Ignite Creation Date:
2025-12-24 @ 7:03 PM
Ignite Modification Date:
2025-12-30 @ 5:57 PM
Study NCT ID:
NCT00454857
Status:
COMPLETED
Last Update Posted:
2013-11-26
First Post:
2007-03-29
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Retrospective & Prospective Observational Study of Patients With Immune (Idiopathic) Thrombocytopenic Purpura (ITP)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Australia', 'France', 'Germany', 'Italy', 'Spain', 'United Kingdom', 'United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D016553', 'term': 'Purpura, Thrombocytopenic, Idiopathic'}, {'id': 'D013921', 'term': 'Thrombocytopenia'}, {'id': 'D011696', 'term': 'Purpura, Thrombocytopenic'}], 'ancestors': [{'id': 'D011693', 'term': 'Purpura'}, {'id': 'D001778', 'term': 'Blood Coagulation Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D057049', 'term': 'Thrombotic Microangiopathies'}, {'id': 'D001791', 'term': 'Blood Platelet Disorders'}, {'id': 'D000095542', 'term': 'Cytopenia'}, {'id': 'D006474', 'term': 'Hemorrhagic Disorders'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012877', 'term': 'Skin Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '866-572-6436', 'title': 'Study Director', 'organization': 'Amgen Inc.'}, 'certainAgreement': {'otherDetails': "The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results aftercompletion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'description': 'No AEs were collected for this protocol', 'eventGroups': [{'id': 'EG000', 'title': 'Overall Study', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants Utilizing Immune (Idiopathic) Thrombocytopenic Purpura (ITP) Therapies for First-line Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '326', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Patients With ITP', 'description': 'Patients diagnosed with ITP were followed prospectively for a period of 12 months.'}], 'classes': [{'title': 'Corticosteroids', 'categories': [{'measurements': [{'value': '128', 'groupId': 'OG000'}]}]}, {'title': 'IVIG (Intravenous immunoglobulin)', 'categories': [{'measurements': [{'value': '37', 'groupId': 'OG000'}]}]}, {'title': 'Rituximab', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Anti-D immunoglobulin', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}]}]}, {'title': 'Splenectomy', 'categories': [{'measurements': [{'value': '74', 'groupId': 'OG000'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Includes the retrospective chart review (from the date of enrollment retrospectively to the date of diagnosis or the previous 36 months, whichever was less) and the prospective portion of the study (enrollment through Month 12).', 'description': 'The number of participants who received ITP therapies for first-line treatment during either the retrospective or prospective phases of the study.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled participants'}, {'type': 'PRIMARY', 'title': 'The Number of Participants Utilizing ITP Therapies for Second-line Treatment.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '326', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Patients With ITP', 'description': 'Patients diagnosed with ITP were followed prospectively for a period of 12 months.'}], 'classes': [{'title': 'Corticosteroids', 'categories': [{'measurements': [{'value': '98', 'groupId': 'OG000'}]}]}, {'title': 'IVIG', 'categories': [{'measurements': [{'value': '54', 'groupId': 'OG000'}]}]}, {'title': 'Rituximab', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}]}]}, {'title': 'Anti-D immunoglobulin', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}]}]}, {'title': 'Splenectomy', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '48', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Includes the retrospective chart review (from the date of enrollment retrospectively to the date of diagnosis or the previous 36 months, whichever was less) and the prospective portion of the study (enrollment through Month 12).', 'description': 'The number of participants who received ITP therapies for second-line treatment during either the retrospective or prospective phases of the study.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled participants'}, {'type': 'PRIMARY', 'title': 'The Number of Participants Utilizing ITP Therapies for Third-line Treatment.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '326', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Patients With ITP', 'description': 'Patients diagnosed with ITP were followed prospectively for a period of 12 months.'}], 'classes': [{'title': 'Corticosteroids', 'categories': [{'measurements': [{'value': '47', 'groupId': 'OG000'}]}]}, {'title': 'IVIG', 'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000'}]}]}, {'title': 'Rituximab', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}]}]}, {'title': 'Anti-D immunoglobulin', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}]}]}, {'title': 'Splenectomy', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Includes the retrospective chart review (from the date of enrollment retrospectively to the date of diagnosis or the previous 36 months, whichever was less) and the prospective portion of the study (enrollment through Month 12).', 'description': 'The number of participants who received ITP therapies for third-line treatment during either the retrospective or prospective phases of the study.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled participants'}, {'type': 'PRIMARY', 'title': 'The Number of Participants Utilizing ITP Therapies for Fourth-line Treatment.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '326', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Patients With ITP', 'description': 'Patients diagnosed with ITP were followed prospectively for a period of 12 months.'}], 'classes': [{'title': 'Corticosteroids', 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}]}]}, {'title': 'IVIG', 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}]}]}, {'title': 'Rituximab', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}]}]}, {'title': 'Anti-D immunoglobulin', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}]}]}, {'title': 'Splenectomy', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '56', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Includes the retrospective chart review (from the date of enrollment retrospectively to the date of diagnosis or the previous 36 months, whichever was less) and the prospective portion of the study (enrollment through Month 12).', 'description': 'The number of participants who received ITP therapies for fourth-line treatment during either the retrospective or prospective phases of the study.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled participants'}, {'type': 'PRIMARY', 'title': 'The Number of Participants Utilizing ITP Therapies for Fifth-line Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '326', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Patients With ITP', 'description': 'Patients diagnosed with ITP were followed prospectively for a period of 12 months.'}], 'classes': [{'title': 'Corticosteriods', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}]}]}, {'title': 'IVIG', 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}]}]}, {'title': 'Rituximab', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}]}]}, {'title': 'Anti-D immunoglobulin', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}]}]}, {'title': 'Splenectomy', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '41', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Includes the retrospective chart review (from the date of enrollment retrospectively to the date of diagnosis or the previous 36 months, whichever was less) and the prospective portion of the study (enrollment through Month 12).', 'description': 'The number of participants who received ITP therapies for fifth-line treatment during either the retrospective or prospective phases of the study.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled participants'}, {'type': 'PRIMARY', 'title': 'The Number of Participants Utilizing ITP Therapies for Sixth-line Treatment.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '326', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Patients With ITP', 'description': 'Patients diagnosed with ITP were followed prospectively for a period of 12 months.'}], 'classes': [{'title': 'Corticosteriods', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}]}]}, {'title': 'IVIG', 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}]}]}, {'title': 'Rituximab', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}, {'title': 'Anti-D immunoglobulin', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}, {'title': 'Splenectomy', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Includes the retrospective chart review (from the date of enrollment retrospectively to the date of diagnosis or the previous 36 months, whichever was less) and the prospective portion of the study (enrollment through Month 12).', 'description': 'Assessed the number of participants who received ITP therapies for sixth-line treatment during either the retrospective or prospective phases of the study.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled participants'}, {'type': 'PRIMARY', 'title': 'The Number of Participants Utilizing ITP Therapies for Seventh or Greater-line Treatment.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '326', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Patients With ITP', 'description': 'Patients diagnosed with ITP were followed prospectively for a period of 12 months.'}], 'classes': [{'title': 'Corticosteroids', 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}]}]}, {'title': 'IVIG', 'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000'}]}]}, {'title': 'Rituximab', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}]}]}, {'title': 'Anti-D immunoglobulin', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}]}]}, {'title': 'Splenectomy', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '41', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Includes the retrospective chart review (from the date of enrollment retrospectively to the date of diagnosis or the previous 36 months, whichever was less) and the prospective portion of the study (enrollment through Month 12).', 'description': 'The number participants who received ITP therapies as seventh or greater-line treatment during either the retrospective or prospective phases of the study.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled participants'}, {'type': 'PRIMARY', 'title': 'The Number of Participants Utilizing ITP Therapies: Treatments With Unknown Starting Date.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '326', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Patients With ITP', 'description': 'Patients diagnosed with ITP were followed prospectively for a period of 12 months.'}], 'classes': [{'title': 'Corticosteroids', 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}]}]}, {'title': 'IVIG', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Rituximab', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Anti-D immunoglobulin', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Splenectomy', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Includes the retrospective chart review (from the date of enrollment retrospectively to the date of diagnosis or the previous 36 months, whichever was less) and the prospective portion of the study (enrollment through Month 12).', 'description': 'The number of participants who received ITP therapies for treatments with unknown starting date during either the retrospective or prospective phases of the study.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled participants'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Month 12 in Quality of Life Measured by the ITP-Patient Assessment Questionnaire (PAQ)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '274', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Patients With ITP', 'description': 'Patients diagnosed with ITP were followed prospectively for a period of 12 months.'}], 'classes': [{'title': 'Physical Health-Symptoms score', 'categories': [{'measurements': [{'value': '6.7', 'spread': '17.1', 'groupId': 'OG000'}]}]}, {'title': 'Physical Health - Fatigue score', 'categories': [{'measurements': [{'value': '7.2', 'spread': '23.7', 'groupId': 'OG000'}]}]}, {'title': 'Physical Health - Bother score', 'categories': [{'measurements': [{'value': '9.4', 'spread': '22', 'groupId': 'OG000'}]}]}, {'title': 'Physical Health - Activity score', 'categories': [{'measurements': [{'value': '9', 'spread': '24.5', 'groupId': 'OG000'}]}]}, {'title': 'Emotional Health - Psychological score', 'categories': [{'measurements': [{'value': '6.4', 'spread': '21.2', 'groupId': 'OG000'}]}]}, {'title': 'Emotional Health - Fear score', 'categories': [{'measurements': [{'value': '4', 'spread': '16', 'groupId': 'OG000'}]}]}, {'title': 'Quality of Life score', 'categories': [{'measurements': [{'value': '9.2', 'spread': '21.9', 'groupId': 'OG000'}]}]}, {'title': 'Social Quality of Life score', 'categories': [{'measurements': [{'value': '3.4', 'spread': '15.5', 'groupId': 'OG000'}]}]}, {'title': "Woman's Reproductive Health (WRH) score", 'categories': [{'measurements': [{'value': '4.7', 'spread': '17', 'groupId': 'OG000'}]}]}, {'title': 'WRH: Menstrual Symptoms score', 'categories': [{'measurements': [{'value': '5.9', 'spread': '22.4', 'groupId': 'OG000'}]}]}, {'title': "Woman's Reproductive Health: Fertility score", 'categories': [{'measurements': [{'value': '4.2', 'spread': '19', 'groupId': 'OG000'}]}]}, {'title': 'Work Quality of Life score', 'categories': [{'measurements': [{'value': '3.8', 'spread': '14', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to month 12 during prospective data collection phase', 'description': "The Immune Thrombocytopenic Purpura Patient Assessment Questionnaire (ITP-PAQ) was developed to assess disease-specific quality of life (QoL) in adults with ITP. It is a 44-item questionnaire that includes scales for physical health (symptoms, fatigue/sleep, bother, and activity), emotional health (psychological and fear), overall QoL, social activity, women's reproductive health, and work. Scores for each scale range from 0 (worst) to 100 (best).", 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Patient Reported Outcome (PRO) Analysis Set includes all participants who completed at least one questionnaire during the prospective observation period.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Month 12 in Health-related Quality of Life Assessed by EuroQol Visual Analog Scale (EQ-5D VAS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '274', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Patients With ITP', 'description': 'Patients diagnosed with ITP were followed prospectively for a period of 12 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.1', 'spread': '18.00', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Month 12 during prospective data collection phase', 'description': "The EQ VAS records the respondent's self-rated health on a vertical, visual analogue scale where the endpoints are labelled 'Best imaginable health state' (score = 100) and 'Worst imaginable health state' (score = 0).", 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Patient Reported Outcome (PRO) Analysis Set includes all subjects who completed at least one questionnaire during the prospective observation period.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Month 12 in Treatment Satisfaction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '274', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Patients With ITP', 'description': 'Patients diagnosed with ITP were followed prospectively for a period of 12 months.'}], 'classes': [{'title': 'Overall Satisfaction score', 'categories': [{'measurements': [{'value': '1.8', 'spread': '19.40', 'groupId': 'OG000'}]}]}, {'title': 'Efficacy score', 'categories': [{'measurements': [{'value': '2.8', 'spread': '21.02', 'groupId': 'OG000'}]}]}, {'title': 'Side Effects score', 'categories': [{'measurements': [{'value': '7.9', 'spread': '20.79', 'groupId': 'OG000'}]}]}, {'title': 'Convenience score', 'categories': [{'measurements': [{'value': '0.3', 'spread': '17.74', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Month 12 during prospective data collection phase', 'description': 'Participant satisfaction with treatment was measured using the Treatment Satisfaction Questionnaire for Medication (TSQM), an 11-item questionnaire providing scores on four scales - side effects, effectiveness, convenience and global satisfaction. TSQM Scale scores range from 0 to 100 with higher scores indicating more satisfaction with treatment.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Patient Reported Outcome (PRO) Analysis Set includes all participants who completed at least one questionnaire during the prospective observation period.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Receiving Drug Therapies for Treatment of ITP During the Prospective Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '319', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Patients With ITP', 'description': 'Patients diagnosed with ITP were followed prospectively for a period of 12 months.'}], 'classes': [{'title': 'Anti-D', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}]}]}, {'title': 'Azathioprine', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}]}]}, {'title': 'Corticosteroids-IV (Intravenous)', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}, {'title': 'Corticosteroids-Oral', 'categories': [{'measurements': [{'value': '49', 'groupId': 'OG000'}]}]}, {'title': 'Cyclophosphamide', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Danazol', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}]}]}, {'title': 'IVIG', 'categories': [{'measurements': [{'value': '42', 'groupId': 'OG000'}]}]}, {'title': 'Rituximab', 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}]}]}, {'title': 'Vincristine/Vinblastine', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '43', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 months (prospective data collection phase)', 'description': 'The number of participants who received drug therapies for the treatment of ITP during the prospective phase of the study. Use of multiple medications by the same participants is possible.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled participants who completed at least 1 observational study visit during the prospective phase.'}, {'type': 'SECONDARY', 'title': 'Duration of Exposure to ITP Medication', 'denoms': [{'units': 'Participants', 'counts': [{'value': '319', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Patients With ITP', 'description': 'Patients diagnosed with ITP were followed prospectively for a period of 12 months.'}], 'classes': [{'title': 'Anti-D immunoglobulin (N=14)', 'categories': [{'measurements': [{'value': '2.0', 'spread': '3.90', 'groupId': 'OG000'}]}]}, {'title': 'Azathioprine (N=13)', 'categories': [{'measurements': [{'value': '7.3', 'spread': '5.18', 'groupId': 'OG000'}]}]}, {'title': 'Corticosteriods-Intravenous (N=7)', 'categories': [{'measurements': [{'value': '0.2', 'spread': '0.41', 'groupId': 'OG000'}]}]}, {'title': 'Corticosteriods-Oral (N=37)', 'categories': [{'measurements': [{'value': '3.6', 'spread': '3.78', 'groupId': 'OG000'}]}]}, {'title': 'Cyclophosphamide (N=4)', 'categories': [{'measurements': [{'value': '1.5', 'spread': '1.59', 'groupId': 'OG000'}]}]}, {'title': 'Danazol (N=18)', 'categories': [{'measurements': [{'value': '7.5', 'spread': '4.27', 'groupId': 'OG000'}]}]}, {'title': 'Intravenous immunoglobulin (N=41)', 'categories': [{'measurements': [{'value': '0.7', 'spread': '2.00', 'groupId': 'OG000'}]}]}, {'title': 'Rituximab (N=24)', 'categories': [{'measurements': [{'value': '0.7', 'spread': '0.44', 'groupId': 'OG000'}]}]}, {'title': 'Vincristine/Vinblastine (N=1)', 'categories': [{'measurements': [{'value': '0.0', 'spread': 'NA', 'comment': 'Only 1 participant with data', 'groupId': 'OG000'}]}]}, {'title': 'Other (N=42)', 'categories': [{'measurements': [{'value': '6.6', 'spread': '6.57', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 months (prospective data collection phase)', 'description': 'Duration of exposure to each ITP medication measured from enrollment until the end of the 12-month data collection phase.', 'unitOfMeasure': 'Months', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled participants who completed at least 1 observational study visit during the prospective phase. N=number of participants using each medication.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Requiring Splenectomy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '319', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Patients With ITP', 'description': 'Patients diagnosed with ITP were followed prospectively for a period of 12 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 months', 'description': 'The number of participants who required a splenectomy during the 12-month prospective phase of the study.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled participants who completed at least 1 observational study visit during the prospective phase.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Patients With ITP', 'description': 'Patients diagnosed with Immune (Idiopathic) Thrombocytopenic Purpura (ITP) were followed prospectively for a period of 12 months.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '326'}]}, {'type': 'Completed Retrospective Chart Review', 'achievements': [{'groupId': 'FG000', 'numSubjects': '324'}]}, {'type': 'Completed ≥1 Observational Study Visit', 'achievements': [{'groupId': 'FG000', 'numSubjects': '319'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '272'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '54'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '15'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '16'}]}, {'type': 'Noncompliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}]}, {'type': 'Reason unknown', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '326', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Patients With ITP', 'description': 'Patients diagnosed with ITP were followed prospectively for a period of 12 months.'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '53.4', 'spread': '18.1', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '195', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '131', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'NONE_RETAINED', 'description': 'None retained.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 326}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-10', 'completionDateStruct': {'date': '2008-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-10-23', 'studyFirstSubmitDate': '2007-03-29', 'resultsFirstSubmitDate': '2009-10-16', 'studyFirstSubmitQcDate': '2007-03-29', 'lastUpdatePostDateStruct': {'date': '2013-11-26', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2010-04-23', 'studyFirstPostDateStruct': {'date': '2007-04-02', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2010-05-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants Utilizing Immune (Idiopathic) Thrombocytopenic Purpura (ITP) Therapies for First-line Treatment', 'timeFrame': 'Includes the retrospective chart review (from the date of enrollment retrospectively to the date of diagnosis or the previous 36 months, whichever was less) and the prospective portion of the study (enrollment through Month 12).', 'description': 'The number of participants who received ITP therapies for first-line treatment during either the retrospective or prospective phases of the study.'}, {'measure': 'The Number of Participants Utilizing ITP Therapies for Second-line Treatment.', 'timeFrame': 'Includes the retrospective chart review (from the date of enrollment retrospectively to the date of diagnosis or the previous 36 months, whichever was less) and the prospective portion of the study (enrollment through Month 12).', 'description': 'The number of participants who received ITP therapies for second-line treatment during either the retrospective or prospective phases of the study.'}, {'measure': 'The Number of Participants Utilizing ITP Therapies for Third-line Treatment.', 'timeFrame': 'Includes the retrospective chart review (from the date of enrollment retrospectively to the date of diagnosis or the previous 36 months, whichever was less) and the prospective portion of the study (enrollment through Month 12).', 'description': 'The number of participants who received ITP therapies for third-line treatment during either the retrospective or prospective phases of the study.'}, {'measure': 'The Number of Participants Utilizing ITP Therapies for Fourth-line Treatment.', 'timeFrame': 'Includes the retrospective chart review (from the date of enrollment retrospectively to the date of diagnosis or the previous 36 months, whichever was less) and the prospective portion of the study (enrollment through Month 12).', 'description': 'The number of participants who received ITP therapies for fourth-line treatment during either the retrospective or prospective phases of the study.'}, {'measure': 'The Number of Participants Utilizing ITP Therapies for Fifth-line Treatment', 'timeFrame': 'Includes the retrospective chart review (from the date of enrollment retrospectively to the date of diagnosis or the previous 36 months, whichever was less) and the prospective portion of the study (enrollment through Month 12).', 'description': 'The number of participants who received ITP therapies for fifth-line treatment during either the retrospective or prospective phases of the study.'}, {'measure': 'The Number of Participants Utilizing ITP Therapies for Sixth-line Treatment.', 'timeFrame': 'Includes the retrospective chart review (from the date of enrollment retrospectively to the date of diagnosis or the previous 36 months, whichever was less) and the prospective portion of the study (enrollment through Month 12).', 'description': 'Assessed the number of participants who received ITP therapies for sixth-line treatment during either the retrospective or prospective phases of the study.'}, {'measure': 'The Number of Participants Utilizing ITP Therapies for Seventh or Greater-line Treatment.', 'timeFrame': 'Includes the retrospective chart review (from the date of enrollment retrospectively to the date of diagnosis or the previous 36 months, whichever was less) and the prospective portion of the study (enrollment through Month 12).', 'description': 'The number participants who received ITP therapies as seventh or greater-line treatment during either the retrospective or prospective phases of the study.'}, {'measure': 'The Number of Participants Utilizing ITP Therapies: Treatments With Unknown Starting Date.', 'timeFrame': 'Includes the retrospective chart review (from the date of enrollment retrospectively to the date of diagnosis or the previous 36 months, whichever was less) and the prospective portion of the study (enrollment through Month 12).', 'description': 'The number of participants who received ITP therapies for treatments with unknown starting date during either the retrospective or prospective phases of the study.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline to Month 12 in Quality of Life Measured by the ITP-Patient Assessment Questionnaire (PAQ)', 'timeFrame': 'Baseline to month 12 during prospective data collection phase', 'description': "The Immune Thrombocytopenic Purpura Patient Assessment Questionnaire (ITP-PAQ) was developed to assess disease-specific quality of life (QoL) in adults with ITP. It is a 44-item questionnaire that includes scales for physical health (symptoms, fatigue/sleep, bother, and activity), emotional health (psychological and fear), overall QoL, social activity, women's reproductive health, and work. Scores for each scale range from 0 (worst) to 100 (best)."}, {'measure': 'Change From Baseline to Month 12 in Health-related Quality of Life Assessed by EuroQol Visual Analog Scale (EQ-5D VAS)', 'timeFrame': 'Baseline to Month 12 during prospective data collection phase', 'description': "The EQ VAS records the respondent's self-rated health on a vertical, visual analogue scale where the endpoints are labelled 'Best imaginable health state' (score = 100) and 'Worst imaginable health state' (score = 0)."}, {'measure': 'Change From Baseline to Month 12 in Treatment Satisfaction', 'timeFrame': 'Baseline to Month 12 during prospective data collection phase', 'description': 'Participant satisfaction with treatment was measured using the Treatment Satisfaction Questionnaire for Medication (TSQM), an 11-item questionnaire providing scores on four scales - side effects, effectiveness, convenience and global satisfaction. TSQM Scale scores range from 0 to 100 with higher scores indicating more satisfaction with treatment.'}, {'measure': 'Number of Participants Receiving Drug Therapies for Treatment of ITP During the Prospective Phase', 'timeFrame': '12 months (prospective data collection phase)', 'description': 'The number of participants who received drug therapies for the treatment of ITP during the prospective phase of the study. Use of multiple medications by the same participants is possible.'}, {'measure': 'Duration of Exposure to ITP Medication', 'timeFrame': '12 months (prospective data collection phase)', 'description': 'Duration of exposure to each ITP medication measured from enrollment until the end of the 12-month data collection phase.'}, {'measure': 'Number of Participants Requiring Splenectomy', 'timeFrame': '12 months', 'description': 'The number of participants who required a splenectomy during the 12-month prospective phase of the study.'}]}, 'conditionsModule': {'keywords': ['Thrombocytopenia', 'Chart Review', 'Platelet', 'Retrospective', 'Prospective', 'Non-interventional', 'Health Resource Utilization (HRU)', 'Quality of Life (QOL)', 'Immune Thrombocytopenic Purpura (ITP)', 'Idiopathic Thrombocytopenic Purpura (ITP)', 'Immune (Idiopathic) Thrombocytopenic Purpura (ITP)', 'Observational'], 'conditions': ['Idiopathic Thrombocytopenic Purpura', 'Thrombocytopenia', 'Thrombocytopenia in Subjects With Immune (Idiopathic) Thrombocytopenic Purpura (ITP)', 'Thrombocytopenic Purpura']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.nplate.com/', 'label': 'FDA-approved Drug Labeling'}, {'url': 'http://www.amgentrials.com', 'label': 'AmgenTrials clinical trials website'}]}, 'descriptionModule': {'briefSummary': "This is a multi-center prospective observational descriptive study complemented by a retrospective chart review. Patients diagnosed with ITP and currently treated for ITP by a hematologist or hematologist-oncologist will be recruited from community-based clinics and academic/referral centers. They will be followed prospectively for a period of 12 months. At inception, participants' charts will also be reviewed from the date of enrollment retrospectively to the date of diagnosis or the previous 36 months, whichever is less.", 'detailedDescription': 'Time Perspective: 12 months prospective chart review study with a retrospective chart review for a period up to 36 months from the start of the study, since the date of diagnosis for ITP.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients s diagnosed with ITP and currently treated for ITP by a hematologist or hematologist-oncologist recruited from community based clinics and adademic/referral centers.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Has a diagnosis of ITP according to the American Society of Hematology guidelines (George et al., 1996).\n* Is equal to or greater than 18 years of age.\n* Is willing and able to complete a series of questionnaires.\n* Before any study-specific procedure, the appropriate written informed consent must be obtained.\n\nExclusion Criteria:\n\n* Participated in clinical trial(s) during the past 36 months.\n* Is considering participation in a clinical trial within the next 12 months.'}, 'identificationModule': {'nctId': 'NCT00454857', 'briefTitle': 'Retrospective & Prospective Observational Study of Patients With Immune (Idiopathic) Thrombocytopenic Purpura (ITP)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Amgen'}, 'officialTitle': 'A Prospective Observational Descriptive Study and Retrospective Chart Review of Subjects With Immune (Idiopathic) Thrombocytopenic Purpura (ITP)', 'orgStudyIdInfo': {'id': '20050237'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with ITP', 'description': 'Participants with ITP and currently treated for ITP were followed prospectively for a period of 12 months.', 'interventionNames': ['Other: Retrospective Chart Review', 'Other: Patient-reported Outcome Questionnaires', 'Other: Physician Survey']}], 'interventions': [{'name': 'Retrospective Chart Review', 'type': 'OTHER', 'description': 'Retrospective chart review for up to 36 months of enrollment date.', 'armGroupLabels': ['Patients with ITP']}, {'name': 'Patient-reported Outcome Questionnaires', 'type': 'OTHER', 'description': 'Quality of lige questionnaires as well as treatment satisfaction questionnaires are required monthly. Includes QOL, ITP-PAQ (immune thrombocytopenic purpura - patient assessment questionnaire), EQ-5D, and TSQM (Treatment Satisfaction Questionnaire for Medication).', 'armGroupLabels': ['Patients with ITP']}, {'name': 'Physician Survey', 'type': 'OTHER', 'description': 'Physician characteristics to be collected include demographics, years of practice, medical specialty or primary treating physician, and the referral process.', 'armGroupLabels': ['Patients with ITP']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Amgen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Amgen', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}