Trial Outcomes & Findings for An Observational Study of Bevacizumab in Combination With 5-FU-Based Chemotherapy in Chinese Participants With Metastatic Colorectal Cancer (NCT NCT01319877)
NCT ID: NCT01319877
Last Updated: 2016-09-07
Results Overview
An adverse event (AE) is defined as any untoward medical occurrence in a participant after administration of a pharmaceutical product and which did not necessarily have a causal relationship with this treatment.
Recruitment status
COMPLETED
Target enrollment
609 participants
Primary outcome timeframe
36 months
Results posted on
2016-09-07
Participant Flow
Three enrolled participants received third-line therapy and were not included in the evaluable population.
Participant milestones
| Measure |
First Line Treatment
Participants received bevacizumab in combination with 5-FU based chemotherapy as a first line therapy.
|
Second Line Treatment
Participants received bevacizumab in combination with 5-FU based chemotherapy as a second line therapy.
|
|---|---|---|
|
Overall Study
STARTED
|
453
|
153
|
|
Overall Study
COMPLETED
|
345
|
108
|
|
Overall Study
NOT COMPLETED
|
108
|
45
|
Reasons for withdrawal
| Measure |
First Line Treatment
Participants received bevacizumab in combination with 5-FU based chemotherapy as a first line therapy.
|
Second Line Treatment
Participants received bevacizumab in combination with 5-FU based chemotherapy as a second line therapy.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
100
|
37
|
|
Overall Study
Physician Decision
|
2
|
0
|
|
Overall Study
Disease Progression
|
2
|
2
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
|
Overall Study
Reason Not Specified
|
4
|
5
|
Baseline Characteristics
An Observational Study of Bevacizumab in Combination With 5-FU-Based Chemotherapy in Chinese Participants With Metastatic Colorectal Cancer
Baseline characteristics by cohort
| Measure |
First Line Treatment
n=453 Participants
Participants received bevacizumab in combination with 5-FU based chemotherapy as a first line therapy.
|
Second Line Treatment
n=153 Participants
Participants received bevacizumab in combination with 5-FU based chemotherapy as a second line therapy.
|
Total
n=606 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
55.7 years
STANDARD_DEVIATION 11.9 • n=99 Participants
|
54.5 years
STANDARD_DEVIATION 11.9 • n=107 Participants
|
55.4 years
STANDARD_DEVIATION 11.9 • n=206 Participants
|
|
Sex: Female, Male
Female
|
183 Participants
n=99 Participants
|
53 Participants
n=107 Participants
|
236 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
270 Participants
n=99 Participants
|
100 Participants
n=107 Participants
|
370 Participants
n=206 Participants
|
|
Region of Enrollment
China
|
453 participants
n=99 Participants
|
153 participants
n=107 Participants
|
606 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 36 monthsAn adverse event (AE) is defined as any untoward medical occurrence in a participant after administration of a pharmaceutical product and which did not necessarily have a causal relationship with this treatment.
Outcome measures
| Measure |
First Line Treatment
n=453 Participants
Participants received bevacizumab in combination with 5-FU based chemotherapy as a first line therapy.
|
Second Line Treatment
n=153 Participants
Participants received bevacizumab in combination with 5-FU based chemotherapy as a second line therapy.
|
|---|---|---|
|
Percentage of Participants With Adverse Events
|
76.4 percentage of participants
|
68.0 percentage of participants
|
PRIMARY outcome
Timeframe: 36 monthsA Serious Adverse Event (SAE) was any untoward medical occurrence that at any dose was fatal, required inpatient hospitalization or prolongation of an existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was medically significant, or required intervention to prevent one or other of the outcomes listed above.
Outcome measures
| Measure |
First Line Treatment
n=453 Participants
Participants received bevacizumab in combination with 5-FU based chemotherapy as a first line therapy.
|
Second Line Treatment
n=153 Participants
Participants received bevacizumab in combination with 5-FU based chemotherapy as a second line therapy.
|
|---|---|---|
|
Percentage of Participants With Serious Adverse Events
|
4.9 percentage of participants
|
4.6 percentage of participants
|
PRIMARY outcome
Timeframe: 36 monthsOutcome measures
| Measure |
First Line Treatment
n=453 Participants
Participants received bevacizumab in combination with 5-FU based chemotherapy as a first line therapy.
|
Second Line Treatment
n=153 Participants
Participants received bevacizumab in combination with 5-FU based chemotherapy as a second line therapy.
|
|---|---|---|
|
Percentage of Participants With Adverse Events of Special Interest
|
9.1 percentage of participants
|
5.9 percentage of participants
|
PRIMARY outcome
Timeframe: 36 monthsOutcome measures
| Measure |
First Line Treatment
n=453 Participants
Participants received bevacizumab in combination with 5-FU based chemotherapy as a first line therapy.
|
Second Line Treatment
n=153 Participants
Participants received bevacizumab in combination with 5-FU based chemotherapy as a second line therapy.
|
|---|---|---|
|
Percentage of Participants With Bevacizumab-Related Adverse Events
|
54.5 percentage of participants
|
45.8 percentage of participants
|
PRIMARY outcome
Timeframe: 36 monthsOutcome measures
| Measure |
First Line Treatment
n=453 Participants
Participants received bevacizumab in combination with 5-FU based chemotherapy as a first line therapy.
|
Second Line Treatment
n=153 Participants
Participants received bevacizumab in combination with 5-FU based chemotherapy as a second line therapy.
|
|---|---|---|
|
Percentage of Participants With Bevacizumab-related Serious Adverse Events
|
3.1 percentage of participants
|
2.0 percentage of participants
|
SECONDARY outcome
Timeframe: 36 monthsOverall response was defined as complete response (CR) or partial response (PR) confirmed per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. CR: Disappearance of all target lesions, all non-target lesions, and no new lesions. PR: At least a 30% decrease in the sum of the diameters of target lesions, no progression in non-target lesions, and no new lesions.
Outcome measures
| Measure |
First Line Treatment
n=453 Participants
Participants received bevacizumab in combination with 5-FU based chemotherapy as a first line therapy.
|
Second Line Treatment
n=153 Participants
Participants received bevacizumab in combination with 5-FU based chemotherapy as a second line therapy.
|
|---|---|---|
|
Percentage of Participants Achieving an Overall Response
|
21.0 percentage of participants
Interval 17.3 to 25.0
|
10.5 percentage of participants
Interval 6.1 to 16.4
|
SECONDARY outcome
Timeframe: 36 monthsProgression-free-survival (PFS) was defined as the time from the date when the participant signed the informed consent form to the time of first documented disease progression or death, whichever occurred first.
Outcome measures
| Measure |
First Line Treatment
n=453 Participants
Participants received bevacizumab in combination with 5-FU based chemotherapy as a first line therapy.
|
Second Line Treatment
n=153 Participants
Participants received bevacizumab in combination with 5-FU based chemotherapy as a second line therapy.
|
|---|---|---|
|
Progression-free Survival
|
9.1 months
Interval 8.2 to 10.0
|
8.1 months
Interval 6.0 to 11.0
|
SECONDARY outcome
Timeframe: 1 yearOne year progression-free survival rate was defined as the percentage of participants who were free of progression or death from the date when the participant signed the informed consent form to one year.
Outcome measures
| Measure |
First Line Treatment
n=453 Participants
Participants received bevacizumab in combination with 5-FU based chemotherapy as a first line therapy.
|
Second Line Treatment
n=153 Participants
Participants received bevacizumab in combination with 5-FU based chemotherapy as a second line therapy.
|
|---|---|---|
|
One-year Progression-free Survival Rate
|
34.2 percentage of participants
Interval 26.8 to 41.7
|
29.9 percentage of participants
Interval 18.6 to 42.1
|
SECONDARY outcome
Timeframe: 1 yearOutcome measures
| Measure |
First Line Treatment
n=453 Participants
Participants received bevacizumab in combination with 5-FU based chemotherapy as a first line therapy.
|
Second Line Treatment
n=153 Participants
Participants received bevacizumab in combination with 5-FU based chemotherapy as a second line therapy.
|
|---|---|---|
|
One-year Survival Rate
|
68.7 percentage of participants
Interval 62.7 to 74.0
|
69.1 percentage of participants
Interval 59.1 to 77.2
|
SECONDARY outcome
Timeframe: 36 monthsPopulation: Participants with known KRAS status were evaluated.
Overall response was defined as complete response (CR) or partial response (PR) confirmed per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. CR: Disappearance of all target lesions, all non-target lesions, and no new lesions. PR: At least a 30% decrease in the sum of the diameters of target lesions, no progression in non-target lesions, and no new lesions. Results are reported per participants' Kirsten Rat Sarcoma Viral (KRAS) oncogene subgroup.
Outcome measures
| Measure |
First Line Treatment
n=453 Participants
Participants received bevacizumab in combination with 5-FU based chemotherapy as a first line therapy.
|
Second Line Treatment
n=153 Participants
Participants received bevacizumab in combination with 5-FU based chemotherapy as a second line therapy.
|
|---|---|---|
|
Percentage of Participants Achieving an Overall Response Per Kirsten Rat Sarcoma Viral (KRAS) Oncogene Subgroup
Wild-type
|
18.6 percentage of participants
Interval 9.7 to 30.9
|
10.3 percentage of participants
Interval 2.2 to 27.4
|
|
Percentage of Participants Achieving an Overall Response Per Kirsten Rat Sarcoma Viral (KRAS) Oncogene Subgroup
Mutant-type
|
10.7 percentage of participants
Interval 5.0 to 19.4
|
4.8 percentage of participants
Interval 0.1 to 23.8
|
SECONDARY outcome
Timeframe: 1 yearPopulation: Participants with known KRAS status were evaluated.
One year progression-free survival rate was defined as the percentage of participants who were free of progression or death from the date when the participant signed the informed consent form to one year. Results are reported per participants' Kirsten Rat Sarcoma Viral (KRAS) oncogene subgroup.
Outcome measures
| Measure |
First Line Treatment
n=453 Participants
Participants received bevacizumab in combination with 5-FU based chemotherapy as a first line therapy.
|
Second Line Treatment
n=153 Participants
Participants received bevacizumab in combination with 5-FU based chemotherapy as a second line therapy.
|
|---|---|---|
|
One-year Progression-free Survival Rate Per KRAS Subgroup
Wild-type
|
45.2 percentage of participants
Interval 22.6 to 65.4
|
31.3 percentage of participants
Interval 8.8 to 57.3
|
|
One-year Progression-free Survival Rate Per KRAS Subgroup
Mutant-type
|
19.5 percentage of participants
Interval 7.5 to 35.6
|
0 percentage of participants
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: 1 yearPopulation: Participants with known KRAS status were evaluated
Outcome measures
| Measure |
First Line Treatment
n=453 Participants
Participants received bevacizumab in combination with 5-FU based chemotherapy as a first line therapy.
|
Second Line Treatment
n=153 Participants
Participants received bevacizumab in combination with 5-FU based chemotherapy as a second line therapy.
|
|---|---|---|
|
One-year Survival Rate by the KRAS Subgroup
Wild-type
|
81.0 percentage of participants
Interval 64.7 to 90.3
|
69.1 percentage of participants
Interval 43.4 to 84.9
|
|
One-year Survival Rate by the KRAS Subgroup
Mutant-type
|
57.9 percentage of participants
Interval 42.7 to 70.4
|
33.9 percentage of participants
Interval 8.4 to 62.2
|
SECONDARY outcome
Timeframe: Up to 36 MonthsPopulation: Participants with known prior chemotherapy regimens were evaluated
Overall response was defined as complete response (CR) or partial response (PR) confirmed per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. CR: Disappearance of all target lesions, all non-target lesions, and no new lesions. PR: At least a 30% decrease in the sum of the diameters of target lesions, no progression in non-target lesions, and no new lesions. Results are reported per participants' chemotherapy regimen subgroup.
Outcome measures
| Measure |
First Line Treatment
n=453 Participants
Participants received bevacizumab in combination with 5-FU based chemotherapy as a first line therapy.
|
Second Line Treatment
n=153 Participants
Participants received bevacizumab in combination with 5-FU based chemotherapy as a second line therapy.
|
|---|---|---|
|
Percentage of Participants Achieving an Overall Response by the Chemotherapy Regimen Subgroup
FOLFOX
|
25.7 percentage of participants
Interval 19.4 to 32.9
|
15.2 percentage of participants
Interval 5.1 to 31.9
|
|
Percentage of Participants Achieving an Overall Response by the Chemotherapy Regimen Subgroup
IFL
|
18.5 percentage of participants
Interval 12.9 to 25.4
|
10.9 percentage of participants
Interval 5.3 to 19.1
|
|
Percentage of Participants Achieving an Overall Response by the Chemotherapy Regimen Subgroup
XELIRI
|
45.5 percentage of participants
Interval 16.7 to 76.6
|
14.3 percentage of participants
Interval 0.4 to 57.9
|
|
Percentage of Participants Achieving an Overall Response by the Chemotherapy Regimen Subgroup
XELOX
|
32.1 percentage of participants
Interval 19.9 to 46.3
|
0 percentage of participants
Interval 0.0 to 41.0
|
|
Percentage of Participants Achieving an Overall Response by the Chemotherapy Regimen Subgroup
Others
|
5.8 percentage of participants
Interval 1.2 to 15.9
|
7.1 percentage of participants
Interval 0.2 to 33.9
|
SECONDARY outcome
Timeframe: 1 yearPopulation: Participants with known prior chemotherapy regimens were evaluated.
One year progression-free survival rate was defined as the percentage of participants who were free of progression or death from the date when the participant signed the informed consent form to one year. Results are reported per participants' chemotherapy regimen subgroup.
Outcome measures
| Measure |
First Line Treatment
n=453 Participants
Participants received bevacizumab in combination with 5-FU based chemotherapy as a first line therapy.
|
Second Line Treatment
n=153 Participants
Participants received bevacizumab in combination with 5-FU based chemotherapy as a second line therapy.
|
|---|---|---|
|
One-year Progression-free Survival Rate Per Chemotherapy Regimen Subgroup
FOLFOX
|
38.9 percentage of participants
Interval 28.1 to 49.5
|
38.1 percentage of participants
Interval 16.0 to 60.1
|
|
One-year Progression-free Survival Rate Per Chemotherapy Regimen Subgroup
IFL
|
29.1 percentage of participants
Interval 16.9 to 42.4
|
32.2 percentage of participants
Interval 16.5 to 49.1
|
|
One-year Progression-free Survival Rate Per Chemotherapy Regimen Subgroup
XELIRI
|
13.3 percentage of participants
Interval 0.8 to 43.3
|
20.0 percentage of participants
Interval 0.8 to 58.2
|
|
One-year Progression-free Survival Rate Per Chemotherapy Regimen Subgroup
XELOX
|
44.9 percentage of participants
Interval 17.1 to 69.6
|
20.8 percentage of participants
Interval 0.9 to 59.5
|
|
One-year Progression-free Survival Rate Per Chemotherapy Regimen Subgroup
Others
|
19.5 percentage of participants
Interval 3.6 to 45.0
|
16.7 percentage of participants
Interval 0.8 to 51.7
|
SECONDARY outcome
Timeframe: 1 yearPopulation: Participants with known prior chemotherapy regimens were evaluated
Outcome measures
| Measure |
First Line Treatment
n=453 Participants
Participants received bevacizumab in combination with 5-FU based chemotherapy as a first line therapy.
|
Second Line Treatment
n=153 Participants
Participants received bevacizumab in combination with 5-FU based chemotherapy as a second line therapy.
|
|---|---|---|
|
One-year Survival Rate by the Chemotherapy Regimen Subgroup
Others
|
64.7 percentage of participants
Interval 38.4 to 82.0
|
60.0 percentage of participants
Interval 25.3 to 82.7
|
|
One-year Survival Rate by the Chemotherapy Regimen Subgroup
FOLFOX
|
66.6 percentage of participants
Interval 56.8 to 74.7
|
71.6 percentage of participants
Interval 47.0 to 86.2
|
|
One-year Survival Rate by the Chemotherapy Regimen Subgroup
IFL
|
70.8 percentage of participants
Interval 60.6 to 78.8
|
71.4 percentage of participants
Interval 58.2 to 81.0
|
|
One-year Survival Rate by the Chemotherapy Regimen Subgroup
XELIRI
|
66.7 percentage of participants
Interval 27.2 to 88.1
|
20.8 percentage of participants
Interval 0.9 to 59.5
|
|
One-year Survival Rate by the Chemotherapy Regimen Subgroup
XELOX
|
75.2 percentage of participants
Interval 56.1 to 86.9
|
0 percentage of participants
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: Up to 36 MonthsPopulation: Evaluable participants.
Quality of life was assessed at baseline and every three months after treatment by the EORTC QLQ-C30 questionnaire. The possible score range was 0 to 100, with a higher score indicating better functioning.
Outcome measures
| Measure |
First Line Treatment
n=248 Participants
Participants received bevacizumab in combination with 5-FU based chemotherapy as a first line therapy.
|
Second Line Treatment
n=67 Participants
Participants received bevacizumab in combination with 5-FU based chemotherapy as a second line therapy.
|
|---|---|---|
|
Quality of Life: European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 Questionnaire
Visit 5 (n=26,9)
|
57.05 score on a scale
Standard Deviation 15.758
|
62.96 score on a scale
Standard Deviation 16.724
|
|
Quality of Life: European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 Questionnaire
Baseline (n=248,67)
|
63.68 score on a scale
Standard Deviation 18.020
|
65.67 score on a scale
Standard Deviation 14.103
|
|
Quality of Life: European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 Questionnaire
Visit 2 (n=159,44)
|
62.89 score on a scale
Standard Deviation 15.875
|
64.96 score on a scale
Standard Deviation 17.105
|
|
Quality of Life: European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 Questionnaire
Visit 3 (n=80,21)
|
59.79 score on a scale
Standard Deviation 18.073
|
56.35 score on a scale
Standard Deviation 19.168
|
|
Quality of Life: European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 Questionnaire
Visit 4 (n=50,12)
|
54.83 score on a scale
Standard Deviation 22.718
|
61.11 score on a scale
Standard Deviation 14.360
|
|
Quality of Life: European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 Questionnaire
Visit 6 (n=15,5)
|
57.22 score on a scale
Standard Deviation 14.389
|
73.33 score on a scale
Standard Deviation 16.030
|
|
Quality of Life: European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 Questionnaire
Visit 7 (n=11,4)
|
56.82 score on a scale
Standard Deviation 16.168
|
72.92 score on a scale
Standard Deviation 15.773
|
|
Quality of Life: European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 Questionnaire
Visit 8 (n=7,3)
|
60.72 score on a scale
Standard Deviation 14.205
|
66.67 score on a scale
Standard Deviation 8.335
|
|
Quality of Life: European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 Questionnaire
Visit 9 (n=4,1)
|
45.83 score on a scale
Standard Deviation 15.960
|
66.67 score on a scale
Standard Deviation NA
Not calculable, due to single data point.
|
|
Quality of Life: European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 Questionnaire
Visit 10 (n=1,0)
|
50.00 score on a scale
Standard Deviation NA
Not calculable, due to single data point.
|
NA score on a scale
Standard Deviation NA
Not calculable, due to no participants for this data point.
|
Adverse Events
First and Second Line Treatment
Serious events: 29 serious events
Other events: 450 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
First and Second Line Treatment
n=606 participants at risk
The participants from the first line and second line treatments were combined for the adverse event analysis.
|
|---|---|
|
Gastrointestinal disorders
Enteritis
|
0.33%
2/606 • Up to 36 months
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.33%
2/606 • Up to 36 months
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.33%
2/606 • Up to 36 months
|
|
Gastrointestinal disorders
Gastritis
|
0.17%
1/606 • Up to 36 months
|
|
Gastrointestinal disorders
Gastrointestinal hemorrhage
|
0.17%
1/606 • Up to 36 months
|
|
Gastrointestinal disorders
Gastrointestinal perforation
|
0.17%
1/606 • Up to 36 months
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.17%
1/606 • Up to 36 months
|
|
Gastrointestinal disorders
Large intestinal obstruction
|
0.17%
1/606 • Up to 36 months
|
|
Gastrointestinal disorders
Enterovesical fistula
|
0.17%
1/606 • Up to 36 months
|
|
Infections and infestations
Infection
|
0.33%
2/606 • Up to 36 months
|
|
Infections and infestations
Bacteremia
|
0.17%
1/606 • Up to 36 months
|
|
Infections and infestations
Peritonitis
|
0.17%
1/606 • Up to 36 months
|
|
Infections and infestations
Urinary tract infection
|
0.17%
1/606 • Up to 36 months
|
|
Vascular disorders
Deep vein thrombosis
|
0.66%
4/606 • Up to 36 months
|
|
Cardiac disorders
Myocardial infarction
|
0.33%
2/606 • Up to 36 months
|
|
Cardiac disorders
Angina pectoris
|
0.17%
1/606 • Up to 36 months
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.17%
1/606 • Up to 36 months
|
|
Blood and lymphatic system disorders
Bone marrow failure
|
0.17%
1/606 • Up to 36 months
|
|
General disorders
Pyrexia
|
0.33%
2/606 • Up to 36 months
|
|
Investigations
Neutrophil count decreased
|
0.33%
2/606 • Up to 36 months
|
|
Injury, poisoning and procedural complications
Urinary tract stoma complication
|
0.17%
1/606 • Up to 36 months
|
|
Nervous system disorders
Hypoxic-ischaemic encephalopathy
|
0.17%
1/606 • Up to 36 months
|
|
Renal and urinary disorders
Ureteric fistula
|
0.17%
1/606 • Up to 36 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.17%
1/606 • Up to 36 months
|
Other adverse events
| Measure |
First and Second Line Treatment
n=606 participants at risk
The participants from the first line and second line treatments were combined for the adverse event analysis.
|
|---|---|
|
Gastrointestinal disorders
Nausea
|
17.8%
108/606 • Up to 36 months
|
|
Gastrointestinal disorders
Vomiting
|
15.3%
93/606 • Up to 36 months
|
|
Gastrointestinal disorders
Diarrhea
|
10.7%
65/606 • Up to 36 months
|
|
Gastrointestinal disorders
Constipation
|
5.1%
31/606 • Up to 36 months
|
|
Investigations
White blood cell count decreased
|
21.5%
130/606 • Up to 36 months
|
|
Investigations
Neutrophil count decreased
|
16.5%
100/606 • Up to 36 months
|
|
Investigations
Platelet count decreased
|
6.4%
39/606 • Up to 36 months
|
|
Investigations
Alanine aminotransferase increased
|
6.1%
37/606 • Up to 36 months
|
|
Investigations
Aspartate aminotransferase increased
|
5.9%
36/606 • Up to 36 months
|
|
General disorders
Pyrexia
|
9.6%
58/606 • Up to 36 months
|
|
General disorders
Fatigue
|
8.6%
52/606 • Up to 36 months
|
|
Blood and lymphatic system disorders
Bone marrow failure
|
12.0%
73/606 • Up to 36 months
|
|
Metabolism and nutrition disorders
Decreased appetite
|
8.3%
50/606 • Up to 36 months
|
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