Trial Outcomes & Findings for Gastrointestinal Tolerability Study Of Dimethyl Fumarate In Participants With Relapsing-Remitting Multiple Sclerosis In Germany (NCT NCT02125604)
NCT ID: NCT02125604
Last Updated: 2017-04-18
Results Overview
The MOGISS is a questionnaire about the severity of overall gastrointestinal-related events, including specifically symptoms of nausea, diarrhea, upper abdominal pain, lower abdominal pain, vomiting, indigestion, constipation, bloating, and flatulence for 24 hours before the AM dose. Participants who rated the intensity of symptoms reported on the MOGISS and included each symptomatic therapy used in the eDiary are presented.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
214 participants
Primary outcome timeframe
Up to Week 12
Results posted on
2017-04-18
Participant Flow
A total of 214 participants were screened and enrolled; 3 participants did not receive study drug (1 withdrew consent and 2 did not meet all inclusion/exclusion criteria). A total of 211 participants were included in the safety population.
Participant milestones
| Measure |
Dimethyl Fumarate
Dimethyl fumarate administered orally at 120 mg BID for the first 7 days and 240 mg BID thereafter for a total of 12 weeks.
|
|---|---|
|
Overall Study
STARTED
|
211
|
|
Overall Study
COMPLETED
|
180
|
|
Overall Study
NOT COMPLETED
|
31
|
Reasons for withdrawal
| Measure |
Dimethyl Fumarate
Dimethyl fumarate administered orally at 120 mg BID for the first 7 days and 240 mg BID thereafter for a total of 12 weeks.
|
|---|---|
|
Overall Study
Other
|
4
|
|
Overall Study
Investigator Decision
|
1
|
|
Overall Study
Lost to Follow-up
|
2
|
|
Overall Study
Consent Withdrawn
|
4
|
|
Overall Study
Adverse Event
|
20
|
Baseline Characteristics
Gastrointestinal Tolerability Study Of Dimethyl Fumarate In Participants With Relapsing-Remitting Multiple Sclerosis In Germany
Baseline characteristics by cohort
| Measure |
Dimethyl Fumarate
n=211 Participants
Dimethyl fumarate administered orally at 120 mg BID for the first 7 days and 240 mg BID thereafter for a total of 12 weeks.
|
|---|---|
|
Age, Continuous
|
40.09 years
STANDARD_DEVIATION 10.97 • n=5 Participants
|
|
Sex: Female, Male
Female
|
149 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
62 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to Week 12Population: Safety Population: all participants who received at least 1 dose of dimethyl fumarate; n=participants with an assessment during given time period.
The MOGISS is a questionnaire about the severity of overall gastrointestinal-related events, including specifically symptoms of nausea, diarrhea, upper abdominal pain, lower abdominal pain, vomiting, indigestion, constipation, bloating, and flatulence for 24 hours before the AM dose. Participants who rated the intensity of symptoms reported on the MOGISS and included each symptomatic therapy used in the eDiary are presented.
Outcome measures
| Measure |
Dimethyl Fumarate
n=211 Participants
Dimethyl fumarate administered orally at 120 mg BID for the first 7 days and 240 mg BID thereafter for a total of 12 weeks.
|
|---|---|
|
Number of Participants Who Utilized Symptomatic Therapy With Gastrointestinal-Related Events During the 12-Week Treatment Period: Modified Overall Gastrointestinal Symptom Scale (MOGISS)
Overall Treatment Period; n=211
|
82 Participants
|
|
Number of Participants Who Utilized Symptomatic Therapy With Gastrointestinal-Related Events During the 12-Week Treatment Period: Modified Overall Gastrointestinal Symptom Scale (MOGISS)
Weeks 1-4; n=211
|
71 Participants
|
|
Number of Participants Who Utilized Symptomatic Therapy With Gastrointestinal-Related Events During the 12-Week Treatment Period: Modified Overall Gastrointestinal Symptom Scale (MOGISS)
Weeks 5-8; n=186
|
33 Participants
|
|
Number of Participants Who Utilized Symptomatic Therapy With Gastrointestinal-Related Events During the 12-Week Treatment Period: Modified Overall Gastrointestinal Symptom Scale (MOGISS)
Weeks 9-12; n=178
|
22 Participants
|
PRIMARY outcome
Timeframe: Up to Week 12Population: Safety Population: all participants who received at least 1 dose of dimethyl fumarate; n=participants with an assessment during given time period.
The MAGISS is a questionnaire in which participants reported overall acute gastrointestinal-related events, (especially symptoms of nausea, diarrhea, upper abdominal pain, lower abdominal pain, vomiting, indigestion, constipation, bloating, and flatulence) for each 10 hours after the AM and PM doses of study drug. Participants who rated the intensity of gastrointestinal-related events reported on MAGISS, included the duration of the gastrointestinal-related events and each symptomatic therapy used in the eDiary are presented.
Outcome measures
| Measure |
Dimethyl Fumarate
n=211 Participants
Dimethyl fumarate administered orally at 120 mg BID for the first 7 days and 240 mg BID thereafter for a total of 12 weeks.
|
|---|---|
|
Number of Participants Who Utilized Symptomatic Therapy With Gastrointestinal-Related Events During the 12-Week Treatment Period: Modified Acute Gastrointestinal Symptom Scale (MAGISS)
Overall Treatment Period; n=211
|
83 Participants
|
|
Number of Participants Who Utilized Symptomatic Therapy With Gastrointestinal-Related Events During the 12-Week Treatment Period: Modified Acute Gastrointestinal Symptom Scale (MAGISS)
Weeks 1-4; n=211
|
72 Participants
|
|
Number of Participants Who Utilized Symptomatic Therapy With Gastrointestinal-Related Events During the 12-Week Treatment Period: Modified Acute Gastrointestinal Symptom Scale (MAGISS)
Weeks 5-8; n=189
|
34 Participants
|
|
Number of Participants Who Utilized Symptomatic Therapy With Gastrointestinal-Related Events During the 12-Week Treatment Period: Modified Acute Gastrointestinal Symptom Scale (MAGISS)
Weeks 9-12; n=180
|
26 Participants
|
PRIMARY outcome
Timeframe: Up to Week 12Population: Safety Population: all participants who received at least 1 dose of dimethyl fumarate and used symptomatic therapy; n=participants with an evaluable assessment during given time period.
The MOGISS is a questionnaire about overall events related to the gastrointestinal system (including nausea, diarrhea, upper abdominal pain, lower abdominal pain, vomiting, indigestion, constipation, bloating, and flatulence) during the 24 hours prior to each AM dose. MOGISS is based on a 0- to 10-point scale, with 0 representing absence of symptoms and 10 representing the most severe symptoms. The worst overall severity score for gastrointestinal-related events was calculated for each participant for the overall treatment period of 12 weeks, and for each 4-week period therein.
Outcome measures
| Measure |
Dimethyl Fumarate
n=84 Participants
Dimethyl fumarate administered orally at 120 mg BID for the first 7 days and 240 mg BID thereafter for a total of 12 weeks.
|
|---|---|
|
Worst Severity Of Gastrointestinal-Related Events In Participants Who Utilized Symptomatic Therapy During the 12-Week Treatment Period, MOGISS
Overall treatment period; n=84
|
5.94 units on a scale
Standard Deviation 2.427
|
|
Worst Severity Of Gastrointestinal-Related Events In Participants Who Utilized Symptomatic Therapy During the 12-Week Treatment Period, MOGISS
Week 1-4; n=73
|
5.75 units on a scale
Standard Deviation 2.554
|
|
Worst Severity Of Gastrointestinal-Related Events In Participants Who Utilized Symptomatic Therapy During the 12-Week Treatment Period, MOGISS
Week 5-8; n=38
|
3.53 units on a scale
Standard Deviation 2.533
|
|
Worst Severity Of Gastrointestinal-Related Events In Participants Who Utilized Symptomatic Therapy During the 12-Week Treatment Period, MOGISS
Week 9-12; n=29
|
3.1 units on a scale
Standard Deviation 2.568
|
PRIMARY outcome
Timeframe: Up to Week 12Population: Safety Population: all participants who received at least 1 dose of dimethyl fumarate and used symptomatic therapy; n=participants with an evaluable assessment during given time period.
The MAGISS is a questionnaire about the overall events related to the gastrointestinal system (including nausea, diarrhea, upper abdominal pain, lower abdominal pain, vomiting, indigestion, constipation, bloating, and flatulence) following drug administration (acute symptoms). MAGISS is based on a 0- to 10-point scale, with 0 representing absence of symptoms and 10 representing the most severe symptoms. The worst overall severity score for gastrointestinal-related events was calculated for each participant for the overall treatment period of 12 weeks, and for each 4-week period therein.
Outcome measures
| Measure |
Dimethyl Fumarate
n=84 Participants
Dimethyl fumarate administered orally at 120 mg BID for the first 7 days and 240 mg BID thereafter for a total of 12 weeks.
|
|---|---|
|
Worst Severity Of Gastrointestinal-Related Events In Participants Who Utilized Symptomatic Therapy During the 12-Week Treatment Period, MAGISS
Overall treatment period; n=84
|
5.93 units on a scale
Standard Deviation 2.516
|
|
Worst Severity Of Gastrointestinal-Related Events In Participants Who Utilized Symptomatic Therapy During the 12-Week Treatment Period, MAGISS
Week 1-4; n=73
|
5.88 units on a scale
Standard Deviation 2.614
|
|
Worst Severity Of Gastrointestinal-Related Events In Participants Who Utilized Symptomatic Therapy During the 12-Week Treatment Period, MAGISS
Week 5-8; n=39
|
3.31 units on a scale
Standard Deviation 2.307
|
|
Worst Severity Of Gastrointestinal-Related Events In Participants Who Utilized Symptomatic Therapy During the 12-Week Treatment Period, MAGISS
Week 9-12; n=29
|
3.55 units on a scale
Standard Deviation 2.772
|
PRIMARY outcome
Timeframe: Up to Week 12Population: Safety Population: all participants who received at least 1 dose of dimethyl fumarate and used symptomatic therapy; n=participants with an evaluable assessment during given time period.
The percentage of days with GI events as reported on MOGISS was calculated for each participant and each analysis period using the following formula: 100 x (# of days with \[GI\] events / # of days tolerability scale completed). The symptomatic therapy (ST) categories were provided by Biogen Medical team as follows: ST1=anti-acid production; ST2=anti-bloating/anti-constipation agent; ST3=multitarget/ herbal agents; ST4=anti-diarrheal (anti-peristaltic); ST5=analgesic (NSAID); ST6=anti-emetic (central); ST7=anti-emetic (pro-kinetic); ST8=antacid; ST9=other; ST10=laxative (pro-kinetic). Overall GI events were reported in the second day after the dose. Relative day for Overall GI events = assessment date-first dose date.
Outcome measures
| Measure |
Dimethyl Fumarate
n=84 Participants
Dimethyl fumarate administered orally at 120 mg BID for the first 7 days and 240 mg BID thereafter for a total of 12 weeks.
|
|---|---|
|
Duration of Gastrointestinal-Related Events in Participants Who Utilized Symptomatic Therapy During the 12-Week Treatment Period, MOGISS
Overall treatment period; Any ST (n=84)
|
38.13 percentage of days
Standard Deviation 29.263
|
|
Duration of Gastrointestinal-Related Events in Participants Who Utilized Symptomatic Therapy During the 12-Week Treatment Period, MOGISS
Overall treatment period; ST1 (n=50)
|
42.08 percentage of days
Standard Deviation 27.495
|
|
Duration of Gastrointestinal-Related Events in Participants Who Utilized Symptomatic Therapy During the 12-Week Treatment Period, MOGISS
Overall treatment period; ST2 (n=26)
|
36.98 percentage of days
Standard Deviation 29.754
|
|
Duration of Gastrointestinal-Related Events in Participants Who Utilized Symptomatic Therapy During the 12-Week Treatment Period, MOGISS
Overall treatment period; ST3 (n=20)
|
39.61 percentage of days
Standard Deviation 29.197
|
|
Duration of Gastrointestinal-Related Events in Participants Who Utilized Symptomatic Therapy During the 12-Week Treatment Period, MOGISS
Overall treatment period; ST4 (n=16)
|
48.15 percentage of days
Standard Deviation 30.140
|
|
Duration of Gastrointestinal-Related Events in Participants Who Utilized Symptomatic Therapy During the 12-Week Treatment Period, MOGISS
Overall treatment period; ST5 (n=10)
|
45.94 percentage of days
Standard Deviation 27.147
|
|
Duration of Gastrointestinal-Related Events in Participants Who Utilized Symptomatic Therapy During the 12-Week Treatment Period, MOGISS
Overall treatment period; ST6 (n=8)
|
44.33 percentage of days
Standard Deviation 29.095
|
|
Duration of Gastrointestinal-Related Events in Participants Who Utilized Symptomatic Therapy During the 12-Week Treatment Period, MOGISS
Overall treatment period; ST7 (n=6)
|
57.52 percentage of days
Standard Deviation 21.998
|
|
Duration of Gastrointestinal-Related Events in Participants Who Utilized Symptomatic Therapy During the 12-Week Treatment Period, MOGISS
Overall treatment period; ST8 (n=5)
|
52.71 percentage of days
Standard Deviation 31.829
|
|
Duration of Gastrointestinal-Related Events in Participants Who Utilized Symptomatic Therapy During the 12-Week Treatment Period, MOGISS
Overall treatment period; ST9 (n=3)
|
32.78 percentage of days
Standard Deviation 26.995
|
|
Duration of Gastrointestinal-Related Events in Participants Who Utilized Symptomatic Therapy During the 12-Week Treatment Period, MOGISS
Overall treatment period; ST10 (n=2)
|
9.20 percentage of days
Standard Deviation 2.137
|
|
Duration of Gastrointestinal-Related Events in Participants Who Utilized Symptomatic Therapy During the 12-Week Treatment Period, MOGISS
Week 1-4; Any ST (n=73)
|
49.58 percentage of days
Standard Deviation 29.547
|
|
Duration of Gastrointestinal-Related Events in Participants Who Utilized Symptomatic Therapy During the 12-Week Treatment Period, MOGISS
Week 1-4; ST1 (n=44)
|
53.92 percentage of days
Standard Deviation 27.197
|
|
Duration of Gastrointestinal-Related Events in Participants Who Utilized Symptomatic Therapy During the 12-Week Treatment Period, MOGISS
Week 1-4; ST2 (n=23)
|
49.53 percentage of days
Standard Deviation 32.012
|
|
Duration of Gastrointestinal-Related Events in Participants Who Utilized Symptomatic Therapy During the 12-Week Treatment Period, MOGISS
Week 1-4; ST3 (n=18)
|
55.31 percentage of days
Standard Deviation 29.869
|
|
Duration of Gastrointestinal-Related Events in Participants Who Utilized Symptomatic Therapy During the 12-Week Treatment Period, MOGISS
Week 1-4; ST4 (n=13)
|
56.63 percentage of days
Standard Deviation 25.764
|
|
Duration of Gastrointestinal-Related Events in Participants Who Utilized Symptomatic Therapy During the 12-Week Treatment Period, MOGISS
Week 1-4; ST5 (n=9)
|
44.42 percentage of days
Standard Deviation 32.470
|
|
Duration of Gastrointestinal-Related Events in Participants Who Utilized Symptomatic Therapy During the 12-Week Treatment Period, MOGISS
Week 1-4; ST6 (n=6)
|
48.48 percentage of days
Standard Deviation 35.539
|
|
Duration of Gastrointestinal-Related Events in Participants Who Utilized Symptomatic Therapy During the 12-Week Treatment Period, MOGISS
Week 1-4; ST7 (n=6)
|
69.78 percentage of days
Standard Deviation 24.808
|
|
Duration of Gastrointestinal-Related Events in Participants Who Utilized Symptomatic Therapy During the 12-Week Treatment Period, MOGISS
Week 1-4; ST8 (n=5)
|
66.43 percentage of days
Standard Deviation 31.400
|
|
Duration of Gastrointestinal-Related Events in Participants Who Utilized Symptomatic Therapy During the 12-Week Treatment Period, MOGISS
Week 1-4; ST9 (n=3)
|
41.41 percentage of days
Standard Deviation 34.085
|
|
Duration of Gastrointestinal-Related Events in Participants Who Utilized Symptomatic Therapy During the 12-Week Treatment Period, MOGISS
Week 1-4; ST10 (n=0)
|
NA percentage of days
Standard Deviation NA
No participants used this symptomatic therapy in this time period.
|
|
Duration of Gastrointestinal-Related Events in Participants Who Utilized Symptomatic Therapy During the 12-Week Treatment Period, MOGISS
Week 5-8; Any ST (n=38)
|
41.55 percentage of days
Standard Deviation 38.612
|
|
Duration of Gastrointestinal-Related Events in Participants Who Utilized Symptomatic Therapy During the 12-Week Treatment Period, MOGISS
Week 5-8; ST1 (n=23)
|
44.04 percentage of days
Standard Deviation 41.414
|
|
Duration of Gastrointestinal-Related Events in Participants Who Utilized Symptomatic Therapy During the 12-Week Treatment Period, MOGISS
Week 5-8; ST2 (n=3)
|
41.67 percentage of days
Standard Deviation 52.042
|
|
Duration of Gastrointestinal-Related Events in Participants Who Utilized Symptomatic Therapy During the 12-Week Treatment Period, MOGISS
Week 5-8; ST3 (n=8)
|
37.45 percentage of days
Standard Deviation 37.388
|
|
Duration of Gastrointestinal-Related Events in Participants Who Utilized Symptomatic Therapy During the 12-Week Treatment Period, MOGISS
Week 5-8; ST4 (n=3)
|
69.14 percentage of days
Standard Deviation 44.186
|
|
Duration of Gastrointestinal-Related Events in Participants Who Utilized Symptomatic Therapy During the 12-Week Treatment Period, MOGISS
Week 5-8; ST5 (n=3)
|
63.75 percentage of days
Standard Deviation 31.332
|
|
Duration of Gastrointestinal-Related Events in Participants Who Utilized Symptomatic Therapy During the 12-Week Treatment Period, MOGISS
Week 5-8; ST6 (n=3)
|
70.42 percentage of days
Standard Deviation 25.699
|
|
Duration of Gastrointestinal-Related Events in Participants Who Utilized Symptomatic Therapy During the 12-Week Treatment Period, MOGISS
Week 5-8; ST7 (n=1)
|
35.71 percentage of days
Standard Deviation NA
1 participant used this symptomatic therapy in this time period.
|
|
Duration of Gastrointestinal-Related Events in Participants Who Utilized Symptomatic Therapy During the 12-Week Treatment Period, MOGISS
Week 5-8; ST8 (n=2)
|
56.88 percentage of days
Standard Deviation 40.032
|
|
Duration of Gastrointestinal-Related Events in Participants Who Utilized Symptomatic Therapy During the 12-Week Treatment Period, MOGISS
Week 5-8; ST9 (n=0)
|
NA percentage of days
Standard Deviation NA
No participants used this symptomatic therapy in this time period.
|
|
Duration of Gastrointestinal-Related Events in Participants Who Utilized Symptomatic Therapy During the 12-Week Treatment Period, MOGISS
Week 5-8; ST10 (n=2)
|
1.79 percentage of days
Standard Deviation 2.525
|
|
Duration of Gastrointestinal-Related Events in Participants Who Utilized Symptomatic Therapy During the 12-Week Treatment Period, MOGISS
Week 9-12; Any ST (n=29)
|
43.27 percentage of days
Standard Deviation 42.322
|
|
Duration of Gastrointestinal-Related Events in Participants Who Utilized Symptomatic Therapy During the 12-Week Treatment Period, MOGISS
Week 9-12; ST1 (n=15)
|
47.66 percentage of days
Standard Deviation 43.191
|
|
Duration of Gastrointestinal-Related Events in Participants Who Utilized Symptomatic Therapy During the 12-Week Treatment Period, MOGISS
Week 9-12; ST2 (n=3)
|
82.72 percentage of days
Standard Deviation 29.937
|
|
Duration of Gastrointestinal-Related Events in Participants Who Utilized Symptomatic Therapy During the 12-Week Treatment Period, MOGISS
Week 9-12; ST3 (n=6)
|
48.85 percentage of days
Standard Deviation 50.931
|
|
Duration of Gastrointestinal-Related Events in Participants Who Utilized Symptomatic Therapy During the 12-Week Treatment Period, MOGISS
Week 9-12; ST4 (n=4)
|
22.12 percentage of days
Standard Deviation 20.834
|
|
Duration of Gastrointestinal-Related Events in Participants Who Utilized Symptomatic Therapy During the 12-Week Treatment Period, MOGISS
Week 9-12; ST5 (n=2)
|
62.50 percentage of days
Standard Deviation 53.033
|
|
Duration of Gastrointestinal-Related Events in Participants Who Utilized Symptomatic Therapy During the 12-Week Treatment Period, MOGISS
Week 9-12; ST6 (n=0)
|
NA percentage of days
Standard Deviation NA
No participants used this symptomatic therapy in this time period.
|
|
Duration of Gastrointestinal-Related Events in Participants Who Utilized Symptomatic Therapy During the 12-Week Treatment Period, MOGISS
Week 9-12; ST7 (n=0)
|
NA percentage of days
Standard Deviation NA
No participants used this symptomatic therapy in this time period.
|
|
Duration of Gastrointestinal-Related Events in Participants Who Utilized Symptomatic Therapy During the 12-Week Treatment Period, MOGISS
Week 9-12; ST8 (n=2)
|
9.26 percentage of days
Standard Deviation 13.095
|
|
Duration of Gastrointestinal-Related Events in Participants Who Utilized Symptomatic Therapy During the 12-Week Treatment Period, MOGISS
Week 9-12; ST9 (n=0)
|
NA percentage of days
Standard Deviation NA
No participants used this symptomatic therapy in this time period.
|
|
Duration of Gastrointestinal-Related Events in Participants Who Utilized Symptomatic Therapy During the 12-Week Treatment Period, MOGISS
Week 9-12; ST10 (n=0)
|
NA percentage of days
Standard Deviation NA
No participants used this symptomatic therapy in this time period.
|
PRIMARY outcome
Timeframe: Up to Week 12Population: Safety Population: all participants who received at least 1 dose of dimethyl fumarate and used symptomatic therapy; n=participants with an evaluable assessment during given time period.
Percentage of days with GI events as reported on MAGISS was calculated for each participant and each analysis period using the following formula: 100 x (# of days with \[GI\] events / # of days tolerability scale completed). The ST categories were provided by Biogen Medical team as follows: ST1=anti-acid production; ST2=anti-bloating/anti-constipation agent; ST3=multitarget/ herbal agents; ST4=anti-diarrheal (anti-peristaltic); ST5=analgesic (NSAID); ST6=anti-emetic (central); ST7=anti-emetic (pro-kinetic); ST8=antacid; ST9=other; ST10=laxative (pro-kinetic). Overall GI events were reported in the second day after the dose. Relative day for Overall GI events = assessment date-first dose date.
Outcome measures
| Measure |
Dimethyl Fumarate
n=84 Participants
Dimethyl fumarate administered orally at 120 mg BID for the first 7 days and 240 mg BID thereafter for a total of 12 weeks.
|
|---|---|
|
Duration of Gastrointestinal-Related Events in Participants Who Utilize Symptomatic Therapy During the 12-Week Treatment Period, MAGISS
Overall treatment period; Any ST (n=84)
|
38.20 percentage of days
Standard Deviation 30.516
|
|
Duration of Gastrointestinal-Related Events in Participants Who Utilize Symptomatic Therapy During the 12-Week Treatment Period, MAGISS
Overall treatment period; ST1 (n=50)
|
41.29 percentage of days
Standard Deviation 29.517
|
|
Duration of Gastrointestinal-Related Events in Participants Who Utilize Symptomatic Therapy During the 12-Week Treatment Period, MAGISS
Overall treatment period; ST2 (n=26)
|
33.67 percentage of days
Standard Deviation 27.310
|
|
Duration of Gastrointestinal-Related Events in Participants Who Utilize Symptomatic Therapy During the 12-Week Treatment Period, MAGISS
Overall treatment period; ST3 (n=20)
|
39.28 percentage of days
Standard Deviation 29.165
|
|
Duration of Gastrointestinal-Related Events in Participants Who Utilize Symptomatic Therapy During the 12-Week Treatment Period, MAGISS
Overall treatment period; ST4 (n=16)
|
49.94 percentage of days
Standard Deviation 33.291
|
|
Duration of Gastrointestinal-Related Events in Participants Who Utilize Symptomatic Therapy During the 12-Week Treatment Period, MAGISS
Overall treatment period; ST5 (n=10)
|
45.65 percentage of days
Standard Deviation 27.118
|
|
Duration of Gastrointestinal-Related Events in Participants Who Utilize Symptomatic Therapy During the 12-Week Treatment Period, MAGISS
Overall treatment period; ST6 (n=8)
|
44.71 percentage of days
Standard Deviation 30.374
|
|
Duration of Gastrointestinal-Related Events in Participants Who Utilize Symptomatic Therapy During the 12-Week Treatment Period, MAGISS
Overall treatment period; ST7 (n=6)
|
55.32 percentage of days
Standard Deviation 23.097
|
|
Duration of Gastrointestinal-Related Events in Participants Who Utilize Symptomatic Therapy During the 12-Week Treatment Period, MAGISS
Overall treatment period; ST8 (n=5)
|
53.42 percentage of days
Standard Deviation 31.443
|
|
Duration of Gastrointestinal-Related Events in Participants Who Utilize Symptomatic Therapy During the 12-Week Treatment Period, MAGISS
Overall treatment period; ST9 (n=3)
|
36.92 percentage of days
Standard Deviation 27.800
|
|
Duration of Gastrointestinal-Related Events in Participants Who Utilize Symptomatic Therapy During the 12-Week Treatment Period, MAGISS
Overall treatment period; ST10 (n=2)
|
10.88 percentage of days
Standard Deviation 1.924
|
|
Duration of Gastrointestinal-Related Events in Participants Who Utilize Symptomatic Therapy During the 12-Week Treatment Period, MAGISS
Week 1-4; Any ST (n=73)
|
51.03 percentage of days
Standard Deviation 30.360
|
|
Duration of Gastrointestinal-Related Events in Participants Who Utilize Symptomatic Therapy During the 12-Week Treatment Period, MAGISS
Week 1-4; ST1 (n=44)
|
54.41 percentage of days
Standard Deviation 29.608
|
|
Duration of Gastrointestinal-Related Events in Participants Who Utilize Symptomatic Therapy During the 12-Week Treatment Period, MAGISS
Week 1-4; ST2 (n=23)
|
47.84 percentage of days
Standard Deviation 30.764
|
|
Duration of Gastrointestinal-Related Events in Participants Who Utilize Symptomatic Therapy During the 12-Week Treatment Period, MAGISS
Week 1-4; ST3 (n=18)
|
56.67 percentage of days
Standard Deviation 30.711
|
|
Duration of Gastrointestinal-Related Events in Participants Who Utilize Symptomatic Therapy During the 12-Week Treatment Period, MAGISS
Week 1-4; ST4 (n=13)
|
58.90 percentage of days
Standard Deviation 27.111
|
|
Duration of Gastrointestinal-Related Events in Participants Who Utilize Symptomatic Therapy During the 12-Week Treatment Period, MAGISS
Week 1-4; ST5 (n=9)
|
53.74 percentage of days
Standard Deviation 32.304
|
|
Duration of Gastrointestinal-Related Events in Participants Who Utilize Symptomatic Therapy During the 12-Week Treatment Period, MAGISS
Week 1-4; ST6 (n=6)
|
46.43 percentage of days
Standard Deviation 33.221
|
|
Duration of Gastrointestinal-Related Events in Participants Who Utilize Symptomatic Therapy During the 12-Week Treatment Period, MAGISS
Week 1-4; ST7 (n=6)
|
67.54 percentage of days
Standard Deviation 25.296
|
|
Duration of Gastrointestinal-Related Events in Participants Who Utilize Symptomatic Therapy During the 12-Week Treatment Period, MAGISS
Week 1-4; ST8 (n=5)
|
69.86 percentage of days
Standard Deviation 28.919
|
|
Duration of Gastrointestinal-Related Events in Participants Who Utilize Symptomatic Therapy During the 12-Week Treatment Period, MAGISS
Week 1-4; ST9 (n=3)
|
47.61 percentage of days
Standard Deviation 47.61
|
|
Duration of Gastrointestinal-Related Events in Participants Who Utilize Symptomatic Therapy During the 12-Week Treatment Period, MAGISS
Week 1-4; ST10 (n=0)
|
NA percentage of days
Standard Deviation NA
No participants used this symptomatic therapy in this time period.
|
|
Duration of Gastrointestinal-Related Events in Participants Who Utilize Symptomatic Therapy During the 12-Week Treatment Period, MAGISS
Week 5-8; Any ST (n=38)
|
40.59 percentage of days
Standard Deviation 37.836
|
|
Duration of Gastrointestinal-Related Events in Participants Who Utilize Symptomatic Therapy During the 12-Week Treatment Period, MAGISS
Week 5-8; ST1 (n=23)
|
41.59 percentage of days
Standard Deviation 41.442
|
|
Duration of Gastrointestinal-Related Events in Participants Who Utilize Symptomatic Therapy During the 12-Week Treatment Period, MAGISS
Week 5-8; ST2 (n=3)
|
47.14 percentage of days
Standard Deviation 45.781
|
|
Duration of Gastrointestinal-Related Events in Participants Who Utilize Symptomatic Therapy During the 12-Week Treatment Period, MAGISS
Week 5-8; ST3 (n=8)
|
38.50 percentage of days
Standard Deviation 35.493
|
|
Duration of Gastrointestinal-Related Events in Participants Who Utilize Symptomatic Therapy During the 12-Week Treatment Period, MAGISS
Week 5-8; ST4 (n=3)
|
62.58 percentage of days
Standard Deviation 45.775
|
|
Duration of Gastrointestinal-Related Events in Participants Who Utilize Symptomatic Therapy During the 12-Week Treatment Period, MAGISS
Week 5-8; ST5 (n=3)
|
56.33 percentage of days
Standard Deviation 33.011
|
|
Duration of Gastrointestinal-Related Events in Participants Who Utilize Symptomatic Therapy During the 12-Week Treatment Period, MAGISS
Week 5-8; ST6 (n=3)
|
71.61 percentage of days
Standard Deviation 24.587
|
|
Duration of Gastrointestinal-Related Events in Participants Who Utilize Symptomatic Therapy During the 12-Week Treatment Period, MAGISS
Week 5-8; ST7 (n=1)
|
35.71 percentage of days
Standard Deviation NA
1 participant used this symptomatic therapy in this time period.
|
|
Duration of Gastrointestinal-Related Events in Participants Who Utilize Symptomatic Therapy During the 12-Week Treatment Period, MAGISS
Week 5-8; ST8 (n=2)
|
62.24 percentage of days
Standard Deviation 32.456
|
|
Duration of Gastrointestinal-Related Events in Participants Who Utilize Symptomatic Therapy During the 12-Week Treatment Period, MAGISS
Week 5-8; ST9 (n=0)
|
NA percentage of days
Standard Deviation NA
No participants used this symptomatic therapy in this time period.
|
|
Duration of Gastrointestinal-Related Events in Participants Who Utilize Symptomatic Therapy During the 12-Week Treatment Period, MAGISS
Week 5-8; ST10 (n=2)
|
10.00 percentage of days
Standard Deviation 14.142
|
|
Duration of Gastrointestinal-Related Events in Participants Who Utilize Symptomatic Therapy During the 12-Week Treatment Period, MAGISS
Week 9-12; Any ST (n=29)
|
41.28 percentage of days
Standard Deviation 42.466
|
|
Duration of Gastrointestinal-Related Events in Participants Who Utilize Symptomatic Therapy During the 12-Week Treatment Period, MAGISS
Week 9-12; ST1 (n=15)
|
44.24 percentage of days
Standard Deviation 44.754
|
|
Duration of Gastrointestinal-Related Events in Participants Who Utilize Symptomatic Therapy During the 12-Week Treatment Period, MAGISS
Week 9-12; ST2 (n=3)
|
76.19 percentage of days
Standard Deviation 41.239
|
|
Duration of Gastrointestinal-Related Events in Participants Who Utilize Symptomatic Therapy During the 12-Week Treatment Period, MAGISS
Week 9-12; ST3 (n=6)
|
51.99 percentage of days
Standard Deviation 50.113
|
|
Duration of Gastrointestinal-Related Events in Participants Who Utilize Symptomatic Therapy During the 12-Week Treatment Period, MAGISS
Week 9-12; ST4 (n=4)
|
15.48 percentage of days
Standard Deviation 10.178
|
|
Duration of Gastrointestinal-Related Events in Participants Who Utilize Symptomatic Therapy During the 12-Week Treatment Period, MAGISS
Week 9-12; ST5 (n=2)
|
63.16 percentage of days
Standard Deviation 52.103
|
|
Duration of Gastrointestinal-Related Events in Participants Who Utilize Symptomatic Therapy During the 12-Week Treatment Period, MAGISS
Week 9-12; ST6 (n=0)
|
NA percentage of days
Standard Deviation NA
No participants used this symptomatic therapy in this time period.
|
|
Duration of Gastrointestinal-Related Events in Participants Who Utilize Symptomatic Therapy During the 12-Week Treatment Period, MAGISS
Week 9-12; ST7 (n=0)
|
NA percentage of days
Standard Deviation NA
No participants used this symptomatic therapy in this time period.
|
|
Duration of Gastrointestinal-Related Events in Participants Who Utilize Symptomatic Therapy During the 12-Week Treatment Period, MAGISS
Week 9-12; ST8 (n=2)
|
13.11 percentage of days
Standard Deviation 7.655
|
|
Duration of Gastrointestinal-Related Events in Participants Who Utilize Symptomatic Therapy During the 12-Week Treatment Period, MAGISS
Week 9-12; ST9 (n=0)
|
NA percentage of days
Standard Deviation NA
No participants used this symptomatic therapy in this time period.
|
|
Duration of Gastrointestinal-Related Events in Participants Who Utilize Symptomatic Therapy During the 12-Week Treatment Period, MAGISS
Week 9-12; ST10 (n=0)
|
NA percentage of days
Standard Deviation NA
No participants used this symptomatic therapy in this time period.
|
SECONDARY outcome
Timeframe: Week 4, Week 8, Week 12Population: Safety Population: all participants who received at least 1 dose of dimethyl fumarate and used symptomatic therapy.
The cumulative percentage of dimethyl fumarate-treated participants with relapsing-remitting multiple sclerosis who required symptomatic therapy up to Week 4, Week 8, and Week 12 were estimated using the Kaplan-Meier method.
Outcome measures
| Measure |
Dimethyl Fumarate
n=84 Participants
Dimethyl fumarate administered orally at 120 mg BID for the first 7 days and 240 mg BID thereafter for a total of 12 weeks.
|
|---|---|
|
Percentage of Participants Who First Took Symptomatic Therapy for Gastrointestinal-Related Events at Weeks 4, 8, and 12
Week 4
|
35.3 percentage of participants
|
|
Percentage of Participants Who First Took Symptomatic Therapy for Gastrointestinal-Related Events at Weeks 4, 8, and 12
Week 8
|
38.4 percentage of participants
|
|
Percentage of Participants Who First Took Symptomatic Therapy for Gastrointestinal-Related Events at Weeks 4, 8, and 12
Week 12
|
41.1 percentage of participants
|
SECONDARY outcome
Timeframe: Up to Week 12Population: Safety Population: all participants who received at least 1 dose of dimethyl fumarate and used symptomatic therapy.
Symptomatic therapies were classified into 10 main categories: anti-acid production (eg, pantoprazole, omeprazole, esomeprazole, ranitidine); anti-bloating/anti-constipation agents (eg, hyoscine butylbromide, sodium picosulfate, Agiolax, dimeticone, lactulose, Movicol, simethicone); multitarget/herbal agents (includes Iberogast, Gaviscon, amaratropfen, Wikalin, Gaviscon \& Iberogast, Iberogast \& Wikalin); anti-diarrheal (anti-peristaltic; loperamide, racecadotril); analgesic (non-steroidal anti-inflammatory drug \[NSAID\]; ibuprofen, paracetamol, metamizole); anti-emetic (central; dimenhydrinate, domperidone); anti-emetic (pro-kinetic; metoclopramide); anti-acid (calcium carbonate, magaldrate, sodium hydrogen carbonate, sodium hydroxide/aluminium oxide, Talcid); other (Saccharomyces boulardii, carbon tablet, Lactobacillus acidophilus); laxative (pro-kinetic; bisacodyl). Participants may have taken \> 1 symptomatic therapy but were counted only once for the 'All therapies' summary.
Outcome measures
| Measure |
Dimethyl Fumarate
n=211 Participants
Dimethyl fumarate administered orally at 120 mg BID for the first 7 days and 240 mg BID thereafter for a total of 12 weeks.
|
|---|---|
|
Number of Participants Who Used Symptomatic Therapies for Gastrointestinal-Related Events During the 12-Week Treatment Period, by Category
Overall treatment period (OTP): All therapies
|
84 participants
|
|
Number of Participants Who Used Symptomatic Therapies for Gastrointestinal-Related Events During the 12-Week Treatment Period, by Category
OTP: Anti-acid production
|
50 participants
|
|
Number of Participants Who Used Symptomatic Therapies for Gastrointestinal-Related Events During the 12-Week Treatment Period, by Category
OTP: Anti-bloating/anti-constipation agent
|
26 participants
|
|
Number of Participants Who Used Symptomatic Therapies for Gastrointestinal-Related Events During the 12-Week Treatment Period, by Category
OTP: Multi-target/herbal agents
|
20 participants
|
|
Number of Participants Who Used Symptomatic Therapies for Gastrointestinal-Related Events During the 12-Week Treatment Period, by Category
OTP: Anti-diarrheal (anti-peristaltic)
|
16 participants
|
|
Number of Participants Who Used Symptomatic Therapies for Gastrointestinal-Related Events During the 12-Week Treatment Period, by Category
OTP: Analgesic (NSAID)
|
10 participants
|
|
Number of Participants Who Used Symptomatic Therapies for Gastrointestinal-Related Events During the 12-Week Treatment Period, by Category
OTP: Anti-emetic (central)
|
8 participants
|
|
Number of Participants Who Used Symptomatic Therapies for Gastrointestinal-Related Events During the 12-Week Treatment Period, by Category
OTP: Anti-emetic (pro-kinetic)
|
6 participants
|
|
Number of Participants Who Used Symptomatic Therapies for Gastrointestinal-Related Events During the 12-Week Treatment Period, by Category
OTP: Antacid
|
5 participants
|
|
Number of Participants Who Used Symptomatic Therapies for Gastrointestinal-Related Events During the 12-Week Treatment Period, by Category
OTP: Other
|
3 participants
|
|
Number of Participants Who Used Symptomatic Therapies for Gastrointestinal-Related Events During the 12-Week Treatment Period, by Category
OTP: Laxative (pro-kinetic)
|
2 participants
|
|
Number of Participants Who Used Symptomatic Therapies for Gastrointestinal-Related Events During the 12-Week Treatment Period, by Category
Week 1-4: All therapies
|
73 participants
|
|
Number of Participants Who Used Symptomatic Therapies for Gastrointestinal-Related Events During the 12-Week Treatment Period, by Category
Week 1-4: Anti-acid production
|
44 participants
|
|
Number of Participants Who Used Symptomatic Therapies for Gastrointestinal-Related Events During the 12-Week Treatment Period, by Category
Week 1-4: Anti-bloating/anti-constipation agent
|
23 participants
|
|
Number of Participants Who Used Symptomatic Therapies for Gastrointestinal-Related Events During the 12-Week Treatment Period, by Category
Week 1-4: Multi-target/herbal agents
|
18 participants
|
|
Number of Participants Who Used Symptomatic Therapies for Gastrointestinal-Related Events During the 12-Week Treatment Period, by Category
Week 1-4: Anti-diarrheal (anti-peristaltic)
|
13 participants
|
|
Number of Participants Who Used Symptomatic Therapies for Gastrointestinal-Related Events During the 12-Week Treatment Period, by Category
Week 1-4: Analgesic (NSAID)
|
9 participants
|
|
Number of Participants Who Used Symptomatic Therapies for Gastrointestinal-Related Events During the 12-Week Treatment Period, by Category
Week 1-4: Anti-emetic (central)
|
6 participants
|
|
Number of Participants Who Used Symptomatic Therapies for Gastrointestinal-Related Events During the 12-Week Treatment Period, by Category
Week 1-4: Anti-emetic (pro-kinetic)
|
6 participants
|
|
Number of Participants Who Used Symptomatic Therapies for Gastrointestinal-Related Events During the 12-Week Treatment Period, by Category
Week 1-4: Antacid
|
5 participants
|
|
Number of Participants Who Used Symptomatic Therapies for Gastrointestinal-Related Events During the 12-Week Treatment Period, by Category
Week 1-4: Other
|
3 participants
|
|
Number of Participants Who Used Symptomatic Therapies for Gastrointestinal-Related Events During the 12-Week Treatment Period, by Category
Week 5-8: All therapies
|
38 participants
|
|
Number of Participants Who Used Symptomatic Therapies for Gastrointestinal-Related Events During the 12-Week Treatment Period, by Category
Week 5-8: Anti-acid production
|
23 participants
|
|
Number of Participants Who Used Symptomatic Therapies for Gastrointestinal-Related Events During the 12-Week Treatment Period, by Category
Week 5-8: Multi-target/herbal agents
|
8 participants
|
|
Number of Participants Who Used Symptomatic Therapies for Gastrointestinal-Related Events During the 12-Week Treatment Period, by Category
Week 5-8: Analgesic (NSAID)
|
3 participants
|
|
Number of Participants Who Used Symptomatic Therapies for Gastrointestinal-Related Events During the 12-Week Treatment Period, by Category
Week 5-8: Anti-bloating/anti-constipation agent
|
3 participants
|
|
Number of Participants Who Used Symptomatic Therapies for Gastrointestinal-Related Events During the 12-Week Treatment Period, by Category
Week 5-8: Anti-diarrheal (anti-peristaltic)
|
3 participants
|
|
Number of Participants Who Used Symptomatic Therapies for Gastrointestinal-Related Events During the 12-Week Treatment Period, by Category
Week 5-8: Anti-emetic (central)
|
3 participants
|
|
Number of Participants Who Used Symptomatic Therapies for Gastrointestinal-Related Events During the 12-Week Treatment Period, by Category
Week 5-8: Antacid
|
2 participants
|
|
Number of Participants Who Used Symptomatic Therapies for Gastrointestinal-Related Events During the 12-Week Treatment Period, by Category
Week 5-8: Laxative (pro-kinetic)
|
2 participants
|
|
Number of Participants Who Used Symptomatic Therapies for Gastrointestinal-Related Events During the 12-Week Treatment Period, by Category
Week 5-8: Anti-emetic (pro-kinetic)
|
1 participants
|
|
Number of Participants Who Used Symptomatic Therapies for Gastrointestinal-Related Events During the 12-Week Treatment Period, by Category
Week 9-12: All therapies
|
29 participants
|
|
Number of Participants Who Used Symptomatic Therapies for Gastrointestinal-Related Events During the 12-Week Treatment Period, by Category
Week 9-12: Anti-acid production
|
15 participants
|
|
Number of Participants Who Used Symptomatic Therapies for Gastrointestinal-Related Events During the 12-Week Treatment Period, by Category
Week 9-12: Multi-target/herbal agents
|
6 participants
|
|
Number of Participants Who Used Symptomatic Therapies for Gastrointestinal-Related Events During the 12-Week Treatment Period, by Category
Week 9-12: Anti-diarrheal (anti-peristaltic)
|
4 participants
|
|
Number of Participants Who Used Symptomatic Therapies for Gastrointestinal-Related Events During the 12-Week Treatment Period, by Category
Week 9-12: Anti-bloating.anti-constipation agent
|
3 participants
|
|
Number of Participants Who Used Symptomatic Therapies for Gastrointestinal-Related Events During the 12-Week Treatment Period, by Category
Week 9-12: Analgesic (NSAID)
|
2 participants
|
|
Number of Participants Who Used Symptomatic Therapies for Gastrointestinal-Related Events During the 12-Week Treatment Period, by Category
Week 9-12: Antacid
|
2 participants
|
SECONDARY outcome
Timeframe: Up to Week 12Population: Safety Population: all participants who received at least 1 dose of dimethyl fumarate and used symptomatic therapy; n=participants with an evaluable assessment during given time period.
Symptomatic therapies were classified into 10 categories: anti-acid production (eg, pantoprazole, omeprazole, esomeprazole, ranitidine); anti-bloating/anti-constipation agents (eg, hyoscine butylbromide, sodium picosulfate, Agiolax, dimeticone, lactulose, Movicol, simethicone); multitarget/herbal agents (eg, Iberogast, Gaviscon, amaratropfen, Wikalin, Gaviscon \& Iberogast, Iberogast \& Wikalin); anti-diarrheal (anti-peristaltic; loperamide, racecadotril); analgesic (NSAID; ibuprofen, paracetamol, metamizole); anti-emetic (central; dimenhydrinate, domperidone); anti-emetic (pro-kinetic; metoclopramide); anti-acid (calcium carbonate, magaldrate, sodium hydrogen carbonate, sodium hydroxide/aluminium oxide, Talcid); other (Saccharomyces boulardii, carbon tablet, Lactobacillus acidophilus); laxative (pro-kinetic; bisacodyl). If a participant had multiple different therapies on the same day, the days on symptomatic therapy was calculated as 1 day in 'All therapies'.
Outcome measures
| Measure |
Dimethyl Fumarate
n=84 Participants
Dimethyl fumarate administered orally at 120 mg BID for the first 7 days and 240 mg BID thereafter for a total of 12 weeks.
|
|---|---|
|
Duration of Use of Symptomatic Therapies for Gastrointestinal-Related Events During the 12-Week Treatment Period, by Category
OTP: All therapies; n=84
|
13.15 days
Standard Deviation 19.21
|
|
Duration of Use of Symptomatic Therapies for Gastrointestinal-Related Events During the 12-Week Treatment Period, by Category
OTP: Anti-acid production; n=50
|
16.62 days
Standard Deviation 22.21
|
|
Duration of Use of Symptomatic Therapies for Gastrointestinal-Related Events During the 12-Week Treatment Period, by Category
OTP: Anti-bloating/anti-constipation agent; n=26
|
2.42 days
Standard Deviation 1.81
|
|
Duration of Use of Symptomatic Therapies for Gastrointestinal-Related Events During the 12-Week Treatment Period, by Category
OTP: Multi-target/herbal agents; n=20
|
9.40 days
Standard Deviation 13.95
|
|
Duration of Use of Symptomatic Therapies for Gastrointestinal-Related Events During the 12-Week Treatment Period, by Category
OTP: Anti-diarrheal (anti-peristaltic); n=16
|
3.13 days
Standard Deviation 2.53
|
|
Duration of Use of Symptomatic Therapies for Gastrointestinal-Related Events During the 12-Week Treatment Period, by Category
OTP: Analgesic (NSAID); n=10
|
3.10 days
Standard Deviation 1.73
|
|
Duration of Use of Symptomatic Therapies for Gastrointestinal-Related Events During the 12-Week Treatment Period, by Category
OTP: Anti-emetic (central); n=8
|
3.25 days
Standard Deviation 4.43
|
|
Duration of Use of Symptomatic Therapies for Gastrointestinal-Related Events During the 12-Week Treatment Period, by Category
OTP: Anti-emetic (pro-kinetic); n=6
|
1.83 days
Standard Deviation 0.98
|
|
Duration of Use of Symptomatic Therapies for Gastrointestinal-Related Events During the 12-Week Treatment Period, by Category
OTP: Antacid; n=5
|
3.60 days
Standard Deviation 4.22
|
|
Duration of Use of Symptomatic Therapies for Gastrointestinal-Related Events During the 12-Week Treatment Period, by Category
OTP: Other; n=3
|
1.67 days
Standard Deviation 0.58
|
|
Duration of Use of Symptomatic Therapies for Gastrointestinal-Related Events During the 12-Week Treatment Period, by Category
OTP: Laxative (pro-kinetic); n=2
|
1.00 days
Standard Deviation 0.00
|
|
Duration of Use of Symptomatic Therapies for Gastrointestinal-Related Events During the 12-Week Treatment Period, by Category
Week 1-4: All therapies; n=73
|
6.03 days
Standard Deviation 6.12
|
|
Duration of Use of Symptomatic Therapies for Gastrointestinal-Related Events During the 12-Week Treatment Period, by Category
Week 1-4: Anti-acid production; n=44
|
7.07 days
Standard Deviation 6.73
|
|
Duration of Use of Symptomatic Therapies for Gastrointestinal-Related Events During the 12-Week Treatment Period, by Category
Week 1-4: Anti-bloating/anti-constipation; n=23
|
2.30 days
Standard Deviation 1.89
|
|
Duration of Use of Symptomatic Therapies for Gastrointestinal-Related Events During the 12-Week Treatment Period, by Category
Week 1-4: Multi-target/herbal agents; n=18
|
3.78 days
Standard Deviation 3.06
|
|
Duration of Use of Symptomatic Therapies for Gastrointestinal-Related Events During the 12-Week Treatment Period, by Category
Week 1-4: Anti-diarrheal (anti-peristaltic); n=13
|
2.62 days
Standard Deviation 1.45
|
|
Duration of Use of Symptomatic Therapies for Gastrointestinal-Related Events During the 12-Week Treatment Period, by Category
Week 1-4: Analgesic (NSAID); n=9
|
2.11 days
Standard Deviation 0.93
|
|
Duration of Use of Symptomatic Therapies for Gastrointestinal-Related Events During the 12-Week Treatment Period, by Category
Week 1-4: Anti-emetic (central); n=6
|
3.17 days
Standard Deviation 3.92
|
|
Duration of Use of Symptomatic Therapies for Gastrointestinal-Related Events During the 12-Week Treatment Period, by Category
Week 1-4: Anti-emetic (pro-kinetic); n=6
|
1.67 days
Standard Deviation 0.82
|
|
Duration of Use of Symptomatic Therapies for Gastrointestinal-Related Events During the 12-Week Treatment Period, by Category
Week 1-4: Antacid; n=5
|
1.80 days
Standard Deviation 1.30
|
|
Duration of Use of Symptomatic Therapies for Gastrointestinal-Related Events During the 12-Week Treatment Period, by Category
Week 1-4: Other; n=3
|
1.67 days
Standard Deviation 0.58
|
|
Duration of Use of Symptomatic Therapies for Gastrointestinal-Related Events During the 12-Week Treatment Period, by Category
Week 5-8: All therapies; n=38
|
10.08 days
Standard Deviation 10.56
|
|
Duration of Use of Symptomatic Therapies for Gastrointestinal-Related Events During the 12-Week Treatment Period, by Category
Week 5-8: Anti-acid production; n=23
|
13.00 days
Standard Deviation 11.14
|
|
Duration of Use of Symptomatic Therapies for Gastrointestinal-Related Events During the 12-Week Treatment Period, by Category
Week 5-8: Multi-target/herbal agents; n=8
|
8.50 days
Standard Deviation 10.45
|
|
Duration of Use of Symptomatic Therapies for Gastrointestinal-Related Events During the 12-Week Treatment Period, by Category
Week 5-8: Analgesic (NSAID); n=3
|
2.00 days
Standard Deviation 1.00
|
|
Duration of Use of Symptomatic Therapies for Gastrointestinal-Related Events During the 12-Week Treatment Period, by Category
Week 5-8: Anti-bloating/anti-constipation; n=3
|
1.33 days
Standard Deviation 0.58
|
|
Duration of Use of Symptomatic Therapies for Gastrointestinal-Related Events During the 12-Week Treatment Period, by Category
Week 5-8: Anti-diarrheal (anti-peristaltic); n=3
|
4.00 days
Standard Deviation 3.61
|
|
Duration of Use of Symptomatic Therapies for Gastrointestinal-Related Events During the 12-Week Treatment Period, by Category
Week 5-8: Anti-emetic (central); n=3
|
2.33 days
Standard Deviation 1.15
|
|
Duration of Use of Symptomatic Therapies for Gastrointestinal-Related Events During the 12-Week Treatment Period, by Category
Week 5-8: Antacid; n=2
|
2.50 days
Standard Deviation 2.12
|
|
Duration of Use of Symptomatic Therapies for Gastrointestinal-Related Events During the 12-Week Treatment Period, by Category
Week 5-8: Laxative (pro-kinetic); n=2
|
1.00 days
Standard Deviation 0.00
|
|
Duration of Use of Symptomatic Therapies for Gastrointestinal-Related Events During the 12-Week Treatment Period, by Category
Week 5-8: Anti-emetic (prokinetic); n=1
|
1.00 days
Standard Deviation NA
One participant only was included.
|
|
Duration of Use of Symptomatic Therapies for Gastrointestinal-Related Events During the 12-Week Treatment Period, by Category
Week 9-12: All therapies; n=29
|
9.72 days
Standard Deviation 10.31
|
|
Duration of Use of Symptomatic Therapies for Gastrointestinal-Related Events During the 12-Week Treatment Period, by Category
Week 9-12: Anti-acid production; n=15
|
14.73 days
Standard Deviation 10.91
|
|
Duration of Use of Symptomatic Therapies for Gastrointestinal-Related Events During the 12-Week Treatment Period, by Category
Week 9-12: Multi-target/herbal agents; n=6
|
8.67 days
Standard Deviation 8.57
|
|
Duration of Use of Symptomatic Therapies for Gastrointestinal-Related Events During the 12-Week Treatment Period, by Category
Week 9-12: Anti-diarrheal (anti-peristaltic); n=4
|
1.00 days
Standard Deviation 0.00
|
|
Duration of Use of Symptomatic Therapies for Gastrointestinal-Related Events During the 12-Week Treatment Period, by Category
Week 9-12: Anti-bloating/anti-constipation; n=3
|
2.00 days
Standard Deviation 1.00
|
|
Duration of Use of Symptomatic Therapies for Gastrointestinal-Related Events During the 12-Week Treatment Period, by Category
Week 9-12: Analgesic (NSAID); n=2
|
3.00 days
Standard Deviation 0.00
|
|
Duration of Use of Symptomatic Therapies for Gastrointestinal-Related Events During the 12-Week Treatment Period, by Category
Week 9-12: Antacid; n=2
|
2.00 days
Standard Deviation 1.41
|
SECONDARY outcome
Timeframe: Up to Week 12Population: Safety Population: all participants who received at least 1 dose of dimethyl fumarate.
Dose reductions are defined as participants who take any dimethyl fumarate 120 mg or 0 mg since initiation of dimethyl fumarate 240 mg.
Outcome measures
| Measure |
Dimethyl Fumarate
n=211 Participants
Dimethyl fumarate administered orally at 120 mg BID for the first 7 days and 240 mg BID thereafter for a total of 12 weeks.
|
|---|---|
|
Percentage of Participants Who Required Dimethyl Fumarate Dose Reduction In Response To Gastrointestinal-Related Events
|
34.6 percentage of participants
|
SECONDARY outcome
Timeframe: Up to Week 12Population: Safety Population: all participants who received at least 1 dose of dimethyl fumarate.
Outcome measures
| Measure |
Dimethyl Fumarate
n=211 Participants
Dimethyl fumarate administered orally at 120 mg BID for the first 7 days and 240 mg BID thereafter for a total of 12 weeks.
|
|---|---|
|
Percentage of Participants Who Discontinued Dimethyl Fumarate Due To Gastrointestinal-Related Treatment-Emergent Adverse Events
|
6.6 percentage of participants
|
Adverse Events
Dimethyl Fumarate
Serious events: 5 serious events
Other events: 129 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Dimethyl Fumarate
n=211 participants at risk
Dimethyl fumarate administered orally at 120 mg BID for the first 7 days and 240 mg BID thereafter for a total of 12 weeks.
|
|---|---|
|
Nervous system disorders
Multiple sclerosis relapse
|
0.95%
2/211 • Serious adverse events: from signing of informed consent through last dose (up to 12 weeks (±5 days) plus 2 weeks (±5 days) follow up. Adverse events: from time of first dose of dimethyl fumarate through last dose (up to 12 weeks (±5 days).
|
|
Immune system disorders
Hypersensitivity
|
0.47%
1/211 • Serious adverse events: from signing of informed consent through last dose (up to 12 weeks (±5 days) plus 2 weeks (±5 days) follow up. Adverse events: from time of first dose of dimethyl fumarate through last dose (up to 12 weeks (±5 days).
|
|
Investigations
Alanine aminotransferase increrased
|
0.47%
1/211 • Serious adverse events: from signing of informed consent through last dose (up to 12 weeks (±5 days) plus 2 weeks (±5 days) follow up. Adverse events: from time of first dose of dimethyl fumarate through last dose (up to 12 weeks (±5 days).
|
|
Investigations
Aspartate aminotransferase
|
0.47%
1/211 • Serious adverse events: from signing of informed consent through last dose (up to 12 weeks (±5 days) plus 2 weeks (±5 days) follow up. Adverse events: from time of first dose of dimethyl fumarate through last dose (up to 12 weeks (±5 days).
|
|
Investigations
Gamma-glutamyltransferase
|
0.47%
1/211 • Serious adverse events: from signing of informed consent through last dose (up to 12 weeks (±5 days) plus 2 weeks (±5 days) follow up. Adverse events: from time of first dose of dimethyl fumarate through last dose (up to 12 weeks (±5 days).
|
|
Psychiatric disorders
Alcohol abuse
|
0.47%
1/211 • Serious adverse events: from signing of informed consent through last dose (up to 12 weeks (±5 days) plus 2 weeks (±5 days) follow up. Adverse events: from time of first dose of dimethyl fumarate through last dose (up to 12 weeks (±5 days).
|
Other adverse events
| Measure |
Dimethyl Fumarate
n=211 participants at risk
Dimethyl fumarate administered orally at 120 mg BID for the first 7 days and 240 mg BID thereafter for a total of 12 weeks.
|
|---|---|
|
Vascular disorders
Flushing
|
49.8%
105/211 • Serious adverse events: from signing of informed consent through last dose (up to 12 weeks (±5 days) plus 2 weeks (±5 days) follow up. Adverse events: from time of first dose of dimethyl fumarate through last dose (up to 12 weeks (±5 days).
|
|
Infections and infestations
Nasopharyngitis
|
14.7%
31/211 • Serious adverse events: from signing of informed consent through last dose (up to 12 weeks (±5 days) plus 2 weeks (±5 days) follow up. Adverse events: from time of first dose of dimethyl fumarate through last dose (up to 12 weeks (±5 days).
|
|
Nervous system disorders
Headache
|
6.6%
14/211 • Serious adverse events: from signing of informed consent through last dose (up to 12 weeks (±5 days) plus 2 weeks (±5 days) follow up. Adverse events: from time of first dose of dimethyl fumarate through last dose (up to 12 weeks (±5 days).
|
|
General disorders
Fatigue
|
5.7%
12/211 • Serious adverse events: from signing of informed consent through last dose (up to 12 weeks (±5 days) plus 2 weeks (±5 days) follow up. Adverse events: from time of first dose of dimethyl fumarate through last dose (up to 12 weeks (±5 days).
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
5.7%
12/211 • Serious adverse events: from signing of informed consent through last dose (up to 12 weeks (±5 days) plus 2 weeks (±5 days) follow up. Adverse events: from time of first dose of dimethyl fumarate through last dose (up to 12 weeks (±5 days).
|
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