Trial Outcomes & Findings for Phase 4 Study of Effect of Aspirin on Flushing in Dimethyl Fumarate-Treated Participants With Relapsing-Remitting Multiple Sclerosis (NCT NCT02090413)
NCT ID: NCT02090413
Last Updated: 2016-12-28
Results Overview
Participant-reported flushing events during the first 4 weeks treatment, 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.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
241 participants
Primary outcome timeframe
Day 2 to Week 4
Results posted on
2016-12-28
Participant Flow
Participant milestones
| Measure |
DMF + ASA-Placebo BID
Dimethyl fumarate (DMF) 120 mg taken twice daily (BID) for the first 7 days and 240 mg BID from Week 2 through Week 48. Acetylsalicylic acid (ASA)-Placebo taken BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
|
DMF + ASA 75 mg QAM
DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 75 mg QAM and ASA-Placebo in the evening from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
|
DMF + ASA 150 mg BID
DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 150 mg BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
|
|---|---|---|---|
|
Overall Study
STARTED
|
81
|
80
|
80
|
|
Overall Study
COMPLETED
|
62
|
60
|
57
|
|
Overall Study
NOT COMPLETED
|
19
|
20
|
23
|
Reasons for withdrawal
| Measure |
DMF + ASA-Placebo BID
Dimethyl fumarate (DMF) 120 mg taken twice daily (BID) for the first 7 days and 240 mg BID from Week 2 through Week 48. Acetylsalicylic acid (ASA)-Placebo taken BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
|
DMF + ASA 75 mg QAM
DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 75 mg QAM and ASA-Placebo in the evening from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
|
DMF + ASA 150 mg BID
DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 150 mg BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
11
|
15
|
20
|
|
Overall Study
Flushing event
|
2
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
2
|
2
|
2
|
|
Overall Study
Investigator Decision
|
1
|
1
|
0
|
|
Overall Study
Other
|
2
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
0
|
Baseline Characteristics
Phase 4 Study of Effect of Aspirin on Flushing in Dimethyl Fumarate-Treated Participants With Relapsing-Remitting Multiple Sclerosis
Baseline characteristics by cohort
| Measure |
DMF + ASA-Placebo BID
n=81 Participants
DMF 120 mg taken BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA-Placebo taken BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
|
DMF + ASA 75 mg QAM
n=80 Participants
DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 75 mg QAM and ASA-Placebo in the evening from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
|
DMF + ASA 150 mg BID
n=80 Participants
DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 150 mg BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
|
Total
n=241 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
40.17 years
STANDARD_DEVIATION 10.63 • n=93 Participants
|
39.48 years
STANDARD_DEVIATION 8.48 • n=4 Participants
|
40.16 years
STANDARD_DEVIATION 8.23 • n=27 Participants
|
39.94 years
STANDARD_DEVIATION 9.15 • n=483 Participants
|
|
Gender
Female
|
59 Participants
n=93 Participants
|
62 Participants
n=4 Participants
|
60 Participants
n=27 Participants
|
181 Participants
n=483 Participants
|
|
Gender
Male
|
22 Participants
n=93 Participants
|
18 Participants
n=4 Participants
|
20 Participants
n=27 Participants
|
60 Participants
n=483 Participants
|
PRIMARY outcome
Timeframe: Day 2 to Week 4Population: Evaluable participants in the Safety Population (randomized participants who received at least 1 dose of study drug); n=number of participants evaluable at given time point.
Participant-reported flushing events during the first 4 weeks treatment, 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 |
DMF + ASA-Placebo BID
n=80 Participants
DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA-Placebo BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
|
DMF + ASA 75 mg QAM
n=79 Participants
DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 75 mg QAM and ASA-Placebo in the evening from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
|
DMF + ASA 150 mg BID
n=80 Participants
DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 150 mg BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
|
|---|---|---|---|
|
Percentage of Participants Reporting Overall Flushing Events During the First 4 Weeks of Treatment, as Assessed by the Modified Global Flushing Severity Scale (MGFSS)
Weeks 1-4 combined; n=80, 79, 80
|
90.0 percentage of participants
|
92.4 percentage of participants
|
88.8 percentage of participants
|
|
Percentage of Participants Reporting Overall Flushing Events During the First 4 Weeks of Treatment, as Assessed by the Modified Global Flushing Severity Scale (MGFSS)
Week 1; n=80, 77, 80
|
83.8 percentage of participants
|
85.7 percentage of participants
|
83.8 percentage of participants
|
|
Percentage of Participants Reporting Overall Flushing Events During the First 4 Weeks of Treatment, as Assessed by the Modified Global Flushing Severity Scale (MGFSS)
Week 2; n=77, 76, 79
|
76.6 percentage of participants
|
61.8 percentage of participants
|
69.6 percentage of participants
|
|
Percentage of Participants Reporting Overall Flushing Events During the First 4 Weeks of Treatment, as Assessed by the Modified Global Flushing Severity Scale (MGFSS)
Week 3; n=74, 74, 76
|
73.0 percentage of participants
|
55.4 percentage of participants
|
53.9 percentage of participants
|
|
Percentage of Participants Reporting Overall Flushing Events During the First 4 Weeks of Treatment, as Assessed by the Modified Global Flushing Severity Scale (MGFSS)
Week 4; n=72, 71, 71
|
59.7 percentage of participants
|
54.9 percentage of participants
|
54.9 percentage of participants
|
PRIMARY outcome
Timeframe: Day 1 to Week 4Population: Evaluable participants in the Safety Population (randomized participants who received at least 1 dose of study drug).
Participant-reported flushing events during the first 4 weeks of treatment 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 |
DMF + ASA-Placebo BID
n=80 Participants
DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA-Placebo BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
|
DMF + ASA 75 mg QAM
n=78 Participants
DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 75 mg QAM and ASA-Placebo in the evening from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
|
DMF + ASA 150 mg BID
n=80 Participants
DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 150 mg BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
|
|---|---|---|---|
|
Percentage of Participants Reporting Overall Flushing Events During the First 4 Weeks of Treatment, as Assessed by the Modified Flushing Severity Scale (MFSS)
Overall flushing events
|
91.3 percentage of participants
|
96.2 percentage of participants
|
96.3 percentage of participants
|
|
Percentage of Participants Reporting Overall Flushing Events During the First 4 Weeks of Treatment, as Assessed by the Modified Flushing Severity Scale (MFSS)
Overall redness events
|
90.0 percentage of participants
|
88.5 percentage of participants
|
88.8 percentage of participants
|
|
Percentage of Participants Reporting Overall Flushing Events During the First 4 Weeks of Treatment, as Assessed by the Modified Flushing Severity Scale (MFSS)
Overall warmth events
|
92.5 percentage of participants
|
97.4 percentage of participants
|
97.5 percentage of participants
|
|
Percentage of Participants Reporting Overall Flushing Events During the First 4 Weeks of Treatment, as Assessed by the Modified Flushing Severity Scale (MFSS)
Overall tingling events
|
81.3 percentage of participants
|
87.2 percentage of participants
|
86.3 percentage of participants
|
|
Percentage of Participants Reporting Overall Flushing Events During the First 4 Weeks of Treatment, as Assessed by the Modified Flushing Severity Scale (MFSS)
Overall itching events
|
87.5 percentage of participants
|
79.5 percentage of participants
|
76.3 percentage of participants
|
PRIMARY outcome
Timeframe: Day 2 to Week 4Population: Evaluable participants in the Safety Population (randomized participants who received at least 1 dose of study drug).
Worst severity of participant-reported flushing events during the first 4 weeks of treatment recorded on the 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 |
DMF + ASA-Placebo BID
n=80 Participants
DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA-Placebo BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
|
DMF + ASA 75 mg QAM
n=79 Participants
DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 75 mg QAM and ASA-Placebo in the evening from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
|
DMF + ASA 150 mg BID
n=80 Participants
DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 150 mg BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
|
|---|---|---|---|
|
Worst Severity Scores of Overall Flushing During the First 4 Weeks of Treatment, as Assessed by MGFSS
|
4.36 units on a scale
Standard Deviation 2.66
|
3.99 units on a scale
Standard Deviation 2.63
|
3.93 units on a scale
Standard Deviation 2.47
|
PRIMARY outcome
Timeframe: Day 1 to Week 4Population: Evaluable participants in the Safety Population (randomized participants who received at least 1 dose of study drug).
Worst severity of participant-reported flushing events during the first 4 weeks of treatment 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 |
DMF + ASA-Placebo BID
n=80 Participants
DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA-Placebo BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
|
DMF + ASA 75 mg QAM
n=78 Participants
DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 75 mg QAM and ASA-Placebo in the evening from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
|
DMF + ASA 150 mg BID
n=80 Participants
DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 150 mg BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
|
|---|---|---|---|
|
Worst Severity Scores of Overall Flushing During the First 4 Weeks of Treatment, as Assessed by MFSS
Overall flushing
|
4.84 units on a scale
Standard Deviation 2.77
|
4.73 units on a scale
Standard Deviation 2.43
|
4.78 units on a scale
Standard Deviation 2.53
|
|
Worst Severity Scores of Overall Flushing During the First 4 Weeks of Treatment, as Assessed by MFSS
Redness
|
4.83 units on a scale
Standard Deviation 2.69
|
4.65 units on a scale
Standard Deviation 2.73
|
4.34 units on a scale
Standard Deviation 2.67
|
|
Worst Severity Scores of Overall Flushing During the First 4 Weeks of Treatment, as Assessed by MFSS
Warmth
|
5.03 units on a scale
Standard Deviation 2.54
|
4.88 units on a scale
Standard Deviation 2.38
|
4.9 units on a scale
Standard Deviation 2.46
|
|
Worst Severity Scores of Overall Flushing During the First 4 Weeks of Treatment, as Assessed by MFSS
Tingling
|
3.31 units on a scale
Standard Deviation 2.38
|
3.62 units on a scale
Standard Deviation 2.53
|
3.3 units on a scale
Standard Deviation 2.30
|
|
Worst Severity Scores of Overall Flushing During the First 4 Weeks of Treatment, as Assessed by MFSS
Itching
|
3.7 units on a scale
Standard Deviation 2.55
|
3.64 units on a scale
Standard Deviation 2.76
|
3.23 units on a scale
Standard Deviation 2.66
|
SECONDARY outcome
Timeframe: Week 5 to Week 12Population: Evaluable participants in the Safety Population (randomized participants who received at least 1 dose of study drug). n=number of evaluable participants at given time period.
Participant-reported flushing events during Weeks 5-8 and Weeks 9-12 of the study recorded on the 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).
Outcome measures
| Measure |
DMF + ASA-Placebo BID
n=80 Participants
DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA-Placebo BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
|
DMF + ASA 75 mg QAM
n=79 Participants
DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 75 mg QAM and ASA-Placebo in the evening from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
|
DMF + ASA 150 mg BID
n=80 Participants
DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 150 mg BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
|
|---|---|---|---|
|
Percentage of Participants Reporting Overall Flushing Events During Weeks 5-8 and Weeks 9-12 of Treatment, as Assessed by MGFSS
Weeks 5-8 combined; n=71, 71, 70
|
74.6 percentage of participants
|
73.2 percentage of participants
|
80.0 percentage of participants
|
|
Percentage of Participants Reporting Overall Flushing Events During Weeks 5-8 and Weeks 9-12 of Treatment, as Assessed by MGFSS
Weeks 9-12 combined; n=67, 62, 65
|
61.2 percentage of participants
|
67.7 percentage of participants
|
76.9 percentage of participants
|
SECONDARY outcome
Timeframe: Week 5 to Week 12Population: Evaluable participants in the Safety Population (randomized participants who received at least 1 dose of study drug).
Participant-reported flushing events during Weeks 5-8 and Weeks 9-12 of the study 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 |
DMF + ASA-Placebo BID
n=80 Participants
DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA-Placebo BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
|
DMF + ASA 75 mg QAM
n=78 Participants
DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 75 mg QAM and ASA-Placebo in the evening from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
|
DMF + ASA 150 mg BID
n=80 Participants
DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 150 mg BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
|
|---|---|---|---|
|
Percentage of Participants Reporting Overall Flushing Events During Weeks 5-8 and Weeks 9-12 of Treatment, as Assessed by MFSS
Overall Flushing, Weeks 5-8 combined; n=71, 70, 70
|
80.3 percentage of participants
|
82.9 percentage of participants
|
84.3 percentage of participants
|
|
Percentage of Participants Reporting Overall Flushing Events During Weeks 5-8 and Weeks 9-12 of Treatment, as Assessed by MFSS
Overall Flushing, Weeks 9-12 combined;n=68, 65, 65
|
66.2 percentage of participants
|
69.2 percentage of participants
|
78.5 percentage of participants
|
|
Percentage of Participants Reporting Overall Flushing Events During Weeks 5-8 and Weeks 9-12 of Treatment, as Assessed by MFSS
Redness, Weeks 5-8 combined; n=71, 70, 70
|
77.5 percentage of participants
|
75.7 percentage of participants
|
81.4 percentage of participants
|
|
Percentage of Participants Reporting Overall Flushing Events During Weeks 5-8 and Weeks 9-12 of Treatment, as Assessed by MFSS
Redness, Weeks 9-12 combined; n=68, 65, 65
|
70.6 percentage of participants
|
61.5 percentage of participants
|
73.8 percentage of participants
|
|
Percentage of Participants Reporting Overall Flushing Events During Weeks 5-8 and Weeks 9-12 of Treatment, as Assessed by MFSS
Warmth, Weeks 5-8 combined; n=71, 70, 70
|
80.3 percentage of participants
|
80.0 percentage of participants
|
82.9 percentage of participants
|
|
Percentage of Participants Reporting Overall Flushing Events During Weeks 5-8 and Weeks 9-12 of Treatment, as Assessed by MFSS
Warmth, Weeks 9-12 combined; n=68, 65, 65
|
70.6 percentage of participants
|
70.8 percentage of participants
|
75.4 percentage of participants
|
|
Percentage of Participants Reporting Overall Flushing Events During Weeks 5-8 and Weeks 9-12 of Treatment, as Assessed by MFSS
Tingling, Weeks 5-8 combined; n=71, 70, 70
|
57.7 percentage of participants
|
55.7 percentage of participants
|
71.4 percentage of participants
|
|
Percentage of Participants Reporting Overall Flushing Events During Weeks 5-8 and Weeks 9-12 of Treatment, as Assessed by MFSS
Tingling, Weeks 9-12 combined; n=68, 65, 65
|
54.4 percentage of participants
|
49.2 percentage of participants
|
61.5 percentage of participants
|
|
Percentage of Participants Reporting Overall Flushing Events During Weeks 5-8 and Weeks 9-12 of Treatment, as Assessed by MFSS
Itching, Weeks 5-8 combined; n=71, 70, 70
|
54.9 percentage of participants
|
64.3 percentage of participants
|
64.3 percentage of participants
|
|
Percentage of Participants Reporting Overall Flushing Events During Weeks 5-8 and Weeks 9-12 of Treatment, as Assessed by MFSS
Itching, Weeks 9-12 combined; n=68, 65, 65
|
48.5 percentage of participants
|
52.3 percentage of participants
|
56.9 percentage of participants
|
SECONDARY outcome
Timeframe: Week 5 to Week 12Population: Evaluable participants in the Safety Population (randomized participants who received at least 1 dose of study drug). n=number of evaluable participants at given time period.
Worst severity of participant-reported flushing events during Weeks 5-8 and Weeks 9-12 of the study recorded on the 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).
Outcome measures
| Measure |
DMF + ASA-Placebo BID
n=80 Participants
DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA-Placebo BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
|
DMF + ASA 75 mg QAM
n=79 Participants
DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 75 mg QAM and ASA-Placebo in the evening from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
|
DMF + ASA 150 mg BID
n=80 Participants
DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 150 mg BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
|
|---|---|---|---|
|
Worst Severity Scores of Overall Flushing During Weeks 5-8 and Weeks 9-12 of the Study, as Assessed by MGFSS
Weeks 5-8 combined; n=71, 71, 70
|
3.00 units on a scale
Standard Deviation 2.61
|
2.83 units on a scale
Standard Deviation 2.4
|
3.47 units on a scale
Standard Deviation 2.64
|
|
Worst Severity Scores of Overall Flushing During Weeks 5-8 and Weeks 9-12 of the Study, as Assessed by MGFSS
Weeks 9 to 12 combined; n=67, 62, 65
|
2.43 units on a scale
Standard Deviation 2.72
|
2.81 units on a scale
Standard Deviation 2.76
|
2.95 units on a scale
Standard Deviation 2.5
|
SECONDARY outcome
Timeframe: Week 5 to Week 12Population: Evaluable participants in the Safety Population (randomized participants who received at least 1 dose of study drug). n=number of evaluable participants at given time period.
Worst severity of participant-reported flushing events during Weeks 5-8 and Weeks 9-12 of the study 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 |
DMF + ASA-Placebo BID
n=80 Participants
DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA-Placebo BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
|
DMF + ASA 75 mg QAM
n=78 Participants
DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 75 mg QAM and ASA-Placebo in the evening from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
|
DMF + ASA 150 mg BID
n=80 Participants
DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 150 mg BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
|
|---|---|---|---|
|
Worst Severity Scores of Overall Flushing During Weeks 5-8 and Weeks 9-12 of the Study, as Assessed by MFSS
Overall Flushing, Weeks 5-8 combined; n=71, 70, 70
|
3.37 units on a scale
Standard Deviation 2.8
|
3.24 units on a scale
Standard Deviation 2.57
|
3.57 units on a scale
Standard Deviation 2.45
|
|
Worst Severity Scores of Overall Flushing During Weeks 5-8 and Weeks 9-12 of the Study, as Assessed by MFSS
Overall Flushing, Weeks 9-12 combined;n=68, 65, 65
|
2.5 units on a scale
Standard Deviation 2.65
|
3.15 units on a scale
Standard Deviation 2.98
|
3.45 units on a scale
Standard Deviation 2.74
|
|
Worst Severity Scores of Overall Flushing During Weeks 5-8 and Weeks 9-12 of the Study, as Assessed by MFSS
Redness, Weeks 5-8 combined; n=71, 70, 70
|
3.27 units on a scale
Standard Deviation 2.9
|
2.83 units on a scale
Standard Deviation 2.54
|
3.51 units on a scale
Standard Deviation 2.58
|
|
Worst Severity Scores of Overall Flushing During Weeks 5-8 and Weeks 9-12 of the Study, as Assessed by MFSS
Redness, Weeks 9-12 combined; n=68, 65, 65
|
2.57 units on a scale
Standard Deviation 2.55
|
2.75 units on a scale
Standard Deviation 3.13
|
3.4 units on a scale
Standard Deviation 2.93
|
|
Worst Severity Scores of Overall Flushing During Weeks 5-8 and Weeks 9-12 of the Study, as Assessed by MFSS
Warmth, Weeks 5-8 combined; n=71, 70, 70
|
3.3 units on a scale
Standard Deviation 2.71
|
3.11 units on a scale
Standard Deviation 2.45
|
3.49 units on a scale
Standard Deviation 2.54
|
|
Worst Severity Scores of Overall Flushing During Weeks 5-8 and Weeks 9-12 of the Study, as Assessed by MFSS
Warmth, Weeks 9-12 combined; n=68, 65, 65
|
2.66 units on a scale
Standard Deviation 2.52
|
3.06 units on a scale
Standard Deviation 2.97
|
3.45 units on a scale
Standard Deviation 2.85
|
|
Worst Severity Scores of Overall Flushing During Weeks 5-8 and Weeks 9-12 of the Study, as Assessed by MFSS
Tingling, Weeks 5-8 combined; n=71, 70, 70
|
2.03 units on a scale
Standard Deviation 2.41
|
2.07 units on a scale
Standard Deviation 2.5
|
2.79 units on a scale
Standard Deviation 2.56
|
|
Worst Severity Scores of Overall Flushing During Weeks 5-8 and Weeks 9-12 of the Study, as Assessed by MFSS
Tingling, Weeks 9-12 combined; n=68, 65, 65
|
1.71 units on a scale
Standard Deviation 2.17
|
1.78 units on a scale
Standard Deviation 2.43
|
2.54 units on a scale
Standard Deviation 2.69
|
|
Worst Severity Scores of Overall Flushing During Weeks 5-8 and Weeks 9-12 of the Study, as Assessed by MFSS
Itching, Weeks 5-8 combined; n=71, 70, 70
|
1.92 units on a scale
Standard Deviation 2.35
|
2.17 units on a scale
Standard Deviation 2.32
|
2.64 units on a scale
Standard Deviation 2.59
|
|
Worst Severity Scores of Overall Flushing During Weeks 5-8 and Weeks 9-12 of the Study, as Assessed by MFSS
Itching, Weeks 9-12 combined; n=68, 65, 65
|
1.51 units on a scale
Standard Deviation 2.04
|
1.69 units on a scale
Standard Deviation 2.15
|
2.17 units on a scale
Standard Deviation 2.52
|
SECONDARY outcome
Timeframe: Day 1 to Week 12Population: Although designated as a secondary endpoint, the duration of flushing events based on MGFSS could not be calculated because specific flushing events with start and end times was not captured in the MGFSS.
Duration of participant-reported flushing events during weeks 1-4, 5-8 and 9-12 of the study recorded on the 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).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 1 to Week 12Population: Evaluable participants in the Safety Population (randomized participants who received at least 1 dose of study drug). n=number of evaluable participants at given time period.
Duration of participant-reported flushing events during weeks 1-4, 5-8 and 9-12 of the study 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). For participants with more than 1 flushing event during a visit interval, the average duration for the visit interval was used.
Outcome measures
| Measure |
DMF + ASA-Placebo BID
n=81 Participants
DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA-Placebo BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
|
DMF + ASA 75 mg QAM
n=80 Participants
DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 75 mg QAM and ASA-Placebo in the evening from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
|
DMF + ASA 150 mg BID
n=80 Participants
DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 150 mg BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
|
|---|---|---|---|
|
Duration of Flushing Episodes During Weeks 1-4, 5-8 and 9-12 of the Study, as Assessed by MFSS
Weeks 1-4 combined; n=73, 75, 77
|
0.69 hours
Standard Deviation 0.44
|
0.8 hours
Standard Deviation 0.59
|
1.11 hours
Standard Deviation 1.16
|
|
Duration of Flushing Episodes During Weeks 1-4, 5-8 and 9-12 of the Study, as Assessed by MFSS
Weeks 5-8 combined; n=57, 58, 59
|
1.06 hours
Standard Deviation 2.12
|
0.73 hours
Standard Deviation 0.52
|
1.08 hours
Standard Deviation 1.18
|
|
Duration of Flushing Episodes During Weeks 1-4, 5-8 and 9-12 of the Study, as Assessed by MFSS
Weeks 9-12 combined; n=45, 45, 51
|
0.66 hours
Standard Deviation 0.52
|
0.69 hours
Standard Deviation 0.59
|
0.79 hours
Standard Deviation 0.94
|
SECONDARY outcome
Timeframe: Week 13 to Week 48Population: Evaluable participants in the Safety Population (randomized participants who received at least 1 dose of study drug).
Participant-reported flushing events (which include redness, warmth, tingling, and/or itching of the skin) during Weeks 13 to 48 of treatment were recorded in the CRF.
Outcome measures
| Measure |
DMF + ASA-Placebo BID
n=81 Participants
DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA-Placebo BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
|
DMF + ASA 75 mg QAM
n=80 Participants
DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 75 mg QAM and ASA-Placebo in the evening from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
|
DMF + ASA 150 mg BID
n=80 Participants
DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 150 mg BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
|
|---|---|---|---|
|
Number of Participants With Self-Reported Flushing Events During Weeks 13 to 48
|
36 participants
|
35 participants
|
42 participants
|
SECONDARY outcome
Timeframe: Day 1 to Week 12Population: Evaluable participants in the Safety Population (randomized participants who received at least 1 dose of study drug).
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 participant at immediate risk of death (a life-threatening event); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity, or; results in a congenital anomaly/birth defect. An SAE may also be any other medically important event that, in the opinion of the Investigator, may jeopardize the participant or may require intervention to prevent one of the other outcomes listed above. A treatment-emergent AE is defined as any AE that occurs after the first administration of DMF or ASA/Placebo drug.
Outcome measures
| Measure |
DMF + ASA-Placebo BID
n=81 Participants
DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA-Placebo BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
|
DMF + ASA 75 mg QAM
n=80 Participants
DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 75 mg QAM and ASA-Placebo in the evening from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
|
DMF + ASA 150 mg BID
n=80 Participants
DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 150 mg BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
|
|---|---|---|---|
|
Number of Participants Experiencing Treatment-Emergent Adverse Events (AEs), Serious AEs (SAEs), and Discontinuations Due to AEs in the First 12 Weeks
Any event
|
66 participants
|
68 participants
|
63 participants
|
|
Number of Participants Experiencing Treatment-Emergent Adverse Events (AEs), Serious AEs (SAEs), and Discontinuations Due to AEs in the First 12 Weeks
Moderate or severe event
|
24 participants
|
38 participants
|
26 participants
|
|
Number of Participants Experiencing Treatment-Emergent Adverse Events (AEs), Serious AEs (SAEs), and Discontinuations Due to AEs in the First 12 Weeks
Severe event
|
3 participants
|
5 participants
|
8 participants
|
|
Number of Participants Experiencing Treatment-Emergent Adverse Events (AEs), Serious AEs (SAEs), and Discontinuations Due to AEs in the First 12 Weeks
Related event
|
35 participants
|
38 participants
|
40 participants
|
|
Number of Participants Experiencing Treatment-Emergent Adverse Events (AEs), Serious AEs (SAEs), and Discontinuations Due to AEs in the First 12 Weeks
Serious event
|
1 participants
|
1 participants
|
2 participants
|
|
Number of Participants Experiencing Treatment-Emergent Adverse Events (AEs), Serious AEs (SAEs), and Discontinuations Due to AEs in the First 12 Weeks
Discontinued treatment due to event
|
5 participants
|
9 participants
|
12 participants
|
|
Number of Participants Experiencing Treatment-Emergent Adverse Events (AEs), Serious AEs (SAEs), and Discontinuations Due to AEs in the First 12 Weeks
Discontinued study due to event
|
5 participants
|
9 participants
|
13 participants
|
SECONDARY outcome
Timeframe: Week 13 to Week 48Population: Evaluable participants in the Safety Population (randomized participants who received at least 1 dose of study drug).
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 participant at immediate risk of death (a life-threatening event); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity, or; results in a congenital anomaly/birth defect. An SAE may also be any other medically important event that, in the opinion of the Investigator, may jeopardize the participant or may require intervention to prevent one of the other outcomes listed above. A treatment-emergent AE is defined as any AE that occurs after the first administration of DMF or ASA/Placebo drug.
Outcome measures
| Measure |
DMF + ASA-Placebo BID
n=81 Participants
DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA-Placebo BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
|
DMF + ASA 75 mg QAM
n=80 Participants
DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 75 mg QAM and ASA-Placebo in the evening from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
|
DMF + ASA 150 mg BID
n=80 Participants
DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 150 mg BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
|
|---|---|---|---|
|
Number of Participants Experiencing Treatment-Emergent AEs, SAEs, and Discontinuations Due to AEs in Weeks 13 to 48
Any event
|
66 participants
|
68 participants
|
66 participants
|
|
Number of Participants Experiencing Treatment-Emergent AEs, SAEs, and Discontinuations Due to AEs in Weeks 13 to 48
Moderate or severe event
|
40 participants
|
50 participants
|
51 participants
|
|
Number of Participants Experiencing Treatment-Emergent AEs, SAEs, and Discontinuations Due to AEs in Weeks 13 to 48
Severe event
|
5 participants
|
12 participants
|
12 participants
|
|
Number of Participants Experiencing Treatment-Emergent AEs, SAEs, and Discontinuations Due to AEs in Weeks 13 to 48
Related event
|
45 participants
|
42 participants
|
49 participants
|
|
Number of Participants Experiencing Treatment-Emergent AEs, SAEs, and Discontinuations Due to AEs in Weeks 13 to 48
Serious event
|
3 participants
|
7 participants
|
3 participants
|
|
Number of Participants Experiencing Treatment-Emergent AEs, SAEs, and Discontinuations Due to AEs in Weeks 13 to 48
Discontinued treatment due to event
|
9 participants
|
6 participants
|
10 participants
|
|
Number of Participants Experiencing Treatment-Emergent AEs, SAEs, and Discontinuations Due to AEs in Weeks 13 to 48
Discontinued study due to event
|
9 participants
|
6 participants
|
10 participants
|
SECONDARY outcome
Timeframe: Day 1 to Week 12Population: Evaluable participants in the Safety Population (randomized participants who received at least 1 dose of study drug).
A treatment-emergent AE is defined as any AE that occurs after the first administration of DMF or ASA/Placebo drug. Flushing AEs include redness, warmth, tingling, and/or itching of the skin.
Outcome measures
| Measure |
DMF + ASA-Placebo BID
n=81 Participants
DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA-Placebo BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
|
DMF + ASA 75 mg QAM
n=80 Participants
DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 75 mg QAM and ASA-Placebo in the evening from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
|
DMF + ASA 150 mg BID
n=80 Participants
DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 150 mg BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
|
|---|---|---|---|
|
Number of Participants Discontinuing Treatment and Discontinuing the Study Due to Treatment-emergent Flushing AEs in the First 12 Weeks
Discontinuing treatment
|
0 participants
|
0 participants
|
2 participants
|
|
Number of Participants Discontinuing Treatment and Discontinuing the Study Due to Treatment-emergent Flushing AEs in the First 12 Weeks
Discontinuing study
|
0 participants
|
0 participants
|
2 participants
|
SECONDARY outcome
Timeframe: Week 13 to Week 48Population: Evaluable participants in the Safety Population (randomized participants who received at least 1 dose of study drug).
A treatment-emergent AE is defined as any AE that occurs after the first administration of DMF or ASA/Placebo drug. Flushing AEs include redness, warmth, tingling, and/or itching of the skin.
Outcome measures
| Measure |
DMF + ASA-Placebo BID
n=81 Participants
DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA-Placebo BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
|
DMF + ASA 75 mg QAM
n=80 Participants
DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 75 mg QAM and ASA-Placebo in the evening from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
|
DMF + ASA 150 mg BID
n=80 Participants
DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 150 mg BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
|
|---|---|---|---|
|
Number of Participants Discontinuing Treatment and Discontinuing the Study Due to Treatment-Emergent Flushing AEs in Weeks 13 to 48
Discontinuing treatment
|
2 participants
|
0 participants
|
0 participants
|
|
Number of Participants Discontinuing Treatment and Discontinuing the Study Due to Treatment-Emergent Flushing AEs in Weeks 13 to 48
Discontinuing study
|
2 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Baseline, Week 24, Week 48 or early termination (ET)Population: Evaluable participants in the Safety Population (randomized participants who received at least 1 dose of study drug); n=number of participants with an assessment at given timepoint.
SF-36 is a self-administered, generic health status questionnaire consisting of 36 questions that measure 8 health concepts: physical functioning, role limitations due to physical problems, bodily pain, general health perception, vitality, social functioning, role limitations due to emotional problems and mental health. The score for a domain is an average of the individual question scores, which are scaled 0 (worst health-related quality of life) to 100 (best health-related quality of life). Score from physical function, role physical, bodily pain, and general health domains were averaged to calculate PCS. Total score range for PCS was 0 (lowest level of physical functioning) to 100 (highest level of physical functioning).
Outcome measures
| Measure |
DMF + ASA-Placebo BID
n=81 Participants
DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA-Placebo BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
|
DMF + ASA 75 mg QAM
n=80 Participants
DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 75 mg QAM and ASA-Placebo in the evening from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
|
DMF + ASA 150 mg BID
n=80 Participants
DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 150 mg BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
|
|---|---|---|---|
|
Change From Baseline at Weeks 24 and 48 in Quality of Life Measurements as Assessed by Short Form-36 (SF-36) Questionnaire: Physical Component Summary (PCS)
Baseline; n=81, 80, 80
|
44.627 units on a scale
Standard Deviation 10.822
|
41.99 units on a scale
Standard Deviation 10.966
|
43.16 units on a scale
Standard Deviation 11.438
|
|
Change From Baseline at Weeks 24 and 48 in Quality of Life Measurements as Assessed by Short Form-36 (SF-36) Questionnaire: Physical Component Summary (PCS)
Change at Week 24; n=68, 63, 61
|
-0.014 units on a scale
Standard Deviation 9.154
|
0.551 units on a scale
Standard Deviation 8.473
|
-1.471 units on a scale
Standard Deviation 7.754
|
|
Change From Baseline at Weeks 24 and 48 in Quality of Life Measurements as Assessed by Short Form-36 (SF-36) Questionnaire: Physical Component Summary (PCS)
Change at Week 48/ET; n=68, 65, 64
|
-1.008 units on a scale
Standard Deviation 10.31
|
-1.449 units on a scale
Standard Deviation 10.964
|
-2.989 units on a scale
Standard Deviation 14.22
|
SECONDARY outcome
Timeframe: Baseline, Week 24, Week 48 or ETPopulation: Evaluable participants in the Safety Population (randomized participants who received at least 1 dose of study drug); n=number of participants with an assessment at given timepoint.
SF-36 is a self-administered, generic health status questionnaire consisting of 36 questions that measure 8 health concepts: physical functioning, role limitations due to physical problems, bodily pain, general health perception, vitality, social functioning, role limitations due to emotional problems and mental health. The score for a domain is an average of the individual question scores, which are scaled 0 (worst health-related quality of life) to 100 (best health-related quality of life). Score from mental health, role emotional, social functioning, and vitality domains were averaged to calculate MCS. Total score range for MCS was 0 (lowest level of physical functioning) to 100 (highest level of physical functioning).
Outcome measures
| Measure |
DMF + ASA-Placebo BID
n=81 Participants
DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA-Placebo BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
|
DMF + ASA 75 mg QAM
n=80 Participants
DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 75 mg QAM and ASA-Placebo in the evening from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
|
DMF + ASA 150 mg BID
n=80 Participants
DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 150 mg BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
|
|---|---|---|---|
|
Change From Baseline at Weeks 24 and 48 in Quality of Life Measurements as Assessed by Short Form-36 (SF-36) Questionnaire: Mental Component Summary (MCS)
Baseline; n=81, 80, 80
|
47.413 units on a scale
Standard Deviation 8.772
|
45.048 units on a scale
Standard Deviation 10.531
|
46.496 units on a scale
Standard Deviation 10.812
|
|
Change From Baseline at Weeks 24 and 48 in Quality of Life Measurements as Assessed by Short Form-36 (SF-36) Questionnaire: Mental Component Summary (MCS)
Change at Week 24; n=68, 63, 61
|
-0.139 units on a scale
Standard Deviation 11.66
|
-0.893 units on a scale
Standard Deviation 10.059
|
-0.312 units on a scale
Standard Deviation 12.251
|
|
Change From Baseline at Weeks 24 and 48 in Quality of Life Measurements as Assessed by Short Form-36 (SF-36) Questionnaire: Mental Component Summary (MCS)
Change at Week 48/ET; n=68, 65, 64
|
-0.976 units on a scale
Standard Deviation 13.759
|
-2.081 units on a scale
Standard Deviation 13.733
|
-2.82 units on a scale
Standard Deviation 15.465
|
SECONDARY outcome
Timeframe: Baseline, Week 24, Week 48 or ETPopulation: Evaluable participants in the Safety Population (randomized participants who received at least 1 dose of study drug); n=number of participants with an assessment at given timepoint.
EQ-5D-5L is a standardized, subject-rated instrument for use as a measure of health outcomes. The EQ 5D-5L includes 2 components: the EQ-5D-5L descriptive system and the EQ-Visual Analog Scale (EQ-VAS). The EQ-5D-5L descriptive system provides a profile of the participant's health state in 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). For each dimension, the participant is instructed to indicate whether he or she has "no problems" (1), "some problems" (2), or "severe problems" (3). A negative change from Baseline indicates improvement.
Outcome measures
| Measure |
DMF + ASA-Placebo BID
n=81 Participants
DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA-Placebo BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
|
DMF + ASA 75 mg QAM
n=80 Participants
DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 75 mg QAM and ASA-Placebo in the evening from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
|
DMF + ASA 150 mg BID
n=80 Participants
DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 150 mg BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
|
|---|---|---|---|
|
Change From Baseline to Week 24 and Week 48 in Quality of Life Measurements as Assessed by the European Quality of Life 5-Dimensions Questionnaire (EQ-5D-5L) Questionnaire: Mobility
Baseline; n=81, 79, 80
|
1.877 units on a scale
Standard Deviation 0.967
|
1.785 units on a scale
Standard Deviation 0.887
|
1.888 units on a scale
Standard Deviation 0.928
|
|
Change From Baseline to Week 24 and Week 48 in Quality of Life Measurements as Assessed by the European Quality of Life 5-Dimensions Questionnaire (EQ-5D-5L) Questionnaire: Mobility
Change at Week 24; n=67, 63, 60
|
-0.104 units on a scale
Standard Deviation 0.606
|
0.095 units on a scale
Standard Deviation 1.214
|
-0.05 units on a scale
Standard Deviation 0.467
|
|
Change From Baseline to Week 24 and Week 48 in Quality of Life Measurements as Assessed by the European Quality of Life 5-Dimensions Questionnaire (EQ-5D-5L) Questionnaire: Mobility
Change at Week 48/ET; n=67, 63, 63
|
0.03 units on a scale
Standard Deviation 0.627
|
0.079 units on a scale
Standard Deviation 1.021
|
0.095 units on a scale
Standard Deviation 0.56
|
SECONDARY outcome
Timeframe: Baseline, Week 24, Week 48 or ETPopulation: Evaluable participants in the Safety Population (randomized participants who received at least 1 dose of study drug); n=number of participants with an assessment at given timepoint.
EQ-5D-5L is a standardized, subject-rated instrument for use as a measure of health outcomes. The EQ 5D-5L includes 2 components: the EQ-5D-5L descriptive system and the EQ-VAS. The EQ-5D-5L descriptive system provides a profile of the participant's health state in 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). For each dimension, the participant is instructed to indicate whether he or she has "no problems" (1), "some problems" (2), or "severe problems" (3). A negative change from Baseline indicates improvement.
Outcome measures
| Measure |
DMF + ASA-Placebo BID
n=81 Participants
DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA-Placebo BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
|
DMF + ASA 75 mg QAM
n=80 Participants
DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 75 mg QAM and ASA-Placebo in the evening from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
|
DMF + ASA 150 mg BID
n=80 Participants
DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 150 mg BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
|
|---|---|---|---|
|
Change From Baseline to Week 24 and Week 48 in Quality of Life Measurements as Assessed by the EQ-5D-5L Questionnaire: Self-Care
Baseline; n=81, 79, 80
|
1.321 units on a scale
Standard Deviation 0.668
|
1.38 units on a scale
Standard Deviation 0.722
|
1.363 units on a scale
Standard Deviation 0.621
|
|
Change From Baseline to Week 24 and Week 48 in Quality of Life Measurements as Assessed by the EQ-5D-5L Questionnaire: Self-Care
Change at Week 24; n=67, 63, 60
|
-0.045 units on a scale
Standard Deviation 0.442
|
-0.079 units on a scale
Standard Deviation 1.182
|
0.017 units on a scale
Standard Deviation 0.567
|
|
Change From Baseline to Week 24 and Week 48 in Quality of Life Measurements as Assessed by the EQ-5D-5L Questionnaire: Self-Care
Change at Week 48/ET; n=67, 64, 63
|
-0.045 units on a scale
Standard Deviation 0.367
|
-0.109 units on a scale
Standard Deviation 1.143
|
0.079 units on a scale
Standard Deviation 0.604
|
SECONDARY outcome
Timeframe: Baseline, Week 24, Week 48 or ETPopulation: Evaluable participants in the Safety Population (randomized participants who received at least 1 dose of study drug); n=number of participants with an assessment at given timepoint.
EQ-5D-5L is a standardized, subject-rated instrument for use as a measure of health outcomes. The EQ 5D-5L includes 2 components: the EQ-5D-5L descriptive system and the EQ-VAS. The EQ-5D-5L descriptive system provides a profile of the participant's health state in 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). For each dimension, the participant is instructed to indicate whether he or she has "no problems" (1), "some problems" (2), or "severe problems" (3). A negative change from Baseline indicates improvement.
Outcome measures
| Measure |
DMF + ASA-Placebo BID
n=81 Participants
DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA-Placebo BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
|
DMF + ASA 75 mg QAM
n=80 Participants
DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 75 mg QAM and ASA-Placebo in the evening from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
|
DMF + ASA 150 mg BID
n=80 Participants
DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 150 mg BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
|
|---|---|---|---|
|
Change From Baseline to Week 24 and Week 48 in Quality of Life Measurements as Assessed by the EQ-5D-5L Questionnaire: Usual Activities
Baseline; n=81, 79, 80
|
1.827 units on a scale
Standard Deviation 0.891
|
1.975 units on a scale
Standard Deviation 0.947
|
2.025 units on a scale
Standard Deviation 0.993
|
|
Change From Baseline to Week 24 and Week 48 in Quality of Life Measurements as Assessed by the EQ-5D-5L Questionnaire: Usual Activities
Change at Week 24; n=67, 63, 60
|
-0.06 units on a scale
Standard Deviation 0.694
|
0 units on a scale
Standard Deviation 1.244
|
-0.017 units on a scale
Standard Deviation 0.725
|
|
Change From Baseline to Week 24 and Week 48 in Quality of Life Measurements as Assessed by the EQ-5D-5L Questionnaire: Usual Activities
Change at Week 48/ET; n=67, 64, 63
|
0.149 units on a scale
Standard Deviation 0.783
|
-0.016 units on a scale
Standard Deviation 1.105
|
0.063 units on a scale
Standard Deviation 0.896
|
SECONDARY outcome
Timeframe: Baseline, Week 24, Week 48 or ETPopulation: Evaluable participants in the Safety Population (randomized participants who received at least 1 dose of study drug); n=number of participants with an assessment at given timepoint.
EQ-5D-5L is a standardized, subject-rated instrument for use as a measure of health outcomes. The EQ 5D-5L includes 2 components: the EQ-5D-5L descriptive system and the EQ-VAS. The EQ-5D-5L descriptive system provides a profile of the participant's health state in 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). For each dimension, the participant is instructed to indicate whether he or she has "no problems" (1), "some problems" (2), or "severe problems" (3). A negative change from Baseline indicates improvement.
Outcome measures
| Measure |
DMF + ASA-Placebo BID
n=81 Participants
DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA-Placebo BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
|
DMF + ASA 75 mg QAM
n=80 Participants
DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 75 mg QAM and ASA-Placebo in the evening from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
|
DMF + ASA 150 mg BID
n=80 Participants
DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 150 mg BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
|
|---|---|---|---|
|
Change From Baseline to Week 24 and Week 48 in Quality of Life Measurements as Assessed by the EQ-5D-5L Questionnaire: Pain/Discomfort
Baseline; n=81, 79, 80
|
2 units on a scale
Standard Deviation 0.88
|
2.038 units on a scale
Standard Deviation 0.869
|
1.975 units on a scale
Standard Deviation 0.941
|
|
Change From Baseline to Week 24 and Week 48 in Quality of Life Measurements as Assessed by the EQ-5D-5L Questionnaire: Pain/Discomfort
Change at Week 24; n=67, 63, 60
|
-0.104 units on a scale
Standard Deviation 0.699
|
0 units on a scale
Standard Deviation 1.032
|
0.1 units on a scale
Standard Deviation 0.573
|
|
Change From Baseline to Week 24 and Week 48 in Quality of Life Measurements as Assessed by the EQ-5D-5L Questionnaire: Pain/Discomfort
Change at Week 48/ET; n=67, 64, 63
|
-0.09 units on a scale
Standard Deviation 0.712
|
0.078 units on a scale
Standard Deviation 1.117
|
-0.127 units on a scale
Standard Deviation 0.707
|
SECONDARY outcome
Timeframe: Baseline, Week 24, Week 48 or ETPopulation: Evaluable participants in the Safety Population (randomized participants who received at least 1 dose of study drug); n=number of participants with an assessment at given timepoint.
EQ-5D-5L is a standardized, subject-rated instrument for use as a measure of health outcomes. The EQ 5D-5L includes 2 components: the EQ-5D-5L descriptive system and the EQ-VAS. The EQ-5D-5L descriptive system provides a profile of the participant's health state in 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). For each dimension, the participant is instructed to indicate whether he or she has "no problems" (1), "some problems" (2), or "severe problems" (3). A negative change from Baseline indicates improvement.
Outcome measures
| Measure |
DMF + ASA-Placebo BID
n=81 Participants
DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA-Placebo BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
|
DMF + ASA 75 mg QAM
n=80 Participants
DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 75 mg QAM and ASA-Placebo in the evening from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
|
DMF + ASA 150 mg BID
n=80 Participants
DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 150 mg BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
|
|---|---|---|---|
|
Change From Baseline to Week 24 and Week 48 in Quality of Life Measurements as Assessed by the EQ-5D-5L Questionnaire: Anxiety/Depression
Baseline; n=81, 79, 80
|
1.642 units on a scale
Standard Deviation 0.763
|
1.848 units on a scale
Standard Deviation 0.893
|
1.763 units on a scale
Standard Deviation 0.917
|
|
Change From Baseline to Week 24 and Week 48 in Quality of Life Measurements as Assessed by the EQ-5D-5L Questionnaire: Anxiety/Depression
Change at Week 24; n=67, 63, 60
|
-0.06 units on a scale
Standard Deviation 0.903
|
-0.19 units on a scale
Standard Deviation 1.293
|
0 units on a scale
Standard Deviation 0.803
|
|
Change From Baseline to Week 24 and Week 48 in Quality of Life Measurements as Assessed by the EQ-5D-5L Questionnaire: Anxiety/Depression
Change at Week 48/ET; n=67, 63, 63
|
0.03 units on a scale
Standard Deviation 0.953
|
-0.127 units on a scale
Standard Deviation 1.184
|
-0.032 units on a scale
Standard Deviation 0.842
|
SECONDARY outcome
Timeframe: Baseline, Week 24, Week 48 or ETPopulation: Evaluable participants in the Safety Population (randomized participants who received at least 1 dose of study drug); n=number of participants with an assessment at given timepoint.
For the EQ-VAS, the participant was instructed to draw a line on a 20-cm vertical scale at the point that best describes his or her own health, where 0 represents the "worst imaginable health state" and 100 represents the "best imaginable health state."
Outcome measures
| Measure |
DMF + ASA-Placebo BID
n=81 Participants
DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA-Placebo BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
|
DMF + ASA 75 mg QAM
n=80 Participants
DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 75 mg QAM and ASA-Placebo in the evening from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
|
DMF + ASA 150 mg BID
n=80 Participants
DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 150 mg BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
|
|---|---|---|---|
|
Change From Baseline to Week 24 and Week 48 in Quality of Life Measurements as Assessed by the EQ-VAS
Baseline; n=80, 80, 80
|
78.288 units on a scale
Standard Deviation 16.442
|
69.6 units on a scale
Standard Deviation 19.535
|
73.438 units on a scale
Standard Deviation 16.38
|
|
Change From Baseline to Week 24 and Week 48 in Quality of Life Measurements as Assessed by the EQ-VAS
Change at Week 24; n=66, 63, 60
|
-2.318 units on a scale
Standard Deviation 12.579
|
-0.587 units on a scale
Standard Deviation 17.24
|
-2.95 units on a scale
Standard Deviation 16.326
|
|
Change From Baseline to Week 24 and Week 48 in Quality of Life Measurements as Assessed by the EQ-VAS
Change at Week 48/ET; n=66, 64, 63
|
-3.061 units on a scale
Standard Deviation 18.053
|
-0.438 units on a scale
Standard Deviation 17.834
|
-1.476 units on a scale
Standard Deviation 13.201
|
Adverse Events
DMF + ASA-Placebo BID
Serious events: 4 serious events
Other events: 77 other events
Deaths: 0 deaths
DMF + ASA 75 mg QAM
Serious events: 8 serious events
Other events: 76 other events
Deaths: 0 deaths
DMF + ASA 150 mg BID
Serious events: 5 serious events
Other events: 76 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
DMF + ASA-Placebo BID
n=81 participants at risk
DMF 120 mg taken BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA-Placebo taken BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
|
DMF + ASA 75 mg QAM
n=80 participants at risk
DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 75 mg QAM and ASA-Placebo in the evening from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
|
DMF + ASA 150 mg BID
n=80 participants at risk
DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 150 mg BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
|
|---|---|---|---|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/81 • Screening through Week 48
|
2.5%
2/80 • Screening through Week 48
|
1.2%
1/80 • Screening through Week 48
|
|
Infections and infestations
Appendicitis
|
0.00%
0/81 • Screening through Week 48
|
1.2%
1/80 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/81 • Screening through Week 48
|
1.2%
1/80 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
|
Infections and infestations
Peritonitis
|
0.00%
0/81 • Screening through Week 48
|
1.2%
1/80 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
|
Infections and infestations
Pneumonia
|
0.00%
0/81 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
1.2%
1/80 • Screening through Week 48
|
|
General disorders
Drug intolerance
|
0.00%
0/81 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
1.2%
1/80 • Screening through Week 48
|
|
General disorders
Pain
|
0.00%
0/81 • Screening through Week 48
|
1.2%
1/80 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
|
Nervous system disorders
Multiple sclerosis relapse
|
0.00%
0/81 • Screening through Week 48
|
2.5%
2/80 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.00%
0/81 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
1.2%
1/80 • Screening through Week 48
|
|
General disorders
Abasia
|
0.00%
0/81 • Screening through Week 48
|
1.2%
1/80 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/81 • Screening through Week 48
|
1.2%
1/80 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.00%
0/81 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
1.2%
1/80 • Screening through Week 48
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/81 • Screening through Week 48
|
1.2%
1/80 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
1.2%
1/81 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intraductal proliferative breast lesion
|
1.2%
1/81 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
1.2%
1/81 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
|
Vascular disorders
Deep vein thrombosis
|
1.2%
1/81 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
Other adverse events
| Measure |
DMF + ASA-Placebo BID
n=81 participants at risk
DMF 120 mg taken BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA-Placebo taken BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
|
DMF + ASA 75 mg QAM
n=80 participants at risk
DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 75 mg QAM and ASA-Placebo in the evening from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
|
DMF + ASA 150 mg BID
n=80 participants at risk
DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 150 mg BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
|
|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
21.0%
17/81 • Screening through Week 48
|
26.2%
21/80 • Screening through Week 48
|
23.8%
19/80 • Screening through Week 48
|
|
Gastrointestinal disorders
Nausea
|
14.8%
12/81 • Screening through Week 48
|
20.0%
16/80 • Screening through Week 48
|
28.7%
23/80 • Screening through Week 48
|
|
Gastrointestinal disorders
Vomiting
|
17.3%
14/81 • Screening through Week 48
|
17.5%
14/80 • Screening through Week 48
|
17.5%
14/80 • Screening through Week 48
|
|
Gastrointestinal disorders
Abdominal pain
|
9.9%
8/81 • Screening through Week 48
|
6.2%
5/80 • Screening through Week 48
|
12.5%
10/80 • Screening through Week 48
|
|
Gastrointestinal disorders
Abdominal pain upper
|
11.1%
9/81 • Screening through Week 48
|
12.5%
10/80 • Screening through Week 48
|
8.8%
7/80 • Screening through Week 48
|
|
Gastrointestinal disorders
Constipation
|
3.7%
3/81 • Screening through Week 48
|
8.8%
7/80 • Screening through Week 48
|
6.2%
5/80 • Screening through Week 48
|
|
Gastrointestinal disorders
Abdominal distension
|
7.4%
6/81 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
6.2%
5/80 • Screening through Week 48
|
|
Gastrointestinal disorders
Dyspepsia
|
2.5%
2/81 • Screening through Week 48
|
3.8%
3/80 • Screening through Week 48
|
5.0%
4/80 • Screening through Week 48
|
|
Gastrointestinal disorders
Abdominal discomfort
|
3.7%
3/81 • Screening through Week 48
|
1.2%
1/80 • Screening through Week 48
|
2.5%
2/80 • Screening through Week 48
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/81 • Screening through Week 48
|
3.8%
3/80 • Screening through Week 48
|
5.0%
4/80 • Screening through Week 48
|
|
Gastrointestinal disorders
Abdominal pain lower
|
1.2%
1/81 • Screening through Week 48
|
2.5%
2/80 • Screening through Week 48
|
2.5%
2/80 • Screening through Week 48
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/81 • Screening through Week 48
|
2.5%
2/80 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
|
Gastrointestinal disorders
Eructation
|
0.00%
0/81 • Screening through Week 48
|
1.2%
1/80 • Screening through Week 48
|
1.2%
1/80 • Screening through Week 48
|
|
Gastrointestinal disorders
Flatulence
|
1.2%
1/81 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
1.2%
1/80 • Screening through Week 48
|
|
Gastrointestinal disorders
Gastritis
|
2.5%
2/81 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
1.2%
1/81 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
1.2%
1/80 • Screening through Week 48
|
|
Gastrointestinal disorders
Abdominal mass
|
0.00%
0/81 • Screening through Week 48
|
1.2%
1/80 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/81 • Screening through Week 48
|
1.2%
1/80 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
|
Gastrointestinal disorders
Faeces discoloured
|
0.00%
0/81 • Screening through Week 48
|
1.2%
1/80 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
|
Gastrointestinal disorders
Faeces soft
|
1.2%
1/81 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
|
Gastrointestinal disorders
Gingival bleeding
|
0.00%
0/81 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
1.2%
1/80 • Screening through Week 48
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/81 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
1.2%
1/80 • Screening through Week 48
|
|
Gastrointestinal disorders
Toothache
|
1.2%
1/81 • Screening through Week 48
|
1.2%
1/80 • Screening through Week 48
|
2.5%
2/80 • Screening through Week 48
|
|
Infections and infestations
Nasopharyngitis
|
24.7%
20/81 • Screening through Week 48
|
18.8%
15/80 • Screening through Week 48
|
20.0%
16/80 • Screening through Week 48
|
|
Infections and infestations
Urinary tract infection
|
9.9%
8/81 • Screening through Week 48
|
11.2%
9/80 • Screening through Week 48
|
12.5%
10/80 • Screening through Week 48
|
|
Infections and infestations
Lower respiratory tract infection
|
3.7%
3/81 • Screening through Week 48
|
12.5%
10/80 • Screening through Week 48
|
8.8%
7/80 • Screening through Week 48
|
|
Infections and infestations
Sinusitis
|
2.5%
2/81 • Screening through Week 48
|
1.2%
1/80 • Screening through Week 48
|
6.2%
5/80 • Screening through Week 48
|
|
Infections and infestations
Candida infection
|
1.2%
1/81 • Screening through Week 48
|
3.8%
3/80 • Screening through Week 48
|
2.5%
2/80 • Screening through Week 48
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/81 • Screening through Week 48
|
1.2%
1/80 • Screening through Week 48
|
2.5%
2/80 • Screening through Week 48
|
|
Infections and infestations
Influenza
|
0.00%
0/81 • Screening through Week 48
|
3.8%
3/80 • Screening through Week 48
|
2.5%
2/80 • Screening through Week 48
|
|
Infections and infestations
Upper respiratory tract infection
|
1.2%
1/81 • Screening through Week 48
|
2.5%
2/80 • Screening through Week 48
|
5.0%
4/80 • Screening through Week 48
|
|
Infections and infestations
Gastroenteritis viral
|
1.2%
1/81 • Screening through Week 48
|
1.2%
1/80 • Screening through Week 48
|
1.2%
1/80 • Screening through Week 48
|
|
Infections and infestations
Oral herpes
|
0.00%
0/81 • Screening through Week 48
|
3.8%
3/80 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
|
Infections and infestations
Tooth infection
|
1.2%
1/81 • Screening through Week 48
|
1.2%
1/80 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
|
Infections and infestations
Vulvovaginal candidiasis
|
1.2%
1/81 • Screening through Week 48
|
2.5%
2/80 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
|
Infections and infestations
Bronchitis
|
0.00%
0/81 • Screening through Week 48
|
1.2%
1/80 • Screening through Week 48
|
1.2%
1/80 • Screening through Week 48
|
|
Infections and infestations
Cystitis
|
1.2%
1/81 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
|
Infections and infestations
Gastric infection
|
0.00%
0/81 • Screening through Week 48
|
2.5%
2/80 • Screening through Week 48
|
2.5%
2/80 • Screening through Week 48
|
|
Infections and infestations
Ear infection
|
1.2%
1/81 • Screening through Week 48
|
1.2%
1/80 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
|
Infections and infestations
Herpes zoster
|
1.2%
1/81 • Screening through Week 48
|
2.5%
2/80 • Screening through Week 48
|
1.2%
1/80 • Screening through Week 48
|
|
Infections and infestations
Infected dermal cyst
|
0.00%
0/81 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
1.2%
1/80 • Screening through Week 48
|
|
Infections and infestations
Kidney infection
|
0.00%
0/81 • Screening through Week 48
|
1.2%
1/80 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
|
Infections and infestations
Laryngitis
|
0.00%
0/81 • Screening through Week 48
|
1.2%
1/80 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
|
Infections and infestations
Pneumonia
|
1.2%
1/81 • Screening through Week 48
|
2.5%
2/80 • Screening through Week 48
|
1.2%
1/80 • Screening through Week 48
|
|
Infections and infestations
Eye infection
|
1.2%
1/81 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
|
Infections and infestations
Viral pharyngitis
|
0.00%
0/81 • Screening through Week 48
|
1.2%
1/80 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
|
Nervous system disorders
Headache
|
19.8%
16/81 • Screening through Week 48
|
17.5%
14/80 • Screening through Week 48
|
22.5%
18/80 • Screening through Week 48
|
|
Nervous system disorders
Multiple sclerosis relapse
|
6.2%
5/81 • Screening through Week 48
|
15.0%
12/80 • Screening through Week 48
|
6.2%
5/80 • Screening through Week 48
|
|
Nervous system disorders
Paraesthesia
|
6.2%
5/81 • Screening through Week 48
|
8.8%
7/80 • Screening through Week 48
|
6.2%
5/80 • Screening through Week 48
|
|
Nervous system disorders
Hypoaesthesia
|
4.9%
4/81 • Screening through Week 48
|
10.0%
8/80 • Screening through Week 48
|
5.0%
4/80 • Screening through Week 48
|
|
Nervous system disorders
Migraine
|
2.5%
2/81 • Screening through Week 48
|
2.5%
2/80 • Screening through Week 48
|
1.2%
1/80 • Screening through Week 48
|
|
Nervous system disorders
Balance disorder
|
1.2%
1/81 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
3.8%
3/80 • Screening through Week 48
|
|
Nervous system disorders
Dizziness
|
3.7%
3/81 • Screening through Week 48
|
2.5%
2/80 • Screening through Week 48
|
5.0%
4/80 • Screening through Week 48
|
|
Nervous system disorders
Amnesia
|
0.00%
0/81 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
1.2%
1/80 • Screening through Week 48
|
|
Nervous system disorders
Memory impairment
|
1.2%
1/81 • Screening through Week 48
|
2.5%
2/80 • Screening through Week 48
|
1.2%
1/80 • Screening through Week 48
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/81 • Screening through Week 48
|
1.2%
1/80 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
|
Nervous system disorders
Dystonia
|
0.00%
0/81 • Screening through Week 48
|
1.2%
1/80 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
|
Nervous system disorders
Optic neuritis
|
1.2%
1/81 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
3.8%
3/80 • Screening through Week 48
|
|
Nervous system disorders
Syncope
|
1.2%
1/81 • Screening through Week 48
|
1.2%
1/80 • Screening through Week 48
|
1.2%
1/80 • Screening through Week 48
|
|
Nervous system disorders
Tremor
|
1.2%
1/81 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
1.2%
1/80 • Screening through Week 48
|
|
Nervous system disorders
Uhthoff's phenomenon
|
0.00%
0/81 • Screening through Week 48
|
2.5%
2/80 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
|
Nervous system disorders
Visual field defect
|
0.00%
0/81 • Screening through Week 48
|
1.2%
1/80 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
7.4%
6/81 • Screening through Week 48
|
5.0%
4/80 • Screening through Week 48
|
2.5%
2/80 • Screening through Week 48
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
6.2%
5/81 • Screening through Week 48
|
2.5%
2/80 • Screening through Week 48
|
8.8%
7/80 • Screening through Week 48
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.7%
3/81 • Screening through Week 48
|
7.5%
6/80 • Screening through Week 48
|
3.8%
3/80 • Screening through Week 48
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
2.5%
2/81 • Screening through Week 48
|
2.5%
2/80 • Screening through Week 48
|
3.8%
3/80 • Screening through Week 48
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/81 • Screening through Week 48
|
1.2%
1/80 • Screening through Week 48
|
3.8%
3/80 • Screening through Week 48
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
3.7%
3/81 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/81 • Screening through Week 48
|
2.5%
2/80 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
|
Musculoskeletal and connective tissue disorders
Costochondritis
|
0.00%
0/81 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
1.2%
1/80 • Screening through Week 48
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/81 • Screening through Week 48
|
1.2%
1/80 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
|
Musculoskeletal and connective tissue disorders
Limb discomfort
|
0.00%
0/81 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
1.2%
1/80 • Screening through Week 48
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/81 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
1.2%
1/80 • Screening through Week 48
|
|
Musculoskeletal and connective tissue disorders
Periarthritis
|
1.2%
1/81 • Screening through Week 48
|
1.2%
1/80 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
6.2%
5/81 • Screening through Week 48
|
13.8%
11/80 • Screening through Week 48
|
5.0%
4/80 • Screening through Week 48
|
|
Skin and subcutaneous tissue disorders
Rash
|
2.5%
2/81 • Screening through Week 48
|
2.5%
2/80 • Screening through Week 48
|
5.0%
4/80 • Screening through Week 48
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
3.7%
3/81 • Screening through Week 48
|
1.2%
1/80 • Screening through Week 48
|
2.5%
2/80 • Screening through Week 48
|
|
Skin and subcutaneous tissue disorders
Rash generalised
|
1.2%
1/81 • Screening through Week 48
|
1.2%
1/80 • Screening through Week 48
|
2.5%
2/80 • Screening through Week 48
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
2.5%
2/81 • Screening through Week 48
|
1.2%
1/80 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
|
Skin and subcutaneous tissue disorders
Acne
|
1.2%
1/81 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/81 • Screening through Week 48
|
1.2%
1/80 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/81 • Screening through Week 48
|
1.2%
1/80 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
2.5%
2/81 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
1.2%
1/80 • Screening through Week 48
|
|
Skin and subcutaneous tissue disorders
Xanthelasma
|
1.2%
1/81 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
11.1%
9/81 • Screening through Week 48
|
3.8%
3/80 • Screening through Week 48
|
6.2%
5/80 • Screening through Week 48
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
3.7%
3/81 • Screening through Week 48
|
3.8%
3/80 • Screening through Week 48
|
2.5%
2/80 • Screening through Week 48
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
3.7%
3/81 • Screening through Week 48
|
2.5%
2/80 • Screening through Week 48
|
3.8%
3/80 • Screening through Week 48
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
3.7%
3/81 • Screening through Week 48
|
5.0%
4/80 • Screening through Week 48
|
7.5%
6/80 • Screening through Week 48
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/81 • Screening through Week 48
|
1.2%
1/80 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
|
Respiratory, thoracic and mediastinal disorders
Dry throat
|
0.00%
0/81 • Screening through Week 48
|
1.2%
1/80 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/81 • Screening through Week 48
|
2.5%
2/80 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
1.2%
1/81 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
|
Respiratory, thoracic and mediastinal disorders
Nasal dryness
|
0.00%
0/81 • Screening through Week 48
|
1.2%
1/80 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
1.2%
1/81 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
|
General disorders
Fatigue
|
11.1%
9/81 • Screening through Week 48
|
13.8%
11/80 • Screening through Week 48
|
8.8%
7/80 • Screening through Week 48
|
|
General disorders
Influenza like illness
|
2.5%
2/81 • Screening through Week 48
|
2.5%
2/80 • Screening through Week 48
|
5.0%
4/80 • Screening through Week 48
|
|
General disorders
Asthenia
|
2.5%
2/81 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
2.5%
2/80 • Screening through Week 48
|
|
General disorders
Chest discomfort
|
0.00%
0/81 • Screening through Week 48
|
2.5%
2/80 • Screening through Week 48
|
2.5%
2/80 • Screening through Week 48
|
|
General disorders
Pain
|
0.00%
0/81 • Screening through Week 48
|
2.5%
2/80 • Screening through Week 48
|
1.2%
1/80 • Screening through Week 48
|
|
General disorders
Chills
|
0.00%
0/81 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
2.5%
2/80 • Screening through Week 48
|
|
General disorders
Feeling abnormal
|
0.00%
0/81 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
1.2%
1/80 • Screening through Week 48
|
|
General disorders
Malaise
|
0.00%
0/81 • Screening through Week 48
|
1.2%
1/80 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
|
General disorders
Pyrexia
|
1.2%
1/81 • Screening through Week 48
|
2.5%
2/80 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
|
Psychiatric disorders
Anxiety
|
1.2%
1/81 • Screening through Week 48
|
2.5%
2/80 • Screening through Week 48
|
2.5%
2/80 • Screening through Week 48
|
|
Psychiatric disorders
Depressed mood
|
1.2%
1/81 • Screening through Week 48
|
3.8%
3/80 • Screening through Week 48
|
2.5%
2/80 • Screening through Week 48
|
|
Psychiatric disorders
Depression
|
6.2%
5/81 • Screening through Week 48
|
1.2%
1/80 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
|
Psychiatric disorders
Irritability
|
1.2%
1/81 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
1.2%
1/80 • Screening through Week 48
|
|
Psychiatric disorders
Anger
|
2.5%
2/81 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/81 • Screening through Week 48
|
1.2%
1/80 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
|
Psychiatric disorders
Libido decreased
|
0.00%
0/81 • Screening through Week 48
|
1.2%
1/80 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
|
Psychiatric disorders
Mental disorder
|
1.2%
1/81 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
|
Psychiatric disorders
Sleep disorder
|
0.00%
0/81 • Screening through Week 48
|
1.2%
1/80 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
3.7%
3/81 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
2.5%
2/80 • Screening through Week 48
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/81 • Screening through Week 48
|
2.5%
2/80 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
|
Reproductive system and breast disorders
Menorrhagia
|
2.5%
2/81 • Screening through Week 48
|
1.2%
1/80 • Screening through Week 48
|
1.2%
1/80 • Screening through Week 48
|
|
Reproductive system and breast disorders
Breast cyst
|
0.00%
0/81 • Screening through Week 48
|
1.2%
1/80 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
|
Reproductive system and breast disorders
Breast mass
|
0.00%
0/81 • Screening through Week 48
|
1.2%
1/80 • Screening through Week 48
|
1.2%
1/80 • Screening through Week 48
|
|
Reproductive system and breast disorders
Vulvovaginal pain
|
1.2%
1/81 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
|
Injury, poisoning and procedural complications
Fall
|
6.2%
5/81 • Screening through Week 48
|
2.5%
2/80 • Screening through Week 48
|
7.5%
6/80 • Screening through Week 48
|
|
Injury, poisoning and procedural complications
Contusion
|
1.2%
1/81 • Screening through Week 48
|
3.8%
3/80 • Screening through Week 48
|
1.2%
1/80 • Screening through Week 48
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.00%
0/81 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
1.2%
1/80 • Screening through Week 48
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
1.2%
1/81 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
|
Injury, poisoning and procedural complications
Epicondylitis
|
0.00%
0/81 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
1.2%
1/80 • Screening through Week 48
|
|
Injury, poisoning and procedural complications
Vaccination complication
|
0.00%
0/81 • Screening through Week 48
|
1.2%
1/80 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
|
Eye disorders
Vision blurred
|
2.5%
2/81 • Screening through Week 48
|
2.5%
2/80 • Screening through Week 48
|
2.5%
2/80 • Screening through Week 48
|
|
Eye disorders
Ocular hyperaemia
|
1.2%
1/81 • Screening through Week 48
|
1.2%
1/80 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
|
Eye disorders
Conjunctival haemorrhage
|
0.00%
0/81 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
1.2%
1/80 • Screening through Week 48
|
|
Eye disorders
Eye irritation
|
1.2%
1/81 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
|
Investigations
Alanine aminotransferase abnormal
|
0.00%
0/81 • Screening through Week 48
|
1.2%
1/80 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
|
Investigations
Alanine aminotransferase increased
|
1.2%
1/81 • Screening through Week 48
|
1.2%
1/80 • Screening through Week 48
|
3.8%
3/80 • Screening through Week 48
|
|
Investigations
Aspartate aminotransferase abnormal
|
0.00%
0/81 • Screening through Week 48
|
1.2%
1/80 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
|
Investigations
Liver function test abnormal
|
0.00%
0/81 • Screening through Week 48
|
2.5%
2/80 • Screening through Week 48
|
1.2%
1/80 • Screening through Week 48
|
|
Investigations
Serum ferritin decreased
|
1.2%
1/81 • Screening through Week 48
|
1.2%
1/80 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
|
Investigations
Smear cervix abnormal
|
0.00%
0/81 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
1.2%
1/80 • Screening through Week 48
|
|
Investigations
Weight increased
|
0.00%
0/81 • Screening through Week 48
|
1.2%
1/80 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
|
Vascular disorders
Flushing
|
51.9%
42/81 • Screening through Week 48
|
45.0%
36/80 • Screening through Week 48
|
56.2%
45/80 • Screening through Week 48
|
|
Vascular disorders
Hypertension
|
0.00%
0/81 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
1.2%
1/80 • Screening through Week 48
|
|
Vascular disorders
Peripheral coldness
|
1.2%
1/81 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
|
Ear and labyrinth disorders
Ear discomfort
|
1.2%
1/81 • Screening through Week 48
|
1.2%
1/80 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
|
Ear and labyrinth disorders
Hearing impaired
|
1.2%
1/81 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
|
Ear and labyrinth disorders
Hypoacusis
|
0.00%
0/81 • Screening through Week 48
|
1.2%
1/80 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/81 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
1.2%
1/80 • Screening through Week 48
|
|
Immune system disorders
Hypersensitivity
|
1.2%
1/81 • Screening through Week 48
|
1.2%
1/80 • Screening through Week 48
|
1.2%
1/80 • Screening through Week 48
|
|
Cardiac disorders
Palpitations
|
1.2%
1/81 • Screening through Week 48
|
1.2%
1/80 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/81 • Screening through Week 48
|
1.2%
1/80 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/81 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
1.2%
1/80 • Screening through Week 48
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/81 • Screening through Week 48
|
1.2%
1/80 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
|
Gastrointestinal disorders
Fecal incontinence
|
2.5%
2/81 • Screening through Week 48
|
1.2%
1/80 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
|
Gastrointestinal disorders
Anorectal discomfort
|
1.2%
1/81 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
|
Gastrointestinal disorders
Food poisoning
|
0.00%
0/81 • Screening through Week 48
|
1.2%
1/80 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
|
Gastrointestinal disorders
Gingival swelling
|
1.2%
1/81 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
|
Gastrointestinal disorders
Hemorrhoids
|
0.00%
0/81 • Screening through Week 48
|
1.2%
1/80 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
|
Gastrointestinal disorders
Oesophagitis
|
1.2%
1/81 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
|
Gastrointestinal disorders
Stomach ulcer
|
1.2%
1/81 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
|
Vascular disorders
Hot flush
|
1.2%
1/81 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
|
Infections and infestations
Impetigo
|
1.2%
1/81 • Screening through Week 48
|
1.2%
1/80 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/81 • Screening through Week 48
|
1.2%
1/80 • Screening through Week 48
|
1.2%
1/80 • Screening through Week 48
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/81 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
2.5%
2/80 • Screening through Week 48
|
|
Infections and infestations
Gastroenteritis norovirus
|
0.00%
0/81 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
1.2%
1/80 • Screening through Week 48
|
|
Infections and infestations
Gingivitis
|
1.2%
1/81 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
|
Infections and infestations
Herpes simplex
|
0.00%
0/81 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
1.2%
1/80 • Screening through Week 48
|
|
Infections and infestations
Infected cyst
|
0.00%
0/81 • Screening through Week 48
|
1.2%
1/80 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
|
Infections and infestations
Labyrinthitis
|
0.00%
0/81 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
1.2%
1/80 • Screening through Week 48
|
|
Infections and infestations
Lower respiratory tract infection viral
|
0.00%
0/81 • Screening through Week 48
|
1.2%
1/80 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
|
Infections and infestations
Lyme disease
|
0.00%
0/81 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
1.2%
1/80 • Screening through Week 48
|
|
Infections and infestations
Periodontitis
|
0.00%
0/81 • Screening through Week 48
|
1.2%
1/80 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
|
Infections and infestations
Pyuria
|
0.00%
0/81 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
1.2%
1/80 • Screening through Week 48
|
|
Infections and infestations
Rhinitis
|
1.2%
1/81 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
|
Infections and infestations
Skin infection
|
0.00%
0/81 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
1.2%
1/80 • Screening through Week 48
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/81 • Screening through Week 48
|
1.2%
1/80 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/81 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
1.2%
1/80 • Screening through Week 48
|
|
Nervous system disorders
Sensory disturbance
|
2.5%
2/81 • Screening through Week 48
|
2.5%
2/80 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
|
Nervous system disorders
Neuralgia
|
1.2%
1/81 • Screening through Week 48
|
2.5%
2/80 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
|
Nervous system disorders
Aphasia
|
1.2%
1/81 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
|
Nervous system disorders
Aphonia
|
1.2%
1/81 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
|
Nervous system disorders
Coordination abnormal
|
1.2%
1/81 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/81 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
1.2%
1/80 • Screening through Week 48
|
|
Nervous system disorders
Hemiparesis
|
1.2%
1/81 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
|
Nervous system disorders
Hyperaesthesia
|
0.00%
0/81 • Screening through Week 48
|
1.2%
1/80 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
|
Nervous system disorders
Lethargy
|
0.00%
0/81 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
1.2%
1/80 • Screening through Week 48
|
|
Nervous system disorders
Motor dysfunction
|
1.2%
1/81 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
|
Nervous system disorders
Nerve compression
|
0.00%
0/81 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
1.2%
1/80 • Screening through Week 48
|
|
Nervous system disorders
Pain
|
0.00%
0/81 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
1.2%
1/80 • Screening through Week 48
|
|
Nervous system disorders
Peroneal nerve palsy
|
1.2%
1/81 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
|
Nervous system disorders
Somnolence
|
0.00%
0/81 • Screening through Week 48
|
1.2%
1/80 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.9%
4/81 • Screening through Week 48
|
10.0%
8/80 • Screening through Week 48
|
3.8%
3/80 • Screening through Week 48
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
|
1.2%
1/81 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/81 • Screening through Week 48
|
1.2%
1/80 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
|
Musculoskeletal and connective tissue disorders
Mastication disorder
|
0.00%
0/81 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
1.2%
1/80 • Screening through Week 48
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
0.00%
0/81 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
1.2%
1/80 • Screening through Week 48
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/81 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
1.2%
1/80 • Screening through Week 48
|
|
Musculoskeletal and connective tissue disorders
Temporomandibular joint syndrome
|
0.00%
0/81 • Screening through Week 48
|
1.2%
1/80 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
1.2%
1/81 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
|
Respiratory, thoracic and mediastinal disorders
Throat tightness
|
1.2%
1/81 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
|
Skin and subcutaneous tissue disorders
Dermal cyst
|
0.00%
0/81 • Screening through Week 48
|
1.2%
1/80 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
|
Skin and subcutaneous tissue disorders
Nail hypertrophy
|
1.2%
1/81 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
1.2%
1/81 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
|
Skin and subcutaneous tissue disorders
Pruritis generalised
|
0.00%
0/81 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
1.2%
1/80 • Screening through Week 48
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.00%
0/81 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
1.2%
1/80 • Screening through Week 48
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
1.2%
1/81 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
|
Skin and subcutaneous tissue disorders
Rosacea
|
1.2%
1/81 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
|
Skin and subcutaneous tissue disorders
Skin discolouration
|
0.00%
0/81 • Screening through Week 48
|
1.2%
1/80 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
|
General disorders
Chest pain
|
1.2%
1/81 • Screening through Week 48
|
1.2%
1/80 • Screening through Week 48
|
1.2%
1/80 • Screening through Week 48
|
|
Investigations
Lymphocyte count decreased
|
6.2%
5/81 • Screening through Week 48
|
6.2%
5/80 • Screening through Week 48
|
6.2%
5/80 • Screening through Week 48
|
|
Investigations
Platelet count decreased
|
2.5%
2/81 • Screening through Week 48
|
1.2%
1/80 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
|
Investigations
Blood iron decreased
|
1.2%
1/81 • Screening through Week 48
|
1.2%
1/80 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
|
Investigations
Lymphocyte count abnormal
|
2.5%
2/81 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
|
Investigations
Weight decreased
|
1.2%
1/81 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
1.2%
1/80 • Screening through Week 48
|
|
Investigations
Aspartate aminotransferase increased
|
1.2%
1/81 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/81 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
1.2%
1/80 • Screening through Week 48
|
|
Investigations
Blood folate decreased
|
0.00%
0/81 • Screening through Week 48
|
1.2%
1/80 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/81 • Screening through Week 48
|
1.2%
1/80 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/81 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
1.2%
1/80 • Screening through Week 48
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/81 • Screening through Week 48
|
1.2%
1/80 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
|
Investigations
Vitamin B12 decreased
|
1.2%
1/81 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
|
Investigations
White blood cell count decreased
|
0.00%
0/81 • Screening through Week 48
|
1.2%
1/80 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
|
Investigations
White blood cells urine positive
|
0.00%
0/81 • Screening through Week 48
|
1.2%
1/80 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
2.5%
2/81 • Screening through Week 48
|
1.2%
1/80 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/81 • Screening through Week 48
|
1.2%
1/80 • Screening through Week 48
|
1.2%
1/80 • Screening through Week 48
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
2.5%
2/81 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/81 • Screening through Week 48
|
1.2%
1/80 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/81 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
1.2%
1/80 • Screening through Week 48
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/81 • Screening through Week 48
|
1.2%
1/80 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/81 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
1.2%
1/80 • Screening through Week 48
|
|
Injury, poisoning and procedural complications
Muscle rupture
|
0.00%
0/81 • Screening through Week 48
|
1.2%
1/80 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
|
Injury, poisoning and procedural complications
Patella fracture
|
0.00%
0/81 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
1.2%
1/80 • Screening through Week 48
|
|
Injury, poisoning and procedural complications
Sunburn
|
1.2%
1/81 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.00%
0/81 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
1.2%
1/80 • Screening through Week 48
|
|
Psychiatric disorders
Panic attack
|
1.2%
1/81 • Screening through Week 48
|
1.2%
1/80 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
|
General disorders
Gait disturbance
|
0.00%
0/81 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
3.8%
3/80 • Screening through Week 48
|
|
General disorders
Adverse drug reaction
|
1.2%
1/81 • Screening through Week 48
|
1.2%
1/80 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
|
General disorders
Device failure
|
0.00%
0/81 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
1.2%
1/80 • Screening through Week 48
|
|
General disorders
Feeling hot
|
1.2%
1/81 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
|
Eye disorders
Eye pain
|
2.5%
2/81 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
1.2%
1/80 • Screening through Week 48
|
|
Eye disorders
Colour blindness acquired
|
0.00%
0/81 • Screening through Week 48
|
1.2%
1/80 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
|
Eye disorders
Diplopia
|
0.00%
0/81 • Screening through Week 48
|
1.2%
1/80 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
|
Eye disorders
Scleritis
|
0.00%
0/81 • Screening through Week 48
|
1.2%
1/80 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
|
Ear and labyrinth disorders
Vertigo
|
2.5%
2/81 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
1.2%
1/80 • Screening through Week 48
|
|
Ear and labyrinth disorders
Ear pain
|
1.2%
1/81 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
1.2%
1/80 • Screening through Week 48
|
|
Reproductive system and breast disorders
Metrorrhagia
|
1.2%
1/81 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
1.2%
1/80 • Screening through Week 48
|
|
Reproductive system and breast disorders
Anisomastia
|
0.00%
0/81 • Screening through Week 48
|
1.2%
1/80 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
|
Reproductive system and breast disorders
Menstruation irregular
|
1.2%
1/81 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
|
Reproductive system and breast disorders
Nipple pain
|
0.00%
0/81 • Screening through Week 48
|
1.2%
1/80 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
|
Reproductive system and breast disorders
Pruritus genital
|
0.00%
0/81 • Screening through Week 48
|
1.2%
1/80 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
|
Reproductive system and breast disorders
Testicular cyst
|
0.00%
0/81 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
1.2%
1/80 • Screening through Week 48
|
|
Reproductive system and breast disorders
Testicular pain
|
0.00%
0/81 • Screening through Week 48
|
1.2%
1/80 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
|
Blood and lymphatic system disorders
Lymphopenia
|
1.2%
1/81 • Screening through Week 48
|
1.2%
1/80 • Screening through Week 48
|
1.2%
1/80 • Screening through Week 48
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
1.2%
1/81 • Screening through Week 48
|
1.2%
1/80 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
|
Blood and lymphatic system disorders
Anaemia
|
1.2%
1/81 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
|
Immune system disorders
Food allergy
|
0.00%
0/81 • Screening through Week 48
|
1.2%
1/80 • Screening through Week 48
|
1.2%
1/80 • Screening through Week 48
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/81 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
1.2%
1/80 • Screening through Week 48
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/81 • Screening through Week 48
|
1.2%
1/80 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
|
Renal and urinary disorders
Haematuria
|
1.2%
1/81 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
|
Renal and urinary disorders
Micturition urgency
|
0.00%
0/81 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
1.2%
1/80 • Screening through Week 48
|
|
Renal and urinary disorders
Pollakiuria
|
1.2%
1/81 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
|
Renal and urinary disorders
Renal pain
|
0.00%
0/81 • Screening through Week 48
|
1.2%
1/80 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
|
Metabolism and nutrition disorders
Cow's milk intolerance
|
1.2%
1/81 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/81 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
1.2%
1/80 • Screening through Week 48
|
|
Metabolism and nutrition disorders
Iron deficiency
|
0.00%
0/81 • Screening through Week 48
|
1.2%
1/80 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
|
Nervous system disorders
Burning sensation
|
0.00%
0/81 • Screening through Week 48
|
1.2%
1/80 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
|
Hepatobiliary disorders
Biliary colic
|
0.00%
0/81 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
1.2%
1/80 • Screening through Week 48
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bowen's disease
|
0.00%
0/81 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
1.2%
1/80 • Screening through Week 48
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/81 • Screening through Week 48
|
1.2%
1/80 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
|
Psychiatric disorders
Disturbance in attention
|
0.00%
0/81 • Screening through Week 48
|
1.2%
1/80 • Screening through Week 48
|
0.00%
0/80 • Screening through Week 48
|
|
Infections and infestations
Viral infection
|
0.00%
0/81 • Screening through Week 48
|
1.2%
1/80 • Screening through Week 48
|
3.8%
3/80 • Screening through Week 48
|
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