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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 81331126 | 8133112 | 6 | F | 20160829 | 20110913 | 20160912 | EXP | US-ROCHE-801424 | 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 | 20160909 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 81331126 | 8133112 | 1 | PS | Bevacizumab | BEVACIZUMAB | 1 | Intravenous (not otherwise specified) | U | 125085 | 15 | MG/KG | SOLUTION FOR INFUSION | Q3W | ||||||
| 81331126 | 8133112 | 2 | SS | CAPECITABINE. | CAPECITABINE | 1 | Unknown | DAYS 1 -14 | U | 45305 | 825 | MG/M**2 | BID | ||||||
| 81331126 | 8133112 | 3 | SS | Doxorubicin | DOXORUBICIN | 1 | Unknown | U | 0 | 60 | MG/M**2 | Q3W | |||||||
| 81331126 | 8133112 | 4 | SS | CYCLOPHOSPHAMIDE. | CYCLOPHOSPHAMIDE | 1 | Unknown | 4 CYCLES | U | 0 | 600 | MG/M**2 | Q3W | ||||||
| 81331126 | 8133112 | 5 | SS | GEMCITABINE | GEMCITABINEGEMCITABINE HYDROCHLORIDE | 1 | Unknown | DAYS 1 AND 8 | U | 0 | 1000 | MG/M**2 | |||||||
| 81331126 | 8133112 | 6 | SS | DOCETAXEL. | DOCETAXEL | 1 | Unknown | DAY 1 | U | 0 | 100 | MG/M**2 | |||||||
| 81331126 | 8133112 | 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 |
|---|---|---|---|
| 81331126 | 8133112 | 1 | Breast cancer |
| 81331126 | 8133112 | 2 | Breast cancer |
| 81331126 | 8133112 | 3 | Breast cancer |
| 81331126 | 8133112 | 4 | Breast cancer |
| 81331126 | 8133112 | 5 | Breast cancer |
| 81331126 | 8133112 | 6 | Breast cancer |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 81331126 | 8133112 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 81331126 | 8133112 | Abdominal pain | |
| 81331126 | 8133112 | Alanine aminotransferase increased | |
| 81331126 | 8133112 | Anaemia | |
| 81331126 | 8133112 | Anal haemorrhage | |
| 81331126 | 8133112 | Anaphylactic reaction | |
| 81331126 | 8133112 | Arthralgia | |
| 81331126 | 8133112 | Ascites | |
| 81331126 | 8133112 | Aspartate aminotransferase increased | |
| 81331126 | 8133112 | Bone pain | |
| 81331126 | 8133112 | Cardiac arrest | |
| 81331126 | 8133112 | Cardiac disorder | |
| 81331126 | 8133112 | Cardiac failure | |
| 81331126 | 8133112 | Colitis | |
| 81331126 | 8133112 | Colonic fistula | |
| 81331126 | 8133112 | Constipation | |
| 81331126 | 8133112 | Cough | |
| 81331126 | 8133112 | Cystitis | |
| 81331126 | 8133112 | Dehydration | |
| 81331126 | 8133112 | Diarrhoea | |
| 81331126 | 8133112 | Duodenal ulcer | |
| 81331126 | 8133112 | Dyspepsia | |
| 81331126 | 8133112 | Dysphagia | |
| 81331126 | 8133112 | Dyspnoea | |
| 81331126 | 8133112 | Ear pain | |
| 81331126 | 8133112 | Embolism | |
| 81331126 | 8133112 | Erythema multiforme | |
| 81331126 | 8133112 | Face oedema | |
| 81331126 | 8133112 | Facial pain | |
| 81331126 | 8133112 | Fatigue | |
| 81331126 | 8133112 | Febrile neutropenia | |
| 81331126 | 8133112 | Gastritis | |
| 81331126 | 8133112 | Gastrointestinal disorder | |
| 81331126 | 8133112 | Haemorrhoids | |
| 81331126 | 8133112 | Headache | |
| 81331126 | 8133112 | Hypertension | |
| 81331126 | 8133112 | Hypoxia | |
| 81331126 | 8133112 | Ileus | |
| 81331126 | 8133112 | Influenza like illness | |
| 81331126 | 8133112 | Large intestinal haemorrhage | |
| 81331126 | 8133112 | Large intestine perforation | |
| 81331126 | 8133112 | Left ventricular dysfunction | |
| 81331126 | 8133112 | Leukopenia | |
| 81331126 | 8133112 | Lower gastrointestinal haemorrhage | |
| 81331126 | 8133112 | Lung infection | |
| 81331126 | 8133112 | Mucosal inflammation | |
| 81331126 | 8133112 | Myalgia | |
| 81331126 | 8133112 | Myocardial infarction | |
| 81331126 | 8133112 | Nausea | |
| 81331126 | 8133112 | Neutropenia | |
| 81331126 | 8133112 | Non-cardiac chest pain | |
| 81331126 | 8133112 | Oedema peripheral | |
| 81331126 | 8133112 | Oesophagitis | |
| 81331126 | 8133112 | Pain | |
| 81331126 | 8133112 | Palmar-plantar erythrodysaesthesia syndrome | |
| 81331126 | 8133112 | Peripheral ischaemia | |
| 81331126 | 8133112 | Peripheral motor neuropathy | |
| 81331126 | 8133112 | Peripheral sensory neuropathy | |
| 81331126 | 8133112 | Platelet count decreased | |
| 81331126 | 8133112 | Pneumonitis | |
| 81331126 | 8133112 | Proctalgia | |
| 81331126 | 8133112 | Proctitis | |
| 81331126 | 8133112 | Proteinuria | |
| 81331126 | 8133112 | Pulmonary haemorrhage | |
| 81331126 | 8133112 | Pyrexia | |
| 81331126 | 8133112 | Rash | |
| 81331126 | 8133112 | Sepsis | |
| 81331126 | 8133112 | Small intestinal obstruction | |
| 81331126 | 8133112 | Small intestinal perforation | |
| 81331126 | 8133112 | Stevens-Johnson syndrome | |
| 81331126 | 8133112 | Stomatitis | |
| 81331126 | 8133112 | Vascular access complication | |
| 81331126 | 8133112 | Vomiting | |
| 81331126 | 8133112 | White blood cell count decreased | |
| 81331126 | 8133112 | Wound infection |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |