Trial Outcomes & Findings for (CB-01-02/01) Randomized Placebo Controlled Trial of Budesonide-multi-matrix System (MMX™) 6 mg and 9 mg in Patients With Ulcerative Colitis (NCT NCT00679432)
NCT ID: NCT00679432
Last Updated: 2019-12-10
Results Overview
Clinical and endoscopic remission defined as a 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
510 participants
Primary outcome timeframe
8 weeks
Results posted on
2019-12-10
Participant Flow
Recruited from August 2008 until May 2010.
Diary data for symptoms will be collected prior to randomization. Lab testing and a colonoscopy will be done prior to randomization. 510 patients were randomized. One patient was not treated and was not included in baseline characteristics, efficacy, and safety analyses. 509 patients received study drug and were included in safety analyses.
Participant milestones
| Measure |
1: Budesonide-MMX® 6 mg
One budesonide-MMX® 6 mg plus two placebo Asacol® overencapsulated tablets daily in the morning after breakfast and two placebo Asacol® overencapsulated tablets daily after the mid-day meal and the evening meal for eight weeks.
budesonide-MMX® 6 mg : 6 mg/day, 6 mg tablets
Blood sampling, endoscopy : Blood sampling for hematology and biochemistry and endoscopy with biopsy for histological and endoscopic assessment scores
|
2: Budesonide-MMX® 9 mg
One budesonide-MMX® 9 mg plus two placebo Asacol® overencapsulated tablets daily in the morning after breakfast and two placebo Asacol® overencapsulated tablets daily after the mid-day meal and the evening meal for eight weeks.
Blood sampling, endoscopy : Blood sampling for hematology and biochemistry and endoscopy with biopsy for histological and endoscopic assessment scores
budesonide-MMX® 9 mg : 9 mg/day, 9 mg tablets
|
3: Placebo
Two placebo Asacol® overencapsulated tablets plus one placebo Budesonide MMX® tablet daily in the morning after breakfast and two placebo Asacol® overencapsulated tablets daily after the mid-day meal and the evening meal for eight weeks.
Placebo : Placebo
Blood sampling, endoscopy : Blood sampling for hematology and biochemistry and endoscopy with biopsy for histological and endoscopic assessment scores
|
4: Asacol® 400 mg
Two Asacol® 400 mg overencapsulated tablets plus one placebo budesonide MMX® tablet daily in the morning after breakfast and two Asacol® 400 mg overencapsulated tablets daily after the mid-day meal and the evening meal for eight weeks.
Asacol® 400 mg : 2400 mg/day, 400 mg tablets
Blood sampling, endoscopy : Blood sampling for hematology and biochemistry and endoscopy with biopsy for histological and endoscopic assessment scores
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
126
|
127
|
129
|
127
|
|
Overall Study
COMPLETED
|
89
|
89
|
76
|
95
|
|
Overall Study
NOT COMPLETED
|
37
|
38
|
53
|
32
|
Reasons for withdrawal
| Measure |
1: Budesonide-MMX® 6 mg
One budesonide-MMX® 6 mg plus two placebo Asacol® overencapsulated tablets daily in the morning after breakfast and two placebo Asacol® overencapsulated tablets daily after the mid-day meal and the evening meal for eight weeks.
budesonide-MMX® 6 mg : 6 mg/day, 6 mg tablets
Blood sampling, endoscopy : Blood sampling for hematology and biochemistry and endoscopy with biopsy for histological and endoscopic assessment scores
|
2: Budesonide-MMX® 9 mg
One budesonide-MMX® 9 mg plus two placebo Asacol® overencapsulated tablets daily in the morning after breakfast and two placebo Asacol® overencapsulated tablets daily after the mid-day meal and the evening meal for eight weeks.
Blood sampling, endoscopy : Blood sampling for hematology and biochemistry and endoscopy with biopsy for histological and endoscopic assessment scores
budesonide-MMX® 9 mg : 9 mg/day, 9 mg tablets
|
3: Placebo
Two placebo Asacol® overencapsulated tablets plus one placebo Budesonide MMX® tablet daily in the morning after breakfast and two placebo Asacol® overencapsulated tablets daily after the mid-day meal and the evening meal for eight weeks.
Placebo : Placebo
Blood sampling, endoscopy : Blood sampling for hematology and biochemistry and endoscopy with biopsy for histological and endoscopic assessment scores
|
4: Asacol® 400 mg
Two Asacol® 400 mg overencapsulated tablets plus one placebo budesonide MMX® tablet daily in the morning after breakfast and two Asacol® 400 mg overencapsulated tablets daily after the mid-day meal and the evening meal for eight weeks.
Asacol® 400 mg : 2400 mg/day, 400 mg tablets
Blood sampling, endoscopy : Blood sampling for hematology and biochemistry and endoscopy with biopsy for histological and endoscopic assessment scores
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
5
|
6
|
10
|
7
|
|
Overall Study
Protocol Violation
|
1
|
1
|
2
|
1
|
|
Overall Study
Withdrawal by Subject
|
8
|
11
|
10
|
9
|
|
Overall Study
Lost to Follow-up
|
1
|
5
|
4
|
2
|
|
Overall Study
Physician Decision
|
3
|
2
|
2
|
2
|
|
Overall Study
Sponsor decision
|
1
|
0
|
0
|
0
|
|
Overall Study
Lack of Efficacy
|
13
|
9
|
14
|
8
|
|
Overall Study
Infectious colitis, normal histology
|
5
|
4
|
8
|
3
|
|
Overall Study
Randomization error, return to prior Rx
|
0
|
0
|
3
|
0
|
Baseline Characteristics
(CB-01-02/01) 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=121 Participants
One budesonide-MMX® 6 mg plus two placebo Asacol® overencapsulated tablets daily in the morning after breakfast and two placebo Asacol® overencapsulated tablets daily after the mid-day meal and the evening meal for eight weeks.
budesonide-MMX® 6 mg : 6 mg/day, 6 mg tablets
Blood sampling, endoscopy : Blood sampling for hematology and biochemistry and endoscopy with biopsy for histological and endoscopic assessment scores
|
2: Budesonide-MMX® 9 mg
n=123 Participants
One budesonide-MMX® 9 mg plus two placebo Asacol® overencapsulated tablets daily in the morning after breakfast and two placebo Asacol® overencapsulated tablets daily after the mid-day meal and the evening meal for eight weeks.
Blood sampling, endoscopy : Blood sampling for hematology and biochemistry and endoscopy with biopsy for histological and endoscopic assessment scores
budesonide-MMX® 9 mg : 9 mg/day, 9 mg tablets
|
3: Placebo
n=121 Participants
Two placebo Asacol® overencapsulated tablets plus one placebo Budesonide MMX® tablet daily in the morning after breakfast and two placebo Asacol® overencapsulated tablets daily after the mid-day meal and the evening meal for eight weeks.
Placebo : Placebo
Blood sampling, endoscopy : Blood sampling for hematology and biochemistry and endoscopy with biopsy for histological and endoscopic assessment scores
|
4: Asacol® 400 mg
n=124 Participants
Two Asacol® 400 mg overencapsulated tablets plus one placebo budesonide MMX® tablet daily in the morning after breakfast and two Asacol® 400 mg overencapsulated tablets daily after the mid-day meal and the evening meal for eight weeks.
Asacol® 400 mg : 2400 mg/day, 400 mg tablets
Blood sampling, endoscopy : Blood sampling for hematology and biochemistry and endoscopy with biopsy for histological and endoscopic assessment scores
|
Total
n=489 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
|
117 Participants
n=5 Participants
|
122 Participants
n=7 Participants
|
115 Participants
n=5 Participants
|
118 Participants
n=4 Participants
|
472 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
17 Participants
n=21 Participants
|
|
Age, Continuous
|
43.2 years
STANDARD_DEVIATION 13 • n=5 Participants
|
41.7 years
STANDARD_DEVIATION 12.2 • n=7 Participants
|
41.7 years
STANDARD_DEVIATION 13.6 • n=5 Participants
|
44 years
STANDARD_DEVIATION 12.4 • n=4 Participants
|
42.7 years
STANDARD_DEVIATION 12.8 • n=21 Participants
|
|
Sex: Female, Male
Female
|
62 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
55 Participants
n=4 Participants
|
216 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
59 Participants
n=5 Participants
|
77 Participants
n=7 Participants
|
68 Participants
n=5 Participants
|
69 Participants
n=4 Participants
|
273 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
75 participants
n=5 Participants
|
76 participants
n=7 Participants
|
77 participants
n=5 Participants
|
76 participants
n=4 Participants
|
304 participants
n=21 Participants
|
|
Region of Enrollment
Canada
|
5 participants
n=5 Participants
|
7 participants
n=7 Participants
|
5 participants
n=5 Participants
|
6 participants
n=4 Participants
|
23 participants
n=21 Participants
|
|
Region of Enrollment
India
|
41 participants
n=5 Participants
|
40 participants
n=7 Participants
|
39 participants
n=5 Participants
|
42 participants
n=4 Participants
|
162 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 8 weeksPopulation: Intent-to-Treat (ITT) population= primary population for efficacy/baseline characteristics analyses. ITT population= randomized patients who received study drug, and did not include patients with major entry criteria/GCP violations or normal histology at baseline (N= 509 randomized - 3\[infectious colitis\] - 17\[normal histology at baseline\] = 489).
Clinical and endoscopic remission defined as a 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=121 Participants
One budesonide-MMX® 6 mg plus two placebo Asacol® overencapsulated tablets daily in the morning after breakfast and two placebo Asacol® overencapsulated tablets daily after the mid-day meal and the evening meal for eight weeks.
budesonide-MMX® 6 mg : 6 mg/day, 6 mg tablets
Blood sampling, endoscopy : Blood sampling for hematology and biochemistry and endoscopy with biopsy for histological and endoscopic assessment scores
|
2: Budesonide-MMX® 9 mg
n=123 Participants
One budesonide-MMX® 9 mg plus two placebo Asacol® overencapsulated tablets daily in the morning after breakfast and two placebo Asacol® overencapsulated tablets daily after the mid-day meal and the evening meal for eight weeks.
Blood sampling, endoscopy : Blood sampling for hematology and biochemistry and endoscopy with biopsy for histological and endoscopic assessment scores
budesonide-MMX® 9 mg : 9 mg/day, 9 mg tablets
|
3: Placebo
n=121 Participants
Two placebo Asacol® overencapsulated tablets plus one placebo Budesonide MMX® tablet daily in the morning after breakfast and two placebo Asacol® overencapsulated tablets daily after the mid-day meal and the evening meal for eight weeks.
Placebo : Placebo
Blood sampling, endoscopy : Blood sampling for hematology and biochemistry and endoscopy with biopsy for histological and endoscopic assessment scores
|
4: Asacol® 400 mg
n=124 Participants
Two Asacol® 400 mg overencapsulated tablets plus one placebo budesonide MMX® tablet daily in the morning after breakfast and two Asacol® 400 mg overencapsulated tablets daily after the mid-day meal and the evening meal for eight weeks.
Asacol® 400 mg : 2400 mg/day, 400 mg tablets
Blood sampling, endoscopy : Blood sampling for hematology and biochemistry and endoscopy with biopsy for histological and endoscopic assessment scores
|
|---|---|---|---|---|
|
Clinical and Endoscopic Remission.
|
13.2 percentage of patients
Interval 7.2 to 19.3
|
17.9 percentage of patients
Interval 11.1 to 24.7
|
7.4 percentage of patients
Interval 2.8 to 12.1
|
12.1 percentage of patients
Interval 6.4 to 17.8
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: Intent-to-Treat (ITT) population= primary population for efficacy/baseline characteristics analyses. ITT population= randomized patients who received study drug, and did not include patients with major entry criteria/GCP violations or normal histology at baseline (N= 509 randomized - 3\[infectious colitis\] - 17\[normal histology at baseline\] = 489).
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=121 Participants
One budesonide-MMX® 6 mg plus two placebo Asacol® overencapsulated tablets daily in the morning after breakfast and two placebo Asacol® overencapsulated tablets daily after the mid-day meal and the evening meal for eight weeks.
budesonide-MMX® 6 mg : 6 mg/day, 6 mg tablets
Blood sampling, endoscopy : Blood sampling for hematology and biochemistry and endoscopy with biopsy for histological and endoscopic assessment scores
|
2: Budesonide-MMX® 9 mg
n=123 Participants
One budesonide-MMX® 9 mg plus two placebo Asacol® overencapsulated tablets daily in the morning after breakfast and two placebo Asacol® overencapsulated tablets daily after the mid-day meal and the evening meal for eight weeks.
Blood sampling, endoscopy : Blood sampling for hematology and biochemistry and endoscopy with biopsy for histological and endoscopic assessment scores
budesonide-MMX® 9 mg : 9 mg/day, 9 mg tablets
|
3: Placebo
n=121 Participants
Two placebo Asacol® overencapsulated tablets plus one placebo Budesonide MMX® tablet daily in the morning after breakfast and two placebo Asacol® overencapsulated tablets daily after the mid-day meal and the evening meal for eight weeks.
Placebo : Placebo
Blood sampling, endoscopy : Blood sampling for hematology and biochemistry and endoscopy with biopsy for histological and endoscopic assessment scores
|
4: Asacol® 400 mg
n=124 Participants
Two Asacol® 400 mg overencapsulated tablets plus one placebo budesonide MMX® tablet daily in the morning after breakfast and two Asacol® 400 mg overencapsulated tablets daily after the mid-day meal and the evening meal for eight weeks.
Asacol® 400 mg : 2400 mg/day, 400 mg tablets
Blood sampling, endoscopy : Blood sampling for hematology and biochemistry and endoscopy with biopsy for histological and endoscopic assessment scores
|
|---|---|---|---|---|
|
Clinical Improvement.
|
30.6 percentage of patients
Interval 22.4 to 38.8
|
33.3 percentage of patients
Interval 25.0 to 41.7
|
24.8 percentage of patients
Interval 17.1 to 32.5
|
33.9 percentage of patients
Interval 25.5 to 42.2
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: Intent-to-Treat (ITT) population= primary population for efficacy/baseline characteristics analyses. ITT population= randomized patients who received study drug, and did not include patients with major entry criteria/GCP violations or normal histology at baseline (N= 509 randomized - 3\[infectious colitis\] - 17\[normal histology at baseline\] = 489).
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=121 Participants
One budesonide-MMX® 6 mg plus two placebo Asacol® overencapsulated tablets daily in the morning after breakfast and two placebo Asacol® overencapsulated tablets daily after the mid-day meal and the evening meal for eight weeks.
budesonide-MMX® 6 mg : 6 mg/day, 6 mg tablets
Blood sampling, endoscopy : Blood sampling for hematology and biochemistry and endoscopy with biopsy for histological and endoscopic assessment scores
|
2: Budesonide-MMX® 9 mg
n=123 Participants
One budesonide-MMX® 9 mg plus two placebo Asacol® overencapsulated tablets daily in the morning after breakfast and two placebo Asacol® overencapsulated tablets daily after the mid-day meal and the evening meal for eight weeks.
Blood sampling, endoscopy : Blood sampling for hematology and biochemistry and endoscopy with biopsy for histological and endoscopic assessment scores
budesonide-MMX® 9 mg : 9 mg/day, 9 mg tablets
|
3: Placebo
n=121 Participants
Two placebo Asacol® overencapsulated tablets plus one placebo Budesonide MMX® tablet daily in the morning after breakfast and two placebo Asacol® overencapsulated tablets daily after the mid-day meal and the evening meal for eight weeks.
Placebo : Placebo
Blood sampling, endoscopy : Blood sampling for hematology and biochemistry and endoscopy with biopsy for histological and endoscopic assessment scores
|
4: Asacol® 400 mg
n=124 Participants
Two Asacol® 400 mg overencapsulated tablets plus one placebo budesonide MMX® tablet daily in the morning after breakfast and two Asacol® 400 mg overencapsulated tablets daily after the mid-day meal and the evening meal for eight weeks.
Asacol® 400 mg : 2400 mg/day, 400 mg tablets
Blood sampling, endoscopy : Blood sampling for hematology and biochemistry and endoscopy with biopsy for histological and endoscopic assessment scores
|
|---|---|---|---|---|
|
Endoscopic Improvement
|
35.5 percentage of patients
Interval 27.0 to 44.1
|
41.5 percentage of patients
Interval 32.8 to 50.2
|
33.1 percentage of patients
Interval 24.7 to 41.4
|
33.1 percentage of patients
Interval 24.8 to 41.3
|
Adverse Events
1: Budesonide-MMX® 6 mg
Serious events: 2 serious events
Other events: 35 other events
Deaths: 0 deaths
2: Budesonide-MMX® 9 mg
Serious events: 3 serious events
Other events: 36 other events
Deaths: 0 deaths
3: Placebo
Serious events: 3 serious events
Other events: 34 other events
Deaths: 0 deaths
4: Asacol® 400 mg
Serious events: 4 serious events
Other events: 31 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
1: Budesonide-MMX® 6 mg
n=126 participants at risk
One budesonide-MMX® 6 mg plus two placebo Asacol® overencapsulated tablets daily in the morning after breakfast and two placebo Asacol® overencapsulated tablets daily after the mid-day meal and the evening meal for eight weeks.
budesonide-MMX® 6 mg : 6 mg/day, 6 mg tablets
Blood sampling, endoscopy : Blood sampling for hematology and biochemistry and endoscopy with biopsy for histological and endoscopic assessment scores
|
2: Budesonide-MMX® 9 mg
n=127 participants at risk
One budesonide-MMX® 9 mg plus two placebo Asacol® overencapsulated tablets daily in the morning after breakfast and two placebo Asacol® overencapsulated tablets daily after the mid-day meal and the evening meal for eight weeks.
Blood sampling, endoscopy : Blood sampling for hematology and biochemistry and endoscopy with biopsy for histological and endoscopic assessment scores
budesonide-MMX® 9 mg : 9 mg/day, 9 mg tablets
|
3: Placebo
n=129 participants at risk
Two placebo Asacol® overencapsulated tablets plus one placebo Budesonide MMX® tablet daily in the morning after breakfast and two placebo Asacol® overencapsulated tablets daily after the mid-day meal and the evening meal for eight weeks.
Placebo : Placebo
Blood sampling, endoscopy : Blood sampling for hematology and biochemistry and endoscopy with biopsy for histological and endoscopic assessment scores
|
4: Asacol® 400 mg
n=127 participants at risk
Two Asacol® 400 mg overencapsulated tablets plus one placebo budesonide MMX® tablet daily in the morning after breakfast and two Asacol® 400 mg overencapsulated tablets daily after the mid-day meal and the evening meal for eight weeks.
Asacol® 400 mg : 2400 mg/day, 400 mg tablets
Blood sampling, endoscopy : Blood sampling for hematology and biochemistry and endoscopy with biopsy for histological and endoscopic assessment scores
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Colitis ulcerative
|
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. 509 patients received study drug and were included in safety analyses.
|
2.4%
3/127 • 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. 509 patients received study drug and were included in safety analyses.
|
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. 509 patients received study drug and were included in safety analyses.
|
0.79%
1/127 • 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. 509 patients received study drug and were included in safety analyses.
|
|
Gastrointestinal disorders
Diarrhoea
|
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. 509 patients received study drug and were included in safety analyses.
|
0.79%
1/127 • 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. 509 patients received study drug and were included in safety analyses.
|
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. 509 patients received study drug and were included in safety analyses.
|
0.00%
0/127 • 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. 509 patients received study drug and were included in safety analyses.
|
|
Gastrointestinal disorders
Large intestine perforation
|
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. 509 patients received study drug and were included in safety analyses.
|
0.79%
1/127 • 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. 509 patients received study drug and were included in safety analyses.
|
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. 509 patients received study drug and were included in safety analyses.
|
0.00%
0/127 • 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. 509 patients received study drug and were included in safety analyses.
|
|
Gastrointestinal disorders
Pancreatitis
|
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. 509 patients received study drug and were included in safety analyses.
|
0.00%
0/127 • 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. 509 patients received study drug and were included in safety analyses.
|
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. 509 patients received study drug and were included in safety analyses.
|
0.79%
1/127 • 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. 509 patients received study drug and were included in safety analyses.
|
|
Infections and infestations
Pelvic abscess
|
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. 509 patients received study drug and were included in safety analyses.
|
0.00%
0/127 • 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. 509 patients received study drug and were included in safety analyses.
|
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. 509 patients received study drug and were included in safety analyses.
|
0.00%
0/127 • 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. 509 patients received study drug and were included in safety analyses.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma
|
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. 509 patients received study drug and were included in safety analyses.
|
0.00%
0/127 • 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. 509 patients received study drug and were included in safety analyses.
|
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. 509 patients received study drug and were included in safety analyses.
|
0.79%
1/127 • 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. 509 patients received study drug and were included in safety analyses.
|
|
Nervous system disorders
Cerebrovascular accident
|
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. 509 patients received study drug and were included in safety analyses.
|
0.00%
0/127 • 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. 509 patients received study drug and were included in safety analyses.
|
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. 509 patients received study drug and were included in safety analyses.
|
0.00%
0/127 • 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. 509 patients received study drug and were included in safety analyses.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
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. 509 patients received study drug and were included in safety analyses.
|
0.79%
1/127 • 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. 509 patients received study drug and were included in safety analyses.
|
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. 509 patients received study drug and were included in safety analyses.
|
0.00%
0/127 • 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. 509 patients received study drug and were included in safety analyses.
|
|
Skin and subcutaneous tissue disorders
Pyoderma gangrenosum
|
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. 509 patients received study drug and were included in safety analyses.
|
0.00%
0/127 • 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. 509 patients received study drug and were included in safety analyses.
|
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. 509 patients received study drug and were included in safety analyses.
|
0.79%
1/127 • 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. 509 patients received study drug and were included in safety analyses.
|
|
Vascular disorders
Deep vein thrombosis
|
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. 509 patients received study drug and were included in safety analyses.
|
0.00%
0/127 • 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. 509 patients received study drug and were included in safety analyses.
|
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. 509 patients received study drug and were included in safety analyses.
|
0.00%
0/127 • 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. 509 patients received study drug and were included in safety analyses.
|
Other adverse events
| Measure |
1: Budesonide-MMX® 6 mg
n=126 participants at risk
One budesonide-MMX® 6 mg plus two placebo Asacol® overencapsulated tablets daily in the morning after breakfast and two placebo Asacol® overencapsulated tablets daily after the mid-day meal and the evening meal for eight weeks.
budesonide-MMX® 6 mg : 6 mg/day, 6 mg tablets
Blood sampling, endoscopy : Blood sampling for hematology and biochemistry and endoscopy with biopsy for histological and endoscopic assessment scores
|
2: Budesonide-MMX® 9 mg
n=127 participants at risk
One budesonide-MMX® 9 mg plus two placebo Asacol® overencapsulated tablets daily in the morning after breakfast and two placebo Asacol® overencapsulated tablets daily after the mid-day meal and the evening meal for eight weeks.
Blood sampling, endoscopy : Blood sampling for hematology and biochemistry and endoscopy with biopsy for histological and endoscopic assessment scores
budesonide-MMX® 9 mg : 9 mg/day, 9 mg tablets
|
3: Placebo
n=129 participants at risk
Two placebo Asacol® overencapsulated tablets plus one placebo Budesonide MMX® tablet daily in the morning after breakfast and two placebo Asacol® overencapsulated tablets daily after the mid-day meal and the evening meal for eight weeks.
Placebo : Placebo
Blood sampling, endoscopy : Blood sampling for hematology and biochemistry and endoscopy with biopsy for histological and endoscopic assessment scores
|
4: Asacol® 400 mg
n=127 participants at risk
Two Asacol® 400 mg overencapsulated tablets plus one placebo budesonide MMX® tablet daily in the morning after breakfast and two Asacol® 400 mg overencapsulated tablets daily after the mid-day meal and the evening meal for eight weeks.
Asacol® 400 mg : 2400 mg/day, 400 mg tablets
Blood sampling, endoscopy : Blood sampling for hematology and biochemistry and endoscopy with biopsy for histological and endoscopic assessment scores
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
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. 509 patients received study drug and were included in safety analyses.
|
0.00%
0/127 • 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. 509 patients received study drug and were included in safety analyses.
|
3.1%
4/129 • 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. 509 patients received study drug and were included in safety analyses.
|
1.6%
2/127 • 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. 509 patients received study drug and were included in safety analyses.
|
|
Gastrointestinal disorders
Abdominal distension
|
1.6%
2/126 • 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. 509 patients received study drug and were included in safety analyses.
|
3.1%
4/127 • 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. 509 patients received study drug and were included in safety analyses.
|
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. 509 patients received study drug and were included in safety analyses.
|
3.1%
4/127 • 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. 509 patients received study drug and were included in safety analyses.
|
|
Gastrointestinal disorders
Abdominal pain
|
1.6%
2/126 • 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. 509 patients received study drug and were included in safety analyses.
|
4.7%
6/127 • 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. 509 patients received study drug and were included in safety analyses.
|
6.2%
8/129 • 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. 509 patients received study drug and were included in safety analyses.
|
7.9%
10/127 • 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. 509 patients received study drug and were included in safety analyses.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
4.0%
5/126 • 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. 509 patients received study drug and were included in safety analyses.
|
3.9%
5/127 • 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. 509 patients received study drug and were included in safety analyses.
|
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. 509 patients received study drug and were included in safety analyses.
|
1.6%
2/127 • 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. 509 patients received study drug and were included in safety analyses.
|
|
Gastrointestinal disorders
Abdominal tenderness
|
2.4%
3/126 • 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. 509 patients received study drug and were included in safety analyses.
|
0.79%
1/127 • 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. 509 patients received study drug and were included in safety analyses.
|
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. 509 patients received study drug and were included in safety analyses.
|
2.4%
3/127 • 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. 509 patients received study drug and were included in safety analyses.
|
|
Gastrointestinal disorders
Colitis ulcerative
|
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. 509 patients received study drug and were included in safety analyses.
|
9.4%
12/127 • Number of events 12 • 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. 509 patients received study drug and were included in safety analyses.
|
15.5%
20/129 • 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. 509 patients received study drug and were included in safety analyses.
|
9.4%
12/127 • Number of events 12 • 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. 509 patients received study drug and were included in safety analyses.
|
|
Gastrointestinal disorders
Diarrhoea
|
4.0%
5/126 • 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. 509 patients received study drug and were included in safety analyses.
|
0.79%
1/127 • 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. 509 patients received study drug and were included in safety analyses.
|
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. 509 patients received study drug and were included in safety analyses.
|
6.3%
8/127 • 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. 509 patients received study drug and were included in safety analyses.
|
|
Gastrointestinal disorders
Dyspepsia
|
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. 509 patients received study drug and were included in safety analyses.
|
0.79%
1/127 • 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. 509 patients received study drug and were included in safety analyses.
|
3.1%
4/129 • 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. 509 patients received study drug and were included in safety analyses.
|
3.9%
5/127 • 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. 509 patients received study drug and were included in safety analyses.
|
|
Gastrointestinal disorders
Flatulence
|
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. 509 patients received study drug and were included in safety analyses.
|
0.79%
1/127 • 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. 509 patients received study drug and were included in safety analyses.
|
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. 509 patients received study drug and were included in safety analyses.
|
5.5%
7/127 • 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. 509 patients received study drug and were included in safety analyses.
|
|
Gastrointestinal disorders
Frequent bowel movements
|
1.6%
2/126 • 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. 509 patients received study drug and were included in safety analyses.
|
0.79%
1/127 • 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. 509 patients received study drug and were included in safety analyses.
|
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. 509 patients received study drug and were included in safety analyses.
|
3.1%
4/127 • 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. 509 patients received study drug and were included in safety analyses.
|
|
Gastrointestinal disorders
Nausea
|
4.0%
5/126 • 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. 509 patients received study drug and were included in safety analyses.
|
3.9%
5/127 • 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. 509 patients received study drug and were included in safety analyses.
|
6.2%
8/129 • 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. 509 patients received study drug and were included in safety analyses.
|
7.9%
10/127 • 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. 509 patients received study drug and were included in safety analyses.
|
|
Gastrointestinal disorders
Vomiting
|
4.0%
5/126 • 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. 509 patients received study drug and were included in safety analyses.
|
0.00%
0/127 • 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. 509 patients received study drug and were included in safety analyses.
|
3.1%
4/129 • 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. 509 patients received study drug and were included in safety analyses.
|
2.4%
3/127 • 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. 509 patients received study drug and were included in safety analyses.
|
|
General disorders
Asthenia
|
3.2%
4/126 • 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. 509 patients received study drug and were included in safety analyses.
|
0.00%
0/127 • 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. 509 patients received study drug and were included in safety analyses.
|
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. 509 patients received study drug and were included in safety analyses.
|
0.79%
1/127 • 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. 509 patients received study drug and were included in safety analyses.
|
|
General disorders
Fatigue
|
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. 509 patients received study drug and were included in safety analyses.
|
3.9%
5/127 • 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. 509 patients received study drug and were included in safety analyses.
|
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. 509 patients received study drug and were included in safety analyses.
|
0.00%
0/127 • 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. 509 patients received study drug and were included in safety analyses.
|
|
General disorders
Pyrexia
|
4.0%
5/126 • 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. 509 patients received study drug and were included in safety analyses.
|
2.4%
3/127 • 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. 509 patients received study drug and were included in safety analyses.
|
7.0%
9/129 • 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. 509 patients received study drug and were included in safety analyses.
|
2.4%
3/127 • 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. 509 patients received study drug and were included in safety analyses.
|
|
Infections and infestations
Influenza
|
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. 509 patients received study drug and were included in safety analyses.
|
0.00%
0/127 • 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. 509 patients received study drug and were included in safety analyses.
|
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. 509 patients received study drug and were included in safety analyses.
|
0.79%
1/127 • 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. 509 patients received study drug and were included in safety analyses.
|
|
Infections and infestations
Nasopharyngitis
|
4.0%
5/126 • 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. 509 patients received study drug and were included in safety analyses.
|
2.4%
3/127 • 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. 509 patients received study drug and were included in safety analyses.
|
3.1%
4/129 • 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. 509 patients received study drug and were included in safety analyses.
|
2.4%
3/127 • 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. 509 patients received study drug and were included in safety analyses.
|
|
Infections and infestations
Upper respiratory tract infection
|
4.0%
5/126 • 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. 509 patients received study drug and were included in safety analyses.
|
1.6%
2/127 • 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. 509 patients received study drug and were included in safety analyses.
|
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. 509 patients received study drug and were included in safety analyses.
|
0.79%
1/127 • 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. 509 patients received study drug and were included in safety analyses.
|
|
Infections and infestations
Urinary tract infection
|
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. 509 patients received study drug and were included in safety analyses.
|
3.9%
5/127 • 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. 509 patients received study drug and were included in safety analyses.
|
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. 509 patients received study drug and were included in safety analyses.
|
2.4%
3/127 • 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. 509 patients received study drug and were included in safety analyses.
|
|
Investigations
Alanine aminotransferase increased
|
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. 509 patients received study drug and were included in safety analyses.
|
0.00%
0/127 • 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. 509 patients received study drug and were included in safety analyses.
|
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. 509 patients received study drug and were included in safety analyses.
|
2.4%
3/127 • 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. 509 patients received study drug and were included in safety analyses.
|
|
Investigations
Blood cortisol decreased
|
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. 509 patients received study drug and were included in safety analyses.
|
3.1%
4/127 • 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. 509 patients received study drug and were included in safety analyses.
|
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. 509 patients received study drug and were included in safety analyses.
|
0.00%
0/127 • 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. 509 patients received study drug and were included in safety analyses.
|
|
Investigations
Blood urine present
|
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. 509 patients received study drug and were included in safety analyses.
|
0.00%
0/127 • 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. 509 patients received study drug and were included in safety analyses.
|
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. 509 patients received study drug and were included in safety analyses.
|
2.4%
3/127 • 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. 509 patients received study drug and were included in safety analyses.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
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. 509 patients received study drug and were included in safety analyses.
|
2.4%
3/127 • 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. 509 patients received study drug and were included in safety analyses.
|
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. 509 patients received study drug and were included in safety analyses.
|
3.1%
4/127 • 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. 509 patients received study drug and were included in safety analyses.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
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. 509 patients received study drug and were included in safety analyses.
|
3.9%
5/127 • 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. 509 patients received study drug and were included in safety analyses.
|
5.4%
7/129 • 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. 509 patients received study drug and were included in safety analyses.
|
1.6%
2/127 • 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. 509 patients received study drug and were included in safety analyses.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
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. 509 patients received study drug and were included in safety analyses.
|
0.00%
0/127 • 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. 509 patients received study drug and were included in safety analyses.
|
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. 509 patients received study drug and were included in safety analyses.
|
2.4%
3/127 • 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. 509 patients received study drug and were included in safety analyses.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
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. 509 patients received study drug and were included in safety analyses.
|
1.6%
2/127 • 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. 509 patients received study drug and were included in safety analyses.
|
3.1%
4/129 • 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. 509 patients received study drug and were included in safety analyses.
|
1.6%
2/127 • 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. 509 patients received study drug and were included in safety analyses.
|
|
Nervous system disorders
Dizziness
|
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. 509 patients received study drug and were included in safety analyses.
|
0.00%
0/127 • 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. 509 patients received study drug and were included in safety analyses.
|
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. 509 patients received study drug and were included in safety analyses.
|
3.1%
4/127 • 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. 509 patients received study drug and were included in safety analyses.
|
|
Nervous system disorders
Headache
|
13.5%
17/126 • Number of events 29 • 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. 509 patients received study drug and were included in safety analyses.
|
6.3%
8/127 • 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. 509 patients received study drug and were included in safety analyses.
|
14.7%
19/129 • Number of events 31 • 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. 509 patients received study drug and were included in safety analyses.
|
9.4%
12/127 • 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. 509 patients received study drug and were included in safety analyses.
|
|
Nervous system disorders
Somnolence
|
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. 509 patients received study drug and were included in safety analyses.
|
0.79%
1/127 • 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. 509 patients received study drug and were included in safety analyses.
|
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. 509 patients received study drug and were included in safety analyses.
|
2.4%
3/127 • 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. 509 patients received study drug and were included in safety analyses.
|
|
Psychiatric disorders
Insomnia
|
4.8%
6/126 • 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. 509 patients received study drug and were included in safety analyses.
|
3.9%
5/127 • 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. 509 patients received study drug and were included in safety analyses.
|
7.0%
9/129 • 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. 509 patients received study drug and were included in safety analyses.
|
2.4%
3/127 • 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. 509 patients received study drug and were included in safety analyses.
|
|
Psychiatric disorders
Mood altered
|
3.2%
4/126 • 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. 509 patients received study drug and were included in safety analyses.
|
1.6%
2/127 • 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. 509 patients received study drug and were included in safety analyses.
|
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. 509 patients received study drug and were included in safety analyses.
|
2.4%
3/127 • 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. 509 patients received study drug and were included in safety analyses.
|
|
Renal and urinary disorders
Pollakiuria
|
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. 509 patients received study drug and were included in safety analyses.
|
0.00%
0/127 • 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. 509 patients received study drug and were included in safety analyses.
|
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. 509 patients received study drug and were included in safety analyses.
|
0.79%
1/127 • 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. 509 patients received study drug and were included in safety analyses.
|
|
Skin and subcutaneous tissue disorders
Acne
|
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. 509 patients received study drug and were included in safety analyses.
|
3.1%
4/127 • 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. 509 patients received study drug and were included in safety analyses.
|
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. 509 patients received study drug and were included in safety analyses.
|
3.1%
4/127 • 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. 509 patients received study drug and were included in safety analyses.
|
|
Skin and subcutaneous tissue disorders
Rash
|
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. 509 patients received study drug and were included in safety analyses.
|
1.6%
2/127 • 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. 509 patients received study drug and were included in safety analyses.
|
3.9%
5/129 • 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. 509 patients received study drug and were included in safety analyses.
|
2.4%
3/127 • 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. 509 patients received study drug and were included in safety analyses.
|
|
Vascular disorders
Flushing
|
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. 509 patients received study drug and were included in safety analyses.
|
0.00%
0/127 • 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. 509 patients received study drug and were included in safety analyses.
|
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. 509 patients received study drug and were included in safety analyses.
|
2.4%
3/127 • 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. 509 patients received study drug and were included in safety analyses.
|
Additional Information
Michael Huang, MD, Senior Medical Director, Clinical Research
Santarus, Inc.
Phone: 8583145700
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place