Ignite Creation Date:
2025-12-24 @ 2:53 PM
Ignite Modification Date:
2025-12-26 @ 1:16 PM
Study NCT ID:
NCT05069259
Status:
TERMINATED
Last Update Posted:
2025-12-19
First Post:
2021-09-01
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Generate Real World Data On Tofacitinib Induction Therapy and Changes In Clinical and Patient Reported Outcomes.
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003093', 'term': 'Colitis, Ulcerative'}], 'ancestors': [{'id': 'D003092', 'term': 'Colitis'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov_Inquiries@pfizer.com', 'phone': '1-800-718-1021', 'title': 'Pfizer ClinicalTrials.gov Call Center', 'organization': 'Pfizer Inc.'}, 'certainAgreement': {'otherDetails': 'Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Maximum up to 20 weeks', 'description': 'Same event may appear as both AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. FAS included all participants who were included in the study (i.e., performed baseline visit and received a study identification number).', 'eventGroups': [{'id': 'EG000', 'title': 'All Participants', 'description': 'Participants with moderately to severely active UC who were prescribed tofacitinib by the treating physician in routine clinical practice as per the Swiss prescribing information, were included.', 'otherNumAtRisk': 18, 'deathsNumAtRisk': 18, 'otherNumAffected': 4, 'seriousNumAtRisk': 18, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Worsening Ulcerative Colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE5.0'}, {'term': 'Colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE5.0'}, {'term': 'Enterocolitis infectious', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE5.0'}, {'term': 'Shingles', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE5.0'}], 'seriousEvents': [{'term': 'Worsening Ulcerative Colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE5.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants Who Achieved Clinical Response at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants', 'description': 'Participants with moderately to severely active UC who were prescribed tofacitinib by the treating physician in routine clinical practice as per the Swiss prescribing information, were included.'}], 'classes': [{'categories': [{'measurements': [{'value': '63', 'groupId': 'OG000', 'lowerLimit': '39', 'upperLimit': '82'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 8', 'description': 'Clinical response was defined as a reduction in the partial Mayo score (PMS) from baseline of \\>=2 points or achieving clinical remission. Clinical remission was defined as PMS of \\<= 2 with no subscore \\>1. PMS consisted of 3 components: rectal bleeding, stool frequency, and physician global assessment of disease activity. Each sub score ranged from 0 (normal) to 3 (extreme severity). These sub scores were summed up to give a total score range of 0 (normal) to 9 (extreme severity), where higher scores indicated more disease severity.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS) included all participants who were included in the study (i.e., performed baseline visit and received a study identification number). Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Achieved Clinical Remission at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants', 'description': 'Participants with moderately to severely active UC who were prescribed tofacitinib by the treating physician in routine clinical practice as per the Swiss prescribing information, were included.'}], 'classes': [{'categories': [{'measurements': [{'value': '38', 'groupId': 'OG000', 'lowerLimit': '18', 'upperLimit': '61'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 8', 'description': 'Clinical remission was defined as PMS of \\<= 2 with no subscore \\>1. PMS consisted of 3 components: rectal bleeding, stool frequency, and physician global assessment of disease activity. Each sub score ranged from 0 (normal) to 3 (extreme severity). These sub scores were summed up to give a total score range of 0 (normal) to 9 (extreme severity), where higher scores indicated more disease severity.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants who were included in the study (i.e., performed baseline visit and received a study identification number). Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Achieved Clinical Response at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants', 'description': 'Participants with moderately to severely active UC who were prescribed tofacitinib by the treating physician in routine clinical practice as per the Swiss prescribing information, were included.'}], 'classes': [{'categories': [{'measurements': [{'value': '73', 'groupId': 'OG000', 'lowerLimit': '48', 'upperLimit': '89'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 16', 'description': 'Clinical response was defined as a reduction in the PMS from baseline of \\>=2 points or achieving clinical remission. Clinical remission was defined as PMS of \\<= 2 with no subscore \\>1. PMS consisted of 3 components: rectal bleeding, stool frequency, and physician global assessment of disease activity. Each sub score ranged from 0 (normal) to 3 (extreme severity). These sub scores were summed up to give a total score range of 0 (normal) to 9 (extreme severity), where higher scores indicated more disease severity.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants who were included in the study (i.e., performed baseline visit and received a study identification number). Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Achieved Clinical Remission at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants', 'description': 'Participants with moderately to severely active UC who were prescribed tofacitinib by the treating physician in routine clinical practice as per the Swiss prescribing information, were included.'}], 'classes': [{'categories': [{'measurements': [{'value': '40', 'groupId': 'OG000', 'lowerLimit': '20', 'upperLimit': '64'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 16', 'description': 'Clinical remission was defined as PMS of \\<= 2 with no subscore \\>1. PMS consisted of 3 components: rectal bleeding, stool frequency, and physician global assessment of disease activity. Each sub score ranged from 0 (normal) to 3 (extreme severity). These sub scores were summed up to give a total score range of 0 (normal) to 9 (extreme severity), where higher scores indicated more disease severity.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants who were included in the study (i.e., performed baseline visit and received a study identification number). Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Achieved Inflammatory Bowel Disease Questionnaire (IBDQ) Remission at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants', 'description': 'Participants with moderately to severely active UC who were prescribed tofacitinib by the treating physician in routine clinical practice as per the Swiss prescribing information, were included.'}], 'classes': [{'categories': [{'measurements': [{'value': '46', 'groupId': 'OG000', 'lowerLimit': '23', 'upperLimit': '71'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 8', 'description': 'IBDQ remission was defined as an IBDQ score \\>= 170. The IBDQ was a 32-item questionnaire grouped into four dimensions: bowel symptoms, systemic symptoms, emotional function and social function, where range was as follows: bowel symptoms: 10 to 70; systemic symptoms: 5 to 35; emotional function: 12 to 84 and social function: 5 to 35. The total IBDQ score ranged from 32 to 224. For the total score and each domain, a higher score indicated better quality of life.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants who were included in the study (i.e., performed baseline visit and received a study identification number). Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Achieved IBDQ Remission at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants', 'description': 'Participants with moderately to severely active UC who were prescribed tofacitinib by the treating physician in routine clinical practice as per the Swiss prescribing information, were included.'}], 'classes': [{'categories': [{'measurements': [{'value': '71', 'groupId': 'OG000', 'lowerLimit': '36', 'upperLimit': '92'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 16', 'description': 'IBDQ remission was defined as an IBDQ score \\>= 170. The IBDQ was a 32-item questionnaire grouped into four dimensions: bowel symptoms, systemic symptoms, emotional function and social function, where range was as follows: bowel symptoms: 10 to 70; systemic symptoms: 5 to 35; emotional function: 12 to 84 and social function: 5 to 35. The total IBDQ score ranged from 32 to 224. For the total score and each domain, a higher score indicated better quality of life.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants who were included in the study (i.e., performed baseline visit and received a study identification number). Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Achieved IBDQ Response at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants', 'description': 'Participants with moderately to severely active UC who were prescribed tofacitinib by the treating physician in routine clinical practice as per the Swiss prescribing information, were included.'}], 'classes': [{'categories': [{'measurements': [{'value': '69', 'groupId': 'OG000', 'lowerLimit': '42', 'upperLimit': '87'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 8', 'description': 'IBDQ response was defined as an IBDQ score \\>=16 points higher than IBDQ baseline score. The IBDQ was a 32-item questionnaire grouped into four dimensions: bowel symptoms, systemic symptoms, emotional function and social function, where range was as follows: bowel symptoms: 10 to 70; systemic symptoms: 5 to 35; emotional function: 12 to 84 and social function: 5 to 35. The total IBDQ score ranged from 32 to 224. For the total score and each domain, a higher score indicated better quality of life.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants who were included in the study (i.e., performed baseline visit and received a study identification number). Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Achieved IBDQ Response at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants', 'description': 'Participants with moderately to severely active UC who were prescribed tofacitinib by the treating physician in routine clinical practice as per the Swiss prescribing information, were included.'}], 'classes': [{'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '65', 'upperLimit': '100'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 16', 'description': 'IBDQ response was defined as an IBDQ score \\>=16 points higher than IBDQ baseline score. The IBDQ was a 32-item questionnaire grouped into four dimensions: bowel symptoms, systemic symptoms, emotional function and social function, where range was as follows: bowel symptoms: 10 to 70; systemic symptoms: 5 to 35; emotional function: 12 to 84 and social function: 5 to 35. The total IBDQ score ranged from 32 to 224. For the total score and each domain, a higher score indicated better quality of life.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants who were included in the study (i.e., performed baseline visit and received a study identification number). Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Achieved Biochemical Remission at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants', 'description': 'Participants with moderately to severely active UC who were prescribed tofacitinib by the treating physician in routine clinical practice as per the Swiss prescribing information, were included.'}], 'classes': [{'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000', 'lowerLimit': '2.0', 'upperLimit': '43'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 8', 'description': 'Biochemical remission was defined as a fecal calprotectin (fCAL) concentration \\<=250 micrograms per gram (mcg/g). fCAL is a small anti-microbial protein detected in stool that constitutes approximately 60% of neutrophil cytoplasm. As migration of neutrophils into the intestinal mucosa is a hallmark of active intestinal inflammation, fCAL serves as a non-invasive biomarker for intestinal inflammation.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants who were included in the study (i.e., performed baseline visit and received a study identification number). Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Achieved Biochemical Remission at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants', 'description': 'Participants with moderately to severely active UC who were prescribed tofacitinib by the treating physician in routine clinical practice as per the Swiss prescribing information, were included.'}], 'classes': [{'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000', 'lowerLimit': '9.7', 'upperLimit': '70'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 16', 'description': 'Biochemical remission was defined as a fCAL concentration \\<=250 mcg/g. fCAL is a small anti-microbial protein detected in stool that constitutes approximately 60% of neutrophil cytoplasm. As migration of neutrophils into the intestinal mucosa is a hallmark of active intestinal inflammation, fCAL serves as a non-invasive biomarker for intestinal inflammation.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants who were included in the study (i.e., performed baseline visit and received a study identification number). Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Median Change From Baseline in Stool Frequency Measured by Mayo Score Stool Frequency Subscore at Weeks 8 and 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants', 'description': 'Participants with moderately to severely active UC who were prescribed tofacitinib by the treating physician in routine clinical practice as per the Swiss prescribing information, were included.'}], 'classes': [{'title': 'Change at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '-1', 'upperLimit': '1'}]}]}, {'title': 'Change at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1', 'groupId': 'OG000', 'lowerLimit': '-2', 'upperLimit': '-1'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, Week 8 and Week 16', 'description': 'The stool frequency patient reported outcome (PRO) was assessed with one question about the number of stools on a given day. The Mayo Score stool frequency subscore was used for scoring. Scores ranged from 0 to 3 (0= normal number of stools; 1= 1-2 stools more than normal; 2= 3-4 stools more than normal and 3= 5 or more stools than normal) where higher scores indicated more severe disease activity.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants who were included in the study (i.e., performed baseline visit and received a study identification number). Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure and "Number Analyzed" signifies participants evaluable for specified rows. All participants under "Overall Number of Participants Analyzed" contributed data to the table but may not have data evaluable for every row.'}, {'type': 'SECONDARY', 'title': 'Median Change From Baseline in Rectal Bleeding Measured by Mayo Score Rectal Bleeding Subscore at Weeks 8 and 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants', 'description': 'Participants with moderately to severely active UC who were prescribed tofacitinib by the treating physician in routine clinical practice as per the Swiss prescribing information, were included.'}], 'classes': [{'title': 'Change at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '0'}]}]}, {'title': 'Change at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '-1', 'upperLimit': '0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, Week 8 and Week 16', 'description': 'The rectal bleeding PRO was assessed with one question about most severe rectal bleeding on a given day. The Mayo Score rectal bleeding subscore was used for scoring. Scores ranged from 0 to 3 (0= no blood seen; 1= streaks of blood with stool less than half the time; 2= obvious blood with stool most of the time and 3= blood alone passes) where higher scores indicated more severe bleeding of the day.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants who were included in the study (i.e., performed baseline visit and received a study identification number). Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure and "Number Analyzed" signifies participants evaluable for specified rows. All participants under "Overall Number of Participants Analyzed" contributed data to the table but may not have data evaluable for every row.'}, {'type': 'SECONDARY', 'title': 'Median Change From Baseline in Urgency of Defecation Assessed Using Numeric Rating Scale (NRS) at Weeks 8 and 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants', 'description': 'Participants with moderately to severely active UC who were prescribed tofacitinib by the treating physician in routine clinical practice as per the Swiss prescribing information, were included.'}], 'classes': [{'title': 'Change at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1', 'groupId': 'OG000', 'lowerLimit': '-2', 'upperLimit': '0'}]}]}, {'title': 'Change at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2', 'groupId': 'OG000', 'lowerLimit': '-4', 'upperLimit': '-2'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, Week 8 and Week 16', 'description': 'The urgency of defecation was assessed with the urgency NRS. Scoring was done on a 11-point NRS. Participant provided a score from 0 (no urgency) to 10 (worst possible urgency). Higher scores indicated more severe urgency.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants who were included in the study (i.e., performed baseline visit and received a study identification number). Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure and "Number Analyzed" signifies participants evaluable for specified rows. All participants under "Overall Number of Participants Analyzed" contributed data to the table but may not have data evaluable for every row.'}, {'type': 'SECONDARY', 'title': 'Median Change From Baseline in Abdominal Pain Assessed Using Pain NRS at Weeks 8 and 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants', 'description': 'Participants with moderately to severely active UC who were prescribed tofacitinib by the treating physician in routine clinical practice as per the Swiss prescribing information, were included.'}], 'classes': [{'title': 'Change at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1', 'groupId': 'OG000', 'lowerLimit': '-2', 'upperLimit': '0'}]}]}, {'title': 'Change at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2', 'groupId': 'OG000', 'lowerLimit': '-3', 'upperLimit': '-1'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, Week 8 and Week 16', 'description': 'The abdominal pain was assessed with the pain NRS. Scoring was done on a 10-point horizontal NRS. Participant provided a score from 1 (none) to 10 (very severe). Higher scores indicated more severe pain.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants who were included in the study (i.e., performed baseline visit and received a study identification number). Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure and "Number Analyzed" signifies participants evaluable for specified rows. All participants under "Overall Number of Participants Analyzed" contributed data to the table but may not have data evaluable for every row.'}, {'type': 'SECONDARY', 'title': 'Median Change From Baseline in Quality of Sleep Assessed Using NRS at Weeks 8 and 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants', 'description': 'Participants with moderately to severely active UC who were prescribed tofacitinib by the treating physician in routine clinical practice as per the Swiss prescribing information, were included.'}], 'classes': [{'title': 'Change at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '3'}]}]}, {'title': 'Change at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '3'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, Week 8 and Week 16', 'description': 'The quality of sleep was assessed with a question from the sleep quality visual analogue scale survey. Scoring was done on a 11 NRS. Participant provided a score from 0 (very bad) to 10 (great). Higher scores indicated better quality of sleep.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants who were included in the study (i.e., performed baseline visit and received a study identification number). Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure and "Number Analyzed" signifies participants evaluable for specified rows. All participants under "Overall Number of Participants Analyzed" contributed data to the table but may not have data evaluable for every row.'}, {'type': 'SECONDARY', 'title': 'Median Change From Baseline in Daily Fatigue Assessed Using NRS at Weeks 8 and 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants', 'description': 'Participants with moderately to severely active UC who were prescribed tofacitinib by the treating physician in routine clinical practice as per the Swiss prescribing information, were included.'}], 'classes': [{'title': 'Change at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1', 'groupId': 'OG000', 'lowerLimit': '-3', 'upperLimit': '-1'}]}]}, {'title': 'Change at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-3', 'groupId': 'OG000', 'lowerLimit': '-4', 'upperLimit': '-1'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, Week 8 and Week 16', 'description': 'The daily fatigue was assessed with the fatigue NRS. Scoring was done on a 11-point NRS. Participant provided a score from 0 (no fatigue) to 10 (as bad as you can imagine). Higher scores indicated more severe fatigue.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants who were included in the study (i.e., performed baseline visit and received a study identification number). Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure and "Number Analyzed" signifies participants evaluable for specified rows. All participants under "Overall Number of Participants Analyzed" contributed data to the table but may not have data evaluable for every row.'}, {'type': 'SECONDARY', 'title': 'Median Change From Baseline in Weekly Fatigue Assessed Using FACIT-F at Weeks 8 and 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants', 'description': 'Participants with moderately to severely active UC who were prescribed tofacitinib by the treating physician in routine clinical practice as per the Swiss prescribing information, were included.'}], 'classes': [{'title': 'Change at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000', 'lowerLimit': '-1', 'upperLimit': '14'}]}]}, {'title': 'Change at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000', 'lowerLimit': '11', 'upperLimit': '20'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, Week 8 and Week 16', 'description': 'The weekly fatigue was assessed with 13 questions from the functional assessment of chronic illness therapy - fatigue (FACIT-F) version (v)4. Participants rated the intensity of their fatigue symptoms on a scale of 0 (not at all) to 4 (very much) for each 13 questions. Total score ranged from 0 to 52, with higher scores representing lower fatigue.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants who were included in the study (i.e., performed baseline visit and received a study identification number). Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure and "Number Analyzed" signifies participants evaluable for specified rows. All participants under "Overall Number of Participants Analyzed" contributed data to the table but may not have data evaluable for every row.'}, {'type': 'SECONDARY', 'title': 'Median Change From Baseline in IBDQ Score (Total) at Weeks 8 and 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants', 'description': 'Participants with moderately to severely active UC who were prescribed tofacitinib by the treating physician in routine clinical practice as per the Swiss prescribing information, were included.'}], 'classes': [{'title': 'Change at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000', 'lowerLimit': '11', 'upperLimit': '54'}]}]}, {'title': 'Change at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '48', 'groupId': 'OG000', 'lowerLimit': '44', 'upperLimit': '77'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, Week 8 and Week 16', 'description': 'The IBDQ was a 32-item questionnaire grouped into four dimensions: bowel symptoms, systemic symptoms, emotional function and social function, where range was as follows: bowel symptoms: 10 to 70; systemic symptoms: 5 to 35; emotional function: 12 to 84 and social function: 5 to 35. The total IBDQ score ranged from 32 to 224. For the total score and each domain, a higher score indicated better quality of life.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants who were included in the study (i.e., performed baseline visit and received a study identification number). Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure and "Number Analyzed" signifies participants evaluable for specified rows. All participants under "Overall Number of Participants Analyzed" contributed data to the table but may not have data evaluable for every row.'}, {'type': 'SECONDARY', 'title': 'Median Change From Baseline in fCAL at Weeks 8 and 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants', 'description': 'Participants with moderately to severely active UC who were prescribed tofacitinib by the treating physician in routine clinical practice as per the Swiss prescribing information, were included.'}], 'classes': [{'title': 'Change at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-44', 'groupId': 'OG000', 'lowerLimit': '-392', 'upperLimit': '-12'}]}]}, {'title': 'Change at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-24', 'groupId': 'OG000', 'lowerLimit': '-78', 'upperLimit': '267'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, Week 8 and Week 16', 'description': 'fCAL is a small anti-microbial protein detected in stool that constitutes approximately 60% of neutrophil cytoplasm. As migration of neutrophils into the intestinal mucosa is a hallmark of active intestinal inflammation, fCAL serves as a non-invasive biomarker for intestinal inflammation.', 'unitOfMeasure': 'micrograms per gram', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants who were included in the study (i.e., performed baseline visit and received a study identification number). Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure and "Number Analyzed" signifies participants evaluable for specified rows. All participants under "Overall Number of Participants Analyzed" contributed data to the table but may not have data evaluable for every row.'}, {'type': 'SECONDARY', 'title': 'Correlations Between PMS and IBDQ Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants', 'description': 'Participants with moderately to severely active UC who were prescribed tofacitinib by the treating physician in routine clinical practice as per the Swiss prescribing information, were included.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.5', 'groupId': 'OG000'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.8', 'groupId': 'OG000'}]}]}, {'title': 'Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.5', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Week 8 and Week 16', 'description': 'Correlation between PMS and IBDQ score was assessed by Spearman correlation coefficient. PMS consisted of 3 components: rectal bleeding, stool frequency, and physician global assessment of disease activity. Each sub score ranged from 0 (normal) to 3 (extreme severity). These sub scores were summed up to give a total score range of 0 (normal) to 9 (extreme severity), where higher scores indicated more disease severity. The IBDQ was a 32-item questionnaire grouped into four dimensions: bowel symptoms, systemic symptoms, emotional function and social function, where range was as follows: bowel symptoms: 10 to 70; systemic symptoms: 5 to 35; emotional function: 12 to 84 and social function: 5 to 35. The total IBDQ score ranged from 32 to 224. For the total score and each domain, a higher score indicated better quality of life.', 'unitOfMeasure': 'Correlation Coefficient', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants who were included in the study (i.e., performed baseline visit and received a study identification number). Here, "Number Analyzed" signifies participants evaluable for specified rows. All participants under "Overall Number of Participants Analyzed" contributed data to the table but may not have data evaluable for every row.'}, {'type': 'SECONDARY', 'title': 'Correlations Between PMS and fCAL Concentration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants', 'description': 'Participants with moderately to severely active UC who were prescribed tofacitinib by the treating physician in routine clinical practice as per the Swiss prescribing information, were included.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.4', 'groupId': 'OG000'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.1', 'groupId': 'OG000'}]}]}, {'title': 'Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.8', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Week 8 and Week 16', 'description': 'Correlation between PMS and fCAL concentration was assessed by Spearman correlation coefficient. PMS consisted of 3 components: rectal bleeding, stool frequency, and physician global assessment of disease activity. Each sub score ranged from 0 (normal) to 3 (extreme severity). These sub scores were summed up to give a total score range of 0 (normal) to 9 (extreme severity), where higher scores indicated more disease severity. fCAL is a small anti-microbial protein detected in stool that constitutes approximately 60% of neutrophil cytoplasm. As migration of neutrophils into the intestinal mucosa is a hallmark of active intestinal inflammation, fCAL serves as a non-invasive biomarker for intestinal inflammation.', 'unitOfMeasure': 'Correlation Coefficient', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants who were included in the study (i.e., performed baseline visit and received a study identification number). Here, "Number Analyzed" signifies participants evaluable for specified rows. All participants under "Overall Number of Participants Analyzed" contributed data to the table but may not have data evaluable for every row.'}, {'type': 'SECONDARY', 'title': 'Correlations Between Stool Frequency and fCAL Concentration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants', 'description': 'Participants with moderately to severely active UC who were prescribed tofacitinib by the treating physician in routine clinical practice as per the Swiss prescribing information, were included.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.5', 'groupId': 'OG000'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.3', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Week 8 and Week 16', 'description': 'Correlation between stool frequency PRO and fCAL concentration was assessed by Spearman correlation coefficient. The stool frequency PRO was assessed with one question about the number of stools on a given day. The mayo score stool frequency subscore was used for scoring. Scores ranged from 0 to 3 (0= normal number of stools; 1= 1-2 stools more than normal; 2= 3-4 stools more than normal and 3= 5 or more stools than normal) where higher scores indicated more severe disease activity. fCAL is a small anti-microbial protein detected in stool that constitutes approximately 60% of neutrophil cytoplasm. As migration of neutrophils into the intestinal mucosa is a hallmark of active intestinal inflammation, fCAL serves as a non-invasive biomarker for intestinal inflammation.', 'unitOfMeasure': 'Correlation Coefficient', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants who were included in the study (i.e., performed baseline visit and received a study identification number). Here, "Number Analyzed" signifies participants evaluable for specified rows. All participants under "Overall Number of Participants Analyzed" contributed data to the table but may not have data evaluable for every row.'}, {'type': 'SECONDARY', 'title': 'Correlations Between Rectal Bleeding and fCAL Concentration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants', 'description': 'Participants with moderately to severely active UC who were prescribed tofacitinib by the treating physician in routine clinical practice as per the Swiss prescribing information, were included.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.2', 'groupId': 'OG000'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.4', 'groupId': 'OG000'}]}]}, {'title': 'Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.4', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Week 8 and Week 16', 'description': 'Correlation between rectal bleeding PRO and fCAL concentration was assessed by Spearman correlation coefficient. The rectal bleeding PRO was assessed with one question about most severe rectal bleeding on a given day. The Mayo Score rectal bleeding subscore was used for scoring. Scores ranged from 0 to 3 (0= no blood seen; 1= streaks of blood with stool less than half the time; 2= obvious blood with stool most of the time and 3= blood alone passes) where higher scores indicated more severe bleeding of the day. fCAL is a small anti-microbial protein detected in stool that constitutes approximately 60% of neutrophil cytoplasm. As migration of neutrophils into the intestinal mucosa is a hallmark of active intestinal inflammation, fCAL serves as a non-invasive biomarker for intestinal inflammation.', 'unitOfMeasure': 'Correlation Coefficient', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants who were included in the study (i.e., performed baseline visit and received a study identification number). Here, "Number Analyzed" signifies participants evaluable for specified rows. All participants under "Overall Number of Participants Analyzed" contributed data to the table but may not have data evaluable for every row.'}, {'type': 'SECONDARY', 'title': 'Correlations Between Urgency of Defecation and fCAL Concentration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants', 'description': 'Participants with moderately to severely active UC who were prescribed tofacitinib by the treating physician in routine clinical practice as per the Swiss prescribing information, were included.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.2', 'groupId': 'OG000'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.1', 'groupId': 'OG000'}]}]}, {'title': 'Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.2', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Week 8 and Week 16', 'description': 'Correlation between urgency of defecation and fCAL concentration was assessed by Spearman correlation coefficient. The urgency of defecation was assessed with the urgency NRS. Scoring was done on a 11-point NRS. Participant provided a score from 0 (no urgency) to 10 (worst possible urgency). Higher scores indicated more severe urgency. fCAL is a small anti-microbial protein detected in stool that constitutes approximately 60% of neutrophil cytoplasm. As migration of neutrophils into the intestinal mucosa is a hallmark of active intestinal inflammation, fCAL serves as a non-invasive biomarker for intestinal inflammation.', 'unitOfMeasure': 'Correlation Coefficient', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants who were included in the study (i.e., performed baseline visit and received a study identification number). Here, "Number Analyzed" signifies participants evaluable for specified rows. All participants under "Overall Number of Participants Analyzed" contributed data to the table but may not have data evaluable for every row.'}, {'type': 'SECONDARY', 'title': 'Correlations Between Abdominal Pain and fCAL Concentration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants', 'description': 'Participants with moderately to severely active UC who were prescribed tofacitinib by the treating physician in routine clinical practice as per the Swiss prescribing information, were included.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.4', 'groupId': 'OG000'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.3', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Week 8 and Week 16', 'description': 'Correlation between abdominal pain and fCAL was assessed by Spearman correlation coefficient. The abdominal pain was assessed with the pain NRS. Scoring was done on a 10-point horizontal NRS. Participant provided a score from 1 (none) to 10 (very severe). Higher scores indicated more severe pain. fCAL is a small anti-microbial protein detected in stool that constitutes approximately 60% of neutrophil cytoplasm. As migration of neutrophils into the intestinal mucosa is a hallmark of active intestinal inflammation, fCAL serves as a non-invasive biomarker for intestinal inflammation.', 'unitOfMeasure': 'Correlation Coefficient', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants who were included in the study (i.e., performed baseline visit and received a study identification number). Here, "Number Analyzed" signifies participants evaluable for specified rows. All participants under "Overall Number of Participants Analyzed" contributed data to the table but may not have data evaluable for every row.'}, {'type': 'SECONDARY', 'title': 'Correlations Between Quality of Sleep and fCAL Concentration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants', 'description': 'Participants with moderately to severely active UC who were prescribed tofacitinib by the treating physician in routine clinical practice as per the Swiss prescribing information, were included.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.2', 'groupId': 'OG000'}]}]}, {'title': 'Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Week 8 and Week 16', 'description': 'Correlation between quality of sleep and fCAL concentration was assessed by Spearman correlation coefficient. The quality of sleep was assessed with a question from the sleep quality visual analogue scale survey. Scoring was done on a 11-point NRS. Participant provided a score from 0 (very bad) to 10 (great). Higher scores indicated better quality of sleep. fCAL is a small anti-microbial protein detected in stool that constitutes approximately 60% of neutrophil cytoplasm. As migration of neutrophils into the intestinal mucosa is a hallmark of active intestinal inflammation, fCAL serves as a non-invasive biomarker for intestinal inflammation.', 'unitOfMeasure': 'Correlation Coefficient', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants who were included in the study (i.e., performed baseline visit and received a study identification number). Here, "Number Analyzed" signifies participants evaluable for specified rows. All participants under "Overall Number of Participants Analyzed" contributed data to the table but may not have data evaluable for every row.'}, {'type': 'SECONDARY', 'title': 'Correlations Between Daily Fatigue and fCAL Concentration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants', 'description': 'Participants with moderately to severely active UC who were prescribed tofacitinib by the treating physician in routine clinical practice as per the Swiss prescribing information, were included.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.1', 'groupId': 'OG000'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.1', 'groupId': 'OG000'}]}]}, {'title': 'Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.2', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Week 8 and Week 16', 'description': 'Correlation between daily fatigue and fCAL concentration was assessed by Spearman correlation coefficient. The daily fatigue was assessed with the fatigue NRS. Scoring was done on a 11-point NRS. Participant provided a score from 0 (no fatigue) to 10 (as bad as you can imagine). Higher scores indicated more severe fatigue. fCAL is a small anti-microbial protein detected in stool that constitutes approximately 60% of neutrophil cytoplasm. As migration of neutrophils into the intestinal mucosa is a hallmark of active intestinal inflammation, fCAL serves as a non-invasive biomarker for intestinal inflammation.', 'unitOfMeasure': 'Correlation Coefficient', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants who were included in the study (i.e., performed baseline visit and received a study identification number). Here, "Number Analyzed" signifies participants evaluable for specified rows. All participants under "Overall Number of Participants Analyzed" contributed data to the table but may not have data evaluable for every row.'}, {'type': 'SECONDARY', 'title': 'Correlations Between Weekly Fatigue and fCAL Concentration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants', 'description': 'Participants with moderately to severely active UC who were prescribed tofacitinib by the treating physician in routine clinical practice as per the Swiss prescribing information, were included.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.2', 'groupId': 'OG000'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.5', 'groupId': 'OG000'}]}]}, {'title': 'Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.9', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Week 8 and Week 16', 'description': 'Correlation between weekly fatigue and fCAL concentration was assessed by Spearman correlation coefficient. The weekly fatigue was assessed with 13 questions from the FACIT-F v4. Participants rated the intensity of their fatigue symptoms on a scale of 0 (not at all) to 4 (very much) for each 13 questions. Total score ranged from 0 to 52, with higher scores representing lower fatigue. fCAL is a small anti-microbial protein detected in stool that constitutes approximately 60% of neutrophil cytoplasm. As migration of neutrophils into the intestinal mucosa is a hallmark of active intestinal inflammation, fCAL serves as a non-invasive biomarker for intestinal inflammation.', 'unitOfMeasure': 'Correlation Coefficient', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants who were included in the study (i.e., performed baseline visit and received a study identification number). Here, "Number Analyzed" signifies participants evaluable for specified rows. All participants under "Overall Number of Participants Analyzed" contributed data to the table but may not have data evaluable for every row.'}, {'type': 'SECONDARY', 'title': 'Correlations Between IBDQ Score and fCAL Concentration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants', 'description': 'Participants with moderately to severely active UC who were prescribed tofacitinib by the treating physician in routine clinical practice as per the Swiss prescribing information, were included.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.4', 'groupId': 'OG000'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.1', 'groupId': 'OG000'}]}]}, {'title': 'Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.2', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Week 8 and Week 16', 'description': 'Correlation between IBDQ score and fCAL concentration was assessed by Spearman correlation coefficient. The IBDQ was a 32-item questionnaire grouped into four dimensions: bowel symptoms, systemic symptoms, emotional function and social function, where range was as follows: bowel symptoms: 10 to 70; systemic symptoms: 5 to 35; emotional function: 12 to 84 and social function: 5 to 35. The total IBDQ score ranged from 32 to 224. For the total score and each domain, a higher score indicated better quality of life. fCAL is a small anti-microbial protein detected in stool that constitutes approximately 60% of neutrophil cytoplasm. As migration of neutrophils into the intestinal mucosa is a hallmark of active intestinal inflammation, fCAL serves as a non-invasive biomarker for intestinal inflammation.', 'unitOfMeasure': 'Correlation Coefficient', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants who were included in the study (i.e., performed baseline visit and received a study identification number). Here, "Number Analyzed" signifies participants evaluable for specified rows. All participants under "Overall Number of Participants Analyzed" contributed data to the table but may not have data evaluable for every row.'}, {'type': 'SECONDARY', 'title': 'Correlations Between Stool Frequency and IBDQ Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants', 'description': 'Participants with moderately to severely active UC who were prescribed tofacitinib by the treating physician in routine clinical practice as per the Swiss prescribing information, were included.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.3', 'groupId': 'OG000'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.7', 'groupId': 'OG000'}]}]}, {'title': 'Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.3', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Week 8 and Week 16', 'description': 'Correlation between stool frequency PRO and IBDQ score was assessed by Spearman correlation coefficient. The stool frequency PRO was assessed with one question about the number of stools on a given day. The Mayo Score stool frequency subscore was used for scoring. Scores ranged from 0 to 3 (0= normal number of stools; 1= 1-2 stools more than normal; 2= 3-4 stools more than normal and 3= 5 or more stools than normal) where higher scores indicated more severe disease activity. The IBDQ was a 32-item questionnaire grouped into four dimensions: bowel symptoms, systemic symptoms, emotional function and social function, where range was as follows: bowel symptoms: 10 to 70; systemic symptoms: 5 to 35; emotional function: 12 to 84 and social function: 5 to 35. The total IBDQ score ranged from 32 to 224. For the total score and each domain, a higher score indicated better quality of life.', 'unitOfMeasure': 'Correlation Coefficient', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants who were included in the study (i.e., performed baseline visit and received a study identification number). Here, "Number Analyzed" signifies participants evaluable for specified rows. All participants under "Overall Number of Participants Analyzed" contributed data to the table but may not have data evaluable for every row.'}, {'type': 'SECONDARY', 'title': 'Correlations Between Rectal Bleeding and IBDQ Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants', 'description': 'Participants with moderately to severely active UC who were prescribed tofacitinib by the treating physician in routine clinical practice as per the Swiss prescribing information, were included.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.5', 'groupId': 'OG000'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.6', 'groupId': 'OG000'}]}]}, {'title': 'Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.6', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Week 8 and Week 16', 'description': 'Correlation between rectal bleeding PRO and IBDQ score was assessed by Spearman correlation coefficient. The rectal bleeding PRO was assessed with one question about most severe rectal bleeding on a given day. The Mayo Score rectal bleeding subscore was used for scoring. Scores ranged from 0 to 3 (0= no blood seen; 1= streaks of blood with stool less than half the time; 2= obvious blood with stool most of the time and 3= blood alone passes) where higher scores indicated more severe bleeding of the day. The IBDQ was a 32-item questionnaire grouped into four dimensions: bowel symptoms, systemic symptoms, emotional function and social function, where range was as follows: bowel symptoms: 10 to 70; systemic symptoms: 5 to 35; emotional function: 12 to 84 and social function: 5 to 35. The total IBDQ score ranged from 32 to 224. For the total score and each domain, a higher score indicated better quality of life.', 'unitOfMeasure': 'Correlation Coefficient', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants who were included in the study (i.e., performed baseline visit and received a study identification number). Here, "Number Analyzed" signifies participants evaluable for specified rows. All participants under "Overall Number of Participants Analyzed" contributed data to the table but may not have data evaluable for every row.'}, {'type': 'SECONDARY', 'title': 'Correlations Between Urgency of Defecation and IBDQ Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants', 'description': 'Participants with moderately to severely active UC who were prescribed tofacitinib by the treating physician in routine clinical practice as per the Swiss prescribing information, were included.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.7', 'groupId': 'OG000'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.9', 'groupId': 'OG000'}]}]}, {'title': 'Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Week 8 and Week 16', 'description': 'Correlation between urgency of defecation and IBDQ score was assessed by Spearman correlation coefficient. The urgency of defecation was assessed with the urgency NRS. Scoring was done on a 11-point NRS. Participant provided a score from 0 (no urgency) to 10 (worst possible urgency). Higher scores indicated more severe urgency. The IBDQ was a 32-item questionnaire grouped into four dimensions: bowel symptoms, systemic symptoms, emotional function and social function, where range was as follows: bowel symptoms: 10 to 70; systemic symptoms: 5 to 35; emotional function: 12 to 84 and social function: 5 to 35. The total IBDQ score ranged from 32 to 224. For the total score and each domain, a higher score indicated better quality of life.', 'unitOfMeasure': 'Correlation Coefficient', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants who were included in the study (i.e., performed baseline visit and received a study identification number). Here, "Number Analyzed" signifies participants evaluable for specified rows. All participants under "Overall Number of Participants Analyzed" contributed data to the table but may not have data evaluable for every row.'}, {'type': 'SECONDARY', 'title': 'Correlations Between Abdominal Pain and IBDQ Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants', 'description': 'Participants with moderately to severely active UC who were prescribed tofacitinib by the treating physician in routine clinical practice as per the Swiss prescribing information, were included.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.6', 'groupId': 'OG000'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.9', 'groupId': 'OG000'}]}]}, {'title': 'Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.5', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Week 8 and Week 16', 'description': 'Correlation between abdominal pain and IBDQ score was assessed by Spearman correlation coefficient. The abdominal pain was assessed with the pain NRS. Scoring was done on a 10-point horizontal NRS. Participant provided a score from 1 (none) to 10 (very severe). Higher scores indicated more severe pain. The IBDQ was a 32-item questionnaire grouped into four dimensions: bowel symptoms, systemic symptoms, emotional function and social function, where range was as follows: bowel symptoms: 10 to 70; systemic symptoms: 5 to 35; emotional function: 12 to 84 and social function: 5 to 35. The total IBDQ score ranged from 32 to 224. For the total score and each domain, a higher score indicated better quality of life.', 'unitOfMeasure': 'Correlation Coefficient', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants who were included in the study (i.e., performed baseline visit and received a study identification number). Here, "Number Analyzed" signifies participants evaluable for specified rows. All participants under "Overall Number of Participants Analyzed" contributed data to the table but may not have data evaluable for every row.'}, {'type': 'SECONDARY', 'title': 'Correlations Between Quality of Sleep and IBDQ Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants', 'description': 'Participants with moderately to severely active UC who were prescribed tofacitinib by the treating physician in routine clinical practice as per the Swiss prescribing information, were included.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.3', 'groupId': 'OG000'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.5', 'groupId': 'OG000'}]}]}, {'title': 'Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.4', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Week 8 and Week 16', 'description': 'Correlation between quality of sleep and IBDQ score was assessed by Spearman correlation coefficient. The quality of sleep was assessed with a question from the sleep quality visual analogue scale survey. Scoring was done on a 11-point NRS. Participant provided a score from 0 (very bad) to 10 (great). Higher scores indicated better quality of sleep. The IBDQ was a 32-item questionnaire grouped into four dimensions: bowel symptoms, systemic symptoms, emotional function and social function, where range was as follows: bowel symptoms: 10 to 70; systemic symptoms: 5 to 35; emotional function: 12 to 84 and social function: 5 to 35. The total IBDQ score ranged from 32 to 224. For the total score and each domain, a higher score indicated better quality of life.', 'unitOfMeasure': 'Correlation Coefficient', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants who were included in the study (i.e., performed baseline visit and received a study identification number). Here, "Number Analyzed" signifies participants evaluable for specified rows. All participants under "Overall Number of Participants Analyzed" contributed data to the table but may not have data evaluable for every row.'}, {'type': 'SECONDARY', 'title': 'Correlations Between Daily Fatigue and IBDQ Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants', 'description': 'Participants with moderately to severely active UC who were prescribed tofacitinib by the treating physician in routine clinical practice as per the Swiss prescribing information, were included.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.8', 'groupId': 'OG000'}]}]}, {'title': 'Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.2', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Week 8 and Week 16', 'description': 'Correlation between daily fatigue and IBDQ score was assessed by Spearman correlation coefficient. The daily fatigue was assessed with the fatigue NRS. Scoring was done on a 11-point NRS. Participant provided a score from 0 (no fatigue) to 10 (as bad as you can imagine). Higher scores indicated more severe fatigue. The IBDQ was a 32-item questionnaire grouped into four dimensions: bowel symptoms, systemic symptoms, emotional function and social function, where range was as follows: bowel symptoms: 10 to 70; systemic symptoms: 5 to 35; emotional function: 12 to 84 and social function: 5 to 35. The total IBDQ score ranged from 32 to 224. For the total score and each domain, a higher score indicated better quality of life.', 'unitOfMeasure': 'Correlation Coefficient', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants who were included in the study (i.e., performed baseline visit and received a study identification number). Here, "Number Analyzed" signifies participants evaluable for specified rows. All participants under "Overall Number of Participants Analyzed" contributed data to the table but may not have data evaluable for every row.'}, {'type': 'SECONDARY', 'title': 'Correlations Between Weekly Fatigue and IBDQ Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants', 'description': 'Participants with moderately to severely active UC who were prescribed tofacitinib by the treating physician in routine clinical practice as per the Swiss prescribing information, were included.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.3', 'groupId': 'OG000'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.7', 'groupId': 'OG000'}]}]}, {'title': 'Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Week 8 and Week 16', 'description': 'Correlation between weekly fatigue and IBDQ score was assessed by Spearman correlation coefficient. The weekly fatigue was assessed with 13 questions from the FACIT-F v4. Participants rated the intensity of their fatigue symptoms on a scale of 0 (not at all) to 4 (very much) for each 13 questions. Total score ranged from 0 to 52, with higher scores representing lower fatigue. The IBDQ was a 32-item questionnaire grouped into four dimensions: bowel symptoms, systemic symptoms, emotional function and social function, where range was as follows: bowel symptoms: 10 to 70; systemic symptoms: 5 to 35; emotional function: 12 to 84 and social function: 5 to 35. The total IBDQ score ranged from 32 to 224. For the total score and each domain, a higher score indicated better quality of life.', 'unitOfMeasure': 'Correlation Coefficient', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants who were included in the study (i.e., performed baseline visit and received a study identification number). Here, "Number Analyzed" signifies participants evaluable for specified rows. All participants under "Overall Number of Participants Analyzed" contributed data to the table but may not have data evaluable for every row.'}, {'type': 'SECONDARY', 'title': 'Correlations Between PMS and Stool Frequency', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants', 'description': 'Participants with moderately to severely active UC who were prescribed tofacitinib by the treating physician in routine clinical practice as per the Swiss prescribing information, were included.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.6', 'groupId': 'OG000'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.8', 'groupId': 'OG000'}]}]}, {'title': 'Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.4', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Week 8 and Week 16', 'description': 'Correlation between PMS and stool frequency PRO was assessed by Spearman correlation coefficient. PMS consisted of 3 components: rectal bleeding, stool frequency, and physician global assessment of disease activity. Each sub score ranged from 0 (normal) to 3 (extreme severity). These sub scores were summed up to give a total score range of 0 (normal) to 9 (extreme severity), where higher scores indicated more disease severity. The stool frequency PRO was assessed with one question about the number of stools on a given day. The Mayo Score stool frequency subscore was used for scoring. Scores ranged from 0 to 3 (0= normal number of stools; 1= 1-2 stools more than normal; 2= 3-4 stools more than normal and 3= 5 or more stools than normal) where higher scores indicated more severe disease activity.', 'unitOfMeasure': 'Correlation Coefficient', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants who were included in the study (i.e., performed baseline visit and received a study identification number). Here, "Number Analyzed" signifies participants evaluable for specified rows. All participants under "Overall Number of Participants Analyzed" contributed data to the table but may not have data evaluable for every row.'}, {'type': 'SECONDARY', 'title': 'Correlations Between PMS and Rectal Bleeding', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants', 'description': 'Participants with moderately to severely active UC who were prescribed tofacitinib by the treating physician in routine clinical practice as per the Swiss prescribing information, were included.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.6', 'groupId': 'OG000'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.6', 'groupId': 'OG000'}]}]}, {'title': 'Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.7', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Week 8 and Week 16', 'description': 'Correlation between PMS and rectal bleeding PRO was assessed by Spearman correlation coefficient. PMS consisted of 3 components: rectal bleeding, stool frequency, and physician global assessment of disease activity. Each sub score ranged from 0 (normal) to 3 (extreme severity). These sub scores were summed up to give a total score range of 0 (normal) to 9 (extreme severity), where higher scores indicated more disease severity. The rectal bleeding PRO was assessed with one question about most severe rectal bleeding on a given day. The Mayo Score rectal bleeding subscore was used for scoring. Scores ranged from 0 to 3 (0= no blood seen; 1= streaks of blood with stool less than half the time; 2= obvious blood with stool most of the time and 3= blood alone passes) where higher scores indicated more severe bleeding of the day.', 'unitOfMeasure': 'Correlation Coefficient', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants who were included in the study (i.e., performed baseline visit and received a study identification number). Here, "Number Analyzed" signifies participants evaluable for specified rows. All participants under "Overall Number of Participants Analyzed" contributed data to the table but may not have data evaluable for every row.'}, {'type': 'SECONDARY', 'title': 'Correlations Between PMS and Urgency of Defecation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants', 'description': 'Participants with moderately to severely active UC who were prescribed tofacitinib by the treating physician in routine clinical practice as per the Swiss prescribing information, were included.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.4', 'groupId': 'OG000'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.7', 'groupId': 'OG000'}]}]}, {'title': 'Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Week 8 and Week 16', 'description': 'Correlation between PMS and urgency of defecation was assessed by Spearman correlation coefficient. PMS consisted of 3 components: rectal bleeding, stool frequency, and physician global assessment of disease activity. Each sub score ranged from 0 (normal) to 3 (extreme severity). These sub scores were summed up to give a total score range of 0 (normal) to 9 (extreme severity), where higher scores indicated more disease severity. The urgency of defecation was assessed with the urgency NRS. Scoring was done on a 11-point NRS. Participant provided a score from 0 (no urgency) to 10 (worst possible urgency). Higher scores indicated more severe urgency.', 'unitOfMeasure': 'Correlation Coefficient', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants who were included in the study (i.e., performed baseline visit and received a study identification number). Here, "Number Analyzed" signifies participants evaluable for specified rows. All participants under "Overall Number of Participants Analyzed" contributed data to the table but may not have data evaluable for every row.'}, {'type': 'SECONDARY', 'title': 'Correlations Between PMS and Abdominal Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants', 'description': 'Participants with moderately to severely active UC who were prescribed tofacitinib by the treating physician in routine clinical practice as per the Swiss prescribing information, were included.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.4', 'groupId': 'OG000'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.6', 'groupId': 'OG000'}]}]}, {'title': 'Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Week 8 and Week 16', 'description': 'Correlation between PMS and abdominal pain was assessed by Spearman correlation coefficient. PMS consisted of 3 components: rectal bleeding, stool frequency, and physician global assessment of disease activity. Each sub score ranged from 0 (normal) to 3 (extreme severity). These sub scores were summed up to give a total score range of 0 (normal) to 9 (extreme severity), where higher scores indicated more disease severity. The abdominal pain was assessed with the pain NRS. Scoring was done on a 10-point horizontal NRS. Participant provided a score from 1 (none) to 10 (very severe). Higher scores indicated more severe pain.', 'unitOfMeasure': 'Correlation Coefficient', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants who were included in the study (i.e., performed baseline visit and received a study identification number). Here, "Number Analyzed" signifies participants evaluable for specified rows. All participants under "Overall Number of Participants Analyzed" contributed data to the table but may not have data evaluable for every row.'}, {'type': 'SECONDARY', 'title': 'Correlations Between PMS and Quality of Sleep', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants', 'description': 'Participants with moderately to severely active UC who were prescribed tofacitinib by the treating physician in routine clinical practice as per the Swiss prescribing information, were included.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.1', 'groupId': 'OG000'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.5', 'groupId': 'OG000'}]}]}, {'title': 'Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.4', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Week 8 and Week 16', 'description': 'Correlation between PMS and quality of sleep was assessed by Spearman correlation coefficient. PMS consisted of 3 components: rectal bleeding, stool frequency, and physician global assessment of disease activity. Each sub score ranged from 0 (normal) to 3 (extreme severity). These sub scores were summed up to give a total score range of 0 (normal) to 9 (extreme severity), where higher scores indicated more disease severity. The quality of sleep was assessed with a question from the sleep quality visual analogue scale survey. Scoring was done on a 11-point NRS. Participant provided a score from 0 (very bad) to 10 (great). Higher scores indicated better quality of sleep.', 'unitOfMeasure': 'Correlation Coefficient', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants who were included in the study (i.e., performed baseline visit and received a study identification number). Here, "Number Analyzed" signifies participants evaluable for specified rows. All participants under "Overall Number of Participants Analyzed" contributed data to the table but may not have data evaluable for every row.'}, {'type': 'SECONDARY', 'title': 'Correlations Between PMS and Daily Fatigue', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants', 'description': 'Participants with moderately to severely active UC who were prescribed tofacitinib by the treating physician in routine clinical practice as per the Swiss prescribing information, were included.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.1', 'groupId': 'OG000'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.6', 'groupId': 'OG000'}]}]}, {'title': 'Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.4', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Week 8 and Week 16', 'description': 'Correlation between PMS and daily fatigue was assessed by Spearman correlation coefficient. PMS consisted of 3 components: rectal bleeding, stool frequency, and physician global assessment of disease activity. Each sub score ranged from 0 (normal) to 3 (extreme severity). These sub scores were summed up to give a total score range of 0 (normal) to 9 (extreme severity), where higher scores indicated more disease severity. The daily fatigue was assessed with the fatigue NRS. Scoring was done on a 11-point NRS. Participant provided a score from 0 (no fatigue) to 10 (as bad as you can imagine). Higher scores indicated more severe fatigue.', 'unitOfMeasure': 'Correlation Coefficient', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants who were included in the study (i.e., performed baseline visit and received a study identification number). Here, "Number Analyzed" signifies participants evaluable for specified rows. All participants under "Overall Number of Participants Analyzed" contributed data to the table but may not have data evaluable for every row.'}, {'type': 'SECONDARY', 'title': 'Correlations Between PMS and Weekly Fatigue', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants', 'description': 'Participants with moderately to severely active UC who were prescribed tofacitinib by the treating physician in routine clinical practice as per the Swiss prescribing information, were included.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.2', 'groupId': 'OG000'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.6', 'groupId': 'OG000'}]}]}, {'title': 'Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.6', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Week 8 and Week 16', 'description': 'Correlation between PMS and weekly fatigue was assessed by Spearman correlation coefficient. PMS consisted of 3 components: rectal bleeding, stool frequency, and physician global assessment of disease activity. Each sub score ranged from 0 (normal) to 3 (extreme severity). These sub scores were summed up to give a total score range of 0 (normal) to 9 (extreme severity), where higher scores indicated more disease severity. The weekly fatigue was assessed with 13 questions from the FACIT-F v4. Participants rated the intensity of their fatigue symptoms on a scale of 0 (not at all) to 4 (very much) for each 13 questions. Total score ranged from 0 to 52, with higher scores representing lower fatigue.', 'unitOfMeasure': 'Correlation Coefficient', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants who were included in the study (i.e., performed baseline visit and received a study identification number). Here, "Number Analyzed" signifies participants evaluable for specified rows. All participants under "Overall Number of Participants Analyzed" contributed data to the table but may not have data evaluable for every row.'}, {'type': 'SECONDARY', 'title': 'Median fCAL Concentrations Over Time Stratified by Week 8 Clinical Remission Status', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants', 'description': 'Participants with moderately to severely active UC who were prescribed tofacitinib by the treating physician in routine clinical practice as per the Swiss prescribing information, were included.'}], 'classes': [{'title': 'fCAL concentrations at baseline in participants with clinical remission at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '590', 'groupId': 'OG000', 'lowerLimit': '297', 'upperLimit': '616'}]}]}, {'title': 'fCAL concentrations at week 8 in participants with clinical remission at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '466', 'groupId': 'OG000', 'lowerLimit': '253', 'upperLimit': '638'}]}]}, {'title': 'fCAL concentrations at week 16 in participants with clinical remission at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '788', 'groupId': 'OG000', 'lowerLimit': '681', 'upperLimit': '894'}]}]}, {'title': 'fCAL concentrations at baseline in participants without clinical remission at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '622', 'groupId': 'OG000', 'lowerLimit': '376', 'upperLimit': '984'}]}]}, {'title': 'fCAL concentrations at week 8 in participants without clinical remission at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '586', 'groupId': 'OG000', 'lowerLimit': '581', 'upperLimit': '593'}]}]}, {'title': 'fCAL concentrations at week 16 in participants without clinical remission at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '201', 'groupId': 'OG000', 'lowerLimit': '64', 'upperLimit': '498'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, Week 8 and Week 16', 'description': 'Clinical remission was defined as PMS of \\<= 2 with no subscore \\>1. Partial mayo score consisted of 3 components: rectal bleeding, stool frequency, and physician global assessment of disease activity. Each sub score ranged from 0 (normal) to 3 (extreme severity). These sub scores were summed up to give a total score range of 0 (normal) to 9 (extreme severity), where higher scores indicated more disease severity. In this outcome measure, fCAL concentration are reported at specified time points in those participants who had clinical remission at Week 8 and in those participants who did not have clinical remission at Week 8.', 'unitOfMeasure': 'micrograms per gram', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants who were included in the study (i.e., performed baseline visit and received a study identification number). Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure and "Number Analyzed" signifies participants evaluable for specified rows. All participants under "Overall Number of Participants Analyzed" contributed data to the table but may not have data evaluable for every row.'}, {'type': 'SECONDARY', 'title': 'Median fCAL Concentrations Over Time Stratified by Week 16 Clinical Remission Status', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants', 'description': 'Participants with moderately to severely active UC who were prescribed tofacitinib by the treating physician in routine clinical practice as per the Swiss prescribing information, were included.'}], 'classes': [{'title': 'fCAL concentrations at baseline in participants with clinical remission at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '612', 'groupId': 'OG000', 'lowerLimit': '304', 'upperLimit': '633'}]}]}, {'title': 'fCAL concentrations at week 8 in participants with clinical remission at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '586', 'groupId': 'OG000', 'lowerLimit': '324', 'upperLimit': '593'}]}]}, {'title': 'fCAL concentrations at week 16 in participants with clinical remission at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1000', 'groupId': 'OG000', 'lowerLimit': '788', 'upperLimit': '1000'}]}]}, {'title': 'fCAL concentrations at baseline in participants without clinical remission at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '607', 'groupId': 'OG000', 'lowerLimit': '328', 'upperLimit': '903'}]}]}, {'title': 'fCAL concentrations at week 8 in participants without clinical remission at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '642', 'groupId': 'OG000', 'lowerLimit': '581', 'upperLimit': '708'}]}]}, {'title': 'fCAL concentrations at week 16 in participants without clinical remission at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '71', 'groupId': 'OG000', 'lowerLimit': '58', 'upperLimit': '201'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, Week 8 and Week 16', 'description': 'Clinical remission was defined as PMS of \\<= 2 with no subscore \\>1. Partial mayo score consisted of 3 components: rectal bleeding, stool frequency, and physician global assessment of disease activity. Each sub score ranged from 0 (normal) to 3 (extreme severity). These sub scores were summed up to give a total score range of 0 (normal) to 9 (extreme severity), where higher scores indicated more disease severity. In this outcome measure, fCAL concentration are reported at specified time points in those participants who had clinical remission at Week 16 and in those participants who did not have clinical remission at Week 16.', 'unitOfMeasure': 'micrograms per gram', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants who were included in the study (i.e., performed baseline visit and received a study identification number). Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure and "Number Analyzed" signifies participants evaluable for specified rows. All participants under "Overall Number of Participants Analyzed" contributed data to the table but may not have data evaluable for every row.'}, {'type': 'SECONDARY', 'title': 'Median fCAL Concentrations Over Time Stratified by Week 8 Clinical Response Status', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants', 'description': 'Participants with moderately to severely active UC who were prescribed tofacitinib by the treating physician in routine clinical practice as per the Swiss prescribing information, were included.'}], 'classes': [{'title': 'fCAL concentrations at baseline in participants with clinical response at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '501', 'groupId': 'OG000', 'lowerLimit': '211', 'upperLimit': '616'}]}]}, {'title': 'fCAL concentrations at week 8 in participants with clinical response at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '597', 'groupId': 'OG000', 'lowerLimit': '390', 'upperLimit': '679'}]}]}, {'title': 'fCAL concentrations at week 16 in participants with clinical response at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '331', 'groupId': 'OG000', 'lowerLimit': '71', 'upperLimit': '575'}]}]}, {'title': 'fCAL concentrations at baseline in participants without clinical response at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '819', 'groupId': 'OG000', 'lowerLimit': '630', 'upperLimit': '1000'}]}]}, {'title': 'fCAL concentrations at week 8 in participants without clinical response at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '581', 'groupId': 'OG000', 'lowerLimit': '581', 'upperLimit': '587'}]}]}, {'title': 'fCAL concentrations at week 16 in participants without clinical response at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1000', 'groupId': 'OG000', 'lowerLimit': '1000', 'upperLimit': '1000'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, Week 8 and Week 16', 'description': 'Clinical response was defined as a reduction in the PMS from baseline of \\>=2 points or achieving clinical remission. Clinical remission was defined as PMS of \\<= 2 with no subscore \\>1. PMS consisted of 3 components: rectal bleeding, stool frequency, and physician global assessment of disease activity. Each sub score ranged from 0 (normal) to 3 (extreme severity). These sub scores were summed up to give a total score range of 0 (normal) to 9 (extreme severity), where higher scores indicated more disease severity. In this outcome measure, fCAL concentration are reported at specified time points in those participants who had clinical response at Week 8 and in those participants who did not have clinical response at Week 8.', 'unitOfMeasure': 'micrograms per gram', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants who were included in the study (i.e., performed baseline visit and received a study identification number). Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure and "Number Analyzed" signifies participants evaluable for specified rows. All participants under "Overall Number of Participants Analyzed" contributed data to the table but may not have data evaluable for every row.'}, {'type': 'SECONDARY', 'title': 'Median fCAL Concentrations Over Time Stratified by Week 16 Clinical Response Status', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants', 'description': 'Participants with moderately to severely active UC who were prescribed tofacitinib by the treating physician in routine clinical practice as per the Swiss prescribing information, were included.'}], 'classes': [{'title': 'fCAL concentrations at baseline in participants with clinical response at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '603', 'groupId': 'OG000', 'lowerLimit': '204', 'upperLimit': '637'}]}]}, {'title': 'fCAL concentrations at week 8 in participants with clinical response at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '586', 'groupId': 'OG000', 'lowerLimit': '324', 'upperLimit': '593'}]}]}, {'title': 'fCAL concentrations at week 16 in participants with clinical response at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '575', 'groupId': 'OG000', 'lowerLimit': '71', 'upperLimit': '1000'}]}]}, {'title': 'fCAL concentrations at baseline in participants without clinical response at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '706', 'groupId': 'OG000', 'lowerLimit': '562', 'upperLimit': '854'}]}]}, {'title': 'fCAL concentrations at week 8 in participants without clinical response at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '642', 'groupId': 'OG000', 'lowerLimit': '581', 'upperLimit': '708'}]}]}, {'title': 'fCAL concentrations at week 16 in participants without clinical response at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '331', 'groupId': 'OG000', 'lowerLimit': '331', 'upperLimit': '331'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, Week 8 and Week 16', 'description': 'Clinical response was defined as a reduction in the PMS from baseline of \\>=2 points or achieving clinical remission. Clinical remission was defined as PMS of \\<= 2 with no subscore \\>1. PMS consisted of 3 components: rectal bleeding, stool frequency, and physician global assessment of disease activity. Each sub score ranged from 0 (normal) to 3 (extreme severity). These sub scores were summed up to give a total score range of 0 (normal) to 9 (extreme severity), where higher scores indicated more disease severity. In this outcome measure, fCAL concentration are reported at specified time points in those participants who had clinical response at Week 16 and in those participants who did not have clinical response at Week 16.', 'unitOfMeasure': 'micrograms per gram', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants who were included in the study (i.e., performed baseline visit and received a study identification number). Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure and "Number Analyzed" signifies participants evaluable for specified rows. All participants under "Overall Number of Participants Analyzed" contributed data to the table but may not have data evaluable for every row.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'All Participants', 'description': 'Participants with moderately to severely active UC who were prescribed tofacitinib by the treating physician in routine clinical practice as per the Swiss prescribing information, were included.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Sponsor decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Participants with moderately to severely active ulcerative colitis (UC) who were prescribed tofacitinib in real world setting as routine clinical practice across Switzerland were enrolled in this study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All Participants', 'description': 'Participants with moderately to severely active UC who were prescribed tofacitinib by the treating physician in routine clinical practice as per the Swiss prescribing information, were included.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '41', 'groupId': 'BG000', 'lowerLimit': '30', 'upperLimit': '56'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'Years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '15', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-03-22', 'size': 4710428, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-03-31T09:42', 'hasProtocol': True}, {'date': '2024-07-31', 'size': 2429414, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-03-31T09:43', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Study was terminated due to difficulty in enrolling targeted number of participants. There were no safety and/or efficacy concerns in the decision to stop enrollment.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2022-03-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2024-04-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-03', 'studyFirstSubmitDate': '2021-09-01', 'resultsFirstSubmitDate': '2025-03-31', 'studyFirstSubmitQcDate': '2021-09-27', 'lastUpdatePostDateStruct': {'date': '2025-12-19', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-03-31', 'studyFirstPostDateStruct': {'date': '2021-10-06', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-04-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants Who Achieved Clinical Response at Week 8', 'timeFrame': 'Week 8', 'description': 'Clinical response was defined as a reduction in the partial Mayo score (PMS) from baseline of \\>=2 points or achieving clinical remission. Clinical remission was defined as PMS of \\<= 2 with no subscore \\>1. PMS consisted of 3 components: rectal bleeding, stool frequency, and physician global assessment of disease activity. Each sub score ranged from 0 (normal) to 3 (extreme severity). These sub scores were summed up to give a total score range of 0 (normal) to 9 (extreme severity), where higher scores indicated more disease severity.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants Who Achieved Clinical Remission at Week 8', 'timeFrame': 'Week 8', 'description': 'Clinical remission was defined as PMS of \\<= 2 with no subscore \\>1. PMS consisted of 3 components: rectal bleeding, stool frequency, and physician global assessment of disease activity. Each sub score ranged from 0 (normal) to 3 (extreme severity). These sub scores were summed up to give a total score range of 0 (normal) to 9 (extreme severity), where higher scores indicated more disease severity.'}, {'measure': 'Percentage of Participants Who Achieved Clinical Response at Week 16', 'timeFrame': 'Week 16', 'description': 'Clinical response was defined as a reduction in the PMS from baseline of \\>=2 points or achieving clinical remission. Clinical remission was defined as PMS of \\<= 2 with no subscore \\>1. PMS consisted of 3 components: rectal bleeding, stool frequency, and physician global assessment of disease activity. Each sub score ranged from 0 (normal) to 3 (extreme severity). These sub scores were summed up to give a total score range of 0 (normal) to 9 (extreme severity), where higher scores indicated more disease severity.'}, {'measure': 'Percentage of Participants Who Achieved Clinical Remission at Week 16', 'timeFrame': 'Week 16', 'description': 'Clinical remission was defined as PMS of \\<= 2 with no subscore \\>1. PMS consisted of 3 components: rectal bleeding, stool frequency, and physician global assessment of disease activity. Each sub score ranged from 0 (normal) to 3 (extreme severity). These sub scores were summed up to give a total score range of 0 (normal) to 9 (extreme severity), where higher scores indicated more disease severity.'}, {'measure': 'Percentage of Participants Who Achieved Inflammatory Bowel Disease Questionnaire (IBDQ) Remission at Week 8', 'timeFrame': 'Week 8', 'description': 'IBDQ remission was defined as an IBDQ score \\>= 170. The IBDQ was a 32-item questionnaire grouped into four dimensions: bowel symptoms, systemic symptoms, emotional function and social function, where range was as follows: bowel symptoms: 10 to 70; systemic symptoms: 5 to 35; emotional function: 12 to 84 and social function: 5 to 35. The total IBDQ score ranged from 32 to 224. For the total score and each domain, a higher score indicated better quality of life.'}, {'measure': 'Percentage of Participants Who Achieved IBDQ Remission at Week 16', 'timeFrame': 'Week 16', 'description': 'IBDQ remission was defined as an IBDQ score \\>= 170. The IBDQ was a 32-item questionnaire grouped into four dimensions: bowel symptoms, systemic symptoms, emotional function and social function, where range was as follows: bowel symptoms: 10 to 70; systemic symptoms: 5 to 35; emotional function: 12 to 84 and social function: 5 to 35. The total IBDQ score ranged from 32 to 224. For the total score and each domain, a higher score indicated better quality of life.'}, {'measure': 'Percentage of Participants Who Achieved IBDQ Response at Week 8', 'timeFrame': 'Week 8', 'description': 'IBDQ response was defined as an IBDQ score \\>=16 points higher than IBDQ baseline score. The IBDQ was a 32-item questionnaire grouped into four dimensions: bowel symptoms, systemic symptoms, emotional function and social function, where range was as follows: bowel symptoms: 10 to 70; systemic symptoms: 5 to 35; emotional function: 12 to 84 and social function: 5 to 35. The total IBDQ score ranged from 32 to 224. For the total score and each domain, a higher score indicated better quality of life.'}, {'measure': 'Percentage of Participants Who Achieved IBDQ Response at Week 16', 'timeFrame': 'Week 16', 'description': 'IBDQ response was defined as an IBDQ score \\>=16 points higher than IBDQ baseline score. The IBDQ was a 32-item questionnaire grouped into four dimensions: bowel symptoms, systemic symptoms, emotional function and social function, where range was as follows: bowel symptoms: 10 to 70; systemic symptoms: 5 to 35; emotional function: 12 to 84 and social function: 5 to 35. The total IBDQ score ranged from 32 to 224. For the total score and each domain, a higher score indicated better quality of life.'}, {'measure': 'Percentage of Participants Who Achieved Biochemical Remission at Week 8', 'timeFrame': 'Week 8', 'description': 'Biochemical remission was defined as a fecal calprotectin (fCAL) concentration \\<=250 micrograms per gram (mcg/g). fCAL is a small anti-microbial protein detected in stool that constitutes approximately 60% of neutrophil cytoplasm. As migration of neutrophils into the intestinal mucosa is a hallmark of active intestinal inflammation, fCAL serves as a non-invasive biomarker for intestinal inflammation.'}, {'measure': 'Percentage of Participants Who Achieved Biochemical Remission at Week 16', 'timeFrame': 'Week 16', 'description': 'Biochemical remission was defined as a fCAL concentration \\<=250 mcg/g. fCAL is a small anti-microbial protein detected in stool that constitutes approximately 60% of neutrophil cytoplasm. As migration of neutrophils into the intestinal mucosa is a hallmark of active intestinal inflammation, fCAL serves as a non-invasive biomarker for intestinal inflammation.'}, {'measure': 'Median Change From Baseline in Stool Frequency Measured by Mayo Score Stool Frequency Subscore at Weeks 8 and 16', 'timeFrame': 'Baseline, Week 8 and Week 16', 'description': 'The stool frequency patient reported outcome (PRO) was assessed with one question about the number of stools on a given day. The Mayo Score stool frequency subscore was used for scoring. Scores ranged from 0 to 3 (0= normal number of stools; 1= 1-2 stools more than normal; 2= 3-4 stools more than normal and 3= 5 or more stools than normal) where higher scores indicated more severe disease activity.'}, {'measure': 'Median Change From Baseline in Rectal Bleeding Measured by Mayo Score Rectal Bleeding Subscore at Weeks 8 and 16', 'timeFrame': 'Baseline, Week 8 and Week 16', 'description': 'The rectal bleeding PRO was assessed with one question about most severe rectal bleeding on a given day. The Mayo Score rectal bleeding subscore was used for scoring. Scores ranged from 0 to 3 (0= no blood seen; 1= streaks of blood with stool less than half the time; 2= obvious blood with stool most of the time and 3= blood alone passes) where higher scores indicated more severe bleeding of the day.'}, {'measure': 'Median Change From Baseline in Urgency of Defecation Assessed Using Numeric Rating Scale (NRS) at Weeks 8 and 16', 'timeFrame': 'Baseline, Week 8 and Week 16', 'description': 'The urgency of defecation was assessed with the urgency NRS. Scoring was done on a 11-point NRS. Participant provided a score from 0 (no urgency) to 10 (worst possible urgency). Higher scores indicated more severe urgency.'}, {'measure': 'Median Change From Baseline in Abdominal Pain Assessed Using Pain NRS at Weeks 8 and 16', 'timeFrame': 'Baseline, Week 8 and Week 16', 'description': 'The abdominal pain was assessed with the pain NRS. Scoring was done on a 10-point horizontal NRS. Participant provided a score from 1 (none) to 10 (very severe). Higher scores indicated more severe pain.'}, {'measure': 'Median Change From Baseline in Quality of Sleep Assessed Using NRS at Weeks 8 and 16', 'timeFrame': 'Baseline, Week 8 and Week 16', 'description': 'The quality of sleep was assessed with a question from the sleep quality visual analogue scale survey. Scoring was done on a 11 NRS. Participant provided a score from 0 (very bad) to 10 (great). Higher scores indicated better quality of sleep.'}, {'measure': 'Median Change From Baseline in Daily Fatigue Assessed Using NRS at Weeks 8 and 16', 'timeFrame': 'Baseline, Week 8 and Week 16', 'description': 'The daily fatigue was assessed with the fatigue NRS. Scoring was done on a 11-point NRS. Participant provided a score from 0 (no fatigue) to 10 (as bad as you can imagine). Higher scores indicated more severe fatigue.'}, {'measure': 'Median Change From Baseline in Weekly Fatigue Assessed Using FACIT-F at Weeks 8 and 16', 'timeFrame': 'Baseline, Week 8 and Week 16', 'description': 'The weekly fatigue was assessed with 13 questions from the functional assessment of chronic illness therapy - fatigue (FACIT-F) version (v)4. Participants rated the intensity of their fatigue symptoms on a scale of 0 (not at all) to 4 (very much) for each 13 questions. Total score ranged from 0 to 52, with higher scores representing lower fatigue.'}, {'measure': 'Median Change From Baseline in IBDQ Score (Total) at Weeks 8 and 16', 'timeFrame': 'Baseline, Week 8 and Week 16', 'description': 'The IBDQ was a 32-item questionnaire grouped into four dimensions: bowel symptoms, systemic symptoms, emotional function and social function, where range was as follows: bowel symptoms: 10 to 70; systemic symptoms: 5 to 35; emotional function: 12 to 84 and social function: 5 to 35. The total IBDQ score ranged from 32 to 224. For the total score and each domain, a higher score indicated better quality of life.'}, {'measure': 'Median Change From Baseline in fCAL at Weeks 8 and 16', 'timeFrame': 'Baseline, Week 8 and Week 16', 'description': 'fCAL is a small anti-microbial protein detected in stool that constitutes approximately 60% of neutrophil cytoplasm. As migration of neutrophils into the intestinal mucosa is a hallmark of active intestinal inflammation, fCAL serves as a non-invasive biomarker for intestinal inflammation.'}, {'measure': 'Correlations Between PMS and IBDQ Score', 'timeFrame': 'Baseline, Week 8 and Week 16', 'description': 'Correlation between PMS and IBDQ score was assessed by Spearman correlation coefficient. PMS consisted of 3 components: rectal bleeding, stool frequency, and physician global assessment of disease activity. Each sub score ranged from 0 (normal) to 3 (extreme severity). These sub scores were summed up to give a total score range of 0 (normal) to 9 (extreme severity), where higher scores indicated more disease severity. The IBDQ was a 32-item questionnaire grouped into four dimensions: bowel symptoms, systemic symptoms, emotional function and social function, where range was as follows: bowel symptoms: 10 to 70; systemic symptoms: 5 to 35; emotional function: 12 to 84 and social function: 5 to 35. The total IBDQ score ranged from 32 to 224. For the total score and each domain, a higher score indicated better quality of life.'}, {'measure': 'Correlations Between PMS and fCAL Concentration', 'timeFrame': 'Baseline, Week 8 and Week 16', 'description': 'Correlation between PMS and fCAL concentration was assessed by Spearman correlation coefficient. PMS consisted of 3 components: rectal bleeding, stool frequency, and physician global assessment of disease activity. Each sub score ranged from 0 (normal) to 3 (extreme severity). These sub scores were summed up to give a total score range of 0 (normal) to 9 (extreme severity), where higher scores indicated more disease severity. fCAL is a small anti-microbial protein detected in stool that constitutes approximately 60% of neutrophil cytoplasm. As migration of neutrophils into the intestinal mucosa is a hallmark of active intestinal inflammation, fCAL serves as a non-invasive biomarker for intestinal inflammation.'}, {'measure': 'Correlations Between Stool Frequency and fCAL Concentration', 'timeFrame': 'Baseline, Week 8 and Week 16', 'description': 'Correlation between stool frequency PRO and fCAL concentration was assessed by Spearman correlation coefficient. The stool frequency PRO was assessed with one question about the number of stools on a given day. The mayo score stool frequency subscore was used for scoring. Scores ranged from 0 to 3 (0= normal number of stools; 1= 1-2 stools more than normal; 2= 3-4 stools more than normal and 3= 5 or more stools than normal) where higher scores indicated more severe disease activity. fCAL is a small anti-microbial protein detected in stool that constitutes approximately 60% of neutrophil cytoplasm. As migration of neutrophils into the intestinal mucosa is a hallmark of active intestinal inflammation, fCAL serves as a non-invasive biomarker for intestinal inflammation.'}, {'measure': 'Correlations Between Rectal Bleeding and fCAL Concentration', 'timeFrame': 'Baseline, Week 8 and Week 16', 'description': 'Correlation between rectal bleeding PRO and fCAL concentration was assessed by Spearman correlation coefficient. The rectal bleeding PRO was assessed with one question about most severe rectal bleeding on a given day. The Mayo Score rectal bleeding subscore was used for scoring. Scores ranged from 0 to 3 (0= no blood seen; 1= streaks of blood with stool less than half the time; 2= obvious blood with stool most of the time and 3= blood alone passes) where higher scores indicated more severe bleeding of the day. fCAL is a small anti-microbial protein detected in stool that constitutes approximately 60% of neutrophil cytoplasm. As migration of neutrophils into the intestinal mucosa is a hallmark of active intestinal inflammation, fCAL serves as a non-invasive biomarker for intestinal inflammation.'}, {'measure': 'Correlations Between Urgency of Defecation and fCAL Concentration', 'timeFrame': 'Baseline, Week 8 and Week 16', 'description': 'Correlation between urgency of defecation and fCAL concentration was assessed by Spearman correlation coefficient. The urgency of defecation was assessed with the urgency NRS. Scoring was done on a 11-point NRS. Participant provided a score from 0 (no urgency) to 10 (worst possible urgency). Higher scores indicated more severe urgency. fCAL is a small anti-microbial protein detected in stool that constitutes approximately 60% of neutrophil cytoplasm. As migration of neutrophils into the intestinal mucosa is a hallmark of active intestinal inflammation, fCAL serves as a non-invasive biomarker for intestinal inflammation.'}, {'measure': 'Correlations Between Abdominal Pain and fCAL Concentration', 'timeFrame': 'Baseline, Week 8 and Week 16', 'description': 'Correlation between abdominal pain and fCAL was assessed by Spearman correlation coefficient. The abdominal pain was assessed with the pain NRS. Scoring was done on a 10-point horizontal NRS. Participant provided a score from 1 (none) to 10 (very severe). Higher scores indicated more severe pain. fCAL is a small anti-microbial protein detected in stool that constitutes approximately 60% of neutrophil cytoplasm. As migration of neutrophils into the intestinal mucosa is a hallmark of active intestinal inflammation, fCAL serves as a non-invasive biomarker for intestinal inflammation.'}, {'measure': 'Correlations Between Quality of Sleep and fCAL Concentration', 'timeFrame': 'Baseline, Week 8 and Week 16', 'description': 'Correlation between quality of sleep and fCAL concentration was assessed by Spearman correlation coefficient. The quality of sleep was assessed with a question from the sleep quality visual analogue scale survey. Scoring was done on a 11-point NRS. Participant provided a score from 0 (very bad) to 10 (great). Higher scores indicated better quality of sleep. fCAL is a small anti-microbial protein detected in stool that constitutes approximately 60% of neutrophil cytoplasm. As migration of neutrophils into the intestinal mucosa is a hallmark of active intestinal inflammation, fCAL serves as a non-invasive biomarker for intestinal inflammation.'}, {'measure': 'Correlations Between Daily Fatigue and fCAL Concentration', 'timeFrame': 'Baseline, Week 8 and Week 16', 'description': 'Correlation between daily fatigue and fCAL concentration was assessed by Spearman correlation coefficient. The daily fatigue was assessed with the fatigue NRS. Scoring was done on a 11-point NRS. Participant provided a score from 0 (no fatigue) to 10 (as bad as you can imagine). Higher scores indicated more severe fatigue. fCAL is a small anti-microbial protein detected in stool that constitutes approximately 60% of neutrophil cytoplasm. As migration of neutrophils into the intestinal mucosa is a hallmark of active intestinal inflammation, fCAL serves as a non-invasive biomarker for intestinal inflammation.'}, {'measure': 'Correlations Between Weekly Fatigue and fCAL Concentration', 'timeFrame': 'Baseline, Week 8 and Week 16', 'description': 'Correlation between weekly fatigue and fCAL concentration was assessed by Spearman correlation coefficient. The weekly fatigue was assessed with 13 questions from the FACIT-F v4. Participants rated the intensity of their fatigue symptoms on a scale of 0 (not at all) to 4 (very much) for each 13 questions. Total score ranged from 0 to 52, with higher scores representing lower fatigue. fCAL is a small anti-microbial protein detected in stool that constitutes approximately 60% of neutrophil cytoplasm. As migration of neutrophils into the intestinal mucosa is a hallmark of active intestinal inflammation, fCAL serves as a non-invasive biomarker for intestinal inflammation.'}, {'measure': 'Correlations Between IBDQ Score and fCAL Concentration', 'timeFrame': 'Baseline, Week 8 and Week 16', 'description': 'Correlation between IBDQ score and fCAL concentration was assessed by Spearman correlation coefficient. The IBDQ was a 32-item questionnaire grouped into four dimensions: bowel symptoms, systemic symptoms, emotional function and social function, where range was as follows: bowel symptoms: 10 to 70; systemic symptoms: 5 to 35; emotional function: 12 to 84 and social function: 5 to 35. The total IBDQ score ranged from 32 to 224. For the total score and each domain, a higher score indicated better quality of life. fCAL is a small anti-microbial protein detected in stool that constitutes approximately 60% of neutrophil cytoplasm. As migration of neutrophils into the intestinal mucosa is a hallmark of active intestinal inflammation, fCAL serves as a non-invasive biomarker for intestinal inflammation.'}, {'measure': 'Correlations Between Stool Frequency and IBDQ Score', 'timeFrame': 'Baseline, Week 8 and Week 16', 'description': 'Correlation between stool frequency PRO and IBDQ score was assessed by Spearman correlation coefficient. The stool frequency PRO was assessed with one question about the number of stools on a given day. The Mayo Score stool frequency subscore was used for scoring. Scores ranged from 0 to 3 (0= normal number of stools; 1= 1-2 stools more than normal; 2= 3-4 stools more than normal and 3= 5 or more stools than normal) where higher scores indicated more severe disease activity. The IBDQ was a 32-item questionnaire grouped into four dimensions: bowel symptoms, systemic symptoms, emotional function and social function, where range was as follows: bowel symptoms: 10 to 70; systemic symptoms: 5 to 35; emotional function: 12 to 84 and social function: 5 to 35. The total IBDQ score ranged from 32 to 224. For the total score and each domain, a higher score indicated better quality of life.'}, {'measure': 'Correlations Between Rectal Bleeding and IBDQ Score', 'timeFrame': 'Baseline, Week 8 and Week 16', 'description': 'Correlation between rectal bleeding PRO and IBDQ score was assessed by Spearman correlation coefficient. The rectal bleeding PRO was assessed with one question about most severe rectal bleeding on a given day. The Mayo Score rectal bleeding subscore was used for scoring. Scores ranged from 0 to 3 (0= no blood seen; 1= streaks of blood with stool less than half the time; 2= obvious blood with stool most of the time and 3= blood alone passes) where higher scores indicated more severe bleeding of the day. The IBDQ was a 32-item questionnaire grouped into four dimensions: bowel symptoms, systemic symptoms, emotional function and social function, where range was as follows: bowel symptoms: 10 to 70; systemic symptoms: 5 to 35; emotional function: 12 to 84 and social function: 5 to 35. The total IBDQ score ranged from 32 to 224. For the total score and each domain, a higher score indicated better quality of life.'}, {'measure': 'Correlations Between Urgency of Defecation and IBDQ Score', 'timeFrame': 'Baseline, Week 8 and Week 16', 'description': 'Correlation between urgency of defecation and IBDQ score was assessed by Spearman correlation coefficient. The urgency of defecation was assessed with the urgency NRS. Scoring was done on a 11-point NRS. Participant provided a score from 0 (no urgency) to 10 (worst possible urgency). Higher scores indicated more severe urgency. The IBDQ was a 32-item questionnaire grouped into four dimensions: bowel symptoms, systemic symptoms, emotional function and social function, where range was as follows: bowel symptoms: 10 to 70; systemic symptoms: 5 to 35; emotional function: 12 to 84 and social function: 5 to 35. The total IBDQ score ranged from 32 to 224. For the total score and each domain, a higher score indicated better quality of life.'}, {'measure': 'Correlations Between Abdominal Pain and IBDQ Score', 'timeFrame': 'Baseline, Week 8 and Week 16', 'description': 'Correlation between abdominal pain and IBDQ score was assessed by Spearman correlation coefficient. The abdominal pain was assessed with the pain NRS. Scoring was done on a 10-point horizontal NRS. Participant provided a score from 1 (none) to 10 (very severe). Higher scores indicated more severe pain. The IBDQ was a 32-item questionnaire grouped into four dimensions: bowel symptoms, systemic symptoms, emotional function and social function, where range was as follows: bowel symptoms: 10 to 70; systemic symptoms: 5 to 35; emotional function: 12 to 84 and social function: 5 to 35. The total IBDQ score ranged from 32 to 224. For the total score and each domain, a higher score indicated better quality of life.'}, {'measure': 'Correlations Between Quality of Sleep and IBDQ Score', 'timeFrame': 'Baseline, Week 8 and Week 16', 'description': 'Correlation between quality of sleep and IBDQ score was assessed by Spearman correlation coefficient. The quality of sleep was assessed with a question from the sleep quality visual analogue scale survey. Scoring was done on a 11-point NRS. Participant provided a score from 0 (very bad) to 10 (great). Higher scores indicated better quality of sleep. The IBDQ was a 32-item questionnaire grouped into four dimensions: bowel symptoms, systemic symptoms, emotional function and social function, where range was as follows: bowel symptoms: 10 to 70; systemic symptoms: 5 to 35; emotional function: 12 to 84 and social function: 5 to 35. The total IBDQ score ranged from 32 to 224. For the total score and each domain, a higher score indicated better quality of life.'}, {'measure': 'Correlations Between Daily Fatigue and IBDQ Score', 'timeFrame': 'Baseline, Week 8 and Week 16', 'description': 'Correlation between daily fatigue and IBDQ score was assessed by Spearman correlation coefficient. The daily fatigue was assessed with the fatigue NRS. Scoring was done on a 11-point NRS. Participant provided a score from 0 (no fatigue) to 10 (as bad as you can imagine). Higher scores indicated more severe fatigue. The IBDQ was a 32-item questionnaire grouped into four dimensions: bowel symptoms, systemic symptoms, emotional function and social function, where range was as follows: bowel symptoms: 10 to 70; systemic symptoms: 5 to 35; emotional function: 12 to 84 and social function: 5 to 35. The total IBDQ score ranged from 32 to 224. For the total score and each domain, a higher score indicated better quality of life.'}, {'measure': 'Correlations Between Weekly Fatigue and IBDQ Score', 'timeFrame': 'Baseline, Week 8 and Week 16', 'description': 'Correlation between weekly fatigue and IBDQ score was assessed by Spearman correlation coefficient. The weekly fatigue was assessed with 13 questions from the FACIT-F v4. Participants rated the intensity of their fatigue symptoms on a scale of 0 (not at all) to 4 (very much) for each 13 questions. Total score ranged from 0 to 52, with higher scores representing lower fatigue. The IBDQ was a 32-item questionnaire grouped into four dimensions: bowel symptoms, systemic symptoms, emotional function and social function, where range was as follows: bowel symptoms: 10 to 70; systemic symptoms: 5 to 35; emotional function: 12 to 84 and social function: 5 to 35. The total IBDQ score ranged from 32 to 224. For the total score and each domain, a higher score indicated better quality of life.'}, {'measure': 'Correlations Between PMS and Stool Frequency', 'timeFrame': 'Baseline, Week 8 and Week 16', 'description': 'Correlation between PMS and stool frequency PRO was assessed by Spearman correlation coefficient. PMS consisted of 3 components: rectal bleeding, stool frequency, and physician global assessment of disease activity. Each sub score ranged from 0 (normal) to 3 (extreme severity). These sub scores were summed up to give a total score range of 0 (normal) to 9 (extreme severity), where higher scores indicated more disease severity. The stool frequency PRO was assessed with one question about the number of stools on a given day. The Mayo Score stool frequency subscore was used for scoring. Scores ranged from 0 to 3 (0= normal number of stools; 1= 1-2 stools more than normal; 2= 3-4 stools more than normal and 3= 5 or more stools than normal) where higher scores indicated more severe disease activity.'}, {'measure': 'Correlations Between PMS and Rectal Bleeding', 'timeFrame': 'Baseline, Week 8 and Week 16', 'description': 'Correlation between PMS and rectal bleeding PRO was assessed by Spearman correlation coefficient. PMS consisted of 3 components: rectal bleeding, stool frequency, and physician global assessment of disease activity. Each sub score ranged from 0 (normal) to 3 (extreme severity). These sub scores were summed up to give a total score range of 0 (normal) to 9 (extreme severity), where higher scores indicated more disease severity. The rectal bleeding PRO was assessed with one question about most severe rectal bleeding on a given day. The Mayo Score rectal bleeding subscore was used for scoring. Scores ranged from 0 to 3 (0= no blood seen; 1= streaks of blood with stool less than half the time; 2= obvious blood with stool most of the time and 3= blood alone passes) where higher scores indicated more severe bleeding of the day.'}, {'measure': 'Correlations Between PMS and Urgency of Defecation', 'timeFrame': 'Baseline, Week 8 and Week 16', 'description': 'Correlation between PMS and urgency of defecation was assessed by Spearman correlation coefficient. PMS consisted of 3 components: rectal bleeding, stool frequency, and physician global assessment of disease activity. Each sub score ranged from 0 (normal) to 3 (extreme severity). These sub scores were summed up to give a total score range of 0 (normal) to 9 (extreme severity), where higher scores indicated more disease severity. The urgency of defecation was assessed with the urgency NRS. Scoring was done on a 11-point NRS. Participant provided a score from 0 (no urgency) to 10 (worst possible urgency). Higher scores indicated more severe urgency.'}, {'measure': 'Correlations Between PMS and Abdominal Pain', 'timeFrame': 'Baseline, Week 8 and Week 16', 'description': 'Correlation between PMS and abdominal pain was assessed by Spearman correlation coefficient. PMS consisted of 3 components: rectal bleeding, stool frequency, and physician global assessment of disease activity. Each sub score ranged from 0 (normal) to 3 (extreme severity). These sub scores were summed up to give a total score range of 0 (normal) to 9 (extreme severity), where higher scores indicated more disease severity. The abdominal pain was assessed with the pain NRS. Scoring was done on a 10-point horizontal NRS. Participant provided a score from 1 (none) to 10 (very severe). Higher scores indicated more severe pain.'}, {'measure': 'Correlations Between PMS and Quality of Sleep', 'timeFrame': 'Baseline, Week 8 and Week 16', 'description': 'Correlation between PMS and quality of sleep was assessed by Spearman correlation coefficient. PMS consisted of 3 components: rectal bleeding, stool frequency, and physician global assessment of disease activity. Each sub score ranged from 0 (normal) to 3 (extreme severity). These sub scores were summed up to give a total score range of 0 (normal) to 9 (extreme severity), where higher scores indicated more disease severity. The quality of sleep was assessed with a question from the sleep quality visual analogue scale survey. Scoring was done on a 11-point NRS. Participant provided a score from 0 (very bad) to 10 (great). Higher scores indicated better quality of sleep.'}, {'measure': 'Correlations Between PMS and Daily Fatigue', 'timeFrame': 'Baseline, Week 8 and Week 16', 'description': 'Correlation between PMS and daily fatigue was assessed by Spearman correlation coefficient. PMS consisted of 3 components: rectal bleeding, stool frequency, and physician global assessment of disease activity. Each sub score ranged from 0 (normal) to 3 (extreme severity). These sub scores were summed up to give a total score range of 0 (normal) to 9 (extreme severity), where higher scores indicated more disease severity. The daily fatigue was assessed with the fatigue NRS. Scoring was done on a 11-point NRS. Participant provided a score from 0 (no fatigue) to 10 (as bad as you can imagine). Higher scores indicated more severe fatigue.'}, {'measure': 'Correlations Between PMS and Weekly Fatigue', 'timeFrame': 'Baseline, Week 8 and Week 16', 'description': 'Correlation between PMS and weekly fatigue was assessed by Spearman correlation coefficient. PMS consisted of 3 components: rectal bleeding, stool frequency, and physician global assessment of disease activity. Each sub score ranged from 0 (normal) to 3 (extreme severity). These sub scores were summed up to give a total score range of 0 (normal) to 9 (extreme severity), where higher scores indicated more disease severity. The weekly fatigue was assessed with 13 questions from the FACIT-F v4. Participants rated the intensity of their fatigue symptoms on a scale of 0 (not at all) to 4 (very much) for each 13 questions. Total score ranged from 0 to 52, with higher scores representing lower fatigue.'}, {'measure': 'Median fCAL Concentrations Over Time Stratified by Week 8 Clinical Remission Status', 'timeFrame': 'Baseline, Week 8 and Week 16', 'description': 'Clinical remission was defined as PMS of \\<= 2 with no subscore \\>1. Partial mayo score consisted of 3 components: rectal bleeding, stool frequency, and physician global assessment of disease activity. Each sub score ranged from 0 (normal) to 3 (extreme severity). These sub scores were summed up to give a total score range of 0 (normal) to 9 (extreme severity), where higher scores indicated more disease severity. In this outcome measure, fCAL concentration are reported at specified time points in those participants who had clinical remission at Week 8 and in those participants who did not have clinical remission at Week 8.'}, {'measure': 'Median fCAL Concentrations Over Time Stratified by Week 16 Clinical Remission Status', 'timeFrame': 'Baseline, Week 8 and Week 16', 'description': 'Clinical remission was defined as PMS of \\<= 2 with no subscore \\>1. Partial mayo score consisted of 3 components: rectal bleeding, stool frequency, and physician global assessment of disease activity. Each sub score ranged from 0 (normal) to 3 (extreme severity). These sub scores were summed up to give a total score range of 0 (normal) to 9 (extreme severity), where higher scores indicated more disease severity. In this outcome measure, fCAL concentration are reported at specified time points in those participants who had clinical remission at Week 16 and in those participants who did not have clinical remission at Week 16.'}, {'measure': 'Median fCAL Concentrations Over Time Stratified by Week 8 Clinical Response Status', 'timeFrame': 'Baseline, Week 8 and Week 16', 'description': 'Clinical response was defined as a reduction in the PMS from baseline of \\>=2 points or achieving clinical remission. Clinical remission was defined as PMS of \\<= 2 with no subscore \\>1. PMS consisted of 3 components: rectal bleeding, stool frequency, and physician global assessment of disease activity. Each sub score ranged from 0 (normal) to 3 (extreme severity). These sub scores were summed up to give a total score range of 0 (normal) to 9 (extreme severity), where higher scores indicated more disease severity. In this outcome measure, fCAL concentration are reported at specified time points in those participants who had clinical response at Week 8 and in those participants who did not have clinical response at Week 8.'}, {'measure': 'Median fCAL Concentrations Over Time Stratified by Week 16 Clinical Response Status', 'timeFrame': 'Baseline, Week 8 and Week 16', 'description': 'Clinical response was defined as a reduction in the PMS from baseline of \\>=2 points or achieving clinical remission. Clinical remission was defined as PMS of \\<= 2 with no subscore \\>1. PMS consisted of 3 components: rectal bleeding, stool frequency, and physician global assessment of disease activity. Each sub score ranged from 0 (normal) to 3 (extreme severity). These sub scores were summed up to give a total score range of 0 (normal) to 9 (extreme severity), where higher scores indicated more disease severity. In this outcome measure, fCAL concentration are reported at specified time points in those participants who had clinical response at Week 16 and in those participants who did not have clinical response at Week 16.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Ulcerative Colitis']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://pmiform.com/clinical-trial-info-request?StudyID=A3921395', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': "This study is expected to contribute to the body of real-world data of tofacitinib's safety and efficacy profile in ulcerative colitis. Conventional clinical outcomes will give a better understanding of response and remission rates in a representative, post-marketing population.\n\nRegular patient questionnaires and measurement of a biomarker of gut inflammation will provide detail on how patients experience induction treatment and contextualise the efficacy data.", 'detailedDescription': 'This is a low-interventional study in which the intervention under study is home fecal calprotectin testing which falls outside of normal standard of care in ulcerative colitis. Tofacitinib is prescribed and administered as per the Swiss prescribing information. Accordingly, this study is registered on ClinicalTrials.gov as an interventional study. Under Swiss law, this study is considered and approved as a non-interventional study (Category A, Human Research Ordinance, Swiss Confederation).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '60 adults both male and female who are prescribed tofacitinib for moderately to severely active UC will be enrolled in the study.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Male or female participants 18 years of age or older at screening visit\n* Participants with confirmed diagnosis of UC and who are prescribed tofacitinib (Xeljanz®) for moderately to severely active UC as per the Swiss label\n* Participants who are willing and able to comply with all scheduled visits, treatment plan, study interventions, and other study procedures\n* Capable of giving personally signed informed consent\n\nExclusion Criteria:\n\n* Presence of clinical findings suggestive of Crohn's disease\n* Any previous exposure to tofacitinib including participation in the tofacitinib clinical program\n* Co-medication with any other advanced therapies for UC (biologics\\*, azathioprine, mercaptopurine and methotrexate) or any other JAK inhibitor\n* Any identified contra-indications for use of tofacitinib as per the Swiss label\n* Not owning a handheld digital device compatible with the Sidekick Health App, not willing to have it installed on this device or not capable of using the App\n* Investigator site staff or Pfizer employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family members."}, 'identificationModule': {'nctId': 'NCT05069259', 'acronym': 'KIC-START', 'briefTitle': 'Generate Real World Data On Tofacitinib Induction Therapy and Changes In Clinical and Patient Reported Outcomes.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A LOW-INTERVENTIONAL, PROSPECTIVE, MULTI-CENTER STUDY TO EVALUATE REAL-WORLD CLINICAL, BIOCHEMICAL AND PATIENT-REPORTED RESPONSES TO TOFACITINIB INDUCTION THERAPY IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS IN SWITZERLAND', 'orgStudyIdInfo': {'id': 'A3921395'}, 'secondaryIdInfos': [{'id': 'KIC-START', 'type': 'OTHER', 'domain': 'Alias Study Number'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with active Ulcerative Colitis', 'interventionNames': ['Other: Stool sample collection']}], 'interventions': [{'name': 'Stool sample collection', 'type': 'OTHER', 'description': 'collection for measuring calprotectin levels', 'armGroupLabels': ['Patients with active Ulcerative Colitis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '9007', 'city': 'Sankt Gallen', 'state': 'Canton of St. Gallen', 'country': 'Switzerland', 'facility': 'Kantonsspital St, Gallen', 'geoPoint': {'lat': 47.42391, 'lon': 9.37477}}, {'city': 'Basel', 'country': 'Switzerland', 'facility': 'Clarunis, Universitätsspital', 'geoPoint': {'lat': 47.55839, 'lon': 7.57327}}, {'zip': 'CH - 3012', 'city': 'Bern', 'country': 'Switzerland', 'facility': 'Verein IBD Study Group', 'geoPoint': {'lat': 46.94809, 'lon': 7.44744}}, {'city': 'Fribourg', 'country': 'Switzerland', 'facility': 'Centre Fribourgeois de Gastroenterologie', 'geoPoint': {'lat': 46.80237, 'lon': 7.15128}}, {'city': 'Liestal', 'country': 'Switzerland', 'facility': 'Kantonsspital Baselland', 'geoPoint': {'lat': 47.48455, 'lon': 7.73446}}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'ipdSharingStatementModule': {'url': 'https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests', 'ipdSharing': 'YES', 'description': "Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\\_trials/trial\\_data\\_and\\_results/data\\_requests."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}