Trial Outcomes & Findings for A Study of Avastin (Bevacizumab) and Xeloda (Capecitabine) as Maintenance Treatment in Patients With Metastatic Colorectal Cancer (NCT NCT00623805)
NCT ID: NCT00623805
Last Updated: 2014-08-08
Results Overview
Progression-free survival was defined as the time from the first administration of study drug to the first documented disease progression or death, whichever occurs first. Progressive disease was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since treatment started or the unequivocal progression of existing non-target lesions. All measurable lesions up to a maximum of 5 lesions per organ and 10 lesions in total, representative of all involved organs, should be identified as target lesions at Baseline. Target lesions should be selected on the basis of their size (lesions with the longest diameter) and their suitability for accurate repeated measurements (either by imaging techniques or clinically). A sum of the longest diameter for all target lesions will be calculated and reported as the Baseline sum longest diameter.
COMPLETED
PHASE3
123 participants
Baseline to the end of the study (up to 4 years, 2 months)
2014-08-08
Participant Flow
Participant milestones
| Measure |
Bevacizumab+Capecitabine+Oxaliplatin
Participants received bevacizumab 7.5 mg/kg intravenously (IV) on Day 1 of each 3-week cycle + oxaliplatin 130 mg/m\^2 IV on Day 1 of each 3-week cycle + capecitabine 1000 mg/m\^2 orally twice a day on Days 1-14 of each 3-week cycle until disease progression.
|
Bevacizumab(B)+Capecitabine(C)+Oxaliplatin Followed by B+C
Participants received bevacizumab 7.5 mg/kg intravenously (IV) on Day 1 of each 3-week cycle + oxaliplatin 130 mg/m\^2 IV on Day 1 of each 3-week cycle + capecitabine 1000 mg/m\^2 orally twice a day on Days 1-14 of each 3-week cycle for 6 cycles followed by bevacizumab 7.5 mg/kg intravenously (IV) on Day 1 of each 3-week cycle + capecitabine 1000 mg/m\^2 orally twice a day on Days 1-14 of each 3-week cycle until disease progression.
|
|---|---|---|
|
Overall Study
STARTED
|
62
|
61
|
|
Overall Study
COMPLETED
|
42
|
39
|
|
Overall Study
NOT COMPLETED
|
20
|
22
|
Reasons for withdrawal
| Measure |
Bevacizumab+Capecitabine+Oxaliplatin
Participants received bevacizumab 7.5 mg/kg intravenously (IV) on Day 1 of each 3-week cycle + oxaliplatin 130 mg/m\^2 IV on Day 1 of each 3-week cycle + capecitabine 1000 mg/m\^2 orally twice a day on Days 1-14 of each 3-week cycle until disease progression.
|
Bevacizumab(B)+Capecitabine(C)+Oxaliplatin Followed by B+C
Participants received bevacizumab 7.5 mg/kg intravenously (IV) on Day 1 of each 3-week cycle + oxaliplatin 130 mg/m\^2 IV on Day 1 of each 3-week cycle + capecitabine 1000 mg/m\^2 orally twice a day on Days 1-14 of each 3-week cycle for 6 cycles followed by bevacizumab 7.5 mg/kg intravenously (IV) on Day 1 of each 3-week cycle + capecitabine 1000 mg/m\^2 orally twice a day on Days 1-14 of each 3-week cycle until disease progression.
|
|---|---|---|
|
Overall Study
Adverse Event
|
9
|
6
|
|
Overall Study
Death
|
2
|
0
|
|
Overall Study
Lack of Efficacy
|
3
|
7
|
|
Overall Study
Lost to Follow-up
|
2
|
2
|
|
Overall Study
Protocol Violation
|
1
|
1
|
|
Overall Study
Reason not Specified
|
3
|
6
|
Baseline Characteristics
A Study of Avastin (Bevacizumab) and Xeloda (Capecitabine) as Maintenance Treatment in Patients With Metastatic Colorectal Cancer
Baseline characteristics by cohort
| Measure |
Bevacizumab+Capecitabine+Oxaliplatin
n=62 Participants
Participants received bevacizumab 7.5 mg/kg intravenously (IV) on Day 1 of each 3-week cycle + oxaliplatin 130 mg/m\^2 IV on Day 1 of each 3-week cycle + capecitabine 1000 mg/m\^2 orally twice a day on Days 1-14 of each 3-week cycle until disease progression.
|
Bevacizumab(B)+Capecitabine(C)+Oxaliplatin Followed by B+C
n=61 Participants
Participants received bevacizumab 7.5 mg/kg intravenously (IV) on Day 1 of each 3-week cycle + oxaliplatin 130 mg/m\^2 IV on Day 1 of each 3-week cycle + capecitabine 1000 mg/m\^2 orally twice a day on Days 1-14 of each 3-week cycle for 6 cycles followed by bevacizumab 7.5 mg/kg intravenously (IV) on Day 1 of each 3-week cycle + capecitabine 1000 mg/m\^2 orally twice a day on Days 1-14 of each 3-week cycle until disease progression.
|
Total
n=123 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
56.9 years
STANDARD_DEVIATION 11.2 • n=5 Participants
|
57.6 years
STANDARD_DEVIATION 11.3 • n=7 Participants
|
57.2 years
STANDARD_DEVIATION 11.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
39 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
77 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to the end of the study (up to 4 years, 2 months)Population: Intent-to-treat population: All randomized participants who had at least 1 post-randomization efficacy assessment.
Progression-free survival was defined as the time from the first administration of study drug to the first documented disease progression or death, whichever occurs first. Progressive disease was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since treatment started or the unequivocal progression of existing non-target lesions. All measurable lesions up to a maximum of 5 lesions per organ and 10 lesions in total, representative of all involved organs, should be identified as target lesions at Baseline. Target lesions should be selected on the basis of their size (lesions with the longest diameter) and their suitability for accurate repeated measurements (either by imaging techniques or clinically). A sum of the longest diameter for all target lesions will be calculated and reported as the Baseline sum longest diameter.
Outcome measures
| Measure |
Bevacizumab+Capecitabine+Oxaliplatin
n=62 Participants
Participants received bevacizumab 7.5 mg/kg intravenously (IV) on Day 1 of each 3-week cycle + oxaliplatin 130 mg/m\^2 IV on Day 1 of each 3-week cycle + capecitabine 1000 mg/m\^2 orally twice a day on Days 1-14 of each 3-week cycle until disease progression.
|
Bevacizumab(B)+Capecitabine(C)+Oxaliplatin Followed by B+C
n=61 Participants
Participants received bevacizumab 7.5 mg/kg intravenously (IV) on Day 1 of each 3-week cycle + oxaliplatin 130 mg/m\^2 IV on Day 1 of each 3-week cycle + capecitabine 1000 mg/m\^2 orally twice a day on Days 1-14 of each 3-week cycle for 6 cycles followed by bevacizumab 7.5 mg/kg intravenously (IV) on Day 1 of each 3-week cycle + capecitabine 1000 mg/m\^2 orally twice a day on Days 1-14 of each 3-week cycle until disease progression.
|
|---|---|---|
|
Progression-free Survival
|
9.0 Months
Standard Error 0.7
|
12.6 Months
Standard Error 1.0
|
SECONDARY outcome
Timeframe: Baseline to the end of the study (up to 4 years, 2 months)Population: Intent-to-treat population: All randomized participants who had at least 1 post-randomization efficacy assessment.
Overall survival was defined as the time from the first administration of study drug to death.
Outcome measures
| Measure |
Bevacizumab+Capecitabine+Oxaliplatin
n=62 Participants
Participants received bevacizumab 7.5 mg/kg intravenously (IV) on Day 1 of each 3-week cycle + oxaliplatin 130 mg/m\^2 IV on Day 1 of each 3-week cycle + capecitabine 1000 mg/m\^2 orally twice a day on Days 1-14 of each 3-week cycle until disease progression.
|
Bevacizumab(B)+Capecitabine(C)+Oxaliplatin Followed by B+C
n=61 Participants
Participants received bevacizumab 7.5 mg/kg intravenously (IV) on Day 1 of each 3-week cycle + oxaliplatin 130 mg/m\^2 IV on Day 1 of each 3-week cycle + capecitabine 1000 mg/m\^2 orally twice a day on Days 1-14 of each 3-week cycle for 6 cycles followed by bevacizumab 7.5 mg/kg intravenously (IV) on Day 1 of each 3-week cycle + capecitabine 1000 mg/m\^2 orally twice a day on Days 1-14 of each 3-week cycle until disease progression.
|
|---|---|---|
|
Overall Survival
|
21.0 Months
Standard Error 1.3
|
25.4 Months
Standard Error 1.7
|
SECONDARY outcome
Timeframe: Baseline to the end of the study (up to 4 years, 2 months)Population: Intent-to-treat population: All randomized participants who had at least 1 post-randomization efficacy assessment.
A complete response was defined as the disappearance of all target lesions. A partial response was defined as at least a 30% decrease in the sum of the longest diameter of target lesions taking as reference the Baseline sum longest diameter. All measurable lesions up to a maximum of 5 lesions per organ and 10 lesions in total, representative of all involved organs, should be identified as target lesions at Baseline. All other lesions (or sites of disease) should be identified as non-target lesions. Target lesions should be selected on the basis of their size (lesions with the longest diameter) and their suitability for accurate repeated measurements (either by imaging techniques or clinically). A sum of the longest diameter for all target lesions will be calculated and reported as the Baseline sum longest diameter.
Outcome measures
| Measure |
Bevacizumab+Capecitabine+Oxaliplatin
n=62 Participants
Participants received bevacizumab 7.5 mg/kg intravenously (IV) on Day 1 of each 3-week cycle + oxaliplatin 130 mg/m\^2 IV on Day 1 of each 3-week cycle + capecitabine 1000 mg/m\^2 orally twice a day on Days 1-14 of each 3-week cycle until disease progression.
|
Bevacizumab(B)+Capecitabine(C)+Oxaliplatin Followed by B+C
n=61 Participants
Participants received bevacizumab 7.5 mg/kg intravenously (IV) on Day 1 of each 3-week cycle + oxaliplatin 130 mg/m\^2 IV on Day 1 of each 3-week cycle + capecitabine 1000 mg/m\^2 orally twice a day on Days 1-14 of each 3-week cycle for 6 cycles followed by bevacizumab 7.5 mg/kg intravenously (IV) on Day 1 of each 3-week cycle + capecitabine 1000 mg/m\^2 orally twice a day on Days 1-14 of each 3-week cycle until disease progression.
|
|---|---|---|
|
Percentage of Participants With a Complete Response or a Partial Response
|
53.2 Percentage of participants
|
59.0 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline to Month 13Population: Intent-to-treat population: All randomized participants who had at least 1 post-randomization efficacy assessment. Only participants with a complete response or a partial response were included in the analysis.
Time until a complete response or a partial response was defined as the time from the first administration of study drug until the first complete response or partial response.
Outcome measures
| Measure |
Bevacizumab+Capecitabine+Oxaliplatin
n=33 Participants
Participants received bevacizumab 7.5 mg/kg intravenously (IV) on Day 1 of each 3-week cycle + oxaliplatin 130 mg/m\^2 IV on Day 1 of each 3-week cycle + capecitabine 1000 mg/m\^2 orally twice a day on Days 1-14 of each 3-week cycle until disease progression.
|
Bevacizumab(B)+Capecitabine(C)+Oxaliplatin Followed by B+C
n=36 Participants
Participants received bevacizumab 7.5 mg/kg intravenously (IV) on Day 1 of each 3-week cycle + oxaliplatin 130 mg/m\^2 IV on Day 1 of each 3-week cycle + capecitabine 1000 mg/m\^2 orally twice a day on Days 1-14 of each 3-week cycle for 6 cycles followed by bevacizumab 7.5 mg/kg intravenously (IV) on Day 1 of each 3-week cycle + capecitabine 1000 mg/m\^2 orally twice a day on Days 1-14 of each 3-week cycle until disease progression.
|
|---|---|---|
|
Time Until a Complete Response or a Partial Response
|
3.5 Months
Standard Deviation 2.8
|
2.9 Months
Standard Deviation 2.0
|
SECONDARY outcome
Timeframe: Baseline to the end of the study (up to 4 years, 2 months)Duration of response was defined as the time from the first complete response or partial response until disease progression or death. Progressive disease was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since treatment started or the unequivocal progression of existing non-target lesions. All measurable lesions up to a maximum of 5 lesions per organ and 10 lesions in total, representative of all involved organs, should be identified as target lesions at Baseline. Target lesions should be selected on the basis of their size (lesions with the longest diameter) and their suitability for accurate repeated measurements (either by imaging techniques or clinically). A sum of the longest diameter for all target lesions will be calculated and reported as the Baseline sum longest diameter.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline to the end of the study (up to 4 years, 2 months)Population: Intent-to-treat population: All randomized participants who had at least 1 post-randomization efficacy assessment.
Outcome measures
| Measure |
Bevacizumab+Capecitabine+Oxaliplatin
n=62 Participants
Participants received bevacizumab 7.5 mg/kg intravenously (IV) on Day 1 of each 3-week cycle + oxaliplatin 130 mg/m\^2 IV on Day 1 of each 3-week cycle + capecitabine 1000 mg/m\^2 orally twice a day on Days 1-14 of each 3-week cycle until disease progression.
|
Bevacizumab(B)+Capecitabine(C)+Oxaliplatin Followed by B+C
n=61 Participants
Participants received bevacizumab 7.5 mg/kg intravenously (IV) on Day 1 of each 3-week cycle + oxaliplatin 130 mg/m\^2 IV on Day 1 of each 3-week cycle + capecitabine 1000 mg/m\^2 orally twice a day on Days 1-14 of each 3-week cycle for 6 cycles followed by bevacizumab 7.5 mg/kg intravenously (IV) on Day 1 of each 3-week cycle + capecitabine 1000 mg/m\^2 orally twice a day on Days 1-14 of each 3-week cycle until disease progression.
|
|---|---|---|
|
Percentage of Participants With Metastatic Lesions Previously Considered Inoperable Who Became Operable and Underwent Surgery
|
58.1 Percentage of participants
|
54.1 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline to the end of the study (up to 4 years, 2 months)An R0 resection indicates a microscopically margin-negative resection, in which no gross or microscopic tumor remains in the primary tumor bed.
Outcome measures
Outcome data not reported
Adverse Events
Bevacizumab+Capecitabine+Oxaliplatin
Bevacizumab(B)+Capecitabine(C)+Oxaliplatin Followed by B+C
Serious adverse events
| Measure |
Bevacizumab+Capecitabine+Oxaliplatin
n=62 participants at risk
Participants received bevacizumab 7.5 mg/kg intravenously (IV) on Day 1 of each 3-week cycle + oxaliplatin 130 mg/m\^2 IV on Day 1 of each 3-week cycle + capecitabine 1000 mg/m\^2 orally twice a day on Days 1-14 of each 3-week cycle until disease progression.
|
Bevacizumab(B)+Capecitabine(C)+Oxaliplatin Followed by B+C
n=61 participants at risk
Participants received bevacizumab 7.5 mg/kg intravenously (IV) on Day 1 of each 3-week cycle + oxaliplatin 130 mg/m\^2 IV on Day 1 of each 3-week cycle + capecitabine 1000 mg/m\^2 orally twice a day on Days 1-14 of each 3-week cycle for 6 cycles followed by bevacizumab 7.5 mg/kg intravenously (IV) on Day 1 of each 3-week cycle + capecitabine 1000 mg/m\^2 orally twice a day on Days 1-14 of each 3-week cycle until disease progression.
|
|---|---|---|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/62
Safety population: All participants who received at least 1 dose of study drug.
|
1.6%
1/61
Safety population: All participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Anorexia
|
0.00%
0/62
Safety population: All participants who received at least 1 dose of study drug.
|
1.6%
1/61
Safety population: All participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.00%
0/62
Safety population: All participants who received at least 1 dose of study drug.
|
1.6%
1/61
Safety population: All participants who received at least 1 dose of study drug.
|
|
Infections and infestations
H1N1 infection (influenza)
|
1.6%
1/62
Safety population: All participants who received at least 1 dose of study drug.
|
0.00%
0/61
Safety population: All participants who received at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Anemia
|
1.6%
1/62
Safety population: All participants who received at least 1 dose of study drug.
|
0.00%
0/61
Safety population: All participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
1.6%
1/62
Safety population: All participants who received at least 1 dose of study drug.
|
1.6%
1/61
Safety population: All participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Acute abdomen
|
1.6%
1/62
Safety population: All participants who received at least 1 dose of study drug.
|
0.00%
0/61
Safety population: All participants who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Acute renal failure
|
1.6%
1/62
Safety population: All participants who received at least 1 dose of study drug.
|
0.00%
0/61
Safety population: All participants who received at least 1 dose of study drug.
|
|
General disorders
Clinical worsening
|
0.00%
0/62
Safety population: All participants who received at least 1 dose of study drug.
|
3.3%
2/61
Safety population: All participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Decreased breath sounds on right lower zone
|
0.00%
0/62
Safety population: All participants who received at least 1 dose of study drug.
|
1.6%
1/61
Safety population: All participants who received at least 1 dose of study drug.
|
|
Vascular disorders
Deep vein thrombosis
|
1.6%
1/62
Safety population: All participants who received at least 1 dose of study drug.
|
0.00%
0/61
Safety population: All participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Defence, distension and rigidity in abdomen
|
0.00%
0/62
Safety population: All participants who received at least 1 dose of study drug.
|
1.6%
1/61
Safety population: All participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Diarrhea
|
3.2%
2/62
Safety population: All participants who received at least 1 dose of study drug.
|
3.3%
2/61
Safety population: All participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Difficulty in breathing
|
0.00%
0/62
Safety population: All participants who received at least 1 dose of study drug.
|
1.6%
1/61
Safety population: All participants who received at least 1 dose of study drug.
|
|
General disorders
Fatigue
|
0.00%
0/62
Safety population: All participants who received at least 1 dose of study drug.
|
1.6%
1/61
Safety population: All participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Febrile neutropenia
|
0.00%
0/62
Safety population: All participants who received at least 1 dose of study drug.
|
1.6%
1/61
Safety population: All participants who received at least 1 dose of study drug.
|
|
General disorders
General situational failure
|
0.00%
0/62
Safety population: All participants who received at least 1 dose of study drug.
|
1.6%
1/61
Safety population: All participants who received at least 1 dose of study drug.
|
|
Immune system disorders
Laryngeal edema
|
0.00%
0/62
Safety population: All participants who received at least 1 dose of study drug.
|
1.6%
1/61
Safety population: All participants who received at least 1 dose of study drug.
|
|
General disorders
High level of tiredness
|
0.00%
0/62
Safety population: All participants who received at least 1 dose of study drug.
|
1.6%
1/61
Safety population: All participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Myocardial infarction
|
1.6%
1/62
Safety population: All participants who received at least 1 dose of study drug.
|
0.00%
0/61
Safety population: All participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Neutropenic fever
|
1.6%
1/62
Safety population: All participants who received at least 1 dose of study drug.
|
0.00%
0/61
Safety population: All participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Rapid advanced dyspnea and cyanosis
|
0.00%
0/62
Safety population: All participants who received at least 1 dose of study drug.
|
1.6%
1/61
Safety population: All participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Rectovaginal fistule
|
0.00%
0/62
Safety population: All participants who received at least 1 dose of study drug.
|
1.6%
1/61
Safety population: All participants who received at least 1 dose of study drug.
|
|
General disorders
Severe backache, shivering
|
1.6%
1/62
Safety population: All participants who received at least 1 dose of study drug.
|
0.00%
0/61
Safety population: All participants who received at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/62
Safety population: All participants who received at least 1 dose of study drug.
|
1.6%
1/61
Safety population: All participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Urinary tract infection
|
1.6%
1/62
Safety population: All participants who received at least 1 dose of study drug.
|
3.3%
2/61
Safety population: All participants who received at least 1 dose of study drug.
|
Other adverse events
| Measure |
Bevacizumab+Capecitabine+Oxaliplatin
n=62 participants at risk
Participants received bevacizumab 7.5 mg/kg intravenously (IV) on Day 1 of each 3-week cycle + oxaliplatin 130 mg/m\^2 IV on Day 1 of each 3-week cycle + capecitabine 1000 mg/m\^2 orally twice a day on Days 1-14 of each 3-week cycle until disease progression.
|
Bevacizumab(B)+Capecitabine(C)+Oxaliplatin Followed by B+C
n=61 participants at risk
Participants received bevacizumab 7.5 mg/kg intravenously (IV) on Day 1 of each 3-week cycle + oxaliplatin 130 mg/m\^2 IV on Day 1 of each 3-week cycle + capecitabine 1000 mg/m\^2 orally twice a day on Days 1-14 of each 3-week cycle for 6 cycles followed by bevacizumab 7.5 mg/kg intravenously (IV) on Day 1 of each 3-week cycle + capecitabine 1000 mg/m\^2 orally twice a day on Days 1-14 of each 3-week cycle until disease progression.
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
43.5%
27/62
Safety population: All participants who received at least 1 dose of study drug.
|
27.9%
17/61
Safety population: All participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
38.7%
24/62
Safety population: All participants who received at least 1 dose of study drug.
|
26.2%
16/61
Safety population: All participants who received at least 1 dose of study drug.
|
|
General disorders
Weakness
|
38.7%
24/62
Safety population: All participants who received at least 1 dose of study drug.
|
29.5%
18/61
Safety population: All participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Anorexia
|
27.4%
17/62
Safety population: All participants who received at least 1 dose of study drug.
|
21.3%
13/61
Safety population: All participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Diarrhea
|
38.7%
24/62
Safety population: All participants who received at least 1 dose of study drug.
|
27.9%
17/61
Safety population: All participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Neuropathy
|
40.3%
25/62
Safety population: All participants who received at least 1 dose of study drug.
|
41.0%
25/61
Safety population: All participants who received at least 1 dose of study drug.
|
|
Vascular disorders
Hemifacial spasm
|
37.1%
23/62
Safety population: All participants who received at least 1 dose of study drug.
|
39.3%
24/61
Safety population: All participants who received at least 1 dose of study drug.
|
Additional Information
Medical Communications
Hoffmann-La Roche
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