Trial Outcomes & Findings for A Study to Compare the Efficacy of Arfolitixorin Versus Leucovorin in Combination With 5 Fluorouracil, Oxaliplatin, and Bevacizumab in Patients With Advanced Colorectal Cancer (NCT NCT03750786)
NCT ID: NCT03750786
Last Updated: 2023-10-26
Results Overview
Best ORR, defined as the best response recorded from the start of the study treatment until the end of treatment.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
490 participants
Primary outcome timeframe
Until disease progression, an average of ten months
Results posted on
2023-10-26
Participant Flow
Participant milestones
| Measure |
Group A
ARFOX (Arfolitixorin and 5-FU and Oxaliplatin) and Bevacizumab
Arfolitixorin: Arfolitixorin and 5-FU and Oxaliplatin and Bevacizumab
|
Group B
mFOLFOX-6 (Leucovorin and 5-FU and Oxaliplatin) and Bevacizumab
Leucovorin: Leucovorin and 5-FU and Oxaliplatin and Bevacizumab
|
|---|---|---|
|
Overall Study
STARTED
|
245
|
245
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
245
|
245
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study to Compare the Efficacy of Arfolitixorin Versus Leucovorin in Combination With 5 Fluorouracil, Oxaliplatin, and Bevacizumab in Patients With Advanced Colorectal Cancer
Baseline characteristics by cohort
| Measure |
Group A
n=245 Participants
ARFOX (Arfolitixorin and 5-FU and Oxaliplatin) and Bevacizumab
Arfolitixorin: Arfolitixorin and 5-FU and Oxaliplatin and Bevacizumab
|
Group B
n=245 Participants
mFOLFOX-6 (Leucovorin and 5-FU and Oxaliplatin) and Bevacizumab
Leucovorin: Leucovorin and 5-FU and Oxaliplatin and Bevacizumab
|
Total
n=490 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62.4 years
STANDARD_DEVIATION 10.5 • n=5 Participants
|
62.6 years
STANDARD_DEVIATION 10.7 • n=7 Participants
|
62.5 years
STANDARD_DEVIATION 10.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
83 Participants
n=5 Participants
|
94 Participants
n=7 Participants
|
177 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
162 Participants
n=5 Participants
|
151 Participants
n=7 Participants
|
313 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
204 Participants
n=5 Participants
|
214 Participants
n=7 Participants
|
418 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
41 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
72 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
36 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
71 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
179 Participants
n=5 Participants
|
192 Participants
n=7 Participants
|
371 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
30 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
|
Time since initial diagnosis, months
|
9.7 months
STANDARD_DEVIATION 20.9 • n=5 Participants
|
7.7 months
STANDARD_DEVIATION 15.2 • n=7 Participants
|
8.7 months
STANDARD_DEVIATION 18.1 • n=5 Participants
|
PRIMARY outcome
Timeframe: Until disease progression, an average of ten monthsBest ORR, defined as the best response recorded from the start of the study treatment until the end of treatment.
Outcome measures
| Measure |
Group A
n=245 Participants
ARFOX (Arfolitixorin and 5-FU and Oxaliplatin) and Bevacizumab
Arfolitixorin: Arfolitixorin and 5-FU and Oxaliplatin and Bevacizumab
|
Group B
n=245 Participants
mFOLFOX-6 (Leucovorin and 5-FU and Oxaliplatin) and Bevacizumab
Leucovorin: Leucovorin and 5-FU and Oxaliplatin and Bevacizumab
|
|---|---|---|
|
Overall Response Rate
Complete Response
|
2 Participants
|
5 Participants
|
|
Overall Response Rate
Partial Response
|
116 Participants
|
116 Participants
|
|
Overall Response Rate
Stable Disease
|
106 Participants
|
86 Participants
|
|
Overall Response Rate
Progressive Disease
|
7 Participants
|
11 Participants
|
|
Overall Response Rate
Non-CR/Non-PD
|
6 Participants
|
3 Participants
|
|
Overall Response Rate
No BOR Available
|
6 Participants
|
18 Participants
|
|
Overall Response Rate
Not Evaluable
|
2 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: Until disease progression, an average of ten monthsPFS, defined as the time from randomization to first occurrence of tumor progression based on CT-scans/MRIs.
Outcome measures
| Measure |
Group A
n=245 Participants
ARFOX (Arfolitixorin and 5-FU and Oxaliplatin) and Bevacizumab
Arfolitixorin: Arfolitixorin and 5-FU and Oxaliplatin and Bevacizumab
|
Group B
n=245 Participants
mFOLFOX-6 (Leucovorin and 5-FU and Oxaliplatin) and Bevacizumab
Leucovorin: Leucovorin and 5-FU and Oxaliplatin and Bevacizumab
|
|---|---|---|
|
Progression Free Survival
|
12.8 months
Interval 10.9 to 13.2
|
11.6 months
Interval 11.0 to 14.5
|
SECONDARY outcome
Timeframe: Until disease progression, an average of ten monthsThe duration of response is measured from the time measurement criteria are first met for CR/PR until the first date that recurrent or progressive disease is objectively documented.
Outcome measures
| Measure |
Group A
n=118 Participants
ARFOX (Arfolitixorin and 5-FU and Oxaliplatin) and Bevacizumab
Arfolitixorin: Arfolitixorin and 5-FU and Oxaliplatin and Bevacizumab
|
Group B
n=121 Participants
mFOLFOX-6 (Leucovorin and 5-FU and Oxaliplatin) and Bevacizumab
Leucovorin: Leucovorin and 5-FU and Oxaliplatin and Bevacizumab
|
|---|---|---|
|
Duration of Response
|
12.2 months
Interval 11.1 to 14.1
|
12.9 months
Interval 10.6 to 15.0
|
Adverse Events
Group A
Serious events: 81 serious events
Other events: 239 other events
Deaths: 118 deaths
Group B
Serious events: 86 serious events
Other events: 231 other events
Deaths: 100 deaths
Serious adverse events
| Measure |
Group A
n=243 participants at risk
ARFOX (Arfolitixorin and 5-FU and Oxaliplatin) and Bevacizumab
Arfolitixorin: Arfolitixorin and 5-FU and Oxaliplatin and Bevacizumab
|
Group B
n=238 participants at risk
mFOLFOX-6 (Leucovorin and 5-FU and Oxaliplatin) and Bevacizumab
Leucovorin: Leucovorin and 5-FU and Oxaliplatin and Bevacizumab
|
|---|---|---|
|
Infections and infestations
Enterococcal Infection
|
0.41%
1/243 • 1 year
|
0.00%
0/238 • 1 year
|
|
Infections and infestations
Epididymitis
|
0.00%
0/243 • 1 year
|
0.42%
1/238 • 1 year
|
|
Infections and infestations
Escherichia Infection
|
0.41%
1/243 • 1 year
|
0.00%
0/238 • 1 year
|
|
Infections and infestations
Influenza
|
0.00%
0/243 • 1 year
|
0.42%
1/238 • 1 year
|
|
Infections and infestations
Intestinal Fistula Infection
|
0.41%
1/243 • 1 year
|
0.00%
0/238 • 1 year
|
|
Infections and infestations
Klebsiella Infection
|
0.41%
1/243 • 1 year
|
0.00%
0/238 • 1 year
|
|
Infections and infestations
Liver Abscess
|
0.00%
0/243 • 1 year
|
0.42%
1/238 • 1 year
|
|
Infections and infestations
Pelvic Abscess
|
0.00%
0/243 • 1 year
|
0.42%
1/238 • 1 year
|
|
Infections and infestations
Peritonitis
|
0.41%
1/243 • 1 year
|
0.00%
0/238 • 1 year
|
|
Infections and infestations
Pneumonia Viral
|
0.41%
1/243 • 1 year
|
0.00%
0/238 • 1 year
|
|
Infections and infestations
Pulmonary Sepsis
|
0.41%
1/243 • 1 year
|
0.00%
0/238 • 1 year
|
|
Infections and infestations
Pyelonephritis
|
0.41%
1/243 • 1 year
|
0.00%
0/238 • 1 year
|
|
Infections and infestations
Respiratory Tract Infection
|
0.41%
1/243 • 1 year
|
0.00%
0/238 • 1 year
|
|
Infections and infestations
Tracheobronchitis
|
0.00%
0/243 • 1 year
|
0.42%
1/238 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
3.3%
8/243 • 1 year
|
3.4%
8/238 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
0.82%
2/243 • 1 year
|
0.42%
1/238 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.41%
1/243 • 1 year
|
0.42%
1/238 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial Hyperreactivity
|
0.00%
0/243 • 1 year
|
0.42%
1/238 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea Exertional
|
0.41%
1/243 • 1 year
|
0.00%
0/238 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Hemoptysis
|
0.41%
1/243 • 1 year
|
0.00%
0/238 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial Lung Disease
|
0.41%
1/243 • 1 year
|
0.00%
0/238 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Lung Disorder
|
0.41%
1/243 • 1 year
|
0.00%
0/238 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.41%
1/243 • 1 year
|
0.00%
0/238 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/243 • 1 year
|
0.42%
1/238 • 1 year
|
|
General disorders
Pyrexia
|
2.5%
6/243 • 1 year
|
1.3%
3/238 • 1 year
|
|
General disorders
General Physical Health Deterioration
|
0.41%
1/243 • 1 year
|
1.3%
3/238 • 1 year
|
|
General disorders
Catheter Site Extravasation
|
0.41%
1/243 • 1 year
|
0.00%
0/238 • 1 year
|
|
General disorders
Chest Pain
|
0.00%
0/243 • 1 year
|
0.42%
1/238 • 1 year
|
|
General disorders
Condition Aggravated
|
0.41%
1/243 • 1 year
|
0.00%
0/238 • 1 year
|
|
General disorders
Mucosal Inflammation
|
0.00%
0/243 • 1 year
|
0.42%
1/238 • 1 year
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
1.2%
3/243 • 1 year
|
2.1%
5/238 • 1 year
|
|
Blood and lymphatic system disorders
Anemia
|
0.82%
2/243 • 1 year
|
0.42%
1/238 • 1 year
|
|
Blood and lymphatic system disorders
Hemolytic Anemia
|
0.41%
1/243 • 1 year
|
0.00%
0/238 • 1 year
|
|
Blood and lymphatic system disorders
Leukaemoid Reaction
|
0.00%
0/243 • 1 year
|
0.42%
1/238 • 1 year
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.41%
1/243 • 1 year
|
0.00%
0/238 • 1 year
|
|
Injury, poisoning and procedural complications
Fall
|
0.41%
1/243 • 1 year
|
0.42%
1/238 • 1 year
|
|
Injury, poisoning and procedural complications
Hip Fracture
|
0.41%
1/243 • 1 year
|
0.42%
1/238 • 1 year
|
|
Injury, poisoning and procedural complications
Gastrointestinal Anastomotic Leak
|
0.00%
0/243 • 1 year
|
0.42%
1/238 • 1 year
|
|
Injury, poisoning and procedural complications
Gastrointestinal Stoma Complication
|
0.41%
1/243 • 1 year
|
0.00%
0/238 • 1 year
|
|
Injury, poisoning and procedural complications
Infusion Related Reaction
|
0.41%
1/243 • 1 year
|
0.00%
0/238 • 1 year
|
|
Injury, poisoning and procedural complications
Pelvic Fracture
|
0.00%
0/243 • 1 year
|
0.42%
1/238 • 1 year
|
|
Injury, poisoning and procedural complications
Post Procedural Complication
|
0.41%
1/243 • 1 year
|
0.00%
0/238 • 1 year
|
|
Injury, poisoning and procedural complications
Rib Fracture
|
0.41%
1/243 • 1 year
|
0.00%
0/238 • 1 year
|
|
Injury, poisoning and procedural complications
Road Traffic Accident
|
0.41%
1/243 • 1 year
|
0.00%
0/238 • 1 year
|
|
Injury, poisoning and procedural complications
Skin Laceration
|
0.41%
1/243 • 1 year
|
0.00%
0/238 • 1 year
|
|
Injury, poisoning and procedural complications
Stoma Site Hemorrhage
|
0.00%
0/243 • 1 year
|
0.42%
1/238 • 1 year
|
|
Injury, poisoning and procedural complications
Wound Dehiscence
|
0.41%
1/243 • 1 year
|
0.00%
0/238 • 1 year
|
|
Renal and urinary disorders
Acute Kidney Injury
|
0.82%
2/243 • 1 year
|
1.3%
3/238 • 1 year
|
|
Renal and urinary disorders
Urinary Retention
|
0.41%
1/243 • 1 year
|
0.84%
2/238 • 1 year
|
|
Renal and urinary disorders
Renal Colic
|
0.41%
1/243 • 1 year
|
0.00%
0/238 • 1 year
|
|
Renal and urinary disorders
Ureterolithiasis
|
0.41%
1/243 • 1 year
|
0.00%
0/238 • 1 year
|
|
Cardiac disorders
Atrial Fibrillation
|
0.41%
1/243 • 1 year
|
0.42%
1/238 • 1 year
|
|
Cardiac disorders
Acute Left Ventricular Failure
|
0.00%
0/243 • 1 year
|
0.42%
1/238 • 1 year
|
|
Cardiac disorders
Acute Myocardial Infarction
|
0.41%
1/243 • 1 year
|
0.00%
0/238 • 1 year
|
|
Cardiac disorders
Atrial Thrombosis
|
0.00%
0/243 • 1 year
|
0.42%
1/238 • 1 year
|
|
Cardiac disorders
Bradycardia
|
0.41%
1/243 • 1 year
|
0.00%
0/238 • 1 year
|
|
Cardiac disorders
Cardiac Failure Acute
|
0.41%
1/243 • 1 year
|
0.00%
0/238 • 1 year
|
|
Cardiac disorders
Cardio-Respiratory Arrest
|
0.41%
1/243 • 1 year
|
0.00%
0/238 • 1 year
|
|
Cardiac disorders
Coronary Artery Disease
|
0.41%
1/243 • 1 year
|
0.00%
0/238 • 1 year
|
|
Cardiac disorders
Low Cardiac Output Syndrome
|
0.41%
1/243 • 1 year
|
0.00%
0/238 • 1 year
|
|
Cardiac disorders
Myocardial Infarction
|
0.41%
1/243 • 1 year
|
0.00%
0/238 • 1 year
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.82%
2/243 • 1 year
|
0.42%
1/238 • 1 year
|
|
Metabolism and nutrition disorders
Acidosis Hyperchloremic
|
0.41%
1/243 • 1 year
|
0.00%
0/238 • 1 year
|
|
Metabolism and nutrition disorders
Diabetes Mellitus
|
0.41%
1/243 • 1 year
|
0.00%
0/238 • 1 year
|
|
Metabolism and nutrition disorders
Diabetic Ketoacidosis
|
0.00%
0/243 • 1 year
|
0.42%
1/238 • 1 year
|
|
Metabolism and nutrition disorders
Diabetic Metabolic Decompensation
|
0.41%
1/243 • 1 year
|
0.00%
0/238 • 1 year
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.41%
1/243 • 1 year
|
0.00%
0/238 • 1 year
|
|
Metabolism and nutrition disorders
Lactic Acidosis
|
0.41%
1/243 • 1 year
|
0.00%
0/238 • 1 year
|
|
Nervous system disorders
Syncope
|
0.82%
2/243 • 1 year
|
0.42%
1/238 • 1 year
|
|
Nervous system disorders
Encephalopathy
|
0.41%
1/243 • 1 year
|
0.00%
0/238 • 1 year
|
|
Nervous system disorders
Hypersomnia
|
0.41%
1/243 • 1 year
|
0.00%
0/238 • 1 year
|
|
Nervous system disorders
Lethargy
|
0.41%
1/243 • 1 year
|
0.00%
0/238 • 1 year
|
|
Nervous system disorders
Metabolic Encephalopathy
|
0.41%
1/243 • 1 year
|
0.00%
0/238 • 1 year
|
|
Nervous system disorders
Myoclonus
|
0.41%
1/243 • 1 year
|
0.00%
0/238 • 1 year
|
|
Nervous system disorders
Peroneal Nerve Palsy
|
0.41%
1/243 • 1 year
|
0.00%
0/238 • 1 year
|
|
Nervous system disorders
Status Epilepticus
|
0.41%
1/243 • 1 year
|
0.00%
0/238 • 1 year
|
|
Nervous system disorders
Transient Ischemic Attack
|
0.00%
0/243 • 1 year
|
0.42%
1/238 • 1 year
|
|
Hepatobiliary disorders
Cholangitis
|
0.00%
0/243 • 1 year
|
0.84%
2/238 • 1 year
|
|
Hepatobiliary disorders
Biliary Fistula
|
0.41%
1/243 • 1 year
|
0.00%
0/238 • 1 year
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/243 • 1 year
|
0.42%
1/238 • 1 year
|
|
Hepatobiliary disorders
Hepatic Function Abnormal
|
0.00%
0/243 • 1 year
|
0.42%
1/238 • 1 year
|
|
Hepatobiliary disorders
Jaundice
|
0.41%
1/243 • 1 year
|
0.00%
0/238 • 1 year
|
|
Hepatobiliary disorders
Portosplenomesenteric Venous Thrombosis
|
0.00%
0/243 • 1 year
|
0.42%
1/238 • 1 year
|
|
Vascular disorders
Depp Vein Thrombosis
|
0.82%
2/243 • 1 year
|
0.00%
0/238 • 1 year
|
|
Vascular disorders
Embolism Arterial
|
0.00%
0/243 • 1 year
|
0.42%
1/238 • 1 year
|
|
Vascular disorders
Hypertension
|
0.00%
0/243 • 1 year
|
0.42%
1/238 • 1 year
|
|
Vascular disorders
Hypotension
|
0.41%
1/243 • 1 year
|
0.00%
0/238 • 1 year
|
|
Vascular disorders
Superior Vena Cava Syndrome
|
0.41%
1/243 • 1 year
|
0.00%
0/238 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung Neoplasm Malignant
|
0.00%
0/243 • 1 year
|
0.42%
1/238 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate Cancer
|
0.41%
1/243 • 1 year
|
0.00%
0/238 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour Perforation
|
0.00%
0/243 • 1 year
|
0.42%
1/238 • 1 year
|
|
Investigations
C-Reactive Protein Increased
|
0.41%
1/243 • 1 year
|
0.00%
0/238 • 1 year
|
|
Investigations
Neutrophil Count Decreased
|
0.41%
1/243 • 1 year
|
0.00%
0/238 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/243 • 1 year
|
0.42%
1/238 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Flank Pain
|
0.41%
1/243 • 1 year
|
0.00%
0/238 • 1 year
|
|
Congenital, familial and genetic disorders
Hypertrophic Cardiomyopathy
|
0.00%
0/243 • 1 year
|
0.42%
1/238 • 1 year
|
|
Eye disorders
Retinal Detachment
|
0.00%
0/243 • 1 year
|
0.42%
1/238 • 1 year
|
|
Immune system disorders
Anaphylactic Shock
|
0.00%
0/243 • 1 year
|
0.42%
1/238 • 1 year
|
|
Reproductive system and breast disorders
Rectoprostatic Fistula
|
0.41%
1/243 • 1 year
|
0.00%
0/238 • 1 year
|
|
Skin and subcutaneous tissue disorders
Night Sweats
|
0.00%
0/243 • 1 year
|
0.42%
1/238 • 1 year
|
|
Gastrointestinal disorders
Abdominal Hernia
|
0.00%
0/243 • 1 year
|
0.42%
1/238 • 1 year
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.82%
2/243 • 1 year
|
2.9%
7/238 • 1 year
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
0.82%
2/243 • 1 year
|
0.00%
0/238 • 1 year
|
|
Gastrointestinal disorders
Colitis
|
0.82%
2/243 • 1 year
|
0.42%
1/238 • 1 year
|
|
Gastrointestinal disorders
Crohn's Disease
|
0.41%
1/243 • 1 year
|
0.00%
0/238 • 1 year
|
|
Gastrointestinal disorders
Diarrhea
|
0.82%
2/243 • 1 year
|
0.42%
1/238 • 1 year
|
|
Gastrointestinal disorders
Enterocolitis
|
0.41%
1/243 • 1 year
|
0.00%
0/238 • 1 year
|
|
Gastrointestinal disorders
Gastrointestinal Hemorrhage
|
0.00%
0/243 • 1 year
|
0.42%
1/238 • 1 year
|
|
Gastrointestinal disorders
Ileus
|
0.82%
2/243 • 1 year
|
0.00%
0/238 • 1 year
|
|
Gastrointestinal disorders
Inguinal Hernia
|
0.00%
0/243 • 1 year
|
0.42%
1/238 • 1 year
|
|
Gastrointestinal disorders
Intestinal Obstruction
|
2.5%
6/243 • 1 year
|
4.2%
10/238 • 1 year
|
|
Gastrointestinal disorders
Intestinal Perforation
|
0.41%
1/243 • 1 year
|
0.00%
0/238 • 1 year
|
|
Gastrointestinal disorders
Intra-Abdominal Hemorrhage
|
0.41%
1/243 • 1 year
|
0.00%
0/238 • 1 year
|
|
Gastrointestinal disorders
Large Intestinal Obstruction
|
2.1%
5/243 • 1 year
|
1.7%
4/238 • 1 year
|
|
Gastrointestinal disorders
Large Intestine Perforation
|
1.2%
3/243 • 1 year
|
0.84%
2/238 • 1 year
|
|
Gastrointestinal disorders
Lower Gastrointestinal Hemorrhage
|
0.41%
1/243 • 1 year
|
0.00%
0/238 • 1 year
|
|
Gastrointestinal disorders
Melena
|
0.41%
1/243 • 1 year
|
0.00%
0/238 • 1 year
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/243 • 1 year
|
0.42%
1/238 • 1 year
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/243 • 1 year
|
0.42%
1/238 • 1 year
|
|
Gastrointestinal disorders
Pancreatitis Acute
|
0.41%
1/243 • 1 year
|
0.00%
0/238 • 1 year
|
|
Gastrointestinal disorders
Rectal Hemorrhage
|
0.41%
1/243 • 1 year
|
0.84%
2/238 • 1 year
|
|
Gastrointestinal disorders
Rectal Perforation
|
0.00%
0/243 • 1 year
|
0.42%
1/238 • 1 year
|
|
Gastrointestinal disorders
Small Intestinal Obstruction
|
1.2%
3/243 • 1 year
|
2.1%
5/238 • 1 year
|
|
Gastrointestinal disorders
Subileus
|
0.41%
1/243 • 1 year
|
0.00%
0/238 • 1 year
|
|
Gastrointestinal disorders
Vomiting
|
0.41%
1/243 • 1 year
|
0.00%
0/238 • 1 year
|
|
Infections and infestations
Abdominal Abscess
|
0.41%
1/243 • 1 year
|
0.00%
0/238 • 1 year
|
|
Infections and infestations
Abdominal Sepsis
|
0.41%
1/243 • 1 year
|
0.00%
0/238 • 1 year
|
|
Infections and infestations
Abdominal Wall Abscess
|
0.41%
1/243 • 1 year
|
0.00%
0/238 • 1 year
|
|
Infections and infestations
Appendicitis
|
0.00%
0/243 • 1 year
|
0.42%
1/238 • 1 year
|
|
Infections and infestations
Bacteremia
|
0.00%
0/243 • 1 year
|
0.42%
1/238 • 1 year
|
|
Infections and infestations
Biliary Tract Infection
|
0.00%
0/243 • 1 year
|
0.42%
1/238 • 1 year
|
|
Infections and infestations
Clostridium Difficile Infection
|
0.41%
1/243 • 1 year
|
0.00%
0/238 • 1 year
|
|
Infections and infestations
Corona Virus Infection
|
1.2%
3/243 • 1 year
|
0.42%
1/238 • 1 year
|
|
Infections and infestations
Ecthyma
|
0.00%
0/243 • 1 year
|
0.42%
1/238 • 1 year
|
|
Infections and infestations
Pneumonia
|
1.2%
3/243 • 1 year
|
0.42%
1/238 • 1 year
|
|
Infections and infestations
Sepsis
|
1.2%
3/243 • 1 year
|
1.3%
3/238 • 1 year
|
|
Infections and infestations
Septic Shock
|
0.41%
1/243 • 1 year
|
0.42%
1/238 • 1 year
|
|
Infections and infestations
Urinary Tract Infection
|
0.41%
1/243 • 1 year
|
1.7%
4/238 • 1 year
|
|
Infections and infestations
Urosepsis
|
0.00%
0/243 • 1 year
|
0.84%
2/238 • 1 year
|
|
Infections and infestations
Device Related Infection
|
1.2%
3/243 • 1 year
|
1.3%
3/238 • 1 year
|
Other adverse events
| Measure |
Group A
n=243 participants at risk
ARFOX (Arfolitixorin and 5-FU and Oxaliplatin) and Bevacizumab
Arfolitixorin: Arfolitixorin and 5-FU and Oxaliplatin and Bevacizumab
|
Group B
n=238 participants at risk
mFOLFOX-6 (Leucovorin and 5-FU and Oxaliplatin) and Bevacizumab
Leucovorin: Leucovorin and 5-FU and Oxaliplatin and Bevacizumab
|
|---|---|---|
|
Nervous system disorders
Neurotoxicity
|
16.5%
40/243 • 1 year
|
9.2%
22/238 • 1 year
|
|
Nervous system disorders
Dizziness
|
9.5%
23/243 • 1 year
|
8.4%
20/238 • 1 year
|
|
Nervous system disorders
Polyneuropathy
|
6.6%
16/243 • 1 year
|
6.7%
16/238 • 1 year
|
|
Nervous system disorders
Hypoaesthesia
|
4.5%
11/243 • 1 year
|
7.6%
18/238 • 1 year
|
|
Gastrointestinal disorders
Dyspepsia
|
4.9%
12/243 • 1 year
|
9.7%
23/238 • 1 year
|
|
Gastrointestinal disorders
Gastroesophageal Reflux Disease
|
8.2%
20/243 • 1 year
|
5.0%
12/238 • 1 year
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
6.6%
16/243 • 1 year
|
5.9%
14/238 • 1 year
|
|
General disorders
Malaise
|
5.3%
13/243 • 1 year
|
5.5%
13/238 • 1 year
|
|
General disorders
Oedema Peripheral
|
5.3%
13/243 • 1 year
|
3.4%
8/238 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
8.6%
21/243 • 1 year
|
8.0%
19/238 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
3.7%
9/243 • 1 year
|
9.2%
22/238 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.2%
20/243 • 1 year
|
4.2%
10/238 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
8.6%
21/243 • 1 year
|
2.9%
7/238 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
5.8%
14/243 • 1 year
|
5.9%
14/238 • 1 year
|
|
Investigations
Weight Decreased
|
9.1%
22/243 • 1 year
|
8.4%
20/238 • 1 year
|
|
Investigations
Aspartate Aminotransferase Increased
|
9.1%
22/243 • 1 year
|
5.5%
13/238 • 1 year
|
|
Investigations
Alanine Aminotransferase Increased
|
9.5%
23/243 • 1 year
|
4.6%
11/238 • 1 year
|
|
Investigations
Gamma-glutamyltransferase Increased
|
5.8%
14/243 • 1 year
|
7.1%
17/238 • 1 year
|
|
Investigations
Blood Alkaline Phosphatase Increased
|
3.7%
9/243 • 1 year
|
5.9%
14/238 • 1 year
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
7.4%
18/243 • 1 year
|
11.8%
28/238 • 1 year
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
2.5%
6/243 • 1 year
|
6.7%
16/238 • 1 year
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
5.3%
13/243 • 1 year
|
8.8%
21/238 • 1 year
|
|
Skin and subcutaneous tissue disorders
Rash
|
4.9%
12/243 • 1 year
|
5.5%
13/238 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
9.5%
23/243 • 1 year
|
10.5%
25/238 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.2%
15/243 • 1 year
|
4.6%
11/238 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
4.5%
11/243 • 1 year
|
5.5%
13/238 • 1 year
|
|
Renal and urinary disorders
Proteinuria
|
9.5%
23/243 • 1 year
|
5.5%
13/238 • 1 year
|
|
Psychiatric disorders
Insomnia
|
4.5%
11/243 • 1 year
|
7.6%
18/238 • 1 year
|
|
Psychiatric disorders
Depression
|
2.1%
5/243 • 1 year
|
5.5%
13/238 • 1 year
|
|
Blood and lymphatic system disorders
Anemia
|
18.1%
44/243 • 1 year
|
21.4%
51/238 • 1 year
|
|
Blood and lymphatic system disorders
Neutropenia
|
24.7%
60/243 • 1 year
|
21.4%
51/238 • 1 year
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
13.2%
32/243 • 1 year
|
11.8%
28/238 • 1 year
|
|
Gastrointestinal disorders
Abdominal Pain
|
21.0%
51/243 • 1 year
|
21.0%
50/238 • 1 year
|
|
Gastrointestinal disorders
Constipation
|
28.4%
69/243 • 1 year
|
26.9%
64/238 • 1 year
|
|
Gastrointestinal disorders
Diarrhea
|
48.6%
118/243 • 1 year
|
47.5%
113/238 • 1 year
|
|
Gastrointestinal disorders
Nausea
|
48.1%
117/243 • 1 year
|
51.7%
123/238 • 1 year
|
|
Gastrointestinal disorders
Stomatitis
|
21.4%
52/243 • 1 year
|
26.1%
62/238 • 1 year
|
|
Gastrointestinal disorders
Vomiting
|
24.7%
60/243 • 1 year
|
23.1%
55/238 • 1 year
|
|
General disorders
Asthenia
|
19.8%
48/243 • 1 year
|
17.6%
42/238 • 1 year
|
|
General disorders
Fatigue
|
44.4%
108/243 • 1 year
|
43.3%
103/238 • 1 year
|
|
General disorders
Mucosal Inflammation
|
21.8%
53/243 • 1 year
|
20.6%
49/238 • 1 year
|
|
General disorders
Pyrexia
|
18.5%
45/243 • 1 year
|
16.4%
39/238 • 1 year
|
|
Infections and infestations
Urinary Tract Infection
|
9.9%
24/243 • 1 year
|
11.3%
27/238 • 1 year
|
|
Investigations
Neutrophil Count Decreased
|
21.8%
53/243 • 1 year
|
26.1%
62/238 • 1 year
|
|
Investigations
Platelet Count Decreased
|
13.6%
33/243 • 1 year
|
14.7%
35/238 • 1 year
|
|
Investigations
White Blood Cell Count Decreased
|
9.9%
24/243 • 1 year
|
10.5%
25/238 • 1 year
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
27.2%
66/243 • 1 year
|
25.2%
60/238 • 1 year
|
|
Nervous system disorders
Dysesthesia
|
10.7%
26/243 • 1 year
|
13.0%
31/238 • 1 year
|
|
Nervous system disorders
Dysgeusia
|
16.5%
40/243 • 1 year
|
15.5%
37/238 • 1 year
|
|
Nervous system disorders
Headache
|
10.3%
25/243 • 1 year
|
10.1%
24/238 • 1 year
|
|
Nervous system disorders
Neuropathy Peripheral
|
30.0%
73/243 • 1 year
|
26.9%
64/238 • 1 year
|
|
Nervous system disorders
Paresthesia
|
14.8%
36/243 • 1 year
|
17.6%
42/238 • 1 year
|
|
Nervous system disorders
Peripheral Sensory Neuropathy
|
27.2%
66/243 • 1 year
|
30.3%
72/238 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
26.3%
64/243 • 1 year
|
26.1%
62/238 • 1 year
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
8.6%
21/243 • 1 year
|
13.4%
32/238 • 1 year
|
|
Skin and subcutaneous tissue disorders
Palmar-Plantar Erythrodysesthesia Syndrome
|
8.2%
20/243 • 1 year
|
12.2%
29/238 • 1 year
|
|
Vascular disorders
Hypertension
|
22.6%
55/243 • 1 year
|
25.2%
60/238 • 1 year
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place