Trial Outcomes & Findings for A Study to Assess Clinical Effectiveness and Safety of Vedolizumab Intravenous in Real World Clinical Practice in Ulcerative Colitis (UC) Korean Participants (NCT NCT03535649)
NCT ID: NCT03535649
Last Updated: 2019-12-23
Results Overview
Clinical response based on partial Mayo score was defined as a reduction of at least 3 points and a decrease of at least 30 percent (%) from the baseline Mayo score, with a decrease of at least 1 point on the rectal bleeding subscale, or an absolute rectal bleeding score of 0 or 1. Mayo score was an instrument designed to measure disease activity of UC. Partial Mayo score consisted of 3 sub-scores: stool frequency, most severe rectal bleeding of the day, and global assessment by physician, each graded from 0 to 3 with higher scores indicating more severe disease. These scores were summed to give a total score range of 0 to 9; where higher score indicated more severe disease.
COMPLETED
105 participants
Week 6
2019-12-23
Participant Flow
Participants took part in the study at 13 investigative sites in South Korea from 17 August 2017 to 18 December 2018.
Participants with a diagnosis of moderately to severely active ulcerative colitis (UC), having failed tumor necrosis factor-alpha (TNF-alpha) antagonist therapy and who have been prescribed vedolizumab intravenously under standard clinical practice were enrolled in this observational study.
Participant milestones
| Measure |
Vedolizumab
Participants diagnosed with moderate to severe active UC, having failed TNF-alpha antagonist therapy and received vedolizumab intravenous treatment were observed under standard clinical practice until the end of treatment or death of participants or lost to-follow up, whichever occurred first.
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|---|---|
|
Overall Study
STARTED
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105
|
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Overall Study
COMPLETED
|
105
|
|
Overall Study
NOT COMPLETED
|
0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Vedolizumab
n=105 Participants
Participants diagnosed with moderate to severe active UC, having failed TNF-alpha antagonist therapy and received vedolizumab intravenous treatment were observed under standard clinical practice until the end of treatment or death of participants or lost to-follow up, whichever occurred first.
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|---|---|
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Age, Categorical
<=18 years
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0 Participants
n=105 Participants
|
|
Age, Categorical
Between 18 and 65 years
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95 Participants
n=105 Participants
|
|
Age, Categorical
>=65 years
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10 Participants
n=105 Participants
|
|
Sex: Female, Male
Female
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38 Participants
n=105 Participants
|
|
Sex: Female, Male
Male
|
67 Participants
n=105 Participants
|
|
Region of Enrollment
Korea, Republic Of
|
105 Participants
n=105 Participants
|
|
Body Weight
|
61.4 kilogram (kg)
STANDARD_DEVIATION 12.0 • n=90 Participants • Number analyzed signifies participants for whom body weight data was available at baseline.
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Body Mass Index (BMI)
|
22.0 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 3.47 • n=88 Participants • Number analyzed signifies participants for whom BMI was available at baseline.
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|
Smoking Status
Current smoker
|
4 Participants
n=105 Participants
|
|
Smoking Status
Former smoker
|
31 Participants
n=105 Participants
|
|
Smoking Status
Never smoked
|
62 Participants
n=105 Participants
|
|
Smoking Status
Unknown
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8 Participants
n=105 Participants
|
|
Family History
Crohn's disease
|
0 Participants
n=105 Participants
|
|
Family History
UC- Siblings
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2 Participants
n=105 Participants
|
|
Family History
UC- Parent
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1 Participants
n=105 Participants
|
|
Comorbidities
Hypertension
|
5 Participants
n=105 Participants
|
|
Comorbidities
Diabetes mellitus
|
2 Participants
n=105 Participants
|
|
Comorbidities
Autoimmune hepatitis
|
1 Participants
n=105 Participants
|
|
Comorbidities
Rheumatoid arthritis
|
1 Participants
n=105 Participants
|
PRIMARY outcome
Timeframe: Week 6Population: The full analysis set (FAS) consisted all enrolled participants who received at least one dose of study medication and had active disease at baseline. Here, overall number of participants analyzed signifies participants who were evaluable for this outcome measure.
Clinical response based on partial Mayo score was defined as a reduction of at least 3 points and a decrease of at least 30 percent (%) from the baseline Mayo score, with a decrease of at least 1 point on the rectal bleeding subscale, or an absolute rectal bleeding score of 0 or 1. Mayo score was an instrument designed to measure disease activity of UC. Partial Mayo score consisted of 3 sub-scores: stool frequency, most severe rectal bleeding of the day, and global assessment by physician, each graded from 0 to 3 with higher scores indicating more severe disease. These scores were summed to give a total score range of 0 to 9; where higher score indicated more severe disease.
Outcome measures
| Measure |
Vedolizumab
n=77 Participants
Participants diagnosed with moderate to severe active UC, having failed TNF-alpha antagonist therapy and received vedolizumab intravenous treatment were observed under standard clinical practice until the end of treatment or death of participants or lost to-follow up, whichever occurred first.
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|---|---|
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Percentage of Participants With Clinical Response at Week 6 Based on Partial Mayo Score
|
55.8 percentage of participants
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PRIMARY outcome
Timeframe: From the index date (date when vedolizumab treatment was initiated) until the end of treatment, lost to follow-up or death (up to 15 months)Population: The SAS consisted all enrolled participants who received at least one documented dose of study medication.
Outcome measures
| Measure |
Vedolizumab
n=105 Participants
Participants diagnosed with moderate to severe active UC, having failed TNF-alpha antagonist therapy and received vedolizumab intravenous treatment were observed under standard clinical practice until the end of treatment or death of participants or lost to-follow up, whichever occurred first.
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|---|---|
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Percentage of Participants With Adverse Events of Special Interests (AESIs) and Serious Adverse Events (SAEs)
AESIs
|
4.76 percentage of participants
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Percentage of Participants With Adverse Events of Special Interests (AESIs) and Serious Adverse Events (SAEs)
SAEs
|
4.76 percentage of participants
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PRIMARY outcome
Timeframe: From the index date (date when vedolizumab treatment was initiated) until the end of treatment, lost to follow-up or death (up to 15 months)Population: The SAS consisted all enrolled participants who received at least one documented dose of study medication.
Outcome measures
| Measure |
Vedolizumab
n=105 Participants
Participants diagnosed with moderate to severe active UC, having failed TNF-alpha antagonist therapy and received vedolizumab intravenous treatment were observed under standard clinical practice until the end of treatment or death of participants or lost to-follow up, whichever occurred first.
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|---|---|
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Percentage of Participants With Pregnancy During the Study
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0.00 percentage of participants
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SECONDARY outcome
Timeframe: Week 14Population: The FAS consisted all enrolled participants who received at least one dose of study medication and had active disease at baseline. Here, overall number of participants analyzed signifies participants who were evaluable for this outcome measure.
Clinical response was defined as a reduction of at least 3 points and a decrease of at least 30% from the baseline mayo score, with a decrease of at least 1 point on the rectal bleeding subscale, or an absolute rectal bleeding score of 0 or 1. Mayo score was an instrument designed to measure disease activity of UC. Partial Mayo score consisted of 3 sub-scores: stool frequency, most severe rectal bleeding of the day, endoscopic findings and global assessment by physician, each graded from 0 to 3 with higher scores indicating more severe disease. These scores are summed to give a total score range of 0 to 9. Here, higher scores indicated more severe disease.
Outcome measures
| Measure |
Vedolizumab
n=71 Participants
Participants diagnosed with moderate to severe active UC, having failed TNF-alpha antagonist therapy and received vedolizumab intravenous treatment were observed under standard clinical practice until the end of treatment or death of participants or lost to-follow up, whichever occurred first.
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|---|---|
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Percentage of Participants With Clinical Response at Week 14 Based on Partial Mayo Score
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73.2 percentage of participants
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SECONDARY outcome
Timeframe: Weeks 6 and 14Population: The FAS consisted all enrolled participants who received at least one dose of study medication and had active disease at baseline. Here, n (number analyzed) signifies number of participants who were analyzed at specified time point.
Clinical remission was defined as a total mayo score of less than or equal to (\<=) 2 with no sub-score greater than (\>) 1. Mayo score was an instrument designed to measure disease activity of UC. Partial Mayo score consisted of 3 sub-scores: stool frequency, most severe rectal bleeding of the day, and global assessment by physician, each graded from 0 to 3 with higher scores indicating more severe disease. These scores were summed to give a total score range of 0 to 9; where higher score indicated more severe disease.
Outcome measures
| Measure |
Vedolizumab
n=77 Participants
Participants diagnosed with moderate to severe active UC, having failed TNF-alpha antagonist therapy and received vedolizumab intravenous treatment were observed under standard clinical practice until the end of treatment or death of participants or lost to-follow up, whichever occurred first.
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|---|---|
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Percentage of Participants With Clinical Remission at Week 6 and Week 14 Based on Partial Mayo Score
Week 6
|
18.2 percentage of participants
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Percentage of Participants With Clinical Remission at Week 6 and Week 14 Based on Partial Mayo Score
Week 14
|
39.4 percentage of participants
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SECONDARY outcome
Timeframe: Weeks 6 and 14Population: The FAS consisted all enrolled participants who received at least one dose of study medication and had active disease at baseline. Here, n (number analyzed) signifies number of participants who were analyzed at specified time point.
Mucosal healing was defined as Mayo endoscopic sub-score of 0 or 1 compared to baseline. Mayo score was an instrument designed to measure disease activity of UC. Endoscopic findings was a sub-score of complete Mayo score, which ranges from 0 to 3 (0= Normal or inactive disease; 1= Mild disease; 2= Moderate disease; 3= Severe disease), with higher scores indicating more severe disease.
Outcome measures
| Measure |
Vedolizumab
n=59 Participants
Participants diagnosed with moderate to severe active UC, having failed TNF-alpha antagonist therapy and received vedolizumab intravenous treatment were observed under standard clinical practice until the end of treatment or death of participants or lost to-follow up, whichever occurred first.
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|---|---|
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Percentage of Participants With Mucosal Healing at Weeks 6 and 14
Week 6
|
22.2 percentage of participants
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Percentage of Participants With Mucosal Healing at Weeks 6 and 14
Week 14
|
49.2 percentage of participants
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Adverse Events
Vedolizumab
Serious adverse events
| Measure |
Vedolizumab
n=105 participants at risk
Participants diagnosed with moderate to severe active UC, having failed TNF-alpha antagonist therapy and received vedolizumab intravenous treatment were observed under standard clinical practice until the end of treatment or death of participants or lost to-follow up, whichever occurred first.
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|---|---|
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Gastrointestinal disorders
Colitis ulcerative
|
2.9%
3/105 • Number of events 3 • Treatment-emergent adverse events (TEAEs) are adverse events that started after the first dose of study drug (index date) until end of treatment, lost to follow-up or death (up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
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|
Gastrointestinal disorders
Mouth ulceration
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0.95%
1/105 • Number of events 1 • Treatment-emergent adverse events (TEAEs) are adverse events that started after the first dose of study drug (index date) until end of treatment, lost to follow-up or death (up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
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|
Infections and infestations
Adenoiditis
|
0.95%
1/105 • Number of events 1 • Treatment-emergent adverse events (TEAEs) are adverse events that started after the first dose of study drug (index date) until end of treatment, lost to follow-up or death (up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
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|
Infections and infestations
Cytomegalovirus colitis
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0.95%
1/105 • Number of events 1 • Treatment-emergent adverse events (TEAEs) are adverse events that started after the first dose of study drug (index date) until end of treatment, lost to follow-up or death (up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
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0.95%
1/105 • Number of events 1 • Treatment-emergent adverse events (TEAEs) are adverse events that started after the first dose of study drug (index date) until end of treatment, lost to follow-up or death (up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
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Other adverse events
| Measure |
Vedolizumab
n=105 participants at risk
Participants diagnosed with moderate to severe active UC, having failed TNF-alpha antagonist therapy and received vedolizumab intravenous treatment were observed under standard clinical practice until the end of treatment or death of participants or lost to-follow up, whichever occurred first.
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|---|---|
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Blood and lymphatic system disorders
Anaemia
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0.95%
1/105 • Number of events 1 • Treatment-emergent adverse events (TEAEs) are adverse events that started after the first dose of study drug (index date) until end of treatment, lost to follow-up or death (up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Abdominal discomfort
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0.95%
1/105 • Number of events 2 • Treatment-emergent adverse events (TEAEs) are adverse events that started after the first dose of study drug (index date) until end of treatment, lost to follow-up or death (up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Colitis ulcerative
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2.9%
3/105 • Number of events 3 • Treatment-emergent adverse events (TEAEs) are adverse events that started after the first dose of study drug (index date) until end of treatment, lost to follow-up or death (up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
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|
Gastrointestinal disorders
Haematochezia
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0.95%
1/105 • Number of events 1 • Treatment-emergent adverse events (TEAEs) are adverse events that started after the first dose of study drug (index date) until end of treatment, lost to follow-up or death (up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
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General disorders
Pain
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0.95%
1/105 • Number of events 1 • Treatment-emergent adverse events (TEAEs) are adverse events that started after the first dose of study drug (index date) until end of treatment, lost to follow-up or death (up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
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|
General disorders
Pyrexia
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0.95%
1/105 • Number of events 1 • Treatment-emergent adverse events (TEAEs) are adverse events that started after the first dose of study drug (index date) until end of treatment, lost to follow-up or death (up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
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Infections and infestations
Clostridium difficile colitis
|
0.95%
1/105 • Number of events 1 • Treatment-emergent adverse events (TEAEs) are adverse events that started after the first dose of study drug (index date) until end of treatment, lost to follow-up or death (up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Cytomegalovirus syndrome
|
0.95%
1/105 • Number of events 1 • Treatment-emergent adverse events (TEAEs) are adverse events that started after the first dose of study drug (index date) until end of treatment, lost to follow-up or death (up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
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|
Infections and infestations
Nasopharyngitis
|
0.95%
1/105 • Number of events 1 • Treatment-emergent adverse events (TEAEs) are adverse events that started after the first dose of study drug (index date) until end of treatment, lost to follow-up or death (up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
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|
Infections and infestations
Upper respiratory tract infection
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3.8%
4/105 • Number of events 4 • Treatment-emergent adverse events (TEAEs) are adverse events that started after the first dose of study drug (index date) until end of treatment, lost to follow-up or death (up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.9%
2/105 • Number of events 2 • Treatment-emergent adverse events (TEAEs) are adverse events that started after the first dose of study drug (index date) until end of treatment, lost to follow-up or death (up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.95%
1/105 • Number of events 1 • Treatment-emergent adverse events (TEAEs) are adverse events that started after the first dose of study drug (index date) until end of treatment, lost to follow-up or death (up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.95%
1/105 • Number of events 1 • Treatment-emergent adverse events (TEAEs) are adverse events that started after the first dose of study drug (index date) until end of treatment, lost to follow-up or death (up to 15 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.
- Publication restrictions are in place
Restriction type: OTHER