Site Name Participants Miami Valley Hospital Hawaii Minority Based CCOP University of Chicago University of Cincinnati
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1 1 OUTBACK progress and safety report 22MAY17. Data saved 22MAY2017. Accrual by site 7 patient(s) were found to have been ineligible prior to randomisation and have been excluded. Data for all other randomised patients Site Name Participants Saint Joseph's Hospital (AZ) Oklahoma University Cancer Care Associates Cleveland Clinic - OB/GYN & Women's Health Abington Memorial Hospital The University of Alabama at Birmingham University of Mississippi Riverside Methodist Hospital 1001 MD Anderson Cancer Center Jersey Shore Medical Center Columbus Cancer Council/Ohio State Carilion Clinic Gynecological Oncology Fairview Hospital Hillcrest Hospital Women's Cancer Care Associates Huntsman Cancer Institute Southwestern Medical Center of Texas Akron City Hospital Women and Infants Hospital, Rhode Island Methodist Estabrook Cancer Center Aurora St Luke's Medical Center 1008 Aurora Women's Pavilion Tulane University Health Sciences Center Medical University of South Carolina 1002 Mercy-Springfield University of New Mexico Health Sciences Virginia Commonwealth University Indiana University Cancer Center 1008 Medical College of Wisconsin University of North Carolina 1000 Olive View - UCLA Medical Center Northwestern University Reading Hospital 100 Aurora Baycare Medical Center Saint Luke's Hospital 7
2 2 Site Name Participants 1008 Miami Valley Hospital 1009 Hawaii Minority Based CCOP University of Chicago University of Cincinnati Medical Center Saint Vincent Hospital & Health Care Thomas Jefferson University University of Massachusetts Memorial Health Care Baystate Medical Center West Michigan Cancer Center John Muir Medical Center - Concord Campus The Hospital of Central Connecticut Illinois Cancer Care University of California Medical Center Central Baptist Hospital 1007 Billings Clinic Maine Medical Center University of Minnesota Medical Center MetroHealth Medical Center Memorial Sloan-Kettering Cancer Center Upstate Carolina CCOP Lyndon B Johnson Hospital State University of NY-Downstate 1008 Women's Cancer Center of Nevada Queens Hospital Center Anmed Health Cancer Center Ochsner Clinic Wayne State University University of Maryland 1009 University of Kansas Medical Center 1009 New York University Langone Medical Center University of California - Davis Carolinas Medical Center - NorthEast University of Nebraska Medical Center Hartford Hospital The Rector and Visitors of the University of Virginia Henry Ford Hospital 1011 Walter Reed National Military Medical Center Norton Healthcare Kettering Hospital 1
3 Site Name Participants Northern Indiana CCOP Northside Hospital Cancer Center Morristown Memorial Hospital Northeast Georgia Medical Center Saint Joseph Hospital (CA) UPMC-Shadyside Hospital 1012 Hackensack University Medical Center MD Anderson Cancer Center Orlando Monter Cancer Center University of Miami School of Medicine 1012 Long Island Jewish Medical Center Emory University Winthrop University Black Hills Obstetrics and Gynecology 1018 Memorial Hermann Texas Medical Center 101 William Beaumont Hospital Yale University Alamance Regional Cancer Center University of Wisconsin Hospital University of South Alabama, Mitchell Cancer Institute Stroger Cook County Hospital Roswell Park Cancer Institute University of Kentucky University of Iowa Vince Lombardi Cancer Clinic- Sheboygan Texas Oncology-Central Austin Cancer Center Texas Oncology-South Austin Texas Oncology PA - Bedford Loyola University Medical Center 1019 MD Anderson at Cooper Cancer Center Montana Cancer Consortium CCOP Wake Forest University Health Sciences Sarasota Memorial Hospital University of Pennsylvania Western Oncology Research Consortium University of Arkansas for Medical Sciences Alaska's Women's Cancer Care Kaiser Permanente - Roseville Kaiser Permanente - Oakland 1
4 Site Name Participants 1020 Kaiser Permanente - San Francisco Kaiser Permanente - South San Francisco Kaiser Permanente - San Rafael Kaiser Permanente - Santa Clara Sutter General Hospital RMCC - Penrose 1007 Swedish Medical Center Drexel University School of Medicine 1011 Kapiolani Hospital for Women & Children Jackson Memorial Hospital - Holtz Children's Hospital The New York Methodist Hospital 102 Memorial Medical Center - Illinois 10 The Methodist Hospital System Wentworth-Douglass Hospital West Penn Hospital Houston Methodist Sugar Land Hospital University of Arizona Cancer Center at Saint Joseph's Memorial Medical Center Las Cruses Mercy Cancer Center University of Rochester University Medical Center New Orleans Princess Margaret Hospital Juravinski Cancer Centre Notre-Dame Hospital London Regional Cancer Program Allan Blair Cancer Centre Westmead Hospital Chris O'Brien Lifehouse 6121 Liverpool Hospital Calvary Mater Newcastle Hospital Campbelltown Hospital 6102 Peter MacCallum Cancer Centre Monash Medical Centre Royal Brisbane & Women's Hospital The Townsville Hospital 61 Mater Adult Hospital Flinders Medical Centre Sir Charles Gairdner Hospital Auckland Hospital 1
5 Site Name Participants 6902 Christchurch Hospital 6927 Wellington Hospital 600 National Cancer Institute Singapore Fudan University Shanghai Cancer Center King Faisal Specialist Hospital Total 910
6 6 OUTBACK progress and safety report 22MAY17. Data saved 22MAY2017. Participant characteristics Characteristic Category Participants Age (years) < >=60 1 Stage of cervical cancer (FIGO 2008) Stage IB1 and Node Positive 8 Stage IB2 190 Stage IIA 62 Stage IIB 90 Stage IIIB 190 Stage IVA 0 ECOG performance status Pelvic or common iliac nodal involvement Pelvic nodal involvement 286 Common iliac nodal involvement 6 Both 88 Neither Unknown 18 EFRT required No 799 Yes 111
7 7 OUTBACK progress and safety report 22MAY17. Data saved 22MAY2017. Number of patients on/off treatment On/off treatment Reason Number of patients On treatment Still on study treatment 11 Off treatment Completed protocol treatment 608 Adverse Event 6 Tumour progression 8 Clinician preference 1 Patient preference 92 Other 9
8 8 OUTBACK progress and safety report 22MAY17. Data saved 22MAY2017. Treatment toxicities - number of patients at each toxicity and worst severity Toxicity Not present /not reported 1 2 Anaemia Lymphocyte count decreased Neutrophil count decreased Platelet count decreased Febrile neutropenia Alanine Aminotransferase (ALT) decreased Aspartate Aminotransferase (AST) decreased Creatinine increased Diarrhea Colitis Enterocolitis Proctitis Dermatitis radiation Rectal hemorrhage Hematuria Cystitis noninfective Allergic reaction Fatigue Thromboembolic event Peripheral motor neuropathy Peripheral sensory neuropathy Hearing impaired Nausea Vomiting Dehydration Mucositis oral Myalgia Alopecia
9 9 OUTBACK progress and safety report 22MAY17. Data saved 22MAY2017. Followup toxicities - number of patients at each toxicity and worst severity Toxicity Not present /not reported 1 2 Colonic obstruction Rectal obstruction Samll intestinal obstruction Uterine obstruction GI fistula Female genital tract fistula Vaginal stricture Cystitis noninfective Vaginal discharge Vaginal dryness 7 9 Abdominal pain Anal pain Pain in extremity Pelvic pain Perineal pain Rectal pain Urinary tract pain Tumour pain Vaginal pain Diarrhea Colitis Enterocolitis Proctitis Rectal hemorrhage Hematuria Fatigue Superficial soft tissue fibrosis Fibrosis deep connective tissue Telangiectasia Lymphedema Creatinine increased Peripheral Motor Neuropathy Peripheral Sensory Neuropathy Hearing impaired
10 10 OUTBACK progress and safety report 22MAY17. Data saved 22MAY2017. Other grade // toxicities - number of patients at each toxicity and worst severity Toxicity ABDOMINAL INFECTION 0 0 ABDOMINAL PAIN ACUTE CORONARY SYNDROME ACUTE KIDNEY INJURY ALKALINE PHOSPHATASE INCREASED ALOPECIA ANEMIA ANOREXIA ANXIETY BACK PAIN BLADDER INFECTION BONE PAIN 0 0 BREAST PAIN CARDIAC DISORDERS - OTHER, PACEMAKER INSERTION CERVICITIS INFECTION CHEST PAIN - CARDIAC CHRONIC KIDNEY DISEASE COLONIC ULCER CONSTIPATION DEHYDRATION DENTAL CARIES DEPRESSION DERMATITIS RADIATION DEVICE RELATED INFECTION DIARRHEA DIZZINESS 0 0 DYSARTHRIA DYSPNEA 0 0 EDEMA LIMBS ENTEROCOLITIS ENTEROCOLITIS INFECTIOUS FEVER 0 0 FRACTURE GENERALIZED MUSCLE WEAKNESS GGT INCREASED 0 0 HEADACHE 1 0 0
11 11 Toxicity HEMORRAGHIC CYSTITIS HEPATITIS C HOT FLASHES 0 0 HYPERCALCEMIA HYPERGLYCEMIA HYPERKALEMIA HYPERTENSION HYPERTHYROIDISM HYPOALBUMINEMIA 0 0 HYPOCALCEMIA 0 0 HYPOKALEMIA 1 0 HYPOMAGNESEMIA 9 0 HYPONATREMIA HYPOPHOSPHATEMIA HYPOTENSION 0 0 INFECTIONS AND INFESTATIONS - OTHER (INFECTION, UNKNOWN SOURCE) INJURY, POISONING AND PROCEDURAL COMPLICATIONS - OTHER, REPLACEMENT OF SMIT SLEEVE INR INCREASED INSOMNIA INTRAOPERATIVE REPRODUCTIVE TRACT INJURY INVESTIGATIONS - OTHER, PANCYTOPENIA IRRITABILITY KIDNEY INFECTION 0 0 LEUKOCYTOSIS LUNG INFECTION 0 1 LYMPHOCELE LYMPHOCYTE COUNT DECREASED 1 0 MENOPAUSE MUCOSITIS ORAL MYALGIA MYOCARDIAL INFARCTION NAUSEA 0 0 NEUTROPHIL COUNT DECREASED 0 0 NON-INFECTIVE ENDOCARDITIS OSTEOPOROSIS PAIN 0 0 PAIN IN EXTREMITY PANCREATITIS 1 0 0
12 12 Toxicity PAROXYSMAL ATRIAL TACHYCARDIA PELVIC ABSCESS PELVIC INFECTION PELVIC PAIN PNEUMONITIS PREMATURE MENOPAUSE PROTEINURIA PULMONARY EDEMA PYELONEPHRITIS RADIATION RECALL REACTION (DERMATOLOGIC) RADICULITIS RASH RECTAL FISTULA RENAL AND URINARY DISORDERS - OTHER (HYDRONEPHROSIS) 0 0 REPRODUCTIVE SYSTEM AND BREAST DISORDERS - OTHER (VULVODYNIA) RESPIRATORY DISORDER (COPD) SEPSIS SINUS TACHYCARDIA SKIN INFECTION 0 0 SMALL INTESTINAL OBSTRUCTION STROKE SUPRAVENTRICULAR TACHYCARDIA SYNCOPE THROMBOEMBOLIC EVENT 0 0 TINNITUS UPPER RESPIRATORY INFECTION URINARY INCONTINENCE URINARY RETENTION URINARY TRACT INFECTION URINARY TRACT OBSTRUCTION URINARY TRACT PAIN VAGINAL FISTULA 1 0 VAGINAL HEMORRHAGE VAGINAL PAIN VAGINAL STRICTURE VASCULAR ACCESS COMPLICATION VASOVAGAL REACTION VERTIGO VOMITING 0 0
13 1 Toxicity WEIGHT GAIN 0 0 WEIGHT LOSS WHEEZING WHITE BLOOD CELL DECREASED 10 0 WOUND INFECTION 1 0 0
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