Trial Outcomes & Findings for Ability to Maintain or Achieve Clinical and Endoscopic Remission With MMX Mesalamine Once Daily in Adults With Ulcerative Colitis (NCT NCT01124149)
NCT ID: NCT01124149
Last Updated: 2021-06-09
Results Overview
Complete remission was defined as a modified Ulcerative Colitis Disease Activity Index (UC-DAI) \<=1 with a score of 0 for rectal bleeding and stool frequency and at least a 1-point reduction in endoscopy score from baseline. The modified UC-DAI score is the sum of the scores of 4 parameters (stool frequency, rectal bleeding, endoscopy score, and physician global assessment), each scoring between 0 and 3, making 12 the worst score. Endoscopy score (mucosal appearance) ranges from 0-3 (0 = normal, 1 = mild , 2 = moderate, 3 = severe). Rectal bleeding is assessed on a scale from 0-3 (0 = no rectal bleeding, 1 = streaks of blood, 2 = obvious blood, 3 = mostly blood). Stool frequency is assessed on a scale of 0-2 (0 = 0-1 more than normal per day, 1 = 2-3 more than normal per day, 2 = 4 or more than normal per day).
COMPLETED
PHASE4
759 participants
12 months
2021-06-09
Participant Flow
Although 639 subjects completed the Acute Phase, 167 were not eligible to enter the Maintenance Phase due to lack of efficacy and 2 others withdrew prior to entering the maintenance Phase and 1 was withdrawn per IVRS prior to entering the Mainenance Phase. Therefore, 469 subjects entered the Maintenance Phase.
Participant milestones
| Measure |
MMX Mesalamine/ Mesalazine
4.8g/day given QD for 8 weeks in the Acute Phase and 2.4g/day given QD for 12 months in the Maintenance Phase
|
|---|---|
|
Acute Phase
STARTED
|
722
|
|
Acute Phase
COMPLETED
|
639
|
|
Acute Phase
NOT COMPLETED
|
83
|
|
Maintenance Phase
STARTED
|
469
|
|
Maintenance Phase
COMPLETED
|
373
|
|
Maintenance Phase
NOT COMPLETED
|
96
|
Reasons for withdrawal
| Measure |
MMX Mesalamine/ Mesalazine
4.8g/day given QD for 8 weeks in the Acute Phase and 2.4g/day given QD for 12 months in the Maintenance Phase
|
|---|---|
|
Acute Phase
Withdrawal by Subject
|
22
|
|
Acute Phase
Adverse Event
|
21
|
|
Acute Phase
Lack of Efficacy
|
17
|
|
Acute Phase
Protocol Violation
|
14
|
|
Acute Phase
Lost to Follow-up
|
2
|
|
Acute Phase
Prolonged antibiotic therapy
|
1
|
|
Acute Phase
Sponsor request
|
1
|
|
Acute Phase
UC symptoms not ameliorated
|
1
|
|
Acute Phase
Non-compliance
|
1
|
|
Acute Phase
Low hemoglobin
|
1
|
|
Acute Phase
Travelling to another country
|
1
|
|
Acute Phase
Sponsor decision
|
1
|
|
Maintenance Phase
Lack of Efficacy
|
40
|
|
Maintenance Phase
Adverse Event
|
24
|
|
Maintenance Phase
Lost to Follow-up
|
15
|
|
Maintenance Phase
Withdrawal by Subject
|
10
|
|
Maintenance Phase
Protocol Violation
|
5
|
|
Maintenance Phase
Coordinator error
|
1
|
|
Maintenance Phase
Non-compliance
|
1
|
Baseline Characteristics
Ability to Maintain or Achieve Clinical and Endoscopic Remission With MMX Mesalamine Once Daily in Adults With Ulcerative Colitis
Baseline characteristics by cohort
| Measure |
MMX Mesalamine/ Mesalazine
n=717 Participants
4.8g/day given QD for 8 weeks in the Acute Phase and 2.4g/day given QD for 12 months in the Maintenance Phase
|
|---|---|
|
Age, Continuous
|
42.9 Years
STANDARD_DEVIATION 13.97 • n=99 Participants
|
|
Age, Customized
>=65 years
|
51 Participants
n=99 Participants
|
|
Age, Customized
<=18 years
|
10 Participants
n=99 Participants
|
|
Age, Customized
Between 18 and 65 years
|
656 Participants
n=99 Participants
|
|
Sex: Female, Male
Female
|
308 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
409 Participants
n=99 Participants
|
|
Region of Enrollment
BELGIUM
|
22 Participants
n=99 Participants
|
|
Region of Enrollment
CANADA
|
39 Participants
n=99 Participants
|
|
Region of Enrollment
COLOMBIA
|
74 Participants
n=99 Participants
|
|
Region of Enrollment
CZECH REPUBLIC
|
130 Participants
n=99 Participants
|
|
Region of Enrollment
FRANCE
|
2 Participants
n=99 Participants
|
|
Region of Enrollment
HUNGARY
|
30 Participants
n=99 Participants
|
|
Region of Enrollment
INDIA
|
200 Participants
n=99 Participants
|
|
Region of Enrollment
IRELAND
|
9 Participants
n=99 Participants
|
|
Region of Enrollment
POLAND
|
52 Participants
n=99 Participants
|
|
Region of Enrollment
ROMANIA
|
41 Participants
n=99 Participants
|
|
Region of Enrollment
SOUTH AFRICA
|
21 Participants
n=99 Participants
|
|
Region of Enrollment
SPAIN
|
3 Participants
n=99 Participants
|
|
Region of Enrollment
UNITED KINGDOM
|
3 Participants
n=99 Participants
|
|
Region of Enrollment
UNITED STATES
|
96 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: Maintenance Phase Efficacy Population included all subjects who, during the Maintenance Phase, took at least 1 dose of investigational product and had at least 1 post-dose efficacy assessment.
Complete remission was defined as a modified Ulcerative Colitis Disease Activity Index (UC-DAI) \<=1 with a score of 0 for rectal bleeding and stool frequency and at least a 1-point reduction in endoscopy score from baseline. The modified UC-DAI score is the sum of the scores of 4 parameters (stool frequency, rectal bleeding, endoscopy score, and physician global assessment), each scoring between 0 and 3, making 12 the worst score. Endoscopy score (mucosal appearance) ranges from 0-3 (0 = normal, 1 = mild , 2 = moderate, 3 = severe). Rectal bleeding is assessed on a scale from 0-3 (0 = no rectal bleeding, 1 = streaks of blood, 2 = obvious blood, 3 = mostly blood). Stool frequency is assessed on a scale of 0-2 (0 = 0-1 more than normal per day, 1 = 2-3 more than normal per day, 2 = 4 or more than normal per day).
Outcome measures
| Measure |
MMX Mesalamine/ Mesalazine (Complete Remission Acute Phase)
n=182 Participants
Subjects received 4.8g/day given QD for 8 weeks in the Acute Phase and were classified as having complete remission at the end of the Acute Phase. Complete (clinical and endoscopic) remission was defined as a modified UC-DAI \<=1 with a score of 0 for rectal bleeding and stool frequency and at least a 1-point reduction in endoscopy score from baseline. These subjects then received 2.4g/day given QD for 12 months in the Maintenance Phase.
|
MMX Mesalamine/ Mesalazine (Partial Remission Acute Phase)
n=277 Participants
Subjects received 4.8g/day given QD for 8 weeks in the Acute Phase and were classified as having partial remission at the end of the Acute Phase. Partial remission was defined as a modified UC-DAI \<=3 with a combined stool frequency and rectal bleeding score of \<=1 and not in complete remission. These subjects then received 2.4g/day given QD for 12 months in the Maintenance Phase.
|
|---|---|---|
|
Percentage of Subjects in Complete Remission at Month 12 of Maintenance Phase
|
47.8 percentage of subjects
|
26.0 percentage of subjects
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Maintenance Phase Efficacy Population included all subjects who, during the Maintenance Phase, took at least 1 dose of investigational product and had at least 1 post-dose efficacy assessment.
Clinical remission was defined as a score of 0 for rectal bleeding and stool frequency. Rectal bleeding is assessed on a scale from 0-3 (0 = no rectal bleeding, 1 = streaks of blood, 2 = obvious blood, 3 = mostly blood). Stool frequency is assessed on a scale of 0-2 (0 = 0-1 more than normal per day, 1 = 2-3 more than normal per day, 2 = 4 or more than normal per day).
Outcome measures
| Measure |
MMX Mesalamine/ Mesalazine (Complete Remission Acute Phase)
n=182 Participants
Subjects received 4.8g/day given QD for 8 weeks in the Acute Phase and were classified as having complete remission at the end of the Acute Phase. Complete (clinical and endoscopic) remission was defined as a modified UC-DAI \<=1 with a score of 0 for rectal bleeding and stool frequency and at least a 1-point reduction in endoscopy score from baseline. These subjects then received 2.4g/day given QD for 12 months in the Maintenance Phase.
|
MMX Mesalamine/ Mesalazine (Partial Remission Acute Phase)
n=277 Participants
Subjects received 4.8g/day given QD for 8 weeks in the Acute Phase and were classified as having partial remission at the end of the Acute Phase. Partial remission was defined as a modified UC-DAI \<=3 with a combined stool frequency and rectal bleeding score of \<=1 and not in complete remission. These subjects then received 2.4g/day given QD for 12 months in the Maintenance Phase.
|
|---|---|---|
|
Percentage of Subjects in Clinical Remission at Month 12 of Maintenance Phase
|
58.8 percentage of subjects
|
40.4 percentage of subjects
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Maintenance Phase Efficacy Population included all subjects who, during the Maintenance Phase, took at least 1 dose of investigational product and had at least 1 post-dose efficacy assessment.
Relapse was defined in the Maintenance Phase as the need for alternative treatment for UC (including surgery); subjects were classified as having a relapse if they had withdrawn from the study due to a lack of efficacy.
Outcome measures
| Measure |
MMX Mesalamine/ Mesalazine (Complete Remission Acute Phase)
n=182 Participants
Subjects received 4.8g/day given QD for 8 weeks in the Acute Phase and were classified as having complete remission at the end of the Acute Phase. Complete (clinical and endoscopic) remission was defined as a modified UC-DAI \<=1 with a score of 0 for rectal bleeding and stool frequency and at least a 1-point reduction in endoscopy score from baseline. These subjects then received 2.4g/day given QD for 12 months in the Maintenance Phase.
|
MMX Mesalamine/ Mesalazine (Partial Remission Acute Phase)
n=277 Participants
Subjects received 4.8g/day given QD for 8 weeks in the Acute Phase and were classified as having partial remission at the end of the Acute Phase. Partial remission was defined as a modified UC-DAI \<=3 with a combined stool frequency and rectal bleeding score of \<=1 and not in complete remission. These subjects then received 2.4g/day given QD for 12 months in the Maintenance Phase.
|
|---|---|---|
|
Relapse in Ulcerative Colitis at Month 12 of Maintenance Phase
|
6.0 percentage of subjects
|
10.5 percentage of subjects
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Maintenance Phase Efficacy Population included all subjects who, during the Maintenance Phase, took at least 1 dose of investigational product and had at least 1 post-dose efficacy assessment.
Subjects with mucosal healing were defined as subjects who had an endoscopy score \<=1. Endoscopy score (mucosal appearance) ranges from 0-3 (0 = normal, 1 = mild , 2 = moderate, 3 = severe).
Outcome measures
| Measure |
MMX Mesalamine/ Mesalazine (Complete Remission Acute Phase)
n=182 Participants
Subjects received 4.8g/day given QD for 8 weeks in the Acute Phase and were classified as having complete remission at the end of the Acute Phase. Complete (clinical and endoscopic) remission was defined as a modified UC-DAI \<=1 with a score of 0 for rectal bleeding and stool frequency and at least a 1-point reduction in endoscopy score from baseline. These subjects then received 2.4g/day given QD for 12 months in the Maintenance Phase.
|
MMX Mesalamine/ Mesalazine (Partial Remission Acute Phase)
n=277 Participants
Subjects received 4.8g/day given QD for 8 weeks in the Acute Phase and were classified as having partial remission at the end of the Acute Phase. Partial remission was defined as a modified UC-DAI \<=3 with a combined stool frequency and rectal bleeding score of \<=1 and not in complete remission. These subjects then received 2.4g/day given QD for 12 months in the Maintenance Phase.
|
|---|---|---|
|
Percentage of Subjects With Mucosal Healing at 12 Months of Maintenance Phase
|
76.4 percentage of subjects
|
63.5 percentage of subjects
|
SECONDARY outcome
Timeframe: 3 and 8 weeksPopulation: Acute Phase Safety Population included all subjects who, during the Acute Phase, took at least 1 dose of investigational product.
Improvement was defined as at least a 1-point reduction in the rectal bleeding score from baseline at each assessment point. Rectal bleeding is assessed on a scale from 0-3 (0 = no rectal bleeding, 1 = streaks of blood, 2 = obvious blood, 3 = mostly blood).
Outcome measures
| Measure |
MMX Mesalamine/ Mesalazine (Complete Remission Acute Phase)
n=717 Participants
Subjects received 4.8g/day given QD for 8 weeks in the Acute Phase and were classified as having complete remission at the end of the Acute Phase. Complete (clinical and endoscopic) remission was defined as a modified UC-DAI \<=1 with a score of 0 for rectal bleeding and stool frequency and at least a 1-point reduction in endoscopy score from baseline. These subjects then received 2.4g/day given QD for 12 months in the Maintenance Phase.
|
MMX Mesalamine/ Mesalazine (Partial Remission Acute Phase)
Subjects received 4.8g/day given QD for 8 weeks in the Acute Phase and were classified as having partial remission at the end of the Acute Phase. Partial remission was defined as a modified UC-DAI \<=3 with a combined stool frequency and rectal bleeding score of \<=1 and not in complete remission. These subjects then received 2.4g/day given QD for 12 months in the Maintenance Phase.
|
|---|---|---|
|
Improvement in Rectal Bleeding Score During the Acute Phase
Week 3
|
42.4 percentage of subjects
|
—
|
|
Improvement in Rectal Bleeding Score During the Acute Phase
Week 8
|
59.8 percentage of subjects
|
—
|
SECONDARY outcome
Timeframe: 3 and 8 weeksPopulation: Acute Phase Safety Population included all subjects who, during the Acute Phase, took at least 1 dose of investigational product.
Improvement was defined as at least a 1-point reduction in the stool frequency score from baseline at each assessment point. Stool frequency is assessed on a scale of 0-2 (0 = 0-1 more than normal per day, 1 = 2-3 more than normal per day, 2 = 4 or more than normal per day).
Outcome measures
| Measure |
MMX Mesalamine/ Mesalazine (Complete Remission Acute Phase)
n=717 Participants
Subjects received 4.8g/day given QD for 8 weeks in the Acute Phase and were classified as having complete remission at the end of the Acute Phase. Complete (clinical and endoscopic) remission was defined as a modified UC-DAI \<=1 with a score of 0 for rectal bleeding and stool frequency and at least a 1-point reduction in endoscopy score from baseline. These subjects then received 2.4g/day given QD for 12 months in the Maintenance Phase.
|
MMX Mesalamine/ Mesalazine (Partial Remission Acute Phase)
Subjects received 4.8g/day given QD for 8 weeks in the Acute Phase and were classified as having partial remission at the end of the Acute Phase. Partial remission was defined as a modified UC-DAI \<=3 with a combined stool frequency and rectal bleeding score of \<=1 and not in complete remission. These subjects then received 2.4g/day given QD for 12 months in the Maintenance Phase.
|
|---|---|---|
|
Improvement in Stool Frequency Symptoms During the Acute Phase
3 Weeks
|
38.5 percentage of subjects
|
—
|
|
Improvement in Stool Frequency Symptoms During the Acute Phase
8 Weeks
|
58.9 percentage of subjects
|
—
|
SECONDARY outcome
Timeframe: 8 WeeksPopulation: Acute Phase Safety Population included all subjects who, during the Acute Phase, took at least 1 dose of investigational product.
Complete (clinical and endoscopic) remission was defined as a modified UC-DAI \<=1 with a score of 0 for rectal bleeding and stool frequency and at least a 1-point reduction in endoscopy score from baseline. The modified UC-DAI score is the sum of the scores of 4 parameters (stool frequency, rectal bleeding, endoscopy score, and physician global assessment), each scoring between 0 and 3, making 12 the worst score. Endoscopy score (mucosal appearance) ranges from 0-3 (0 = normal, 1 = mild , 2 = moderate, 3 = severe). Rectal bleeding is assessed on a scale from 0-3 (0 = no rectal bleeding, 1 = streaks of blood, 2 = obvious blood, 3 = mostly blood). Stool frequency is assessed on a scale of 0-2 (0 = 0-1 more than normal per day, 1 = 2-3 more than normal per day, 2 = 4 or more than normal per day).
Outcome measures
| Measure |
MMX Mesalamine/ Mesalazine (Complete Remission Acute Phase)
n=717 Participants
Subjects received 4.8g/day given QD for 8 weeks in the Acute Phase and were classified as having complete remission at the end of the Acute Phase. Complete (clinical and endoscopic) remission was defined as a modified UC-DAI \<=1 with a score of 0 for rectal bleeding and stool frequency and at least a 1-point reduction in endoscopy score from baseline. These subjects then received 2.4g/day given QD for 12 months in the Maintenance Phase.
|
MMX Mesalamine/ Mesalazine (Partial Remission Acute Phase)
Subjects received 4.8g/day given QD for 8 weeks in the Acute Phase and were classified as having partial remission at the end of the Acute Phase. Partial remission was defined as a modified UC-DAI \<=3 with a combined stool frequency and rectal bleeding score of \<=1 and not in complete remission. These subjects then received 2.4g/day given QD for 12 months in the Maintenance Phase.
|
|---|---|---|
|
Percentage of Subjects in Complete Remission at Week 8 of Acute Phase
|
25.9 percentage of subjects
|
—
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: Acute Phase Safety Population included all subjects who, during the Acute Phase, took at least 1 dose of investigational product.
Partial remission was defined as a modified UC-DAI \<=3 with a combined stool frequency and rectal bleeding score of \<=1 and not in complete remission. The modified UC-DAI score is the sum of the scores of 4 parameters (stool frequency, rectal bleeding, endoscopy score, and physician global assessment), each scoring between 0 and 3, making 12 the worst score. Endoscopy score (mucosal appearance) ranges from 0-3 (0 = normal, 1 = mild , 2 = moderate, 3 = severe). Rectal bleeding is assessed on a scale from 0-3 (0 = no rectal bleeding, 1 = streaks of blood, 2 = obvious blood, 3 = mostly blood). Stool frequency is assessed on a scale of 0-2 (0 = 0-1 more than normal per day, 1 = 2-3 more than normal per day, 2 = 4 or more than normal per day).
Outcome measures
| Measure |
MMX Mesalamine/ Mesalazine (Complete Remission Acute Phase)
n=717 Participants
Subjects received 4.8g/day given QD for 8 weeks in the Acute Phase and were classified as having complete remission at the end of the Acute Phase. Complete (clinical and endoscopic) remission was defined as a modified UC-DAI \<=1 with a score of 0 for rectal bleeding and stool frequency and at least a 1-point reduction in endoscopy score from baseline. These subjects then received 2.4g/day given QD for 12 months in the Maintenance Phase.
|
MMX Mesalamine/ Mesalazine (Partial Remission Acute Phase)
Subjects received 4.8g/day given QD for 8 weeks in the Acute Phase and were classified as having partial remission at the end of the Acute Phase. Partial remission was defined as a modified UC-DAI \<=3 with a combined stool frequency and rectal bleeding score of \<=1 and not in complete remission. These subjects then received 2.4g/day given QD for 12 months in the Maintenance Phase.
|
|---|---|---|
|
Percentage of Subjects in Partial Remission at Week 8 of Acute Phase
|
39.3 percentage of subjects
|
—
|
Adverse Events
MMX Mesalamine/ Mesalazine (Acute Phase)
MMX Mesalamine/ Mesalazine (Maintenance Phase)
Serious adverse events
| Measure |
MMX Mesalamine/ Mesalazine (Acute Phase)
n=717 participants at risk
4.8g/day given QD for 8 weeks in the Acute Phase
|
MMX Mesalamine/ Mesalazine (Maintenance Phase)
n=461 participants at risk
2.4 g/day given QD for 12 months in the Maintenance Phase
|
|---|---|---|
|
Cardiac disorders
Myocardial infarction
|
0.14%
1/717
|
0.00%
0/461
|
|
Gastrointestinal disorders
Colitis ulcerative
|
0.28%
2/717
|
0.22%
1/461
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.14%
1/717
|
0.00%
0/461
|
|
Infections and infestations
Arthritis bacterial
|
0.14%
1/717
|
0.00%
0/461
|
|
Infections and infestations
Lung infection
|
0.14%
1/717
|
0.00%
0/461
|
|
Infections and infestations
Pneumonia staphylococcal
|
0.14%
1/717
|
0.00%
0/461
|
|
Infections and infestations
Pyelonephritis acute
|
0.14%
1/717
|
0.00%
0/461
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.14%
1/717
|
0.00%
0/461
|
|
Investigations
HIV test positive
|
0.14%
1/717
|
0.00%
0/461
|
|
Metabolism and nutrition disorders
Dehydration
|
0.14%
1/717
|
0.22%
1/461
|
|
Musculoskeletal and connective tissue disorders
Arthritis reactive
|
0.14%
1/717
|
0.00%
0/461
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy
|
0.14%
1/717
|
0.00%
0/461
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.14%
1/717
|
0.00%
0/461
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/717
|
0.43%
2/461
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/717
|
0.22%
1/461
|
|
Cardiac disorders
Bundle branch block left
|
0.00%
0/717
|
0.22%
1/461
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/717
|
0.43%
2/461
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/717
|
0.65%
3/461
|
|
General disorders
Pyrexia
|
0.00%
0/717
|
0.22%
1/461
|
|
Infections and infestations
Appendicitis
|
0.00%
0/717
|
0.22%
1/461
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/717
|
0.22%
1/461
|
|
Infections and infestations
Hepatitis B
|
0.00%
0/717
|
0.22%
1/461
|
|
Injury, poisoning and procedural complications
Forearm fracture
|
0.00%
0/717
|
0.22%
1/461
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/717
|
0.43%
2/461
|
|
Investigations
C-reactive protein increased
|
0.00%
0/717
|
0.22%
1/461
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/717
|
0.22%
1/461
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain neoplasm
|
0.00%
0/717
|
0.22%
1/461
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/717
|
0.22%
1/461
|
|
Nervous system disorders
Hemorrhagic stroke
|
0.00%
0/717
|
0.22%
1/461
|
|
Nervous system disorders
Radiculopathy
|
0.00%
0/717
|
0.22%
1/461
|
|
Reproductive system and breast disorders
Metrorrhagia
|
0.00%
0/717
|
0.22%
1/461
|
|
Vascular disorders
Venous thrombosis limb
|
0.00%
0/717
|
0.22%
1/461
|
Other adverse events
| Measure |
MMX Mesalamine/ Mesalazine (Acute Phase)
n=717 participants at risk
4.8g/day given QD for 8 weeks in the Acute Phase
|
MMX Mesalamine/ Mesalazine (Maintenance Phase)
n=461 participants at risk
2.4 g/day given QD for 12 months in the Maintenance Phase
|
|---|---|---|
|
Gastrointestinal disorders
Colitis ulcerative
|
1.4%
10/717
|
9.3%
43/461
|
|
General disorders
Drug ineffective
|
7.0%
50/717
|
4.8%
22/461
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee If a multicenter publication is not submitted within twelve (12) months after conclusion, abandonment or termination of the Study at all sites, or after Sponsor confirms there shall be no multicenter Study publication, the Institution and/or such Principal Investigator may publish the results from the Institution site individually.
- Publication restrictions are in place
Restriction type: OTHER