Trial Outcomes & Findings for (CB-01-02/02) Randomized Placebo Controlled Trial of Budesonide-multi-matrix System (MMX™) 6 mg and 9 mg in Patients With Ulcerative Colitis (NCT NCT00679380)
NCT ID: NCT00679380
Last Updated: 2019-12-10
Results Overview
Clinical and endoscopic remission defined as an Ulcerative Colitis Disease Activity Index (UCDAI) score ≤ 1, with subscores of 0 for rectal bleeding, stool frequency, and mucosal appearance and with a ≥ 1 point reduction in the endoscopic index score.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
514 participants
Primary outcome timeframe
8 weeks
Results posted on
2019-12-10
Participant Flow
Recruited from July 2008 to February 2010.
3 randomized patients were not treated and are excluded from all analyses. The safety population, N= 511: 509 randomized and treated + 2 nonrandomized and treated patients. The intent-to-treat (ITT) population, N=410: 511 - 101 patients who were not randomized, had major entry criteria violation, GCP violation, or normal histology at baseline.
Participant milestones
| Measure |
1: Budesonide-MMX® 6 mg
One budesonide-MMX® 6 mg plus three placebo Entocort EC® overencapsulated capsules daily in the morning after breakfast.
|
2: Budesonide-MMX® 9 mg
One budesonide-MMX® 9 mg plus three placebo Entocort EC® overencapsulated capsules daily in the morning after breakfast.
|
3: Entocort EC® 3 mg
Three Entocort EC® 3 mg overencapsulated capsules plus one placebo budesonide MMX® tablet daily in the morning after breakfast.
|
4: Placebo
Three placebo Entocort EC® overencapsulated capsules plus one placebo Budesonide MMX® tablet daily in the morning after breakfast.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
109
|
109
|
103
|
89
|
|
Overall Study
COMPLETED
|
67
|
76
|
68
|
61
|
|
Overall Study
NOT COMPLETED
|
42
|
33
|
35
|
28
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
(CB-01-02/02) Randomized Placebo Controlled Trial of Budesonide-multi-matrix System (MMX™) 6 mg and 9 mg in Patients With Ulcerative Colitis
Baseline characteristics by cohort
| Measure |
1: Budesonide-MMX® 6 mg
n=109 Participants
One budesonide-MMX® 6 mg plus three placebo Entocort EC® overencapsulated capsules daily in the morning after breakfast.
|
2: Budesonide-MMX® 9 mg
n=109 Participants
One budesonide-MMX® 9 mg plus three placebo Entocort EC® overencapsulated capsules daily in the morning after breakfast.
|
3: Entocort EC® 3 mg
n=103 Participants
Three Entocort EC® 3 mg overencapsulated capsules plus one placebo budesonide MMX® tablet daily in the morning after breakfast.
|
4: Placebo
n=89 Participants
Three placebo Entocort EC® overencapsulated capsules plus one placebo Budesonide MMX® tablet daily in the morning after breakfast.
|
Total
n=410 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
102 Participants
n=5 Participants
|
107 Participants
n=7 Participants
|
97 Participants
n=5 Participants
|
82 Participants
n=4 Participants
|
388 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
7 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
22 Participants
n=21 Participants
|
|
Age, Continuous
|
43.6 years
STANDARD_DEVIATION 13.6 • n=5 Participants
|
42.8 years
STANDARD_DEVIATION 13.9 • n=7 Participants
|
43.4 years
STANDARD_DEVIATION 14.0 • n=5 Participants
|
44.8 years
STANDARD_DEVIATION 13.0 • n=4 Participants
|
43.6 years
STANDARD_DEVIATION 13.6 • n=21 Participants
|
|
Sex: Female, Male
Female
|
52 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
32 Participants
n=4 Participants
|
177 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
57 Participants
n=5 Participants
|
64 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
57 Participants
n=4 Participants
|
233 Participants
n=21 Participants
|
|
Region of Enrollment
Estonia
|
11 participants
n=5 Participants
|
6 participants
n=7 Participants
|
6 participants
n=5 Participants
|
5 participants
n=4 Participants
|
28 participants
n=21 Participants
|
|
Region of Enrollment
Slovakia
|
10 participants
n=5 Participants
|
5 participants
n=7 Participants
|
5 participants
n=5 Participants
|
7 participants
n=4 Participants
|
27 participants
n=21 Participants
|
|
Region of Enrollment
Ukraine
|
7 participants
n=5 Participants
|
6 participants
n=7 Participants
|
7 participants
n=5 Participants
|
5 participants
n=4 Participants
|
25 participants
n=21 Participants
|
|
Region of Enrollment
Lithuania
|
19 participants
n=5 Participants
|
17 participants
n=7 Participants
|
11 participants
n=5 Participants
|
12 participants
n=4 Participants
|
59 participants
n=21 Participants
|
|
Region of Enrollment
Russian Federation
|
24 participants
n=5 Participants
|
35 participants
n=7 Participants
|
34 participants
n=5 Participants
|
28 participants
n=4 Participants
|
121 participants
n=21 Participants
|
|
Region of Enrollment
United Kingdom
|
2 participants
n=5 Participants
|
4 participants
n=7 Participants
|
3 participants
n=5 Participants
|
0 participants
n=4 Participants
|
9 participants
n=21 Participants
|
|
Region of Enrollment
Italy
|
18 participants
n=5 Participants
|
12 participants
n=7 Participants
|
18 participants
n=5 Participants
|
13 participants
n=4 Participants
|
61 participants
n=21 Participants
|
|
Region of Enrollment
France
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
1 participants
n=4 Participants
|
3 participants
n=21 Participants
|
|
Region of Enrollment
Poland
|
7 participants
n=5 Participants
|
14 participants
n=7 Participants
|
13 participants
n=5 Participants
|
9 participants
n=4 Participants
|
43 participants
n=21 Participants
|
|
Region of Enrollment
Belgium
|
2 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
2 participants
n=21 Participants
|
|
Region of Enrollment
Romania
|
2 participants
n=5 Participants
|
5 participants
n=7 Participants
|
1 participants
n=5 Participants
|
3 participants
n=4 Participants
|
11 participants
n=21 Participants
|
|
Region of Enrollment
Australia
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
3 participants
n=5 Participants
|
2 participants
n=4 Participants
|
7 participants
n=21 Participants
|
|
Region of Enrollment
Latvia
|
2 participants
n=5 Participants
|
2 participants
n=7 Participants
|
0 participants
n=5 Participants
|
2 participants
n=4 Participants
|
6 participants
n=21 Participants
|
|
Region of Enrollment
Sweden
|
3 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
2 participants
n=4 Participants
|
6 participants
n=21 Participants
|
|
Region of Enrollment
Israel
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
0 participants
n=4 Participants
|
2 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 8 weeksPopulation: Efficacy endpoints were analyzed with the ITT population, defined as randomized patients who received study drug, had no entry criteria/GCP violation, and had abnormal mucosal histology at baseline. ITT population=410 patients: 511 - 101 patients who were not randomized, had entry criteria/GCP violation, or had normal histology at baseline.
Clinical and endoscopic remission defined as an Ulcerative Colitis Disease Activity Index (UCDAI) score ≤ 1, with subscores of 0 for rectal bleeding, stool frequency, and mucosal appearance and with a ≥ 1 point reduction in the endoscopic index score.
Outcome measures
| Measure |
1: Budesonide-MMX® 6 mg
n=109 Participants
One budesonide-MMX® 6 mg plus three placebo Entocort EC® overencapsulated capsules daily in the morning after breakfast.
|
2: Budesonide-MMX® 9 mg
n=109 Participants
One budesonide-MMX® 9 mg plus three placebo Entocort EC® overencapsulated capsules daily in the morning after breakfast.
|
3: Entocort EC® 3 mg
n=103 Participants
Three Entocort EC® 3 mg overencapsulated capsules plus one placebo budesonide MMX® tablet daily in the morning after breakfast.
|
4: Placebo
n=89 Participants
Three placebo Entocort EC® overencapsulated capsules plus one placebo Budesonide MMX® tablet daily in the morning after breakfast.
|
|---|---|---|---|---|
|
Clinical and Endoscopic Remission.
|
8.3 percentage of patients
Interval 3.1 to 13.4
|
17.4 percentage of patients
Interval 10.3 to 24.6
|
12.6 percentage of patients
Interval 6.2 to 19.0
|
4.5 percentage of patients
Interval 0.2 to 8.8
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: Efficacy endpoints were analyzed with the ITT population, defined as randomized patients who received study drug, had no entry criteria/GCP violation, and had abnormal mucosal histology at baseline. ITT population=410 patients: 511 - 101 patients who were not randomized, had entry criteria/GCP violation, or had normal histology at baseline.
Clinical improvement, defined as a ≥ 3-point improvement in UCDAI from baseline to the end of Week 8.
Outcome measures
| Measure |
1: Budesonide-MMX® 6 mg
n=109 Participants
One budesonide-MMX® 6 mg plus three placebo Entocort EC® overencapsulated capsules daily in the morning after breakfast.
|
2: Budesonide-MMX® 9 mg
n=109 Participants
One budesonide-MMX® 9 mg plus three placebo Entocort EC® overencapsulated capsules daily in the morning after breakfast.
|
3: Entocort EC® 3 mg
n=103 Participants
Three Entocort EC® 3 mg overencapsulated capsules plus one placebo budesonide MMX® tablet daily in the morning after breakfast.
|
4: Placebo
n=89 Participants
Three placebo Entocort EC® overencapsulated capsules plus one placebo Budesonide MMX® tablet daily in the morning after breakfast.
|
|---|---|---|---|---|
|
Clinical Improvement.
|
25.7 percentage of patients
Interval 17.5 to 33.9
|
42.2 percentage of patients
Interval 32.9 to 51.5
|
33.0 percentage of patients
Interval 23.9 to 42.1
|
33.7 percentage of patients
Interval 23.9 to 43.5
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: Efficacy endpoints were analyzed with the ITT population, defined as randomized patients who received study drug, had no entry criteria/GCP violation, and had abnormal mucosal histology at baseline. ITT population=410 patients: 511 - 101 patients who were not randomized, had entry criteria/GCP violation, or had normal histology at baseline.
Greater or equal to a 1 point improvement in the mucosal appearance subscore of the UCDAI, from baseline to week 8. As per the hierarchical testing procedure for secondary endpoints, because clinical improvement was not statistically significant in the ITT population, formal statistical comparisons for endoscopic improvement between the 2 budesonide MMX groups and placebo were not conducted.
Outcome measures
| Measure |
1: Budesonide-MMX® 6 mg
n=109 Participants
One budesonide-MMX® 6 mg plus three placebo Entocort EC® overencapsulated capsules daily in the morning after breakfast.
|
2: Budesonide-MMX® 9 mg
n=109 Participants
One budesonide-MMX® 9 mg plus three placebo Entocort EC® overencapsulated capsules daily in the morning after breakfast.
|
3: Entocort EC® 3 mg
n=103 Participants
Three Entocort EC® 3 mg overencapsulated capsules plus one placebo budesonide MMX® tablet daily in the morning after breakfast.
|
4: Placebo
n=89 Participants
Three placebo Entocort EC® overencapsulated capsules plus one placebo Budesonide MMX® tablet daily in the morning after breakfast.
|
|---|---|---|---|---|
|
Endoscopic Improvement.
|
25.7 percentage of patients
Interval 17.5 to 33.9
|
42.2 percentage of patients
Interval 32.9 to 51.5
|
36.9 percentage of patients
Interval 27.6 to 46.2
|
31.5 percentage of patients
Interval 21.8 to 41.1
|
Adverse Events
1: Budesonide-MMX® 6 mg
Serious events: 3 serious events
Other events: 77 other events
Deaths: 0 deaths
2: Budesonide-MMX® 9 mg
Serious events: 4 serious events
Other events: 67 other events
Deaths: 0 deaths
3: Entocort EC® 3 mg
Serious events: 1 serious events
Other events: 68 other events
Deaths: 0 deaths
4: Placebo
Serious events: 5 serious events
Other events: 52 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
1: Budesonide-MMX® 6 mg
n=128 participants at risk
One budesonide-MMX® 6 mg plus three placebo Entocort EC® overencapsulated capsules daily in the morning after breakfast.
|
2: Budesonide-MMX® 9 mg
n=128 participants at risk
One budesonide-MMX® 9 mg plus three placebo Entocort EC® overencapsulated capsules daily in the morning after breakfast.
|
3: Entocort EC® 3 mg
n=126 participants at risk
Three Entocort EC® 3 mg overencapsulated capsules plus one placebo budesonide MMX® tablet daily in the morning after breakfast.
|
4: Placebo
n=129 participants at risk
Three placebo Entocort EC® overencapsulated capsules plus one placebo Budesonide MMX® tablet daily in the morning after breakfast.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Colitis ulcerative
|
0.78%
1/128 • Number of events 1 • 56 day ± 2 day (study duration) + 30 day safety followup period.
Adverse event data were analyzed using the safety population, defined as all patients who received study drug. N= 511 for the safety population: 509 randomized and treated + 2 nonrandomized and treated patients.
|
0.78%
1/128 • Number of events 1 • 56 day ± 2 day (study duration) + 30 day safety followup period.
Adverse event data were analyzed using the safety population, defined as all patients who received study drug. N= 511 for the safety population: 509 randomized and treated + 2 nonrandomized and treated patients.
|
0.79%
1/126 • Number of events 1 • 56 day ± 2 day (study duration) + 30 day safety followup period.
Adverse event data were analyzed using the safety population, defined as all patients who received study drug. N= 511 for the safety population: 509 randomized and treated + 2 nonrandomized and treated patients.
|
2.3%
3/129 • Number of events 3 • 56 day ± 2 day (study duration) + 30 day safety followup period.
Adverse event data were analyzed using the safety population, defined as all patients who received study drug. N= 511 for the safety population: 509 randomized and treated + 2 nonrandomized and treated patients.
|
|
Gastrointestinal disorders
Enterocolitis
|
0.00%
0/128 • 56 day ± 2 day (study duration) + 30 day safety followup period.
Adverse event data were analyzed using the safety population, defined as all patients who received study drug. N= 511 for the safety population: 509 randomized and treated + 2 nonrandomized and treated patients.
|
0.78%
1/128 • Number of events 1 • 56 day ± 2 day (study duration) + 30 day safety followup period.
Adverse event data were analyzed using the safety population, defined as all patients who received study drug. N= 511 for the safety population: 509 randomized and treated + 2 nonrandomized and treated patients.
|
0.00%
0/126 • 56 day ± 2 day (study duration) + 30 day safety followup period.
Adverse event data were analyzed using the safety population, defined as all patients who received study drug. N= 511 for the safety population: 509 randomized and treated + 2 nonrandomized and treated patients.
|
0.00%
0/129 • 56 day ± 2 day (study duration) + 30 day safety followup period.
Adverse event data were analyzed using the safety population, defined as all patients who received study drug. N= 511 for the safety population: 509 randomized and treated + 2 nonrandomized and treated patients.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/128 • 56 day ± 2 day (study duration) + 30 day safety followup period.
Adverse event data were analyzed using the safety population, defined as all patients who received study drug. N= 511 for the safety population: 509 randomized and treated + 2 nonrandomized and treated patients.
|
0.00%
0/128 • 56 day ± 2 day (study duration) + 30 day safety followup period.
Adverse event data were analyzed using the safety population, defined as all patients who received study drug. N= 511 for the safety population: 509 randomized and treated + 2 nonrandomized and treated patients.
|
0.79%
1/126 • Number of events 1 • 56 day ± 2 day (study duration) + 30 day safety followup period.
Adverse event data were analyzed using the safety population, defined as all patients who received study drug. N= 511 for the safety population: 509 randomized and treated + 2 nonrandomized and treated patients.
|
0.00%
0/129 • 56 day ± 2 day (study duration) + 30 day safety followup period.
Adverse event data were analyzed using the safety population, defined as all patients who received study drug. N= 511 for the safety population: 509 randomized and treated + 2 nonrandomized and treated patients.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/128 • 56 day ± 2 day (study duration) + 30 day safety followup period.
Adverse event data were analyzed using the safety population, defined as all patients who received study drug. N= 511 for the safety population: 509 randomized and treated + 2 nonrandomized and treated patients.
|
0.78%
1/128 • Number of events 1 • 56 day ± 2 day (study duration) + 30 day safety followup period.
Adverse event data were analyzed using the safety population, defined as all patients who received study drug. N= 511 for the safety population: 509 randomized and treated + 2 nonrandomized and treated patients.
|
0.00%
0/126 • 56 day ± 2 day (study duration) + 30 day safety followup period.
Adverse event data were analyzed using the safety population, defined as all patients who received study drug. N= 511 for the safety population: 509 randomized and treated + 2 nonrandomized and treated patients.
|
0.00%
0/129 • 56 day ± 2 day (study duration) + 30 day safety followup period.
Adverse event data were analyzed using the safety population, defined as all patients who received study drug. N= 511 for the safety population: 509 randomized and treated + 2 nonrandomized and treated patients.
|
|
General disorders
Treatment failure
|
1.6%
2/128 • Number of events 2 • 56 day ± 2 day (study duration) + 30 day safety followup period.
Adverse event data were analyzed using the safety population, defined as all patients who received study drug. N= 511 for the safety population: 509 randomized and treated + 2 nonrandomized and treated patients.
|
0.00%
0/128 • 56 day ± 2 day (study duration) + 30 day safety followup period.
Adverse event data were analyzed using the safety population, defined as all patients who received study drug. N= 511 for the safety population: 509 randomized and treated + 2 nonrandomized and treated patients.
|
0.00%
0/126 • 56 day ± 2 day (study duration) + 30 day safety followup period.
Adverse event data were analyzed using the safety population, defined as all patients who received study drug. N= 511 for the safety population: 509 randomized and treated + 2 nonrandomized and treated patients.
|
0.00%
0/129 • 56 day ± 2 day (study duration) + 30 day safety followup period.
Adverse event data were analyzed using the safety population, defined as all patients who received study drug. N= 511 for the safety population: 509 randomized and treated + 2 nonrandomized and treated patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.78%
1/128 • Number of events 1 • 56 day ± 2 day (study duration) + 30 day safety followup period.
Adverse event data were analyzed using the safety population, defined as all patients who received study drug. N= 511 for the safety population: 509 randomized and treated + 2 nonrandomized and treated patients.
|
0.00%
0/128 • 56 day ± 2 day (study duration) + 30 day safety followup period.
Adverse event data were analyzed using the safety population, defined as all patients who received study drug. N= 511 for the safety population: 509 randomized and treated + 2 nonrandomized and treated patients.
|
0.00%
0/126 • 56 day ± 2 day (study duration) + 30 day safety followup period.
Adverse event data were analyzed using the safety population, defined as all patients who received study drug. N= 511 for the safety population: 509 randomized and treated + 2 nonrandomized and treated patients.
|
0.00%
0/129 • 56 day ± 2 day (study duration) + 30 day safety followup period.
Adverse event data were analyzed using the safety population, defined as all patients who received study drug. N= 511 for the safety population: 509 randomized and treated + 2 nonrandomized and treated patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Signet-ring cell carcinoma
|
0.00%
0/128 • 56 day ± 2 day (study duration) + 30 day safety followup period.
Adverse event data were analyzed using the safety population, defined as all patients who received study drug. N= 511 for the safety population: 509 randomized and treated + 2 nonrandomized and treated patients.
|
0.00%
0/128 • 56 day ± 2 day (study duration) + 30 day safety followup period.
Adverse event data were analyzed using the safety population, defined as all patients who received study drug. N= 511 for the safety population: 509 randomized and treated + 2 nonrandomized and treated patients.
|
0.00%
0/126 • 56 day ± 2 day (study duration) + 30 day safety followup period.
Adverse event data were analyzed using the safety population, defined as all patients who received study drug. N= 511 for the safety population: 509 randomized and treated + 2 nonrandomized and treated patients.
|
0.78%
1/129 • Number of events 1 • 56 day ± 2 day (study duration) + 30 day safety followup period.
Adverse event data were analyzed using the safety population, defined as all patients who received study drug. N= 511 for the safety population: 509 randomized and treated + 2 nonrandomized and treated patients.
|
|
Psychiatric disorders
Personality disorder
|
0.00%
0/128 • 56 day ± 2 day (study duration) + 30 day safety followup period.
Adverse event data were analyzed using the safety population, defined as all patients who received study drug. N= 511 for the safety population: 509 randomized and treated + 2 nonrandomized and treated patients.
|
0.00%
0/128 • 56 day ± 2 day (study duration) + 30 day safety followup period.
Adverse event data were analyzed using the safety population, defined as all patients who received study drug. N= 511 for the safety population: 509 randomized and treated + 2 nonrandomized and treated patients.
|
0.00%
0/126 • 56 day ± 2 day (study duration) + 30 day safety followup period.
Adverse event data were analyzed using the safety population, defined as all patients who received study drug. N= 511 for the safety population: 509 randomized and treated + 2 nonrandomized and treated patients.
|
0.78%
1/129 • Number of events 1 • 56 day ± 2 day (study duration) + 30 day safety followup period.
Adverse event data were analyzed using the safety population, defined as all patients who received study drug. N= 511 for the safety population: 509 randomized and treated + 2 nonrandomized and treated patients.
|
|
Renal and urinary disorders
Urge incontinence
|
0.00%
0/128 • 56 day ± 2 day (study duration) + 30 day safety followup period.
Adverse event data were analyzed using the safety population, defined as all patients who received study drug. N= 511 for the safety population: 509 randomized and treated + 2 nonrandomized and treated patients.
|
0.78%
1/128 • Number of events 1 • 56 day ± 2 day (study duration) + 30 day safety followup period.
Adverse event data were analyzed using the safety population, defined as all patients who received study drug. N= 511 for the safety population: 509 randomized and treated + 2 nonrandomized and treated patients.
|
0.00%
0/126 • 56 day ± 2 day (study duration) + 30 day safety followup period.
Adverse event data were analyzed using the safety population, defined as all patients who received study drug. N= 511 for the safety population: 509 randomized and treated + 2 nonrandomized and treated patients.
|
0.00%
0/129 • 56 day ± 2 day (study duration) + 30 day safety followup period.
Adverse event data were analyzed using the safety population, defined as all patients who received study drug. N= 511 for the safety population: 509 randomized and treated + 2 nonrandomized and treated patients.
|
Other adverse events
| Measure |
1: Budesonide-MMX® 6 mg
n=128 participants at risk
One budesonide-MMX® 6 mg plus three placebo Entocort EC® overencapsulated capsules daily in the morning after breakfast.
|
2: Budesonide-MMX® 9 mg
n=128 participants at risk
One budesonide-MMX® 9 mg plus three placebo Entocort EC® overencapsulated capsules daily in the morning after breakfast.
|
3: Entocort EC® 3 mg
n=126 participants at risk
Three Entocort EC® 3 mg overencapsulated capsules plus one placebo budesonide MMX® tablet daily in the morning after breakfast.
|
4: Placebo
n=129 participants at risk
Three placebo Entocort EC® overencapsulated capsules plus one placebo Budesonide MMX® tablet daily in the morning after breakfast.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
3.9%
5/128 • Number of events 5 • 56 day ± 2 day (study duration) + 30 day safety followup period.
Adverse event data were analyzed using the safety population, defined as all patients who received study drug. N= 511 for the safety population: 509 randomized and treated + 2 nonrandomized and treated patients.
|
2.3%
3/128 • Number of events 3 • 56 day ± 2 day (study duration) + 30 day safety followup period.
Adverse event data were analyzed using the safety population, defined as all patients who received study drug. N= 511 for the safety population: 509 randomized and treated + 2 nonrandomized and treated patients.
|
0.00%
0/126 • 56 day ± 2 day (study duration) + 30 day safety followup period.
Adverse event data were analyzed using the safety population, defined as all patients who received study drug. N= 511 for the safety population: 509 randomized and treated + 2 nonrandomized and treated patients.
|
0.78%
1/129 • Number of events 1 • 56 day ± 2 day (study duration) + 30 day safety followup period.
Adverse event data were analyzed using the safety population, defined as all patients who received study drug. N= 511 for the safety population: 509 randomized and treated + 2 nonrandomized and treated patients.
|
|
Endocrine disorders
Cushingoid
|
1.6%
2/128 • Number of events 2 • 56 day ± 2 day (study duration) + 30 day safety followup period.
Adverse event data were analyzed using the safety population, defined as all patients who received study drug. N= 511 for the safety population: 509 randomized and treated + 2 nonrandomized and treated patients.
|
0.78%
1/128 • Number of events 1 • 56 day ± 2 day (study duration) + 30 day safety followup period.
Adverse event data were analyzed using the safety population, defined as all patients who received study drug. N= 511 for the safety population: 509 randomized and treated + 2 nonrandomized and treated patients.
|
1.6%
2/126 • Number of events 2 • 56 day ± 2 day (study duration) + 30 day safety followup period.
Adverse event data were analyzed using the safety population, defined as all patients who received study drug. N= 511 for the safety population: 509 randomized and treated + 2 nonrandomized and treated patients.
|
3.9%
5/129 • Number of events 5 • 56 day ± 2 day (study duration) + 30 day safety followup period.
Adverse event data were analyzed using the safety population, defined as all patients who received study drug. N= 511 for the safety population: 509 randomized and treated + 2 nonrandomized and treated patients.
|
|
Gastrointestinal disorders
Abdominal pain
|
2.3%
3/128 • Number of events 5 • 56 day ± 2 day (study duration) + 30 day safety followup period.
Adverse event data were analyzed using the safety population, defined as all patients who received study drug. N= 511 for the safety population: 509 randomized and treated + 2 nonrandomized and treated patients.
|
3.9%
5/128 • Number of events 6 • 56 day ± 2 day (study duration) + 30 day safety followup period.
Adverse event data were analyzed using the safety population, defined as all patients who received study drug. N= 511 for the safety population: 509 randomized and treated + 2 nonrandomized and treated patients.
|
5.6%
7/126 • Number of events 14 • 56 day ± 2 day (study duration) + 30 day safety followup period.
Adverse event data were analyzed using the safety population, defined as all patients who received study drug. N= 511 for the safety population: 509 randomized and treated + 2 nonrandomized and treated patients.
|
5.4%
7/129 • Number of events 7 • 56 day ± 2 day (study duration) + 30 day safety followup period.
Adverse event data were analyzed using the safety population, defined as all patients who received study drug. N= 511 for the safety population: 509 randomized and treated + 2 nonrandomized and treated patients.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
3.9%
5/128 • Number of events 9 • 56 day ± 2 day (study duration) + 30 day safety followup period.
Adverse event data were analyzed using the safety population, defined as all patients who received study drug. N= 511 for the safety population: 509 randomized and treated + 2 nonrandomized and treated patients.
|
2.3%
3/128 • Number of events 3 • 56 day ± 2 day (study duration) + 30 day safety followup period.
Adverse event data were analyzed using the safety population, defined as all patients who received study drug. N= 511 for the safety population: 509 randomized and treated + 2 nonrandomized and treated patients.
|
1.6%
2/126 • Number of events 2 • 56 day ± 2 day (study duration) + 30 day safety followup period.
Adverse event data were analyzed using the safety population, defined as all patients who received study drug. N= 511 for the safety population: 509 randomized and treated + 2 nonrandomized and treated patients.
|
2.3%
3/129 • Number of events 3 • 56 day ± 2 day (study duration) + 30 day safety followup period.
Adverse event data were analyzed using the safety population, defined as all patients who received study drug. N= 511 for the safety population: 509 randomized and treated + 2 nonrandomized and treated patients.
|
|
Gastrointestinal disorders
Colitis ulcerative
|
15.6%
20/128 • Number of events 20 • 56 day ± 2 day (study duration) + 30 day safety followup period.
Adverse event data were analyzed using the safety population, defined as all patients who received study drug. N= 511 for the safety population: 509 randomized and treated + 2 nonrandomized and treated patients.
|
20.3%
26/128 • Number of events 26 • 56 day ± 2 day (study duration) + 30 day safety followup period.
Adverse event data were analyzed using the safety population, defined as all patients who received study drug. N= 511 for the safety population: 509 randomized and treated + 2 nonrandomized and treated patients.
|
11.9%
15/126 • Number of events 15 • 56 day ± 2 day (study duration) + 30 day safety followup period.
Adverse event data were analyzed using the safety population, defined as all patients who received study drug. N= 511 for the safety population: 509 randomized and treated + 2 nonrandomized and treated patients.
|
10.9%
14/129 • Number of events 14 • 56 day ± 2 day (study duration) + 30 day safety followup period.
Adverse event data were analyzed using the safety population, defined as all patients who received study drug. N= 511 for the safety population: 509 randomized and treated + 2 nonrandomized and treated patients.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.78%
1/128 • Number of events 1 • 56 day ± 2 day (study duration) + 30 day safety followup period.
Adverse event data were analyzed using the safety population, defined as all patients who received study drug. N= 511 for the safety population: 509 randomized and treated + 2 nonrandomized and treated patients.
|
1.6%
2/128 • Number of events 3 • 56 day ± 2 day (study duration) + 30 day safety followup period.
Adverse event data were analyzed using the safety population, defined as all patients who received study drug. N= 511 for the safety population: 509 randomized and treated + 2 nonrandomized and treated patients.
|
3.2%
4/126 • Number of events 4 • 56 day ± 2 day (study duration) + 30 day safety followup period.
Adverse event data were analyzed using the safety population, defined as all patients who received study drug. N= 511 for the safety population: 509 randomized and treated + 2 nonrandomized and treated patients.
|
3.1%
4/129 • Number of events 7 • 56 day ± 2 day (study duration) + 30 day safety followup period.
Adverse event data were analyzed using the safety population, defined as all patients who received study drug. N= 511 for the safety population: 509 randomized and treated + 2 nonrandomized and treated patients.
|
|
Gastrointestinal disorders
Flatulence
|
3.9%
5/128 • Number of events 7 • 56 day ± 2 day (study duration) + 30 day safety followup period.
Adverse event data were analyzed using the safety population, defined as all patients who received study drug. N= 511 for the safety population: 509 randomized and treated + 2 nonrandomized and treated patients.
|
5.5%
7/128 • Number of events 18 • 56 day ± 2 day (study duration) + 30 day safety followup period.
Adverse event data were analyzed using the safety population, defined as all patients who received study drug. N= 511 for the safety population: 509 randomized and treated + 2 nonrandomized and treated patients.
|
5.6%
7/126 • Number of events 16 • 56 day ± 2 day (study duration) + 30 day safety followup period.
Adverse event data were analyzed using the safety population, defined as all patients who received study drug. N= 511 for the safety population: 509 randomized and treated + 2 nonrandomized and treated patients.
|
2.3%
3/129 • Number of events 3 • 56 day ± 2 day (study duration) + 30 day safety followup period.
Adverse event data were analyzed using the safety population, defined as all patients who received study drug. N= 511 for the safety population: 509 randomized and treated + 2 nonrandomized and treated patients.
|
|
Gastrointestinal disorders
Nausea
|
6.2%
8/128 • Number of events 10 • 56 day ± 2 day (study duration) + 30 day safety followup period.
Adverse event data were analyzed using the safety population, defined as all patients who received study drug. N= 511 for the safety population: 509 randomized and treated + 2 nonrandomized and treated patients.
|
4.7%
6/128 • Number of events 8 • 56 day ± 2 day (study duration) + 30 day safety followup period.
Adverse event data were analyzed using the safety population, defined as all patients who received study drug. N= 511 for the safety population: 509 randomized and treated + 2 nonrandomized and treated patients.
|
2.4%
3/126 • Number of events 7 • 56 day ± 2 day (study duration) + 30 day safety followup period.
Adverse event data were analyzed using the safety population, defined as all patients who received study drug. N= 511 for the safety population: 509 randomized and treated + 2 nonrandomized and treated patients.
|
2.3%
3/129 • Number of events 3 • 56 day ± 2 day (study duration) + 30 day safety followup period.
Adverse event data were analyzed using the safety population, defined as all patients who received study drug. N= 511 for the safety population: 509 randomized and treated + 2 nonrandomized and treated patients.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/128 • 56 day ± 2 day (study duration) + 30 day safety followup period.
Adverse event data were analyzed using the safety population, defined as all patients who received study drug. N= 511 for the safety population: 509 randomized and treated + 2 nonrandomized and treated patients.
|
3.1%
4/128 • Number of events 5 • 56 day ± 2 day (study duration) + 30 day safety followup period.
Adverse event data were analyzed using the safety population, defined as all patients who received study drug. N= 511 for the safety population: 509 randomized and treated + 2 nonrandomized and treated patients.
|
0.79%
1/126 • Number of events 1 • 56 day ± 2 day (study duration) + 30 day safety followup period.
Adverse event data were analyzed using the safety population, defined as all patients who received study drug. N= 511 for the safety population: 509 randomized and treated + 2 nonrandomized and treated patients.
|
1.6%
2/129 • Number of events 2 • 56 day ± 2 day (study duration) + 30 day safety followup period.
Adverse event data were analyzed using the safety population, defined as all patients who received study drug. N= 511 for the safety population: 509 randomized and treated + 2 nonrandomized and treated patients.
|
|
General disorders
Treatment failure
|
2.3%
3/128 • Number of events 3 • 56 day ± 2 day (study duration) + 30 day safety followup period.
Adverse event data were analyzed using the safety population, defined as all patients who received study drug. N= 511 for the safety population: 509 randomized and treated + 2 nonrandomized and treated patients.
|
1.6%
2/128 • Number of events 2 • 56 day ± 2 day (study duration) + 30 day safety followup period.
Adverse event data were analyzed using the safety population, defined as all patients who received study drug. N= 511 for the safety population: 509 randomized and treated + 2 nonrandomized and treated patients.
|
2.4%
3/126 • Number of events 3 • 56 day ± 2 day (study duration) + 30 day safety followup period.
Adverse event data were analyzed using the safety population, defined as all patients who received study drug. N= 511 for the safety population: 509 randomized and treated + 2 nonrandomized and treated patients.
|
1.6%
2/129 • Number of events 2 • 56 day ± 2 day (study duration) + 30 day safety followup period.
Adverse event data were analyzed using the safety population, defined as all patients who received study drug. N= 511 for the safety population: 509 randomized and treated + 2 nonrandomized and treated patients.
|
|
Infections and infestations
Nasopharyngitis
|
0.78%
1/128 • Number of events 1 • 56 day ± 2 day (study duration) + 30 day safety followup period.
Adverse event data were analyzed using the safety population, defined as all patients who received study drug. N= 511 for the safety population: 509 randomized and treated + 2 nonrandomized and treated patients.
|
6.2%
8/128 • Number of events 9 • 56 day ± 2 day (study duration) + 30 day safety followup period.
Adverse event data were analyzed using the safety population, defined as all patients who received study drug. N= 511 for the safety population: 509 randomized and treated + 2 nonrandomized and treated patients.
|
4.8%
6/126 • Number of events 7 • 56 day ± 2 day (study duration) + 30 day safety followup period.
Adverse event data were analyzed using the safety population, defined as all patients who received study drug. N= 511 for the safety population: 509 randomized and treated + 2 nonrandomized and treated patients.
|
1.6%
2/129 • Number of events 2 • 56 day ± 2 day (study duration) + 30 day safety followup period.
Adverse event data were analyzed using the safety population, defined as all patients who received study drug. N= 511 for the safety population: 509 randomized and treated + 2 nonrandomized and treated patients.
|
|
Infections and infestations
Respiratory tract infection viral
|
0.00%
0/128 • 56 day ± 2 day (study duration) + 30 day safety followup period.
Adverse event data were analyzed using the safety population, defined as all patients who received study drug. N= 511 for the safety population: 509 randomized and treated + 2 nonrandomized and treated patients.
|
0.00%
0/128 • 56 day ± 2 day (study duration) + 30 day safety followup period.
Adverse event data were analyzed using the safety population, defined as all patients who received study drug. N= 511 for the safety population: 509 randomized and treated + 2 nonrandomized and treated patients.
|
0.00%
0/126 • 56 day ± 2 day (study duration) + 30 day safety followup period.
Adverse event data were analyzed using the safety population, defined as all patients who received study drug. N= 511 for the safety population: 509 randomized and treated + 2 nonrandomized and treated patients.
|
2.3%
3/129 • Number of events 3 • 56 day ± 2 day (study duration) + 30 day safety followup period.
Adverse event data were analyzed using the safety population, defined as all patients who received study drug. N= 511 for the safety population: 509 randomized and treated + 2 nonrandomized and treated patients.
|
|
Investigations
Blood cortisol decreased
|
5.5%
7/128 • Number of events 7 • 56 day ± 2 day (study duration) + 30 day safety followup period.
Adverse event data were analyzed using the safety population, defined as all patients who received study drug. N= 511 for the safety population: 509 randomized and treated + 2 nonrandomized and treated patients.
|
2.3%
3/128 • Number of events 3 • 56 day ± 2 day (study duration) + 30 day safety followup period.
Adverse event data were analyzed using the safety population, defined as all patients who received study drug. N= 511 for the safety population: 509 randomized and treated + 2 nonrandomized and treated patients.
|
3.2%
4/126 • Number of events 4 • 56 day ± 2 day (study duration) + 30 day safety followup period.
Adverse event data were analyzed using the safety population, defined as all patients who received study drug. N= 511 for the safety population: 509 randomized and treated + 2 nonrandomized and treated patients.
|
0.78%
1/129 • Number of events 1 • 56 day ± 2 day (study duration) + 30 day safety followup period.
Adverse event data were analyzed using the safety population, defined as all patients who received study drug. N= 511 for the safety population: 509 randomized and treated + 2 nonrandomized and treated patients.
|
|
Investigations
C-reactive protein increased
|
0.78%
1/128 • Number of events 1 • 56 day ± 2 day (study duration) + 30 day safety followup period.
Adverse event data were analyzed using the safety population, defined as all patients who received study drug. N= 511 for the safety population: 509 randomized and treated + 2 nonrandomized and treated patients.
|
2.3%
3/128 • Number of events 3 • 56 day ± 2 day (study duration) + 30 day safety followup period.
Adverse event data were analyzed using the safety population, defined as all patients who received study drug. N= 511 for the safety population: 509 randomized and treated + 2 nonrandomized and treated patients.
|
0.79%
1/126 • Number of events 1 • 56 day ± 2 day (study duration) + 30 day safety followup period.
Adverse event data were analyzed using the safety population, defined as all patients who received study drug. N= 511 for the safety population: 509 randomized and treated + 2 nonrandomized and treated patients.
|
1.6%
2/129 • Number of events 2 • 56 day ± 2 day (study duration) + 30 day safety followup period.
Adverse event data were analyzed using the safety population, defined as all patients who received study drug. N= 511 for the safety population: 509 randomized and treated + 2 nonrandomized and treated patients.
|
|
Investigations
Red blood cell sedimentation rate increased
|
0.78%
1/128 • Number of events 1 • 56 day ± 2 day (study duration) + 30 day safety followup period.
Adverse event data were analyzed using the safety population, defined as all patients who received study drug. N= 511 for the safety population: 509 randomized and treated + 2 nonrandomized and treated patients.
|
0.00%
0/128 • 56 day ± 2 day (study duration) + 30 day safety followup period.
Adverse event data were analyzed using the safety population, defined as all patients who received study drug. N= 511 for the safety population: 509 randomized and treated + 2 nonrandomized and treated patients.
|
0.00%
0/126 • 56 day ± 2 day (study duration) + 30 day safety followup period.
Adverse event data were analyzed using the safety population, defined as all patients who received study drug. N= 511 for the safety population: 509 randomized and treated + 2 nonrandomized and treated patients.
|
2.3%
3/129 • Number of events 3 • 56 day ± 2 day (study duration) + 30 day safety followup period.
Adverse event data were analyzed using the safety population, defined as all patients who received study drug. N= 511 for the safety population: 509 randomized and treated + 2 nonrandomized and treated patients.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.6%
2/128 • Number of events 2 • 56 day ± 2 day (study duration) + 30 day safety followup period.
Adverse event data were analyzed using the safety population, defined as all patients who received study drug. N= 511 for the safety population: 509 randomized and treated + 2 nonrandomized and treated patients.
|
3.1%
4/128 • Number of events 4 • 56 day ± 2 day (study duration) + 30 day safety followup period.
Adverse event data were analyzed using the safety population, defined as all patients who received study drug. N= 511 for the safety population: 509 randomized and treated + 2 nonrandomized and treated patients.
|
0.00%
0/126 • 56 day ± 2 day (study duration) + 30 day safety followup period.
Adverse event data were analyzed using the safety population, defined as all patients who received study drug. N= 511 for the safety population: 509 randomized and treated + 2 nonrandomized and treated patients.
|
1.6%
2/129 • Number of events 3 • 56 day ± 2 day (study duration) + 30 day safety followup period.
Adverse event data were analyzed using the safety population, defined as all patients who received study drug. N= 511 for the safety population: 509 randomized and treated + 2 nonrandomized and treated patients.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.78%
1/128 • Number of events 3 • 56 day ± 2 day (study duration) + 30 day safety followup period.
Adverse event data were analyzed using the safety population, defined as all patients who received study drug. N= 511 for the safety population: 509 randomized and treated + 2 nonrandomized and treated patients.
|
3.1%
4/128 • Number of events 8 • 56 day ± 2 day (study duration) + 30 day safety followup period.
Adverse event data were analyzed using the safety population, defined as all patients who received study drug. N= 511 for the safety population: 509 randomized and treated + 2 nonrandomized and treated patients.
|
2.4%
3/126 • Number of events 7 • 56 day ± 2 day (study duration) + 30 day safety followup period.
Adverse event data were analyzed using the safety population, defined as all patients who received study drug. N= 511 for the safety population: 509 randomized and treated + 2 nonrandomized and treated patients.
|
0.78%
1/129 • Number of events 1 • 56 day ± 2 day (study duration) + 30 day safety followup period.
Adverse event data were analyzed using the safety population, defined as all patients who received study drug. N= 511 for the safety population: 509 randomized and treated + 2 nonrandomized and treated patients.
|
|
Nervous system disorders
Headache
|
16.4%
21/128 • Number of events 30 • 56 day ± 2 day (study duration) + 30 day safety followup period.
Adverse event data were analyzed using the safety population, defined as all patients who received study drug. N= 511 for the safety population: 509 randomized and treated + 2 nonrandomized and treated patients.
|
15.6%
20/128 • Number of events 35 • 56 day ± 2 day (study duration) + 30 day safety followup period.
Adverse event data were analyzed using the safety population, defined as all patients who received study drug. N= 511 for the safety population: 509 randomized and treated + 2 nonrandomized and treated patients.
|
7.1%
9/126 • Number of events 15 • 56 day ± 2 day (study duration) + 30 day safety followup period.
Adverse event data were analyzed using the safety population, defined as all patients who received study drug. N= 511 for the safety population: 509 randomized and treated + 2 nonrandomized and treated patients.
|
6.2%
8/129 • Number of events 11 • 56 day ± 2 day (study duration) + 30 day safety followup period.
Adverse event data were analyzed using the safety population, defined as all patients who received study drug. N= 511 for the safety population: 509 randomized and treated + 2 nonrandomized and treated patients.
|
|
Psychiatric disorders
Insomnia
|
1.6%
2/128 • Number of events 2 • 56 day ± 2 day (study duration) + 30 day safety followup period.
Adverse event data were analyzed using the safety population, defined as all patients who received study drug. N= 511 for the safety population: 509 randomized and treated + 2 nonrandomized and treated patients.
|
2.3%
3/128 • Number of events 3 • 56 day ± 2 day (study duration) + 30 day safety followup period.
Adverse event data were analyzed using the safety population, defined as all patients who received study drug. N= 511 for the safety population: 509 randomized and treated + 2 nonrandomized and treated patients.
|
3.2%
4/126 • Number of events 4 • 56 day ± 2 day (study duration) + 30 day safety followup period.
Adverse event data were analyzed using the safety population, defined as all patients who received study drug. N= 511 for the safety population: 509 randomized and treated + 2 nonrandomized and treated patients.
|
2.3%
3/129 • Number of events 4 • 56 day ± 2 day (study duration) + 30 day safety followup period.
Adverse event data were analyzed using the safety population, defined as all patients who received study drug. N= 511 for the safety population: 509 randomized and treated + 2 nonrandomized and treated patients.
|
|
Psychiatric disorders
Mood altered
|
1.6%
2/128 • Number of events 2 • 56 day ± 2 day (study duration) + 30 day safety followup period.
Adverse event data were analyzed using the safety population, defined as all patients who received study drug. N= 511 for the safety population: 509 randomized and treated + 2 nonrandomized and treated patients.
|
0.00%
0/128 • 56 day ± 2 day (study duration) + 30 day safety followup period.
Adverse event data were analyzed using the safety population, defined as all patients who received study drug. N= 511 for the safety population: 509 randomized and treated + 2 nonrandomized and treated patients.
|
3.2%
4/126 • Number of events 4 • 56 day ± 2 day (study duration) + 30 day safety followup period.
Adverse event data were analyzed using the safety population, defined as all patients who received study drug. N= 511 for the safety population: 509 randomized and treated + 2 nonrandomized and treated patients.
|
1.6%
2/129 • Number of events 2 • 56 day ± 2 day (study duration) + 30 day safety followup period.
Adverse event data were analyzed using the safety population, defined as all patients who received study drug. N= 511 for the safety population: 509 randomized and treated + 2 nonrandomized and treated patients.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
2.3%
3/128 • Number of events 4 • 56 day ± 2 day (study duration) + 30 day safety followup period.
Adverse event data were analyzed using the safety population, defined as all patients who received study drug. N= 511 for the safety population: 509 randomized and treated + 2 nonrandomized and treated patients.
|
1.6%
2/128 • Number of events 2 • 56 day ± 2 day (study duration) + 30 day safety followup period.
Adverse event data were analyzed using the safety population, defined as all patients who received study drug. N= 511 for the safety population: 509 randomized and treated + 2 nonrandomized and treated patients.
|
2.4%
3/126 • Number of events 3 • 56 day ± 2 day (study duration) + 30 day safety followup period.
Adverse event data were analyzed using the safety population, defined as all patients who received study drug. N= 511 for the safety population: 509 randomized and treated + 2 nonrandomized and treated patients.
|
0.78%
1/129 • Number of events 1 • 56 day ± 2 day (study duration) + 30 day safety followup period.
Adverse event data were analyzed using the safety population, defined as all patients who received study drug. N= 511 for the safety population: 509 randomized and treated + 2 nonrandomized and treated patients.
|
|
Skin and subcutaneous tissue disorders
Acne
|
1.6%
2/128 • Number of events 2 • 56 day ± 2 day (study duration) + 30 day safety followup period.
Adverse event data were analyzed using the safety population, defined as all patients who received study drug. N= 511 for the safety population: 509 randomized and treated + 2 nonrandomized and treated patients.
|
0.78%
1/128 • Number of events 2 • 56 day ± 2 day (study duration) + 30 day safety followup period.
Adverse event data were analyzed using the safety population, defined as all patients who received study drug. N= 511 for the safety population: 509 randomized and treated + 2 nonrandomized and treated patients.
|
2.4%
3/126 • Number of events 3 • 56 day ± 2 day (study duration) + 30 day safety followup period.
Adverse event data were analyzed using the safety population, defined as all patients who received study drug. N= 511 for the safety population: 509 randomized and treated + 2 nonrandomized and treated patients.
|
2.3%
3/129 • Number of events 3 • 56 day ± 2 day (study duration) + 30 day safety followup period.
Adverse event data were analyzed using the safety population, defined as all patients who received study drug. N= 511 for the safety population: 509 randomized and treated + 2 nonrandomized and treated patients.
|
Additional Information
Michael Huang, M.D., Senior Medical Director
Santarus, Inc.
Phone: 858-314-5700
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place