Ignite Creation Date:
2025-12-24 @ 9:14 PM
Ignite Modification Date:
2026-02-20 @ 12:46 PM
Study NCT ID:
NCT02125604
Status:
COMPLETED
Last Update Posted:
2017-04-18
First Post:
2014-04-25
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Gastrointestinal Tolerability Study Of Dimethyl Fumarate In Participants With Relapsing-Remitting Multiple Sclerosis In Germany
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020529', 'term': 'Multiple Sclerosis, Relapsing-Remitting'}], 'ancestors': [{'id': 'D009103', 'term': 'Multiple Sclerosis'}, {'id': 'D020278', 'term': 'Demyelinating Autoimmune Diseases, CNS'}, {'id': 'D020274', 'term': 'Autoimmune Diseases of the Nervous System'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D003711', 'term': 'Demyelinating Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069462', 'term': 'Dimethyl Fumarate'}], 'ancestors': [{'id': 'D005650', 'term': 'Fumarates'}, {'id': 'D003998', 'term': 'Dicarboxylic Acids'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrials@biogen.com', 'title': 'Biogen Study Medical Director', 'organization': 'Biogen'}, 'certainAgreement': {'otherDetails': "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.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '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).', 'eventGroups': [{'id': 'EG000', 'title': 'Dimethyl Fumarate', 'description': 'Dimethyl fumarate administered orally at 120 mg BID for the first 7 days and 240 mg BID thereafter for a total of 12 weeks.', 'otherNumAtRisk': 211, 'otherNumAffected': 129, 'seriousNumAtRisk': 211, 'seriousNumAffected': 5}], 'otherEvents': [{'term': 'Flushing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 211, 'numAffected': 105}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 211, 'numAffected': 31}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 211, 'numAffected': 14}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 211, 'numAffected': 12}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Pruritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 211, 'numAffected': 12}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}], 'seriousEvents': [{'term': 'Multiple sclerosis relapse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 211, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 211, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Alanine aminotransferase increrased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 211, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Aspartate aminotransferase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 211, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Gamma-glutamyltransferase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 211, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Alcohol abuse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 211, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants Who Utilized Symptomatic Therapy With Gastrointestinal-Related Events During the 12-Week Treatment Period: Modified Overall Gastrointestinal Symptom Scale (MOGISS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '211', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Dimethyl Fumarate', 'description': 'Dimethyl fumarate administered orally at 120 mg BID for the first 7 days and 240 mg BID thereafter for a total of 12 weeks.'}], 'classes': [{'title': 'Overall Treatment Period; n=211', 'categories': [{'measurements': [{'value': '82', 'groupId': 'OG000'}]}]}, {'title': 'Weeks 1-4; n=211', 'categories': [{'measurements': [{'value': '71', 'groupId': 'OG000'}]}]}, {'title': 'Weeks 5-8; n=186', 'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000'}]}]}, {'title': 'Weeks 9-12; n=178', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Week 12', 'description': '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.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population: all participants who received at least 1 dose of dimethyl fumarate; n=participants with an assessment during given time period.'}, {'type': 'PRIMARY', 'title': 'Number of Participants Who Utilized Symptomatic Therapy With Gastrointestinal-Related Events During the 12-Week Treatment Period: Modified Acute Gastrointestinal Symptom Scale (MAGISS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '211', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Dimethyl Fumarate', 'description': 'Dimethyl fumarate administered orally at 120 mg BID for the first 7 days and 240 mg BID thereafter for a total of 12 weeks.'}], 'classes': [{'title': 'Overall Treatment Period; n=211', 'categories': [{'measurements': [{'value': '83', 'groupId': 'OG000'}]}]}, {'title': 'Weeks 1-4; n=211', 'categories': [{'measurements': [{'value': '72', 'groupId': 'OG000'}]}]}, {'title': 'Weeks 5-8; n=189', 'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000'}]}]}, {'title': 'Weeks 9-12; n=180', 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Week 12', 'description': '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.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population: all participants who received at least 1 dose of dimethyl fumarate; n=participants with an assessment during given time period.'}, {'type': 'PRIMARY', 'title': 'Worst Severity Of Gastrointestinal-Related Events In Participants Who Utilized Symptomatic Therapy During the 12-Week Treatment Period, MOGISS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Dimethyl Fumarate', 'description': 'Dimethyl fumarate administered orally at 120 mg BID for the first 7 days and 240 mg BID thereafter for a total of 12 weeks.'}], 'classes': [{'title': 'Overall treatment period; n=84', 'categories': [{'measurements': [{'value': '5.94', 'spread': '2.427', 'groupId': 'OG000'}]}]}, {'title': 'Week 1-4; n=73', 'categories': [{'measurements': [{'value': '5.75', 'spread': '2.554', 'groupId': 'OG000'}]}]}, {'title': 'Week 5-8; n=38', 'categories': [{'measurements': [{'value': '3.53', 'spread': '2.533', 'groupId': 'OG000'}]}]}, {'title': 'Week 9-12; n=29', 'categories': [{'measurements': [{'value': '3.1', 'spread': '2.568', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to Week 12', 'description': '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.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'PRIMARY', 'title': 'Worst Severity Of Gastrointestinal-Related Events In Participants Who Utilized Symptomatic Therapy During the 12-Week Treatment Period, MAGISS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Dimethyl Fumarate', 'description': 'Dimethyl fumarate administered orally at 120 mg BID for the first 7 days and 240 mg BID thereafter for a total of 12 weeks.'}], 'classes': [{'title': 'Overall treatment period; n=84', 'categories': [{'measurements': [{'value': '5.93', 'spread': '2.516', 'groupId': 'OG000'}]}]}, {'title': 'Week 1-4; n=73', 'categories': [{'measurements': [{'value': '5.88', 'spread': '2.614', 'groupId': 'OG000'}]}]}, {'title': 'Week 5-8; n=39', 'categories': [{'measurements': [{'value': '3.31', 'spread': '2.307', 'groupId': 'OG000'}]}]}, {'title': 'Week 9-12; n=29', 'categories': [{'measurements': [{'value': '3.55', 'spread': '2.772', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to Week 12', 'description': '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.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'PRIMARY', 'title': 'Duration of Gastrointestinal-Related Events in Participants Who Utilized Symptomatic Therapy During the 12-Week Treatment Period, MOGISS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Dimethyl Fumarate', 'description': 'Dimethyl fumarate administered orally at 120 mg BID for the first 7 days and 240 mg BID thereafter for a total of 12 weeks.'}], 'classes': [{'title': 'Overall treatment period; Any ST (n=84)', 'categories': [{'measurements': [{'value': '38.13', 'spread': '29.263', 'groupId': 'OG000'}]}]}, {'title': 'Overall treatment period; ST1 (n=50)', 'categories': [{'measurements': [{'value': '42.08', 'spread': '27.495', 'groupId': 'OG000'}]}]}, {'title': 'Overall treatment period; ST2 (n=26)', 'categories': [{'measurements': [{'value': '36.98', 'spread': '29.754', 'groupId': 'OG000'}]}]}, {'title': 'Overall treatment period; ST3 (n=20)', 'categories': [{'measurements': [{'value': '39.61', 'spread': '29.197', 'groupId': 'OG000'}]}]}, {'title': 'Overall treatment period; ST4 (n=16)', 'categories': [{'measurements': [{'value': '48.15', 'spread': '30.140', 'groupId': 'OG000'}]}]}, {'title': 'Overall treatment period; ST5 (n=10)', 'categories': [{'measurements': [{'value': '45.94', 'spread': '27.147', 'groupId': 'OG000'}]}]}, {'title': 'Overall treatment period; ST6 (n=8)', 'categories': [{'measurements': [{'value': '44.33', 'spread': '29.095', 'groupId': 'OG000'}]}]}, {'title': 'Overall treatment period; ST7 (n=6)', 'categories': [{'measurements': [{'value': '57.52', 'spread': '21.998', 'groupId': 'OG000'}]}]}, {'title': 'Overall treatment period; ST8 (n=5)', 'categories': [{'measurements': [{'value': '52.71', 'spread': '31.829', 'groupId': 'OG000'}]}]}, {'title': 'Overall treatment period; ST9 (n=3)', 'categories': [{'measurements': [{'value': '32.78', 'spread': '26.995', 'groupId': 'OG000'}]}]}, {'title': 'Overall treatment period; ST10 (n=2)', 'categories': [{'measurements': [{'value': '9.20', 'spread': '2.137', 'groupId': 'OG000'}]}]}, {'title': 'Week 1-4; Any ST (n=73)', 'categories': [{'measurements': [{'value': '49.58', 'spread': '29.547', 'groupId': 'OG000'}]}]}, {'title': 'Week 1-4; ST1 (n=44)', 'categories': [{'measurements': [{'value': '53.92', 'spread': '27.197', 'groupId': 'OG000'}]}]}, {'title': 'Week 1-4; ST2 (n=23)', 'categories': [{'measurements': [{'value': '49.53', 'spread': '32.012', 'groupId': 'OG000'}]}]}, {'title': 'Week 1-4; ST3 (n=18)', 'categories': [{'measurements': [{'value': '55.31', 'spread': '29.869', 'groupId': 'OG000'}]}]}, {'title': 'Week 1-4; ST4 (n=13)', 'categories': [{'measurements': [{'value': '56.63', 'spread': '25.764', 'groupId': 'OG000'}]}]}, {'title': 'Week 1-4; ST5 (n=9)', 'categories': [{'measurements': [{'value': '44.42', 'spread': '32.470', 'groupId': 'OG000'}]}]}, {'title': 'Week 1-4; ST6 (n=6)', 'categories': [{'measurements': [{'value': '48.48', 'spread': '35.539', 'groupId': 'OG000'}]}]}, {'title': 'Week 1-4; ST7 (n=6)', 'categories': [{'measurements': [{'value': '69.78', 'spread': '24.808', 'groupId': 'OG000'}]}]}, {'title': 'Week 1-4; ST8 (n=5)', 'categories': [{'measurements': [{'value': '66.43', 'spread': '31.400', 'groupId': 'OG000'}]}]}, {'title': 'Week 1-4; ST9 (n=3)', 'categories': [{'measurements': [{'value': '41.41', 'spread': '34.085', 'groupId': 'OG000'}]}]}, {'title': 'Week 1-4; ST10 (n=0)', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'No participants used this symptomatic therapy in this time period.', 'groupId': 'OG000'}]}]}, {'title': 'Week 5-8; Any ST (n=38)', 'categories': [{'measurements': [{'value': '41.55', 'spread': '38.612', 'groupId': 'OG000'}]}]}, {'title': 'Week 5-8; ST1 (n=23)', 'categories': [{'measurements': [{'value': '44.04', 'spread': '41.414', 'groupId': 'OG000'}]}]}, {'title': 'Week 5-8; ST2 (n=3)', 'categories': [{'measurements': [{'value': '41.67', 'spread': '52.042', 'groupId': 'OG000'}]}]}, {'title': 'Week 5-8; ST3 (n=8)', 'categories': [{'measurements': [{'value': '37.45', 'spread': '37.388', 'groupId': 'OG000'}]}]}, {'title': 'Week 5-8; ST4 (n=3)', 'categories': [{'measurements': [{'value': '69.14', 'spread': '44.186', 'groupId': 'OG000'}]}]}, {'title': 'Week 5-8; ST5 (n=3)', 'categories': [{'measurements': [{'value': '63.75', 'spread': '31.332', 'groupId': 'OG000'}]}]}, {'title': 'Week 5-8; ST6 (n=3)', 'categories': [{'measurements': [{'value': '70.42', 'spread': '25.699', 'groupId': 'OG000'}]}]}, {'title': 'Week 5-8; ST7 (n=1)', 'categories': [{'measurements': [{'value': '35.71', 'spread': 'NA', 'comment': '1 participant used this symptomatic therapy in this time period.', 'groupId': 'OG000'}]}]}, {'title': 'Week 5-8; ST8 (n=2)', 'categories': [{'measurements': [{'value': '56.88', 'spread': '40.032', 'groupId': 'OG000'}]}]}, {'title': 'Week 5-8; ST9 (n=0)', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'No participants used this symptomatic therapy in this time period.', 'groupId': 'OG000'}]}]}, {'title': 'Week 5-8; ST10 (n=2)', 'categories': [{'measurements': [{'value': '1.79', 'spread': '2.525', 'groupId': 'OG000'}]}]}, {'title': 'Week 9-12; Any ST (n=29)', 'categories': [{'measurements': [{'value': '43.27', 'spread': '42.322', 'groupId': 'OG000'}]}]}, {'title': 'Week 9-12; ST1 (n=15)', 'categories': [{'measurements': [{'value': '47.66', 'spread': '43.191', 'groupId': 'OG000'}]}]}, {'title': 'Week 9-12; ST2 (n=3)', 'categories': [{'measurements': [{'value': '82.72', 'spread': '29.937', 'groupId': 'OG000'}]}]}, {'title': 'Week 9-12; ST3 (n=6)', 'categories': [{'measurements': [{'value': '48.85', 'spread': '50.931', 'groupId': 'OG000'}]}]}, {'title': 'Week 9-12; ST4 (n=4)', 'categories': [{'measurements': [{'value': '22.12', 'spread': '20.834', 'groupId': 'OG000'}]}]}, {'title': 'Week 9-12; ST5 (n=2)', 'categories': [{'measurements': [{'value': '62.50', 'spread': '53.033', 'groupId': 'OG000'}]}]}, {'title': 'Week 9-12; ST6 (n=0)', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'No participants used this symptomatic therapy in this time period.', 'groupId': 'OG000'}]}]}, {'title': 'Week 9-12; ST7 (n=0)', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'No participants used this symptomatic therapy in this time period.', 'groupId': 'OG000'}]}]}, {'title': 'Week 9-12; ST8 (n=2)', 'categories': [{'measurements': [{'value': '9.26', 'spread': '13.095', 'groupId': 'OG000'}]}]}, {'title': 'Week 9-12; ST9 (n=0)', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'No participants used this symptomatic therapy in this time period.', 'groupId': 'OG000'}]}]}, {'title': 'Week 9-12; ST10 (n=0)', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'No participants used this symptomatic therapy in this time period.', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to Week 12', 'description': '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.', 'unitOfMeasure': 'percentage of days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who First Took Symptomatic Therapy for Gastrointestinal-Related Events at Weeks 4, 8, and 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Dimethyl Fumarate', 'description': 'Dimethyl fumarate administered orally at 120 mg BID for the first 7 days and 240 mg BID thereafter for a total of 12 weeks.'}], 'classes': [{'title': 'Week 4', 'categories': [{'measurements': [{'value': '35.3', 'groupId': 'OG000'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '38.4', 'groupId': 'OG000'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '41.1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 4, Week 8, Week 12', 'description': '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.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population: all participants who received at least 1 dose of dimethyl fumarate and used symptomatic therapy.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Used Symptomatic Therapies for Gastrointestinal-Related Events During the 12-Week Treatment Period, by Category', 'denoms': [{'units': 'Participants', 'counts': [{'value': '211', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Dimethyl Fumarate', 'description': 'Dimethyl fumarate administered orally at 120 mg BID for the first 7 days and 240 mg BID thereafter for a total of 12 weeks.'}], 'classes': [{'title': 'Overall treatment period (OTP): All therapies', 'categories': [{'measurements': [{'value': '84', 'groupId': 'OG000'}]}]}, {'title': 'OTP: Anti-acid production', 'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000'}]}]}, {'title': 'OTP: Anti-bloating/anti-constipation agent', 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}]}]}, {'title': 'OTP: Multi-target/herbal agents', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}]}]}, {'title': 'OTP: Anti-diarrheal (anti-peristaltic)', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}]}]}, {'title': 'OTP: Analgesic (NSAID)', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}]}]}, {'title': 'OTP: Anti-emetic (central)', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}, {'title': 'OTP: Anti-emetic (pro-kinetic)', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'OTP: Antacid', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'OTP: Other', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'OTP: Laxative (pro-kinetic)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Week 1-4: All therapies', 'categories': [{'measurements': [{'value': '73', 'groupId': 'OG000'}]}]}, {'title': 'Week 1-4: Anti-acid production', 'categories': [{'measurements': [{'value': '44', 'groupId': 'OG000'}]}]}, {'title': 'Week 1-4: Anti-bloating/anti-constipation agent', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}]}]}, {'title': 'Week 1-4: Multi-target/herbal agents', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}]}]}, {'title': 'Week 1-4: Anti-diarrheal (anti-peristaltic)', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}]}]}, {'title': 'Week 1-4: Analgesic (NSAID)', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}, {'title': 'Week 1-4: Anti-emetic (central)', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'Week 1-4: Anti-emetic (pro-kinetic)', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'Week 1-4: Antacid', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Week 1-4: Other', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Week 5-8: All therapies', 'categories': [{'measurements': [{'value': '38', 'groupId': 'OG000'}]}]}, {'title': 'Week 5-8: Anti-acid production', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}]}]}, {'title': 'Week 5-8: Multi-target/herbal agents', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}, {'title': 'Week 5-8: Analgesic (NSAID)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Week 5-8: Anti-bloating/anti-constipation agent', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Week 5-8: Anti-diarrheal (anti-peristaltic)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Week 5-8: Anti-emetic (central)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Week 5-8: Antacid', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Week 5-8: Laxative (pro-kinetic)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Week 5-8: Anti-emetic (pro-kinetic)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Week 9-12: All therapies', 'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}]}]}, {'title': 'Week 9-12: Anti-acid production', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}]}]}, {'title': 'Week 9-12: Multi-target/herbal agents', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'Week 9-12: Anti-diarrheal (anti-peristaltic)', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Week 9-12: Anti-bloating.anti-constipation agent', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Week 9-12: Analgesic (NSAID)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Week 9-12: Antacid', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Week 12', 'description': "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.", 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population: all participants who received at least 1 dose of dimethyl fumarate and used symptomatic therapy.'}, {'type': 'SECONDARY', 'title': 'Duration of Use of Symptomatic Therapies for Gastrointestinal-Related Events During the 12-Week Treatment Period, by Category', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Dimethyl Fumarate', 'description': 'Dimethyl fumarate administered orally at 120 mg BID for the first 7 days and 240 mg BID thereafter for a total of 12 weeks.'}], 'classes': [{'title': 'OTP: All therapies; n=84', 'categories': [{'measurements': [{'value': '13.15', 'spread': '19.21', 'groupId': 'OG000'}]}]}, {'title': 'OTP: Anti-acid production; n=50', 'categories': [{'measurements': [{'value': '16.62', 'spread': '22.21', 'groupId': 'OG000'}]}]}, {'title': 'OTP: Anti-bloating/anti-constipation agent; n=26', 'categories': [{'measurements': [{'value': '2.42', 'spread': '1.81', 'groupId': 'OG000'}]}]}, {'title': 'OTP: Multi-target/herbal agents; n=20', 'categories': [{'measurements': [{'value': '9.40', 'spread': '13.95', 'groupId': 'OG000'}]}]}, {'title': 'OTP: Anti-diarrheal (anti-peristaltic); n=16', 'categories': [{'measurements': [{'value': '3.13', 'spread': '2.53', 'groupId': 'OG000'}]}]}, {'title': 'OTP: Analgesic (NSAID); n=10', 'categories': [{'measurements': [{'value': '3.10', 'spread': '1.73', 'groupId': 'OG000'}]}]}, {'title': 'OTP: Anti-emetic (central); n=8', 'categories': [{'measurements': [{'value': '3.25', 'spread': '4.43', 'groupId': 'OG000'}]}]}, {'title': 'OTP: Anti-emetic (pro-kinetic); n=6', 'categories': [{'measurements': [{'value': '1.83', 'spread': '0.98', 'groupId': 'OG000'}]}]}, {'title': 'OTP: Antacid; n=5', 'categories': [{'measurements': [{'value': '3.60', 'spread': '4.22', 'groupId': 'OG000'}]}]}, {'title': 'OTP: Other; n=3', 'categories': [{'measurements': [{'value': '1.67', 'spread': '0.58', 'groupId': 'OG000'}]}]}, {'title': 'OTP: Laxative (pro-kinetic); n=2', 'categories': [{'measurements': [{'value': '1.00', 'spread': '0.00', 'groupId': 'OG000'}]}]}, {'title': 'Week 1-4: All therapies; n=73', 'categories': [{'measurements': [{'value': '6.03', 'spread': '6.12', 'groupId': 'OG000'}]}]}, {'title': 'Week 1-4: Anti-acid production; n=44', 'categories': [{'measurements': [{'value': '7.07', 'spread': '6.73', 'groupId': 'OG000'}]}]}, {'title': 'Week 1-4: Anti-bloating/anti-constipation; n=23', 'categories': [{'measurements': [{'value': '2.30', 'spread': '1.89', 'groupId': 'OG000'}]}]}, {'title': 'Week 1-4: Multi-target/herbal agents; n=18', 'categories': [{'measurements': [{'value': '3.78', 'spread': '3.06', 'groupId': 'OG000'}]}]}, {'title': 'Week 1-4: Anti-diarrheal (anti-peristaltic); n=13', 'categories': [{'measurements': [{'value': '2.62', 'spread': '1.45', 'groupId': 'OG000'}]}]}, {'title': 'Week 1-4: Analgesic (NSAID); n=9', 'categories': [{'measurements': [{'value': '2.11', 'spread': '0.93', 'groupId': 'OG000'}]}]}, {'title': 'Week 1-4: Anti-emetic (central); n=6', 'categories': [{'measurements': [{'value': '3.17', 'spread': '3.92', 'groupId': 'OG000'}]}]}, {'title': 'Week 1-4: Anti-emetic (pro-kinetic); n=6', 'categories': [{'measurements': [{'value': '1.67', 'spread': '0.82', 'groupId': 'OG000'}]}]}, {'title': 'Week 1-4: Antacid; n=5', 'categories': [{'measurements': [{'value': '1.80', 'spread': '1.30', 'groupId': 'OG000'}]}]}, {'title': 'Week 1-4: Other; n=3', 'categories': [{'measurements': [{'value': '1.67', 'spread': '0.58', 'groupId': 'OG000'}]}]}, {'title': 'Week 5-8: All therapies; n=38', 'categories': [{'measurements': [{'value': '10.08', 'spread': '10.56', 'groupId': 'OG000'}]}]}, {'title': 'Week 5-8: Anti-acid production; n=23', 'categories': [{'measurements': [{'value': '13.00', 'spread': '11.14', 'groupId': 'OG000'}]}]}, {'title': 'Week 5-8: Multi-target/herbal agents; n=8', 'categories': [{'measurements': [{'value': '8.50', 'spread': '10.45', 'groupId': 'OG000'}]}]}, {'title': 'Week 5-8: Analgesic (NSAID); n=3', 'categories': [{'measurements': [{'value': '2.00', 'spread': '1.00', 'groupId': 'OG000'}]}]}, {'title': 'Week 5-8: Anti-bloating/anti-constipation; n=3', 'categories': [{'measurements': [{'value': '1.33', 'spread': '0.58', 'groupId': 'OG000'}]}]}, {'title': 'Week 5-8: Anti-diarrheal (anti-peristaltic); n=3', 'categories': [{'measurements': [{'value': '4.00', 'spread': '3.61', 'groupId': 'OG000'}]}]}, {'title': 'Week 5-8: Anti-emetic (central); n=3', 'categories': [{'measurements': [{'value': '2.33', 'spread': '1.15', 'groupId': 'OG000'}]}]}, {'title': 'Week 5-8: Antacid; n=2', 'categories': [{'measurements': [{'value': '2.50', 'spread': '2.12', 'groupId': 'OG000'}]}]}, {'title': 'Week 5-8: Laxative (pro-kinetic); n=2', 'categories': [{'measurements': [{'value': '1.00', 'spread': '0.00', 'groupId': 'OG000'}]}]}, {'title': 'Week 5-8: Anti-emetic (prokinetic); n=1', 'categories': [{'measurements': [{'value': '1.00', 'spread': 'NA', 'comment': 'One participant only was included.', 'groupId': 'OG000'}]}]}, {'title': 'Week 9-12: All therapies; n=29', 'categories': [{'measurements': [{'value': '9.72', 'spread': '10.31', 'groupId': 'OG000'}]}]}, {'title': 'Week 9-12: Anti-acid production; n=15', 'categories': [{'measurements': [{'value': '14.73', 'spread': '10.91', 'groupId': 'OG000'}]}]}, {'title': 'Week 9-12: Multi-target/herbal agents; n=6', 'categories': [{'measurements': [{'value': '8.67', 'spread': '8.57', 'groupId': 'OG000'}]}]}, {'title': 'Week 9-12: Anti-diarrheal (anti-peristaltic); n=4', 'categories': [{'measurements': [{'value': '1.00', 'spread': '0.00', 'groupId': 'OG000'}]}]}, {'title': 'Week 9-12: Anti-bloating/anti-constipation; n=3', 'categories': [{'measurements': [{'value': '2.00', 'spread': '1.00', 'groupId': 'OG000'}]}]}, {'title': 'Week 9-12: Analgesic (NSAID); n=2', 'categories': [{'measurements': [{'value': '3.00', 'spread': '0.00', 'groupId': 'OG000'}]}]}, {'title': 'Week 9-12: Antacid; n=2', 'categories': [{'measurements': [{'value': '2.00', 'spread': '1.41', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to Week 12', 'description': "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'.", 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Required Dimethyl Fumarate Dose Reduction In Response To Gastrointestinal-Related Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '211', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Dimethyl Fumarate', 'description': 'Dimethyl fumarate administered orally at 120 mg BID for the first 7 days and 240 mg BID thereafter for a total of 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '34.6', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Week 12', 'description': 'Dose reductions are defined as participants who take any dimethyl fumarate 120 mg or 0 mg since initiation of dimethyl fumarate 240 mg.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population: all participants who received at least 1 dose of dimethyl fumarate.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Discontinued Dimethyl Fumarate Due To Gastrointestinal-Related Treatment-Emergent Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '211', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Dimethyl Fumarate', 'description': 'Dimethyl fumarate administered orally at 120 mg BID for the first 7 days and 240 mg BID thereafter for a total of 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.6', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Week 12', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population: all participants who received at least 1 dose of dimethyl fumarate.'}, {'type': 'PRIMARY', 'title': 'Duration of Gastrointestinal-Related Events in Participants Who Utilize Symptomatic Therapy During the 12-Week Treatment Period, MAGISS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Dimethyl Fumarate', 'description': 'Dimethyl fumarate administered orally at 120 mg BID for the first 7 days and 240 mg BID thereafter for a total of 12 weeks.'}], 'classes': [{'title': 'Overall treatment period; Any ST (n=84)', 'categories': [{'measurements': [{'value': '38.20', 'spread': '30.516', 'groupId': 'OG000'}]}]}, {'title': 'Overall treatment period; ST1 (n=50)', 'categories': [{'measurements': [{'value': '41.29', 'spread': '29.517', 'groupId': 'OG000'}]}]}, {'title': 'Overall treatment period; ST2 (n=26)', 'categories': [{'measurements': [{'value': '33.67', 'spread': '27.310', 'groupId': 'OG000'}]}]}, {'title': 'Overall treatment period; ST3 (n=20)', 'categories': [{'measurements': [{'value': '39.28', 'spread': '29.165', 'groupId': 'OG000'}]}]}, {'title': 'Overall treatment period; ST4 (n=16)', 'categories': [{'measurements': [{'value': '49.94', 'spread': '33.291', 'groupId': 'OG000'}]}]}, {'title': 'Overall treatment period; ST5 (n=10)', 'categories': [{'measurements': [{'value': '45.65', 'spread': '27.118', 'groupId': 'OG000'}]}]}, {'title': 'Overall treatment period; ST6 (n=8)', 'categories': [{'measurements': [{'value': '44.71', 'spread': '30.374', 'groupId': 'OG000'}]}]}, {'title': 'Overall treatment period; ST7 (n=6)', 'categories': [{'measurements': [{'value': '55.32', 'spread': '23.097', 'groupId': 'OG000'}]}]}, {'title': 'Overall treatment period; ST8 (n=5)', 'categories': [{'measurements': [{'value': '53.42', 'spread': '31.443', 'groupId': 'OG000'}]}]}, {'title': 'Overall treatment period; ST9 (n=3)', 'categories': [{'measurements': [{'value': '36.92', 'spread': '27.800', 'groupId': 'OG000'}]}]}, {'title': 'Overall treatment period; ST10 (n=2)', 'categories': [{'measurements': [{'value': '10.88', 'spread': '1.924', 'groupId': 'OG000'}]}]}, {'title': 'Week 1-4; Any ST (n=73)', 'categories': [{'measurements': [{'value': '51.03', 'spread': '30.360', 'groupId': 'OG000'}]}]}, {'title': 'Week 1-4; ST1 (n=44)', 'categories': [{'measurements': [{'value': '54.41', 'spread': '29.608', 'groupId': 'OG000'}]}]}, {'title': 'Week 1-4; ST2 (n=23)', 'categories': [{'measurements': [{'value': '47.84', 'spread': '30.764', 'groupId': 'OG000'}]}]}, {'title': 'Week 1-4; ST3 (n=18)', 'categories': [{'measurements': [{'value': '56.67', 'spread': '30.711', 'groupId': 'OG000'}]}]}, {'title': 'Week 1-4; ST4 (n=13)', 'categories': [{'measurements': [{'value': '58.90', 'spread': '27.111', 'groupId': 'OG000'}]}]}, {'title': 'Week 1-4; ST5 (n=9)', 'categories': [{'measurements': [{'value': '53.74', 'spread': '32.304', 'groupId': 'OG000'}]}]}, {'title': 'Week 1-4; ST6 (n=6)', 'categories': [{'measurements': [{'value': '46.43', 'spread': '33.221', 'groupId': 'OG000'}]}]}, {'title': 'Week 1-4; ST7 (n=6)', 'categories': [{'measurements': [{'value': '67.54', 'spread': '25.296', 'groupId': 'OG000'}]}]}, {'title': 'Week 1-4; ST8 (n=5)', 'categories': [{'measurements': [{'value': '69.86', 'spread': '28.919', 'groupId': 'OG000'}]}]}, {'title': 'Week 1-4; ST9 (n=3)', 'categories': [{'measurements': [{'value': '47.61', 'spread': '47.61', 'groupId': 'OG000'}]}]}, {'title': 'Week 1-4; ST10 (n=0)', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'No participants used this symptomatic therapy in this time period.', 'groupId': 'OG000'}]}]}, {'title': 'Week 5-8; Any ST (n=38)', 'categories': [{'measurements': [{'value': '40.59', 'spread': '37.836', 'groupId': 'OG000'}]}]}, {'title': 'Week 5-8; ST1 (n=23)', 'categories': [{'measurements': [{'value': '41.59', 'spread': '41.442', 'groupId': 'OG000'}]}]}, {'title': 'Week 5-8; ST2 (n=3)', 'categories': [{'measurements': [{'value': '47.14', 'spread': '45.781', 'groupId': 'OG000'}]}]}, {'title': 'Week 5-8; ST3 (n=8)', 'categories': [{'measurements': [{'value': '38.50', 'spread': '35.493', 'groupId': 'OG000'}]}]}, {'title': 'Week 5-8; ST4 (n=3)', 'categories': [{'measurements': [{'value': '62.58', 'spread': '45.775', 'groupId': 'OG000'}]}]}, {'title': 'Week 5-8; ST5 (n=3)', 'categories': [{'measurements': [{'value': '56.33', 'spread': '33.011', 'groupId': 'OG000'}]}]}, {'title': 'Week 5-8; ST6 (n=3)', 'categories': [{'measurements': [{'value': '71.61', 'spread': '24.587', 'groupId': 'OG000'}]}]}, {'title': 'Week 5-8; ST7 (n=1)', 'categories': [{'measurements': [{'value': '35.71', 'spread': 'NA', 'comment': '1 participant used this symptomatic therapy in this time period.', 'groupId': 'OG000'}]}]}, {'title': 'Week 5-8; ST8 (n=2)', 'categories': [{'measurements': [{'value': '62.24', 'spread': '32.456', 'groupId': 'OG000'}]}]}, {'title': 'Week 5-8; ST9 (n=0)', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'No participants used this symptomatic therapy in this time period.', 'groupId': 'OG000'}]}]}, {'title': 'Week 5-8; ST10 (n=2)', 'categories': [{'measurements': [{'value': '10.00', 'spread': '14.142', 'groupId': 'OG000'}]}]}, {'title': 'Week 9-12; Any ST (n=29)', 'categories': [{'measurements': [{'value': '41.28', 'spread': '42.466', 'groupId': 'OG000'}]}]}, {'title': 'Week 9-12; ST1 (n=15)', 'categories': [{'measurements': [{'value': '44.24', 'spread': '44.754', 'groupId': 'OG000'}]}]}, {'title': 'Week 9-12; ST2 (n=3)', 'categories': [{'measurements': [{'value': '76.19', 'spread': '41.239', 'groupId': 'OG000'}]}]}, {'title': 'Week 9-12; ST3 (n=6)', 'categories': [{'measurements': [{'value': '51.99', 'spread': '50.113', 'groupId': 'OG000'}]}]}, {'title': 'Week 9-12; ST4 (n=4)', 'categories': [{'measurements': [{'value': '15.48', 'spread': '10.178', 'groupId': 'OG000'}]}]}, {'title': 'Week 9-12; ST5 (n=2)', 'categories': [{'measurements': [{'value': '63.16', 'spread': '52.103', 'groupId': 'OG000'}]}]}, {'title': 'Week 9-12; ST6 (n=0)', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'No participants used this symptomatic therapy in this time period.', 'groupId': 'OG000'}]}]}, {'title': 'Week 9-12; ST7 (n=0)', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'No participants used this symptomatic therapy in this time period.', 'groupId': 'OG000'}]}]}, {'title': 'Week 9-12; ST8 (n=2)', 'categories': [{'measurements': [{'value': '13.11', 'spread': '7.655', 'groupId': 'OG000'}]}]}, {'title': 'Week 9-12; ST9 (n=0)', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'No participants used this symptomatic therapy in this time period.', 'groupId': 'OG000'}]}]}, {'title': 'Week 9-12; ST10 (n=0)', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'No participants used this symptomatic therapy in this time period.', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to Week 12', 'description': '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.', 'unitOfMeasure': 'percentage of days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Dimethyl Fumarate', 'description': 'Dimethyl fumarate administered orally at 120 mg BID for the first 7 days and 240 mg BID thereafter for a total of 12 weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'enrolled and received at least 1 dose of study drug', 'groupId': 'FG000', 'numSubjects': '211'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '180'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '31'}]}], 'dropWithdraws': [{'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}]}, {'type': 'Investigator Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Consent Withdrawn', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '20'}]}]}], 'preAssignmentDetails': '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.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '211', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Dimethyl Fumarate', 'description': 'Dimethyl fumarate administered orally at 120 mg BID for the first 7 days and 240 mg BID thereafter for a total of 12 weeks.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '40.09', 'spread': '10.97', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '149', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '62', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 214}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-03-07', 'studyFirstSubmitDate': '2014-04-25', 'resultsFirstSubmitDate': '2017-03-07', 'studyFirstSubmitQcDate': '2014-04-25', 'lastUpdatePostDateStruct': {'date': '2017-04-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-03-07', 'studyFirstPostDateStruct': {'date': '2014-04-29', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-04-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants Who Utilized Symptomatic Therapy With Gastrointestinal-Related Events During the 12-Week Treatment Period: Modified Overall Gastrointestinal Symptom Scale (MOGISS)', 'timeFrame': 'Up to Week 12', 'description': '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.'}, {'measure': 'Number of Participants Who Utilized Symptomatic Therapy With Gastrointestinal-Related Events During the 12-Week Treatment Period: Modified Acute Gastrointestinal Symptom Scale (MAGISS)', 'timeFrame': 'Up to Week 12', 'description': '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.'}, {'measure': 'Worst Severity Of Gastrointestinal-Related Events In Participants Who Utilized Symptomatic Therapy During the 12-Week Treatment Period, MOGISS', 'timeFrame': 'Up to Week 12', 'description': '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.'}, {'measure': 'Worst Severity Of Gastrointestinal-Related Events In Participants Who Utilized Symptomatic Therapy During the 12-Week Treatment Period, MAGISS', 'timeFrame': 'Up to Week 12', 'description': '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.'}, {'measure': 'Duration of Gastrointestinal-Related Events in Participants Who Utilized Symptomatic Therapy During the 12-Week Treatment Period, MOGISS', 'timeFrame': 'Up to Week 12', 'description': '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.'}, {'measure': 'Duration of Gastrointestinal-Related Events in Participants Who Utilize Symptomatic Therapy During the 12-Week Treatment Period, MAGISS', 'timeFrame': 'Up to Week 12', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants Who First Took Symptomatic Therapy for Gastrointestinal-Related Events at Weeks 4, 8, and 12', 'timeFrame': 'Week 4, Week 8, Week 12', 'description': '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.'}, {'measure': 'Number of Participants Who Used Symptomatic Therapies for Gastrointestinal-Related Events During the 12-Week Treatment Period, by Category', 'timeFrame': 'Up to Week 12', 'description': "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."}, {'measure': 'Duration of Use of Symptomatic Therapies for Gastrointestinal-Related Events During the 12-Week Treatment Period, by Category', 'timeFrame': 'Up to Week 12', 'description': "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'."}, {'measure': 'Percentage of Participants Who Required Dimethyl Fumarate Dose Reduction In Response To Gastrointestinal-Related Events', 'timeFrame': 'Up to Week 12', 'description': 'Dose reductions are defined as participants who take any dimethyl fumarate 120 mg or 0 mg since initiation of dimethyl fumarate 240 mg.'}, {'measure': 'Percentage of Participants Who Discontinued Dimethyl Fumarate Due To Gastrointestinal-Related Treatment-Emergent Adverse Events', 'timeFrame': 'Up to Week 12'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Gastrointestinal event'], 'conditions': ['Relapsing-Remitting Multiple Sclerosis']}, 'descriptionModule': {'briefSummary': "The primary objective of this study is to evaluate the effect of symptomatic therapies on gastrointestinal-related events reported by participants with relapsing-remitting multiple sclerosis initiating therapy with BG00012 (dimethyl fumarate, DMF) in the clinical practice setting.\n\nThe secondary objectives of this study in this study population are as follows: to evaluate gastrointestinal-related events requiring symptomatic therapy and the role of those therapies over time; to evaluate gastrointestinal-related events that lead to a physician's decision to manage the events with BG00012 dose modification; and to evaluate gastrointestinal-related events that lead to BG00012 discontinuation after the use of symptomatic therapy."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* Have a confirmed diagnosis of relapsing-remitting multiple sclerosis according to the current McDonald Criteria and satisfy the therapeutic indication as described in the official local registration for Tecfidera (dimethyl fumarate)\n* Naïve to dimethyl fumarate and fumaric acid esters\n\nKey Exclusion Criteria:\n\n* Female subjects who are currently pregnant or breastfeeding or who are considering becoming pregnant while in the study\n* History of significant gastrointestinal disease (e.g., irritable bowel disease, peptic ulcer disease, history of major gastrointestinal surgeries), or chronic use of gastrointestinal-related symptomatic therapy as determined by the Investigator (or ≥ 7 consecutive days of gastrointestinal-related symptomatic therapy\n* Known active malignancies\n* History of anaphylaxis or severe allergic reactions or known drug hypersensitivity\n* Current use of B vitamin supplements\n* In the opinion of the Investigator, blood test values suggestive of a low lymphocyte count or renal or hepatic impairment, as described in the product label precautions for use\n\nNOTE: Other protocol-defined inclusion/exclusion criteria may apply'}, 'identificationModule': {'nctId': 'NCT02125604', 'acronym': 'TOLERATE', 'briefTitle': 'Gastrointestinal Tolerability Study Of Dimethyl Fumarate In Participants With Relapsing-Remitting Multiple Sclerosis In Germany', 'organization': {'class': 'INDUSTRY', 'fullName': 'Biogen'}, 'officialTitle': 'A Multicenter, Open-Label, Single-Arm Study to Evaluate Gastrointestinal Tolerability in Subjects With Relapsing-Remitting Multiple Sclerosis Receiving Dimethyl Fumarate (TOLERATE)', 'orgStudyIdInfo': {'id': '109MS407'}, 'secondaryIdInfos': [{'id': '2013-001486-17', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dimethyl Fumarate', 'description': 'Dimethyl fumarate administered orally at 120 mg twice daily (BID) for the first 7 days and 240 mg BID thereafter for a total of 12 weeks.', 'interventionNames': ['Drug: dimethyl fumarate']}], 'interventions': [{'name': 'dimethyl fumarate', 'type': 'DRUG', 'otherNames': ['BG00012', 'Tecfidera', 'DMF'], 'description': 'capsules administered according to the prevailing product label', 'armGroupLabels': ['Dimethyl Fumarate']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Augsburg', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 48.37154, 'lon': 10.89851}}, {'city': 'Bamburg', 'country': 'Germany', 'facility': 'Research Site'}, {'city': 'Bayreuth', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 49.94782, 'lon': 11.57893}}, {'city': 'Berlin', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'city': 'Bochum', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 51.48165, 'lon': 7.21648}}, {'city': 'Bonn', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 50.73438, 'lon': 7.09549}}, {'city': 'Erbach im Odenwald', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 49.66148, 'lon': 8.99402}}, {'city': 'Erlangen', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 49.59099, 'lon': 11.00783}}, {'city': 'Freiburg im Breisgau', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 47.9959, 'lon': 7.85222}}, {'city': 'Hamburg', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'city': 'Leipzig', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 51.33962, 'lon': 12.37129}}, {'city': 'Marburg', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 50.80904, 'lon': 8.77069}}, {'city': 'Minden', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 52.28953, 'lon': 8.91455}}, {'city': 'Mittweida', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 50.98622, 'lon': 12.97537}}, {'city': 'München', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 51.60698, 'lon': 13.31243}}, {'city': 'Münster', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 51.96236, 'lon': 7.62571}}, {'city': 'Osnabrück', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 52.27264, 'lon': 8.0498}}, {'city': 'Potsdam', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 52.39886, 'lon': 13.06566}}, {'city': 'Siegen', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 50.87481, 'lon': 8.02431}}], 'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Biogen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Biogen', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}