Trial Outcomes & Findings for A Study of Two Different Schedules of Xeloda (Capecitabine) as First Line Therapy in Patients With Metastatic Colorectal Cancer (NCT NCT00118755)

Last Updated: 2011-03-03

Results Overview

Progression-free survival was defined as the time from the date of randomization to the first occurrence of having documented disease progression or death due to any cause, whichever comes first. Progression was based on tumor assessments made by the investigators according to Response Evaluation Criteria in Solid Tumors (RECIST).

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

435 participants

Primary outcome timeframe

Time to disease progression or death (through follow-up phase)

Results posted on

2011-03-03

Participant Flow

Participant milestones

Participant milestones
Measure	XELOX Q3W + Bevacizumab Capecitabine 850 mg/m\^2 twice-daily was given orally. Bevacizumab 7.5 mg/kg via 30-90 minute intravenous (IV) infusion was administered on day 1 every three weeks prior to administration of oxaliplatin. Oxaliplatin 130 mg/m\^2 via 2-hour IV infusion was administered on day 1 every 3 weeks.	XELOX Q2W + Bevacizumab Capecitabine 1500 mg/m\^2 twice-daily was given orally. Bevacizumab 5 mg/kg via 30-90 minute intravenous (IV) infusion was administered on day 1 every two weeks prior to administration of oxaliplatin. Oxaliplatin 85 mg/m\^2 via 2-hour IV infusion was administered on day 1 every 2 weeks.
Overall Study STARTED	217	218
Overall Study Safety Population	208	211
Overall Study COMPLETED	7	3
Overall Study NOT COMPLETED	210	215

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study of Two Different Schedules of Xeloda (Capecitabine) as First Line Therapy in Patients With Metastatic Colorectal Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	XELOX Q3W + Bevacizumab n=217 Participants Capecitabine 850 mg/m\^2 twice-daily was given orally. Bevacizumab 7.5 mg/kg via 30-90 minute intravenous (IV) infusion was administered on day 1 every three weeks prior to administration of oxaliplatin. Oxaliplatin 130 mg/m\^2 via 2-hour IV infusion was administered on day 1 every 3 weeks.	XELOX Q2W + Bevacizumab n=218 Participants Capecitabine 1500 mg/m\^2 twice-daily was given orally. Bevacizumab 5 mg/kg via 30-90 minute intravenous (IV) infusion was administered on day 1 every two weeks prior to administration of oxaliplatin. Oxaliplatin 85 mg/m\^2 via 2-hour IV infusion was administered on day 1 every 2 weeks.	Total n=435 Participants Total of all reporting groups
Age Continuous	60.6 years STANDARD_DEVIATION 11.45 • n=5 Participants	60.8 years STANDARD_DEVIATION 12.17 • n=7 Participants	60.7 years STANDARD_DEVIATION 11.81 • n=5 Participants
Sex: Female, Male Female	89 Participants n=5 Participants	96 Participants n=7 Participants	185 Participants n=5 Participants
Sex: Female, Male Male	128 Participants n=5 Participants	122 Participants n=7 Participants	250 Participants n=5 Participants

PRIMARY outcome

Timeframe: Time to disease progression or death (through follow-up phase)

Population: Intent-to-treat population

Outcome measures

Outcome measures
Measure	XELOX Q3W + Bevacizumab n=217 Participants Capecitabine 850 mg/m\^2 twice-daily was given orally. Bevacizumab 7.5 mg/kg via 30-90 minute intravenous (IV) infusion was administered on day 1 every three weeks prior to administration of oxaliplatin. Oxaliplatin 130 mg/m\^2 via 2-hour IV infusion was administered on day 1 every 3 weeks.	XELOX Q2W + Bevacizumab n=218 Participants Capecitabine 1500 mg/m\^2 twice-daily was given orally. Bevacizumab 5 mg/kg via 30-90 minute intravenous (IV) infusion was administered on day 1 every two weeks prior to administration of oxaliplatin. Oxaliplatin 85 mg/m\^2 via 2-hour IV infusion was administered on day 1 every 2 weeks.
Progression-free Survival (PFS)	287 Days Interval 234.0 to 329.0	273 Days Interval 231.0 to 313.0

SECONDARY outcome

Timeframe: Time to death (through follow-up phase): Approximate Median of 718 days

Population: Intent-to-treat population

Overall survival was defined as the time from the date of randomization to the date of death, for any cause.

Outcome measures

Outcome measures
Measure	XELOX Q3W + Bevacizumab n=217 Participants Capecitabine 850 mg/m\^2 twice-daily was given orally. Bevacizumab 7.5 mg/kg via 30-90 minute intravenous (IV) infusion was administered on day 1 every three weeks prior to administration of oxaliplatin. Oxaliplatin 130 mg/m\^2 via 2-hour IV infusion was administered on day 1 every 3 weeks.	XELOX Q2W + Bevacizumab n=218 Participants Capecitabine 1500 mg/m\^2 twice-daily was given orally. Bevacizumab 5 mg/kg via 30-90 minute intravenous (IV) infusion was administered on day 1 every two weeks prior to administration of oxaliplatin. Oxaliplatin 85 mg/m\^2 via 2-hour IV infusion was administered on day 1 every 2 weeks.
Overall Survival	852 Days Interval 605.0 to 1052.0	662 Days Interval 595.0 to 762.0

SECONDARY outcome

Timeframe: Through follow-up phase: Approximate Median of 318 days

Population: Intent-to-treat population

Overall response rate was assessed according to RECIST (the best response recorded from the time of randomization to the first CR or PR. The patient's overall best response was complete response (CR), partial response (PR) (CR and PR considered "responders"), stable disease (SD), or progressive disease (PD). To be assigned a status of complete response (CR) or partial response (PR), changes in tumor measurements were confirmed by repeat assessments performed no less than 4 weeks after the criteria for response were first met.

Outcome measures

Outcome measures
Measure	XELOX Q3W + Bevacizumab n=217 Participants Capecitabine 850 mg/m\^2 twice-daily was given orally. Bevacizumab 7.5 mg/kg via 30-90 minute intravenous (IV) infusion was administered on day 1 every three weeks prior to administration of oxaliplatin. Oxaliplatin 130 mg/m\^2 via 2-hour IV infusion was administered on day 1 every 3 weeks.	XELOX Q2W + Bevacizumab n=218 Participants Capecitabine 1500 mg/m\^2 twice-daily was given orally. Bevacizumab 5 mg/kg via 30-90 minute intravenous (IV) infusion was administered on day 1 every two weeks prior to administration of oxaliplatin. Oxaliplatin 85 mg/m\^2 via 2-hour IV infusion was administered on day 1 every 2 weeks.
Best Overall Clinical Response Nonresponders (without CR or PR)	145 Patients	167 Patients
Best Overall Clinical Response Responders (with CR or PR)	72 Patients	51 Patients
Best Overall Clinical Response Complete Response (CR)	2 Patients	3 Patients
Best Overall Clinical Response Partial Response (PR)	70 Patients	48 Patients

SECONDARY outcome

Timeframe: Time to Disease Progression or Death (through follow-up phase): Approximate Median of 302 days

Population: Intent-to-treat population

Among tumor responders (i.e., patients with overall best response of CR or PR), duration of overall response was measured from the time criteria were first met for CR or PR (whichever status was recorded first) to the date of either recurrent/progressive disease was objectively documented or death from any cause.

Outcome measures

Outcome measures
Measure	XELOX Q3W + Bevacizumab n=217 Participants Capecitabine 850 mg/m\^2 twice-daily was given orally. Bevacizumab 7.5 mg/kg via 30-90 minute intravenous (IV) infusion was administered on day 1 every three weeks prior to administration of oxaliplatin. Oxaliplatin 130 mg/m\^2 via 2-hour IV infusion was administered on day 1 every 3 weeks.	XELOX Q2W + Bevacizumab n=218 Participants Capecitabine 1500 mg/m\^2 twice-daily was given orally. Bevacizumab 5 mg/kg via 30-90 minute intravenous (IV) infusion was administered on day 1 every two weeks prior to administration of oxaliplatin. Oxaliplatin 85 mg/m\^2 via 2-hour IV infusion was administered on day 1 every 2 weeks.
Duration of Overall Clinical Response (CR or PR)	281 Days to event Interval 225.0 to 397.0	316 Days to event Interval 244.0 to 522.0

Adverse Events

XELOX Q3W + Bevacizumab

Serious events: 84 serious events

Other events: 202 other events

Deaths: 0 deaths

XELOX Q2W + Bevacizumab

Serious events: 94 serious events

Other events: 206 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Medical Communications

Hoffmann-La Roche

Phone: 800-821-8590

Results disclosure agreements

Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
Publication restrictions are in place

Restriction type: OTHER

Measure	XELOX Q3W + Bevacizumab n=208 participants at risk Capecitabine 850 mg/m\^2 twice-daily was given orally. Bevacizumab 7.5 mg/kg via 30-90 minute intravenous (IV) infusion was administered on day 1 every three weeks prior to administration of oxaliplatin. Oxaliplatin 130 mg/m\^2 via 2-hour IV infusion was administered on day 1 every 3 weeks.	XELOX Q2W + Bevacizumab n=211 participants at risk Capecitabine 1500 mg/m\^2 twice-daily was given orally. Bevacizumab 5 mg/kg via 30-90 minute intravenous (IV) infusion was administered on day 1 every two weeks prior to administration of oxaliplatin. Oxaliplatin 85 mg/m\^2 via 2-hour IV infusion was administered on day 1 every 2 weeks.
Gastrointestinal disorders Abdominal Pain Upper	6.2% 13/208 Safety Population = Received at least 1 dose of study medication. XELOX Q3W + Bevacizumab n=208 XELOX Q2W + Bevacizumab n=211	5.7% 12/211 Safety Population = Received at least 1 dose of study medication. XELOX Q3W + Bevacizumab n=208 XELOX Q2W + Bevacizumab n=211
Gastrointestinal disorders Flatulence	5.8% 12/208 Safety Population = Received at least 1 dose of study medication. XELOX Q3W + Bevacizumab n=208 XELOX Q2W + Bevacizumab n=211	4.7% 10/211 Safety Population = Received at least 1 dose of study medication. XELOX Q3W + Bevacizumab n=208 XELOX Q2W + Bevacizumab n=211
General disorders Fatigue	59.1% 123/208 Safety Population = Received at least 1 dose of study medication. XELOX Q3W + Bevacizumab n=208 XELOX Q2W + Bevacizumab n=211	49.8% 105/211 Safety Population = Received at least 1 dose of study medication. XELOX Q3W + Bevacizumab n=208 XELOX Q2W + Bevacizumab n=211
General disorders Temperature Intolerance	17.8% 37/208 Safety Population = Received at least 1 dose of study medication. XELOX Q3W + Bevacizumab n=208 XELOX Q2W + Bevacizumab n=211	16.1% 34/211 Safety Population = Received at least 1 dose of study medication. XELOX Q3W + Bevacizumab n=208 XELOX Q2W + Bevacizumab n=211
General disorders Mucosal Inflammation	7.2% 15/208 Safety Population = Received at least 1 dose of study medication. XELOX Q3W + Bevacizumab n=208 XELOX Q2W + Bevacizumab n=211	15.2% 32/211 Safety Population = Received at least 1 dose of study medication. XELOX Q3W + Bevacizumab n=208 XELOX Q2W + Bevacizumab n=211
General disorders Pyrexia	10.6% 22/208 Safety Population = Received at least 1 dose of study medication. XELOX Q3W + Bevacizumab n=208 XELOX Q2W + Bevacizumab n=211	11.8% 25/211 Safety Population = Received at least 1 dose of study medication. XELOX Q3W + Bevacizumab n=208 XELOX Q2W + Bevacizumab n=211
General disorders Asthenia	6.7% 14/208 Safety Population = Received at least 1 dose of study medication. XELOX Q3W + Bevacizumab n=208 XELOX Q2W + Bevacizumab n=211	7.6% 16/211 Safety Population = Received at least 1 dose of study medication. XELOX Q3W + Bevacizumab n=208 XELOX Q2W + Bevacizumab n=211
General disorders Oedema Peripheral	5.3% 11/208 Safety Population = Received at least 1 dose of study medication. XELOX Q3W + Bevacizumab n=208 XELOX Q2W + Bevacizumab n=211	6.2% 13/211 Safety Population = Received at least 1 dose of study medication. XELOX Q3W + Bevacizumab n=208 XELOX Q2W + Bevacizumab n=211
Nervous system disorders Neuropathy Peripheral	32.2% 67/208 Safety Population = Received at least 1 dose of study medication. XELOX Q3W + Bevacizumab n=208 XELOX Q2W + Bevacizumab n=211	27.0% 57/211 Safety Population = Received at least 1 dose of study medication. XELOX Q3W + Bevacizumab n=208 XELOX Q2W + Bevacizumab n=211
Nervous system disorders Peripheral Sensory Neuropathy	24.5% 51/208 Safety Population = Received at least 1 dose of study medication. XELOX Q3W + Bevacizumab n=208 XELOX Q2W + Bevacizumab n=211	19.0% 40/211 Safety Population = Received at least 1 dose of study medication. XELOX Q3W + Bevacizumab n=208 XELOX Q2W + Bevacizumab n=211
Nervous system disorders Headache	14.9% 31/208 Safety Population = Received at least 1 dose of study medication. XELOX Q3W + Bevacizumab n=208 XELOX Q2W + Bevacizumab n=211	12.8% 27/211 Safety Population = Received at least 1 dose of study medication. XELOX Q3W + Bevacizumab n=208 XELOX Q2W + Bevacizumab n=211
Nervous system disorders Paraesthesia	13.0% 27/208 Safety Population = Received at least 1 dose of study medication. XELOX Q3W + Bevacizumab n=208 XELOX Q2W + Bevacizumab n=211	11.8% 25/211 Safety Population = Received at least 1 dose of study medication. XELOX Q3W + Bevacizumab n=208 XELOX Q2W + Bevacizumab n=211
Gastrointestinal disorders Vomiting	35.6% 74/208 Safety Population = Received at least 1 dose of study medication. XELOX Q3W + Bevacizumab n=208 XELOX Q2W + Bevacizumab n=211	38.4% 81/211 Safety Population = Received at least 1 dose of study medication. XELOX Q3W + Bevacizumab n=208 XELOX Q2W + Bevacizumab n=211
Gastrointestinal disorders Abdominal Pain	26.4% 55/208 Safety Population = Received at least 1 dose of study medication. XELOX Q3W + Bevacizumab n=208 XELOX Q2W + Bevacizumab n=211	23.2% 49/211 Safety Population = Received at least 1 dose of study medication. XELOX Q3W + Bevacizumab n=208 XELOX Q2W + Bevacizumab n=211
Gastrointestinal disorders Constipation	17.3% 36/208 Safety Population = Received at least 1 dose of study medication. XELOX Q3W + Bevacizumab n=208 XELOX Q2W + Bevacizumab n=211	18.5% 39/211 Safety Population = Received at least 1 dose of study medication. XELOX Q3W + Bevacizumab n=208 XELOX Q2W + Bevacizumab n=211
Gastrointestinal disorders Dyspepsia	7.7% 16/208 Safety Population = Received at least 1 dose of study medication. XELOX Q3W + Bevacizumab n=208 XELOX Q2W + Bevacizumab n=211	11.8% 25/211 Safety Population = Received at least 1 dose of study medication. XELOX Q3W + Bevacizumab n=208 XELOX Q2W + Bevacizumab n=211
Gastrointestinal disorders Stomatitis	7.7% 16/208 Safety Population = Received at least 1 dose of study medication. XELOX Q3W + Bevacizumab n=208 XELOX Q2W + Bevacizumab n=211	11.4% 24/211 Safety Population = Received at least 1 dose of study medication. XELOX Q3W + Bevacizumab n=208 XELOX Q2W + Bevacizumab n=211
Gastrointestinal disorders Diarrhoea	63.0% 131/208 Safety Population = Received at least 1 dose of study medication. XELOX Q3W + Bevacizumab n=208 XELOX Q2W + Bevacizumab n=211	72.0% 152/211 Safety Population = Received at least 1 dose of study medication. XELOX Q3W + Bevacizumab n=208 XELOX Q2W + Bevacizumab n=211
Gastrointestinal disorders Nausea	56.2% 117/208 Safety Population = Received at least 1 dose of study medication. XELOX Q3W + Bevacizumab n=208 XELOX Q2W + Bevacizumab n=211	65.9% 139/211 Safety Population = Received at least 1 dose of study medication. XELOX Q3W + Bevacizumab n=208 XELOX Q2W + Bevacizumab n=211
Nervous system disorders Dizziness	9.6% 20/208 Safety Population = Received at least 1 dose of study medication. XELOX Q3W + Bevacizumab n=208 XELOX Q2W + Bevacizumab n=211	7.6% 16/211 Safety Population = Received at least 1 dose of study medication. XELOX Q3W + Bevacizumab n=208 XELOX Q2W + Bevacizumab n=211
Nervous system disorders Dysgeusia	7.2% 15/208 Safety Population = Received at least 1 dose of study medication. XELOX Q3W + Bevacizumab n=208 XELOX Q2W + Bevacizumab n=211	8.5% 18/211 Safety Population = Received at least 1 dose of study medication. XELOX Q3W + Bevacizumab n=208 XELOX Q2W + Bevacizumab n=211
Skin and subcutaneous tissue disorders Palmar-Plantar Erythrodysaesthesia Syndrome	24.0% 50/208 Safety Population = Received at least 1 dose of study medication. XELOX Q3W + Bevacizumab n=208 XELOX Q2W + Bevacizumab n=211	40.8% 86/211 Safety Population = Received at least 1 dose of study medication. XELOX Q3W + Bevacizumab n=208 XELOX Q2W + Bevacizumab n=211
Skin and subcutaneous tissue disorders Rash	10.1% 21/208 Safety Population = Received at least 1 dose of study medication. XELOX Q3W + Bevacizumab n=208 XELOX Q2W + Bevacizumab n=211	11.8% 25/211 Safety Population = Received at least 1 dose of study medication. XELOX Q3W + Bevacizumab n=208 XELOX Q2W + Bevacizumab n=211
Skin and subcutaneous tissue disorders Dry Skin	12.5% 26/208 Safety Population = Received at least 1 dose of study medication. XELOX Q3W + Bevacizumab n=208 XELOX Q2W + Bevacizumab n=211	7.1% 15/211 Safety Population = Received at least 1 dose of study medication. XELOX Q3W + Bevacizumab n=208 XELOX Q2W + Bevacizumab n=211
Skin and subcutaneous tissue disorders Skin Hyperpigmentation	3.8% 8/208 Safety Population = Received at least 1 dose of study medication. XELOX Q3W + Bevacizumab n=208 XELOX Q2W + Bevacizumab n=211	6.2% 13/211 Safety Population = Received at least 1 dose of study medication. XELOX Q3W + Bevacizumab n=208 XELOX Q2W + Bevacizumab n=211
Skin and subcutaneous tissue disorders Skin Reaction	2.9% 6/208 Safety Population = Received at least 1 dose of study medication. XELOX Q3W + Bevacizumab n=208 XELOX Q2W + Bevacizumab n=211	6.6% 14/211 Safety Population = Received at least 1 dose of study medication. XELOX Q3W + Bevacizumab n=208 XELOX Q2W + Bevacizumab n=211
Metabolism and nutrition disorders Anorexia	24.5% 51/208 Safety Population = Received at least 1 dose of study medication. XELOX Q3W + Bevacizumab n=208 XELOX Q2W + Bevacizumab n=211	27.5% 58/211 Safety Population = Received at least 1 dose of study medication. XELOX Q3W + Bevacizumab n=208 XELOX Q2W + Bevacizumab n=211
Metabolism and nutrition disorders Dehydration	13.5% 28/208 Safety Population = Received at least 1 dose of study medication. XELOX Q3W + Bevacizumab n=208 XELOX Q2W + Bevacizumab n=211	16.1% 34/211 Safety Population = Received at least 1 dose of study medication. XELOX Q3W + Bevacizumab n=208 XELOX Q2W + Bevacizumab n=211
Metabolism and nutrition disorders Hypokalaemia	15.9% 33/208 Safety Population = Received at least 1 dose of study medication. XELOX Q3W + Bevacizumab n=208 XELOX Q2W + Bevacizumab n=211	10.4% 22/211 Safety Population = Received at least 1 dose of study medication. XELOX Q3W + Bevacizumab n=208 XELOX Q2W + Bevacizumab n=211
Respiratory, thoracic and mediastinal disorders Dyspnoea	12.0% 25/208 Safety Population = Received at least 1 dose of study medication. XELOX Q3W + Bevacizumab n=208 XELOX Q2W + Bevacizumab n=211	11.4% 24/211 Safety Population = Received at least 1 dose of study medication. XELOX Q3W + Bevacizumab n=208 XELOX Q2W + Bevacizumab n=211
Respiratory, thoracic and mediastinal disorders Epistaxis	9.1% 19/208 Safety Population = Received at least 1 dose of study medication. XELOX Q3W + Bevacizumab n=208 XELOX Q2W + Bevacizumab n=211	8.5% 18/211 Safety Population = Received at least 1 dose of study medication. XELOX Q3W + Bevacizumab n=208 XELOX Q2W + Bevacizumab n=211
Respiratory, thoracic and mediastinal disorders Cough	3.4% 7/208 Safety Population = Received at least 1 dose of study medication. XELOX Q3W + Bevacizumab n=208 XELOX Q2W + Bevacizumab n=211	10.9% 23/211 Safety Population = Received at least 1 dose of study medication. XELOX Q3W + Bevacizumab n=208 XELOX Q2W + Bevacizumab n=211
Respiratory, thoracic and mediastinal disorders Hiccups	5.3% 11/208 Safety Population = Received at least 1 dose of study medication. XELOX Q3W + Bevacizumab n=208 XELOX Q2W + Bevacizumab n=211	4.7% 10/211 Safety Population = Received at least 1 dose of study medication. XELOX Q3W + Bevacizumab n=208 XELOX Q2W + Bevacizumab n=211
Blood and lymphatic system disorders Anaemia	17.3% 36/208 Safety Population = Received at least 1 dose of study medication. XELOX Q3W + Bevacizumab n=208 XELOX Q2W + Bevacizumab n=211	10.4% 22/211 Safety Population = Received at least 1 dose of study medication. XELOX Q3W + Bevacizumab n=208 XELOX Q2W + Bevacizumab n=211
Blood and lymphatic system disorders Neutropenia	10.1% 21/208 Safety Population = Received at least 1 dose of study medication. XELOX Q3W + Bevacizumab n=208 XELOX Q2W + Bevacizumab n=211	8.1% 17/211 Safety Population = Received at least 1 dose of study medication. XELOX Q3W + Bevacizumab n=208 XELOX Q2W + Bevacizumab n=211
Blood and lymphatic system disorders Thrombocytopenia	12.5% 26/208 Safety Population = Received at least 1 dose of study medication. XELOX Q3W + Bevacizumab n=208 XELOX Q2W + Bevacizumab n=211	4.3% 9/211 Safety Population = Received at least 1 dose of study medication. XELOX Q3W + Bevacizumab n=208 XELOX Q2W + Bevacizumab n=211
Musculoskeletal and connective tissue disorders Pain In Extremity	11.1% 23/208 Safety Population = Received at least 1 dose of study medication. XELOX Q3W + Bevacizumab n=208 XELOX Q2W + Bevacizumab n=211	8.5% 18/211 Safety Population = Received at least 1 dose of study medication. XELOX Q3W + Bevacizumab n=208 XELOX Q2W + Bevacizumab n=211
Musculoskeletal and connective tissue disorders Back Pain	6.7% 14/208 Safety Population = Received at least 1 dose of study medication. XELOX Q3W + Bevacizumab n=208 XELOX Q2W + Bevacizumab n=211	5.7% 12/211 Safety Population = Received at least 1 dose of study medication. XELOX Q3W + Bevacizumab n=208 XELOX Q2W + Bevacizumab n=211
Musculoskeletal and connective tissue disorders Myalgia	4.3% 9/208 Safety Population = Received at least 1 dose of study medication. XELOX Q3W + Bevacizumab n=208 XELOX Q2W + Bevacizumab n=211	5.2% 11/211 Safety Population = Received at least 1 dose of study medication. XELOX Q3W + Bevacizumab n=208 XELOX Q2W + Bevacizumab n=211
Musculoskeletal and connective tissue disorders Arthralgia	5.3% 11/208 Safety Population = Received at least 1 dose of study medication. XELOX Q3W + Bevacizumab n=208 XELOX Q2W + Bevacizumab n=211	2.8% 6/211 Safety Population = Received at least 1 dose of study medication. XELOX Q3W + Bevacizumab n=208 XELOX Q2W + Bevacizumab n=211
Psychiatric disorders Insomnia	12.0% 25/208 Safety Population = Received at least 1 dose of study medication. XELOX Q3W + Bevacizumab n=208 XELOX Q2W + Bevacizumab n=211	11.4% 24/211 Safety Population = Received at least 1 dose of study medication. XELOX Q3W + Bevacizumab n=208 XELOX Q2W + Bevacizumab n=211
Psychiatric disorders Anxiety	4.8% 10/208 Safety Population = Received at least 1 dose of study medication. XELOX Q3W + Bevacizumab n=208 XELOX Q2W + Bevacizumab n=211	8.5% 18/211 Safety Population = Received at least 1 dose of study medication. XELOX Q3W + Bevacizumab n=208 XELOX Q2W + Bevacizumab n=211
Psychiatric disorders Depression	5.3% 11/208 Safety Population = Received at least 1 dose of study medication. XELOX Q3W + Bevacizumab n=208 XELOX Q2W + Bevacizumab n=211	8.1% 17/211 Safety Population = Received at least 1 dose of study medication. XELOX Q3W + Bevacizumab n=208 XELOX Q2W + Bevacizumab n=211
Investigations Weight Decreased	14.9% 31/208 Safety Population = Received at least 1 dose of study medication. XELOX Q3W + Bevacizumab n=208 XELOX Q2W + Bevacizumab n=211	21.3% 45/211 Safety Population = Received at least 1 dose of study medication. XELOX Q3W + Bevacizumab n=208 XELOX Q2W + Bevacizumab n=211
Infections and infestations Urinary Tract Infection	5.3% 11/208 Safety Population = Received at least 1 dose of study medication. XELOX Q3W + Bevacizumab n=208 XELOX Q2W + Bevacizumab n=211	6.2% 13/211 Safety Population = Received at least 1 dose of study medication. XELOX Q3W + Bevacizumab n=208 XELOX Q2W + Bevacizumab n=211
Infections and infestations Upper Respiratory Tract Infection	4.8% 10/208 Safety Population = Received at least 1 dose of study medication. XELOX Q3W + Bevacizumab n=208 XELOX Q2W + Bevacizumab n=211	5.2% 11/211 Safety Population = Received at least 1 dose of study medication. XELOX Q3W + Bevacizumab n=208 XELOX Q2W + Bevacizumab n=211
Vascular disorders Hypertension	11.1% 23/208 Safety Population = Received at least 1 dose of study medication. XELOX Q3W + Bevacizumab n=208 XELOX Q2W + Bevacizumab n=211	9.0% 19/211 Safety Population = Received at least 1 dose of study medication. XELOX Q3W + Bevacizumab n=208 XELOX Q2W + Bevacizumab n=211