Trial Outcomes & Findings for Effect of Aspirin Pretreatment or Slow Dose Titration on Flushing and Gastrointestinal Events in Healthy Volunteers Receiving Delayed-release Dimethyl Fumarate (NCT NCT01568112)
NCT ID: NCT01568112
Last Updated: 2016-06-13
Results Overview
Participant-reported flushing side effect events during the treatment period recorded on the eDiary as assessed by MFSS. MFSS questionnaire measures the side effects related to flushing following drug administration. Flushing means redness, warmth, tingling or itching of the skin. This questionnaire relates only to the period of time since the investigational drug was administered and was to be completed within 10 hours of taking the study drug (2 times/day). Each question is rated on a scale from 0 (no flushing side effects) to 10 (extreme flushing side effects).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
173 participants
Primary outcome timeframe
Day 1 to Week 8
Results posted on
2016-06-13
Participant Flow
Participant milestones
| Measure |
Placebo
Participants received BG00012 placebo for 8 weeks and premedication with ASA placebo during the first 4 weeks.
|
BG00012
Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA placebo during the first 4 weeks.
|
BG00012 + ASA
Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA during the first 4 weeks.
|
BG00012 Slow Titration
Participants received BG00012 for 8 weeks (120 mg once daily \[QD\] during Week 1, 120 mg BID during Week 2, 240 mg AM/120mg PM during Week 3, and 240 mg BID during Week 4, and 240 mg BID during Weeks 5 to 8) and premedication with ASA placebo during the first 4 weeks.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
44
|
44
|
43
|
42
|
|
Overall Study
COMPLETED
|
39
|
36
|
36
|
30
|
|
Overall Study
NOT COMPLETED
|
5
|
8
|
7
|
12
|
Reasons for withdrawal
| Measure |
Placebo
Participants received BG00012 placebo for 8 weeks and premedication with ASA placebo during the first 4 weeks.
|
BG00012
Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA placebo during the first 4 weeks.
|
BG00012 + ASA
Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA during the first 4 weeks.
|
BG00012 Slow Titration
Participants received BG00012 for 8 weeks (120 mg once daily \[QD\] during Week 1, 120 mg BID during Week 2, 240 mg AM/120mg PM during Week 3, and 240 mg BID during Week 4, and 240 mg BID during Weeks 5 to 8) and premedication with ASA placebo during the first 4 weeks.
|
|---|---|---|---|---|
|
Overall Study
Randomized But Not Treated
|
0
|
1
|
0
|
0
|
|
Overall Study
Withdrew due to Adverse Event
|
2
|
4
|
6
|
3
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
2
|
3
|
0
|
7
|
|
Overall Study
Withdrawal by Physician
|
1
|
0
|
1
|
1
|
Baseline Characteristics
Effect of Aspirin Pretreatment or Slow Dose Titration on Flushing and Gastrointestinal Events in Healthy Volunteers Receiving Delayed-release Dimethyl Fumarate
Baseline characteristics by cohort
| Measure |
Placebo
n=44 Participants
Participants received BG00012 placebo for 8 weeks and premedication with ASA placebo during the first 4 weeks.
|
BG00012
n=43 Participants
Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA placebo during the first 4 weeks.
|
BG00012 + ASA
n=43 Participants
Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA during the first 4 weeks.
|
BG00012 Slow Titration
n=42 Participants
Participants received BG00012 for 8 weeks (120 mg once daily \[QD\] during Week 1, 120 mg BID during Week 2, 240 mg AM/120mg PM during Week 3, and 240 mg BID during Week 4, and 240 mg BID during Weeks 5 to 8) and premedication with ASA placebo during the first 4 weeks.
|
Total
n=172 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
35.5 years
STANDARD_DEVIATION 8.78 • n=5 Participants
|
39.0 years
STANDARD_DEVIATION 9.61 • n=7 Participants
|
38.1 years
STANDARD_DEVIATION 10.29 • n=5 Participants
|
36.2 years
STANDARD_DEVIATION 9.33 • n=4 Participants
|
37.2 years
STANDARD_DEVIATION 9.54 • n=21 Participants
|
|
Age, Customized
25 to 34 years
|
22 participants
n=5 Participants
|
19 participants
n=7 Participants
|
17 participants
n=5 Participants
|
21 participants
n=4 Participants
|
79 participants
n=21 Participants
|
|
Age, Customized
35 to 44 years
|
13 participants
n=5 Participants
|
7 participants
n=7 Participants
|
13 participants
n=5 Participants
|
10 participants
n=4 Participants
|
43 participants
n=21 Participants
|
|
Age, Customized
45 to 55 years
|
9 participants
n=5 Participants
|
17 participants
n=7 Participants
|
13 participants
n=5 Participants
|
11 participants
n=4 Participants
|
50 participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
72 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
30 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
100 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Day 1 to Week 8Population: Participants who received at least 1 dose of study medication and who had at least 1 diary entry of the relevant questionnaire data during the visit interval.
Participant-reported flushing side effect events during the treatment period recorded on the eDiary as assessed by MFSS. MFSS questionnaire measures the side effects related to flushing following drug administration. Flushing means redness, warmth, tingling or itching of the skin. This questionnaire relates only to the period of time since the investigational drug was administered and was to be completed within 10 hours of taking the study drug (2 times/day). Each question is rated on a scale from 0 (no flushing side effects) to 10 (extreme flushing side effects).
Outcome measures
| Measure |
Placebo
n=44 Participants
Participants received BG00012 placebo for 8 weeks and premedication with ASA placebo during the first 4 weeks.
|
BG00012
n=43 Participants
Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA placebo during the first 4 weeks.
|
BG00012 + ASA
n=43 Participants
Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA during the first 4 weeks.
|
BG00012 Slow Titration
n=42 Participants
Participants received BG00012 for 8 weeks (120 mg once daily \[QD\] during Week 1, 120 mg BID during Week 2, 240 mg AM/120mg PM during Week 3, and 240 mg BID during Week 4, and 240 mg BID during Weeks 5 to 8) and premedication with ASA placebo during the first 4 weeks.
|
|---|---|---|---|---|
|
Percentage of Participants Reporting Overall Flushing Events During the Overall Treatment Period, as Assessed by the Modified Flushing Severity Scale (MFSS)
Overall flushing events
|
41 percentage of participants
|
91 percentage of participants
|
81 percentage of participants
|
98 percentage of participants
|
|
Percentage of Participants Reporting Overall Flushing Events During the Overall Treatment Period, as Assessed by the Modified Flushing Severity Scale (MFSS)
Overall redness events
|
27 percentage of participants
|
86 percentage of participants
|
77 percentage of participants
|
90 percentage of participants
|
|
Percentage of Participants Reporting Overall Flushing Events During the Overall Treatment Period, as Assessed by the Modified Flushing Severity Scale (MFSS)
Overall warmth events
|
41 percentage of participants
|
93 percentage of participants
|
84 percentage of participants
|
98 percentage of participants
|
|
Percentage of Participants Reporting Overall Flushing Events During the Overall Treatment Period, as Assessed by the Modified Flushing Severity Scale (MFSS)
Overall tingling events
|
23 percentage of participants
|
88 percentage of participants
|
67 percentage of participants
|
86 percentage of participants
|
|
Percentage of Participants Reporting Overall Flushing Events During the Overall Treatment Period, as Assessed by the Modified Flushing Severity Scale (MFSS)
Overall itching events
|
20 percentage of participants
|
86 percentage of participants
|
72 percentage of participants
|
98 percentage of participants
|
PRIMARY outcome
Timeframe: Week 1 to Week 4Population: Participants who received at least 1 dose of study medication and who had at least 1 diary entry of the relevant questionnaire data during the visit interval.
Participant-reported flushing side effect events during Weeks 1 to 4 recorded on the eDiary as assessed by MFSS. MFSS questionnaire measures the side effects related to flushing following drug administration. Flushing means redness, warmth, tingling or itching of the skin. This questionnaire relates only to the period of time since the investigational drug was administered and was to be completed within 10 hours of taking the study drug (2 times/day). Each question is rated on a scale from 0 (no flushing side effects) to 10 (extreme flushing side effects).
Outcome measures
| Measure |
Placebo
n=44 Participants
Participants received BG00012 placebo for 8 weeks and premedication with ASA placebo during the first 4 weeks.
|
BG00012
n=43 Participants
Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA placebo during the first 4 weeks.
|
BG00012 + ASA
n=43 Participants
Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA during the first 4 weeks.
|
BG00012 Slow Titration
n=42 Participants
Participants received BG00012 for 8 weeks (120 mg once daily \[QD\] during Week 1, 120 mg BID during Week 2, 240 mg AM/120mg PM during Week 3, and 240 mg BID during Week 4, and 240 mg BID during Weeks 5 to 8) and premedication with ASA placebo during the first 4 weeks.
|
|---|---|---|---|---|
|
Percentage of Participants Reporting Overall Flushing Events During Weeks 1 to 4 (Combined), as Assessed by MFSS
Overall flushing events
|
41 percentage of participants
|
86 percentage of participants
|
72 percentage of participants
|
98 percentage of participants
|
|
Percentage of Participants Reporting Overall Flushing Events During Weeks 1 to 4 (Combined), as Assessed by MFSS
Overall redness events
|
25 percentage of participants
|
81 percentage of participants
|
63 percentage of participants
|
88 percentage of participants
|
|
Percentage of Participants Reporting Overall Flushing Events During Weeks 1 to 4 (Combined), as Assessed by MFSS
Overall warmth events
|
41 percentage of participants
|
88 percentage of participants
|
67 percentage of participants
|
95 percentage of participants
|
|
Percentage of Participants Reporting Overall Flushing Events During Weeks 1 to 4 (Combined), as Assessed by MFSS
Overall tingling events
|
23 percentage of participants
|
84 percentage of participants
|
51 percentage of participants
|
83 percentage of participants
|
|
Percentage of Participants Reporting Overall Flushing Events During Weeks 1 to 4 (Combined), as Assessed by MFSS
Overall itching events
|
16 percentage of participants
|
77 percentage of participants
|
56 percentage of participants
|
95 percentage of participants
|
PRIMARY outcome
Timeframe: Week 5 to Week 8Population: Participants who received at least 1 dose of study medication and who had at least 1 diary entry of the relevant questionnaire data during the visit interval.
Participant-reported flushing side effect events during Weeks 1 to 4 recorded on the eDiary as assessed by MFSS. MFSS questionnaire measures the side effects related to flushing following drug administration. Flushing means redness, warmth, tingling or itching of the skin. This questionnaire relates only to the period of time since the investigational drug was administered and was to be completed within 10 hours of taking the study drug (2 times/day). Each question is rated on a scale from 0 (no flushing side effects) to 10 (extreme flushing side effects).
Outcome measures
| Measure |
Placebo
n=41 Participants
Participants received BG00012 placebo for 8 weeks and premedication with ASA placebo during the first 4 weeks.
|
BG00012
n=37 Participants
Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA placebo during the first 4 weeks.
|
BG00012 + ASA
n=36 Participants
Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA during the first 4 weeks.
|
BG00012 Slow Titration
n=33 Participants
Participants received BG00012 for 8 weeks (120 mg once daily \[QD\] during Week 1, 120 mg BID during Week 2, 240 mg AM/120mg PM during Week 3, and 240 mg BID during Week 4, and 240 mg BID during Weeks 5 to 8) and premedication with ASA placebo during the first 4 weeks.
|
|---|---|---|---|---|
|
Percentage of Participants Reporting Overall Flushing Events During Weeks 5 to 8 (Combined), as Assessed by MFSS
Overall flushing events
|
24 percentage of participants
|
86 percentage of participants
|
72 percentage of participants
|
85 percentage of participants
|
|
Percentage of Participants Reporting Overall Flushing Events During Weeks 5 to 8 (Combined), as Assessed by MFSS
Overall redness events
|
15 percentage of participants
|
78 percentage of participants
|
64 percentage of participants
|
79 percentage of participants
|
|
Percentage of Participants Reporting Overall Flushing Events During Weeks 5 to 8 (Combined), as Assessed by MFSS
Overall warmth events
|
17 percentage of participants
|
86 percentage of participants
|
75 percentage of participants
|
82 percentage of participants
|
|
Percentage of Participants Reporting Overall Flushing Events During Weeks 5 to 8 (Combined), as Assessed by MFSS
Overall tingling events
|
15 percentage of participants
|
81 percentage of participants
|
64 percentage of participants
|
70 percentage of participants
|
|
Percentage of Participants Reporting Overall Flushing Events During Weeks 5 to 8 (Combined), as Assessed by MFSS
Overall itching events
|
22 percentage of participants
|
78 percentage of participants
|
58 percentage of participants
|
61 percentage of participants
|
PRIMARY outcome
Timeframe: Day 1 to Week 4Population: Participants who received at least 1 dose of study medication and who had at least 1 diary entry of the relevant questionnaire data during the visit interval.
Worst severity of participant-reported flushing events during Weeks 1-4 of treatment combined, recorded on the eDiary as assessed by MFSS. MFSS questionnaire measures the side effects related to flushing following drug administration. Flushing means redness, warmth, tingling or itching of the skin. This questionnaire relates only to the period of time since the investigational drug was administered and was to be completed within 10 hours of taking the study drug (2 times/day). Each question is rated on a scale from 0 (no flushing side effects) to 10 (extreme flushing side effects).
Outcome measures
| Measure |
Placebo
n=44 Participants
Participants received BG00012 placebo for 8 weeks and premedication with ASA placebo during the first 4 weeks.
|
BG00012
n=43 Participants
Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA placebo during the first 4 weeks.
|
BG00012 + ASA
n=43 Participants
Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA during the first 4 weeks.
|
BG00012 Slow Titration
n=42 Participants
Participants received BG00012 for 8 weeks (120 mg once daily \[QD\] during Week 1, 120 mg BID during Week 2, 240 mg AM/120mg PM during Week 3, and 240 mg BID during Week 4, and 240 mg BID during Weeks 5 to 8) and premedication with ASA placebo during the first 4 weeks.
|
|---|---|---|---|---|
|
Worst Severity Scores of Overall Flushing During Weeks 1 to 4 of Treatment (Combined), as Assessed by MFSS
Overall flushing
|
1.2 units on a scale
Standard Deviation 1.70
|
4.4 units on a scale
Standard Deviation 2.68
|
2.4 units on a scale
Standard Deviation 2.26
|
5.6 units on a scale
Standard Deviation 2.24
|
|
Worst Severity Scores of Overall Flushing During Weeks 1 to 4 of Treatment (Combined), as Assessed by MFSS
Redness
|
0.7 units on a scale
Standard Deviation 1.33
|
3.8 units on a scale
Standard Deviation 2.76
|
1.6 units on a scale
Standard Deviation 1.75
|
5.1 units on a scale
Standard Deviation 2.93
|
|
Worst Severity Scores of Overall Flushing During Weeks 1 to 4 of Treatment (Combined), as Assessed by MFSS
Warmth
|
1.2 units on a scale
Standard Deviation 1.76
|
4.0 units on a scale
Standard Deviation 2.55
|
2.3 units on a scale
Standard Deviation 2.17
|
5.2 units on a scale
Standard Deviation 2.37
|
|
Worst Severity Scores of Overall Flushing During Weeks 1 to 4 of Treatment (Combined), as Assessed by MFSS
Tingling
|
0.5 units on a scale
Standard Deviation 1.00
|
3.4 units on a scale
Standard Deviation 2.21
|
1.6 units on a scale
Standard Deviation 2.13
|
4.0 units on a scale
Standard Deviation 2.62
|
|
Worst Severity Scores of Overall Flushing During Weeks 1 to 4 of Treatment (Combined), as Assessed by MFSS
Itching
|
0.5 units on a scale
Standard Deviation 1.21
|
3.2 units on a scale
Standard Deviation 2.45
|
1.3 units on a scale
Standard Deviation 1.72
|
4.3 units on a scale
Standard Deviation 2.10
|
PRIMARY outcome
Timeframe: Week 5 to Week 8Population: Participants who received at least 1 dose of study medication and who had at least 1 diary entry of the relevant questionnaire data during the visit interval.
Worst severity of participant-reported flushing events during Weeks 1-4 of treatment combined, recorded on the eDiary as assessed by MFSS. MFSS questionnaire measures the side effects related to flushing following drug administration. Flushing means redness, warmth, tingling or itching of the skin.This questionnaire relates only to the period of time since the investigational drug was administered and was to be completed within 10 hours of taking the study drug (2 times/day). Each question is rated on a scale from 0 (no flushing side effects) to 10 (extreme flushing side effects).
Outcome measures
| Measure |
Placebo
n=41 Participants
Participants received BG00012 placebo for 8 weeks and premedication with ASA placebo during the first 4 weeks.
|
BG00012
n=37 Participants
Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA placebo during the first 4 weeks.
|
BG00012 + ASA
n=36 Participants
Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA during the first 4 weeks.
|
BG00012 Slow Titration
n=33 Participants
Participants received BG00012 for 8 weeks (120 mg once daily \[QD\] during Week 1, 120 mg BID during Week 2, 240 mg AM/120mg PM during Week 3, and 240 mg BID during Week 4, and 240 mg BID during Weeks 5 to 8) and premedication with ASA placebo during the first 4 weeks.
|
|---|---|---|---|---|
|
Worst Severity Scores of Overall Flushing During Weeks 5 to 8 of Treatment (Combined), as Assessed by MFSS
Overall flushing
|
0.9 units on a scale
Standard Deviation 1.67
|
3.8 units on a scale
Standard Deviation 2.48
|
3.3 units on a scale
Standard Deviation 2.78
|
3.1 units on a scale
Standard Deviation 2.26
|
|
Worst Severity Scores of Overall Flushing During Weeks 5 to 8 of Treatment (Combined), as Assessed by MFSS
Redness
|
0.4 units on a scale
Standard Deviation 1.14
|
3.6 units on a scale
Standard Deviation 2.73
|
2.9 units on a scale
Standard Deviation 2.67
|
2.9 units on a scale
Standard Deviation 2.30
|
|
Worst Severity Scores of Overall Flushing During Weeks 5 to 8 of Treatment (Combined), as Assessed by MFSS
Warmth
|
0.8 units on a scale
Standard Deviation 1.79
|
3.9 units on a scale
Standard Deviation 2.53
|
3.1 units on a scale
Standard Deviation 2.50
|
2.9 units on a scale
Standard Deviation 2.15
|
|
Worst Severity Scores of Overall Flushing During Weeks 5 to 8 of Treatment (Combined), as Assessed by MFSS
Tingling
|
0.3 units on a scale
Standard Deviation 0.82
|
3.3 units on a scale
Standard Deviation 2.50
|
2.3 units on a scale
Standard Deviation 2.36
|
2.2 units on a scale
Standard Deviation 1.96
|
|
Worst Severity Scores of Overall Flushing During Weeks 5 to 8 of Treatment (Combined), as Assessed by MFSS
Itching
|
0.7 units on a scale
Standard Deviation 1.58
|
3.1 units on a scale
Standard Deviation 2.71
|
2.3 units on a scale
Standard Deviation 2.52
|
1.8 units on a scale
Standard Deviation 2.04
|
PRIMARY outcome
Timeframe: Day 2 to Week 8Population: Participants who received at least 1 dose of study medication and who had at least 1 diary entry of the relevant questionnaire data during the visit interval.
Participant-reported flushing events during the overall treatment period, recorded on the hand-held participant reporting device (eDiary) as assessed by MGFSS. The MGFSS measures the side effects related to flushing during the past 24 hours. Flushing means redness, warmth, tingling or itching of the skin. Each question is rated on a scale from 0 (no flushing side effects) to 10 (extreme flushing side effects). Day 1 data are not included in the analysis because MGFSS question refers to events reported in the 24 hours after the first dose on Day 1.
Outcome measures
| Measure |
Placebo
n=44 Participants
Participants received BG00012 placebo for 8 weeks and premedication with ASA placebo during the first 4 weeks.
|
BG00012
n=43 Participants
Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA placebo during the first 4 weeks.
|
BG00012 + ASA
n=42 Participants
Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA during the first 4 weeks.
|
BG00012 Slow Titration
n=42 Participants
Participants received BG00012 for 8 weeks (120 mg once daily \[QD\] during Week 1, 120 mg BID during Week 2, 240 mg AM/120mg PM during Week 3, and 240 mg BID during Week 4, and 240 mg BID during Weeks 5 to 8) and premedication with ASA placebo during the first 4 weeks.
|
|---|---|---|---|---|
|
Percentage of Participants Reporting Overall Flushing Events During the Overall Treatment Period, as Assessed by the Modified Global Flushing Severity Scale (MGFSS)
|
43 percentage of participants
|
86 percentage of participants
|
74 percentage of participants
|
93 percentage of participants
|
PRIMARY outcome
Timeframe: Day 2 to Week 4Population: Participants who received at least 1 dose of study medication and who had at least 1 diary entry of the relevant questionnaire data during the visit interval.
Participant-reported flushing events during Weeks 1 to 4 of treatment (combined), recorded on the hand-held participant reporting device (eDiary) as assessed by MGFSS. The MGFSS measures the side effects related to flushing during the past 24 hours. Flushing means redness, warmth, tingling or itching of the skin. Each question is rated on a scale from 0 (no flushing side effects) to 10 (extreme flushing side effects). Day 1 data are not included in the analysis because MGFSS question refers to events reported in the 24 hours after the first dose on Day 1.
Outcome measures
| Measure |
Placebo
n=44 Participants
Participants received BG00012 placebo for 8 weeks and premedication with ASA placebo during the first 4 weeks.
|
BG00012
n=43 Participants
Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA placebo during the first 4 weeks.
|
BG00012 + ASA
n=42 Participants
Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA during the first 4 weeks.
|
BG00012 Slow Titration
n=42 Participants
Participants received BG00012 for 8 weeks (120 mg once daily \[QD\] during Week 1, 120 mg BID during Week 2, 240 mg AM/120mg PM during Week 3, and 240 mg BID during Week 4, and 240 mg BID during Weeks 5 to 8) and premedication with ASA placebo during the first 4 weeks.
|
|---|---|---|---|---|
|
Percentage of Participants Reporting Overall Flushing Events During Weeks 1 to 4 of Treatment (Combined), as Assessed by MGFSS
|
41 percentage of participants
|
84 percentage of participants
|
62 percentage of participants
|
90 percentage of participants
|
PRIMARY outcome
Timeframe: Week 5 to Week 8Population: Participants who received at least 1 dose of study medication and who had at least 1 diary entry of the relevant questionnaire data during the visit interval.
Participant-reported flushing events during Weeks 5 to 8 of treatment (combined), recorded on the hand-held participant reporting device (eDiary) as assessed by MGFSS. The MGFSS measures the side effects related to flushing during the past 24 hours. Flushing means redness, warmth, tingling or itching of the skin. Each question is rated on a scale from 0 (no flushing side effects) to 10 (extreme flushing side effects). Day 1 data are not included in the analysis because MGFSS question refers to last 24 hours flushing score.
Outcome measures
| Measure |
Placebo
n=41 Participants
Participants received BG00012 placebo for 8 weeks and premedication with ASA placebo during the first 4 weeks.
|
BG00012
n=37 Participants
Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA placebo during the first 4 weeks.
|
BG00012 + ASA
n=36 Participants
Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA during the first 4 weeks.
|
BG00012 Slow Titration
n=33 Participants
Participants received BG00012 for 8 weeks (120 mg once daily \[QD\] during Week 1, 120 mg BID during Week 2, 240 mg AM/120mg PM during Week 3, and 240 mg BID during Week 4, and 240 mg BID during Weeks 5 to 8) and premedication with ASA placebo during the first 4 weeks.
|
|---|---|---|---|---|
|
Percentage of Participants Reporting Overall Flushing Events During Weeks 5 to 8 of Treatment (Combined), as Assessed by MGFSS
|
24 percentage of participants
|
86 percentage of participants
|
67 percentage of participants
|
85 percentage of participants
|
PRIMARY outcome
Timeframe: Day 1 to Week 8Population: Participants who received at least 1 dose of study medication and who had at least 1 diary entry of the relevant questionnaire data during the visit interval.
The MAGISS is a participant-reported questionnaire about side effects of the gastrointestinal system following drug administration, and is based on a 0- to 10-point scale, with 0 representing absence of symptoms and 10 representing the most severe symptoms. A participant was considered having overall GI side effect if he/she had a score of \>=1 for at least one of the GI side effects including nausea, diarrhea, upper abdominal pain, lower abdominal pain, vomiting, indigestion, constipation, bloating and flatulence.
Outcome measures
| Measure |
Placebo
n=44 Participants
Participants received BG00012 placebo for 8 weeks and premedication with ASA placebo during the first 4 weeks.
|
BG00012
n=43 Participants
Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA placebo during the first 4 weeks.
|
BG00012 + ASA
n=43 Participants
Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA during the first 4 weeks.
|
BG00012 Slow Titration
n=42 Participants
Participants received BG00012 for 8 weeks (120 mg once daily \[QD\] during Week 1, 120 mg BID during Week 2, 240 mg AM/120mg PM during Week 3, and 240 mg BID during Week 4, and 240 mg BID during Weeks 5 to 8) and premedication with ASA placebo during the first 4 weeks.
|
|---|---|---|---|---|
|
Percentage of Participants Reporting Gastrointestinal (GI) Events During the Overall Treatment Period, as Assessed by the Modified Acute Gastrointestinal Scale (MAGISS)
|
73 percentage of participants
|
81 percentage of participants
|
81 percentage of participants
|
86 percentage of participants
|
PRIMARY outcome
Timeframe: Day 1 to Week 4Population: Participants who received at least 1 dose of study medication and who had at least 1 diary entry of the relevant questionnaire data during the visit interval.
The MAGISS is a participant-reported questionnaire about side effects of the gastrointestinal system following drug administration, and is based on a 0- to 10-point scale, with 0 representing absence of symptoms and 10 representing the most severe symptoms. A participant was considered having overall GI side effect if he/she had a score of \>=1 for at least one of the GI side effects including nausea, diarrhea, upper abdominal pain, lower abdominal pain, vomiting, indigestion, constipation, bloating and flatulence.
Outcome measures
| Measure |
Placebo
n=44 Participants
Participants received BG00012 placebo for 8 weeks and premedication with ASA placebo during the first 4 weeks.
|
BG00012
n=43 Participants
Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA placebo during the first 4 weeks.
|
BG00012 + ASA
n=43 Participants
Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA during the first 4 weeks.
|
BG00012 Slow Titration
n=42 Participants
Participants received BG00012 for 8 weeks (120 mg once daily \[QD\] during Week 1, 120 mg BID during Week 2, 240 mg AM/120mg PM during Week 3, and 240 mg BID during Week 4, and 240 mg BID during Weeks 5 to 8) and premedication with ASA placebo during the first 4 weeks.
|
|---|---|---|---|---|
|
Percentage of Participants Reporting GI Events During Weeks 1 to 4 of Treatment (Combined), as Assessed by MAGISS
|
66 percentage of participants
|
81 percentage of participants
|
79 percentage of participants
|
79 percentage of participants
|
PRIMARY outcome
Timeframe: Week 5 to Week 8Population: Participants who received at least 1 dose of study medication and who had at least 1 diary entry of the relevant questionnaire data during the visit interval.
The MAGISS is a participant-reported questionnaire about side effects of the gastrointestinal system following drug administration, and is based on a 0- to 10-point scale, with 0 representing absence of symptoms and 10 representing the most severe symptoms. A participant was considered having overall GI side effect if he/she had a score of \>=1 for at least one of the GI side effects including nausea, diarrhea, upper abdominal pain, lower abdominal pain, vomiting, indigestion, constipation, bloating and flatulence.
Outcome measures
| Measure |
Placebo
n=41 Participants
Participants received BG00012 placebo for 8 weeks and premedication with ASA placebo during the first 4 weeks.
|
BG00012
n=37 Participants
Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA placebo during the first 4 weeks.
|
BG00012 + ASA
n=36 Participants
Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA during the first 4 weeks.
|
BG00012 Slow Titration
n=33 Participants
Participants received BG00012 for 8 weeks (120 mg once daily \[QD\] during Week 1, 120 mg BID during Week 2, 240 mg AM/120mg PM during Week 3, and 240 mg BID during Week 4, and 240 mg BID during Weeks 5 to 8) and premedication with ASA placebo during the first 4 weeks.
|
|---|---|---|---|---|
|
Percentage of Participants Reporting GI Events During Weeks 5 to 8 of Treatment (Combined), as Assessed by MAGISS
|
41 percentage of participants
|
59 percentage of participants
|
53 percentage of participants
|
61 percentage of participants
|
PRIMARY outcome
Timeframe: Day 1 to Week 4Population: Participants who received at least 1 dose of study medication and who had at least 1 diary entry of the relevant questionnaire data during the visit interval.
Severity of GI-related events using the MAGISS to measure GI symptoms (nausea, diarrhea, upper abdominal pain, lower abdominal pain, vomiting, indigestion, constipation, bloating, flatulence), based on a 0- to 10-point scale, with 0 representing absence of symptoms and 10 representing the most severe symptoms.
Outcome measures
| Measure |
Placebo
n=44 Participants
Participants received BG00012 placebo for 8 weeks and premedication with ASA placebo during the first 4 weeks.
|
BG00012
n=43 Participants
Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA placebo during the first 4 weeks.
|
BG00012 + ASA
n=43 Participants
Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA during the first 4 weeks.
|
BG00012 Slow Titration
n=42 Participants
Participants received BG00012 for 8 weeks (120 mg once daily \[QD\] during Week 1, 120 mg BID during Week 2, 240 mg AM/120mg PM during Week 3, and 240 mg BID during Week 4, and 240 mg BID during Weeks 5 to 8) and premedication with ASA placebo during the first 4 weeks.
|
|---|---|---|---|---|
|
Worst Severity Scores of Acute GI Events During Weeks 1 to 4 of Treatment (Combined), as Assessed by MAGISS
Nausea
|
0.7 units on a scale
Standard Deviation 1.59
|
1.6 units on a scale
Standard Deviation 2.41
|
1.6 units on a scale
Standard Deviation 2.54
|
1.5 units on a scale
Standard Deviation 2.09
|
|
Worst Severity Scores of Acute GI Events During Weeks 1 to 4 of Treatment (Combined), as Assessed by MAGISS
Diarrhea
|
1.0 units on a scale
Standard Deviation 1.97
|
1.8 units on a scale
Standard Deviation 2.47
|
1.5 units on a scale
Standard Deviation 2.76
|
1.0 units on a scale
Standard Deviation 1.67
|
|
Worst Severity Scores of Acute GI Events During Weeks 1 to 4 of Treatment (Combined), as Assessed by MAGISS
Upper abdominal pain
|
0.8 units on a scale
Standard Deviation 1.38
|
1.1 units on a scale
Standard Deviation 2.16
|
1.7 units on a scale
Standard Deviation 2.71
|
1.4 units on a scale
Standard Deviation 2.47
|
|
Worst Severity Scores of Acute GI Events During Weeks 1 to 4 of Treatment (Combined), as Assessed by MAGISS
Lower abdominal pain
|
0.5 units on a scale
Standard Deviation 1.21
|
1.4 units on a scale
Standard Deviation 2.14
|
1.3 units on a scale
Standard Deviation 2.32
|
1.2 units on a scale
Standard Deviation 2.12
|
|
Worst Severity Scores of Acute GI Events During Weeks 1 to 4 of Treatment (Combined), as Assessed by MAGISS
Vomiting
|
0.2 units on a scale
Standard Deviation 0.75
|
0.3 units on a scale
Standard Deviation 1.28
|
0.3 units on a scale
Standard Deviation 1.63
|
0.2 units on a scale
Standard Deviation 1.10
|
|
Worst Severity Scores of Acute GI Events During Weeks 1 to 4 of Treatment (Combined), as Assessed by MAGISS
Indigestion
|
0.7 units on a scale
Standard Deviation 1.29
|
0.9 units on a scale
Standard Deviation 1.83
|
0.6 units on a scale
Standard Deviation 1.26
|
0.9 units on a scale
Standard Deviation 1.97
|
|
Worst Severity Scores of Acute GI Events During Weeks 1 to 4 of Treatment (Combined), as Assessed by MAGISS
Constipation
|
0.4 units on a scale
Standard Deviation 1.45
|
0.9 units on a scale
Standard Deviation 2.23
|
0.6 units on a scale
Standard Deviation 1.45
|
0.9 units on a scale
Standard Deviation 1.85
|
|
Worst Severity Scores of Acute GI Events During Weeks 1 to 4 of Treatment (Combined), as Assessed by MAGISS
Bloating
|
0.5 units on a scale
Standard Deviation 1.17
|
1.1 units on a scale
Standard Deviation 1.96
|
1.3 units on a scale
Standard Deviation 2.08
|
1.0 units on a scale
Standard Deviation 1.88
|
|
Worst Severity Scores of Acute GI Events During Weeks 1 to 4 of Treatment (Combined), as Assessed by MAGISS
Flatulence
|
1.3 units on a scale
Standard Deviation 1.73
|
1.3 units on a scale
Standard Deviation 2.03
|
1.4 units on a scale
Standard Deviation 1.76
|
1.6 units on a scale
Standard Deviation 2.20
|
PRIMARY outcome
Timeframe: Week 5 to Week 8Population: Participants who received at least 1 dose of study medication and who had at least 1 diary entry of the relevant questionnaire data during the visit interval.
Severity of GI-related events using the MAGISS to measure GI symptoms (nausea, diarrhea, upper abdominal pain, lower abdominal pain, vomiting, indigestion, constipation, bloating, flatulence), based on a 0- to 10-point scale, with 0 representing absence of symptoms and 10 representing the most severe symptoms.
Outcome measures
| Measure |
Placebo
n=41 Participants
Participants received BG00012 placebo for 8 weeks and premedication with ASA placebo during the first 4 weeks.
|
BG00012
n=37 Participants
Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA placebo during the first 4 weeks.
|
BG00012 + ASA
n=36 Participants
Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA during the first 4 weeks.
|
BG00012 Slow Titration
n=33 Participants
Participants received BG00012 for 8 weeks (120 mg once daily \[QD\] during Week 1, 120 mg BID during Week 2, 240 mg AM/120mg PM during Week 3, and 240 mg BID during Week 4, and 240 mg BID during Weeks 5 to 8) and premedication with ASA placebo during the first 4 weeks.
|
|---|---|---|---|---|
|
Worst Severity Scores of Acute GI Events During Weeks 5 to 8 of Treatment (Combined), as Assessed by MAGISS
Nausea
|
0.4 units on a scale
Standard Deviation 1.51
|
0.9 units on a scale
Standard Deviation 1.79
|
0.8 units on a scale
Standard Deviation 1.94
|
0.9 units on a scale
Standard Deviation 1.65
|
|
Worst Severity Scores of Acute GI Events During Weeks 5 to 8 of Treatment (Combined), as Assessed by MAGISS
Diarrhea
|
1.0 units on a scale
Standard Deviation 2.01
|
1.4 units on a scale
Standard Deviation 2.29
|
0.8 units on a scale
Standard Deviation 2.13
|
0.7 units on a scale
Standard Deviation 1.42
|
|
Worst Severity Scores of Acute GI Events During Weeks 5 to 8 of Treatment (Combined), as Assessed by MAGISS
Upper abdominal pain
|
0.6 units on a scale
Standard Deviation 1.69
|
0.5 units on a scale
Standard Deviation 1.50
|
0.4 units on a scale
Standard Deviation 1.21
|
0.6 units on a scale
Standard Deviation 1.56
|
|
Worst Severity Scores of Acute GI Events During Weeks 5 to 8 of Treatment (Combined), as Assessed by MAGISS
Lower abdominal pain
|
0.6 units on a scale
Standard Deviation 1.48
|
0.4 units on a scale
Standard Deviation 1.42
|
0.5 units on a scale
Standard Deviation 1.38
|
0.9 units on a scale
Standard Deviation 1.72
|
|
Worst Severity Scores of Acute GI Events During Weeks 5 to 8 of Treatment (Combined), as Assessed by MAGISS
Vomiting
|
0.2 units on a scale
Standard Deviation 1.41
|
0.1 units on a scale
Standard Deviation 0.82
|
0.1 units on a scale
Standard Deviation 0.83
|
0.0 units on a scale
Standard Deviation 0.00
|
|
Worst Severity Scores of Acute GI Events During Weeks 5 to 8 of Treatment (Combined), as Assessed by MAGISS
Indigestion
|
0.4 units on a scale
Standard Deviation 1.26
|
0.5 units on a scale
Standard Deviation 1.32
|
0.5 units on a scale
Standard Deviation 1.38
|
0.4 units on a scale
Standard Deviation 1.06
|
|
Worst Severity Scores of Acute GI Events During Weeks 5 to 8 of Treatment (Combined), as Assessed by MAGISS
Constipation
|
0.4 units on a scale
Standard Deviation 1.20
|
0.1 units on a scale
Standard Deviation 0.59
|
0.6 units on a scale
Standard Deviation 1.63
|
0.3 units on a scale
Standard Deviation 1.05
|
|
Worst Severity Scores of Acute GI Events During Weeks 5 to 8 of Treatment (Combined), as Assessed by MAGISS
Bloating
|
0.5 units on a scale
Standard Deviation 1.23
|
0.7 units on a scale
Standard Deviation 1.61
|
0.7 units on a scale
Standard Deviation 1.55
|
0.8 units on a scale
Standard Deviation 1.52
|
|
Worst Severity Scores of Acute GI Events During Weeks 5 to 8 of Treatment (Combined), as Assessed by MAGISS
Flatulence
|
0.8 units on a scale
Standard Deviation 1.65
|
1.2 units on a scale
Standard Deviation 2.04
|
0.4 units on a scale
Standard Deviation 1.08
|
0.9 units on a scale
Standard Deviation 1.54
|
PRIMARY outcome
Timeframe: Day 1 to Week 8Population: Participants who received at least 1 dose of study medication and who had at least 1 diary entry of the relevant questionnaire data during the visit interval.
The MOGISS is a questionnaire about overall side effects related to the gastrointestinal system (including nausea, diarrhea, upper abdominal pain, lower abdominal pain, vomiting, indigestion, constipation, bloating, and flatulence) during the 24 hours prior to each AM dose. Participants were to answer the questions at the same time each day, before the morning drug administration.
Outcome measures
| Measure |
Placebo
n=44 Participants
Participants received BG00012 placebo for 8 weeks and premedication with ASA placebo during the first 4 weeks.
|
BG00012
n=43 Participants
Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA placebo during the first 4 weeks.
|
BG00012 + ASA
n=42 Participants
Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA during the first 4 weeks.
|
BG00012 Slow Titration
n=42 Participants
Participants received BG00012 for 8 weeks (120 mg once daily \[QD\] during Week 1, 120 mg BID during Week 2, 240 mg AM/120mg PM during Week 3, and 240 mg BID during Week 4, and 240 mg BID during Weeks 5 to 8) and premedication with ASA placebo during the first 4 weeks.
|
|---|---|---|---|---|
|
Percentage of Participants Reporting GI Events During the Overall Treatment Period, as Assessed by the Modified Overall Gastrointestinal Symptom Scale (MOGISS)
|
59 percentage of participants
|
70 percentage of participants
|
79 percentage of participants
|
79 percentage of participants
|
PRIMARY outcome
Timeframe: Week 1 to Week 4Population: Participants who received at least 1 dose of study medication and who had at least 1 diary entry of the relevant questionnaire data during the visit interval.
The MOGISS is a questionnaire about overall side effects related to the gastrointestinal system (including nausea, diarrhea, upper abdominal pain, lower abdominal pain, vomiting, indigestion, constipation, bloating, and flatulence) during the 24 hours prior to each AM dose. Participants were to answer the questions at the same time each day, before the morning drug administration.
Outcome measures
| Measure |
Placebo
n=44 Participants
Participants received BG00012 placebo for 8 weeks and premedication with ASA placebo during the first 4 weeks.
|
BG00012
n=43 Participants
Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA placebo during the first 4 weeks.
|
BG00012 + ASA
n=42 Participants
Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA during the first 4 weeks.
|
BG00012 Slow Titration
n=42 Participants
Participants received BG00012 for 8 weeks (120 mg once daily \[QD\] during Week 1, 120 mg BID during Week 2, 240 mg AM/120mg PM during Week 3, and 240 mg BID during Week 4, and 240 mg BID during Weeks 5 to 8) and premedication with ASA placebo during the first 4 weeks.
|
|---|---|---|---|---|
|
Percentage of Participants Reporting GI Events During Weeks 1 to 4 (Combined), as Assessed by the Modified Overall Gastrointestinal Symptom Scale (MOGISS)
|
57 percentage of participants
|
65 percentage of participants
|
67 percentage of participants
|
71 percentage of participants
|
PRIMARY outcome
Timeframe: Week 5 to Week 8Population: Participants who received at least 1 dose of study medication and who had at least 1 diary entry of the relevant questionnaire data during the visit interval.
The MOGISS is a questionnaire about overall side effects related to the gastrointestinal system (including nausea, diarrhea, upper abdominal pain, lower abdominal pain, vomiting, indigestion, constipation, bloating, and flatulence) during the 24 hours prior to each AM dose. Participants were to answer the questions at the same time each day, before the morning drug administration.
Outcome measures
| Measure |
Placebo
n=41 Participants
Participants received BG00012 placebo for 8 weeks and premedication with ASA placebo during the first 4 weeks.
|
BG00012
n=37 Participants
Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA placebo during the first 4 weeks.
|
BG00012 + ASA
n=36 Participants
Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA during the first 4 weeks.
|
BG00012 Slow Titration
n=33 Participants
Participants received BG00012 for 8 weeks (120 mg once daily \[QD\] during Week 1, 120 mg BID during Week 2, 240 mg AM/120mg PM during Week 3, and 240 mg BID during Week 4, and 240 mg BID during Weeks 5 to 8) and premedication with ASA placebo during the first 4 weeks.
|
|---|---|---|---|---|
|
Percentage of Participants Reporting GI Events During Weeks 5 to 8 (Combined), as Assessed by the Modified Overall Gastrointestinal Symptom Scale (MOGISS)
|
34 percentage of participants
|
59 percentage of participants
|
50 percentage of participants
|
58 percentage of participants
|
SECONDARY outcome
Timeframe: Day 1 up to end of Safety Follow-up (9 weeks)Population: Safety population: participants who received at least 1 dose of study treatment (BG00012/BG00012 placebo).
AE: any untoward medical occurrence that does not necessarily have a causal relationship with treatment. SAE: any untoward medical occurrence that at any dose: results in death; in the view of the Investigator, places the subject at immediate risk of death; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; results in a congenital anomaly/birth defect; any other medically important event that, in the opinion of the Investigator, may jeopardize the subject or may require intervention to prevent one of the other outcomes. An AE was considered treatment-emergent if it occurred after the start of study treatment or was present prior to the start of study treatment but subsequently worsened.
Outcome measures
| Measure |
Placebo
n=44 Participants
Participants received BG00012 placebo for 8 weeks and premedication with ASA placebo during the first 4 weeks.
|
BG00012
n=43 Participants
Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA placebo during the first 4 weeks.
|
BG00012 + ASA
n=43 Participants
Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA during the first 4 weeks.
|
BG00012 Slow Titration
n=42 Participants
Participants received BG00012 for 8 weeks (120 mg once daily \[QD\] during Week 1, 120 mg BID during Week 2, 240 mg AM/120mg PM during Week 3, and 240 mg BID during Week 4, and 240 mg BID during Weeks 5 to 8) and premedication with ASA placebo during the first 4 weeks.
|
|---|---|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious AEs (SAEs)
Any event
|
24 participants
|
24 participants
|
26 participants
|
26 participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious AEs (SAEs)
Moderate or severe event
|
10 participants
|
13 participants
|
12 participants
|
11 participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious AEs (SAEs)
Severe event
|
0 participants
|
4 participants
|
4 participants
|
1 participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious AEs (SAEs)
Related event
|
8 participants
|
17 participants
|
16 participants
|
18 participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious AEs (SAEs)
Serious event
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious AEs (SAEs)
Discontinuation of treatment due to an event
|
2 participants
|
4 participants
|
6 participants
|
3 participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious AEs (SAEs)
Withdrawal from study due to an event
|
2 participants
|
4 participants
|
6 participants
|
3 participants
|
SECONDARY outcome
Timeframe: Day 1 to Week 8Population: Safety population: participants who received at least 1 dose of study treatment (BG00012/BG00012 placebo); n=number of participants whose baseline value was not low (or high) and who had at least 1 post-baseline value.
Number of participants with clinical laboratory shifts from baseline in hematology values. Shift to low includes normal to low, high to low, and unknown to low. Shift to high includes normal to high, low to high, and unknown to high. abs=absolute
Outcome measures
| Measure |
Placebo
n=44 Participants
Participants received BG00012 placebo for 8 weeks and premedication with ASA placebo during the first 4 weeks.
|
BG00012
n=43 Participants
Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA placebo during the first 4 weeks.
|
BG00012 + ASA
n=43 Participants
Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA during the first 4 weeks.
|
BG00012 Slow Titration
n=42 Participants
Participants received BG00012 for 8 weeks (120 mg once daily \[QD\] during Week 1, 120 mg BID during Week 2, 240 mg AM/120mg PM during Week 3, and 240 mg BID during Week 4, and 240 mg BID during Weeks 5 to 8) and premedication with ASA placebo during the first 4 weeks.
|
|---|---|---|---|---|
|
Clinical Laboratory Shifts From Baseline in Reported Values: Hematology
White blood cells: shift to low; n=43, 43, 43, 41
|
0 participants
|
2 participants
|
0 participants
|
0 participants
|
|
Clinical Laboratory Shifts From Baseline in Reported Values: Hematology
White blood cells: shift to high; n=44, 43, 43, 42
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Clinical Laboratory Shifts From Baseline in Reported Values: Hematology
Neutrophils abs: shift to low; n=42, 42, 42, 41
|
3 participants
|
6 participants
|
2 participants
|
2 participants
|
|
Clinical Laboratory Shifts From Baseline in Reported Values: Hematology
Neutrophils abs: shift to high; n=44, 43, 43, 42
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Clinical Laboratory Shifts From Baseline in Reported Values: Hematology
Lymphocytes abs: shift to low; n=43, 43, 43, 41
|
1 participants
|
5 participants
|
2 participants
|
3 participants
|
|
Clinical Laboratory Shifts From Baseline in Reported Values: Hematology
Lymphocytes abs: shift to high; n=44, 43, 42, 42
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Clinical Laboratory Shifts From Baseline in Reported Values: Hematology
Monocytes abs: shift to low; n=44, 43, 43, 42
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Clinical Laboratory Shifts From Baseline in Reported Values: Hematology
Monocytes abs: shift to high; n=44, 43, 43, 42
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Clinical Laboratory Shifts From Baseline in Reported Values: Hematology
Eosinophils abs: shift to low; n=44, 43, 43, 42
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Clinical Laboratory Shifts From Baseline in Reported Values: Hematology
Eosinophils abs: shift to high; n=44, 43, 43, 42
|
0 participants
|
5 participants
|
6 participants
|
6 participants
|
|
Clinical Laboratory Shifts From Baseline in Reported Values: Hematology
Basophils abs: shift to high; n=44, 43, 43, 42
|
0 participants
|
1 participants
|
1 participants
|
0 participants
|
|
Clinical Laboratory Shifts From Baseline in Reported Values: Hematology
Red blood cells: shift to low; n=44, 43, 43, 40
|
0 participants
|
2 participants
|
0 participants
|
0 participants
|
|
Clinical Laboratory Shifts From Baseline in Reported Values: Hematology
Red blood cells: shift to high; n=44, 43, 43, 42
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Clinical Laboratory Shifts From Baseline in Reported Values: Hematology
Hemoglobin: shift to low; n=43, 41, 43, 42
|
1 participants
|
3 participants
|
1 participants
|
0 participants
|
|
Clinical Laboratory Shifts From Baseline in Reported Values: Hematology
Hemoglobin: shift to high; n=44, 43, 43, 42
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Clinical Laboratory Shifts From Baseline in Reported Values: Hematology
Hematocrit: shift to low; n=44, 43, 43, 42
|
0 participants
|
2 participants
|
0 participants
|
0 participants
|
|
Clinical Laboratory Shifts From Baseline in Reported Values: Hematology
Hematocrit: shift to high; n=43, 43, 43, 42
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Clinical Laboratory Shifts From Baseline in Reported Values: Hematology
Platelets: shift to low; n=44, 43, 43, 42
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Clinical Laboratory Shifts From Baseline in Reported Values: Hematology
Platelets: shift to high; n=44, 41, 43, 42
|
0 participants
|
0 participants
|
1 participants
|
1 participants
|
SECONDARY outcome
Timeframe: Day 1 to Week 8Population: Safety population: participants who received at least 1 dose of study treatment (BG00012/BG00012 placebo); n=number of participants whose baseline value was not low (or high) and who had at least 1 post-baseline value.
Number of participants with clinical laboratory shifts from baseline in blood chemistry values. Shift to low includes normal to low, high to low, and unknown to low. Shift to high includes normal to high, low to high, and unknown to high. ALP=alkaline phosphatase, ALT=alanine aminotransferase, AST=aspartate aminotransferase, GGT=gamma-glutamyl transferase, LDH=lactate dehydrogenase, BUN=blood urea nitrogen.
Outcome measures
| Measure |
Placebo
n=44 Participants
Participants received BG00012 placebo for 8 weeks and premedication with ASA placebo during the first 4 weeks.
|
BG00012
n=43 Participants
Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA placebo during the first 4 weeks.
|
BG00012 + ASA
n=44 Participants
Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA during the first 4 weeks.
|
BG00012 Slow Titration
n=43 Participants
Participants received BG00012 for 8 weeks (120 mg once daily \[QD\] during Week 1, 120 mg BID during Week 2, 240 mg AM/120mg PM during Week 3, and 240 mg BID during Week 4, and 240 mg BID during Weeks 5 to 8) and premedication with ASA placebo during the first 4 weeks.
|
|---|---|---|---|---|
|
Clinical Laboratory Shifts From Baseline in Reported Values: Blood Chemistry
Potassium: shift to low: n=44, 43, 43, 42
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Clinical Laboratory Shifts From Baseline in Reported Values: Blood Chemistry
BUN: shift to low; n=44, 43, 43, 42
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Clinical Laboratory Shifts From Baseline in Reported Values: Blood Chemistry
BUN: shift to high; n=44, 43, 41, 42
|
1 participants
|
0 participants
|
1 participants
|
1 participants
|
|
Clinical Laboratory Shifts From Baseline in Reported Values: Blood Chemistry
Creatinine: shift to low; n=44, 43, 43, 42
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
|
Clinical Laboratory Shifts From Baseline in Reported Values: Blood Chemistry
Creatinine: shift to high; n=44, 43, 43, 42
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Clinical Laboratory Shifts From Baseline in Reported Values: Blood Chemistry
Uric Acid: shift to low; n=44, 43, 43, 42
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Clinical Laboratory Shifts From Baseline in Reported Values: Blood Chemistry
Uric Acid: shift to high; n=44, 43, 43, 42
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Clinical Laboratory Shifts From Baseline in Reported Values: Blood Chemistry
Sodium: shift to low; n=44, 43, 43, 42
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Clinical Laboratory Shifts From Baseline in Reported Values: Blood Chemistry
Sodium: shift to high; n=44, 43, 43, 42
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Clinical Laboratory Shifts From Baseline in Reported Values: Blood Chemistry
Potassium: shift to high: n=44, 42, 42, 41
|
1 participants
|
1 participants
|
1 participants
|
0 participants
|
|
Clinical Laboratory Shifts From Baseline in Reported Values: Blood Chemistry
Chloride: shift to low; n=44, 43, 43, 42
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Clinical Laboratory Shifts From Baseline in Reported Values: Blood Chemistry
Chloride: shift to high; n=44, 43, 43, 42
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Clinical Laboratory Shifts From Baseline in Reported Values: Blood Chemistry
Bicarbonate: shift to low; n=44, 43, 43, 42
|
1 participants
|
1 participants
|
1 participants
|
0 participants
|
|
Clinical Laboratory Shifts From Baseline in Reported Values: Blood Chemistry
Bicarbonate: shift to high; n=44, 43, 43, 42
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Clinical Laboratory Shifts From Baseline in Reported Values: Blood Chemistry
Calcium: shift to low; n=44, 42, 43, 42
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Clinical Laboratory Shifts From Baseline in Reported Values: Blood Chemistry
Calcium: shift to high; n=44, 43, 43, 42
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Clinical Laboratory Shifts From Baseline in Reported Values: Blood Chemistry
Glucose: shift to low; n=43, 43, 41, 41
|
3 participants
|
1 participants
|
1 participants
|
2 participants
|
|
Clinical Laboratory Shifts From Baseline in Reported Values: Blood Chemistry
Glucose: shift to high; n=44, 43, 43, 42
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Clinical Laboratory Shifts From Baseline in Reported Values: Blood Chemistry
Magnesium: shift to low; n=44, 43, 43, 42
|
1 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Clinical Laboratory Shifts From Baseline in Reported Values: Blood Chemistry
Magnesium: shift to high; n=44, 43, 43, 42
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Clinical Laboratory Shifts From Baseline in Reported Values: Blood Chemistry
Phosphorus: shift to low; n=44, 43, 43, 41
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
|
Clinical Laboratory Shifts From Baseline in Reported Values: Blood Chemistry
Phosphorus: shift to high; n=44, 43, 43, 42
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Clinical Laboratory Shifts From Baseline in Reported Values: Blood Chemistry
Albumin: shift to low; n=44, 43, 43, 42
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Clinical Laboratory Shifts From Baseline in Reported Values: Blood Chemistry
ALP: shift to high; n=44, 42, 43, 42
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Clinical Laboratory Shifts From Baseline in Reported Values: Blood Chemistry
ALT: shift to high; n=44, 42, 43, 42
|
1 participants
|
2 participants
|
5 participants
|
2 participants
|
|
Clinical Laboratory Shifts From Baseline in Reported Values: Blood Chemistry
AST: shift to high; n=44, 43, 43, 41
|
2 participants
|
3 participants
|
4 participants
|
1 participants
|
|
Clinical Laboratory Shifts From Baseline in Reported Values: Blood Chemistry
GGT: shift to high; n=44, 41, 43, 42
|
0 participants
|
0 participants
|
2 participants
|
0 participants
|
|
Clinical Laboratory Shifts From Baseline in Reported Values: Blood Chemistry
LDH: shift to low; n=44, 43, 43, 42
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Clinical Laboratory Shifts From Baseline in Reported Values: Blood Chemistry
LDH: shift to high; n=44, 43, 43, 42
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Clinical Laboratory Shifts From Baseline in Reported Values: Blood Chemistry
Total bilirubin: shift to high; n=44, 42, 42, 40
|
1 participants
|
1 participants
|
0 participants
|
1 participants
|
|
Clinical Laboratory Shifts From Baseline in Reported Values: Blood Chemistry
Albumin: shift to high; n=44, 43, 43, 42
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Clinical Laboratory Shifts From Baseline in Reported Values: Blood Chemistry
Direct bilirubin: shift to high; n=44, 43, 43, 40
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Clinical Laboratory Shifts From Baseline in Reported Values: Blood Chemistry
Total protein: shift to low; n=44, 41, 43, 41
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Clinical Laboratory Shifts From Baseline in Reported Values: Blood Chemistry
Total protein: shift to high; n=44, 43, 43, 42
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Day 1 to Week 8Population: Safety population: participants who received at least 1 dose of study treatment (BG00012/BG00012 placebo); n=number of participants whose baseline value was not low (or high or positive) and who had at least 1 post-baseline value.
Number of participants with clinical laboratory shifts from baseline in urinalysis values.Shift to low includes normal to low, high to low, and unknown to low. Shift to high includes normal to high, low to high, and unknown to high. Shift to positive includes negative to positive and unknown to positive. RBC=red blood cells, WBC=white blood cells.
Outcome measures
| Measure |
Placebo
n=44 Participants
Participants received BG00012 placebo for 8 weeks and premedication with ASA placebo during the first 4 weeks.
|
BG00012
n=43 Participants
Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA placebo during the first 4 weeks.
|
BG00012 + ASA
n=43 Participants
Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA during the first 4 weeks.
|
BG00012 Slow Titration
n=42 Participants
Participants received BG00012 for 8 weeks (120 mg once daily \[QD\] during Week 1, 120 mg BID during Week 2, 240 mg AM/120mg PM during Week 3, and 240 mg BID during Week 4, and 240 mg BID during Weeks 5 to 8) and premedication with ASA placebo during the first 4 weeks.
|
|---|---|---|---|---|
|
Clinical Laboratory Shifts From Baseline in Reported Values: Urinalysis
Specific gravity: shift to low; n=44, 43, 43, 42
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Clinical Laboratory Shifts From Baseline in Reported Values: Urinalysis
Specific gravity: shift to high; n=44, 42, 43, 42
|
0 participants
|
0 participants
|
2 participants
|
0 participants
|
|
Clinical Laboratory Shifts From Baseline in Reported Values: Urinalysis
pH: shift to low; n=44, 43, 43, 42
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Clinical Laboratory Shifts From Baseline in Reported Values: Urinalysis
pH: shift to high; n=44, 43, 43, 42
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Clinical Laboratory Shifts From Baseline in Reported Values: Urinalysis
Blood: shift to positive; n=42, 39, 39, 42
|
3 participants
|
6 participants
|
1 participants
|
2 participants
|
|
Clinical Laboratory Shifts From Baseline in Reported Values: Urinalysis
Color: shift to positive; n=41, 43, 41, 39
|
2 participants
|
1 participants
|
4 participants
|
5 participants
|
|
Clinical Laboratory Shifts From Baseline in Reported Values: Urinalysis
Glucose: shift to positive; n=44, 43, 43, 41
|
0 participants
|
2 participants
|
1 participants
|
0 participants
|
|
Clinical Laboratory Shifts From Baseline in Reported Values: Urinalysis
Ketones: shift to positive; n=44, 43, 43, 42
|
1 participants
|
7 participants
|
9 participants
|
6 participants
|
|
Clinical Laboratory Shifts From Baseline in Reported Values: Urinalysis
Protein: shift to positive; n=44, 41, 43, 41
|
0 participants
|
1 participants
|
1 participants
|
1 participants
|
|
Clinical Laboratory Shifts From Baseline in Reported Values: Urinalysis
Microscopic RBC; n=44, 40, 40, 41
|
3 participants
|
4 participants
|
1 participants
|
2 participants
|
|
Clinical Laboratory Shifts From Baseline in Reported Values: Urinalysis
Microscopic WBC; n=43, 40, 41, 42
|
4 participants
|
9 participants
|
3 participants
|
3 participants
|
SECONDARY outcome
Timeframe: Day 1 to Week 8Population: Safety population: participants who received at least 1 dose of study treatment (BG00012/BG00012 placebo); n=number of participants who had a baseline value and had at least 1 post-baseline value.
↑=increase; ↓=decrease; BL=baseline; bpm=beats per minute; SBP=systolic blood pressure; DBP=diastolic blood pressure; b/m=breaths per minute
Outcome measures
| Measure |
Placebo
n=44 Participants
Participants received BG00012 placebo for 8 weeks and premedication with ASA placebo during the first 4 weeks.
|
BG00012
n=43 Participants
Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA placebo during the first 4 weeks.
|
BG00012 + ASA
n=43 Participants
Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA during the first 4 weeks.
|
BG00012 Slow Titration
n=42 Participants
Participants received BG00012 for 8 weeks (120 mg once daily \[QD\] during Week 1, 120 mg BID during Week 2, 240 mg AM/120mg PM during Week 3, and 240 mg BID during Week 4, and 240 mg BID during Weeks 5 to 8) and premedication with ASA placebo during the first 4 weeks.
|
|---|---|---|---|---|
|
Number of Participants With Abnormalities in Vital Signs
Temperature >38°C + ↑ from BL of ≥1°C
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Abnormalities in Vital Signs
Pulse >120 bpm or ↑ from BL of >20 bpm
|
8 participants
|
10 participants
|
20 participants
|
17 participants
|
|
Number of Participants With Abnormalities in Vital Signs
Pulse <50 bpm or ↓ from BL of >20 bpm
|
11 participants
|
4 participants
|
3 participants
|
4 participants
|
|
Number of Participants With Abnormalities in Vital Signs
SBP >180 mm Hg or ↑ from BL of >40 mm Hg
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Abnormalities in Vital Signs
SBP <90 mm Hg or ↓ from BL of >30 mm Hg
|
1 participants
|
2 participants
|
1 participants
|
1 participants
|
|
Number of Participants With Abnormalities in Vital Signs
DBP >105 mm Hg or ↑ from BL of >30 mm Hg
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Abnormalities in Vital Signs
DBP <50 mm Hg or ↓ from BL of >20 mm Hg
|
1 participants
|
3 participants
|
0 participants
|
1 participants
|
|
Number of Participants With Abnormalities in Vital Signs
Respiration rate >25 b/m or ↑ from BL of ≥50%
|
1 participants
|
2 participants
|
3 participants
|
3 participants
|
|
Number of Participants With Abnormalities in Vital Signs
Respiration rate 10 b/m or ↓ from BL of ≥50%
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Day 1 to Week 8Population: Safety population: participants who received at least 1 dose of study treatment (BG00012/BG00012 placebo); n=number of participants whose baseline value was not abnormal and who had at least 1 post-baseline value.
Shift to 'abnormal, not adverse event' includes unknown or normal to 'abnormal, not adverse event.' Shift to 'abnormal, adverse event' includes unknown or normal to 'abnormal, adverse event.'
Outcome measures
| Measure |
Placebo
n=44 Participants
Participants received BG00012 placebo for 8 weeks and premedication with ASA placebo during the first 4 weeks.
|
BG00012
n=43 Participants
Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA placebo during the first 4 weeks.
|
BG00012 + ASA
n=43 Participants
Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA during the first 4 weeks.
|
BG00012 Slow Titration
n=42 Participants
Participants received BG00012 for 8 weeks (120 mg once daily \[QD\] during Week 1, 120 mg BID during Week 2, 240 mg AM/120mg PM during Week 3, and 240 mg BID during Week 4, and 240 mg BID during Weeks 5 to 8) and premedication with ASA placebo during the first 4 weeks.
|
|---|---|---|---|---|
|
Number of Participants With Shifts From Baseline in Electrocardiogram (ECG) Results
Shift to abnormal, not adverse event
|
2 participants
|
3 participants
|
2 participants
|
4 participants
|
|
Number of Participants With Shifts From Baseline in Electrocardiogram (ECG) Results
Shift to abnormal, adverse event
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Day 1 to Week 8Population: Participants with a flushing event.
For participants with more than 1 flushing episode during a visit interval, the average duration for the visit interval was used. The average duration is calculated as: the total duration of all flushing episodes / the total number of flushing episodes.
Outcome measures
| Measure |
Placebo
n=18 Participants
Participants received BG00012 placebo for 8 weeks and premedication with ASA placebo during the first 4 weeks.
|
BG00012
n=39 Participants
Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA placebo during the first 4 weeks.
|
BG00012 + ASA
n=35 Participants
Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA during the first 4 weeks.
|
BG00012 Slow Titration
n=41 Participants
Participants received BG00012 for 8 weeks (120 mg once daily \[QD\] during Week 1, 120 mg BID during Week 2, 240 mg AM/120mg PM during Week 3, and 240 mg BID during Week 4, and 240 mg BID during Weeks 5 to 8) and premedication with ASA placebo during the first 4 weeks.
|
|---|---|---|---|---|
|
Duration of Flushing Events During the Overall Treatment Period, Based on MFSS
|
98.4 minutes
Standard Deviation 92.04
|
63.2 minutes
Standard Deviation 34.55
|
69.8 minutes
Standard Deviation 78.09
|
68.9 minutes
Standard Deviation 52.82
|
SECONDARY outcome
Timeframe: Week 1 to Week 4Population: Participants with a flushing event.
For participants with more than 1 flushing episode during a visit interval, the average duration for the visit interval was used. The average duration is calculated as: the total duration of all flushing episodes / the total number of flushing episodes.
Outcome measures
| Measure |
Placebo
n=18 Participants
Participants received BG00012 placebo for 8 weeks and premedication with ASA placebo during the first 4 weeks.
|
BG00012
n=37 Participants
Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA placebo during the first 4 weeks.
|
BG00012 + ASA
n=31 Participants
Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA during the first 4 weeks.
|
BG00012 Slow Titration
n=41 Participants
Participants received BG00012 for 8 weeks (120 mg once daily \[QD\] during Week 1, 120 mg BID during Week 2, 240 mg AM/120mg PM during Week 3, and 240 mg BID during Week 4, and 240 mg BID during Weeks 5 to 8) and premedication with ASA placebo during the first 4 weeks.
|
|---|---|---|---|---|
|
Duration of Flushing Events During the Weeks 1 to 4 (Combined), Based on MFSS
|
117.6 minutes
Standard Deviation 143.90
|
67.6 minutes
Standard Deviation 43.83
|
89.8 minutes
Standard Deviation 140.67
|
69.2 minutes
Standard Deviation 53.00
|
SECONDARY outcome
Timeframe: Week 5 to Week 8Population: Participants with a flushing event.
For participants with more than 1 flushing episode during a visit interval, the average duration for the visit interval was used. The average duration is calculated as: the total duration of all flushing episodes / the total number of flushing episodes.
Outcome measures
| Measure |
Placebo
n=10 Participants
Participants received BG00012 placebo for 8 weeks and premedication with ASA placebo during the first 4 weeks.
|
BG00012
n=32 Participants
Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA placebo during the first 4 weeks.
|
BG00012 + ASA
n=26 Participants
Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA during the first 4 weeks.
|
BG00012 Slow Titration
n=28 Participants
Participants received BG00012 for 8 weeks (120 mg once daily \[QD\] during Week 1, 120 mg BID during Week 2, 240 mg AM/120mg PM during Week 3, and 240 mg BID during Week 4, and 240 mg BID during Weeks 5 to 8) and premedication with ASA placebo during the first 4 weeks.
|
|---|---|---|---|---|
|
Duration of Flushing Events During the Weeks 5 to 8 (Combined), Based on MFSS
|
113.2 minutes
Standard Deviation 160.82
|
55.7 minutes
Standard Deviation 32.37
|
73.2 minutes
Standard Deviation 66.34
|
56.0 minutes
Standard Deviation 35.79
|
SECONDARY outcome
Timeframe: Day 1 to Week 8Population: Participants in the safety population who have at least 1 diary entry of the relevant questionnaire data during the visit interval; n=number of participants with the given GI episode during the visit interval.
Duration is calculated as follows: \[(GI side effect) end date/time - (GI side effect) start date/time\]/3600. For GI side effects with no end date, the end date is imputed using the last diary date/time. For subjects with more than 1 GI episode during a visit interval, the average duration for the study visit interval is used. The average duration is calculated as the total duration of the GI side effect / the total number of GI side effects.
Outcome measures
| Measure |
Placebo
n=44 Participants
Participants received BG00012 placebo for 8 weeks and premedication with ASA placebo during the first 4 weeks.
|
BG00012
n=43 Participants
Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA placebo during the first 4 weeks.
|
BG00012 + ASA
n=43 Participants
Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA during the first 4 weeks.
|
BG00012 Slow Titration
n=42 Participants
Participants received BG00012 for 8 weeks (120 mg once daily \[QD\] during Week 1, 120 mg BID during Week 2, 240 mg AM/120mg PM during Week 3, and 240 mg BID during Week 4, and 240 mg BID during Weeks 5 to 8) and premedication with ASA placebo during the first 4 weeks.
|
|---|---|---|---|---|
|
Duration of Acute GI Episodes During the Overall Treatment Period, Based on MAGISS
Lower abdominal pain; n=12, 19, 17, 16
|
6.65 hours
Standard Deviation 5.307
|
13.93 hours
Standard Deviation 26.850
|
10.84 hours
Standard Deviation 16.312
|
7.75 hours
Standard Deviation 10.456
|
|
Duration of Acute GI Episodes During the Overall Treatment Period, Based on MAGISS
Nausea; n=12, 21, 21, 22
|
9.74 hours
Standard Deviation 17.008
|
7.05 hours
Standard Deviation 10.498
|
10.01 hours
Standard Deviation 18.283
|
2.98 hours
Standard Deviation 3.247
|
|
Duration of Acute GI Episodes During the Overall Treatment Period, Based on MAGISS
Diarrhea; n=20, 20 17, 15
|
5.57 hours
Standard Deviation 10.037
|
2.92 hours
Standard Deviation 3.329
|
14.66 hours
Standard Deviation 32.686
|
4.97 hours
Standard Deviation 9.687
|
|
Duration of Acute GI Episodes During the Overall Treatment Period, Based on MAGISS
Upper abdominal pain; n=17, 14, 19, 19
|
19.08 hours
Standard Deviation 46.873
|
6.67 hours
Standard Deviation 16.916
|
15.88 hours
Standard Deviation 25.307
|
3.83 hours
Standard Deviation 5.712
|
|
Duration of Acute GI Episodes During the Overall Treatment Period, Based on MAGISS
Vomiting; n=3, 3, 3, 2
|
5.87 hours
Standard Deviation 5.033
|
10.08 hours
Standard Deviation 8.755
|
1.88 hours
Standard Deviation 2.717
|
0.75 hours
Standard Deviation 0.707
|
|
Duration of Acute GI Episodes During the Overall Treatment Period, Based on MAGISS
Indigestion; n=12, 13, 12, 12
|
4.76 hours
Standard Deviation 8.203
|
16.49 hours
Standard Deviation 28.865
|
3.80 hours
Standard Deviation 2.543
|
4.91 hours
Standard Deviation 8.263
|
|
Duration of Acute GI Episodes During the Overall Treatment Period, Based on MAGISS
Constipation; n=6, 8, 13, 11
|
20.49 hours
Standard Deviation 12.040
|
28.20 hours
Standard Deviation 35.425
|
14.26 hours
Standard Deviation 9.783
|
20.90 hours
Standard Deviation 18.060
|
|
Duration of Acute GI Episodes During the Overall Treatment Period, Based on MAGISS
Bloating; n=14, 14, 21, 12
|
9.50 hours
Standard Deviation 9.066
|
16.91 hours
Standard Deviation 27.128
|
9.68 hours
Standard Deviation 10.108
|
77.24 hours
Standard Deviation 125.961
|
|
Duration of Acute GI Episodes During the Overall Treatment Period, Based on MAGISS
Flatulence; n=23, 20, 22, 20
|
16.41 hours
Standard Deviation 44.149
|
9.06 hours
Standard Deviation 9.626
|
68.93 hours
Standard Deviation 290.248
|
63.84 hours
Standard Deviation 180.597
|
SECONDARY outcome
Timeframe: Week 1 to Week 4Population: Participants in the safety population who have at least 1 diary entry of the relevant questionnaire data during the visit interval; n=number of participants with the given GI episode during the visit interval.
Duration is calculated as follows: \[(GI side effect) end date/time - (GI side effect) start date/time\]/3600. For GI side effects with no end date, the end date is imputed using the last diary date/time. For subjects with more than 1 GI episode during a visit interval, the average duration for the study visit interval is used. The average duration is calculated as the total duration of the GI side effect / the total number of GI side effects.
Outcome measures
| Measure |
Placebo
n=44 Participants
Participants received BG00012 placebo for 8 weeks and premedication with ASA placebo during the first 4 weeks.
|
BG00012
n=43 Participants
Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA placebo during the first 4 weeks.
|
BG00012 + ASA
n=43 Participants
Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA during the first 4 weeks.
|
BG00012 Slow Titration
n=42 Participants
Participants received BG00012 for 8 weeks (120 mg once daily \[QD\] during Week 1, 120 mg BID during Week 2, 240 mg AM/120mg PM during Week 3, and 240 mg BID during Week 4, and 240 mg BID during Weeks 5 to 8) and premedication with ASA placebo during the first 4 weeks.
|
|---|---|---|---|---|
|
Duration of Acute GI Episodes During Weeks 1 to 4 (Combined), Based on MAGISS
Nausea; n=10, 18, 18, 20
|
10.47 hours
Standard Deviation 18.678
|
7.23 hours
Standard Deviation 10.916
|
11.18 hours
Standard Deviation 19.568
|
2.86 hours
Standard Deviation 3.359
|
|
Duration of Acute GI Episodes During Weeks 1 to 4 (Combined), Based on MAGISS
Diarrhea; n=13, 20, 14, 14
|
5.20 hours
Standard Deviation 11.309
|
2.53 hours
Standard Deviation 3.013
|
16.04 hours
Standard Deviation 35.945
|
4.97 hours
Standard Deviation 10.074
|
|
Duration of Acute GI Episodes During Weeks 1 to 4 (Combined), Based on MAGISS
Upper abdominal pain; n=14, 14, 17, 15
|
21.37 hours
Standard Deviation 51.620
|
6.81 hours
Standard Deviation 16.876
|
17.65 hours
Standard Deviation 26.294
|
4.31 hours
Standard Deviation 6.350
|
|
Duration of Acute GI Episodes During Weeks 1 to 4 (Combined), Based on MAGISS
Lower abdominal pain; n=9, 18, 14, 13
|
5.40 hours
Standard Deviation 4.658
|
14.20 hours
Standard Deviation 27.637
|
12.51 hours
Standard Deviation 17.621
|
6.30 hours
Standard Deviation 6.080
|
|
Duration of Acute GI Episodes During Weeks 1 to 4 (Combined), Based on MAGISS
Vomiting; n=2, 2, 2, 2
|
4.31 hours
Standard Deviation 5.999
|
5.63 hours
Standard Deviation 5.834
|
2.53 hours
Standard Deviation 3.500
|
0.75 hours
Standard Deviation 0.707
|
|
Duration of Acute GI Episodes During Weeks 1 to 4 (Combined), Based on MAGISS
Indigestion; n=11, 11, 9, 11
|
5.08 hours
Standard Deviation 8.552
|
29.00 hours
Standard Deviation 48.416
|
3.93 hours
Standard Deviation 2.873
|
5.05 hours
Standard Deviation 8.665
|
|
Duration of Acute GI Episodes During Weeks 1 to 4 (Combined), Based on MAGISS
Constipation; n=4, 8, 11, 11
|
17.05 hours
Standard Deviation 7.452
|
27.61 hours
Standard Deviation 35.177
|
15.12 hours
Standard Deviation 7.761
|
21.28 hours
Standard Deviation 19.298
|
|
Duration of Acute GI Episodes During Weeks 1 to 4 (Combined), Based on MAGISS
Bloating; n=9, 14, 19, 11
|
6.70 hours
Standard Deviation 6.792
|
13.81 hours
Standard Deviation 25.321
|
11.07 hours
Standard Deviation 10.631
|
95.69 hours
Standard Deviation 186.884
|
|
Duration of Acute GI Episodes During Weeks 1 to 4 (Combined), Based on MAGISS
Flatulence; n=21, 17, 22, 19
|
12.83 hours
Standard Deviation 27.948
|
9.34 hours
Standard Deviation 12.946
|
35.86 hours
Standard Deviation 134.748
|
61.13 hours
Standard Deviation 168.572
|
SECONDARY outcome
Timeframe: Week 5 to Week 8Population: Participants in the safety population who have at least 1 diary entry of the relevant questionnaire data during the visit interval; n=number of participants with the given GI episode during the visit interval.
Duration is calculated as follows: \[(GI side effect) end date/time - (GI side effect) start date/time\]/3600. For GI side effects with no end date, the end date is imputed using the last diary date/time. For subjects with more than 1 GI episode during a visit interval, the average duration for the study visit interval is used. The average duration is calculated as the total duration of the GI side effect / the total number of GI side effects.
Outcome measures
| Measure |
Placebo
n=44 Participants
Participants received BG00012 placebo for 8 weeks and premedication with ASA placebo during the first 4 weeks.
|
BG00012
n=43 Participants
Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA placebo during the first 4 weeks.
|
BG00012 + ASA
n=43 Participants
Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA during the first 4 weeks.
|
BG00012 Slow Titration
n=42 Participants
Participants received BG00012 for 8 weeks (120 mg once daily \[QD\] during Week 1, 120 mg BID during Week 2, 240 mg AM/120mg PM during Week 3, and 240 mg BID during Week 4, and 240 mg BID during Weeks 5 to 8) and premedication with ASA placebo during the first 4 weeks.
|
|---|---|---|---|---|
|
Duration of Acute GI Episodes During Weeks 5 to 8 (Combined), Based on MAGISS
Constipation; n=5, 2, 4, 4
|
23.35 hours
Standard Deviation 17.110
|
15.47 hours
Standard Deviation 21.143
|
21.30 hours
Standard Deviation 23.181
|
18.24 hours
Standard Deviation 8.644
|
|
Duration of Acute GI Episodes During Weeks 5 to 8 (Combined), Based on MAGISS
Nausea; n=4, 9, 6, 9
|
3.96 hours
Standard Deviation 3.668
|
4.34 hours
Standard Deviation 6.256
|
2.66 hours
Standard Deviation 1.390
|
2.34 hours
Standard Deviation 1.904
|
|
Duration of Acute GI Episodes During Weeks 5 to 8 (Combined), Based on MAGISS
Diarrhea; n=12, 13, 6, 8
|
4.50 hours
Standard Deviation 6.389
|
6.62 hours
Standard Deviation 12.782
|
7.05 hours
Standard Deviation 8.002
|
2.14 hours
Standard Deviation 2.007
|
|
Duration of Acute GI Episodes During Weeks 5 to 8 (Combined), Based on MAGISS
Upper abdominal pain; n=6, 5, 5, 5
|
5.29 hours
Standard Deviation 5.785
|
1.12 hours
Standard Deviation 0.965
|
1.86 hours
Standard Deviation 1.491
|
1.73 hours
Standard Deviation 1.440
|
|
Duration of Acute GI Episodes During Weeks 5 to 8 (Combined), Based on MAGISS
Lower abdominal pain; n=7, 5, 5, 9
|
6.63 hours
Standard Deviation 7.739
|
3.98 hours
Standard Deviation 3.516
|
2.84 hours
Standard Deviation 1.477
|
22.54 hours
Standard Deviation 61.180
|
|
Duration of Acute GI Episodes During Weeks 5 to 8 (Combined), Based on MAGISS
Vomiting; n=1, 1, 1, 0
|
9.00 hours
Standard Deviation NA
n=1 participant
|
19.00 hours
Standard Deviation NA
n=1 participant
|
0.58 hours
Standard Deviation NA
n=1 participant
|
NA hours
Standard Deviation NA
n=0 participants
|
|
Duration of Acute GI Episodes During Weeks 5 to 8 (Combined), Based on MAGISS
Indigestion; n=6, 7, 7, 5
|
2.43 hours
Standard Deviation 1.569
|
2.57 hours
Standard Deviation 2.586
|
5.02 hours
Standard Deviation 6.944
|
1.63 hours
Standard Deviation 1.101
|
|
Duration of Acute GI Episodes During Weeks 5 to 8 (Combined), Based on MAGISS
Bloating; n=7, 8, 7, 8
|
12.49 hours
Standard Deviation 10.595
|
18.52 hours
Standard Deviation 25.682
|
4.16 hours
Standard Deviation 3.018
|
85.64 hours
Standard Deviation 115.872
|
|
Duration of Acute GI Episodes During Weeks 5 to 8 (Combined), Based on MAGISS
Flatulence; n=9, 13, 7, 10
|
44.67 hours
Standard Deviation 112.426
|
7.21 hours
Standard Deviation 10.051
|
105.86 hours
Standard Deviation 275.125
|
18.48 hours
Standard Deviation 26.347
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
BG00012
Serious events: 1 serious events
Other events: 12 other events
Deaths: 0 deaths
BG00012 + ASA
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
BG00012 Slow Titration
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=44 participants at risk
Participants received BG00012 placebo for 8 weeks and premedication with ASA placebo during the first 4 weeks.
|
BG00012
n=43 participants at risk
Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA placebo during the first 4 weeks.
|
BG00012 + ASA
n=43 participants at risk
Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA during the first 4 weeks.
|
BG00012 Slow Titration
n=42 participants at risk
Participants received BG00012 for 8 weeks (120 mg once daily \[QD\] during Week 1, 120 mg BID during Week 2, 240 mg AM/120mg PM during Week 3, and 240 mg BID during Week 4, and 240 mg BID during Weeks 5 to 8) and premedication with ASA placebo during the first 4 weeks.
|
|---|---|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian germ cell teratoma stage I
|
0.00%
0/44 • AEs: from the administration of the first dose of study treatment to the Safety Follow-up (approximately 9 weeks). SAEs: from signing of informed consent to the Safety Follow-up (up to approximately 13 weeks).
Flushing and GI events/symptoms captured separately in the eDiary were not recorded on the AE eCRF unless the events/symptoms led to discontinuation or withdrawal from the study, were classified as SAEs, or were ongoing at the final eDiary entry.
|
2.3%
1/43 • AEs: from the administration of the first dose of study treatment to the Safety Follow-up (approximately 9 weeks). SAEs: from signing of informed consent to the Safety Follow-up (up to approximately 13 weeks).
Flushing and GI events/symptoms captured separately in the eDiary were not recorded on the AE eCRF unless the events/symptoms led to discontinuation or withdrawal from the study, were classified as SAEs, or were ongoing at the final eDiary entry.
|
0.00%
0/43 • AEs: from the administration of the first dose of study treatment to the Safety Follow-up (approximately 9 weeks). SAEs: from signing of informed consent to the Safety Follow-up (up to approximately 13 weeks).
Flushing and GI events/symptoms captured separately in the eDiary were not recorded on the AE eCRF unless the events/symptoms led to discontinuation or withdrawal from the study, were classified as SAEs, or were ongoing at the final eDiary entry.
|
0.00%
0/42 • AEs: from the administration of the first dose of study treatment to the Safety Follow-up (approximately 9 weeks). SAEs: from signing of informed consent to the Safety Follow-up (up to approximately 13 weeks).
Flushing and GI events/symptoms captured separately in the eDiary were not recorded on the AE eCRF unless the events/symptoms led to discontinuation or withdrawal from the study, were classified as SAEs, or were ongoing at the final eDiary entry.
|
Other adverse events
| Measure |
Placebo
n=44 participants at risk
Participants received BG00012 placebo for 8 weeks and premedication with ASA placebo during the first 4 weeks.
|
BG00012
n=43 participants at risk
Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA placebo during the first 4 weeks.
|
BG00012 + ASA
n=43 participants at risk
Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA during the first 4 weeks.
|
BG00012 Slow Titration
n=42 participants at risk
Participants received BG00012 for 8 weeks (120 mg once daily \[QD\] during Week 1, 120 mg BID during Week 2, 240 mg AM/120mg PM during Week 3, and 240 mg BID during Week 4, and 240 mg BID during Weeks 5 to 8) and premedication with ASA placebo during the first 4 weeks.
|
|---|---|---|---|---|
|
Infections and infestations
Upper respiratory tract infection
|
2.3%
1/44 • AEs: from the administration of the first dose of study treatment to the Safety Follow-up (approximately 9 weeks). SAEs: from signing of informed consent to the Safety Follow-up (up to approximately 13 weeks).
Flushing and GI events/symptoms captured separately in the eDiary were not recorded on the AE eCRF unless the events/symptoms led to discontinuation or withdrawal from the study, were classified as SAEs, or were ongoing at the final eDiary entry.
|
7.0%
3/43 • AEs: from the administration of the first dose of study treatment to the Safety Follow-up (approximately 9 weeks). SAEs: from signing of informed consent to the Safety Follow-up (up to approximately 13 weeks).
Flushing and GI events/symptoms captured separately in the eDiary were not recorded on the AE eCRF unless the events/symptoms led to discontinuation or withdrawal from the study, were classified as SAEs, or were ongoing at the final eDiary entry.
|
16.3%
7/43 • AEs: from the administration of the first dose of study treatment to the Safety Follow-up (approximately 9 weeks). SAEs: from signing of informed consent to the Safety Follow-up (up to approximately 13 weeks).
Flushing and GI events/symptoms captured separately in the eDiary were not recorded on the AE eCRF unless the events/symptoms led to discontinuation or withdrawal from the study, were classified as SAEs, or were ongoing at the final eDiary entry.
|
2.4%
1/42 • AEs: from the administration of the first dose of study treatment to the Safety Follow-up (approximately 9 weeks). SAEs: from signing of informed consent to the Safety Follow-up (up to approximately 13 weeks).
Flushing and GI events/symptoms captured separately in the eDiary were not recorded on the AE eCRF unless the events/symptoms led to discontinuation or withdrawal from the study, were classified as SAEs, or were ongoing at the final eDiary entry.
|
|
Blood and lymphatic system disorders
Eosinophilia
|
0.00%
0/44 • AEs: from the administration of the first dose of study treatment to the Safety Follow-up (approximately 9 weeks). SAEs: from signing of informed consent to the Safety Follow-up (up to approximately 13 weeks).
Flushing and GI events/symptoms captured separately in the eDiary were not recorded on the AE eCRF unless the events/symptoms led to discontinuation or withdrawal from the study, were classified as SAEs, or were ongoing at the final eDiary entry.
|
2.3%
1/43 • AEs: from the administration of the first dose of study treatment to the Safety Follow-up (approximately 9 weeks). SAEs: from signing of informed consent to the Safety Follow-up (up to approximately 13 weeks).
Flushing and GI events/symptoms captured separately in the eDiary were not recorded on the AE eCRF unless the events/symptoms led to discontinuation or withdrawal from the study, were classified as SAEs, or were ongoing at the final eDiary entry.
|
7.0%
3/43 • AEs: from the administration of the first dose of study treatment to the Safety Follow-up (approximately 9 weeks). SAEs: from signing of informed consent to the Safety Follow-up (up to approximately 13 weeks).
Flushing and GI events/symptoms captured separately in the eDiary were not recorded on the AE eCRF unless the events/symptoms led to discontinuation or withdrawal from the study, were classified as SAEs, or were ongoing at the final eDiary entry.
|
4.8%
2/42 • AEs: from the administration of the first dose of study treatment to the Safety Follow-up (approximately 9 weeks). SAEs: from signing of informed consent to the Safety Follow-up (up to approximately 13 weeks).
Flushing and GI events/symptoms captured separately in the eDiary were not recorded on the AE eCRF unless the events/symptoms led to discontinuation or withdrawal from the study, were classified as SAEs, or were ongoing at the final eDiary entry.
|
|
Nervous system disorders
Headache
|
9.1%
4/44 • AEs: from the administration of the first dose of study treatment to the Safety Follow-up (approximately 9 weeks). SAEs: from signing of informed consent to the Safety Follow-up (up to approximately 13 weeks).
Flushing and GI events/symptoms captured separately in the eDiary were not recorded on the AE eCRF unless the events/symptoms led to discontinuation or withdrawal from the study, were classified as SAEs, or were ongoing at the final eDiary entry.
|
20.9%
9/43 • AEs: from the administration of the first dose of study treatment to the Safety Follow-up (approximately 9 weeks). SAEs: from signing of informed consent to the Safety Follow-up (up to approximately 13 weeks).
Flushing and GI events/symptoms captured separately in the eDiary were not recorded on the AE eCRF unless the events/symptoms led to discontinuation or withdrawal from the study, were classified as SAEs, or were ongoing at the final eDiary entry.
|
4.7%
2/43 • AEs: from the administration of the first dose of study treatment to the Safety Follow-up (approximately 9 weeks). SAEs: from signing of informed consent to the Safety Follow-up (up to approximately 13 weeks).
Flushing and GI events/symptoms captured separately in the eDiary were not recorded on the AE eCRF unless the events/symptoms led to discontinuation or withdrawal from the study, were classified as SAEs, or were ongoing at the final eDiary entry.
|
21.4%
9/42 • AEs: from the administration of the first dose of study treatment to the Safety Follow-up (approximately 9 weeks). SAEs: from signing of informed consent to the Safety Follow-up (up to approximately 13 weeks).
Flushing and GI events/symptoms captured separately in the eDiary were not recorded on the AE eCRF unless the events/symptoms led to discontinuation or withdrawal from the study, were classified as SAEs, or were ongoing at the final eDiary entry.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/44 • AEs: from the administration of the first dose of study treatment to the Safety Follow-up (approximately 9 weeks). SAEs: from signing of informed consent to the Safety Follow-up (up to approximately 13 weeks).
Flushing and GI events/symptoms captured separately in the eDiary were not recorded on the AE eCRF unless the events/symptoms led to discontinuation or withdrawal from the study, were classified as SAEs, or were ongoing at the final eDiary entry.
|
0.00%
0/43 • AEs: from the administration of the first dose of study treatment to the Safety Follow-up (approximately 9 weeks). SAEs: from signing of informed consent to the Safety Follow-up (up to approximately 13 weeks).
Flushing and GI events/symptoms captured separately in the eDiary were not recorded on the AE eCRF unless the events/symptoms led to discontinuation or withdrawal from the study, were classified as SAEs, or were ongoing at the final eDiary entry.
|
7.0%
3/43 • AEs: from the administration of the first dose of study treatment to the Safety Follow-up (approximately 9 weeks). SAEs: from signing of informed consent to the Safety Follow-up (up to approximately 13 weeks).
Flushing and GI events/symptoms captured separately in the eDiary were not recorded on the AE eCRF unless the events/symptoms led to discontinuation or withdrawal from the study, were classified as SAEs, or were ongoing at the final eDiary entry.
|
0.00%
0/42 • AEs: from the administration of the first dose of study treatment to the Safety Follow-up (approximately 9 weeks). SAEs: from signing of informed consent to the Safety Follow-up (up to approximately 13 weeks).
Flushing and GI events/symptoms captured separately in the eDiary were not recorded on the AE eCRF unless the events/symptoms led to discontinuation or withdrawal from the study, were classified as SAEs, or were ongoing at the final eDiary entry.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/44 • AEs: from the administration of the first dose of study treatment to the Safety Follow-up (approximately 9 weeks). SAEs: from signing of informed consent to the Safety Follow-up (up to approximately 13 weeks).
Flushing and GI events/symptoms captured separately in the eDiary were not recorded on the AE eCRF unless the events/symptoms led to discontinuation or withdrawal from the study, were classified as SAEs, or were ongoing at the final eDiary entry.
|
4.7%
2/43 • AEs: from the administration of the first dose of study treatment to the Safety Follow-up (approximately 9 weeks). SAEs: from signing of informed consent to the Safety Follow-up (up to approximately 13 weeks).
Flushing and GI events/symptoms captured separately in the eDiary were not recorded on the AE eCRF unless the events/symptoms led to discontinuation or withdrawal from the study, were classified as SAEs, or were ongoing at the final eDiary entry.
|
11.6%
5/43 • AEs: from the administration of the first dose of study treatment to the Safety Follow-up (approximately 9 weeks). SAEs: from signing of informed consent to the Safety Follow-up (up to approximately 13 weeks).
Flushing and GI events/symptoms captured separately in the eDiary were not recorded on the AE eCRF unless the events/symptoms led to discontinuation or withdrawal from the study, were classified as SAEs, or were ongoing at the final eDiary entry.
|
0.00%
0/42 • AEs: from the administration of the first dose of study treatment to the Safety Follow-up (approximately 9 weeks). SAEs: from signing of informed consent to the Safety Follow-up (up to approximately 13 weeks).
Flushing and GI events/symptoms captured separately in the eDiary were not recorded on the AE eCRF unless the events/symptoms led to discontinuation or withdrawal from the study, were classified as SAEs, or were ongoing at the final eDiary entry.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/44 • AEs: from the administration of the first dose of study treatment to the Safety Follow-up (approximately 9 weeks). SAEs: from signing of informed consent to the Safety Follow-up (up to approximately 13 weeks).
Flushing and GI events/symptoms captured separately in the eDiary were not recorded on the AE eCRF unless the events/symptoms led to discontinuation or withdrawal from the study, were classified as SAEs, or were ongoing at the final eDiary entry.
|
4.7%
2/43 • AEs: from the administration of the first dose of study treatment to the Safety Follow-up (approximately 9 weeks). SAEs: from signing of informed consent to the Safety Follow-up (up to approximately 13 weeks).
Flushing and GI events/symptoms captured separately in the eDiary were not recorded on the AE eCRF unless the events/symptoms led to discontinuation or withdrawal from the study, were classified as SAEs, or were ongoing at the final eDiary entry.
|
7.0%
3/43 • AEs: from the administration of the first dose of study treatment to the Safety Follow-up (approximately 9 weeks). SAEs: from signing of informed consent to the Safety Follow-up (up to approximately 13 weeks).
Flushing and GI events/symptoms captured separately in the eDiary were not recorded on the AE eCRF unless the events/symptoms led to discontinuation or withdrawal from the study, were classified as SAEs, or were ongoing at the final eDiary entry.
|
0.00%
0/42 • AEs: from the administration of the first dose of study treatment to the Safety Follow-up (approximately 9 weeks). SAEs: from signing of informed consent to the Safety Follow-up (up to approximately 13 weeks).
Flushing and GI events/symptoms captured separately in the eDiary were not recorded on the AE eCRF unless the events/symptoms led to discontinuation or withdrawal from the study, were classified as SAEs, or were ongoing at the final eDiary entry.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Our agreement is subject to confidentiality but generally the PI can publish, for noncommercial purposes only, results and methods of the trial, but no other Sponsor Confidential Information. PI must give Sponsor no less than 60 days to review any manuscript for a proposed publication and must delay publication for up to an additional 90 days thereafter if Sponsor needs to file any patent application to protect any of Sponsor's intellectual property contained in the proposed publication.
- Publication restrictions are in place
Restriction type: OTHER