Trial Outcomes & Findings for Vedolizumab Intravenous (IV) Dose Optimization in Ulcerative Colitis (NCT NCT03029143)
NCT ID: NCT03029143
Last Updated: 2023-07-28
Results Overview
Mucosal healing is defined as Mayo endoscopic subscore \<=1 point. Mayo score was used in clinical trials to assess UC disease activity. It consisted of 4 disease activity variables (stool frequency, rectal bleeding, findings on sigmoidoscopy and physician's global assessment), each scored on a scale of 0 to 3, where 0 normal condition and 3 = severe disease condition. The total Mayo score ranges from 0 to 12, with higher scores indicating more severe disease.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
278 participants
Primary outcome timeframe
Week 30
Results posted on
2023-07-28
Participant Flow
Participants with ulcerative colitis (UC) took part in the study at 90 investigative sites in the United States and Canada from 29 March 2017 to 16 October 2020.
Participants with UC enrolled in Lead-in Period received vedolizumab 300 mg at Day 1 and Week 2. At Week 5, participants were assessed for clearance and at Week 6 for clinical response per partial Mayo Score. The non-responders were randomized to receive optimized treatment (Regimen A or B, dose decided by vedolizumab clearance) or standard vedolizumab treatment. The responders or participants with low vedolizumab clearance received vedolizumab 300 mg at Week 6 plus 18-week follow-up.
Participant milestones
| Measure |
Lead-in Period: Vedolizumab 300 mg
Vedolizumab 300 mg intravenous (IV) infusion once at Day 1 and at Week 2. Participants were then assessed to estimate the vedolizumab clearance at Week 5 and response at Week 6.
|
Randomized Treatment Period (RTP): Standard Treatment Arm
Following Lead-in Period, participants received vedolizumab 300 mg, IV infusion, once every 8 weeks (Q8W) at Weeks 6, 14 and 22 as standard treatment plus 18 weeks follow-up.
|
RTP: Dose Optimized Arm
Following Lead-in Period participants received vedolizumab 600 mg, IV infusion at Week 6, followed by Regimen A: vedolizumab 300 mg once in every 4 weeks (Q4W) thereafter (Weeks 10, 14, 18, 22 and 26) plus 18 weeks follow-up, or Regimen B: vedolizumab 600 mg, IV infusion Q4W (Weeks 6, 10, 14, 18, 22 and 26) plus 18 weeks follow-up based on drug clearance.
|
|---|---|---|---|
|
Lead-in Period (6 Weeks)
STARTED
|
278
|
0
|
0
|
|
Lead-in Period (6 Weeks)
COMPLETED
|
109
|
0
|
0
|
|
Lead-in Period (6 Weeks)
NOT COMPLETED
|
169
|
0
|
0
|
|
Randomized Treatment Period (24 Weeks)
STARTED
|
0
|
54
|
55
|
|
Randomized Treatment Period (24 Weeks)
Not Treated Post Randomization
|
0
|
1
|
0
|
|
Randomized Treatment Period (24 Weeks)
Safety Population
|
0
|
53
|
55
|
|
Randomized Treatment Period (24 Weeks)
COMPLETED
|
0
|
31
|
31
|
|
Randomized Treatment Period (24 Weeks)
NOT COMPLETED
|
0
|
23
|
24
|
Reasons for withdrawal
| Measure |
Lead-in Period: Vedolizumab 300 mg
Vedolizumab 300 mg intravenous (IV) infusion once at Day 1 and at Week 2. Participants were then assessed to estimate the vedolizumab clearance at Week 5 and response at Week 6.
|
Randomized Treatment Period (RTP): Standard Treatment Arm
Following Lead-in Period, participants received vedolizumab 300 mg, IV infusion, once every 8 weeks (Q8W) at Weeks 6, 14 and 22 as standard treatment plus 18 weeks follow-up.
|
RTP: Dose Optimized Arm
Following Lead-in Period participants received vedolizumab 600 mg, IV infusion at Week 6, followed by Regimen A: vedolizumab 300 mg once in every 4 weeks (Q4W) thereafter (Weeks 10, 14, 18, 22 and 26) plus 18 weeks follow-up, or Regimen B: vedolizumab 600 mg, IV infusion Q4W (Weeks 6, 10, 14, 18, 22 and 26) plus 18 weeks follow-up based on drug clearance.
|
|---|---|---|---|
|
Lead-in Period (6 Weeks)
Pretreatment Event/Adverse Event
|
8
|
0
|
0
|
|
Lead-in Period (6 Weeks)
Significant Protocol Deviation
|
12
|
0
|
0
|
|
Lead-in Period (6 Weeks)
Lost to Follow-up
|
1
|
0
|
0
|
|
Lead-in Period (6 Weeks)
Voluntary Withdrawal
|
6
|
0
|
0
|
|
Lead-in Period (6 Weeks)
Randomized but not Treated
|
142
|
0
|
0
|
|
Randomized Treatment Period (24 Weeks)
Pretreatment Event/Adverse Event
|
0
|
3
|
9
|
|
Randomized Treatment Period (24 Weeks)
Significant Protocol Deviation
|
0
|
1
|
3
|
|
Randomized Treatment Period (24 Weeks)
Lost to Follow-up
|
0
|
1
|
3
|
|
Randomized Treatment Period (24 Weeks)
Voluntary Withdrawal
|
0
|
10
|
1
|
|
Randomized Treatment Period (24 Weeks)
Lack of Efficacy
|
0
|
6
|
7
|
|
Randomized Treatment Period (24 Weeks)
Reason not Specified
|
0
|
2
|
1
|
Baseline Characteristics
Vedolizumab Intravenous (IV) Dose Optimization in Ulcerative Colitis
Baseline characteristics by cohort
| Measure |
Lead-in Period: Vedolizumab 300 mg
n=278 Participants
Vedolizumab 300 mg intravenous (IV) infusion once at Day 1 and at Week 2 . Participants were then assessed to estimate the vedolizumab clearance at Week 5 and response at Week 6.
|
|---|---|
|
Age, Continuous
|
40.9 years
STANDARD_DEVIATION 15.11 • n=93 Participants
|
|
Sex: Female, Male
Female
|
122 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
156 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
34 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
244 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
18 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
2 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
28 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
228 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Height
|
171.5 cm
STANDARD_DEVIATION 9.39 • n=93 Participants
|
|
Weight
|
80.41 kg
STANDARD_DEVIATION 20.112 • n=93 Participants
|
|
Body Mass Index (BMI)
|
27.24 kg/m^2
STANDARD_DEVIATION 5.942 • n=93 Participants
|
|
Smoking Classification
Participant has never smoked
|
179 Participants
n=93 Participants
|
|
Smoking Classification
Participant is a current smoker
|
12 Participants
n=93 Participants
|
|
Smoking Classification
Participant is an ex-smoker
|
87 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: Week 30Population: Full Analysis Set included all participants who were randomized and received at least one dose of study medication post-randomization.
Mucosal healing is defined as Mayo endoscopic subscore \<=1 point. Mayo score was used in clinical trials to assess UC disease activity. It consisted of 4 disease activity variables (stool frequency, rectal bleeding, findings on sigmoidoscopy and physician's global assessment), each scored on a scale of 0 to 3, where 0 normal condition and 3 = severe disease condition. The total Mayo score ranges from 0 to 12, with higher scores indicating more severe disease.
Outcome measures
| Measure |
RTP: Standard Treatment Arm
n=53 Participants
Following Lead-in Period participants received vedolizumab 300 mg, IV infusion, once at Weeks 6, 14 and 22 \[every 8 weeks (Q8W)\] as standard treatment plus 18 weeks follow-up.
|
RTP: Dose Optimized Arm
n=55 Participants
Following Lead-in Period participants received vedolizumab 600 mg, IV infusion at Week 6, followed by Regimen A: vedolizumab 300 mg once in every 4 weeks (Q4W) thereafter (Weeks 10, 14, 18, 22 and 26) plus 18 weeks follow-up, or Regimen B: vedolizumab 600 mg, IV infusion Q4W (Weeks 6, 10, 14, 18, 22 and 26) plus 18 weeks follow-up based on drug clearance.
|
|---|---|---|
|
Percentage of Participants Achieving Mucosal Healing at Week 30
|
18.9 percentage of participants
Interval 9.4 to 32.0
|
14.5 percentage of participants
Interval 6.5 to 26.7
|
SECONDARY outcome
Timeframe: Week 30Population: Full Analysis Set included all participants who were randomized and received at least one dose of study medication post-randomization.
Clinical remission is defined as a complete Mayo score of ≤2 points and no individual subscore \>1 point at Week 30. Mayo score was used in clinical trials to assess UC disease activity. It consisted of 4 disease activity variables (stool frequency, rectal bleeding, findings on sigmoidoscopy and physician's global assessment), each scored on a scale of 0 to 3, where 0 = normal condition and 3 = severe disease condition. The total Mayo score ranges from 0 to 12, with higher scores indicating more severe disease.
Outcome measures
| Measure |
RTP: Standard Treatment Arm
n=53 Participants
Following Lead-in Period participants received vedolizumab 300 mg, IV infusion, once at Weeks 6, 14 and 22 \[every 8 weeks (Q8W)\] as standard treatment plus 18 weeks follow-up.
|
RTP: Dose Optimized Arm
n=55 Participants
Following Lead-in Period participants received vedolizumab 600 mg, IV infusion at Week 6, followed by Regimen A: vedolizumab 300 mg once in every 4 weeks (Q4W) thereafter (Weeks 10, 14, 18, 22 and 26) plus 18 weeks follow-up, or Regimen B: vedolizumab 600 mg, IV infusion Q4W (Weeks 6, 10, 14, 18, 22 and 26) plus 18 weeks follow-up based on drug clearance.
|
|---|---|---|
|
Percentage of Participants Achieving Clinical Remission at Week 30
|
9.4 percentage of participants
Interval 3.1 to 20.7
|
9.1 percentage of participants
Interval 3.0 to 20.0
|
SECONDARY outcome
Timeframe: Week 30Population: Full Analysis Set included all participants who were randomized and received at least one dose of study medication post-randomization.
Clinical response is defined as a reduction in complete Mayo score of ≥3 points and ≥30% from Baseline (Day 1) with an accompanying decrease in rectal bleeding subscore of ≥1 point or absolute rectal bleeding subscore of ≤1 point, at Week 30. Mayo score was used in clinical trials to assess UC disease activity. It consisted of 4 disease activity variables (stool frequency, rectal bleeding, findings on sigmoidoscopy and physician's global assessment), each scored on a scale of 0 to 3, where 0 = normal condition and 3 = severe disease condition. The total Mayo score ranges from 0 to 12, with higher scores indicating more severe disease.
Outcome measures
| Measure |
RTP: Standard Treatment Arm
n=53 Participants
Following Lead-in Period participants received vedolizumab 300 mg, IV infusion, once at Weeks 6, 14 and 22 \[every 8 weeks (Q8W)\] as standard treatment plus 18 weeks follow-up.
|
RTP: Dose Optimized Arm
n=55 Participants
Following Lead-in Period participants received vedolizumab 600 mg, IV infusion at Week 6, followed by Regimen A: vedolizumab 300 mg once in every 4 weeks (Q4W) thereafter (Weeks 10, 14, 18, 22 and 26) plus 18 weeks follow-up, or Regimen B: vedolizumab 600 mg, IV infusion Q4W (Weeks 6, 10, 14, 18, 22 and 26) plus 18 weeks follow-up based on drug clearance.
|
|---|---|---|
|
Percentage of Participants Achieving Clinical Response at Week 30
|
32.1 percentage of particpants
Interval 19.9 to 46.3
|
30.9 percentage of particpants
Interval 19.1 to 44.8
|
SECONDARY outcome
Timeframe: Week 14Population: Full Analysis Set included all participants who were randomized and received at least one dose of study medication post-randomization.
Clinical response is defined as A reduction in partial Mayo score of ≥2 points and ≥25% from Baseline (Day 1) with an accompanying decrease in rectal bleeding subscore of ≥1 point or absolute rectal bleeding subscore of ≤1 point. Mayo score was used in clinical trials to assess UC disease activity. A composite index of 3 disease activity variables (stool frequency, rectal bleeding, and physician's global assessment), each scored on a scale from 0 to 3 with total partial Mayo score ranging from 0 to 9 (higher scores indicate greater disease activity). Partial Mayo score is calculated analogously to the complete Mayo score but excludes the sigmoidoscopy subscore.
Outcome measures
| Measure |
RTP: Standard Treatment Arm
n=53 Participants
Following Lead-in Period participants received vedolizumab 300 mg, IV infusion, once at Weeks 6, 14 and 22 \[every 8 weeks (Q8W)\] as standard treatment plus 18 weeks follow-up.
|
RTP: Dose Optimized Arm
n=55 Participants
Following Lead-in Period participants received vedolizumab 600 mg, IV infusion at Week 6, followed by Regimen A: vedolizumab 300 mg once in every 4 weeks (Q4W) thereafter (Weeks 10, 14, 18, 22 and 26) plus 18 weeks follow-up, or Regimen B: vedolizumab 600 mg, IV infusion Q4W (Weeks 6, 10, 14, 18, 22 and 26) plus 18 weeks follow-up based on drug clearance.
|
|---|---|---|
|
Percentage of Participants Achieving Clinical Response at Week 14
|
34.0 percentage of participants
Interval 21.5 to 48.3
|
40.0 percentage of participants
Interval 27.0 to 54.1
|
SECONDARY outcome
Timeframe: Week 30Population: Full Analysis Set included all participants who were randomized and received at least one dose of study medication post-randomization. Overall number analyzed are the participants with data available for analyses.
Participants using oral corticosteroids at Baseline who have discontinued corticosteroids and are in clinical remission. Mayo score was used in clinical trials to assess UC disease activity. Clinical Remission is defined as a complete Mayo score of \<=2 points and no individual subscore \>1 point at Week 30. It consisted of 4 disease activity variables (stool frequency, rectal bleeding, findings on sigmoidoscopy and physician's global assessment), each scored on a scale of 0 to 3, where 0 = normal condition and 3 = severe disease condition. The total Mayo score ranges from 0 to 12, with higher scores indicating more severe disease.
Outcome measures
| Measure |
RTP: Standard Treatment Arm
n=14 Participants
Following Lead-in Period participants received vedolizumab 300 mg, IV infusion, once at Weeks 6, 14 and 22 \[every 8 weeks (Q8W)\] as standard treatment plus 18 weeks follow-up.
|
RTP: Dose Optimized Arm
n=21 Participants
Following Lead-in Period participants received vedolizumab 600 mg, IV infusion at Week 6, followed by Regimen A: vedolizumab 300 mg once in every 4 weeks (Q4W) thereafter (Weeks 10, 14, 18, 22 and 26) plus 18 weeks follow-up, or Regimen B: vedolizumab 600 mg, IV infusion Q4W (Weeks 6, 10, 14, 18, 22 and 26) plus 18 weeks follow-up based on drug clearance.
|
|---|---|---|
|
Percentage of Participants Achieving Corticosteroid-Free Remission
|
21.4 percentage of participants
Interval 4.7 to 50.8
|
14.3 percentage of participants
Interval 3.0 to 36.3
|
SECONDARY outcome
Timeframe: Weeks 14 and 30Population: Full Analysis Set included all participants who were randomized and received at least one dose of study medication post-randomization.
A clinical response (based on partial Mayo score), which is defined as a reduction in partial Mayo score of ≥2 points and ≥25% from Baseline with an accompanying decrease in rectal bleeding subscore of ≥1 point or absolute rectal bleeding subscore of ≤1 point at Weeks 14 and 30. Mayo score was used in clinical trials to assess UC disease activity. A composite index of 3 disease activity variables (stool frequency, rectal bleeding, and physician's global assessment), each scored on a scale from 0 to 3 with total partial Mayo score ranging from 0 to 9 (higher scores indicate greater disease activity). Partial Mayo score is calculated analogously to the complete Mayo score but excludes the sigmoidoscopy subscore. Percentage of participants with durable clinical response, clinical response achieved at both Weeks 14 and 30 are reported.
Outcome measures
| Measure |
RTP: Standard Treatment Arm
n=53 Participants
Following Lead-in Period participants received vedolizumab 300 mg, IV infusion, once at Weeks 6, 14 and 22 \[every 8 weeks (Q8W)\] as standard treatment plus 18 weeks follow-up.
|
RTP: Dose Optimized Arm
n=55 Participants
Following Lead-in Period participants received vedolizumab 600 mg, IV infusion at Week 6, followed by Regimen A: vedolizumab 300 mg once in every 4 weeks (Q4W) thereafter (Weeks 10, 14, 18, 22 and 26) plus 18 weeks follow-up, or Regimen B: vedolizumab 600 mg, IV infusion Q4W (Weeks 6, 10, 14, 18, 22 and 26) plus 18 weeks follow-up based on drug clearance.
|
|---|---|---|
|
Percentage of Participants Achieving Durable Clinical Response
|
22.6 percentage of participants
Interval 12.3 to 36.2
|
30.9 percentage of participants
Interval 19.1 to 44.8
|
Adverse Events
Lead-in Period
Serious events: 12 serious events
Other events: 10 other events
Deaths: 1 deaths
Lead-in Failure Follow-up Period
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
RTP: Standard Treatment Arm
Serious events: 4 serious events
Other events: 9 other events
Deaths: 0 deaths
RTP: VDZ Dose Optimization: Regimen A
Serious events: 4 serious events
Other events: 12 other events
Deaths: 0 deaths
RTP: VDZ Dose Optimization: Regimen B
Serious events: 1 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Lead-in Period
n=278 participants at risk
Vedolizumab 300 mg intravenous (IV) infusion once at Day 1 and at Week 2.
|
Lead-in Failure Follow-up Period
n=170 participants at risk
Following Lead in Period, participants who were responders at Week 6 or had normal-to-low vedolizumab clearance at Week 5 were not eligible for randomization and received vedolizumab 300 mg IV infusion at Week 6 plus 18 weeks follow-up.
|
RTP: Standard Treatment Arm
n=53 participants at risk
Following Lead-in Period, participants received vedolizumab 300 mg, IV infusion, once at Weeks 6, 14 and 22 \[every 8 weeks (Q8W)\] as standard treatment plus 18 weeks follow-up.
|
RTP: VDZ Dose Optimization: Regimen A
n=28 participants at risk
Following Lead-in Period, participants received vedolizumab 600 mg at Week 6 and 300 mg IV infusion once every 4 weeks up to Week 26 in regimen A plus 18 weeks follow-up.
|
RTP: VDZ Dose Optimization: Regimen B
n=27 participants at risk
Following Lead-in Period, participants received vedolizumab 600 mg at Week 6 followed by vedolizumab 600 mg once every 4 weeks up to Week 26 in regimen B plus 18 weeks follow-up.
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.36%
1/278 • From the first dose of study drug up to 18 weeks after the last dose (approximately 44 weeks)
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. Data is reported for Safety Analysis Set, as per the treatment received throughout the study. Data for adverse events for Regimen A and B are reported per dose.
|
0.00%
0/170 • From the first dose of study drug up to 18 weeks after the last dose (approximately 44 weeks)
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. Data is reported for Safety Analysis Set, as per the treatment received throughout the study. Data for adverse events for Regimen A and B are reported per dose.
|
0.00%
0/53 • From the first dose of study drug up to 18 weeks after the last dose (approximately 44 weeks)
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. Data is reported for Safety Analysis Set, as per the treatment received throughout the study. Data for adverse events for Regimen A and B are reported per dose.
|
0.00%
0/28 • From the first dose of study drug up to 18 weeks after the last dose (approximately 44 weeks)
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. Data is reported for Safety Analysis Set, as per the treatment received throughout the study. Data for adverse events for Regimen A and B are reported per dose.
|
0.00%
0/27 • From the first dose of study drug up to 18 weeks after the last dose (approximately 44 weeks)
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. Data is reported for Safety Analysis Set, as per the treatment received throughout the study. Data for adverse events for Regimen A and B are reported per dose.
|
|
Congenital, familial and genetic disorders
Benign familial haematuria
|
0.00%
0/278 • From the first dose of study drug up to 18 weeks after the last dose (approximately 44 weeks)
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. Data is reported for Safety Analysis Set, as per the treatment received throughout the study. Data for adverse events for Regimen A and B are reported per dose.
|
0.00%
0/170 • From the first dose of study drug up to 18 weeks after the last dose (approximately 44 weeks)
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. Data is reported for Safety Analysis Set, as per the treatment received throughout the study. Data for adverse events for Regimen A and B are reported per dose.
|
1.9%
1/53 • From the first dose of study drug up to 18 weeks after the last dose (approximately 44 weeks)
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. Data is reported for Safety Analysis Set, as per the treatment received throughout the study. Data for adverse events for Regimen A and B are reported per dose.
|
0.00%
0/28 • From the first dose of study drug up to 18 weeks after the last dose (approximately 44 weeks)
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. Data is reported for Safety Analysis Set, as per the treatment received throughout the study. Data for adverse events for Regimen A and B are reported per dose.
|
0.00%
0/27 • From the first dose of study drug up to 18 weeks after the last dose (approximately 44 weeks)
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. Data is reported for Safety Analysis Set, as per the treatment received throughout the study. Data for adverse events for Regimen A and B are reported per dose.
|
|
Gastrointestinal disorders
Colitis ulcerative
|
2.5%
7/278 • From the first dose of study drug up to 18 weeks after the last dose (approximately 44 weeks)
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. Data is reported for Safety Analysis Set, as per the treatment received throughout the study. Data for adverse events for Regimen A and B are reported per dose.
|
0.59%
1/170 • From the first dose of study drug up to 18 weeks after the last dose (approximately 44 weeks)
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. Data is reported for Safety Analysis Set, as per the treatment received throughout the study. Data for adverse events for Regimen A and B are reported per dose.
|
3.8%
2/53 • From the first dose of study drug up to 18 weeks after the last dose (approximately 44 weeks)
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. Data is reported for Safety Analysis Set, as per the treatment received throughout the study. Data for adverse events for Regimen A and B are reported per dose.
|
10.7%
3/28 • From the first dose of study drug up to 18 weeks after the last dose (approximately 44 weeks)
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. Data is reported for Safety Analysis Set, as per the treatment received throughout the study. Data for adverse events for Regimen A and B are reported per dose.
|
3.7%
1/27 • From the first dose of study drug up to 18 weeks after the last dose (approximately 44 weeks)
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. Data is reported for Safety Analysis Set, as per the treatment received throughout the study. Data for adverse events for Regimen A and B are reported per dose.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.36%
1/278 • From the first dose of study drug up to 18 weeks after the last dose (approximately 44 weeks)
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. Data is reported for Safety Analysis Set, as per the treatment received throughout the study. Data for adverse events for Regimen A and B are reported per dose.
|
0.00%
0/170 • From the first dose of study drug up to 18 weeks after the last dose (approximately 44 weeks)
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. Data is reported for Safety Analysis Set, as per the treatment received throughout the study. Data for adverse events for Regimen A and B are reported per dose.
|
0.00%
0/53 • From the first dose of study drug up to 18 weeks after the last dose (approximately 44 weeks)
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. Data is reported for Safety Analysis Set, as per the treatment received throughout the study. Data for adverse events for Regimen A and B are reported per dose.
|
0.00%
0/28 • From the first dose of study drug up to 18 weeks after the last dose (approximately 44 weeks)
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. Data is reported for Safety Analysis Set, as per the treatment received throughout the study. Data for adverse events for Regimen A and B are reported per dose.
|
0.00%
0/27 • From the first dose of study drug up to 18 weeks after the last dose (approximately 44 weeks)
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. Data is reported for Safety Analysis Set, as per the treatment received throughout the study. Data for adverse events for Regimen A and B are reported per dose.
|
|
Infections and infestations
Appendicitis
|
0.36%
1/278 • From the first dose of study drug up to 18 weeks after the last dose (approximately 44 weeks)
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. Data is reported for Safety Analysis Set, as per the treatment received throughout the study. Data for adverse events for Regimen A and B are reported per dose.
|
0.00%
0/170 • From the first dose of study drug up to 18 weeks after the last dose (approximately 44 weeks)
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. Data is reported for Safety Analysis Set, as per the treatment received throughout the study. Data for adverse events for Regimen A and B are reported per dose.
|
0.00%
0/53 • From the first dose of study drug up to 18 weeks after the last dose (approximately 44 weeks)
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. Data is reported for Safety Analysis Set, as per the treatment received throughout the study. Data for adverse events for Regimen A and B are reported per dose.
|
0.00%
0/28 • From the first dose of study drug up to 18 weeks after the last dose (approximately 44 weeks)
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. Data is reported for Safety Analysis Set, as per the treatment received throughout the study. Data for adverse events for Regimen A and B are reported per dose.
|
0.00%
0/27 • From the first dose of study drug up to 18 weeks after the last dose (approximately 44 weeks)
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. Data is reported for Safety Analysis Set, as per the treatment received throughout the study. Data for adverse events for Regimen A and B are reported per dose.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.36%
1/278 • From the first dose of study drug up to 18 weeks after the last dose (approximately 44 weeks)
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. Data is reported for Safety Analysis Set, as per the treatment received throughout the study. Data for adverse events for Regimen A and B are reported per dose.
|
0.00%
0/170 • From the first dose of study drug up to 18 weeks after the last dose (approximately 44 weeks)
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. Data is reported for Safety Analysis Set, as per the treatment received throughout the study. Data for adverse events for Regimen A and B are reported per dose.
|
0.00%
0/53 • From the first dose of study drug up to 18 weeks after the last dose (approximately 44 weeks)
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. Data is reported for Safety Analysis Set, as per the treatment received throughout the study. Data for adverse events for Regimen A and B are reported per dose.
|
0.00%
0/28 • From the first dose of study drug up to 18 weeks after the last dose (approximately 44 weeks)
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. Data is reported for Safety Analysis Set, as per the treatment received throughout the study. Data for adverse events for Regimen A and B are reported per dose.
|
0.00%
0/27 • From the first dose of study drug up to 18 weeks after the last dose (approximately 44 weeks)
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. Data is reported for Safety Analysis Set, as per the treatment received throughout the study. Data for adverse events for Regimen A and B are reported per dose.
|
|
Infections and infestations
Clostridium difficile infection
|
0.00%
0/278 • From the first dose of study drug up to 18 weeks after the last dose (approximately 44 weeks)
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. Data is reported for Safety Analysis Set, as per the treatment received throughout the study. Data for adverse events for Regimen A and B are reported per dose.
|
0.00%
0/170 • From the first dose of study drug up to 18 weeks after the last dose (approximately 44 weeks)
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. Data is reported for Safety Analysis Set, as per the treatment received throughout the study. Data for adverse events for Regimen A and B are reported per dose.
|
1.9%
1/53 • From the first dose of study drug up to 18 weeks after the last dose (approximately 44 weeks)
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. Data is reported for Safety Analysis Set, as per the treatment received throughout the study. Data for adverse events for Regimen A and B are reported per dose.
|
0.00%
0/28 • From the first dose of study drug up to 18 weeks after the last dose (approximately 44 weeks)
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. Data is reported for Safety Analysis Set, as per the treatment received throughout the study. Data for adverse events for Regimen A and B are reported per dose.
|
0.00%
0/27 • From the first dose of study drug up to 18 weeks after the last dose (approximately 44 weeks)
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. Data is reported for Safety Analysis Set, as per the treatment received throughout the study. Data for adverse events for Regimen A and B are reported per dose.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/278 • From the first dose of study drug up to 18 weeks after the last dose (approximately 44 weeks)
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. Data is reported for Safety Analysis Set, as per the treatment received throughout the study. Data for adverse events for Regimen A and B are reported per dose.
|
0.00%
0/170 • From the first dose of study drug up to 18 weeks after the last dose (approximately 44 weeks)
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. Data is reported for Safety Analysis Set, as per the treatment received throughout the study. Data for adverse events for Regimen A and B are reported per dose.
|
1.9%
1/53 • From the first dose of study drug up to 18 weeks after the last dose (approximately 44 weeks)
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. Data is reported for Safety Analysis Set, as per the treatment received throughout the study. Data for adverse events for Regimen A and B are reported per dose.
|
0.00%
0/28 • From the first dose of study drug up to 18 weeks after the last dose (approximately 44 weeks)
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. Data is reported for Safety Analysis Set, as per the treatment received throughout the study. Data for adverse events for Regimen A and B are reported per dose.
|
0.00%
0/27 • From the first dose of study drug up to 18 weeks after the last dose (approximately 44 weeks)
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. Data is reported for Safety Analysis Set, as per the treatment received throughout the study. Data for adverse events for Regimen A and B are reported per dose.
|
|
Vascular disorders
Deep vein thrombosis
|
0.36%
1/278 • From the first dose of study drug up to 18 weeks after the last dose (approximately 44 weeks)
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. Data is reported for Safety Analysis Set, as per the treatment received throughout the study. Data for adverse events for Regimen A and B are reported per dose.
|
0.00%
0/170 • From the first dose of study drug up to 18 weeks after the last dose (approximately 44 weeks)
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. Data is reported for Safety Analysis Set, as per the treatment received throughout the study. Data for adverse events for Regimen A and B are reported per dose.
|
0.00%
0/53 • From the first dose of study drug up to 18 weeks after the last dose (approximately 44 weeks)
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. Data is reported for Safety Analysis Set, as per the treatment received throughout the study. Data for adverse events for Regimen A and B are reported per dose.
|
0.00%
0/28 • From the first dose of study drug up to 18 weeks after the last dose (approximately 44 weeks)
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. Data is reported for Safety Analysis Set, as per the treatment received throughout the study. Data for adverse events for Regimen A and B are reported per dose.
|
0.00%
0/27 • From the first dose of study drug up to 18 weeks after the last dose (approximately 44 weeks)
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. Data is reported for Safety Analysis Set, as per the treatment received throughout the study. Data for adverse events for Regimen A and B are reported per dose.
|
|
Vascular disorders
Hypotension
|
0.36%
1/278 • From the first dose of study drug up to 18 weeks after the last dose (approximately 44 weeks)
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. Data is reported for Safety Analysis Set, as per the treatment received throughout the study. Data for adverse events for Regimen A and B are reported per dose.
|
0.00%
0/170 • From the first dose of study drug up to 18 weeks after the last dose (approximately 44 weeks)
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. Data is reported for Safety Analysis Set, as per the treatment received throughout the study. Data for adverse events for Regimen A and B are reported per dose.
|
0.00%
0/53 • From the first dose of study drug up to 18 weeks after the last dose (approximately 44 weeks)
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. Data is reported for Safety Analysis Set, as per the treatment received throughout the study. Data for adverse events for Regimen A and B are reported per dose.
|
0.00%
0/28 • From the first dose of study drug up to 18 weeks after the last dose (approximately 44 weeks)
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. Data is reported for Safety Analysis Set, as per the treatment received throughout the study. Data for adverse events for Regimen A and B are reported per dose.
|
0.00%
0/27 • From the first dose of study drug up to 18 weeks after the last dose (approximately 44 weeks)
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. Data is reported for Safety Analysis Set, as per the treatment received throughout the study. Data for adverse events for Regimen A and B are reported per dose.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/278 • From the first dose of study drug up to 18 weeks after the last dose (approximately 44 weeks)
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. Data is reported for Safety Analysis Set, as per the treatment received throughout the study. Data for adverse events for Regimen A and B are reported per dose.
|
0.00%
0/170 • From the first dose of study drug up to 18 weeks after the last dose (approximately 44 weeks)
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. Data is reported for Safety Analysis Set, as per the treatment received throughout the study. Data for adverse events for Regimen A and B are reported per dose.
|
0.00%
0/53 • From the first dose of study drug up to 18 weeks after the last dose (approximately 44 weeks)
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. Data is reported for Safety Analysis Set, as per the treatment received throughout the study. Data for adverse events for Regimen A and B are reported per dose.
|
3.6%
1/28 • From the first dose of study drug up to 18 weeks after the last dose (approximately 44 weeks)
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. Data is reported for Safety Analysis Set, as per the treatment received throughout the study. Data for adverse events for Regimen A and B are reported per dose.
|
0.00%
0/27 • From the first dose of study drug up to 18 weeks after the last dose (approximately 44 weeks)
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. Data is reported for Safety Analysis Set, as per the treatment received throughout the study. Data for adverse events for Regimen A and B are reported per dose.
|
Other adverse events
| Measure |
Lead-in Period
n=278 participants at risk
Vedolizumab 300 mg intravenous (IV) infusion once at Day 1 and at Week 2.
|
Lead-in Failure Follow-up Period
n=170 participants at risk
Following Lead in Period, participants who were responders at Week 6 or had normal-to-low vedolizumab clearance at Week 5 were not eligible for randomization and received vedolizumab 300 mg IV infusion at Week 6 plus 18 weeks follow-up.
|
RTP: Standard Treatment Arm
n=53 participants at risk
Following Lead-in Period, participants received vedolizumab 300 mg, IV infusion, once at Weeks 6, 14 and 22 \[every 8 weeks (Q8W)\] as standard treatment plus 18 weeks follow-up.
|
RTP: VDZ Dose Optimization: Regimen A
n=28 participants at risk
Following Lead-in Period, participants received vedolizumab 600 mg at Week 6 and 300 mg IV infusion once every 4 weeks up to Week 26 in regimen A plus 18 weeks follow-up.
|
RTP: VDZ Dose Optimization: Regimen B
n=27 participants at risk
Following Lead-in Period, participants received vedolizumab 600 mg at Week 6 followed by vedolizumab 600 mg once every 4 weeks up to Week 26 in regimen B plus 18 weeks follow-up.
|
|---|---|---|---|---|---|
|
Nervous system disorders
Headache
|
2.9%
8/278 • From the first dose of study drug up to 18 weeks after the last dose (approximately 44 weeks)
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. Data is reported for Safety Analysis Set, as per the treatment received throughout the study. Data for adverse events for Regimen A and B are reported per dose.
|
0.59%
1/170 • From the first dose of study drug up to 18 weeks after the last dose (approximately 44 weeks)
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. Data is reported for Safety Analysis Set, as per the treatment received throughout the study. Data for adverse events for Regimen A and B are reported per dose.
|
1.9%
1/53 • From the first dose of study drug up to 18 weeks after the last dose (approximately 44 weeks)
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. Data is reported for Safety Analysis Set, as per the treatment received throughout the study. Data for adverse events for Regimen A and B are reported per dose.
|
10.7%
3/28 • From the first dose of study drug up to 18 weeks after the last dose (approximately 44 weeks)
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. Data is reported for Safety Analysis Set, as per the treatment received throughout the study. Data for adverse events for Regimen A and B are reported per dose.
|
7.4%
2/27 • From the first dose of study drug up to 18 weeks after the last dose (approximately 44 weeks)
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. Data is reported for Safety Analysis Set, as per the treatment received throughout the study. Data for adverse events for Regimen A and B are reported per dose.
|
|
Gastrointestinal disorders
Colitis ulcerative
|
0.72%
2/278 • From the first dose of study drug up to 18 weeks after the last dose (approximately 44 weeks)
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. Data is reported for Safety Analysis Set, as per the treatment received throughout the study. Data for adverse events for Regimen A and B are reported per dose.
|
1.2%
2/170 • From the first dose of study drug up to 18 weeks after the last dose (approximately 44 weeks)
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. Data is reported for Safety Analysis Set, as per the treatment received throughout the study. Data for adverse events for Regimen A and B are reported per dose.
|
7.5%
4/53 • From the first dose of study drug up to 18 weeks after the last dose (approximately 44 weeks)
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. Data is reported for Safety Analysis Set, as per the treatment received throughout the study. Data for adverse events for Regimen A and B are reported per dose.
|
0.00%
0/28 • From the first dose of study drug up to 18 weeks after the last dose (approximately 44 weeks)
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. Data is reported for Safety Analysis Set, as per the treatment received throughout the study. Data for adverse events for Regimen A and B are reported per dose.
|
11.1%
3/27 • From the first dose of study drug up to 18 weeks after the last dose (approximately 44 weeks)
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. Data is reported for Safety Analysis Set, as per the treatment received throughout the study. Data for adverse events for Regimen A and B are reported per dose.
|
|
Investigations
C-reactive protein increased
|
0.36%
1/278 • From the first dose of study drug up to 18 weeks after the last dose (approximately 44 weeks)
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. Data is reported for Safety Analysis Set, as per the treatment received throughout the study. Data for adverse events for Regimen A and B are reported per dose.
|
0.59%
1/170 • From the first dose of study drug up to 18 weeks after the last dose (approximately 44 weeks)
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. Data is reported for Safety Analysis Set, as per the treatment received throughout the study. Data for adverse events for Regimen A and B are reported per dose.
|
5.7%
3/53 • From the first dose of study drug up to 18 weeks after the last dose (approximately 44 weeks)
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. Data is reported for Safety Analysis Set, as per the treatment received throughout the study. Data for adverse events for Regimen A and B are reported per dose.
|
3.6%
1/28 • From the first dose of study drug up to 18 weeks after the last dose (approximately 44 weeks)
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. Data is reported for Safety Analysis Set, as per the treatment received throughout the study. Data for adverse events for Regimen A and B are reported per dose.
|
7.4%
2/27 • From the first dose of study drug up to 18 weeks after the last dose (approximately 44 weeks)
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. Data is reported for Safety Analysis Set, as per the treatment received throughout the study. Data for adverse events for Regimen A and B are reported per dose.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/278 • From the first dose of study drug up to 18 weeks after the last dose (approximately 44 weeks)
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. Data is reported for Safety Analysis Set, as per the treatment received throughout the study. Data for adverse events for Regimen A and B are reported per dose.
|
0.00%
0/170 • From the first dose of study drug up to 18 weeks after the last dose (approximately 44 weeks)
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. Data is reported for Safety Analysis Set, as per the treatment received throughout the study. Data for adverse events for Regimen A and B are reported per dose.
|
1.9%
1/53 • From the first dose of study drug up to 18 weeks after the last dose (approximately 44 weeks)
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. Data is reported for Safety Analysis Set, as per the treatment received throughout the study. Data for adverse events for Regimen A and B are reported per dose.
|
0.00%
0/28 • From the first dose of study drug up to 18 weeks after the last dose (approximately 44 weeks)
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. Data is reported for Safety Analysis Set, as per the treatment received throughout the study. Data for adverse events for Regimen A and B are reported per dose.
|
7.4%
2/27 • From the first dose of study drug up to 18 weeks after the last dose (approximately 44 weeks)
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. Data is reported for Safety Analysis Set, as per the treatment received throughout the study. Data for adverse events for Regimen A and B are reported per dose.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/278 • From the first dose of study drug up to 18 weeks after the last dose (approximately 44 weeks)
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. Data is reported for Safety Analysis Set, as per the treatment received throughout the study. Data for adverse events for Regimen A and B are reported per dose.
|
0.00%
0/170 • From the first dose of study drug up to 18 weeks after the last dose (approximately 44 weeks)
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. Data is reported for Safety Analysis Set, as per the treatment received throughout the study. Data for adverse events for Regimen A and B are reported per dose.
|
0.00%
0/53 • From the first dose of study drug up to 18 weeks after the last dose (approximately 44 weeks)
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. Data is reported for Safety Analysis Set, as per the treatment received throughout the study. Data for adverse events for Regimen A and B are reported per dose.
|
10.7%
3/28 • From the first dose of study drug up to 18 weeks after the last dose (approximately 44 weeks)
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. Data is reported for Safety Analysis Set, as per the treatment received throughout the study. Data for adverse events for Regimen A and B are reported per dose.
|
7.4%
2/27 • From the first dose of study drug up to 18 weeks after the last dose (approximately 44 weeks)
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. Data is reported for Safety Analysis Set, as per the treatment received throughout the study. Data for adverse events for Regimen A and B are reported per dose.
|
|
General disorders
Fatigue
|
0.00%
0/278 • From the first dose of study drug up to 18 weeks after the last dose (approximately 44 weeks)
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. Data is reported for Safety Analysis Set, as per the treatment received throughout the study. Data for adverse events for Regimen A and B are reported per dose.
|
0.00%
0/170 • From the first dose of study drug up to 18 weeks after the last dose (approximately 44 weeks)
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. Data is reported for Safety Analysis Set, as per the treatment received throughout the study. Data for adverse events for Regimen A and B are reported per dose.
|
1.9%
1/53 • From the first dose of study drug up to 18 weeks after the last dose (approximately 44 weeks)
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. Data is reported for Safety Analysis Set, as per the treatment received throughout the study. Data for adverse events for Regimen A and B are reported per dose.
|
3.6%
1/28 • From the first dose of study drug up to 18 weeks after the last dose (approximately 44 weeks)
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. Data is reported for Safety Analysis Set, as per the treatment received throughout the study. Data for adverse events for Regimen A and B are reported per dose.
|
7.4%
2/27 • From the first dose of study drug up to 18 weeks after the last dose (approximately 44 weeks)
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. Data is reported for Safety Analysis Set, as per the treatment received throughout the study. Data for adverse events for Regimen A and B are reported per dose.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/278 • From the first dose of study drug up to 18 weeks after the last dose (approximately 44 weeks)
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. Data is reported for Safety Analysis Set, as per the treatment received throughout the study. Data for adverse events for Regimen A and B are reported per dose.
|
0.00%
0/170 • From the first dose of study drug up to 18 weeks after the last dose (approximately 44 weeks)
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. Data is reported for Safety Analysis Set, as per the treatment received throughout the study. Data for adverse events for Regimen A and B are reported per dose.
|
1.9%
1/53 • From the first dose of study drug up to 18 weeks after the last dose (approximately 44 weeks)
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. Data is reported for Safety Analysis Set, as per the treatment received throughout the study. Data for adverse events for Regimen A and B are reported per dose.
|
0.00%
0/28 • From the first dose of study drug up to 18 weeks after the last dose (approximately 44 weeks)
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. Data is reported for Safety Analysis Set, as per the treatment received throughout the study. Data for adverse events for Regimen A and B are reported per dose.
|
7.4%
2/27 • From the first dose of study drug up to 18 weeks after the last dose (approximately 44 weeks)
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. Data is reported for Safety Analysis Set, as per the treatment received throughout the study. Data for adverse events for Regimen A and B are reported per dose.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/278 • From the first dose of study drug up to 18 weeks after the last dose (approximately 44 weeks)
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. Data is reported for Safety Analysis Set, as per the treatment received throughout the study. Data for adverse events for Regimen A and B are reported per dose.
|
0.00%
0/170 • From the first dose of study drug up to 18 weeks after the last dose (approximately 44 weeks)
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. Data is reported for Safety Analysis Set, as per the treatment received throughout the study. Data for adverse events for Regimen A and B are reported per dose.
|
0.00%
0/53 • From the first dose of study drug up to 18 weeks after the last dose (approximately 44 weeks)
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. Data is reported for Safety Analysis Set, as per the treatment received throughout the study. Data for adverse events for Regimen A and B are reported per dose.
|
7.1%
2/28 • From the first dose of study drug up to 18 weeks after the last dose (approximately 44 weeks)
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. Data is reported for Safety Analysis Set, as per the treatment received throughout the study. Data for adverse events for Regimen A and B are reported per dose.
|
3.7%
1/27 • From the first dose of study drug up to 18 weeks after the last dose (approximately 44 weeks)
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. Data is reported for Safety Analysis Set, as per the treatment received throughout the study. Data for adverse events for Regimen A and B are reported per dose.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/278 • From the first dose of study drug up to 18 weeks after the last dose (approximately 44 weeks)
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. Data is reported for Safety Analysis Set, as per the treatment received throughout the study. Data for adverse events for Regimen A and B are reported per dose.
|
0.00%
0/170 • From the first dose of study drug up to 18 weeks after the last dose (approximately 44 weeks)
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. Data is reported for Safety Analysis Set, as per the treatment received throughout the study. Data for adverse events for Regimen A and B are reported per dose.
|
0.00%
0/53 • From the first dose of study drug up to 18 weeks after the last dose (approximately 44 weeks)
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. Data is reported for Safety Analysis Set, as per the treatment received throughout the study. Data for adverse events for Regimen A and B are reported per dose.
|
7.1%
2/28 • From the first dose of study drug up to 18 weeks after the last dose (approximately 44 weeks)
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. Data is reported for Safety Analysis Set, as per the treatment received throughout the study. Data for adverse events for Regimen A and B are reported per dose.
|
0.00%
0/27 • From the first dose of study drug up to 18 weeks after the last dose (approximately 44 weeks)
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. Data is reported for Safety Analysis Set, as per the treatment received throughout the study. Data for adverse events for Regimen A and B are reported per dose.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/278 • From the first dose of study drug up to 18 weeks after the last dose (approximately 44 weeks)
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. Data is reported for Safety Analysis Set, as per the treatment received throughout the study. Data for adverse events for Regimen A and B are reported per dose.
|
0.00%
0/170 • From the first dose of study drug up to 18 weeks after the last dose (approximately 44 weeks)
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. Data is reported for Safety Analysis Set, as per the treatment received throughout the study. Data for adverse events for Regimen A and B are reported per dose.
|
1.9%
1/53 • From the first dose of study drug up to 18 weeks after the last dose (approximately 44 weeks)
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. Data is reported for Safety Analysis Set, as per the treatment received throughout the study. Data for adverse events for Regimen A and B are reported per dose.
|
7.1%
2/28 • From the first dose of study drug up to 18 weeks after the last dose (approximately 44 weeks)
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. Data is reported for Safety Analysis Set, as per the treatment received throughout the study. Data for adverse events for Regimen A and B are reported per dose.
|
0.00%
0/27 • From the first dose of study drug up to 18 weeks after the last dose (approximately 44 weeks)
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. Data is reported for Safety Analysis Set, as per the treatment received throughout the study. Data for adverse events for Regimen A and B are reported per dose.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/278 • From the first dose of study drug up to 18 weeks after the last dose (approximately 44 weeks)
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. Data is reported for Safety Analysis Set, as per the treatment received throughout the study. Data for adverse events for Regimen A and B are reported per dose.
|
0.00%
0/170 • From the first dose of study drug up to 18 weeks after the last dose (approximately 44 weeks)
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. Data is reported for Safety Analysis Set, as per the treatment received throughout the study. Data for adverse events for Regimen A and B are reported per dose.
|
0.00%
0/53 • From the first dose of study drug up to 18 weeks after the last dose (approximately 44 weeks)
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. Data is reported for Safety Analysis Set, as per the treatment received throughout the study. Data for adverse events for Regimen A and B are reported per dose.
|
7.1%
2/28 • From the first dose of study drug up to 18 weeks after the last dose (approximately 44 weeks)
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. Data is reported for Safety Analysis Set, as per the treatment received throughout the study. Data for adverse events for Regimen A and B are reported per dose.
|
0.00%
0/27 • From the first dose of study drug up to 18 weeks after the last dose (approximately 44 weeks)
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. Data is reported for Safety Analysis Set, as per the treatment received throughout the study. Data for adverse events for Regimen A and B are reported per dose.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/278 • From the first dose of study drug up to 18 weeks after the last dose (approximately 44 weeks)
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. Data is reported for Safety Analysis Set, as per the treatment received throughout the study. Data for adverse events for Regimen A and B are reported per dose.
|
0.00%
0/170 • From the first dose of study drug up to 18 weeks after the last dose (approximately 44 weeks)
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. Data is reported for Safety Analysis Set, as per the treatment received throughout the study. Data for adverse events for Regimen A and B are reported per dose.
|
3.8%
2/53 • From the first dose of study drug up to 18 weeks after the last dose (approximately 44 weeks)
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. Data is reported for Safety Analysis Set, as per the treatment received throughout the study. Data for adverse events for Regimen A and B are reported per dose.
|
7.1%
2/28 • From the first dose of study drug up to 18 weeks after the last dose (approximately 44 weeks)
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. Data is reported for Safety Analysis Set, as per the treatment received throughout the study. Data for adverse events for Regimen A and B are reported per dose.
|
0.00%
0/27 • From the first dose of study drug up to 18 weeks after the last dose (approximately 44 weeks)
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. Data is reported for Safety Analysis Set, as per the treatment received throughout the study. Data for adverse events for Regimen A and B are reported per dose.
|
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