Trial Outcomes & Findings for Front Line Ibrutinib Without Corticosteroids for Newly Diagnosed Chronic Graft-versus-Host Disease (NCT NCT04294641)
NCT ID: NCT04294641
Last Updated: 2026-01-23
Results Overview
To evaluate the efficacy of Ibrutinib as a first-line treatment for persons with newly diagnosed chronic graft-versus-host disease (GvHD) overall response rate was measured using the 2014 National Institutes of Health (NIH) consensus criteria and reported with an 80% confidence interval. CR is defined as complete resolution in all of signs and symptoms at all affected organs or tissues. PR is defined as improvement in ≥1 organ or tissue with no progression in any other affected organ or tissue.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
10 participants
Primary outcome timeframe
At 6 months
Results posted on
2026-01-23
Participant Flow
Participant milestones
| Measure |
Dose Level 1 Ibrutinib Dose of 420 mg (3 x 140 mg Capsules) Daily
Ibrutinib Dose of 420 mg (3 x 140 mg capsules) daily by mouth for up to 12 months.
Cohort 1: Participants with newly diagnosed moderate or severe chronic graft-versus-host disease) GvHD requiring systemic immunosuppression.
|
|---|---|
|
Overall Study
STARTED
|
10
|
|
Overall Study
COMPLETED
|
6
|
|
Overall Study
NOT COMPLETED
|
4
|
Reasons for withdrawal
| Measure |
Dose Level 1 Ibrutinib Dose of 420 mg (3 x 140 mg Capsules) Daily
Ibrutinib Dose of 420 mg (3 x 140 mg capsules) daily by mouth for up to 12 months.
Cohort 1: Participants with newly diagnosed moderate or severe chronic graft-versus-host disease) GvHD requiring systemic immunosuppression.
|
|---|---|
|
Overall Study
Screen failure
|
4
|
Baseline Characteristics
Front Line Ibrutinib Without Corticosteroids for Newly Diagnosed Chronic Graft-versus-Host Disease
Baseline characteristics by cohort
| Measure |
Dose Level 1 Ibrutinib Dose of 420 mg (3 x 140 mg Capsules) Daily
n=10 Participants
Ibrutinib Dose of 420 mg (3 x 140 mg capsules) daily by mouth for up to 12 months.
Participants with newly diagnosed moderate or severe chronic graft-versus-host disease) GvHD requiring systemic immunosuppression.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=270 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
9 Participants
n=270 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=270 Participants
|
|
Age, Continuous
|
51.2 years
STANDARD_DEVIATION 12.87 • n=270 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=270 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=270 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=270 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=270 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=270 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=270 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=270 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=270 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=270 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=270 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=270 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=270 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=270 Participants
|
|
Baseline Global Scoring
Mild
|
0 Participants
n=270 Participants
|
|
Baseline Global Scoring
Moderate
|
3 Participants
n=270 Participants
|
|
Baseline Global Scoring
Severe
|
3 Participants
n=270 Participants
|
PRIMARY outcome
Timeframe: At 6 monthsPopulation: Six out of ten participants were analyzed because 4 participants were screen failures.
To evaluate the efficacy of Ibrutinib as a first-line treatment for persons with newly diagnosed chronic graft-versus-host disease (GvHD) overall response rate was measured using the 2014 National Institutes of Health (NIH) consensus criteria and reported with an 80% confidence interval. CR is defined as complete resolution in all of signs and symptoms at all affected organs or tissues. PR is defined as improvement in ≥1 organ or tissue with no progression in any other affected organ or tissue.
Outcome measures
| Measure |
Dose Level 1 Ibrutinib Dose of 420 mg (3 x 140 mg Capsules) Daily
n=6 Participants
Ibrutinib Dose of 420 mg (3 x 140 mg capsules) daily by mouth for up to 12 months.
Participants with newly diagnosed moderate or severe chronic graft-versus-host disease) GvHD requiring systemic immunosuppression.
|
|---|---|
|
Fraction of Participants With an Overall Response Rate (Complete Response [CR] + Partial Response [PR]) Reported With an 80% Confidence Interval at 6 Months
Complete Response
|
0 proportion of participants
Interval 0.0 to 0.319
|
|
Fraction of Participants With an Overall Response Rate (Complete Response [CR] + Partial Response [PR]) Reported With an 80% Confidence Interval at 6 Months
Partial Response
|
0.1667 proportion of participants
Interval 0.0174 to 0.5103
|
PRIMARY outcome
Timeframe: At 6 monthsPopulation: Six out of ten participants were analyzed because 4 participants were screen failures.
To evaluate the efficacy of Ibrutinib as a first-line treatment for persons with newly diagnosed chronic graft-versus-host disease (GvHD) overall response rate was measured using the 2014 National Institutes of Health (NIH) consensus criteria and reported with a 95% confidence interval. CR is defined as complete resolution in all of signs and symptoms at all affected organs or tissues. PR is defined as improvement in ≥1 organ or tissue with no progression in any other affected organ or tissue.
Outcome measures
| Measure |
Dose Level 1 Ibrutinib Dose of 420 mg (3 x 140 mg Capsules) Daily
n=6 Participants
Ibrutinib Dose of 420 mg (3 x 140 mg capsules) daily by mouth for up to 12 months.
Participants with newly diagnosed moderate or severe chronic graft-versus-host disease) GvHD requiring systemic immunosuppression.
|
|---|---|
|
Fraction of Participants With an Overall Response Rate (Complete Response [CR] + Partial Response [PR]) Reported With an 95% Confidence Interval at 6 Months
Complete Response
|
0 proportion of participants
Interval 0.0 to 0.459
|
|
Fraction of Participants With an Overall Response Rate (Complete Response [CR] + Partial Response [PR]) Reported With an 95% Confidence Interval at 6 Months
Partial Response
|
0.167 proportion of participants
Interval 0.004 to 0.641
|
SECONDARY outcome
Timeframe: Adverse events are captured from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the participant received the last study drug administration.Population: Six out of ten participants were analyzed because 4 participants were screen failures.
Safety of the agent will be determined by the fraction of grade of 3 and 4 serious and non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. Grade 3 is severe, and Grade 4 is life-threatening.
Outcome measures
| Measure |
Dose Level 1 Ibrutinib Dose of 420 mg (3 x 140 mg Capsules) Daily
n=6 Participants
Ibrutinib Dose of 420 mg (3 x 140 mg capsules) daily by mouth for up to 12 months.
Participants with newly diagnosed moderate or severe chronic graft-versus-host disease) GvHD requiring systemic immunosuppression.
|
|---|---|
|
Fraction of Grade 3 and Grade 4 Serious and/or Non-serious Adverse Events in Participants With Newly Diagnosed Chronic Graft-versus-host Disease (GvHD)
Grade 3
|
0.667 proportion of adverse events
Interval 0.223 to 0.957
|
|
Fraction of Grade 3 and Grade 4 Serious and/or Non-serious Adverse Events in Participants With Newly Diagnosed Chronic Graft-versus-host Disease (GvHD)
Grade 4
|
0 proportion of adverse events
Interval 0.0 to -0.459
|
SECONDARY outcome
Timeframe: Participants were followed from enrollment without death, relapse or new GVHD treatment up to 14 monthsPopulation: Six out of ten participants were analyzed because 4 participants were screen failures.
Time to event endpoint failure free survival will be determined using a Kaplan-Meier curve and confidence intervals is calculated using the Brookmeyer-Crowley method. Failure-free survival (FFS) is defined as survival (from enrollment) without death, relapse of the underlying malignancy, or the addition of a new systemic chronic graft-versus-host-disease (GVHD) treatment.
Outcome measures
| Measure |
Dose Level 1 Ibrutinib Dose of 420 mg (3 x 140 mg Capsules) Daily
n=6 Participants
Ibrutinib Dose of 420 mg (3 x 140 mg capsules) daily by mouth for up to 12 months.
Participants with newly diagnosed moderate or severe chronic graft-versus-host disease) GvHD requiring systemic immunosuppression.
|
|---|---|
|
Failure-free Survival (FFS)
|
3.9 Months
Interval 2.5 to
The upper confidence interval was not reached because limits are calculated using the Brookmeyer-Crowley method, and if the upper limit of the interval does not intersect the median, then it is recorded as not able to be estimated.
|
SECONDARY outcome
Timeframe: 24 monthsSurvival will be determined using a Kaplan-Meier curve at 24 months.
Outcome measures
| Measure |
Dose Level 1 Ibrutinib Dose of 420 mg (3 x 140 mg Capsules) Daily
n=6 Participants
Ibrutinib Dose of 420 mg (3 x 140 mg capsules) daily by mouth for up to 12 months.
Participants with newly diagnosed moderate or severe chronic graft-versus-host disease) GvHD requiring systemic immunosuppression.
|
|---|---|
|
Fraction of Participants Alive at 24 Months Follow-up Post-treatment
|
NA proportion of participants
FFS at 24 months is reported as NA since no one's time from post treatment to death or last follow-up equals or exceeds 24 months.
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Adverse events are collected from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the participant received the last study drug administration.Population: Six out of ten participants were analyzed because 3 participants were screen failures, and one participant was ineligible.
Here is the number of participants with serious and/or non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.
Outcome measures
| Measure |
Dose Level 1 Ibrutinib Dose of 420 mg (3 x 140 mg Capsules) Daily
n=6 Participants
Ibrutinib Dose of 420 mg (3 x 140 mg capsules) daily by mouth for up to 12 months.
Participants with newly diagnosed moderate or severe chronic graft-versus-host disease) GvHD requiring systemic immunosuppression.
|
|---|---|
|
Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0)
|
6 Participants
|
Adverse Events
Dose Level 1 Ibrutinib Dose of 420 mg (3 x 140 mg Capsules) Daily
Serious events: 3 serious events
Other events: 6 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Dose Level 1 Ibrutinib Dose of 420 mg (3 x 140 mg Capsules) Daily
n=6 participants at risk
Ibrutinib Dose of 420 mg (3 x 140 mg capsules) daily by mouth for up to 12 months.
Participants with newly diagnosed moderate or severe chronic graft-versus-host disease) GvHD requiring systemic immunosuppression.
|
|---|---|
|
Cardiac disorders
Atrial fibrillation
|
16.7%
1/6 • Number of events 1 • Beyond 30 days after the last intervention, only adverse events which are serious and related to the study intervention need to be recorded, up to 25 months.
Six out of ten participants were analyzed because 4 participants were screen failures.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
16.7%
1/6 • Number of events 1 • Beyond 30 days after the last intervention, only adverse events which are serious and related to the study intervention need to be recorded, up to 25 months.
Six out of ten participants were analyzed because 4 participants were screen failures.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
16.7%
1/6 • Number of events 1 • Beyond 30 days after the last intervention, only adverse events which are serious and related to the study intervention need to be recorded, up to 25 months.
Six out of ten participants were analyzed because 4 participants were screen failures.
|
|
Infections and infestations
Upper respiratory infection
|
16.7%
1/6 • Number of events 1 • Beyond 30 days after the last intervention, only adverse events which are serious and related to the study intervention need to be recorded, up to 25 months.
Six out of ten participants were analyzed because 4 participants were screen failures.
|
Other adverse events
| Measure |
Dose Level 1 Ibrutinib Dose of 420 mg (3 x 140 mg Capsules) Daily
n=6 participants at risk
Ibrutinib Dose of 420 mg (3 x 140 mg capsules) daily by mouth for up to 12 months.
Participants with newly diagnosed moderate or severe chronic graft-versus-host disease) GvHD requiring systemic immunosuppression.
|
|---|---|
|
Investigations
Activated partial thromboplastin time prolonged
|
16.7%
1/6 • Number of events 1 • Beyond 30 days after the last intervention, only adverse events which are serious and related to the study intervention need to be recorded, up to 25 months.
Six out of ten participants were analyzed because 4 participants were screen failures.
|
|
Nervous system disorders
Amnesia
|
16.7%
1/6 • Number of events 1 • Beyond 30 days after the last intervention, only adverse events which are serious and related to the study intervention need to be recorded, up to 25 months.
Six out of ten participants were analyzed because 4 participants were screen failures.
|
|
Eye disorders
Blurred vision
|
16.7%
1/6 • Number of events 1 • Beyond 30 days after the last intervention, only adverse events which are serious and related to the study intervention need to be recorded, up to 25 months.
Six out of ten participants were analyzed because 4 participants were screen failures.
|
|
Injury, poisoning and procedural complications
Bruising
|
16.7%
1/6 • Number of events 1 • Beyond 30 days after the last intervention, only adverse events which are serious and related to the study intervention need to be recorded, up to 25 months.
Six out of ten participants were analyzed because 4 participants were screen failures.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
33.3%
2/6 • Number of events 2 • Beyond 30 days after the last intervention, only adverse events which are serious and related to the study intervention need to be recorded, up to 25 months.
Six out of ten participants were analyzed because 4 participants were screen failures.
|
|
Gastrointestinal disorders
Diarrhea
|
33.3%
2/6 • Number of events 2 • Beyond 30 days after the last intervention, only adverse events which are serious and related to the study intervention need to be recorded, up to 25 months.
Six out of ten participants were analyzed because 4 participants were screen failures.
|
|
Nervous system disorders
Dizziness
|
33.3%
2/6 • Number of events 2 • Beyond 30 days after the last intervention, only adverse events which are serious and related to the study intervention need to be recorded, up to 25 months.
Six out of ten participants were analyzed because 4 participants were screen failures.
|
|
Nervous system disorders
Dysgeusia
|
16.7%
1/6 • Number of events 1 • Beyond 30 days after the last intervention, only adverse events which are serious and related to the study intervention need to be recorded, up to 25 months.
Six out of ten participants were analyzed because 4 participants were screen failures.
|
|
Gastrointestinal disorders
Dyspepsia
|
16.7%
1/6 • Number of events 1 • Beyond 30 days after the last intervention, only adverse events which are serious and related to the study intervention need to be recorded, up to 25 months.
Six out of ten participants were analyzed because 4 participants were screen failures.
|
|
Gastrointestinal disorders
Dysphagia
|
33.3%
2/6 • Number of events 2 • Beyond 30 days after the last intervention, only adverse events which are serious and related to the study intervention need to be recorded, up to 25 months.
Six out of ten participants were analyzed because 4 participants were screen failures.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
33.3%
2/6 • Number of events 2 • Beyond 30 days after the last intervention, only adverse events which are serious and related to the study intervention need to be recorded, up to 25 months.
Six out of ten participants were analyzed because 4 participants were screen failures.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
16.7%
1/6 • Number of events 1 • Beyond 30 days after the last intervention, only adverse events which are serious and related to the study intervention need to be recorded, up to 25 months.
Six out of ten participants were analyzed because 4 participants were screen failures.
|
|
Injury, poisoning and procedural complications
Fall
|
16.7%
1/6 • Number of events 1 • Beyond 30 days after the last intervention, only adverse events which are serious and related to the study intervention need to be recorded, up to 25 months.
Six out of ten participants were analyzed because 4 participants were screen failures.
|
|
General disorders
Fatigue
|
50.0%
3/6 • Number of events 4 • Beyond 30 days after the last intervention, only adverse events which are serious and related to the study intervention need to be recorded, up to 25 months.
Six out of ten participants were analyzed because 4 participants were screen failures.
|
|
General disorders
Fever
|
16.7%
1/6 • Number of events 1 • Beyond 30 days after the last intervention, only adverse events which are serious and related to the study intervention need to be recorded, up to 25 months.
Six out of ten participants were analyzed because 4 participants were screen failures.
|
|
Musculoskeletal and connective tissue disorders
Fibrosis deep connective tissue
|
16.7%
1/6 • Number of events 1 • Beyond 30 days after the last intervention, only adverse events which are serious and related to the study intervention need to be recorded, up to 25 months.
Six out of ten participants were analyzed because 4 participants were screen failures.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, Soft stool
|
16.7%
1/6 • Number of events 1 • Beyond 30 days after the last intervention, only adverse events which are serious and related to the study intervention need to be recorded, up to 25 months.
Six out of ten participants were analyzed because 4 participants were screen failures.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
16.7%
1/6 • Number of events 1 • Beyond 30 days after the last intervention, only adverse events which are serious and related to the study intervention need to be recorded, up to 25 months.
Six out of ten participants were analyzed because 4 participants were screen failures.
|
|
Nervous system disorders
Headache
|
16.7%
1/6 • Number of events 1 • Beyond 30 days after the last intervention, only adverse events which are serious and related to the study intervention need to be recorded, up to 25 months.
Six out of ten participants were analyzed because 4 participants were screen failures.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
16.7%
1/6 • Number of events 1 • Beyond 30 days after the last intervention, only adverse events which are serious and related to the study intervention need to be recorded, up to 25 months.
Six out of ten participants were analyzed because 4 participants were screen failures.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
16.7%
1/6 • Number of events 1 • Beyond 30 days after the last intervention, only adverse events which are serious and related to the study intervention need to be recorded, up to 25 months.
Six out of ten participants were analyzed because 4 participants were screen failures.
|
|
Vascular disorders
Hypotension
|
16.7%
1/6 • Number of events 1 • Beyond 30 days after the last intervention, only adverse events which are serious and related to the study intervention need to be recorded, up to 25 months.
Six out of ten participants were analyzed because 4 participants were screen failures.
|
|
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications - Other, Tooth fracture
|
16.7%
1/6 • Number of events 1 • Beyond 30 days after the last intervention, only adverse events which are serious and related to the study intervention need to be recorded, up to 25 months.
Six out of ten participants were analyzed because 4 participants were screen failures.
|
|
Infections and infestations
Lung infection
|
33.3%
2/6 • Number of events 2 • Beyond 30 days after the last intervention, only adverse events which are serious and related to the study intervention need to be recorded, up to 25 months.
Six out of ten participants were analyzed because 4 participants were screen failures.
|
|
Investigations
Lymphocyte count increased
|
16.7%
1/6 • Number of events 2 • Beyond 30 days after the last intervention, only adverse events which are serious and related to the study intervention need to be recorded, up to 25 months.
Six out of ten participants were analyzed because 4 participants were screen failures.
|
|
General disorders
Malaise
|
16.7%
1/6 • Number of events 1 • Beyond 30 days after the last intervention, only adverse events which are serious and related to the study intervention need to be recorded, up to 25 months.
Six out of ten participants were analyzed because 4 participants were screen failures.
|
|
Musculoskeletal and connective tissue disorders
Muscle cramp
|
50.0%
3/6 • Number of events 4 • Beyond 30 days after the last intervention, only adverse events which are serious and related to the study intervention need to be recorded, up to 25 months.
Six out of ten participants were analyzed because 4 participants were screen failures.
|
|
Gastrointestinal disorders
Nausea
|
33.3%
2/6 • Number of events 3 • Beyond 30 days after the last intervention, only adverse events which are serious and related to the study intervention need to be recorded, up to 25 months.
Six out of ten participants were analyzed because 4 participants were screen failures.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
|
16.7%
1/6 • Number of events 1 • Beyond 30 days after the last intervention, only adverse events which are serious and related to the study intervention need to be recorded, up to 25 months.
Six out of ten participants were analyzed because 4 participants were screen failures.
|
|
Investigations
Neutrophil count decreased
|
33.3%
2/6 • Number of events 2 • Beyond 30 days after the last intervention, only adverse events which are serious and related to the study intervention need to be recorded, up to 25 months.
Six out of ten participants were analyzed because 4 participants were screen failures.
|
|
Gastrointestinal disorders
Oral hemorrhage
|
16.7%
1/6 • Number of events 1 • Beyond 30 days after the last intervention, only adverse events which are serious and related to the study intervention need to be recorded, up to 25 months.
Six out of ten participants were analyzed because 4 participants were screen failures.
|
|
Cardiac disorders
Palpitations
|
50.0%
3/6 • Number of events 3 • Beyond 30 days after the last intervention, only adverse events which are serious and related to the study intervention need to be recorded, up to 25 months.
Six out of ten participants were analyzed because 4 participants were screen failures.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
16.7%
1/6 • Number of events 1 • Beyond 30 days after the last intervention, only adverse events which are serious and related to the study intervention need to be recorded, up to 25 months.
Six out of ten participants were analyzed because 4 participants were screen failures.
|
|
Musculoskeletal and connective tissue disorders
Superficial soft tissue fibrosis
|
16.7%
1/6 • Number of events 1 • Beyond 30 days after the last intervention, only adverse events which are serious and related to the study intervention need to be recorded, up to 25 months.
Six out of ten participants were analyzed because 4 participants were screen failures.
|
|
Infections and infestations
Upper respiratory infection
|
33.3%
2/6 • Number of events 2 • Beyond 30 days after the last intervention, only adverse events which are serious and related to the study intervention need to be recorded, up to 25 months.
Six out of ten participants were analyzed because 4 participants were screen failures.
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
2/6 • Number of events 2 • Beyond 30 days after the last intervention, only adverse events which are serious and related to the study intervention need to be recorded, up to 25 months.
Six out of ten participants were analyzed because 4 participants were screen failures.
|
|
Investigations
Weight loss
|
16.7%
1/6 • Number of events 1 • Beyond 30 days after the last intervention, only adverse events which are serious and related to the study intervention need to be recorded, up to 25 months.
Six out of ten participants were analyzed because 4 participants were screen failures.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place