | Dizziness | |
| 127335871 | 12733587 | Enterocolitis infectious | |
| 127335871 | 12733587 | Epistaxis | |
| 127335871 | 12733587 | Gamma-glutamyltransferase increased | |
| 127335871 | 12733587 | Hot flush | |
| 127335871 | 12733587 | Hyperglycaemia | |
| 127335871 | 12733587 | Hypoalbuminaemia | |
| 127335871 | 12733587 | Hypocalcaemia | |
| 127335871 | 12733587 | Hypokalaemia | |
| 127335871 | 12733587 | Hyponatraemia | |
| 127335871 | 12733587 | Hypophosphataemia | |
| 127335871 | 12733587 | Hypotension | |
| 127335871 | 12733587 | Infection | |
| 127335871 | 12733587 | Infective myositis | |
| 127335871 | 12733587 | Infestation | |
| 127335871 | 12733587 | Insomnia | |
| 127335871 | 12733587 | International normalised ratio increased | |
| 127335871 | 12733587 | Joint effusion | |
| 127335871 | 12733587 | Kidney infection | |
| 127335871 | 12733587 | Leukaemia | |
| 127335871 | 12733587 | Lipase increased | |
| 127335871 | 12733587 | Menstruation irregular | |
| 127335871 | 12733587 | Muscular weakness | |
| 127335871 | 12733587 | Myositis | |
| 127335871 | 12733587 | Nail infection | |
| 127335871 | 12733587 | Neck pain | |
| 127335871 | 12733587 | Nervous system disorder | |
| 127335871 | 12733587 | Otitis media | |
| 127335871 | 12733587 | Pharyngeal inflammation | |
| 127335871 | 12733587 | Pharyngitis | |
| 127335871 | 12733587 | Pleural effusion | |
| 127335871 | 12733587 | Presyncope | |
| 127335871 | 12733587 | Pruritus | |
| 127335871 | 12733587 | Radiation skin injury | |
| 127335871 | 12733587 | Renal disorder | |
| 127335871 | 12733587 | Reproductive tract disorder | |
| 127335871 | 12733587 | Respiratory failure | |
| 127335871 | 12733587 | Second primary malignancy | |
| 127335871 | 12733587 | Seroma | |
| 127335871 | 12733587 | Sinusitis | |
| 127335871 | 12733587 | Skin disorder | |
| 127335871 | 12733587 | Skin infection | |
| 127335871 | 12733587 | Syncope | |
| 127335871 | 12733587 | Trismus | |
| 127335871 | 12733587 | Troponin I increased | |
| 127335871 | 12733587 | Upper respiratory tract infection | |
| 127335871 | 12733587 | Urinary tract disorder | |
| 127335871 | 12733587 | Urinary tract infection | |
| 127335871 | 12733587 | Urinary tract pain | |
| 127335871 | 12733587 | Uterine haemorrhage | |
| 127335871 | 12733587 | Vaginal haemorrhage | |
| 127335871 | 12733587 | Vaginal perforation | |
| 127335871 | 12733587 | Weight decreased |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |