Trial Outcomes & Findings for Phase 4 Gastrointestinal Tolerability Study of Dimethyl Fumarate in Patients With Relapsing Forms of Multiple Sclerosis in the United States (NCT NCT01873417)
NCT ID: NCT01873417
Last Updated: 2017-03-21
Results Overview
Severity of GI-related events in DMF-treated participants using the MOGISS to measure GI symptoms, based on a 0- to 10-point scale, with 0 representing absence of symptoms and 10 representing the most severe symptoms.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
237 participants
Primary outcome timeframe
12 Weeks
Results posted on
2017-03-21
Participant Flow
Participant milestones
| Measure |
Dimethyl Fumarate
120 mg dimethyl fumarate (DMF) twice daily (BID) for the first 7 days and 240 mg DMF BID thereafter for 12 weeks of treatment. Participants were instructed to take the DMF dose with food (with a meal or within 1 hour after a meal).
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|---|---|
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Overall Study
STARTED
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237
|
|
Overall Study
Safety Population
|
233
|
|
Overall Study
COMPLETED
|
202
|
|
Overall Study
NOT COMPLETED
|
35
|
Reasons for withdrawal
| Measure |
Dimethyl Fumarate
120 mg dimethyl fumarate (DMF) twice daily (BID) for the first 7 days and 240 mg DMF BID thereafter for 12 weeks of treatment. Participants were instructed to take the DMF dose with food (with a meal or within 1 hour after a meal).
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|---|---|
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Overall Study
Did Not Receive Any Study Drug
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4
|
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Overall Study
Adverse Event
|
24
|
|
Overall Study
Lost to Follow-up
|
2
|
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Overall Study
Withdrawal by Subject
|
2
|
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Overall Study
Physician Decision
|
3
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Baseline Characteristics
Phase 4 Gastrointestinal Tolerability Study of Dimethyl Fumarate in Patients With Relapsing Forms of Multiple Sclerosis in the United States
Baseline characteristics by cohort
| Measure |
Dimethyl Fumarate
n=233 Participants
120 mg dimethyl fumarate (DMF) twice daily (BID) for the first 7 days and 240 mg DMF BID thereafter for 12 weeks of treatment. Participants were instructed to take the DMF dose with food (with a meal or within 1 hour after a meal).
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|---|---|
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Age, Continuous
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46.9 years
STANDARD_DEVIATION 11.66 • n=93 Participants
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Sex: Female, Male
Female
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181 Participants
n=93 Participants
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Sex: Female, Male
Male
|
52 Participants
n=93 Participants
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PRIMARY outcome
Timeframe: 12 WeeksPopulation: Evaluable participants (treated participants who utilized symptomatic therapy during the overall treatment period \[12 weeks\]).
Severity of GI-related events in DMF-treated participants using the MOGISS to measure GI symptoms, based on a 0- to 10-point scale, with 0 representing absence of symptoms and 10 representing the most severe symptoms.
Outcome measures
| Measure |
Dimethyl Fumarate
n=128 Participants
120 mg dimethyl fumarate (DMF) twice daily (BID) for the first 7 days and 240 mg DMF BID thereafter for 12 weeks of treatment. Participants were instructed to take the DMF dose with food (with a meal or within 1 hour after a meal).
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|---|---|
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Worst Severity Score of Overall Gastrointestinal (GI) Events, Modified Overall GI Symptom Scale (MOGISS)
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4.8 units on a scale
Standard Deviation 2.34
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PRIMARY outcome
Timeframe: 12 WeeksPopulation: Evaluable participants (treated participants who utilized symptomatic therapy during the overall treatment period \[12 weeks\]).
Severity of GI-related events in DMF-treated participants using the MAGISS to measure GI symptoms, based on a 0- to 10-point scale, with 0 representing absence of symptoms and 10 representing the most severe symptoms.
Outcome measures
| Measure |
Dimethyl Fumarate
n=128 Participants
120 mg dimethyl fumarate (DMF) twice daily (BID) for the first 7 days and 240 mg DMF BID thereafter for 12 weeks of treatment. Participants were instructed to take the DMF dose with food (with a meal or within 1 hour after a meal).
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|---|---|
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Worst Severity Score of Overall GI Events, Modified Acute Gl Symptom Scale
|
4.7 units on a scale
Standard Deviation 2.13
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PRIMARY outcome
Timeframe: 12 WeeksPopulation: Safety Population (participants who received at least 1 dose of DMF, recorded in diary data)
Percentage of participants reporting GI symptoms on the MOGISS, by those who utilized symptomatic therapy.
Outcome measures
| Measure |
Dimethyl Fumarate
n=233 Participants
120 mg dimethyl fumarate (DMF) twice daily (BID) for the first 7 days and 240 mg DMF BID thereafter for 12 weeks of treatment. Participants were instructed to take the DMF dose with food (with a meal or within 1 hour after a meal).
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|---|---|
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Percentage of DMF-treated Participants Who Reported GI-related Symptoms and Who Utilized Symptomatic Therapy
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54.1 percentage of participants
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PRIMARY outcome
Timeframe: 12 WeeksPopulation: Evaluable participants (treated participants who utilized symptomatic therapy during the overall treatment period \[12 weeks\]); n=number of participants with evaluable GI symptom specified.
In participants who took symptomatic therapy, the median duration of acute GI episodes (in hours) was summarized for the overall treatment period, by symptom (nausea, diarrhea, lower abdominal pain, upper abdominal pain, vomiting, indigestion, constipation, bloating, and flatulence). Table only includes the symptom duration for those symptoms with start and stop times entered in the eDiary (evaluable GI episodes), based on the MAGISS.
Outcome measures
| Measure |
Dimethyl Fumarate
n=128 Participants
120 mg dimethyl fumarate (DMF) twice daily (BID) for the first 7 days and 240 mg DMF BID thereafter for 12 weeks of treatment. Participants were instructed to take the DMF dose with food (with a meal or within 1 hour after a meal).
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|---|---|
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Duration of GI-related Episodes in DMF-treated Participants
Nausea; n=88
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2.0 hours
Full Range 1.81 • Interval 0.0 to 8.8
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Duration of GI-related Episodes in DMF-treated Participants
Diarrhea; n=78
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1.6 hours
Interval 0.0 to 11.0
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Duration of GI-related Episodes in DMF-treated Participants
Lower Abdominal Pain; n=67
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2.0 hours
Interval 0.0 to 8.0
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Duration of GI-related Episodes in DMF-treated Participants
Upper Abdominal Pain; n=66
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1.8 hours
Interval 0.1 to 9.5
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Duration of GI-related Episodes in DMF-treated Participants
Vomiting; n=27
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0.4 hours
Interval 0.0 to 8.0
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Duration of GI-related Episodes in DMF-treated Participants
Indigestion; n=52
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1.9 hours
Interval 0.0 to 11.0
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Duration of GI-related Episodes in DMF-treated Participants
Constipation; n=7
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6.0 hours
Interval 0.0 to 23.0
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Duration of GI-related Episodes in DMF-treated Participants
Bloating; n=41
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3.0 hours
Interval 0.0 to 12.7
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Duration of GI-related Episodes in DMF-treated Participants
Flatulence; n=68
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2.1 hours
Interval 0.2 to 12.7
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SECONDARY outcome
Timeframe: 12 WeeksPopulation: Safety Population (participants who received at least 1 dose of DMF, recorded in diary data)
Percentage of participants reporting that they required GI symptomatic therapy, based on the MOGISS.
Outcome measures
| Measure |
Dimethyl Fumarate
n=233 Participants
120 mg dimethyl fumarate (DMF) twice daily (BID) for the first 7 days and 240 mg DMF BID thereafter for 12 weeks of treatment. Participants were instructed to take the DMF dose with food (with a meal or within 1 hour after a meal).
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|---|---|
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Percentage of DMF-treated Participants Who Required GI Symptomatic Therapy
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54.1 percentage of participants
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SECONDARY outcome
Timeframe: 12 WeeksPopulation: Safety Population (participants who received at least 1 dose of DMF, recorded in diary data)
The symptomatic therapies used by DMF-treated participants were self-reported by type and category. Each participant may have taken more than one symptomatic therapy type but was counted only once within each therapy category. Acetylsalicylic acid (ASA) is abbreviated in the table.
Outcome measures
| Measure |
Dimethyl Fumarate
n=233 Participants
120 mg dimethyl fumarate (DMF) twice daily (BID) for the first 7 days and 240 mg DMF BID thereafter for 12 weeks of treatment. Participants were instructed to take the DMF dose with food (with a meal or within 1 hour after a meal).
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|---|---|
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Participants' Use of Symptomatic Therapy, by Type and Category
Category: Antacid
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57 participants
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Participants' Use of Symptomatic Therapy, by Type and Category
Therapy: Calcium carbonate
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50 participants
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Participants' Use of Symptomatic Therapy, by Type and Category
Therapy: Magnesium (Mg) hydroxide
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4 participants
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Participants' Use of Symptomatic Therapy, by Type and Category
Therapy: Aluminum (Al) hydroxide
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1 participants
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Participants' Use of Symptomatic Therapy, by Type and Category
Therapy: Al hydroxide, Mg hydroxide, simethicone
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3 participants
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Participants' Use of Symptomatic Therapy, by Type and Category
Therapy: ASA, citric acid, sodium bicarbonate
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2 participants
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Participants' Use of Symptomatic Therapy, by Type and Category
Therapy: Generic anatacid
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1 participants
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Participants' Use of Symptomatic Therapy, by Type and Category
Therapy: Nauzene
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1 participants
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Participants' Use of Symptomatic Therapy, by Type and Category
Therapy: Sucralfate
|
1 participants
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Participants' Use of Symptomatic Therapy, by Type and Category
Category: Antisecretory/antimicrobial
|
49 participants
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Participants' Use of Symptomatic Therapy, by Type and Category
Therapy: Bismuth subsalicylate
|
49 participants
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Participants' Use of Symptomatic Therapy, by Type and Category
Category: Anti-acid production
|
43 participants
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Participants' Use of Symptomatic Therapy, by Type and Category
Therapy: Omeprazole
|
18 participants
|
|
Participants' Use of Symptomatic Therapy, by Type and Category
Therapy: Ranitidine
|
15 participants
|
|
Participants' Use of Symptomatic Therapy, by Type and Category
Therapy: Famotidine
|
14 participants
|
|
Participants' Use of Symptomatic Therapy, by Type and Category
Therapy: Lansoprazole
|
10 participants
|
|
Participants' Use of Symptomatic Therapy, by Type and Category
Therapy: Pantoprazole
|
3 participants
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|
Participants' Use of Symptomatic Therapy, by Type and Category
Therapy: Cimetidine
|
1 participants
|
|
Participants' Use of Symptomatic Therapy, by Type and Category
Category: Anti-bloating/anti-constipation agent
|
33 participants
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|
Participants' Use of Symptomatic Therapy, by Type and Category
Therapy: Simethicone
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29 participants
|
|
Participants' Use of Symptomatic Therapy, by Type and Category
Therapy: Docusate
|
5 participants
|
|
Participants' Use of Symptomatic Therapy, by Type and Category
Therapy: Alpha-galactosidase
|
1 participants
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Participants' Use of Symptomatic Therapy, by Type and Category
Therapy: Enema
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1 participants
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Participants' Use of Symptomatic Therapy, by Type and Category
Category: Antidiarrheal (anti-peristaltic)
|
32 participants
|
|
Participants' Use of Symptomatic Therapy, by Type and Category
Therapy: Loperamide
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29 participants
|
|
Participants' Use of Symptomatic Therapy, by Type and Category
Therapy: Diphenoxylate
|
3 participants
|
|
Participants' Use of Symptomatic Therapy, by Type and Category
Therapy: Dicyclomine
|
2 participants
|
|
Participants' Use of Symptomatic Therapy, by Type and Category
Category: Anti-emetic (central)
|
18 participants
|
|
Participants' Use of Symptomatic Therapy, by Type and Category
Therapy: Ondansetron
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8 participants
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|
Participants' Use of Symptomatic Therapy, by Type and Category
Therapy: Promethazine
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7 participants
|
|
Participants' Use of Symptomatic Therapy, by Type and Category
Therapy: Dimenhydrinate
|
3 participants
|
|
Participants' Use of Symptomatic Therapy, by Type and Category
Therapy: Tetrahydrocannabinol
|
1 participants
|
|
Participants' Use of Symptomatic Therapy, by Type and Category
Category: Laxative, fiber/probiotic
|
10 participants
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|
Participants' Use of Symptomatic Therapy, by Type and Category
Therapy: Generic laxative
|
5 participants
|
|
Participants' Use of Symptomatic Therapy, by Type and Category
Therapy: Psyllium fiber
|
3 participants
|
|
Participants' Use of Symptomatic Therapy, by Type and Category
Therapy: Culturelle
|
2 participants
|
|
Participants' Use of Symptomatic Therapy, by Type and Category
Category: Laxative, hygroscopic/osmotic
|
10 participants
|
|
Participants' Use of Symptomatic Therapy, by Type and Category
Therapy: Polyethylene glycol
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4 participants
|
|
Participants' Use of Symptomatic Therapy, by Type and Category
Therapy: Phosphorated carbohydrate solution
|
3 participants
|
|
Participants' Use of Symptomatic Therapy, by Type and Category
Therapy: Sennosides
|
2 participants
|
|
Participants' Use of Symptomatic Therapy, by Type and Category
Therapy: Osmotic
|
1 participants
|
|
Participants' Use of Symptomatic Therapy, by Type and Category
Category: Laxative, prokinetic
|
7 participants
|
|
Participants' Use of Symptomatic Therapy, by Type and Category
Therapy: Bisacodyl
|
7 participants
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|
Participants' Use of Symptomatic Therapy, by Type and Category
Category:Analgesic (nonsteroidal antiinflammatory)
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5 participants
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|
Participants' Use of Symptomatic Therapy, by Type and Category
Therapy: Ibuprofen
|
3 participants
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|
Participants' Use of Symptomatic Therapy, by Type and Category
Therapy: Naproxen
|
2 participants
|
|
Participants' Use of Symptomatic Therapy, by Type and Category
Therapy: ASA
|
1 participants
|
|
Participants' Use of Symptomatic Therapy, by Type and Category
Category: Anti-allergic
|
3 participants
|
|
Participants' Use of Symptomatic Therapy, by Type and Category
Therapy: Montelukast
|
2 participants
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|
Participants' Use of Symptomatic Therapy, by Type and Category
Therapy: Diphenhydramine
|
1 participants
|
|
Participants' Use of Symptomatic Therapy, by Type and Category
Category: Anti-emetic (pro-kinetic)
|
3 participants
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|
Participants' Use of Symptomatic Therapy, by Type and Category
Therapy: Metoclopramide
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3 participants
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|
Participants' Use of Symptomatic Therapy, by Type and Category
Category: Analgesic
|
2 participants
|
|
Participants' Use of Symptomatic Therapy, by Type and Category
Therapy: Acetaminophen
|
2 participants
|
|
Participants' Use of Symptomatic Therapy, by Type and Category
Category: No treatment type recorded
|
1 participants
|
|
Participants' Use of Symptomatic Therapy, by Type and Category
Therapy: Not available
|
1 participants
|
SECONDARY outcome
Timeframe: 12 WeeksPopulation: Evaluable participants (treated participants who utilized symptomatic therapy during the overall treatment period \[12 weeks\]). n= number of participants using the therapy specified.
The total duration (in days) of use of each symptomatic therapy by participants as a result of GI symptoms experienced by DMF-treated participants is presented. If a participant had multiple different therapies on the same day, the days on symptomatic therapy was calculated as 1 day in the 'All Therapies' category.
Outcome measures
| Measure |
Dimethyl Fumarate
n=128 Participants
120 mg dimethyl fumarate (DMF) twice daily (BID) for the first 7 days and 240 mg DMF BID thereafter for 12 weeks of treatment. Participants were instructed to take the DMF dose with food (with a meal or within 1 hour after a meal).
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|---|---|
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Summary of Use and Days on Symptomatic Therapy, by Category
All therapies; n=128
|
10.4 days
Standard Deviation 13.46
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Summary of Use and Days on Symptomatic Therapy, by Category
Antacid; n=57
|
5.9 days
Standard Deviation 10.77
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|
Summary of Use and Days on Symptomatic Therapy, by Category
Antisecretory/antimicrobial; n=49
|
6.3 days
Standard Deviation 12.34
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|
Summary of Use and Days on Symptomatic Therapy, by Category
Anti-acid production; n=43
|
9.0 days
Standard Deviation 11.16
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Summary of Use and Days on Symptomatic Therapy, by Category
Anti-bloating/anti-constipation agent; n=33
|
5.9 days
Standard Deviation 10.86
|
|
Summary of Use and Days on Symptomatic Therapy, by Category
Anti-diarrheal (anti-peristaltic); n=32
|
3.9 days
Standard Deviation 3.88
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Summary of Use and Days on Symptomatic Therapy, by Category
Anti-emetic (central); n=18
|
2.9 days
Standard Deviation 2.00
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|
Summary of Use and Days on Symptomatic Therapy, by Category
Laxative, fiber/probiotic; n=10
|
5.0 days
Standard Deviation 5.64
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|
Summary of Use and Days on Symptomatic Therapy, by Category
Laxative, hygroscopic/osmotic; n=10
|
3.7 days
Standard Deviation 3.06
|
|
Summary of Use and Days on Symptomatic Therapy, by Category
Laxative, prokinetic; n=7
|
1.6 days
Standard Deviation 0.79
|
|
Summary of Use and Days on Symptomatic Therapy, by Category
Analgesic (nonsteroidal antiinflammatory); n=5
|
4.6 days
Standard Deviation 7.50
|
|
Summary of Use and Days on Symptomatic Therapy, by Category
Anti-allergic; n=3
|
12.0 days
Standard Deviation 9.85
|
|
Summary of Use and Days on Symptomatic Therapy, by Category
Anti-emetic; n=3
|
9.7 days
Standard Deviation 12.42
|
|
Summary of Use and Days on Symptomatic Therapy, by Category
Analgesic; n=2
|
4.5 days
Standard Deviation 4.95
|
|
Summary of Use and Days on Symptomatic Therapy, by Category
No treatment type recorded; n=1
|
1.0 days
Standard Deviation NA
only 1 participant analyzed
|
SECONDARY outcome
Timeframe: 12 WeeksPopulation: Safety Population (participants who received at least 1 dose of DMF, recorded in diary data)
The last symptomatic therapy prior to last dose of study medication was used to summarize the number of participants who discontinued DMF due to GI-related events. Participants may have taken more than one symptomatic therapy but are counted only once in the 'All Therapies' category.
Outcome measures
| Measure |
Dimethyl Fumarate
n=233 Participants
120 mg dimethyl fumarate (DMF) twice daily (BID) for the first 7 days and 240 mg DMF BID thereafter for 12 weeks of treatment. Participants were instructed to take the DMF dose with food (with a meal or within 1 hour after a meal).
|
|---|---|
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Number of DMF-treated Participants Who Discontinued DMF Due to GI-related Events Requiring Symptomatic Therapy
Anti-diarrheal (anti-peristaltic)
|
5 participants
|
|
Number of DMF-treated Participants Who Discontinued DMF Due to GI-related Events Requiring Symptomatic Therapy
All therapies
|
13 participants
|
|
Number of DMF-treated Participants Who Discontinued DMF Due to GI-related Events Requiring Symptomatic Therapy
Anti-acid production
|
10 participants
|
|
Number of DMF-treated Participants Who Discontinued DMF Due to GI-related Events Requiring Symptomatic Therapy
Antacid
|
6 participants
|
|
Number of DMF-treated Participants Who Discontinued DMF Due to GI-related Events Requiring Symptomatic Therapy
Antisecretory/antimicrobial
|
6 participants
|
|
Number of DMF-treated Participants Who Discontinued DMF Due to GI-related Events Requiring Symptomatic Therapy
Anti-emetic (central)
|
5 participants
|
|
Number of DMF-treated Participants Who Discontinued DMF Due to GI-related Events Requiring Symptomatic Therapy
Anti-emetic (prokinetic)
|
2 participants
|
|
Number of DMF-treated Participants Who Discontinued DMF Due to GI-related Events Requiring Symptomatic Therapy
Laxative, fiber/probiotic
|
1 participants
|
|
Number of DMF-treated Participants Who Discontinued DMF Due to GI-related Events Requiring Symptomatic Therapy
Laxative, prokinetic
|
1 participants
|
Adverse Events
Dimethyl Fumarate
Serious events: 7 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Dimethyl Fumarate
n=233 participants at risk
120 mg dimethyl fumarate (DMF) twice daily (BID) for the first 7 days and 240 mg DMF BID thereafter for 12 weeks of treatment. Participants were instructed to take the DMF dose with food (with a meal or within 1 hour after a meal).
|
|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
0.86%
2/233 • All serious adverse events (SAEs) from time of signed/dated informed consent through 12 weeks of treatment plus 4 weeks (± 5 days) post last dose.
Non-serious adverse events (other than GI-related events and events resulting in discontinuation of the study drug or withdrawal from the study) were not collected in this study, per protocol.
|
|
Gastrointestinal disorders
Abdominal Pain Lower
|
0.43%
1/233 • All serious adverse events (SAEs) from time of signed/dated informed consent through 12 weeks of treatment plus 4 weeks (± 5 days) post last dose.
Non-serious adverse events (other than GI-related events and events resulting in discontinuation of the study drug or withdrawal from the study) were not collected in this study, per protocol.
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
0.43%
1/233 • All serious adverse events (SAEs) from time of signed/dated informed consent through 12 weeks of treatment plus 4 weeks (± 5 days) post last dose.
Non-serious adverse events (other than GI-related events and events resulting in discontinuation of the study drug or withdrawal from the study) were not collected in this study, per protocol.
|
|
Gastrointestinal disorders
Nausea
|
0.43%
1/233 • All serious adverse events (SAEs) from time of signed/dated informed consent through 12 weeks of treatment plus 4 weeks (± 5 days) post last dose.
Non-serious adverse events (other than GI-related events and events resulting in discontinuation of the study drug or withdrawal from the study) were not collected in this study, per protocol.
|
|
Gastrointestinal disorders
Salivary Gland Calculus
|
0.43%
1/233 • All serious adverse events (SAEs) from time of signed/dated informed consent through 12 weeks of treatment plus 4 weeks (± 5 days) post last dose.
Non-serious adverse events (other than GI-related events and events resulting in discontinuation of the study drug or withdrawal from the study) were not collected in this study, per protocol.
|
|
Gastrointestinal disorders
Vomiting
|
0.43%
1/233 • All serious adverse events (SAEs) from time of signed/dated informed consent through 12 weeks of treatment plus 4 weeks (± 5 days) post last dose.
Non-serious adverse events (other than GI-related events and events resulting in discontinuation of the study drug or withdrawal from the study) were not collected in this study, per protocol.
|
|
Blood and lymphatic system disorders
Lymphadenitis
|
0.43%
1/233 • All serious adverse events (SAEs) from time of signed/dated informed consent through 12 weeks of treatment plus 4 weeks (± 5 days) post last dose.
Non-serious adverse events (other than GI-related events and events resulting in discontinuation of the study drug or withdrawal from the study) were not collected in this study, per protocol.
|
|
Cardiac disorders
Atrial Fibrillation
|
0.43%
1/233 • All serious adverse events (SAEs) from time of signed/dated informed consent through 12 weeks of treatment plus 4 weeks (± 5 days) post last dose.
Non-serious adverse events (other than GI-related events and events resulting in discontinuation of the study drug or withdrawal from the study) were not collected in this study, per protocol.
|
|
General disorders
Sudden Cardiac Death
|
0.43%
1/233 • All serious adverse events (SAEs) from time of signed/dated informed consent through 12 weeks of treatment plus 4 weeks (± 5 days) post last dose.
Non-serious adverse events (other than GI-related events and events resulting in discontinuation of the study drug or withdrawal from the study) were not collected in this study, per protocol.
|
|
Investigations
Troponin Increased
|
0.43%
1/233 • All serious adverse events (SAEs) from time of signed/dated informed consent through 12 weeks of treatment plus 4 weeks (± 5 days) post last dose.
Non-serious adverse events (other than GI-related events and events resulting in discontinuation of the study drug or withdrawal from the study) were not collected in this study, per protocol.
|
|
Musculoskeletal and connective tissue disorders
Pain In Jaw
|
0.43%
1/233 • All serious adverse events (SAEs) from time of signed/dated informed consent through 12 weeks of treatment plus 4 weeks (± 5 days) post last dose.
Non-serious adverse events (other than GI-related events and events resulting in discontinuation of the study drug or withdrawal from the study) were not collected in this study, per protocol.
|
|
Psychiatric disorders
Confusional State
|
0.43%
1/233 • All serious adverse events (SAEs) from time of signed/dated informed consent through 12 weeks of treatment plus 4 weeks (± 5 days) post last dose.
Non-serious adverse events (other than GI-related events and events resulting in discontinuation of the study drug or withdrawal from the study) were not collected in this study, per protocol.
|
Other adverse events
Adverse event data not reported
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