Trial Outcomes & Findings for A Study of Avastin (Bevacizumab) and Oxaliplatin Plus Xeloda (Capecitabine) in Patients With Advanced Colorectal Cancer. (NCT NCT01159171)
NCT ID: NCT01159171
Last Updated: 2014-08-15
Results Overview
Percentage of participants with OR was defined as the percentage of participants who achieved complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). CR was defined as disappearance of all target lesions, non-target lesions, and normalization of tumor marker level. PR was defined as greater than or equal to (≥)30 percent (%) decrease under baseline of the sum of the longest diameter (LD) diameters of all target lesions. No unequivocal progression of non-target disease. No new lesions. Complete and partial responses must have been confirmed no less than 4 weeks after the criteria for response were first met.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
50 participants
Primary outcome timeframe
Baseline, every 3 months to progression of disease or end of study (up to 24 months)
Results posted on
2014-08-15
Participant Flow
Participant milestones
| Measure |
Bevacizumab + Oxaliplatin + Capecitabine
Participants received bevacizumab 5 milligrams per kilograms (mg/kg) intravenously (IV) on Days 1 and 15; oxaliplatin 40 mg per square meter (mg/m\^2) IV on Days 1, 8, 15, and 22; and capecitabine 1000 mg/m\^2 orally (PO) twice daily (BID) on Days 1 through 14 followed by 2 weeks without treatment. This cycle was repeated until disease progression, unacceptable toxicity, or participant withdrawal.
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|---|---|
|
Overall Study
STARTED
|
50
|
|
Overall Study
COMPLETED
|
0
|
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Overall Study
NOT COMPLETED
|
50
|
Reasons for withdrawal
| Measure |
Bevacizumab + Oxaliplatin + Capecitabine
Participants received bevacizumab 5 milligrams per kilograms (mg/kg) intravenously (IV) on Days 1 and 15; oxaliplatin 40 mg per square meter (mg/m\^2) IV on Days 1, 8, 15, and 22; and capecitabine 1000 mg/m\^2 orally (PO) twice daily (BID) on Days 1 through 14 followed by 2 weeks without treatment. This cycle was repeated until disease progression, unacceptable toxicity, or participant withdrawal.
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|---|---|
|
Overall Study
Adverse Event
|
11
|
|
Overall Study
Progression of Disease
|
28
|
|
Overall Study
Protocol Violation
|
1
|
|
Overall Study
Need for Surgery
|
5
|
|
Overall Study
Medical Decision
|
4
|
|
Overall Study
Death
|
1
|
Baseline Characteristics
A Study of Avastin (Bevacizumab) and Oxaliplatin Plus Xeloda (Capecitabine) in Patients With Advanced Colorectal Cancer.
Baseline characteristics by cohort
| Measure |
Bevacizumab + Oxaliplatin + Capecitabine
n=49 Participants
Participants received bevacizumab 5 mg/kg IV on Days 1 and 15; oxaliplatin 40 mg/m\^2 IV on Days 1, 8, 15, and 22; and capecitabine 1000 mg/m\^2 PO BID on Days 1 through 14 followed by 2 weeks without treatment. This cycle was repeated until disease progression, unacceptable toxicity, or participant withdrawal.
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|---|---|
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Age, Continuous
|
59.08 years
STANDARD_DEVIATION 9.62 • n=5 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=5 Participants
|
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Sex: Female, Male
Male
|
24 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, every 3 months to progression of disease or end of study (up to 24 months)Population: Intent to Treat (ITT) Population: all participants who signed the informed consent, were assigned a study patient number, and who were administered at least 1 dose of 1 study medication.
Percentage of participants with OR was defined as the percentage of participants who achieved complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). CR was defined as disappearance of all target lesions, non-target lesions, and normalization of tumor marker level. PR was defined as greater than or equal to (≥)30 percent (%) decrease under baseline of the sum of the longest diameter (LD) diameters of all target lesions. No unequivocal progression of non-target disease. No new lesions. Complete and partial responses must have been confirmed no less than 4 weeks after the criteria for response were first met.
Outcome measures
| Measure |
Bevacizumab + Oxaliplatin + Capecitabine
n=49 Participants
Participants received bevacizumab 5 mg/kg IV on Days 1 and 15; oxaliplatin 40 mg/m\^2 IV on Days 1, 8, 15, and 22; and capecitabine 1000 mg/m\^2 PO BID on Days 1 through 14 followed by 2 weeks without treatment. This cycle was repeated until disease progression, unacceptable toxicity, or participant withdrawal.
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|---|---|
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Percentage of Participants With Objective Response (OR)
|
42.86 percentage of participants
Interval 0.31 to
|
PRIMARY outcome
Timeframe: Baseline, every 3 months to progression of disease or end of study (up to 24 months)Population: ITT Population. 5 participants were not assessed as they did not reach the 3 month time-point.
Best response recorded from the start of treatment until disease progression. Based on assessment of CR, PR, stable disease (SD), or progressive disease (PD), according to RECIST. CR: disappearance of all target lesions, non-target lesions, and normalization of tumor marker level. PR: ≥30% decrease under baseline of the sum of the LD diameters of all target lesions. CR and PR persist on repeat imaging study at least 4 weeks after initial documentation. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. Reference is the smallest sum LD. PD: at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum longest diameter recorded or the appearance of one or more new lesions.
Outcome measures
| Measure |
Bevacizumab + Oxaliplatin + Capecitabine
n=49 Participants
Participants received bevacizumab 5 mg/kg IV on Days 1 and 15; oxaliplatin 40 mg/m\^2 IV on Days 1, 8, 15, and 22; and capecitabine 1000 mg/m\^2 PO BID on Days 1 through 14 followed by 2 weeks without treatment. This cycle was repeated until disease progression, unacceptable toxicity, or participant withdrawal.
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|---|---|
|
Percentage of Participants by Best Overall Response
CR
|
4.08 percentage of participants
|
|
Percentage of Participants by Best Overall Response
PR
|
38.78 percentage of participants
|
|
Percentage of Participants by Best Overall Response
SD
|
38.78 percentage of participants
|
|
Percentage of Participants by Best Overall Response
PD
|
8.16 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, every 3 months to progression of disease or end of study (up to 24 months)Population: ITT population; only participants with a best overall response of CR or PR were included in the analysis.
Duration of overall response (CR or PR) was calculated only for participants of the ITT population whose best overall response was CR or PR based on RECIST criteria. Duration of overall response was defined as the time from the date of the first assessment of CR or PR status until the date of progression or death. Data for participants who were alive without any objectively documented disease progression at the end of the study were censored as of the date of last contact.
Outcome measures
| Measure |
Bevacizumab + Oxaliplatin + Capecitabine
n=21 Participants
Participants received bevacizumab 5 mg/kg IV on Days 1 and 15; oxaliplatin 40 mg/m\^2 IV on Days 1, 8, 15, and 22; and capecitabine 1000 mg/m\^2 PO BID on Days 1 through 14 followed by 2 weeks without treatment. This cycle was repeated until disease progression, unacceptable toxicity, or participant withdrawal.
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|---|---|
|
Duration of Response - Percentage of Participants With an Event by 24 Months
|
57.14 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, every 3 months to progression of disease or end of study (up to 24 months)Population: ITT Population; only participants with a best overall response of CR or PR were included in the analysis.
Duration of overall response (CR or PR) was calculated for participants of the ITT population whose best overall response was CR or PR based on RECIST criteria. Duration of overall response was defined as the time from the date of the first assessment of CR or PR status until the date of progression or death. Data for participants who were alive without any objectively documented disease progression at the end of the study were censored as of the date of last contact. Mean time to event was estimated using the Kaplan-Meier method.
Outcome measures
| Measure |
Bevacizumab + Oxaliplatin + Capecitabine
n=21 Participants
Participants received bevacizumab 5 mg/kg IV on Days 1 and 15; oxaliplatin 40 mg/m\^2 IV on Days 1, 8, 15, and 22; and capecitabine 1000 mg/m\^2 PO BID on Days 1 through 14 followed by 2 weeks without treatment. This cycle was repeated until disease progression, unacceptable toxicity, or participant withdrawal.
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|---|---|
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Duration of Response
|
8.31 months
Standard Deviation 1.97
|
SECONDARY outcome
Timeframe: Baseline, every 3 months to progression of disease or end of study (up to 24 months)Population: ITT Population; only participants with a best overall response of CR, PR, or SD were included in the analysis.
Duration of stable response (CR, PR, or stable disease \[SD\]) was calculated only for participants of the ITT population whose best overall response was CR, PR, or SD based on RECIST criteria. Duration of overall response was defined as the time from the date of the first assessment of CR, PR, or SD status until the date of progression or death. Data for participants who were alive without any objectively documented disease progression at the end of the study were censored as of the date of last contact.
Outcome measures
| Measure |
Bevacizumab + Oxaliplatin + Capecitabine
n=40 Participants
Participants received bevacizumab 5 mg/kg IV on Days 1 and 15; oxaliplatin 40 mg/m\^2 IV on Days 1, 8, 15, and 22; and capecitabine 1000 mg/m\^2 PO BID on Days 1 through 14 followed by 2 weeks without treatment. This cycle was repeated until disease progression, unacceptable toxicity, or participant withdrawal.
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|---|---|
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Duration of Stable Disease - Percentage of Participants With an Event by 24 Months
|
52.50 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, every 3 months to progression of disease or end of study (up to 24 months)Population: ITT Population: only participants with a best overall response of CR, PR, or SD were included in the analysis.
Duration of stable response (CR, PR, or SD) was calculated only for participants of the ITT population whose best overall response was CR, PR, or SD based on RECIST criteria. Duration of overall response was defined as the time from the date of the first assessment of CR, PR, or SD status until the date of progression or death. Data for participants who were alive without any objectively documented disease progression at the end of the study were censored as of the date of last contact. Mean time to event was estimated using the Kaplan-Meier method.
Outcome measures
| Measure |
Bevacizumab + Oxaliplatin + Capecitabine
n=40 Participants
Participants received bevacizumab 5 mg/kg IV on Days 1 and 15; oxaliplatin 40 mg/m\^2 IV on Days 1, 8, 15, and 22; and capecitabine 1000 mg/m\^2 PO BID on Days 1 through 14 followed by 2 weeks without treatment. This cycle was repeated until disease progression, unacceptable toxicity, or participant withdrawal.
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|---|---|
|
Duration of Stable Disease
|
10.09 months
Standard Deviation 1.30
|
SECONDARY outcome
Timeframe: Baseline, every month to end of treatment (up to 24 months)Population: ITT Population
TTF was defined as the time in months from Day 1 until discontinuation of treatment for any reasons. These reasons included: death due to any cause, treatment toxicity (adverse event), insufficient therapeutic response (progression of disease), failure to return (lost to follow-up), refusing treatment (participant non-compliance), being unwilling to cooperate and withdrawing consent (participant withdrew consent).
Outcome measures
| Measure |
Bevacizumab + Oxaliplatin + Capecitabine
n=49 Participants
Participants received bevacizumab 5 mg/kg IV on Days 1 and 15; oxaliplatin 40 mg/m\^2 IV on Days 1, 8, 15, and 22; and capecitabine 1000 mg/m\^2 PO BID on Days 1 through 14 followed by 2 weeks without treatment. This cycle was repeated until disease progression, unacceptable toxicity, or participant withdrawal.
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|---|---|
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Time to Treatment Failure (TTF) - Percentage of Participants With an Event by 24 Months
|
81.63 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, monthly to end of study (up to 24 months)Population: ITT Population
TTF was defined as the time in months from Day 1 until discontinuation of treatment for any reasons. These reasons included: death due to any cause, treatment toxicity (adverse event), insufficient therapeutic response (progression of disease), failure to return (lost to follow-up), refusing treatment (participant non-compliance), being unwilling to cooperate and withdrawing consent (participant withdrew consent). Mean TTF was estimated using the Kaplan-Meier method.
Outcome measures
| Measure |
Bevacizumab + Oxaliplatin + Capecitabine
n=49 Participants
Participants received bevacizumab 5 mg/kg IV on Days 1 and 15; oxaliplatin 40 mg/m\^2 IV on Days 1, 8, 15, and 22; and capecitabine 1000 mg/m\^2 PO BID on Days 1 through 14 followed by 2 weeks without treatment. This cycle was repeated until disease progression, unacceptable toxicity, or participant withdrawal.
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|---|---|
|
Time to Treatment Failure
|
7.44 months
Standard Deviation 0.84
|
SECONDARY outcome
Timeframe: Baseline, monthly to end of study (up to 24 months)Population: ITT Population
TTP was defined as the time time in months from Day 1 until the date of first documented progressive disease, or death due to any cause. Data for participants who were alive without disease progression at the end of study, or who were non-responder participants (without tumor assessment after baseline) were censored at Day 1.
Outcome measures
| Measure |
Bevacizumab + Oxaliplatin + Capecitabine
n=49 Participants
Participants received bevacizumab 5 mg/kg IV on Days 1 and 15; oxaliplatin 40 mg/m\^2 IV on Days 1, 8, 15, and 22; and capecitabine 1000 mg/m\^2 PO BID on Days 1 through 14 followed by 2 weeks without treatment. This cycle was repeated until disease progression, unacceptable toxicity, or participant withdrawal.
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|---|---|
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Time to Progression (TTP) - Percentage of Participants With an Event by 24 Months
|
91.84 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, monthly to end of study (up to 24 months)Population: ITT Population
TTP was defined as the time in months from Day 1 until the date of first documented progressive disease, or death due to any cause. Data for participants who were alive without disease progression at the end of study, or who were non-responder participants (without tumor assessment after baseline) were censored at Day 1. Mean TTP was estimated using the Kaplan-Meier method.
Outcome measures
| Measure |
Bevacizumab + Oxaliplatin + Capecitabine
n=49 Participants
Participants received bevacizumab 5 mg/kg IV on Days 1 and 15; oxaliplatin 40 mg/m\^2 IV on Days 1, 8, 15, and 22; and capecitabine 1000 mg/m\^2 PO BID on Days 1 through 14 followed by 2 weeks without treatment. This cycle was repeated until disease progression, unacceptable toxicity, or participant withdrawal.
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|---|---|
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Time to Progression
|
9.61 months
Standard Deviation 0.90
|
SECONDARY outcome
Timeframe: Baseline, monthly to end of study (up to 24 months)Population: ITT Population
OS was defined as the time in months from Day 1 until the date of death due to any cause. Data for participants who were alive at the end of the study were censored at the date of the last available follow-up visit.
Outcome measures
| Measure |
Bevacizumab + Oxaliplatin + Capecitabine
n=49 Participants
Participants received bevacizumab 5 mg/kg IV on Days 1 and 15; oxaliplatin 40 mg/m\^2 IV on Days 1, 8, 15, and 22; and capecitabine 1000 mg/m\^2 PO BID on Days 1 through 14 followed by 2 weeks without treatment. This cycle was repeated until disease progression, unacceptable toxicity, or participant withdrawal.
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|---|---|
|
Overall Survival (OS) - Percentage of Participants With an Event by 24 Months
|
89.90 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, monthly to end of study (up to 24 months)Population: ITT Population
OS was defined as the time in months from Day 1 until the date of death due to any cause. Data for participants who were alive at the end of the study were censored at the date of the last available follow-up visit. Mean OS was estimated using the Kaplan-Meier method.
Outcome measures
| Measure |
Bevacizumab + Oxaliplatin + Capecitabine
n=49 Participants
Participants received bevacizumab 5 mg/kg IV on Days 1 and 15; oxaliplatin 40 mg/m\^2 IV on Days 1, 8, 15, and 22; and capecitabine 1000 mg/m\^2 PO BID on Days 1 through 14 followed by 2 weeks without treatment. This cycle was repeated until disease progression, unacceptable toxicity, or participant withdrawal.
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|---|---|
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Overall Survival
|
20.23 months
Standard Deviation 1.68
|
Adverse Events
Bevacizumab + Oxaliplatin + Capecitabine
Serious events: 18 serious events
Other events: 48 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Bevacizumab + Oxaliplatin + Capecitabine
n=49 participants at risk
Participants received bevacizumab 5 mg/kg IV on Days 1 and 15; oxaliplatin 40 mg/m\^2 IV on Days 1, 8, 15, and 22; and capecitabine 1000 mg/m\^2 PO BID on Days 1 through 14 followed by 2 weeks without treatment. This cycle was repeated until disease progression, unacceptable toxicity, or participant withdrawal.
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|---|---|
|
Cardiac disorders
Angina pectoris
|
2.0%
1/49 • Adverse events (AEs) were collected form the date of first study-drug intake until 28 days after the date of last study-drug intake.
All participants who received at least 1 dose of study treatment were included in the safety population. Nonserious AEs presented in this record include all AEs reported during the study, not just nonserious events.
|
|
Gastrointestinal disorders
Diarrhea
|
4.1%
2/49 • Adverse events (AEs) were collected form the date of first study-drug intake until 28 days after the date of last study-drug intake.
All participants who received at least 1 dose of study treatment were included in the safety population. Nonserious AEs presented in this record include all AEs reported during the study, not just nonserious events.
|
|
Gastrointestinal disorders
Gastrointestinal obstruction
|
2.0%
1/49 • Adverse events (AEs) were collected form the date of first study-drug intake until 28 days after the date of last study-drug intake.
All participants who received at least 1 dose of study treatment were included in the safety population. Nonserious AEs presented in this record include all AEs reported during the study, not just nonserious events.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
2.0%
1/49 • Adverse events (AEs) were collected form the date of first study-drug intake until 28 days after the date of last study-drug intake.
All participants who received at least 1 dose of study treatment were included in the safety population. Nonserious AEs presented in this record include all AEs reported during the study, not just nonserious events.
|
|
Gastrointestinal disorders
Subileus
|
6.1%
3/49 • Adverse events (AEs) were collected form the date of first study-drug intake until 28 days after the date of last study-drug intake.
All participants who received at least 1 dose of study treatment were included in the safety population. Nonserious AEs presented in this record include all AEs reported during the study, not just nonserious events.
|
|
General disorders
Pain
|
2.0%
1/49 • Adverse events (AEs) were collected form the date of first study-drug intake until 28 days after the date of last study-drug intake.
All participants who received at least 1 dose of study treatment were included in the safety population. Nonserious AEs presented in this record include all AEs reported during the study, not just nonserious events.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
2.0%
1/49 • Adverse events (AEs) were collected form the date of first study-drug intake until 28 days after the date of last study-drug intake.
All participants who received at least 1 dose of study treatment were included in the safety population. Nonserious AEs presented in this record include all AEs reported during the study, not just nonserious events.
|
|
Metabolism and nutrition disorders
Dehydration
|
2.0%
1/49 • Adverse events (AEs) were collected form the date of first study-drug intake until 28 days after the date of last study-drug intake.
All participants who received at least 1 dose of study treatment were included in the safety population. Nonserious AEs presented in this record include all AEs reported during the study, not just nonserious events.
|
|
Nervous system disorders
Syncope
|
2.0%
1/49 • Adverse events (AEs) were collected form the date of first study-drug intake until 28 days after the date of last study-drug intake.
All participants who received at least 1 dose of study treatment were included in the safety population. Nonserious AEs presented in this record include all AEs reported during the study, not just nonserious events.
|
|
Nervous system disorders
Transient ischaemic attack
|
2.0%
1/49 • Adverse events (AEs) were collected form the date of first study-drug intake until 28 days after the date of last study-drug intake.
All participants who received at least 1 dose of study treatment were included in the safety population. Nonserious AEs presented in this record include all AEs reported during the study, not just nonserious events.
|
|
Renal and urinary disorders
Hematuria
|
2.0%
1/49 • Adverse events (AEs) were collected form the date of first study-drug intake until 28 days after the date of last study-drug intake.
All participants who received at least 1 dose of study treatment were included in the safety population. Nonserious AEs presented in this record include all AEs reported during the study, not just nonserious events.
|
|
Reproductive system and breast disorders
Pelvic pain
|
2.0%
1/49 • Adverse events (AEs) were collected form the date of first study-drug intake until 28 days after the date of last study-drug intake.
All participants who received at least 1 dose of study treatment were included in the safety population. Nonserious AEs presented in this record include all AEs reported during the study, not just nonserious events.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.0%
1/49 • Adverse events (AEs) were collected form the date of first study-drug intake until 28 days after the date of last study-drug intake.
All participants who received at least 1 dose of study treatment were included in the safety population. Nonserious AEs presented in this record include all AEs reported during the study, not just nonserious events.
|
|
Vascular disorders
Deep vein thrombosis
|
2.0%
1/49 • Adverse events (AEs) were collected form the date of first study-drug intake until 28 days after the date of last study-drug intake.
All participants who received at least 1 dose of study treatment were included in the safety population. Nonserious AEs presented in this record include all AEs reported during the study, not just nonserious events.
|
|
Vascular disorders
Hypertensive crisis
|
2.0%
1/49 • Adverse events (AEs) were collected form the date of first study-drug intake until 28 days after the date of last study-drug intake.
All participants who received at least 1 dose of study treatment were included in the safety population. Nonserious AEs presented in this record include all AEs reported during the study, not just nonserious events.
|
|
Vascular disorders
Vena cava thrombosis
|
4.1%
2/49 • Adverse events (AEs) were collected form the date of first study-drug intake until 28 days after the date of last study-drug intake.
All participants who received at least 1 dose of study treatment were included in the safety population. Nonserious AEs presented in this record include all AEs reported during the study, not just nonserious events.
|
Other adverse events
| Measure |
Bevacizumab + Oxaliplatin + Capecitabine
n=49 participants at risk
Participants received bevacizumab 5 mg/kg IV on Days 1 and 15; oxaliplatin 40 mg/m\^2 IV on Days 1, 8, 15, and 22; and capecitabine 1000 mg/m\^2 PO BID on Days 1 through 14 followed by 2 weeks without treatment. This cycle was repeated until disease progression, unacceptable toxicity, or participant withdrawal.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
6.1%
3/49 • Adverse events (AEs) were collected form the date of first study-drug intake until 28 days after the date of last study-drug intake.
All participants who received at least 1 dose of study treatment were included in the safety population. Nonserious AEs presented in this record include all AEs reported during the study, not just nonserious events.
|
|
Blood and lymphatic system disorders
Neutropenia
|
14.3%
7/49 • Adverse events (AEs) were collected form the date of first study-drug intake until 28 days after the date of last study-drug intake.
All participants who received at least 1 dose of study treatment were included in the safety population. Nonserious AEs presented in this record include all AEs reported during the study, not just nonserious events.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
22.4%
11/49 • Adverse events (AEs) were collected form the date of first study-drug intake until 28 days after the date of last study-drug intake.
All participants who received at least 1 dose of study treatment were included in the safety population. Nonserious AEs presented in this record include all AEs reported during the study, not just nonserious events.
|
|
Gastrointestinal disorders
Abdominal pain
|
28.6%
14/49 • Adverse events (AEs) were collected form the date of first study-drug intake until 28 days after the date of last study-drug intake.
All participants who received at least 1 dose of study treatment were included in the safety population. Nonserious AEs presented in this record include all AEs reported during the study, not just nonserious events.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
14.3%
7/49 • Adverse events (AEs) were collected form the date of first study-drug intake until 28 days after the date of last study-drug intake.
All participants who received at least 1 dose of study treatment were included in the safety population. Nonserious AEs presented in this record include all AEs reported during the study, not just nonserious events.
|
|
Gastrointestinal disorders
Constipation
|
20.4%
10/49 • Adverse events (AEs) were collected form the date of first study-drug intake until 28 days after the date of last study-drug intake.
All participants who received at least 1 dose of study treatment were included in the safety population. Nonserious AEs presented in this record include all AEs reported during the study, not just nonserious events.
|
|
Gastrointestinal disorders
Diarrhea
|
44.9%
22/49 • Adverse events (AEs) were collected form the date of first study-drug intake until 28 days after the date of last study-drug intake.
All participants who received at least 1 dose of study treatment were included in the safety population. Nonserious AEs presented in this record include all AEs reported during the study, not just nonserious events.
|
|
Gastrointestinal disorders
Gingival bleeding
|
6.1%
3/49 • Adverse events (AEs) were collected form the date of first study-drug intake until 28 days after the date of last study-drug intake.
All participants who received at least 1 dose of study treatment were included in the safety population. Nonserious AEs presented in this record include all AEs reported during the study, not just nonserious events.
|
|
Gastrointestinal disorders
Nausea
|
38.8%
19/49 • Adverse events (AEs) were collected form the date of first study-drug intake until 28 days after the date of last study-drug intake.
All participants who received at least 1 dose of study treatment were included in the safety population. Nonserious AEs presented in this record include all AEs reported during the study, not just nonserious events.
|
|
Gastrointestinal disorders
Stomatitis
|
10.2%
5/49 • Adverse events (AEs) were collected form the date of first study-drug intake until 28 days after the date of last study-drug intake.
All participants who received at least 1 dose of study treatment were included in the safety population. Nonserious AEs presented in this record include all AEs reported during the study, not just nonserious events.
|
|
Gastrointestinal disorders
Subileus
|
6.1%
3/49 • Adverse events (AEs) were collected form the date of first study-drug intake until 28 days after the date of last study-drug intake.
All participants who received at least 1 dose of study treatment were included in the safety population. Nonserious AEs presented in this record include all AEs reported during the study, not just nonserious events.
|
|
Gastrointestinal disorders
Vomiting
|
30.6%
15/49 • Adverse events (AEs) were collected form the date of first study-drug intake until 28 days after the date of last study-drug intake.
All participants who received at least 1 dose of study treatment were included in the safety population. Nonserious AEs presented in this record include all AEs reported during the study, not just nonserious events.
|
|
General disorders
Asthenia
|
22.4%
11/49 • Adverse events (AEs) were collected form the date of first study-drug intake until 28 days after the date of last study-drug intake.
All participants who received at least 1 dose of study treatment were included in the safety population. Nonserious AEs presented in this record include all AEs reported during the study, not just nonserious events.
|
|
General disorders
Fatigue
|
18.4%
9/49 • Adverse events (AEs) were collected form the date of first study-drug intake until 28 days after the date of last study-drug intake.
All participants who received at least 1 dose of study treatment were included in the safety population. Nonserious AEs presented in this record include all AEs reported during the study, not just nonserious events.
|
|
General disorders
Mucosal inflammation
|
18.4%
9/49 • Adverse events (AEs) were collected form the date of first study-drug intake until 28 days after the date of last study-drug intake.
All participants who received at least 1 dose of study treatment were included in the safety population. Nonserious AEs presented in this record include all AEs reported during the study, not just nonserious events.
|
|
General disorders
Pyrexia
|
24.5%
12/49 • Adverse events (AEs) were collected form the date of first study-drug intake until 28 days after the date of last study-drug intake.
All participants who received at least 1 dose of study treatment were included in the safety population. Nonserious AEs presented in this record include all AEs reported during the study, not just nonserious events.
|
|
Infections and infestations
Influenza
|
8.2%
4/49 • Adverse events (AEs) were collected form the date of first study-drug intake until 28 days after the date of last study-drug intake.
All participants who received at least 1 dose of study treatment were included in the safety population. Nonserious AEs presented in this record include all AEs reported during the study, not just nonserious events.
|
|
Investigations
Blood alkaline phosphatase increased
|
8.2%
4/49 • Adverse events (AEs) were collected form the date of first study-drug intake until 28 days after the date of last study-drug intake.
All participants who received at least 1 dose of study treatment were included in the safety population. Nonserious AEs presented in this record include all AEs reported during the study, not just nonserious events.
|
|
Investigations
Blood lactate dehydrogenase increased
|
8.2%
4/49 • Adverse events (AEs) were collected form the date of first study-drug intake until 28 days after the date of last study-drug intake.
All participants who received at least 1 dose of study treatment were included in the safety population. Nonserious AEs presented in this record include all AEs reported during the study, not just nonserious events.
|
|
Investigations
Neutrophil count
|
6.1%
3/49 • Adverse events (AEs) were collected form the date of first study-drug intake until 28 days after the date of last study-drug intake.
All participants who received at least 1 dose of study treatment were included in the safety population. Nonserious AEs presented in this record include all AEs reported during the study, not just nonserious events.
|
|
Metabolism and nutrition disorders
Anorexia
|
6.1%
3/49 • Adverse events (AEs) were collected form the date of first study-drug intake until 28 days after the date of last study-drug intake.
All participants who received at least 1 dose of study treatment were included in the safety population. Nonserious AEs presented in this record include all AEs reported during the study, not just nonserious events.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
10.2%
5/49 • Adverse events (AEs) were collected form the date of first study-drug intake until 28 days after the date of last study-drug intake.
All participants who received at least 1 dose of study treatment were included in the safety population. Nonserious AEs presented in this record include all AEs reported during the study, not just nonserious events.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
8.2%
4/49 • Adverse events (AEs) were collected form the date of first study-drug intake until 28 days after the date of last study-drug intake.
All participants who received at least 1 dose of study treatment were included in the safety population. Nonserious AEs presented in this record include all AEs reported during the study, not just nonserious events.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.1%
3/49 • Adverse events (AEs) were collected form the date of first study-drug intake until 28 days after the date of last study-drug intake.
All participants who received at least 1 dose of study treatment were included in the safety population. Nonserious AEs presented in this record include all AEs reported during the study, not just nonserious events.
|
|
Nervous system disorders
Headache
|
8.2%
4/49 • Adverse events (AEs) were collected form the date of first study-drug intake until 28 days after the date of last study-drug intake.
All participants who received at least 1 dose of study treatment were included in the safety population. Nonserious AEs presented in this record include all AEs reported during the study, not just nonserious events.
|
|
Nervous system disorders
Neuropathy peripheral
|
26.5%
13/49 • Adverse events (AEs) were collected form the date of first study-drug intake until 28 days after the date of last study-drug intake.
All participants who received at least 1 dose of study treatment were included in the safety population. Nonserious AEs presented in this record include all AEs reported during the study, not just nonserious events.
|
|
Nervous system disorders
Paraesthesia
|
44.9%
22/49 • Adverse events (AEs) were collected form the date of first study-drug intake until 28 days after the date of last study-drug intake.
All participants who received at least 1 dose of study treatment were included in the safety population. Nonserious AEs presented in this record include all AEs reported during the study, not just nonserious events.
|
|
Nervous system disorders
Sciatica
|
6.1%
3/49 • Adverse events (AEs) were collected form the date of first study-drug intake until 28 days after the date of last study-drug intake.
All participants who received at least 1 dose of study treatment were included in the safety population. Nonserious AEs presented in this record include all AEs reported during the study, not just nonserious events.
|
|
Nervous system disorders
Syncope
|
6.1%
3/49 • Adverse events (AEs) were collected form the date of first study-drug intake until 28 days after the date of last study-drug intake.
All participants who received at least 1 dose of study treatment were included in the safety population. Nonserious AEs presented in this record include all AEs reported during the study, not just nonserious events.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.1%
3/49 • Adverse events (AEs) were collected form the date of first study-drug intake until 28 days after the date of last study-drug intake.
All participants who received at least 1 dose of study treatment were included in the safety population. Nonserious AEs presented in this record include all AEs reported during the study, not just nonserious events.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
12.2%
6/49 • Adverse events (AEs) were collected form the date of first study-drug intake until 28 days after the date of last study-drug intake.
All participants who received at least 1 dose of study treatment were included in the safety population. Nonserious AEs presented in this record include all AEs reported during the study, not just nonserious events.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
18.4%
9/49 • Adverse events (AEs) were collected form the date of first study-drug intake until 28 days after the date of last study-drug intake.
All participants who received at least 1 dose of study treatment were included in the safety population. Nonserious AEs presented in this record include all AEs reported during the study, not just nonserious events.
|
|
Skin and subcutaneous tissue disorders
Rash
|
8.2%
4/49 • Adverse events (AEs) were collected form the date of first study-drug intake until 28 days after the date of last study-drug intake.
All participants who received at least 1 dose of study treatment were included in the safety population. Nonserious AEs presented in this record include all AEs reported during the study, not just nonserious events.
|
|
Vascular disorders
Hypertension
|
24.5%
12/49 • Adverse events (AEs) were collected form the date of first study-drug intake until 28 days after the date of last study-drug intake.
All participants who received at least 1 dose of study treatment were included in the safety population. Nonserious AEs presented in this record include all AEs reported during the study, not just nonserious events.
|
|
Vascular disorders
Phlebitis
|
8.2%
4/49 • Adverse events (AEs) were collected form the date of first study-drug intake until 28 days after the date of last study-drug intake.
All participants who received at least 1 dose of study treatment were included in the safety population. Nonserious AEs presented in this record include all AEs reported during the study, not just nonserious events.
|
Additional Information
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