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Tirzepatide for Metabolic Dysfunction-Associated Steatohepatitis with Liver Fibrosis. N Engl J Med. 2024 Jul 25;391(4):299-310. doi: 10.1056/NEJMoa2401943. Epub 2024 Jun 8."}],"seeAlsoLinks":[{"label":"A Study of Tirzepatide (LY3298176) in Participants With Nonalcoholic Steatohepatitis (NASH)","url":"https://trials.lillytrialguide.com/en-US/trial/3lQTuBFU3GBu9vi4SAlDDp"}]},"ipdSharingStatementModule":{"ipdSharing":"YES","description":"Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.","infoTypes":["STUDY_PROTOCOL","SAP","CSR"],"timeFrame":"Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. 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CI, and p-value for endpoint measures are from logistic regression model with baseline diabetes status, region, treatment as factors."}]},{"type":"SECONDARY","title":"Percentage of Participants With ≥1 Point Increase in Fibrosis Stage on Liver Histology","description":"Participants were evaluated with the NASH CRN scoring system with ≥1 stage increase in fibrosis.","populationDescription":"All randomized participants who received at least one dose of study drug with baseline and post-baseline values and had evaluable data for this outcome prior to treatment discontinuation.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Percentage of participants","timeFrame":"Week 52","groups":[{"id":"OG000","title":"5 mg Tirzepatide","description":"Participants received 5 mg tirzepatide administered SC QW for 52 weeks \\[initially 2.5 mg tirzepatide SC QW for 4 weeks, then 5 mg tirzepatide SC QW from weeks 5-52\\]."},{"id":"OG001","title":"10 mg 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weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"39"},{"groupId":"OG001","value":"41"},{"groupId":"OG002","value":"40"},{"groupId":"OG003","value":"35"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"12.04"},{"groupId":"OG001","value":"9.81"},{"groupId":"OG002","value":"5.53"},{"groupId":"OG003","value":"13.03"}]}]}],"analyses":[{"groupIds":["OG000","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"0.893","statisticalMethod":"Regression, Logistic","paramType":"Odds Ratio (OR)","paramValue":"0.91","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.25","ciUpperLimit":"3.40","estimateComment":"Odds ratio, CI, and p-value for endpoint measures are from logistic regression model with baseline diabetes status, region, treatment as factors."},{"groupIds":["OG001","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"0.647","statisticalMethod":"Regression, Logistic","paramType":"Odds Ratio (OR)","paramValue":"0.73","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.18","ciUpperLimit":"2.87","estimateComment":"Odds ratio, CI, and p-value for endpoint measures are from logistic regression model with baseline diabetes status, region, treatment as factors."},{"groupIds":["OG002","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"0.246","statisticalMethod":"Regression, Logistic","paramType":"Odds Ratio (OR)","paramValue":"0.39","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.08","ciUpperLimit":"1.91","estimateComment":"Odds ratio, CI, and p-value for endpoint measures are from logistic regression model with baseline diabetes status, region, treatment as factors."}]},{"type":"SECONDARY","title":"Percentage of Participants That Achieve a ≥2 Point Decrease in NAFLD (Non-alcoholic Fatty Liver Disease) Activity Score (NAS) on Liver Histology, With ≥1 Point Reduction in at Least 2 NAS Components","description":"Hepatic histological improvement in NAS was defined as a decrease (improvement) in NAS by ≥ 2 with at least a 1-point reduction in at least 2 NAS components (lobular inflammation, hepatocellular ballooning or steatosis). The NAS was derived as the unweighted sum of steatosis (0 to 3), lobular inflammation (0 to 3), and hepatocellular ballooning (0 to 2) scores. The NAS ranges from 0-8, with the higher score indicating more aggressive disease.","populationDescription":"All randomized participants who received at least one dose of study drug with baseline and post-baseline values and had evaluable data for this outcome prior to treatment discontinuation.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Percentage of participants","timeFrame":"Week 52","groups":[{"id":"OG000","title":"5 mg Tirzepatide","description":"Participants received 5 mg tirzepatide administered SC QW for 52 weeks \\[initially 2.5 mg tirzepatide SC QW for 4 weeks, then 5 mg tirzepatide SC QW from weeks 5-52\\]."},{"id":"OG001","title":"10 mg Tirzepatide","description":"Participants received 10 mg tirzepatide administered SC QW for 52 weeks \\[initially 2.5 mg tirzepatide SC QW for 4 weeks, then dose escalated to 5 mg, 7.5 mg, and 10 mg every 4 weeks until target dose (10 mg) was reached\\]."},{"id":"OG002","title":"15 mg Tirzepatide","description":"Participants received 15 mg tirzepatide administered SC QW for 52 weeks \\[initially 2.5 mg tirzepatide SC QW for 4 weeks, then dose escalated to 5 mg, 7.5 mg, 10 mg, 12.5 mg, and 15 mg every 4 weeks until target dose (15 mg) was reached\\]."},{"id":"OG003","title":"Placebo","description":"Participants received placebo administered SC QW for 52 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"39"},{"groupId":"OG001","value":"41"},{"groupId":"OG002","value":"40"},{"groupId":"OG003","value":"35"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"81.02"},{"groupId":"OG001","value":"86.55"},{"groupId":"OG002","value":"88.77"},{"groupId":"OG003","value":"38.09"}]}]}],"analyses":[{"groupIds":["OG000","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"Regression, Logistic","paramType":"Odds Ratio (OR)","paramValue":"6.94","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"2.41","ciUpperLimit":"20.00","estimateComment":"Odds ratio, CI, and p-value for endpoint measures are from logistic regression model with baseline diabetes status, region, treatment as factors."},{"groupIds":["OG001","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"Regression, Logistic","paramType":"Odds Ratio (OR)","paramValue":"10.46","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"3.36","ciUpperLimit":"32.61","estimateComment":"Odds ratio, CI, and p-value for endpoint measures are from logistic regression model with baseline diabetes status, region, treatment as factors."},{"groupIds":["OG002","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"Regression, Logistic","paramType":"Odds Ratio (OR)","paramValue":"12.85","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"3.87","ciUpperLimit":"42.65","estimateComment":"Odds ratio, CI, and p-value for endpoint measures are from logistic regression model with baseline diabetes status, region, treatment as factors."}]},{"type":"SECONDARY","title":"Mean Absolute Change From Baseline in Liver Fat Content by Magnetic Resonance Imaging - Proton Density Fat Fraction (MRI-PDFF)","description":"MRI-PDFF is an established method that enables quantification of fat content in the liver. The value of whole liver fat as assessed by MRI-PDFF is expressed in percentage (%) and ranges from 0 to 100% with higher values representing higher liver fat level. Least square (LS) mean was calculated using mixed model repeated measures (MMRM) model for post-baseline measures: Variable = Baseline + Diabetes Flag (DIABFL) + REGION1 + Treatment + Time + Treatment\\*Time (Type III sum of squares). Variance-Covariance structure (Change from Baseline) = Unstructured.","populationDescription":"All randomized participants who received at least one dose of study drug with baseline and post-baseline values and had evaluable data for this outcome prior to treatment discontinuation.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"absolute percentage of liver fat","timeFrame":"Baseline to Week 52","groups":[{"id":"OG000","title":"5 mg Tirzepatide","description":"Participants received 5 mg tirzepatide administered SC QW for 52 weeks \\[initially 2.5 mg tirzepatide SC QW for 4 weeks, then 5 mg tirzepatide SC QW from weeks 5-52\\]."},{"id":"OG001","title":"10 mg Tirzepatide","description":"Participants received 10 mg tirzepatide administered SC QW for 52 weeks \\[initially 2.5 mg tirzepatide SC QW for 4 weeks, then dose escalated to 5 mg, 7.5 mg, and 10 mg every 4 weeks until target dose (10 mg) was reached\\]."},{"id":"OG002","title":"15 mg Tirzepatide","description":"Participants received 15 mg tirzepatide administered SC QW for 52 weeks \\[initially 2.5 mg tirzepatide SC QW for 4 weeks, then dose escalated to 5 mg, 7.5 mg, 10 mg, 12.5 mg, and 15 mg every 4 weeks until target dose (15 mg) was reached\\]."},{"id":"OG003","title":"Placebo","description":"Participants received placebo administered SC QW for 52 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"28"},{"groupId":"OG001","value":"33"},{"groupId":"OG002","value":"32"},{"groupId":"OG003","value":"27"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-10.12","spread":"1.165"},{"groupId":"OG001","value":"-10.15","spread":"1.071"},{"groupId":"OG002","value":"-11.34","spread":"1.107"},{"groupId":"OG003","value":"-1.31","spread":"1.142"}]}]}],"analyses":[{"groupIds":["OG000","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"Mixed Models Analysis","paramType":"LS Mean difference (Final Values)","paramValue":"-8.81","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-12.04","ciUpperLimit":"-5.58","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"1.632"},{"groupIds":["OG001","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"Mixed Models Analysis","paramType":"LS Mean difference (Final Values)","paramValue":"-8.83","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-11.93","ciUpperLimit":"-5.73","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"1.566"},{"groupIds":["OG002","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"Mixed Models Analysis","paramType":"LS Mean difference (Final Values)","paramValue":"-10.02","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-13.17","ciUpperLimit":"-6.87","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"1.591"}]},{"type":"SECONDARY","title":"Mean Change From Baseline in Body Weight","description":"Change in body weight at the end of 52 weeks measured in kilogram (kg) using a calibrated scale. LS mean was calculated using MMRM model for post-baseline measures: Variable = Baseline + DIABFL + REGION1 + Treatment + Time + Treatment\\*Time (Type III sum of squares). Variance-Covariance structure (Change from Baseline) = Unstructured.","populationDescription":"All randomized participants who received at least one dose of study drug with baseline and post-baseline values and had evaluable data for this outcome prior to treatment discontinuation.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"Kilogram (kg)","timeFrame":"Baseline to Week 52","groups":[{"id":"OG000","title":"5 mg Tirzepatide","description":"Participants received 5 mg tirzepatide administered SC QW for 52 weeks \\[initially 2.5 mg tirzepatide SC QW for 4 weeks, then 5 mg tirzepatide SC QW from week 5-52\\]."},{"id":"OG001","title":"10 mg Tirzepatide","description":"Participants received 10 mg tirzepatide administered SC QW for 52 weeks \\[initially 2.5 mg tirzepatide SC QW for 4 weeks, then dose escalated to 5 mg, 7.5 mg and 10 mg every 4 weeks until target dose (10 mg) was reached\\]."},{"id":"OG002","title":"15 mg Tirzepatide","description":"Participants received 15 mg tirzepatide administered SC QW for 52 weeks \\[initially 2.5 mg tirzepatide SC QW for 4 weeks, then dose escalated to 5 mg, 7.5 mg, 10 mg, 12.5 mg, and 15 mg every 4 weeks until target dose (15 mg) was reached\\]."},{"id":"OG003","title":"Placebo","description":"Participants received placebo administered SC QW for 52 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"40"},{"groupId":"OG001","value":"42"},{"groupId":"OG002","value":"42"},{"groupId":"OG003","value":"37"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-11.46","spread":"1.404"},{"groupId":"OG001","value":"-14.22","spread":"1.380"},{"groupId":"OG002","value":"-17.88","spread":"1.376"},{"groupId":"OG003","value":"-1.04","spread":"1.392"}]}]}],"analyses":[{"groupIds":["OG000","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"Mixed Models Analysis","paramType":"LS Mean difference (Final Values)","paramValue":"-10.42","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-14.32","ciUpperLimit":"-6.52","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"1.976"},{"groupIds":["OG001","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"Mixed Models Analysis","paramType":"LS Mean difference (Final Values)","paramValue":"-13.19","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-17.05","ciUpperLimit":"-9.32","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"1.960"},{"groupIds":["OG002","OG003"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"Mixed Models Analysis","paramType":"LS Mean difference (Final Values)","paramValue":"-16.84","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-20.71","ciUpperLimit":"-12.98","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"1.957"}]}]},"adverseEventsModule":{"frequencyThreshold":"0","timeFrame":"Baseline Up to Week 56","description":"All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly","eventGroups":[{"id":"EG000","title":"5 mg Tirzepatide","description":"Participants received 5 mg tirzepatide administered SC QW for 52 weeks \\[initially 2.5 mg tirzepatide SC QW for 4 weeks, then 5 mg tirzepatide SC QW from weeks 5-52\\].","deathsNumAffected":0,"deathsNumAtRisk":47,"seriousNumAffected":5,"seriousNumAtRisk":47,"otherNumAffected":43,"otherNumAtRisk":47},{"id":"EG001","title":"10 mg Tirzepatide","description":"Participants received 10 mg tirzepatide administered SC QW for 52 weeks \\[initially 2.5 mg tirzepatide SC QW for 4 weeks, then dose escalated to 5 mg, 7.5 mg, and 10 mg every 4 weeks until target dose (10 mg) was reached\\].","deathsNumAffected":0,"deathsNumAtRisk":47,"seriousNumAffected":4,"seriousNumAtRisk":47,"otherNumAffected":43,"otherNumAtRisk":47},{"id":"EG002","title":"15 mg Tirzepatide","description":"Participants received 15 mg tirzepatide administered SC QW for 52 weeks \\[initially 2.5 mg tirzepatide SC QW for 4 weeks, then dose escalated to 5 mg, 7.5 mg, 10 mg, 12.5 mg, and 15 mg every 4 weeks until target dose (15 mg) was reached\\].","deathsNumAffected":0,"deathsNumAtRisk":48,"seriousNumAffected":0,"seriousNumAtRisk":48,"otherNumAffected":44,"otherNumAtRisk":48},{"id":"EG003","title":"Placebo","description":"Participants received placebo administered SC QW for 52 weeks.","deathsNumAffected":0,"deathsNumAtRisk":48,"seriousNumAffected":3,"seriousNumAtRisk":48,"otherNumAffected":40,"otherNumAtRisk":48}],"seriousEvents":[{"term":"Developmental hip dysplasia","organSystem":"Congenital, familial and genetic disorders","sourceVocabulary":"MedDRA 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26.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":47},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":47},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":48},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":48}]},{"term":"Rectal haemorrhage","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 26.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":47},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":47},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":48},{"groupId":"EG003","numEvents":3,"numAffected":1,"numAtRisk":48}]},{"term":"Umbilical hernia","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 26.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":47},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":47},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":48},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":48}]},{"term":"Cholecystitis","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 26.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":47},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":47},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":48},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":48}]},{"term":"Bacteraemia","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 26.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":47},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":47},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":48},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":48}]},{"term":"Covid-19 pneumonia","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 26.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":47},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":47},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":48},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":48}]},{"term":"Hypokalaemia","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 26.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":47},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":47},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":48},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":48}]},{"term":"Rhabdomyolysis","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 26.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":47},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":47},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":48},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":48}]},{"term":"Ovarian neoplasm","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 26.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":27},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":26},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":29},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":27}]},{"term":"Transient ischaemic attack","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 26.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":47},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":47},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":48},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":48}]},{"term":"Ureterolithiasis","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 26.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":47},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":47},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":48},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":48}]},{"term":"Endometrial thickening","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA 26.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":27},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":26},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":29},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":27}]},{"term":"Phlebitis","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 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26.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":47},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":47},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":48},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":48}]},{"term":"Thrombocytopenia","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 26.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":47},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":47},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":48},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":48}]},{"term":"Atrial tachycardia","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 26.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":47},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":47},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":48},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":48}]},{"term":"Bradycardia","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 26.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":47},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":47},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":48},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":48}]},{"term":"Cardiac failure","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 26.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":47},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":47},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":48},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":48}]},{"term":"Palpitations","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 26.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":47},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":47},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":48},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":48}]},{"term":"Sinus bradycardia","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 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