Ignite Creation Date:
2025-12-24 @ 9:19 PM
Ignite Modification Date:
2025-12-25 @ 7:06 PM
Study NCT ID:
NCT01976104
Status:
COMPLETED
Last Update Posted:
2018-02-27
First Post:
2013-10-24
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Treatment of Thrombocytopenia in Patients With Chronic Liver Disease Undergoing an Elective Procedure
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Thailand', 'United Kingdom']}, 'conditionBrowseModule': {'meshes': [{'id': 'D013921', 'term': 'Thrombocytopenia'}], 'ancestors': [{'id': 'D001791', 'term': 'Blood Platelet Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D000095542', 'term': 'Cytopenia'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C533238', 'term': 'avatrombopag'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'esi_medinfo@eisai.com', 'phone': '888-422-4743', 'title': 'Eisai Inc.', 'organization': 'Eisai Call Center'}, 'certainAgreement': {'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From date of first dose of study drug up to 30 days after the last dose of study drug, up to approximately 3 years and 2 months', 'description': 'Treatment-emergent adverse events and treatment-emergent serious adverse events. Adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4. Safety analysis set included the group of participants who received at least 1 dose of study drug and had at least 1 post dose safety assessment. Serious adverse events (SAEs) were collected for 30 days after the last dose.', 'eventGroups': [{'id': 'EG000', 'title': '60 mg Placebo (Lower Baseline Platelet Count)', 'description': 'Participants with a baseline platelet count of less than 40 x 10\\^9/liters (L) took three 20 milligrams (mg) matching placebo tablets orally, once daily with a meal on Days 1 through 5.', 'otherNumAtRisk': 43, 'deathsNumAtRisk': 43, 'otherNumAffected': 22, 'seriousNumAtRisk': 43, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': '60 mg Avatrombopag (Lower Baseline Platelet Count)', 'description': 'Participants with a baseline platelet count of less than 40 x 10\\^9/L took three 20 mg tablets (60 mg total) avatrombopag (2nd generation) orally, once daily with a meal on Days 1 through 5.', 'otherNumAtRisk': 70, 'deathsNumAtRisk': 70, 'otherNumAffected': 30, 'seriousNumAtRisk': 70, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': '40 mg Placebo (Higher Baseline Platelet Count)', 'description': 'Participants with a baseline platelet count of greater than or equal to 40 to less than 50 x 10\\^9/L took two 20 mg matching placebo tablets orally, once daily with a meal on Days 1 through 5.', 'otherNumAtRisk': 33, 'deathsNumAtRisk': 33, 'otherNumAffected': 15, 'seriousNumAtRisk': 33, 'deathsNumAffected': 1, 'seriousNumAffected': 1}, {'id': 'EG003', 'title': '40 mg Avatrombopag (Higher Baseline Platelet Count)', 'description': 'Participants with a baseline platelet count of greater than or equal to 40 to less than 50 x 10\\^9/L took two 20 mg tablets (40 mg total) avatrombopag (2nd generation) orally, once daily with a meal on Days 1 through 5.', 'otherNumAtRisk': 57, 'deathsNumAtRisk': 57, 'otherNumAffected': 14, 'seriousNumAtRisk': 57, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 33, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 57, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 33, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 57, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 57, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 33, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 57, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 57, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Puncture site haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 33, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 57, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 33, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 57, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Transfusion reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 33, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 57, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 33, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 57, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 33, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 57, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Haematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 33, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 57, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}], 'seriousEvents': [{'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 33, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 57, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Haematemesis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 57, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Ileus paralytic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 57, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Multiple organ dysfunction syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 33, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 57, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Hepatic encephalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 57, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Acute respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 57, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants Who Did Not Require a Platelet Transfusion After Randomization and up to 7 Days Following a Scheduled Procedure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}, {'value': '58', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '60 mg Placebo (Lower Baseline Platelet Count)', 'description': 'Participants with a baseline platelet count of less than 40 x 10\\^9/liters (L) took three 20 milligram (mg) matching placebo tablets orally, once daily with a meal on Days 1 through 5.'}, {'id': 'OG001', 'title': '60 mg Avatrombopag (Lower Baseline Platelet Count)', 'description': 'Participants with a baseline platelet count of less than 40 x 10\\^9/L took three 20 mg tablets (60 mg total) avatrombopag (2nd generation) orally, once daily with a meal on Days 1 through 5.'}, {'id': 'OG002', 'title': '40 mg Placebo (Higher Baseline Platelet Count)', 'description': 'Participants with a baseline platelet count of greater than or equal to 40 to less than 50 x 10\\^9/L took two 20 mg matching placebo tablets orally, once daily with a meal on Days 1 through 5.'}, {'id': 'OG003', 'title': '40 mg Avatrombopag (Higher Baseline Platelet Count)', 'description': 'Participants with a baseline platelet count of greater than or equal to 40 to less than 50 x 10\\^9/L took two 20 mg tablets (40 mg total) avatrombopag (2nd generation) orally, once daily with a meal on Days 1 through 5.'}], 'classes': [{'categories': [{'measurements': [{'value': '34.9', 'groupId': 'OG000', 'lowerLimit': '20.6', 'upperLimit': '49.1'}, {'value': '68.6', 'groupId': 'OG001', 'lowerLimit': '57.7', 'upperLimit': '79.4'}, {'value': '33.3', 'groupId': 'OG002', 'lowerLimit': '17.2', 'upperLimit': '49.4'}, {'value': '87.9', 'groupId': 'OG003', 'lowerLimit': '79.5', 'upperLimit': '96.3'}]}]}], 'analyses': [{'pValue': '=0.0006', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference of proportion versus placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '33.7', 'ciLowerLimit': '15.8', 'ciUpperLimit': '51.6', 'estimateComment': 'Difference of proportion vs placebo = proportion of Responders for avatrombopag - proportion of Responders for placebo; 95% CI is calculated based on normal approximation.', 'groupDescription': 'The null hypothesis was that the proportion of participants not requiring a platelet transfusion or any rescue procedure for bleeding after randomization and up to 7 days following a scheduled procedure was the same between the 60 mg avatrombopag and matched placebo treatment groups.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Stratified by the risk of bleeding associated with the scheduled procedure within each Baseline platelet count cohort.'}, {'pValue': '<0.0001', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Difference of proportion versus placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '54.6', 'ciLowerLimit': '36.5', 'ciUpperLimit': '72.7', 'estimateComment': 'Difference of proportion vs placebo = proportion of Responders for avatrombopag - proportion of Responders for placebo; 95% CI is calculated based on normal approximation.', 'groupDescription': 'The null hypothesis was that the proportion of participants not requiring a platelet transfusion or any rescue procedure for bleeding after randomization and up to 7 days following a scheduled procedure was the same between the 60 mg avatrombopag and matched placebo treatment groups.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Stratified by the risk of bleeding associated with the scheduled procedure within each Baseline platelet count cohort'}], 'paramType': 'NUMBER', 'timeFrame': 'Randomization (Visit 2), up to 7 Days following a scheduled procedure', 'description': 'Responders were defined as participants who did not require a platelet transfusion or any rescue procedure for bleeding after randomization and up to 7 days following a scheduled procedure. Participants with missing information due to early withdrawal or other reasons were conservatively considered as having received a transfusion in the analysis, (i.e. a Non-responder).', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis Set (FAS) was defined as the group of all randomized participants.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Achieved a Platelet Count Greater Than or Equal to 50 x 10^9/L on Scheduled Procedure Day', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}, {'value': '58', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '60 mg Placebo (Lower Baseline Platelet Count)', 'description': 'Participants with a baseline platelet count of less than 40 x 10\\^9/L took three 20 mg matching placebo tablets orally, once daily with a meal on Days 1 through 5.'}, {'id': 'OG001', 'title': '60 mg Avatrombopag (Lower Baseline Platelet Count)', 'description': 'Participants with a baseline platelet count of less than 40 x 10\\^9/L took three 20 mg tablets (60 mg total) avatrombopag (2nd generation) orally, once daily with a meal on Days 1 through 5.'}, {'id': 'OG002', 'title': '40 mg Placebo (Higher Baseline Platelet Count)', 'description': 'Participants with a baseline platelet count of greater than or equal to 40 to less than 50 x 10\\^9/L took two 20 mg matching placebo tablets orally, once daily with a meal on Days 1 through 5.'}, {'id': 'OG003', 'title': '40 mg Avatrombopag (Higher Baseline Platelet Count)', 'description': 'Participants with a baseline platelet count of greater than or equal to 40 to less than 50 x 10\\^9/L took two 20 mg tablets (40 mg total) avatrombopag (2nd generation) orally, once daily with a meal on Days 1 through 5.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '14.6'}, {'value': '67.1', 'groupId': 'OG001', 'lowerLimit': '56.1', 'upperLimit': '78.1'}, {'value': '39.4', 'groupId': 'OG002', 'lowerLimit': '22.7', 'upperLimit': '56.1'}, {'value': '93.1', 'groupId': 'OG003', 'lowerLimit': '86.6', 'upperLimit': '99.6'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference of proportion versus placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '60.2', 'ciLowerLimit': '46.8', 'ciUpperLimit': '73.5', 'estimateComment': 'Difference of proportion vs placebo = proportion of responders for avatrombopag - proportion of responders for placebo; 95% CI is calculated based on normal approximation.', 'groupDescription': 'The null hypothesis was that the proportion of participants not requiring a platelet transfusion or any rescue procedure for bleeding after randomization and up to 7 days following a scheduled procedure was the same between the avatrombopag and placebo treatment groups.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Stratified by the risk of bleeding associated with the scheduled procedure within each Baseline platelet count cohort.'}, {'pValue': '<0.0001', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Difference of proportion versus placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '53.7', 'ciLowerLimit': '35.8', 'ciUpperLimit': '71.6', 'estimateComment': 'Difference of proportion vs placebo = proportion of responders for avatrombopag - proportion of responders for placebo; 95% CI is calculated based on normal approximation.', 'groupDescription': 'The null hypothesis was that the proportion of participants not requiring a platelet transfusion or any rescue procedure for bleeding after randomization and up to 7 days following a scheduled procedure was the same between the avatrombopag and placebo treatment groups', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Stratified by the risk of bleeding associated with the scheduled procedure within each Baseline platelet count cohort.'}], 'paramType': 'NUMBER', 'timeFrame': 'Day 10 to Day 13 (Visit 4)', 'description': 'Responders were defined as participants who achieved a platelet count greater than or equal to 50 x 10\\^9/L on the procedure day. Participants missing a platelet count on the procedure day were conservatively considered as not achieving a platelet count of 50x10\\^9/L in the analysis, (i.e. Non-responders).', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Platelet Counts on Scheduled Procedure Day', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}, {'value': '58', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '60 mg Placebo (Lower Baseline Platelet Count)', 'description': 'Participants with a baseline platelet count of less than 40 x 10\\^9/L took three 20 mg matching placebo tablets orally, once daily with a meal on Days 1 through 5.'}, {'id': 'OG001', 'title': '60 mg Avatrombopag (Lower Baseline Platelet Count)', 'description': 'Participants with a baseline platelet count of less than 40 x 10\\^9/L took three 20 mg tablets (60 mg total) avatrombopag (2nd generation) orally, once daily with a meal on Days 1 through 5.'}, {'id': 'OG002', 'title': '40 mg Placebo (Higher Baseline Platelet Count)', 'description': 'Participants with a baseline platelet count of greater than or equal to 40 to less than 50 x 10\\^9/L took two 20 mg matching placebo tablets orally, once daily with a meal on Days 1 through 5.'}, {'id': 'OG003', 'title': '40 mg Avatrombopag (Higher Baseline Platelet Count)', 'description': 'Participants with a baseline platelet count of greater than or equal to 40 to less than 50 x 10\\^9/L took two 20 mg tablets (40 mg total) avatrombopag (2nd generation) orally, once daily with a meal on Days 1 through 5.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.0', 'spread': '10.01', 'groupId': 'OG000'}, {'value': '31.3', 'spread': '24.9', 'groupId': 'OG001'}, {'value': '5.9', 'spread': '14.89', 'groupId': 'OG002'}, {'value': '44.9', 'spread': '32.96', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in change of platelet count', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '25.4', 'ciLowerLimit': '19.5', 'ciUpperLimit': '32.0', 'estimateComment': 'Difference in change from Baseline of platelet count for avatrombopag versus placebo within each Baseline platelet count cohort was based on Hodges-Lehmann estimation; 95% CI was the asymptotic (Moses) CI', 'statisticalMethod': 'Wilcoxon Rank Sum Test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'P-value was based on Wilcoxon Rank Sum Test for each avatrombopag treatment group versus placebo within each Baseline platelet count cohort.'}, {'pValue': '<0.0001', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Difference in change of platelet count', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '36.3', 'ciLowerLimit': '25.5', 'ciUpperLimit': '45.5', 'estimateComment': 'Difference in change from baseline of platelet count for avatrombopag vs. placebo within each baseline platelet count cohort is based on Hodges-Lehmann estimation; 95% confidence interval is the asymptotic (Moses) CI.', 'statisticalMethod': 'Wilcoxon Rank Sum Test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'P-value was based on Wilcoxon Rank Sum Test for each avatrombopag treatment group versus placebo within each Baseline platelet count cohort.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Visit 2) to Procedure Day 10 to Day 13 (Visit 4)', 'description': 'Last observation carried forward was used for participants with a missing platelet count on the scheduled procedure day. Platelet count was measured preprocedure and before any platelet transfusion.', 'unitOfMeasure': 'platelet count x 10^9 per liter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS. Only those participants with data available at both Baseline and post-Baseline were analyzed.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percentage of Participants With a World Health Organization (WHO) Bleeding Score Greater Than or Equal to 2 After Randomization and up to 7 Days After an Scheduled Procedure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}, {'value': '58', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '60 mg Placebo (Lower Baseline Platelet Count)', 'description': 'Participants with a baseline platelet count of less than 40 x 10\\^9/L took three 20 mg matching placebo tablets orally, once daily with a meal on Days 1 through 5.'}, {'id': 'OG001', 'title': '60 mg Avatrombopag (Lower Baseline Platelet Count)', 'description': 'Participants with a baseline platelet count of less than 40 x 10\\^9/L took three 20 mg tablets (60 mg total) avatrombopag (2nd generation) orally, once daily with a meal on Days 1 through 5.'}, {'id': 'OG002', 'title': '40 mg Placebo (Higher Baseline Platelet Count)', 'description': 'Participants with a baseline platelet count of greater than or equal to 40 to less than 50 x 10\\^9/L took two 20 mg matching placebo tablets orally, once daily with a meal on Days 1 through 5.'}, {'id': 'OG003', 'title': '40 mg Avatrombopag (Higher Baseline Platelet Count)', 'description': 'Participants with a baseline platelet count of greater than or equal to 40 to less than 50 x 10\\^9/L took two 20 mg tablets (40 mg total) avatrombopag (2nd generation) orally, once daily with a meal on Days 1 through 5.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '1.4', 'groupId': 'OG001'}, {'value': '6.1', 'groupId': 'OG002'}, {'value': '1.7', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (Visit 2) up to 7 days post scheduled procedure', 'description': 'The severity of bleeding events was assessed by the investigator (or appropriately delegated study site personnel) using the WHO bleeding scale. The WHO bleeding scale is a clinical investigator-assessed five-point scale with Grade 0 = No bleeding, Grade 1 = Petechial bleeding, Grade 2 = Mild blood loss (clinically significant), Grade 3 = Gross blood loss requires transfusion (severe), and Grade 4 = Debilitating blood loss, retinal or cerebral associated with fatality. Participants with missing information are considered as having a WHO bleeding score greater than or equal to 2 in the analysis.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants Experiencing an Adverse Event', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}, {'value': '57', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '60 mg Placebo (Lower Baseline Platelet Count)', 'description': 'Participants with a baseline platelet count of less than 40 x 10\\^9/L took three 20 mg matching placebo tablets orally, once daily with a meal on Days 1 through 5.'}, {'id': 'OG001', 'title': '60 mg Avatrombopag (Lower Baseline Platelet Count)', 'description': 'Participants with a baseline platelet count of less than 40 x 10\\^9/L took three 20 mg tablets (60 mg total) avatrombopag (2nd generation) orally, once daily with a meal on Days 1 through 5.'}, {'id': 'OG002', 'title': '40 mg Placebo (Higher Baseline Platelet Count)', 'description': 'Participants with a baseline platelet count of greater than or equal to 40 to less than 50 x 10\\^9/L took two 20 mg matching placebo tablets orally, once daily with a meal on Days 1 through 5.'}, {'id': 'OG003', 'title': '40 mg Avatrombopag (Higher Baseline Platelet Count)', 'description': 'Participants with a baseline platelet count of greater than or equal to 40 to less than 50 x 10\\^9/L took two 20 mg tablets (40 mg total) avatrombopag (2nd generation) orally, once daily with a meal on Days 1 through 5.'}], 'classes': [{'title': 'TEAEs', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}]}]}, {'title': 'Treatment-related TEAEs', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}]}, {'title': 'Serious TEAEs', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'TEAEs leading to study drug dose adjustment', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'TEAEs leading to study drug withdrawal', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'TEAEs leading to study drug dose reduction', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'TEAEs leading to study drug dose interruption', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From date of first dose of study drug up to 30 days after the last dose of study drug, up to approximately 3 years and 2 months', 'description': 'Safety assessments consisted of monitoring and recording all adverse events (AEs) and serious adverse events, including platelet transfusion-related complications; routine laboratory evaluation for hematology, serum chemistry, and urine values; periodic measurement of vital signs and electrocardiograms (ECGs); the performance of physical examinations; and Doppler sonography. AE severity was graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0, where Grade 1 = mild, Grade 2 = moderate, Grade 3 = Severe, Grade 4 = Life-threatening, and Grade 5 = Death related to the AE. All AEs graded as 4 or 5 were considered to be serious. Treatment-emergent adverse events (TEAEs) were defined as an AE that started on or after the date of first dose of study drug, up to 30 days after the last dose of study drug. Treatment-related AEs were considered by the investigator to be possibly or probably related to study drug.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set included all participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. One participant in the High Baseline Platelet Count Cohort received 60 mg avatrombopag and hence was included in the \\<40×10\\^9/L Low Baseline Platelet Count Cohort in all safety analyses.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '60 mg Placebo (Lower Baseline Platelet Count)', 'description': 'Participants with a baseline platelet count of less than 40 x 10\\^9/liters (L) took three 20 millilgrams (mg) matching placebo tablets orally, once daily with a meal on Days 1 through 5.'}, {'id': 'FG001', 'title': '60 mg Avatrombopag (Lower Baseline Platelet Count)', 'description': 'Participants with a baseline platelet count of less than 40 x 10\\^9/L took three 20 mg tablets (60 mg total) avatrombopag (2nd generation) orally, once daily with a meal on Days 1 through 5.'}, {'id': 'FG002', 'title': '40 mg Placebo (Higher Baseline Platelet Count)', 'description': 'Participants with a baseline platelet count of greater than or equal to 40 to less than 50 x 10\\^9/L took two 20 mg matching placebo tablets orally, once daily with a meal on Days 1 through 5.'}, {'id': 'FG003', 'title': '40 mg Avatrombopag (Higher Baseline Platelet Count)', 'description': 'Participants with a baseline platelet count of greater than or equal to 40 to less than 50 x 10\\^9/L took two 20 mg tablets (40 mg total) avatrombopag (2nd generation) orally, once daily with a meal on Days 1 through 5.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '43'}, {'groupId': 'FG001', 'numSubjects': '70'}, {'groupId': 'FG002', 'numSubjects': '33'}, {'groupId': 'FG003', 'numSubjects': '58'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '37'}, {'groupId': 'FG001', 'numSubjects': '68'}, {'groupId': 'FG002', 'numSubjects': '31'}, {'groupId': 'FG003', 'numSubjects': '55'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Subject Choice', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'A total of 346 participants signed informed consent. Of these 346 participants, 142 were screen failures and 204 were randomized into the study. Of the 142 screen failures, 119 did not meet inclusion/exclusion criteria and 13 withdrew consent, 3 experienced an adverse event, 1 was lost to follow-up and 6 had other not specified reasons.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'BG000'}, {'value': '70', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}, {'value': '58', 'groupId': 'BG003'}, {'value': '204', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': '60 mg Placebo (Lower Baseline Platelet Count)', 'description': 'Participants with a baseline platelet count of less than 40 x 10\\^9/liters (L) took three 20 milligrams (mg) matching placebo tablets orally, once daily with a meal on Days 1 through 5.'}, {'id': 'BG001', 'title': '60 mg Avatrombopag (Lower Baseline Platelet Count)', 'description': 'Participants with a baseline platelet count of less than 40 x 10\\^9/L took three 20 mg tablets (60 mg total) avatrombopag (2nd generation) orally, once daily with a meal on Days 1 through 5.'}, {'id': 'BG002', 'title': '40 mg Placebo (Higher Baseline Platelet Count)', 'description': 'Participants with a baseline platelet count of greater than or equal to 40 to less than 50 x 10\\^9/L took two 20 mg matching placebo tablets orally, once daily with a meal on Days 1 through 5.'}, {'id': 'BG003', 'title': '40 mg Avatrombopag (Higher Baseline Platelet Count)', 'description': 'Participants with a baseline platelet count of greater than or equal to 40 to less than 50 x 10\\^9/L took two 20 mg tablets (40 mg total) avatrombopag (2nd generation) orally, once daily with a meal on Days 1 through 5.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '57.3', 'spread': '11.98', 'groupId': 'BG000'}, {'value': '58.6', 'spread': '14.18', 'groupId': 'BG001'}, {'value': '59.2', 'spread': '10.31', 'groupId': 'BG002'}, {'value': '57.9', 'spread': '11.11', 'groupId': 'BG003'}, {'value': '58.2', 'spread': '12.24', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}, {'value': '25', 'groupId': 'BG003'}, {'value': '77', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}, {'value': '33', 'groupId': 'BG003'}, {'value': '127', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}, {'value': '45', 'groupId': 'BG004'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '56', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}, {'value': '42', 'groupId': 'BG003'}, {'value': '152', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '7', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Asian', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}, {'value': '55', 'groupId': 'BG004'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Black or African American', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}]}, {'title': 'White', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}, {'value': '40', 'groupId': 'BG003'}, {'value': '131', 'groupId': 'BG004'}]}, {'title': 'More than one race', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '11', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Full Analysis Set (FAS) was defined as the group of all randomized participants.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-12-02', 'size': 882226, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2017-12-22T13:08', 'hasProtocol': True}, {'date': '2017-02-16', 'size': 469958, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2018-01-29T10:53', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 204}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2017-02-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-01-29', 'studyFirstSubmitDate': '2013-10-24', 'resultsFirstSubmitDate': '2017-12-27', 'studyFirstSubmitQcDate': '2013-10-29', 'lastUpdatePostDateStruct': {'date': '2018-02-27', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-01-29', 'studyFirstPostDateStruct': {'date': '2013-11-05', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-02-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-01-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Percentage of Participants With a World Health Organization (WHO) Bleeding Score Greater Than or Equal to 2 After Randomization and up to 7 Days After an Scheduled Procedure', 'timeFrame': 'Baseline (Visit 2) up to 7 days post scheduled procedure', 'description': 'The severity of bleeding events was assessed by the investigator (or appropriately delegated study site personnel) using the WHO bleeding scale. The WHO bleeding scale is a clinical investigator-assessed five-point scale with Grade 0 = No bleeding, Grade 1 = Petechial bleeding, Grade 2 = Mild blood loss (clinically significant), Grade 3 = Gross blood loss requires transfusion (severe), and Grade 4 = Debilitating blood loss, retinal or cerebral associated with fatality. Participants with missing information are considered as having a WHO bleeding score greater than or equal to 2 in the analysis.'}, {'measure': 'Number of Participants Experiencing an Adverse Event', 'timeFrame': 'From date of first dose of study drug up to 30 days after the last dose of study drug, up to approximately 3 years and 2 months', 'description': 'Safety assessments consisted of monitoring and recording all adverse events (AEs) and serious adverse events, including platelet transfusion-related complications; routine laboratory evaluation for hematology, serum chemistry, and urine values; periodic measurement of vital signs and electrocardiograms (ECGs); the performance of physical examinations; and Doppler sonography. AE severity was graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0, where Grade 1 = mild, Grade 2 = moderate, Grade 3 = Severe, Grade 4 = Life-threatening, and Grade 5 = Death related to the AE. All AEs graded as 4 or 5 were considered to be serious. Treatment-emergent adverse events (TEAEs) were defined as an AE that started on or after the date of first dose of study drug, up to 30 days after the last dose of study drug. Treatment-related AEs were considered by the investigator to be possibly or probably related to study drug.'}], 'primaryOutcomes': [{'measure': 'Percentage of Participants Who Did Not Require a Platelet Transfusion After Randomization and up to 7 Days Following a Scheduled Procedure', 'timeFrame': 'Randomization (Visit 2), up to 7 Days following a scheduled procedure', 'description': 'Responders were defined as participants who did not require a platelet transfusion or any rescue procedure for bleeding after randomization and up to 7 days following a scheduled procedure. Participants with missing information due to early withdrawal or other reasons were conservatively considered as having received a transfusion in the analysis, (i.e. a Non-responder).'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants Who Achieved a Platelet Count Greater Than or Equal to 50 x 10^9/L on Scheduled Procedure Day', 'timeFrame': 'Day 10 to Day 13 (Visit 4)', 'description': 'Responders were defined as participants who achieved a platelet count greater than or equal to 50 x 10\\^9/L on the procedure day. Participants missing a platelet count on the procedure day were conservatively considered as not achieving a platelet count of 50x10\\^9/L in the analysis, (i.e. Non-responders).'}, {'measure': 'Change From Baseline in Platelet Counts on Scheduled Procedure Day', 'timeFrame': 'Baseline (Visit 2) to Procedure Day 10 to Day 13 (Visit 4)', 'description': 'Last observation carried forward was used for participants with a missing platelet count on the scheduled procedure day. Platelet count was measured preprocedure and before any platelet transfusion.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Thrombocytopenia', 'Chronic Liver Disease'], 'conditions': ['Thrombocytopenia Associated With Liver Disease']}, 'referencesModule': {'references': [{'pmid': '32047671', 'type': 'DERIVED', 'citation': 'Poordad F, Terrault NA, Alkhouri N, Tian W, Allen LF, Rabinovitz M. Avatrombopag, an Alternate Treatment Option to Reduce Platelet Transfusions in Patients with Thrombocytopenia and Chronic Liver Disease-Integrated Analyses of 2 Phase 3 Studies. Int J Hepatol. 2020 Jan 25;2020:5421632. doi: 10.1155/2020/5421632. eCollection 2020.'}, {'pmid': '29778606', 'type': 'DERIVED', 'citation': 'Terrault N, Chen YC, Izumi N, Kayali Z, Mitrut P, Tak WY, Allen LF, Hassanein T. Avatrombopag Before Procedures Reduces Need for Platelet Transfusion in Patients With Chronic Liver Disease and Thrombocytopenia. Gastroenterology. 2018 Sep;155(3):705-718. doi: 10.1053/j.gastro.2018.05.025. Epub 2018 May 17.'}]}, 'descriptionModule': {'briefSummary': 'This is a global, multicenter, randomized, double-blind, placebo-controlled, parallel group study using avatrombopag to treat adults with thrombocytopenia associated with liver disease. The study will evaluate avatrombopag in the treatment of thrombocytopenia associated with liver disease prior to an elective procedure to reduce the need for platelet transfusions or any rescue procedure for bleeding due to procedural and post-procedural bleeding complications. Participants will be enrolled into 2 cohorts according to mean baseline platelet count and, within each baseline platelet count cohort will be further stratified by risk of bleeding associated with the elective procedure (low, moderate, or high) and hepatocellular carcinoma (HCC) status (Yes or No).', 'detailedDescription': 'This study will consist of 3 phases: Prerandomization, Randomization, and a Follow-up Phase. The Prerandomization Phase includes one Screening Visit that will take place from Day -14 through Day -1; the Randomization Phase includes the Baseline Period, Treatment Period, and Procedure Day Period (5 to 8 days after last dose of study drug \\[Study Day 10 to 13\\]). The Follow-up Phase comprises 2 visits: 7 days post Procedure Day and 30 days after receiving the last dose of study drug. Permitted procedures include: Paracentesis; Thoracentesis; Gastrointestinal endoscopy with or without plans for biopsy, colonoscopy, polypectomy, or variceal banding; Liver biopsy; Bronchoscopy with or without plans for biopsy; Ethanol ablation therapy or chemoembolization for HCC; Vascular catheterization (including right side procedures in participants with pulmonary hypertension); Transjugular intrahepatic portosystemic shunt; Dental procedures; Renal biopsy; Biliary interventions; Nephrostomy tube placement; Radiofrequency ablation; and Laparoscopic interventions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria\n\n1. Participants greater than or equal to 18 years of age at Screening with chronic liver disease\n2. Participants who have a mean baseline platelet count of less than 50 x 10\\^9/L. Platelet counts must be measured on 2 separate occasions, during the Screening Period and at Baseline, and must be performed at least one day apart with neither platelet count greater than 60 x 10\\^9/L. The mean of these 2 platelet counts (mean baseline platelet count) will be used for entry criteria and for assignment to the low or high baseline platelet count cohort.\n3. Participants scheduled to undergo a permitted elective procedure who, in the opinion of the investigator, will require a platelet transfusion to address a risk of bleeding associated with the procedure unless there is a clinically significant increase in platelet count from baseline\n4. Model For End-stage Liver Disease (MELD) score less than or equal to 24 at Screening\n5. If taking inhibitors of P glycoprotein (P-gp), except for verapamil, dose must be stable for 7 days prior to Screening\n6. Provide written informed consent\n7. Willing and able to comply with all aspects of the protocol\n\nExclusion Criteria\n\n1. Any history of arterial or venous thrombosis, including partial or complete thrombosis\n2. Evidence of thrombosis (partial or complete) in the main portal vein, portal vein branches, or any part of the splenic mesenteric system at Screening\n3. Portal vein blood flow velocity rate \\<10 centimeters/second at Screening\n4. Hepatic encephalopathy that cannot be effectively treated\n5. Participants with HCC with Barcelona Clinic Liver Cancer (BCLC) staging classification C or D\n6. Platelet transfusion or receipt of blood products containing platelets within 7 days of Screening. However packed red blood cells are permitted.\n7. Heparin, warfarin, nonsteroidal anti-inflammatory drugs (NSAID), aspirin, verapamil, and antiplatelet therapy with ticlopidine or glycoprotein IIb/IIIa antagonists (eg, tirofiban) within 7 days of Screening\n8. Use of erythropoietin stimulating agents within 7 days of Screening\n9. Interferon (IFN) use within 14 days of Screening\n10. Estrogen-containing hormonal contraceptive or hormone replacement therapy use within 30 days of Screening\n11. Active infection requiring systemic antibiotic therapy within 7 days of Screening. However, prophylactic use of antibiotics is permitted.\n12. Alcohol abuse, alcohol dependence syndrome, drug abuse, or drug dependence within 6 months of the study start (unless participating in a controlled rehabilitation program) or acute alcoholic hepatitis (chronic alcoholic hepatitis is allowed) within 6 months of the study start\n13. Elective procedure performed prior to Visit 4 (Procedure Day)\n14. Known to be human immunodeficiency virus positive\n15. Any clinically significant acute or active bleeding (eg, gastrointestinal, central nervous system)\n16. Known history of any primary hematologic disorder (eg, immune thrombocytopenic purpura, myelodysplastic syndrome)\n17. Known medical history of genetic prothrombotic syndromes (eg, Factor V Leiden; prothrombin G20210A; ATIII deficiency, etc.)\n18. Participants with a history of significant cardiovascular disease (eg, congestive heart failure New York Heart Association Grade III/IV, arrhythmia known to increase the risk of thromboembolic events \\[eg, atrial fibrillation\\], coronary artery stent placement, angioplasty, and coronary artery bypass grafting)\n19. Females of childbearing potential who have had unprotected sexual intercourse within 30 days before study entry and who do not agree to use a highly effective method of contraception (eg, total abstinence, an intrauterine device, a double-barrier method \\[such as condom plus diaphragm with spermicide\\], a progesterone-only contraceptive implant/injection, or have a vasectomized partner with confirmed azoospermia) throughout the entire study period and for 30 days after study drug discontinuation. If currently abstinent, the participant must agree to use a double-barrier method as described above if she becomes sexually active during the study period or for 30 days after study drug discontinuation. All females will be considered to be of childbearing potential unless they are postmenopausal (at least 12 months consecutive amenorrhea in the appropriate age group and without other known or suspected cause) or have been sterilized surgically (ie, bilateral tubal ligation, hysterectomy, or bilateral oophorectomy) at least 1 month before dosing.\n20. Females who are lactating or pregnant at Screening or Baseline (as documented by a positive serum beta-human chorionic gonadotropin \\[B-hCG\\] test with a minimum sensitivity 25 IU/L or equivalent units of B-hCG). A separate baseline assessment is required if a negative screening pregnancy test was obtained more than 72 hours before the first dose of study drug.\n21. Post liver transplant subjects\n22. Any participant who has previously received avatrombopag\n23. Hypersensitivity to avatrombopag maleate or any of its excipients\n24. Hemoglobin levels ≤ 8.0 or ≥ 18.0 g/dL for men and \\> 15 for women at Screening, with hematocrit ≥ 54% for men and ≥ 45% for women\n25. Current malignancy including solid tumors and hematologic malignancies (except HCC)\n26. Any history of concomitant medical condition that, in the opinion of the investigator(s), would compromise the participant's ability to safely complete the study\n27. 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