Trial Outcomes & Findings for Biomarkers of Intestinal Mucosal Healing in Crohn's Disease (P08143) (NCT NCT01349920)
NCT ID: NCT01349920
Last Updated: 2018-10-15
Results Overview
CDEIS endoscopically assesses mucosal status, by summing the following six component scores: number of bowel segments with deep ulcerations divided by number of visualized bowel segments; number of bowel segments with superficial ulcerations divided by number of visualized bowel segments; mean proportion of bowel segment surface involved by disease measured on 0-10 cm visual analog scale (VAS); mean proportion of bowel segment surface area involved by ulcerations measured on 0-10 cm VAS; presence of ulcerated stenosis anywhere; and presence of non-ulcerated stenosis anywhere. An observer who viewed procedural videotape while blinded to the allocation number and visit of the endoscopy scored the CDEIS. The sum of the six components can range from 0-44, with a higher sum indicating greater severity of mucosal inflammation. Change from baseline is defined as Week 6 minus baseline CDEIS scores, with a negative change from baseline indicating improvement.
COMPLETED
15 participants
Baseline and Week 6
2018-10-15
Participant Flow
Participants 18 to 60 years of age, with moderate to severe Crohn's Disease (CD) who had not been previously treated with anti-inflammatory biologic agents were enrolled in this trial.
Participant milestones
| Measure |
Infliximab 5mg/kg
Infliximab administered intravenously at a dose of 5 mg/kg at study weeks 0, 2, 6, 14, and 22
|
|---|---|
|
Overall Study
STARTED
|
15
|
|
Overall Study
COMPLETED
|
15
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Biomarkers of Intestinal Mucosal Healing in Crohn's Disease (P08143)
Baseline characteristics by cohort
| Measure |
Infliximab 5mg/kg
n=15 Participants
Infliximab administered intravenously at a dose of 5 mg/kg at study weeks 0, 2, 6, 14, and 22
|
|---|---|
|
Age, Continuous
|
25.0 Years
STANDARD_DEVIATION 9.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 6Population: Participants who had a blinded CDEIS score at both baseline and at Week 6.
CDEIS endoscopically assesses mucosal status, by summing the following six component scores: number of bowel segments with deep ulcerations divided by number of visualized bowel segments; number of bowel segments with superficial ulcerations divided by number of visualized bowel segments; mean proportion of bowel segment surface involved by disease measured on 0-10 cm visual analog scale (VAS); mean proportion of bowel segment surface area involved by ulcerations measured on 0-10 cm VAS; presence of ulcerated stenosis anywhere; and presence of non-ulcerated stenosis anywhere. An observer who viewed procedural videotape while blinded to the allocation number and visit of the endoscopy scored the CDEIS. The sum of the six components can range from 0-44, with a higher sum indicating greater severity of mucosal inflammation. Change from baseline is defined as Week 6 minus baseline CDEIS scores, with a negative change from baseline indicating improvement.
Outcome measures
| Measure |
Infliximab 5 mg/kg
n=13 Participants
Infliximab administered intravenously at a dose of 5 mg/kg at study weeks 0, 2, 6, 14, and 22
|
|---|---|
|
Change From Baseline in the Crohn's Disease Endoscopic Index of Severity (CDEIS) Blinded Score at Week 6
|
-4.8 Score on a scale
Standard Deviation 4.2
|
PRIMARY outcome
Timeframe: Baseline and Week 22Population: Participants who had a blinded CDEIS score at both baseline and at Week 22.
CDEIS endoscopically assesses mucosal status, by summing the following six component scores: number of bowel segments with deep ulcerations divided by number of visualized bowel segments; number of bowel segments with superficial ulcerations divided by number of visualized bowel segments; mean proportion of bowel segment surface involved by disease measured on 0-10 cm visual analog scale (VAS); mean proportion of bowel segment surface area involved by ulcerations measured on 0-10 cm VAS; presence of ulcerated stenosis anywhere; and presence of non-ulcerated stenosis anywhere. An observer who viewed procedural videotape while blinded to the allocation number and visit of the endoscopy scored the CDEIS. The sum of the six components can range from 0-44, with a higher sum indicating greater severity of mucosal inflammation. Change from baseline is defined as Week 22 minus baseline CDEIS scores, with a negative change from baseline indicating improvement.
Outcome measures
| Measure |
Infliximab 5 mg/kg
n=12 Participants
Infliximab administered intravenously at a dose of 5 mg/kg at study weeks 0, 2, 6, 14, and 22
|
|---|---|
|
Change From Baseline in CDEIS Blinded Score at Week 22
|
-7.3 Score on a scale
Standard Deviation 5.5
|
PRIMARY outcome
Timeframe: Baseline and Week 6Population: Participants with measurements for hsCRP at both baseline and at Week 6.
Concentrations of the serum biomarker hsCRP were determined at baseline and at Week 6. The change from baseline was Week 6 minus baseline.
Outcome measures
| Measure |
Infliximab 5 mg/kg
n=12 Participants
Infliximab administered intravenously at a dose of 5 mg/kg at study weeks 0, 2, 6, 14, and 22
|
|---|---|
|
Change From Baseline in Serum High Sensitivity C-reactive Protein (hsCRP) at Week 6
|
-38.1 mg/L
Standard Deviation 30.4
|
PRIMARY outcome
Timeframe: Baseline and Week 22Population: Participants with measurements for hsCRP at both baseline and at Week 22.
Concentrations of the serum biomarker hsCRP were determined at baseline and at Week 22. The change from baseline was Week 22 minus baseline.
Outcome measures
| Measure |
Infliximab 5 mg/kg
n=14 Participants
Infliximab administered intravenously at a dose of 5 mg/kg at study weeks 0, 2, 6, 14, and 22
|
|---|---|
|
Change From Baseline in Serum hsCRP at Week 22
|
-28.0 mg/L
Standard Deviation 39.3
|
PRIMARY outcome
Timeframe: Baseline and Week 6Population: Participants with measurements for calprotectin at both baseline and at Week 6.
Concentrations of the stool biomarker calprotectin were determined at baseline and at Week 6. The change from baseline was Week 6 minus baseline.
Outcome measures
| Measure |
Infliximab 5 mg/kg
n=15 Participants
Infliximab administered intravenously at a dose of 5 mg/kg at study weeks 0, 2, 6, 14, and 22
|
|---|---|
|
Change From Baseline in Stool Calprotectin at Week 6
|
231.1 µg/g
Standard Deviation 4099.6
|
PRIMARY outcome
Timeframe: Baseline and Week 22Population: Participants with measurements for calprotectin at both baseline and at Week 22.
Concentrations of the stool biomarker calprotectin were determined at baseline and at Week 22. The change from baseline was Week 22 minus baseline.
Outcome measures
| Measure |
Infliximab 5 mg/kg
n=13 Participants
Infliximab administered intravenously at a dose of 5 mg/kg at study weeks 0, 2, 6, 14, and 22
|
|---|---|
|
Change From Baseline in Stool Calprotectin at Week 22
|
98.3 µg/g
Standard Deviation 3236.7
|
PRIMARY outcome
Timeframe: Baseline and Week 6Population: Participants with measurements for lipocalin-2 at both baseline and at Week 6.
Concentrations of the serum biomarker lipocalin-2 were determined at baseline and at Week 6. The change from baseline was Week 6 minus baseline.
Outcome measures
| Measure |
Infliximab 5 mg/kg
n=15 Participants
Infliximab administered intravenously at a dose of 5 mg/kg at study weeks 0, 2, 6, 14, and 22
|
|---|---|
|
Change From Baseline in Serum Lipocalin-2 at Week 6
|
-103.7 ng/mL
Standard Deviation 108.3
|
PRIMARY outcome
Timeframe: Baseline and Week 22Population: Participants with measurements for lipocalin-2 at both baseline and at Week 22.
Concentrations of the serum biomarker lipocalin-2 were determined at baseline and at Week 22. The change from baseline was Week 22 minus baseline.
Outcome measures
| Measure |
Infliximab 5 mg/kg
n=15 Participants
Infliximab administered intravenously at a dose of 5 mg/kg at study weeks 0, 2, 6, 14, and 22
|
|---|---|
|
Change From Baseline in Serum Lipocalin-2 at Week 22
|
-104.6 ng/mL
Standard Deviation 108.9
|
PRIMARY outcome
Timeframe: Baseline and Week 6Population: Participants with measurements for REG3-A at both baseline and at Week 6.
Concentrations of the serum biomarker REG3-A were determined at baseline and at Week 6. The change from baseline was Week 6 minus baseline.
Outcome measures
| Measure |
Infliximab 5 mg/kg
n=14 Participants
Infliximab administered intravenously at a dose of 5 mg/kg at study weeks 0, 2, 6, 14, and 22
|
|---|---|
|
Change From Baseline in Regenerating Islet-Derived 3-Alpha (REG3-A) at Week 6
|
-20.7 ng/mL
Standard Deviation 20.9
|
PRIMARY outcome
Timeframe: Baseline and Week 22Population: Participants with measurements for REG3-A at both baseline and at Week 22.
Concentrations of the serum biomarker REG3-A were determined at baseline and at Week 22. The change from baseline was Week 22 minus baseline.
Outcome measures
| Measure |
Infliximab 5 mg/kg
n=15 Participants
Infliximab administered intravenously at a dose of 5 mg/kg at study weeks 0, 2, 6, 14, and 22
|
|---|---|
|
Change From Baseline in REG3-A at Week 22
|
-21.2 ng/mL
Standard Deviation 30.3
|
PRIMARY outcome
Timeframe: Baseline and Week 6 or 22Population: Participants who had a blinded CDEIS score and measurements for each of the biomarkers included in the models at both baseline and at Week 6 or 22.
To determine R\^2 a multiple linear regression analysis was conducted with the change from baseline in CDEIS score as the response variable and the baseline CDEIS score, changes from baseline in the four biomarkers serum hsCRP, serum lipocalin-2, serum Reg3-A, and stool calprotectin (their concentrations were log-transformed to make the mean function of the response more linear) at Weeks 6 and 22 as the predictor variables. CDEIS scores were provided by a blinded observer who viewed procedural videotape while blinded to the allocation number and visit of the endoscopy. The R\^2 can range from 0 to 1; with higher values indicating greater predictability of the model. The primary hypothesis is that the true R\^2 at weeks 6 and 22 is approximately 0.7.
Outcome measures
| Measure |
Infliximab 5 mg/kg
n=15 Participants
Infliximab administered intravenously at a dose of 5 mg/kg at study weeks 0, 2, 6, 14, and 22
|
|---|---|
|
Coefficient of Determination (R^2) For Predicting The Change From Baseline In Blinded CDEIS Score From The Changes From Baseline In Four Biomarkers At Weeks 6 and 22
Week 6 (n = 9)
|
0.920 Coefficient of Determination
Interval 0.458 to 0.929
|
|
Coefficient of Determination (R^2) For Predicting The Change From Baseline In Blinded CDEIS Score From The Changes From Baseline In Four Biomarkers At Weeks 6 and 22
Week 22 (n = 10)
|
0.638 Coefficient of Determination
Interval 0.539 to 0.946
|
SECONDARY outcome
Timeframe: Baseline Visit 1 (one week prior to dosing), Baseline Visit 2 (1-2 days prior to dosing)Population: Participants who had both baseline serum or stool measurements available for analysis.
Based on two measurements at baseline, the concordance correlation coefficient (CCC) was computed for each of four biomarkers, using a mixed effects model with a fixed factor for repeat measurements and a random factor for participant. The CCC can range from 0 to 1 with higher values indicating greater concordance between the 2 measurements.
Outcome measures
| Measure |
Infliximab 5 mg/kg
n=15 Participants
Infliximab administered intravenously at a dose of 5 mg/kg at study weeks 0, 2, 6, 14, and 22
|
|---|---|
|
Concordance Correlation Coefficient for Comparison of Repeat Baseline Measurements of Biochemical Biomarkers
serum hsCRP (n=14)
|
0.954 Correlation coefficient
Interval 0.913 to 0.995
|
|
Concordance Correlation Coefficient for Comparison of Repeat Baseline Measurements of Biochemical Biomarkers
serum REG3-A (n=15)
|
0.974 Correlation coefficient
Interval 0.952 to 0.996
|
|
Concordance Correlation Coefficient for Comparison of Repeat Baseline Measurements of Biochemical Biomarkers
serum lipocalin-2 (n=15)
|
0.910 Correlation coefficient
Interval 0.835 to 0.986
|
|
Concordance Correlation Coefficient for Comparison of Repeat Baseline Measurements of Biochemical Biomarkers
stool calprotectin (n=15)
|
0.792 Correlation coefficient
Interval 0.629 to 0.954
|
SECONDARY outcome
Timeframe: Baseline, Week 6, Week 22Population: Participants who had both blinded and unblinded scores available for analysis.
The CCC of blinded (central) versus unblinded (site) scores from either CDEIS or the Simple Endoscopic Score for Crohn's Disease (SES-CD) was determined at Baseline, Week 6 and Week 22. SES-CD sums the following scores: presence and size of ulcers in five visualized bowel segments; extent of ulcerated surface in five visualized bowel segments; extent of affected surface in five visualized bowel segments; presence and type of narrowings in five visualized bowel segments; and can range from 0-56, with a higher sum indicating greater severity of mucosal inflammation. The CCC can range from 0 to 1 with higher values indicating greater concordance between the 2 measurements.
Outcome measures
| Measure |
Infliximab 5 mg/kg
n=15 Participants
Infliximab administered intravenously at a dose of 5 mg/kg at study weeks 0, 2, 6, 14, and 22
|
|---|---|
|
Concordance Correlation Coefficient for Comparison Between Central Endoscopic Evaluation and Site Endoscopic Evaluation
CDEIS Baseline (n = 15)
|
0.662 Correlation coefficient
Interval 0.428 to 0.896
|
|
Concordance Correlation Coefficient for Comparison Between Central Endoscopic Evaluation and Site Endoscopic Evaluation
CDEIS Week 6 (n = 13)
|
0.693 Correlation coefficient
Interval 0.458 to 0.929
|
|
Concordance Correlation Coefficient for Comparison Between Central Endoscopic Evaluation and Site Endoscopic Evaluation
CDEIS Week 22 (n = 12)
|
0.743 Correlation coefficient
Interval 0.539 to 0.946
|
|
Concordance Correlation Coefficient for Comparison Between Central Endoscopic Evaluation and Site Endoscopic Evaluation
SES-CD Baseline (n = 15)
|
0.453 Correlation coefficient
Interval 0.176 to 0.729
|
|
Concordance Correlation Coefficient for Comparison Between Central Endoscopic Evaluation and Site Endoscopic Evaluation
SES-CD Week 6 (n = 13)
|
0.937 Correlation coefficient
Interval 0.879 to 0.995
|
|
Concordance Correlation Coefficient for Comparison Between Central Endoscopic Evaluation and Site Endoscopic Evaluation
SES-CD Week 22 (n = 13)
|
0.753 Correlation coefficient
Interval 0.562 to 0.945
|
Adverse Events
Pre-study
Infliximab 5mg/kg
Post-study
Serious adverse events
| Measure |
Pre-study
n=15 participants at risk
From 4 weeks prior to first dose, up to first dose of infliximab
|
Infliximab 5mg/kg
n=15 participants at risk
Infliximab administered intravenously at a dose of 5 mg/kg at study weeks 0, 2, 6, 14, and 22
|
Post-study
n=15 participants at risk
From last dose of study drug, up to 24 days after last dose of infliximab
|
|---|---|---|---|
|
Gastrointestinal disorders
Crohn's disease
|
0.00%
0/15 • From 4 weeks prior to first dose, until 2 weeks after last dose (up to 28 weeks)
All enrolled participants
|
6.7%
1/15 • Number of events 1 • From 4 weeks prior to first dose, until 2 weeks after last dose (up to 28 weeks)
All enrolled participants
|
0.00%
0/15 • From 4 weeks prior to first dose, until 2 weeks after last dose (up to 28 weeks)
All enrolled participants
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/15 • From 4 weeks prior to first dose, until 2 weeks after last dose (up to 28 weeks)
All enrolled participants
|
6.7%
1/15 • Number of events 1 • From 4 weeks prior to first dose, until 2 weeks after last dose (up to 28 weeks)
All enrolled participants
|
0.00%
0/15 • From 4 weeks prior to first dose, until 2 weeks after last dose (up to 28 weeks)
All enrolled participants
|
Other adverse events
| Measure |
Pre-study
n=15 participants at risk
From 4 weeks prior to first dose, up to first dose of infliximab
|
Infliximab 5mg/kg
n=15 participants at risk
Infliximab administered intravenously at a dose of 5 mg/kg at study weeks 0, 2, 6, 14, and 22
|
Post-study
n=15 participants at risk
From last dose of study drug, up to 24 days after last dose of infliximab
|
|---|---|---|---|
|
Psychiatric disorders
Anxiety
|
0.00%
0/15 • From 4 weeks prior to first dose, until 2 weeks after last dose (up to 28 weeks)
All enrolled participants
|
6.7%
1/15 • Number of events 1 • From 4 weeks prior to first dose, until 2 weeks after last dose (up to 28 weeks)
All enrolled participants
|
0.00%
0/15 • From 4 weeks prior to first dose, until 2 weeks after last dose (up to 28 weeks)
All enrolled participants
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/15 • From 4 weeks prior to first dose, until 2 weeks after last dose (up to 28 weeks)
All enrolled participants
|
6.7%
1/15 • Number of events 3 • From 4 weeks prior to first dose, until 2 weeks after last dose (up to 28 weeks)
All enrolled participants
|
0.00%
0/15 • From 4 weeks prior to first dose, until 2 weeks after last dose (up to 28 weeks)
All enrolled participants
|
|
Eye disorders
Eye irritation
|
0.00%
0/15 • From 4 weeks prior to first dose, until 2 weeks after last dose (up to 28 weeks)
All enrolled participants
|
6.7%
1/15 • Number of events 1 • From 4 weeks prior to first dose, until 2 weeks after last dose (up to 28 weeks)
All enrolled participants
|
0.00%
0/15 • From 4 weeks prior to first dose, until 2 weeks after last dose (up to 28 weeks)
All enrolled participants
|
|
Eye disorders
Eye pain
|
0.00%
0/15 • From 4 weeks prior to first dose, until 2 weeks after last dose (up to 28 weeks)
All enrolled participants
|
6.7%
1/15 • Number of events 1 • From 4 weeks prior to first dose, until 2 weeks after last dose (up to 28 weeks)
All enrolled participants
|
0.00%
0/15 • From 4 weeks prior to first dose, until 2 weeks after last dose (up to 28 weeks)
All enrolled participants
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/15 • From 4 weeks prior to first dose, until 2 weeks after last dose (up to 28 weeks)
All enrolled participants
|
6.7%
1/15 • Number of events 2 • From 4 weeks prior to first dose, until 2 weeks after last dose (up to 28 weeks)
All enrolled participants
|
0.00%
0/15 • From 4 weeks prior to first dose, until 2 weeks after last dose (up to 28 weeks)
All enrolled participants
|
|
Gastrointestinal disorders
Aphthous ulcer
|
0.00%
0/15 • From 4 weeks prior to first dose, until 2 weeks after last dose (up to 28 weeks)
All enrolled participants
|
6.7%
1/15 • Number of events 1 • From 4 weeks prior to first dose, until 2 weeks after last dose (up to 28 weeks)
All enrolled participants
|
0.00%
0/15 • From 4 weeks prior to first dose, until 2 weeks after last dose (up to 28 weeks)
All enrolled participants
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/15 • From 4 weeks prior to first dose, until 2 weeks after last dose (up to 28 weeks)
All enrolled participants
|
6.7%
1/15 • Number of events 2 • From 4 weeks prior to first dose, until 2 weeks after last dose (up to 28 weeks)
All enrolled participants
|
0.00%
0/15 • From 4 weeks prior to first dose, until 2 weeks after last dose (up to 28 weeks)
All enrolled participants
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/15 • From 4 weeks prior to first dose, until 2 weeks after last dose (up to 28 weeks)
All enrolled participants
|
6.7%
1/15 • Number of events 1 • From 4 weeks prior to first dose, until 2 weeks after last dose (up to 28 weeks)
All enrolled participants
|
0.00%
0/15 • From 4 weeks prior to first dose, until 2 weeks after last dose (up to 28 weeks)
All enrolled participants
|
|
Gastrointestinal disorders
Gastrointestinal sounds abnormal
|
0.00%
0/15 • From 4 weeks prior to first dose, until 2 weeks after last dose (up to 28 weeks)
All enrolled participants
|
6.7%
1/15 • Number of events 1 • From 4 weeks prior to first dose, until 2 weeks after last dose (up to 28 weeks)
All enrolled participants
|
0.00%
0/15 • From 4 weeks prior to first dose, until 2 weeks after last dose (up to 28 weeks)
All enrolled participants
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/15 • From 4 weeks prior to first dose, until 2 weeks after last dose (up to 28 weeks)
All enrolled participants
|
13.3%
2/15 • Number of events 3 • From 4 weeks prior to first dose, until 2 weeks after last dose (up to 28 weeks)
All enrolled participants
|
0.00%
0/15 • From 4 weeks prior to first dose, until 2 weeks after last dose (up to 28 weeks)
All enrolled participants
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/15 • From 4 weeks prior to first dose, until 2 weeks after last dose (up to 28 weeks)
All enrolled participants
|
6.7%
1/15 • Number of events 1 • From 4 weeks prior to first dose, until 2 weeks after last dose (up to 28 weeks)
All enrolled participants
|
0.00%
0/15 • From 4 weeks prior to first dose, until 2 weeks after last dose (up to 28 weeks)
All enrolled participants
|
|
Gastrointestinal disorders
Vomiting
|
20.0%
3/15 • Number of events 3 • From 4 weeks prior to first dose, until 2 weeks after last dose (up to 28 weeks)
All enrolled participants
|
13.3%
2/15 • Number of events 2 • From 4 weeks prior to first dose, until 2 weeks after last dose (up to 28 weeks)
All enrolled participants
|
—
0/0 • From 4 weeks prior to first dose, until 2 weeks after last dose (up to 28 weeks)
All enrolled participants
|
|
General disorders
Axillary pain
|
0.00%
0/15 • From 4 weeks prior to first dose, until 2 weeks after last dose (up to 28 weeks)
All enrolled participants
|
6.7%
1/15 • Number of events 1 • From 4 weeks prior to first dose, until 2 weeks after last dose (up to 28 weeks)
All enrolled participants
|
0.00%
0/15 • From 4 weeks prior to first dose, until 2 weeks after last dose (up to 28 weeks)
All enrolled participants
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/15 • From 4 weeks prior to first dose, until 2 weeks after last dose (up to 28 weeks)
All enrolled participants
|
6.7%
1/15 • Number of events 2 • From 4 weeks prior to first dose, until 2 weeks after last dose (up to 28 weeks)
All enrolled participants
|
0.00%
0/15 • From 4 weeks prior to first dose, until 2 weeks after last dose (up to 28 weeks)
All enrolled participants
|
|
General disorders
Pain
|
0.00%
0/15 • From 4 weeks prior to first dose, until 2 weeks after last dose (up to 28 weeks)
All enrolled participants
|
6.7%
1/15 • Number of events 1 • From 4 weeks prior to first dose, until 2 weeks after last dose (up to 28 weeks)
All enrolled participants
|
0.00%
0/15 • From 4 weeks prior to first dose, until 2 weeks after last dose (up to 28 weeks)
All enrolled participants
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/15 • From 4 weeks prior to first dose, until 2 weeks after last dose (up to 28 weeks)
All enrolled participants
|
6.7%
1/15 • Number of events 1 • From 4 weeks prior to first dose, until 2 weeks after last dose (up to 28 weeks)
All enrolled participants
|
0.00%
0/15 • From 4 weeks prior to first dose, until 2 weeks after last dose (up to 28 weeks)
All enrolled participants
|
|
Infections and infestations
Ear infection
|
0.00%
0/15 • From 4 weeks prior to first dose, until 2 weeks after last dose (up to 28 weeks)
All enrolled participants
|
6.7%
1/15 • Number of events 1 • From 4 weeks prior to first dose, until 2 weeks after last dose (up to 28 weeks)
All enrolled participants
|
0.00%
0/15 • From 4 weeks prior to first dose, until 2 weeks after last dose (up to 28 weeks)
All enrolled participants
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/15 • From 4 weeks prior to first dose, until 2 weeks after last dose (up to 28 weeks)
All enrolled participants
|
13.3%
2/15 • Number of events 2 • From 4 weeks prior to first dose, until 2 weeks after last dose (up to 28 weeks)
All enrolled participants
|
0.00%
0/15 • From 4 weeks prior to first dose, until 2 weeks after last dose (up to 28 weeks)
All enrolled participants
|
|
Infections and infestations
Nasopharyngitis
|
6.7%
1/15 • Number of events 1 • From 4 weeks prior to first dose, until 2 weeks after last dose (up to 28 weeks)
All enrolled participants
|
33.3%
5/15 • Number of events 6 • From 4 weeks prior to first dose, until 2 weeks after last dose (up to 28 weeks)
All enrolled participants
|
0.00%
0/15 • From 4 weeks prior to first dose, until 2 weeks after last dose (up to 28 weeks)
All enrolled participants
|
|
Infections and infestations
Rhinitis
|
0.00%
0/15 • From 4 weeks prior to first dose, until 2 weeks after last dose (up to 28 weeks)
All enrolled participants
|
6.7%
1/15 • Number of events 1 • From 4 weeks prior to first dose, until 2 weeks after last dose (up to 28 weeks)
All enrolled participants
|
0.00%
0/15 • From 4 weeks prior to first dose, until 2 weeks after last dose (up to 28 weeks)
All enrolled participants
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/15 • From 4 weeks prior to first dose, until 2 weeks after last dose (up to 28 weeks)
All enrolled participants
|
6.7%
1/15 • Number of events 1 • From 4 weeks prior to first dose, until 2 weeks after last dose (up to 28 weeks)
All enrolled participants
|
0.00%
0/15 • From 4 weeks prior to first dose, until 2 weeks after last dose (up to 28 weeks)
All enrolled participants
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/15 • From 4 weeks prior to first dose, until 2 weeks after last dose (up to 28 weeks)
All enrolled participants
|
6.7%
1/15 • Number of events 1 • From 4 weeks prior to first dose, until 2 weeks after last dose (up to 28 weeks)
All enrolled participants
|
0.00%
0/15 • From 4 weeks prior to first dose, until 2 weeks after last dose (up to 28 weeks)
All enrolled participants
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.00%
0/15 • From 4 weeks prior to first dose, until 2 weeks after last dose (up to 28 weeks)
All enrolled participants
|
6.7%
1/15 • Number of events 1 • From 4 weeks prior to first dose, until 2 weeks after last dose (up to 28 weeks)
All enrolled participants
|
0.00%
0/15 • From 4 weeks prior to first dose, until 2 weeks after last dose (up to 28 weeks)
All enrolled participants
|
|
Injury, poisoning and procedural complications
Procedural hypotension
|
0.00%
0/15 • From 4 weeks prior to first dose, until 2 weeks after last dose (up to 28 weeks)
All enrolled participants
|
13.3%
2/15 • Number of events 2 • From 4 weeks prior to first dose, until 2 weeks after last dose (up to 28 weeks)
All enrolled participants
|
0.00%
0/15 • From 4 weeks prior to first dose, until 2 weeks after last dose (up to 28 weeks)
All enrolled participants
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/15 • From 4 weeks prior to first dose, until 2 weeks after last dose (up to 28 weeks)
All enrolled participants
|
6.7%
1/15 • Number of events 1 • From 4 weeks prior to first dose, until 2 weeks after last dose (up to 28 weeks)
All enrolled participants
|
0.00%
0/15 • From 4 weeks prior to first dose, until 2 weeks after last dose (up to 28 weeks)
All enrolled participants
|
|
Metabolism and nutrition disorders
Dehydration
|
6.7%
1/15 • Number of events 1 • From 4 weeks prior to first dose, until 2 weeks after last dose (up to 28 weeks)
All enrolled participants
|
0.00%
0/15 • From 4 weeks prior to first dose, until 2 weeks after last dose (up to 28 weeks)
All enrolled participants
|
0.00%
0/15 • From 4 weeks prior to first dose, until 2 weeks after last dose (up to 28 weeks)
All enrolled participants
|
|
Metabolism and nutrition disorders
Iron deficiency
|
13.3%
2/15 • Number of events 2 • From 4 weeks prior to first dose, until 2 weeks after last dose (up to 28 weeks)
All enrolled participants
|
0.00%
0/15 • From 4 weeks prior to first dose, until 2 weeks after last dose (up to 28 weeks)
All enrolled participants
|
0.00%
0/15 • From 4 weeks prior to first dose, until 2 weeks after last dose (up to 28 weeks)
All enrolled participants
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/15 • From 4 weeks prior to first dose, until 2 weeks after last dose (up to 28 weeks)
All enrolled participants
|
13.3%
2/15 • Number of events 2 • From 4 weeks prior to first dose, until 2 weeks after last dose (up to 28 weeks)
All enrolled participants
|
0.00%
0/15 • From 4 weeks prior to first dose, until 2 weeks after last dose (up to 28 weeks)
All enrolled participants
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/15 • From 4 weeks prior to first dose, until 2 weeks after last dose (up to 28 weeks)
All enrolled participants
|
20.0%
3/15 • Number of events 3 • From 4 weeks prior to first dose, until 2 weeks after last dose (up to 28 weeks)
All enrolled participants
|
0.00%
0/15 • From 4 weeks prior to first dose, until 2 weeks after last dose (up to 28 weeks)
All enrolled participants
|
|
Nervous system disorders
Dizziness
|
0.00%
0/15 • From 4 weeks prior to first dose, until 2 weeks after last dose (up to 28 weeks)
All enrolled participants
|
6.7%
1/15 • Number of events 1 • From 4 weeks prior to first dose, until 2 weeks after last dose (up to 28 weeks)
All enrolled participants
|
0.00%
0/15 • From 4 weeks prior to first dose, until 2 weeks after last dose (up to 28 weeks)
All enrolled participants
|
|
Nervous system disorders
Headache
|
0.00%
0/15 • From 4 weeks prior to first dose, until 2 weeks after last dose (up to 28 weeks)
All enrolled participants
|
20.0%
3/15 • Number of events 7 • From 4 weeks prior to first dose, until 2 weeks after last dose (up to 28 weeks)
All enrolled participants
|
0.00%
0/15 • From 4 weeks prior to first dose, until 2 weeks after last dose (up to 28 weeks)
All enrolled participants
|
|
Nervous system disorders
Migraine
|
0.00%
0/15 • From 4 weeks prior to first dose, until 2 weeks after last dose (up to 28 weeks)
All enrolled participants
|
6.7%
1/15 • Number of events 1 • From 4 weeks prior to first dose, until 2 weeks after last dose (up to 28 weeks)
All enrolled participants
|
0.00%
0/15 • From 4 weeks prior to first dose, until 2 weeks after last dose (up to 28 weeks)
All enrolled participants
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/15 • From 4 weeks prior to first dose, until 2 weeks after last dose (up to 28 weeks)
All enrolled participants
|
13.3%
2/15 • Number of events 3 • From 4 weeks prior to first dose, until 2 weeks after last dose (up to 28 weeks)
All enrolled participants
|
0.00%
0/15 • From 4 weeks prior to first dose, until 2 weeks after last dose (up to 28 weeks)
All enrolled participants
|
|
Nervous system disorders
Syncope
|
6.7%
1/15 • Number of events 1 • From 4 weeks prior to first dose, until 2 weeks after last dose (up to 28 weeks)
All enrolled participants
|
0.00%
0/15 • From 4 weeks prior to first dose, until 2 weeks after last dose (up to 28 weeks)
All enrolled participants
|
0.00%
0/15 • From 4 weeks prior to first dose, until 2 weeks after last dose (up to 28 weeks)
All enrolled participants
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/15 • From 4 weeks prior to first dose, until 2 weeks after last dose (up to 28 weeks)
All enrolled participants
|
13.3%
2/15 • Number of events 2 • From 4 weeks prior to first dose, until 2 weeks after last dose (up to 28 weeks)
All enrolled participants
|
0.00%
0/15 • From 4 weeks prior to first dose, until 2 weeks after last dose (up to 28 weeks)
All enrolled participants
|
|
Renal and urinary disorders
Bladder pain
|
0.00%
0/15 • From 4 weeks prior to first dose, until 2 weeks after last dose (up to 28 weeks)
All enrolled participants
|
6.7%
1/15 • Number of events 1 • From 4 weeks prior to first dose, until 2 weeks after last dose (up to 28 weeks)
All enrolled participants
|
0.00%
0/15 • From 4 weeks prior to first dose, until 2 weeks after last dose (up to 28 weeks)
All enrolled participants
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/15 • From 4 weeks prior to first dose, until 2 weeks after last dose (up to 28 weeks)
All enrolled participants
|
13.3%
2/15 • Number of events 2 • From 4 weeks prior to first dose, until 2 weeks after last dose (up to 28 weeks)
All enrolled participants
|
0.00%
0/15 • From 4 weeks prior to first dose, until 2 weeks after last dose (up to 28 weeks)
All enrolled participants
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/15 • From 4 weeks prior to first dose, until 2 weeks after last dose (up to 28 weeks)
All enrolled participants
|
6.7%
1/15 • Number of events 1 • From 4 weeks prior to first dose, until 2 weeks after last dose (up to 28 weeks)
All enrolled participants
|
0.00%
0/15 • From 4 weeks prior to first dose, until 2 weeks after last dose (up to 28 weeks)
All enrolled participants
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/15 • From 4 weeks prior to first dose, until 2 weeks after last dose (up to 28 weeks)
All enrolled participants
|
13.3%
2/15 • Number of events 4 • From 4 weeks prior to first dose, until 2 weeks after last dose (up to 28 weeks)
All enrolled participants
|
0.00%
0/15 • From 4 weeks prior to first dose, until 2 weeks after last dose (up to 28 weeks)
All enrolled participants
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/15 • From 4 weeks prior to first dose, until 2 weeks after last dose (up to 28 weeks)
All enrolled participants
|
13.3%
2/15 • Number of events 2 • From 4 weeks prior to first dose, until 2 weeks after last dose (up to 28 weeks)
All enrolled participants
|
0.00%
0/15 • From 4 weeks prior to first dose, until 2 weeks after last dose (up to 28 weeks)
All enrolled participants
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/15 • From 4 weeks prior to first dose, until 2 weeks after last dose (up to 28 weeks)
All enrolled participants
|
6.7%
1/15 • Number of events 1 • From 4 weeks prior to first dose, until 2 weeks after last dose (up to 28 weeks)
All enrolled participants
|
0.00%
0/15 • From 4 weeks prior to first dose, until 2 weeks after last dose (up to 28 weeks)
All enrolled participants
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/15 • From 4 weeks prior to first dose, until 2 weeks after last dose (up to 28 weeks)
All enrolled participants
|
13.3%
2/15 • Number of events 2 • From 4 weeks prior to first dose, until 2 weeks after last dose (up to 28 weeks)
All enrolled participants
|
0.00%
0/15 • From 4 weeks prior to first dose, until 2 weeks after last dose (up to 28 weeks)
All enrolled participants
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Results disclosure agreements
- Principal investigator is a sponsor employee The investigator agrees to provide to the sponsor 45 days prior to submission for publication or presentation, review copies of abstracts or manuscripts for publication that report any results of the trial. The sponsor shall have the right to review and comment with respect to publications, and on the presentation with regard to the following: proprietary information; the accuracy of the information; and that the presentation is fairly balanced and in compliance with FDA regulations.
- Publication restrictions are in place
Restriction type: OTHER