Trial Outcomes & Findings for Fluorouracil, Leucovorin, and Oxaliplatin With or Without Bevacizumab in Treating Patients Who Have Undergone Surgery for Stage II or Stage III Colon Cancer (NCT NCT00096278)

NCT ID: NCT00096278

Last Updated: 2019-07-30

Results Overview

Where events are defined as recurrence, second primary cancer, or death from any cause

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 2710 participants
• Primary outcome timeframe: 3 years
• Results posted on: 2019-07-30

Participant Flow

Participant milestones

Measure	Arm 1: Oxaliplatin + Leucovorin + 5-Fluorouracil Oxaliplatin + Leucovorin + 5-Fluorouracil	Arm 2: Oxaliplatin + Leucovorin + 5-Fluorouracil + Bevacizumab Oxaliplatin + Leucovorin + 5-Fluorouracil + Bevacizumab
Overall Study STARTED	1356	1354
Overall Study COMPLETED	1338	1334
Overall Study NOT COMPLETED	18	20

Reasons for withdrawal

Measure	Arm 1: Oxaliplatin + Leucovorin + 5-Fluorouracil Oxaliplatin + Leucovorin + 5-Fluorouracil	Arm 2: Oxaliplatin + Leucovorin + 5-Fluorouracil + Bevacizumab Oxaliplatin + Leucovorin + 5-Fluorouracil + Bevacizumab
Overall Study No follow-up data	15	18
Overall Study Patient not at risk for primary endpoint	3	2

Baseline Characteristics

Fluorouracil, Leucovorin, and Oxaliplatin With or Without Bevacizumab in Treating Patients Who Have Undergone Surgery for Stage II or Stage III Colon Cancer

Baseline characteristics by cohort

Measure	Oxaliplatin + Leucovorin + 5-Fluorouracil n=1356 Participants Oxaliplatin + Leucovorin + 5-Fluorouracil	Oxaliplatin + Leucovorin + 5-Fluorouracil + Bevacizumab n=1354 Participants Oxaliplatin + Leucovorin + 5-Fluorouracil + Bevacizumab	Total n=2710 Participants Total of all reporting groups
Age, Continuous	57 years STANDARD_DEVIATION 11.6 • n=5 Participants	56 years STANDARD_DEVIATION 11.3 • n=7 Participants	57 years STANDARD_DEVIATION 11.4 • n=5 Participants
Sex: Female, Male Female	680 Participants n=5 Participants	678 Participants n=7 Participants	1358 Participants n=5 Participants
Sex: Female, Male Male	676 Participants n=5 Participants	676 Participants n=7 Participants	1352 Participants n=5 Participants

PRIMARY outcome

Timeframe: 3 years

Where events are defined as recurrence, second primary cancer, or death from any cause

Outcome measures

Measure	Arm 1: Oxaliplatin + Leucovorin + 5-Fluorouracil n=1338 Participants Oxaliplatin + Leucovorin + 5-Fluorouracil	Arm 2: Oxaliplatin + Leucovorin + 5-Fluorouracil + Bevacizumab n=1334 Participants Oxaliplatin + Leucovorin + 5-Fluorouracil + Bevacizumab
Disease-free Survival	75.5 percentage of patients	77.4 percentage of patients

SECONDARY outcome

Timeframe: 5 years

Population: Survival analysis was done 2 years after Disease Free Survival analysis. For Arm 2 one additional patient had follow up at the later analysis.

Percentage of patients who did not experience an event where events are defined as death from any cause.

Outcome measures

Measure	Arm 1: Oxaliplatin + Leucovorin + 5-Fluorouracil n=1338 Participants Oxaliplatin + Leucovorin + 5-Fluorouracil	Arm 2: Oxaliplatin + Leucovorin + 5-Fluorouracil + Bevacizumab n=1335 Participants Oxaliplatin + Leucovorin + 5-Fluorouracil + Bevacizumab
Survival	77.6 percentage of patients	78.7 percentage of patients

OTHER_PRE_SPECIFIED outcome

Timeframe: Group 2: Pre-therapy, every 2 weeks during chemotherapy/bevacizumab therapy, every 6 weeks during bevacizumab therapy and at 3 and 6 months after completion of bevacizumab therapy

Population: Results of definitive analysis were negative. Tertiary outcomes therefore were not analyzed.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Group 2: Measured pre-therapy and then every 6 months for 2 years following randomization

Population: Results of definitive analysis were negative. Tertiary outcomes therefore were not analyzed.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Events measured regularly during chemotherapy and bevacizumab therapy

Population: Results of definitive analysis were negative. Tertiary outcomes therefore were not analyzed.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Group 2, every 3 months for one year post treatment

Population: Results of definitive analysis were negative. Tertiary outcomes therefore were not analyzed.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: For Groups 1 and 2 at the end of every 3 cycles of chemotherapy plus or minus bevacizumab; for Group 2 patients, every 6 weeks for 6 months. If UPC ratio is greater than or equal to 1.0 at the end of therapy then test every 3 months for 12 months

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: For Groups 1 and 2 at the end of every 3 cycles of chemotherapy plus or minus bevacizumab; for Group 2 patients, every 6 weeks for 6 months. If UPC ratio is greater than or equal to 1.0 at the end of therapy then test every 3 months for 12 months

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: For Groups 1 and 2 at the end of every 3 cycles of chemotherapy plus or minus bevacizumab; for Group 2 patients, every 6 weeks for 6 months. If UPC ratio is greater than or equal to 1.0 at the end of therapy then test every 3 months for 12 months

Outcome measures

Outcome data not reported

Adverse Events

Oxaliplatin + Leucovorin + 5-Fluorouracil

Serious events: 81 serious events

Other events: 954 other events

Deaths: 0 deaths

Oxaliplatin + Leucovorin + 5-Fluorouracil + Bevacizumab

Serious events: 270 serious events

Other events: 1043 other events

Deaths: 0 deaths

Serious adverse events

Measure	Oxaliplatin + Leucovorin + 5-Fluorouracil n=1326 participants at risk Oxaliplatin + Leucovorin + 5-Fluorouracil	Oxaliplatin + Leucovorin + 5-Fluorouracil + Bevacizumab n=1334 participants at risk Oxaliplatin + Leucovorin + 5-Fluorouracil + Bevacizumab
Gastrointestinal disorders Abdominal distension	0.00% 0/1326 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.	0.22% 3/1334 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.
Gastrointestinal disorders Abdominal pain	0.08% 1/1326 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.	1.1% 15/1334 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.
Metabolism and nutrition disorders Acidosis	0.08% 1/1326 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.	0.30% 4/1334 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.
Investigations Activated partial thromboplastin time prolonged	0.08% 1/1326 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.	0.00% 0/1334 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.
Respiratory, thoracic and mediastinal disorders Adult respiratory distress syndrome	0.15% 2/1326 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.	0.07% 1/1334 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.
Investigations Alanine aminotransferase increased (ALT/SGPT)	0.08% 1/1326 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.	0.22% 3/1334 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.
Investigations Alkaline phosphatase increased	0.08% 1/1326 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.	0.07% 1/1334 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.
Blood and lymphatic system disorders Anemia	0.23% 3/1326 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.	0.22% 3/1334 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.
Metabolism and nutrition disorders Anorexia	0.00% 0/1326 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.	0.22% 3/1334 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.
Psychiatric disorders Anxiety	0.00% 0/1326 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.	0.07% 1/1334 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.
Infections and infestations Appendicitis	0.08% 1/1326 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.	0.00% 0/1334 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.
Infections and infestations Appendicitis perforated	0.08% 1/1326 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.	0.00% 0/1334 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.
Musculoskeletal and connective tissue disorders Arthralgia	0.08% 1/1326 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.	0.07% 1/1334 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.
Musculoskeletal and connective tissue disorders Arthritis	0.00% 0/1326 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.	0.07% 1/1334 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.
Gastrointestinal disorders Ascites	0.00% 0/1326 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.	0.07% 1/1334 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.
Investigations Aspartate aminotransferase increased (AST/SGOT)	0.08% 1/1326 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.	0.30% 4/1334 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.
Respiratory, thoracic and mediastinal disorders Aspiration	0.00% 0/1326 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.	0.07% 1/1334 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.
Cardiac disorders Atrial fibrillation	0.23% 3/1326 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.	0.30% 4/1334 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.
Musculoskeletal and connective tissue disorders Back pain	0.08% 1/1326 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.	0.30% 4/1334 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.
Infections and infestations Bladder infection	0.00% 0/1326 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.	0.15% 2/1334 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.
Blood and lymphatic system disorders Blood and lymphatic system disorders - Other, specify	0.00% 0/1326 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.	0.07% 1/1334 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.
Investigations Blood bilirubin increased	0.08% 1/1326 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.	0.22% 3/1334 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.
Cardiac disorders Cardiac arrest	0.15% 2/1326 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.	0.00% 0/1334 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.
Cardiac disorders Cardiac disorders - Other, specify	0.00% 0/1326 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.	0.15% 2/1334 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.
Investigations Cardiac troponin I increased	0.15% 2/1326 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.	0.45% 6/1334 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.
Investigations Cardiac troponin T increased	0.00% 0/1326 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.	0.22% 3/1334 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.
Infections and infestations Catheter related infection	0.15% 2/1326 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.	0.60% 8/1334 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.
Cardiac disorders Chest pain - cardiac	0.00% 0/1326 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.	0.15% 2/1334 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.
General disorders Chills	0.00% 0/1326 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.	0.07% 1/1334 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.
Hepatobiliary disorders Cholecystitis	0.08% 1/1326 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.	0.52% 7/1334 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.
Investigations Cholesterol high	0.15% 2/1326 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.	0.00% 0/1334 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.
Gastrointestinal disorders Colitis	0.08% 1/1326 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.	0.45% 6/1334 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.
Gastrointestinal disorders Colonic hemorrhage	0.08% 1/1326 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.	0.07% 1/1334 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.
Gastrointestinal disorders Colonic obstruction	0.00% 0/1326 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.	0.07% 1/1334 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.
Gastrointestinal disorders Colonic perforation	0.00% 0/1326 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.	0.22% 3/1334 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.
Gastrointestinal disorders Colonic stenosis	0.00% 0/1326 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.	0.07% 1/1334 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.
Cardiac disorders Conduction disorder	0.00% 0/1326 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.	0.15% 2/1334 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.
Psychiatric disorders Confusion	0.00% 0/1326 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.	0.30% 4/1334 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.
Gastrointestinal disorders Constipation	0.00% 0/1326 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.	0.22% 3/1334 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/1326 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.	0.22% 3/1334 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.
Investigations Creatinine increased	0.15% 2/1326 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.	0.37% 5/1334 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.
General disorders Death NOS	0.00% 0/1326 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.	0.30% 4/1334 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.
Metabolism and nutrition disorders Dehydration	0.15% 2/1326 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.	1.6% 22/1334 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.
Nervous system disorders Depressed level of consciousness	0.00% 0/1326 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.	0.15% 2/1334 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.
Psychiatric disorders Depression	0.00% 0/1326 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.	0.15% 2/1334 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.
Gastrointestinal disorders Diarrhea	0.08% 1/1326 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.	1.5% 20/1334 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.
Blood and lymphatic system disorders Disseminated intravascular coagulation	0.08% 1/1326 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.	0.00% 0/1334 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.
Nervous system disorders Dizziness	0.00% 0/1326 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.	0.45% 6/1334 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.
Gastrointestinal disorders Duodenal obstruction	0.00% 0/1326 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.	0.07% 1/1334 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.
Gastrointestinal disorders Duodenal perforation	0.08% 1/1326 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.	0.07% 1/1334 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.
Gastrointestinal disorders Duodenal ulcer	0.00% 0/1326 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.	0.07% 1/1334 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.
Nervous system disorders Dysgeusia	0.00% 0/1326 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.	0.15% 2/1334 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.
Gastrointestinal disorders Dyspepsia	0.00% 0/1326 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.	0.07% 1/1334 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.
Respiratory, thoracic and mediastinal disorders Dyspnea	0.23% 3/1326 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.	0.97% 13/1334 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.
General disorders Edema face	0.00% 0/1326 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.	0.07% 1/1334 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.
Investigations Electrocardiogram QT corrected interval prolonged	0.00% 0/1326 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.	0.07% 1/1334 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.
Endocrine disorders Endocrine disorders - Other, specify	0.08% 1/1326 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.	0.00% 0/1334 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.
Gastrointestinal disorders Enterocolitis	0.00% 0/1326 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.	0.22% 3/1334 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.15% 2/1326 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.	0.00% 0/1334 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.
Gastrointestinal disorders Esophagitis	0.00% 0/1326 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.	0.07% 1/1334 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.
Eye disorders Extraocular muscle paresis	0.00% 0/1326 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.	0.07% 1/1334 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.
Eye disorders Eye disorders - Other, specify	0.00% 0/1326 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.	0.07% 1/1334 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.
General disorders Fatigue	0.00% 0/1326 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.	0.67% 9/1334 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.
Blood and lymphatic system disorders Febrile neutropenia	0.08% 1/1326 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.	0.30% 4/1334 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.
General disorders Fever	0.00% 0/1326 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.	0.22% 3/1334 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.
Injury, poisoning and procedural complications Fracture	0.00% 0/1326 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.	0.15% 2/1334 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.
Gastrointestinal disorders Gastric ulcer	0.08% 1/1326 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.	0.00% 0/1334 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.
Gastrointestinal disorders Gastrointestinal disorders - Other, specify	0.00% 0/1326 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.	0.30% 4/1334 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.
Gastrointestinal disorders Gastrointestinal pain	0.00% 0/1326 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.	0.07% 1/1334 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.
General disorders General disorders and administration site conditions - Other, specify	0.00% 0/1326 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.	0.22% 3/1334 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.
Nervous system disorders Headache	0.08% 1/1326 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.	0.37% 5/1334 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.
Cardiac disorders Heart failure	0.00% 0/1326 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.	0.15% 2/1334 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.
Vascular disorders Hematoma	0.08% 1/1326 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.	0.00% 0/1334 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.
Renal and urinary disorders Hematuria	0.00% 0/1326 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.	0.07% 1/1334 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.
Blood and lymphatic system disorders Hemolysis	0.00% 0/1326 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.	0.07% 1/1334 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.
Hepatobiliary disorders Hepatobiliary disorders - Other, specify	0.00% 0/1326 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.	0.15% 2/1334 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.
Metabolism and nutrition disorders Hyperglycemia	0.45% 6/1326 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.	0.67% 9/1334 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.
Metabolism and nutrition disorders Hyperkalemia	0.00% 0/1326 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.	0.15% 2/1334 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.
Vascular disorders Hypertension	0.00% 0/1326 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.	1.3% 17/1334 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.
Metabolism and nutrition disorders Hypertriglyceridemia	0.15% 2/1326 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.	0.15% 2/1334 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.
Metabolism and nutrition disorders Hyperuricemia	0.08% 1/1326 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.	0.07% 1/1334 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.
Metabolism and nutrition disorders Hypoalbuminemia	0.08% 1/1326 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.	0.22% 3/1334 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.
Metabolism and nutrition disorders Hypocalcemia	0.08% 1/1326 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.	0.22% 3/1334 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.
Metabolism and nutrition disorders Hypoglycemia	0.00% 0/1326 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.	0.07% 1/1334 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.
Metabolism and nutrition disorders Hypokalemia	0.00% 0/1326 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.	0.67% 9/1334 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.
Metabolism and nutrition disorders Hyponatremia	0.08% 1/1326 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.	0.45% 6/1334 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.
Metabolism and nutrition disorders Hypophosphatemia	0.00% 0/1326 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.	0.30% 4/1334 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.
Vascular disorders Hypotension	0.00% 0/1326 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.	0.30% 4/1334 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.15% 2/1326 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.	0.30% 4/1334 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.
Gastrointestinal disorders Ileus	0.08% 1/1326 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.	0.60% 8/1334 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.
Infections and infestations Infections and infestations - Other, specify	0.15% 2/1326 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.	0.90% 12/1334 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.
General disorders Injection site reaction	0.00% 0/1326 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.	0.07% 1/1334 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.
Injury, poisoning and procedural complications Injury, poisoning and procedural complications - Other, specify	0.00% 0/1326 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.	0.07% 1/1334 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.
Investigations INR increased	0.23% 3/1326 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.	0.15% 2/1334 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.
Nervous system disorders Intracranial hemorrhage	0.15% 2/1326 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.	0.07% 1/1334 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.
Investigations Investigations - Other, specify	0.00% 0/1326 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.	0.07% 1/1334 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.
Nervous system disorders Ischemia cerebrovascular	0.00% 0/1326 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.	0.07% 1/1334 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.
Infections and infestations Kidney infection	0.00% 0/1326 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.	0.07% 1/1334 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.
Investigations Lipase increased	0.00% 0/1326 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.	0.37% 5/1334 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.
Gastrointestinal disorders Mucositis oral	0.08% 1/1326 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.	0.07% 1/1334 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.
Cardiac disorders Myocardial infarction	0.53% 7/1326 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.	0.67% 9/1334 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.
Musculoskeletal and connective tissue disorders Myositis	0.00% 0/1326 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.	0.07% 1/1334 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.
Gastrointestinal disorders Nausea	0.08% 1/1326 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.	1.0% 14/1334 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/1326 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.	0.22% 3/1334 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.
Nervous system disorders Nervous system disorders - Other, specify	0.30% 4/1326 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.	0.52% 7/1334 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.
Investigations Neutrophil count decreased	0.15% 2/1326 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.	0.45% 6/1334 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.
Gastrointestinal disorders Pancreatitis	0.00% 0/1326 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.	0.22% 3/1334 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.
Cardiac disorders Pericardial effusion	0.08% 1/1326 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.	0.00% 0/1334 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.
Vascular disorders Peripheral ischemia	0.23% 3/1326 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.	0.00% 0/1334 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.
Nervous system disorders Peripheral motor neuropathy	0.08% 1/1326 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.	0.15% 2/1334 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.
Nervous system disorders Peripheral sensory neuropathy	0.08% 1/1326 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.	0.37% 5/1334 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.
Vascular disorders Phlebitis	0.00% 0/1326 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.	0.15% 2/1334 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.
Investigations Platelet count decreased	0.23% 3/1326 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.	0.45% 6/1334 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/1326 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.	0.07% 1/1334 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.08% 1/1326 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.	0.52% 7/1334 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/1326 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.	0.07% 1/1334 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.
Gastrointestinal disorders Proctitis	0.00% 0/1326 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.	0.22% 3/1334 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.
Renal and urinary disorders Proteinuria	0.15% 2/1326 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.	0.30% 4/1334 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.
Respiratory, thoracic and mediastinal disorders Pulmonary fibrosis	0.15% 2/1326 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.	0.30% 4/1334 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.
Gastrointestinal disorders Rectal hemorrhage	0.15% 2/1326 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.	0.15% 2/1334 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.
Gastrointestinal disorders Rectal pain	0.00% 0/1326 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.	0.07% 1/1334 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.
Renal and urinary disorders Renal and urinary disorders - Other, specify	0.08% 1/1326 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.	0.00% 0/1334 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.
Eye disorders Retinal detachment	0.00% 0/1326 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.	0.07% 1/1334 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.
Reproductive system and breast disorders Scrotal pain	0.00% 0/1326 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.	0.07% 1/1334 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.
Nervous system disorders Seizure	0.30% 4/1326 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.	0.07% 1/1334 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.
Infections and infestations Sepsis	0.08% 1/1326 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.	0.07% 1/1334 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.
Investigations Serum amylase increased	0.08% 1/1326 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.	0.30% 4/1334 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.
Cardiac disorders Sinus bradycardia	0.00% 0/1326 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.	0.07% 1/1334 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.
Cardiac disorders Sinus tachycardia	0.00% 0/1326 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.	0.45% 6/1334 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, specify	0.08% 1/1326 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.	0.07% 1/1334 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.
Infections and infestations Skin infection	0.00% 0/1326 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.	0.37% 5/1334 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.
Skin and subcutaneous tissue disorders Skin ulceration	0.00% 0/1326 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.	0.15% 2/1334 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.
Gastrointestinal disorders Small intestinal obstruction	0.00% 0/1326 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.	0.82% 11/1334 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.
General disorders Sudden death NOS	0.15% 2/1326 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.	0.30% 4/1334 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.
Cardiac disorders Supraventricular tachycardia	0.00% 0/1326 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.	0.15% 2/1334 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.
Nervous system disorders Syncope	0.23% 3/1326 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.	0.45% 6/1334 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.
Vascular disorders Thromboembolic event	2.1% 28/1326 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.	3.5% 47/1334 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.
Infections and infestations Upper respiratory infection	0.00% 0/1326 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.	0.07% 1/1334 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.
Renal and urinary disorders Urinary retention	0.00% 0/1326 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.	0.07% 1/1334 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.
Infections and infestations Urinary tract infection	0.00% 0/1326 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.	0.22% 3/1334 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.
Reproductive system and breast disorders Uterine hemorrhage	0.00% 0/1326 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.	0.15% 2/1334 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.
Reproductive system and breast disorders Vaginal hemorrhage	0.15% 2/1326 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.	0.07% 1/1334 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.
Vascular disorders Vascular disorders - Other, specify	0.15% 2/1326 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.	0.07% 1/1334 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.
Vascular disorders Vasculitis	0.00% 0/1326 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.	0.07% 1/1334 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.
Cardiac disorders Ventricular arrhythmia	0.00% 0/1326 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.	0.07% 1/1334 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.
Cardiac disorders Ventricular fibrillation	0.23% 3/1326 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.	0.07% 1/1334 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.
Gastrointestinal disorders Vomiting	0.08% 1/1326 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.	1.2% 16/1334 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.
Investigations Weight loss	0.00% 0/1326 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.	0.30% 4/1334 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.
Injury, poisoning and procedural complications Wound dehiscence	0.08% 1/1326 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.	1.2% 16/1334 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.
Infections and infestations Wound infection	0.00% 0/1326 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.	0.75% 10/1334 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.
Investigations White blood cell decreased	0.15% 2/1326 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.	0.45% 6/1334 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.
General disorders Edema limbs	0.00% 0/1326 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.	0.07% 1/1334 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.
Cardiac disorders Acute coronary syndrome	0.00% 0/1326 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.	0.30% 4/1334 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.
Gastrointestinal disorders Lower gastrointestinal hemorrhage	0.00% 0/1326 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.	0.07% 1/1334 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.
Metabolism and nutrition disorders Glucose intolerance	0.00% 0/1326 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.	0.15% 2/1334 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.
Vascular disorders Visceral arterial ischemia	0.00% 0/1326 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.	0.07% 1/1334 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.
Gastrointestinal disorders Duodenal hemorrhage	0.08% 1/1326 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.	0.00% 0/1334 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.
Gastrointestinal disorders Upper gastrointestinal hemorrhage	0.08% 1/1326 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.	0.15% 2/1334 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.
Infections and infestations Abdominal infection	0.15% 2/1326 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.	0.22% 3/1334 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.
Infections and infestations Peritoneal infection	0.00% 0/1326 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.	0.15% 2/1334 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.
Infections and infestations Pelvic infection	0.00% 0/1326 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.	0.15% 2/1334 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.
Infections and infestations Enterocolitis infectious	0.00% 0/1326 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.	0.75% 10/1334 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.
Infections and infestations Lung infection	0.23% 3/1326 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.	0.75% 10/1334 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.
Reproductive system and breast disorders Erectile dysfunction	0.00% 0/1326 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.	0.07% 1/1334 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.
Renal and urinary disorders Urinary tract obstruction	0.00% 0/1326 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.	0.15% 2/1334 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.
Infections and infestations Anorectal infection	0.00% 0/1326 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.	0.15% 2/1334 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.
Infections and infestations Scrotal infection	0.00% 0/1326 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.	0.07% 1/1334 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.
Injury, poisoning and procedural complications Vascular access complication	0.38% 5/1326 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.	1.9% 25/1334 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.
Respiratory, thoracic and mediastinal disorders Sinus disorder	0.00% 0/1326 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.	0.07% 1/1334 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.
General disorders Non-cardiac chest pain	0.00% 0/1326 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.	0.30% 4/1334 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.
Musculoskeletal and connective tissue disorders Generalized muscle weakness	0.00% 0/1326 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.	0.22% 3/1334 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.
Gastrointestinal disorders Jejunal obstruction	0.00% 0/1326 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.	0.15% 2/1334 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.
Infections and infestations Small intestine infection	0.00% 0/1326 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.	0.07% 1/1334 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.
Musculoskeletal and connective tissue disorders Muscle weakness lower limb	0.08% 1/1326 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.	0.07% 1/1334 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.
Musculoskeletal and connective tissue disorders Pelvic soft tissue necrosis	0.00% 0/1326 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.	0.07% 1/1334 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.
Ear and labyrinth disorders External ear inflammation	0.00% 0/1326 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.	0.07% 1/1334 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.
Injury, poisoning and procedural complications Large intestinal anastomotic leak	0.08% 1/1326 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.	0.22% 3/1334 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.
Renal and urinary disorders Acute kidney injury	0.23% 3/1326 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.	0.60% 8/1334 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.
Cardiac disorders Left ventricular systolic dysfunction	0.08% 1/1326 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.	0.37% 5/1334 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.

Other adverse events

Measure	Oxaliplatin + Leucovorin + 5-Fluorouracil n=1326 participants at risk Oxaliplatin + Leucovorin + 5-Fluorouracil	Oxaliplatin + Leucovorin + 5-Fluorouracil + Bevacizumab n=1334 participants at risk Oxaliplatin + Leucovorin + 5-Fluorouracil + Bevacizumab
General disorders Fatigue	7.4% 98/1326 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.	9.1% 122/1334 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.
Vascular disorders Hypertension	1.8% 24/1326 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.	12.9% 172/1334 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.
Investigations Neutrophil count decreased	32.7% 433/1326 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.	30.0% 400/1334 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.
Nervous system disorders Peripheral sensory neuropathy	44.2% 586/1326 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.	49.5% 660/1334 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.
Vascular disorders Thromboembolic event	4.8% 64/1326 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.	6.4% 85/1334 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.
Investigations White blood cell decreased	5.5% 73/1326 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.	4.3% 58/1334 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.
Metabolism and nutrition disorders Dehydration	4.0% 53/1326 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.	5.0% 67/1334 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.
Psychiatric disorders Depression	4.0% 53/1326 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.	5.2% 70/1334 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.
Gastrointestinal disorders Diarrhea	9.7% 128/1326 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.	11.5% 153/1334 Participants at Risk includes any patient who submitted an Adverse Event (AE) form.

Additional Information

Director, Division of Regulatory Affairs

NSABP Foundation, Inc.

Phone: 412-330-4600

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60