Ignite Creation Date:
2025-12-25 @ 3:39 AM
Ignite Modification Date:
2026-01-06 @ 6:51 AM
Study NCT ID:
NCT00567502
Status:
COMPLETED
Last Update Posted:
2021-06-09
First Post:
2007-12-04
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety and Pregnancy Outcomes in Thrombocythemia Patients Exposed to XAGRID® (Anagrelide Hydrochloride) Compared to Other Treatments
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013920', 'term': 'Thrombocythemia, Essential'}], 'ancestors': [{'id': 'D001778', 'term': 'Blood Coagulation Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D013922', 'term': 'Thrombocytosis'}, {'id': 'D001791', 'term': 'Blood Platelet Disorders'}, {'id': 'D009196', 'term': 'Myeloproliferative Disorders'}, {'id': 'D001855', 'term': 'Bone Marrow Diseases'}, {'id': 'D006474', 'term': 'Hemorrhagic Disorders'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTransparency@shire.com', 'phone': '+1 866 842 5335', 'title': 'Study Director', 'organization': 'Shire'}, 'certainAgreement': {'otherDetails': 'If a multicenter publication is not submitted within twelve (12) months after conclusion, abandonment or termination of the Study at all sites, or after Sponsor confirms there shall be no multicenter Study publication, the Institution and/or such Principal Investigator may publish the results from the Institution site individually.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': "Results for other adverse events (excluding SAEs) was reported under OM 1 due to limitation in basic result's format, as SAEs and non-SAEs were not planned to be reported separately."}}, 'adverseEventsModule': {'timeFrame': 'Up to 5 years', 'description': 'SSARs \\[defined in outcome measure (OM) 2\\]= SAEs considered related to cytoreductive drug and only "XAGRID" and "Other" treatment groups were to be reported. SAEs and non-SAEs was not planned to be reported separately, therefore, reported under OM 1.', 'eventGroups': [{'id': 'EG000', 'title': 'XAGRID', 'description': 'Participants who received XAGRID from "Xagrid only" or "Xagrid+other (cytoreductives)" arm groups (for serious adverse events) at a dose and mode of administration managed as per investigator\'s discretion and the relevant Summary of Product Characteristics (SmPC) at the time of registering into the study or after switching from another treatment (other adverse events) any time during the 5 year observation period.', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 1300, 'seriousNumAffected': 37}, {'id': 'EG001', 'title': 'Other (Cytoreductives)', 'description': 'Participants who received other (cytoreductives) from " other (cytoreductives" or "Xagrid+other (cytoreductives)" arm groups (for serious adverse events) at a dose and mode of administration managed as per investigator\'s discretion and the relevant Summary of Product Characteristics (SmPC) at the time of registering into the study or after switching from another treatment (other adverse events) any time during the 5 year observation period. Other Cytoreductives included Hydroxyurea, Interferon- alpha, Pegylated interferon, Busulphan, Pipobroman, Sodium phosphate P32.', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 3069, 'seriousNumAffected': 70}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1300, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3069, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1300, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3069, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1300, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3069, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Pancytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1300, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3069, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Splenic infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1300, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3069, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1300, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3069, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1300, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3069, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1300, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3069, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1300, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 3069, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1300, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 3069, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Cardiac failure Congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1300, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 3069, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Cardiomyopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1300, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3069, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Left ventricular failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1300, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 3069, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Myocardial Infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1300, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 3069, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1300, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 3069, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Pericardial effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1300, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3069, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1300, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3069, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1300, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3069, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Enteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1300, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3069, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1300, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 3069, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Haemorrhagic erosive gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1300, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3069, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Melaena', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1300, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3069, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Mouth ulceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1300, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3069, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Rectal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1300, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3069, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1300, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3069, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1300, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3069, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Drug hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1300, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3069, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1300, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3069, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1300, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3069, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Klebsiella sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1300, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3069, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1300, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3069, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Overdose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1300, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3069, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Post procedural haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1300, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3069, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Skin injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1300, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3069, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Haemoglobin decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1300, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3069, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1300, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3069, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Acute myeloid leukaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1300, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3069, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Basal cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1300, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3069, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Bladder cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1300, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3069, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Lung neoplasm malignant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1300, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3069, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Metastases to adrenals', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1300, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3069, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Myelodysplastic syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1300, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3069, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Myelodysplastic syndrome transformation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1300, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3069, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Myelofibrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1300, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3069, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Neoplasm skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1300, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3069, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Refractory anaemia with an excess of blasts', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1300, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3069, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Squamous cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1300, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3069, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Squamous cell carcinoma of skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1300, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3069, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1300, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3069, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1300, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3069, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1300, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3069, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Subarachnoid haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1300, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3069, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Transient ischaemic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1300, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3069, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Vasculitis cerebral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1300, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3069, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Confusional state', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1300, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3069, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Menorrhagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1300, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3069, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Acute pulmonary oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1300, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3069, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1300, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3069, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1300, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 3069, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Pneumonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1300, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3069, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Pulmonary fibrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1300, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3069, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Pulmonary hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1300, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 3069, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Erythrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1300, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3069, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Skin ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1300, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3069, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Aneurysm ruptured', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1300, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3069, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Venous thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1300, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3069, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With At Least One Pre-Defined Event (PDE), Deaths, Pregnancies', 'denoms': [{'units': 'Participants', 'counts': [{'value': '804', 'groupId': 'OG000'}, {'value': '141', 'groupId': 'OG001'}, {'value': '2666', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'XAGRID Only', 'description': "Participants who received XAGRID at a dose and mode of administration managed as per investigator's discretion and the relevant SmPC at the time of registering into the study or after switching from another treatment any time during the 5 year observation period."}, {'id': 'OG001', 'title': 'XAGRID+Other (Cytoreductives)', 'description': "Participants who received XAGRID+Other (Cytoreductives) at a dose and mode of administration managed as per investigator's discretion and the relevant SmPC at the time of registering into the study or after switching from another treatment any time during the 5 year observation period. Other Cytoreductives included Hydroxyurea, Interferon- alpha, Pegylated interferon, Busulphan, Pipobroman, Sodium phosphate P32."}, {'id': 'OG002', 'title': 'Other (Cytoreductives)', 'description': "Participants who received other (Cytoreductives) at a dose and mode of administration managed as per investigator's discretion and the relevant SmPC at the time of registering into the study or after switching from another treatment any time during the 5 year observation period. Other Cytoreductives included Hydroxyurea, Interferon- alpha, Pegylated interferon, Busulphan, Pipobroman, Sodium phosphate P32."}], 'classes': [{'title': 'Myocardial infarction', 'categories': [{'measurements': [{'value': '1.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '1.5', 'groupId': 'OG002'}]}]}, {'title': 'Angina', 'categories': [{'measurements': [{'value': '0.7', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.7', 'groupId': 'OG002'}]}]}, {'title': 'Congestive heart failure', 'categories': [{'measurements': [{'value': '1.2', 'groupId': 'OG000'}, {'value': '1.4', 'groupId': 'OG001'}, {'value': '1.2', 'groupId': 'OG002'}]}]}, {'title': 'Cardiomyopathy', 'categories': [{'measurements': [{'value': '0.5', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.3', 'groupId': 'OG002'}]}]}, {'title': 'Other cardiovascular symptoms', 'categories': [{'measurements': [{'value': '5.8', 'groupId': 'OG000'}, {'value': '8.5', 'groupId': 'OG001'}, {'value': '3.2', 'groupId': 'OG002'}]}]}, {'title': 'Stroke', 'categories': [{'measurements': [{'value': '1.4', 'groupId': 'OG000'}, {'value': '1.4', 'groupId': 'OG001'}, {'value': '1.8', 'groupId': 'OG002'}]}]}, {'title': 'Transient ischemic attack', 'categories': [{'measurements': [{'value': '1.1', 'groupId': 'OG000'}, {'value': '0.7', 'groupId': 'OG001'}, {'value': '1.3', 'groupId': 'OG002'}]}]}, {'title': 'Severe Mucocutaneous Disorders', 'categories': [{'measurements': [{'value': '0.5', 'groupId': 'OG000'}, {'value': '1.4', 'groupId': 'OG001'}, {'value': '2.4', 'groupId': 'OG002'}]}]}, {'title': 'Pulmonary hypertension', 'categories': [{'measurements': [{'value': '0.5', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.2', 'groupId': 'OG002'}]}]}, {'title': 'Pulmonary fibrosis/ Interstitial pneumonia', 'categories': [{'measurements': [{'value': '0.1', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.3', 'groupId': 'OG002'}]}]}, {'title': 'Venous thromboembolic events', 'categories': [{'measurements': [{'value': '0.5', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '1.9', 'groupId': 'OG002'}]}]}, {'title': 'Pancreatitis', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.1', 'groupId': 'OG002'}]}]}, {'title': 'Intermittent Claudication/ digital ischaemia', 'categories': [{'measurements': [{'value': '0.7', 'groupId': 'OG000'}, {'value': '0.7', 'groupId': 'OG001'}, {'value': '0.6', 'groupId': 'OG002'}]}]}, {'title': 'Transformations', 'categories': [{'measurements': [{'value': '4.5', 'groupId': 'OG000'}, {'value': '6.4', 'groupId': 'OG001'}, {'value': '3.1', 'groupId': 'OG002'}]}]}, {'title': 'Myelofibrosis', 'categories': [{'measurements': [{'value': '3.5', 'groupId': 'OG000'}, {'value': '5.0', 'groupId': 'OG001'}, {'value': '1.1', 'groupId': 'OG002'}]}]}, {'title': 'Myelodysplasia', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.5', 'groupId': 'OG002'}]}]}, {'title': 'Acute leukaemia', 'categories': [{'measurements': [{'value': '0.2', 'groupId': 'OG000'}, {'value': '1.4', 'groupId': 'OG001'}, {'value': '1.0', 'groupId': 'OG002'}]}]}, {'title': 'Other leukaemia', 'categories': [{'measurements': [{'value': '0.6', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.5', 'groupId': 'OG002'}]}]}, {'title': 'Other transformations', 'categories': [{'measurements': [{'value': '0.1', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.1', 'groupId': 'OG002'}]}]}, {'title': 'Major haemorrhagic events', 'categories': [{'measurements': [{'value': '3.0', 'groupId': 'OG000'}, {'value': '0.7', 'groupId': 'OG001'}, {'value': '1.6', 'groupId': 'OG002'}]}]}, {'title': 'Rhabdomyolysis/ myalgia', 'categories': [{'measurements': [{'value': '0.2', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.1', 'groupId': 'OG002'}]}]}, {'title': 'Non-haematological malignancy', 'categories': [{'measurements': [{'value': '1.5', 'groupId': 'OG000'}, {'value': '1.4', 'groupId': 'OG001'}, {'value': '4.6', 'groupId': 'OG002'}]}]}, {'title': 'Non-PDE death', 'categories': [{'measurements': [{'value': '2.2', 'groupId': 'OG000'}, {'value': '1.4', 'groupId': 'OG001'}, {'value': '3.9', 'groupId': 'OG002'}]}]}, {'title': 'Pregnancy', 'categories': [{'measurements': [{'value': '0.5', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.5', 'groupId': 'OG002'}]}]}, {'title': 'Thrombohaemorrhagic events', 'categories': [{'measurements': [{'value': '8.1', 'groupId': 'OG000'}, {'value': '3.5', 'groupId': 'OG001'}, {'value': '8.5', 'groupId': 'OG002'}]}]}, {'title': 'Major thrombotic events', 'categories': [{'measurements': [{'value': '5.3', 'groupId': 'OG000'}, {'value': '2.8', 'groupId': 'OG001'}, {'value': '7.3', 'groupId': 'OG002'}]}]}, {'title': 'Arterial events', 'categories': [{'measurements': [{'value': '4.9', 'groupId': 'OG000'}, {'value': '2.8', 'groupId': 'OG001'}, {'value': '5.5', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 5 years', 'description': 'Pre-defined events (PDEs) were evaluated whenever an event occurred and was defined by a panel of independent qualified physicians, blinded to cytoreductive therapy, validated all PDEs prior to analysis (Event Validation Panel). Non-PDE death only included deaths not recorded as outcome of another PDE.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'First Treatment Safety Population included participants who received cytoreductive therapy at registration. All events/data were allocated to the treatment that a participant was receiving at the time of the event/assessment.'}, {'type': 'SECONDARY', 'title': 'Event Rate of Thrombohaemorrhagic Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1127', 'groupId': 'OG000'}, {'value': '451', 'groupId': 'OG001'}, {'value': '2909', 'groupId': 'OG002'}, {'value': '645', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'XAGRID Only', 'description': "Participants who received XAGRID at a dose and mode of administration managed as per investigator's discretion and the relevant SmPC at the time of registering into the study or after switching from another treatment any time during the 5 year observation period."}, {'id': 'OG001', 'title': 'XAGRID+Other (Cytoreductives)', 'description': "Participants who received XAGRID+Other (Cytoreductives) at a dose and mode of administration managed as per investigator's discretion and the relevant SmPC at the time of registering into the study or after switching from another treatment any time during the 5 year observation period. Other Cytoreductives included Hydroxyurea, Interferon- alpha, Pegylated interferon, Busulphan, Pipobroman, Sodium phosphate P32."}, {'id': 'OG002', 'title': 'Other (Cytoreductives)', 'description': "Participants who received other (Cytoreductives) at a dose and mode of administration managed as per investigator's discretion and the relevant SmPC at the time of registering into the study or after switching from another treatment any time during the 5 year observation period. Other Cytoreductives included Hydroxyurea, Interferon- alpha, Pegylated interferon, Busulphan, Pipobroman, Sodium phosphate P32."}, {'id': 'OG003', 'title': 'No Essential Thrombocythemia (ET) Therapy', 'description': "Participants who were not receiving any cytoreductive treatment for at least 28 consecutive days at the time of registering into the study for a 5 year observation period, during which participants were able to switch treatments per investigator's discretion."}], 'classes': [{'categories': [{'measurements': [{'value': '2.75', 'groupId': 'OG000'}, {'value': '2.86', 'groupId': 'OG001'}, {'value': '2.60', 'groupId': 'OG002'}, {'value': '4.91', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 5 years', 'description': 'Event Rate of Thrombohaemorrhagic Events was calculated by dividing number of participants with events by total patient-year exposure. The reporting unit is per 100 participant-years of treatment exposure. Thrombohaemorrhagic Events is a composite endpoint of the PDEs myocardial infarction, angina, stroke, transient ischaemic attack, venous thromboembolic events, intermittent claudication/digital ischaemia, and major haemorrhagic events.', 'unitOfMeasure': 'participants/100 participant-years', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall Treatment Safety Population. As participant could switch between therapies a participant with an event could be allocated to more than one therapy group. Participants analyzed included who were exposed to the specific treatment any time during the study.'}, {'type': 'SECONDARY', 'title': 'Platelet Count', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1127', 'groupId': 'OG000'}, {'value': '451', 'groupId': 'OG001'}, {'value': '2909', 'groupId': 'OG002'}, {'value': '645', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'XAGRID Only', 'description': "Participants who received XAGRID at a dose and mode of administration managed as per investigator's discretion and the relevant SmPC at the time of registering into the study or after switching from another treatment any time during the 5 year observation period."}, {'id': 'OG001', 'title': 'XAGRID+Other (Cytoreductives)', 'description': "Participants who received XAGRID+Other (Cytoreductives) at a dose and mode of administration managed as per investigator's discretion and the relevant SmPC at the time of registering into the study or after switching from another treatment any time during the 5 year observation period. Other Cytoreductives included Hydroxyurea, Interferon- alpha, Pegylated interferon, Busulphan, Pipobroman, Sodium phosphate P32."}, {'id': 'OG002', 'title': 'Other (Cytoreductives)', 'description': "Participants who received other (Cytoreductives) at a dose and mode of administration managed as per investigator's discretion and the relevant SmPC at the time of registering into the study or after switching from another treatment any time during the 5 year observation period.Other Cytoreductives included Hydroxyurea, Interferon- alpha, Pegylated interferon, Busulphan, Pipobroman, Sodium phosphate P32."}, {'id': 'OG003', 'title': 'No Essential Thrombocythemia (ET) Therapy', 'description': "Participants who were not receiving any cytoreductive treatment for at least 28 consecutive days at the time of registering into the study for a 5 year observation period, during which participants were able to switch treatments per investigator's discretion."}], 'classes': [{'title': 'Baseline (n = 671, 120, 2279,136)', 'categories': [{'measurements': [{'value': '486.90', 'spread': '210.106', 'groupId': 'OG000'}, {'value': '542.77', 'spread': '250.440', 'groupId': 'OG001'}, {'value': '471.29', 'spread': '201.620', 'groupId': 'OG002'}, {'value': '837.23', 'spread': '377.104', 'groupId': 'OG003'}]}]}, {'title': 'Month 6 (n = 777, 145, 2469, 60)', 'categories': [{'measurements': [{'value': '1093.73', 'spread': '17634.779', 'groupId': 'OG000'}, {'value': '521.44', 'spread': '266.512', 'groupId': 'OG001'}, {'value': '439.44', 'spread': '153.766', 'groupId': 'OG002'}, {'value': '545.30', 'spread': '202.936', 'groupId': 'OG003'}]}]}, {'title': 'Month 12 (n= 739, 158, 2400, 81)', 'categories': [{'measurements': [{'value': '969.61', 'spread': '14404.677', 'groupId': 'OG000'}, {'value': '516.66', 'spread': '245.789', 'groupId': 'OG001'}, {'value': '436.64', 'spread': '154.958', 'groupId': 'OG002'}, {'value': '501.46', 'spread': '275.880', 'groupId': 'OG003'}]}]}, {'title': 'Month 18 (n= 706, 170, 2231, 86)', 'categories': [{'measurements': [{'value': '1612.14', 'spread': '22193.573', 'groupId': 'OG000'}, {'value': '541.78', 'spread': '706.564', 'groupId': 'OG001'}, {'value': '432.99', 'spread': '145.694', 'groupId': 'OG002'}, {'value': '476.72', 'spread': '245.450', 'groupId': 'OG003'}]}]}, {'title': 'Month 24 (n= 673, 181, 2106, 119)', 'categories': [{'measurements': [{'value': '865.09', 'spread': '11047.483', 'groupId': 'OG000'}, {'value': '492.67', 'spread': '194.534', 'groupId': 'OG001'}, {'value': '1025.11', 'spread': '15888.471', 'groupId': 'OG002'}, {'value': '499.29', 'spread': '249.164', 'groupId': 'OG003'}]}]}, {'title': 'Month 30 (n= 642, 183, 2001, 116)', 'categories': [{'measurements': [{'value': '418.97', 'spread': '159.129', 'groupId': 'OG000'}, {'value': '467.37', 'spread': '170.733', 'groupId': 'OG001'}, {'value': '693.30', 'spread': '8293.353', 'groupId': 'OG002'}, {'value': '467.54', 'spread': '255.641', 'groupId': 'OG003'}]}]}, {'title': 'Month 36 (n= 628, 167, 1917, 124)', 'categories': [{'measurements': [{'value': '423.10', 'spread': '153.278', 'groupId': 'OG000'}, {'value': '1138.81', 'spread': '8787.658', 'groupId': 'OG001'}, {'value': '1221.09', 'spread': '20612.960', 'groupId': 'OG002'}, {'value': '462.06', 'spread': '256.357', 'groupId': 'OG003'}]}]}, {'title': 'Month 42 (n= 597, 161, 1799, 138)', 'categories': [{'measurements': [{'value': '831.62', 'spread': '10257.081', 'groupId': 'OG000'}, {'value': '466.83', 'spread': '205.575', 'groupId': 'OG001'}, {'value': '1898.48', 'spread': '26724.419', 'groupId': 'OG002'}, {'value': '463.52', 'spread': '271.690', 'groupId': 'OG003'}]}]}, {'title': 'Month 48 (n= 581, 167, 1735, 131)', 'categories': [{'measurements': [{'value': '2461.07', 'spread': '28879.771', 'groupId': 'OG000'}, {'value': '443.91', 'spread': '173.453', 'groupId': 'OG001'}, {'value': '1360.17', 'spread': '20669.182', 'groupId': 'OG002'}, {'value': '457.44', 'spread': '250.165', 'groupId': 'OG003'}]}]}, {'title': 'Month 54 (n= 557, 164, 1644, 132)', 'categories': [{'measurements': [{'value': '413.93', 'spread': '145.601', 'groupId': 'OG000'}, {'value': '447.17', 'spread': '171.608', 'groupId': 'OG001'}, {'value': '1771.77', 'spread': '25187.992', 'groupId': 'OG002'}, {'value': '408.41', 'spread': '254.971', 'groupId': 'OG003'}]}]}, {'title': 'Month 60 (n = 523, 167, 1586, 144)', 'categories': [{'measurements': [{'value': '1174.87', 'spread': '17473.437', 'groupId': 'OG000'}, {'value': '466.31', 'spread': '193.689', 'groupId': 'OG001'}, {'value': '1362.94', 'spread': '19098.693', 'groupId': 'OG002'}, {'value': '425.22', 'spread': '268.377', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 6,12,18, 24, 30, 36, 42, 48, 54, 60', 'unitOfMeasure': '10^9 per Liter (10^9/L)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall Treatment Safety population, Here n = participants evaluable at specified time-points. As participant could switch between therapies a participant with an event could be allocated to more than one therapy group. Participants analyzed included who were exposed to the specific treatment any time during the study.'}, {'type': 'SECONDARY', 'title': 'Duration of Exposure for Each Essential Thrombocythemia (ET) Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1300', 'groupId': 'OG000'}, {'value': '2742', 'groupId': 'OG001'}, {'value': '193', 'groupId': 'OG002'}, {'value': '144', 'groupId': 'OG003'}, {'value': '105', 'groupId': 'OG004'}, {'value': '159', 'groupId': 'OG005'}, {'value': '12', 'groupId': 'OG006'}, {'value': '5', 'groupId': 'OG007'}, {'value': '91', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': 'XAGRID Taken', 'description': 'Participants who received XAGRID from "Xagrid only" or "Xagrid+other (cytoreductives)" arm groups at a dose and mode of administration managed as per investigator\'s discretion and the relevant SmPC at the time of registering into the study for a 5 year observation period.'}, {'id': 'OG001', 'title': 'Other (Cytoreductives)-Hydroxyurea', 'description': "Participants who received other (Cytoreductives)-Hydroxyurea at a dose and mode of administration managed as per investigator's discretion and the relevant SmPC, was observed for 5 years."}, {'id': 'OG002', 'title': 'Other (Cytoreductives)-Interferon Alpha', 'description': "Participants who received other (Cytoreductives)-Interferon Alpha at a dose and mode of administration managed as per investigator's discretion and the relevant SmPC, was observed for 5 years."}, {'id': 'OG003', 'title': 'Other (Cytoreductives)-Pegylated Interferon', 'description': "Participants who received other (Cytoreductives)-Pegylated Interferon at a dose and mode of administration managed as per investigator's discretion and the relevant SmPC, was observed for 5 years."}, {'id': 'OG004', 'title': 'Other (Cytoreductives)-Busulphan', 'description': "Participants who received other (Cytoreductives)-Busulphan at a dose and mode of administration managed as per investigator's discretion and the relevant SmPC, was observed for 5 years."}, {'id': 'OG005', 'title': 'Other (Cytoreductives)-Pipobroman', 'description': "Participants who received other (Cytoreductives)-Pipobroman at a dose and mode of administration managed as per investigator's discretion and the relevant SmPC, was observed for 5 years."}, {'id': 'OG006', 'title': 'Other (Cytoreductives)-Sodium Phosphate P32', 'description': "Participants who received other (Cytoreductives)-Sodium Phosphate P32 at a dose and mode of administration managed as per investigator's discretion and the relevant SmPC, was observed for 5 years."}, {'id': 'OG007', 'title': 'Other (Cytoreductives)-Thromboreductin', 'description': "Participants who received other (Cytoreductives)-Thromboreductin at a dose and mode of administration managed as per investigator's discretion and the relevant SmPC, was observed for 5 years."}, {'id': 'OG008', 'title': 'Other', 'description': "Participants who received other therapies at a dose and mode of administration managed as per investigator's discretion and the relevant SmPC, was observed for 5 years."}], 'classes': [{'categories': [{'measurements': [{'value': '1213.7', 'spread': '687.83', 'groupId': 'OG000'}, {'value': '1382.3', 'spread': '609.33', 'groupId': 'OG001'}, {'value': '933.3', 'spread': '748.09', 'groupId': 'OG002'}, {'value': '744.0', 'spread': '660.93', 'groupId': 'OG003'}, {'value': '510.2', 'spread': '560.28', 'groupId': 'OG004'}, {'value': '992.8', 'spread': '690.80', 'groupId': 'OG005'}, {'value': '39.7', 'spread': '96.73', 'groupId': 'OG006'}, {'value': '979.0', 'spread': '859.27', 'groupId': 'OG007'}, {'value': '446.3', 'spread': '561.46', 'groupId': 'OG008'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 5 years', 'description': 'Total duration for each participant = sum of \\[stop date - start date + 1\\] across all periods of time where the specific treatment was taken during the study, where start date = registration/consent date for treatments started before registration/consent date and/or stop date withdrawal/final date for treatments ongoing at the time of withdrawal/end of study. Where a participant has multiple records of the same therapy on the same day, the therapy is counted once for that day.', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall Treatment Safety Population. As participant could switch between therapies a participant with an event could be allocated to more than one therapy group. Participants analyzed included who were exposed to the specific treatment any time during the study.'}, {'type': 'SECONDARY', 'title': 'Cumulative Dose for Each Essential Thrombocythemia (ET) Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1162', 'groupId': 'OG000'}, {'value': '2168', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '92', 'groupId': 'OG004'}, {'value': '112', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '4', 'groupId': 'OG007'}, {'value': '70', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': 'XAGRID Only', 'description': "Participants who received XAGRID at a dose and mode of administration managed as per investigator's discretion and the relevant SmPC, was observed for 5 years."}, {'id': 'OG001', 'title': 'Other (Cytoreductives)-Hydroxyurea', 'description': "Participants who received other (Cytoreductives)-Hydroxyurea at a dose and mode of administration managed as per investigator's discretion and the relevant SmPC, was observed for 5 years."}, {'id': 'OG002', 'title': 'Other (Cytoreductives)-Interferon Alpha', 'description': "Participants who received other (Cytoreductives)-Interferon Alpha at a dose and mode of administration managed as per investigator's discretion and the relevant SmPC, was observed for 5 years."}, {'id': 'OG003', 'title': 'Other (Cytoreductives)-Pegylated Interferon', 'description': "Participants who received other (Cytoreductives)-Pegylated Interferon at a dose and mode of administration managed as per investigator's discretion and the relevant SmPC, was observed for 5 years."}, {'id': 'OG004', 'title': 'Other (Cytoreductives)-Busulphan', 'description': "Participants who received other (Cytoreductives)-Busulphan at a dose and mode of administration managed as per investigator's discretion and the relevant SmPC, was observed for 5 years."}, {'id': 'OG005', 'title': 'Other (Cytoreductives)-Pipobroman', 'description': "Participants who received other (Cytoreductives)-Pipobroman at a dose and mode of administration managed as per investigator's discretion and the relevant SmPC, was observed for 5 years."}, {'id': 'OG006', 'title': 'Other (Cytoreductives)-Sodium Phosphate P32', 'description': "Participants who received other (Cytoreductives)-Sodium Phosphate P32 at a dose and mode of administration managed as per investigator's discretion and the relevant SmPC, was observed for 5 years."}, {'id': 'OG007', 'title': 'Other (Cytoreductives)-Thromboreductin', 'description': "Participants who received other (Cytoreductives)-Thromboreductin at a dose and mode of administration managed as per investigator's discretion and the relevant SmPC, was observed for 5 years."}, {'id': 'OG008', 'title': 'Other', 'description': "Participants who received other therapies at a dose and mode of administration managed as per investigator's discretion and the relevant SmPC, was observed for 5 years."}], 'classes': [{'categories': [{'measurements': [{'value': '29096.2', 'spread': '291472.25', 'groupId': 'OG000'}, {'value': '957751.4', 'spread': '883174.77', 'groupId': 'OG001'}, {'value': '3592.2', 'spread': '5076.77', 'groupId': 'OG002'}, {'value': '5103.1', 'spread': '10730.47', 'groupId': 'OG003'}, {'value': '7749.6', 'spread': '56031.79', 'groupId': 'OG004'}, {'value': '28612.7', 'spread': '67374.96', 'groupId': 'OG005'}, {'value': '2745.0', 'groupId': 'OG006'}, {'value': '2140.0', 'spread': '835.26', 'groupId': 'OG007'}, {'value': '111639.7', 'spread': '190370.57', 'groupId': 'OG008'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 5 years', 'description': 'Since the study is observational nature, interpreting the table is difficult due to inconsistencies in reporting the units of the dose.', 'unitOfMeasure': 'milligram (mg)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall Treatment Safety Population. As participant could switch between therapies a participant with an event could be allocated to more than one therapy group. Participants analyzed included who were exposed to the specific treatment any time during the study.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Suspected Serious Adverse Reaction (SSAR) Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1300', 'groupId': 'OG000'}, {'value': '3069', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'XAGRID', 'description': "Participants who received XAGRID at a dose and mode of administration managed as per investigator's discretion and the relevant SmPC, was observed for 5 years."}, {'id': 'OG001', 'title': 'Other (Cytoreductives)', 'description': "Participants who received other (Cytoreductives) at a dose and mode of administration managed as per investigator's discretion and the relevant SmPC, was observed for 5 years. Other Cytoreductives included Hydroxyurea, Interferonalpha, Pegylated interferon, Busulphan, Pipobroman, Sodium phosphate P32."}], 'classes': [{'categories': [{'measurements': [{'value': '37', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 5 years', 'description': 'SSAR: serious adverse event (SAE) that was considered related to cytoreductive therapy. SAE: any untoward medical occurrence that at any dose resulted in death, life-threatening (at the time of the event), in-patient hospitalization/prolongation of existing hospitalization (elective hospitalizations/procedures for pre-existing conditions that had not worsened were excluded), resulted in persistent or significant disability/incapacity or congenital abnormality/birth defect. Relatedness (suspected/not suspected) to XAGRID or other cytoreductive theraphy was determined by the investigator. As for SSARs, it was important to consider whether the events were related to XAGRID or other cytoreductive therapy. A participant was included in Xagrid or other treatment group based on treatment exposure, participants received Xagrid + Other was counted both in Xagrid and other treatment group.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall treatment safety population. All events/data were allocated to the treatment that a participant was receiving at the time of the event/assessment. Participants who had exposed to XAGRID (alone or in combination with other) was counted in Xagrid arm and those who had received other ET therapy in the "Other (Cytoreductives)".'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'XAGRID Only', 'description': "Participants who received XAGRID at a dose and mode of administration managed as per investigator's discretion and the relevant Summary of Product Characteristics (SmPC) at the time of registering into the study for a 5 year observation period, during which participants were able to switch treatments per investigator's discretion"}, {'id': 'FG001', 'title': 'XAGRID+Other (Cytoreductives)', 'description': "Participants who received XAGRID+Other (Cytoreductives) at a dose and mode of administration managed as per investigator's discretion and the relevant SmPC at the time of registering into the study for a 5 year observation period, during which participants were able to switch treatments per investigator's discretion. Other Cytoreductives included Hydroxyurea, Interferon- alpha, Pegylated interferon, Busulphan, Pipobroman, Sodium phosphate P32."}, {'id': 'FG002', 'title': 'Other (Cytoreductives)', 'description': "Participants who received other (Cytoreductives) at a dose and mode of administration managed as per investigator's discretion and the relevant SmPC at the time of registering into the study for a 5 year observation period, during which participants were able to switch treatments per investigator's discretion. Other Cytoreductives included Hydroxyurea, Interferon- alpha, Pegylated interferon, Busulphan, Pipobroman, Sodium phosphate P32."}, {'id': 'FG003', 'title': 'No Essential Thrombocythemia (ET) Therapy', 'description': "Participants who were not receiving any cytoreductive treatment for at least 28 consecutive days at the time of registering into the study for a 5 year observation period, during which participants were able to switch treatments per investigator's discretion."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '804'}, {'groupId': 'FG001', 'numSubjects': '141'}, {'groupId': 'FG002', 'numSubjects': '2666'}, {'groupId': 'FG003', 'numSubjects': '110'}]}, {'type': 'Initiated Treatment', 'achievements': [{'groupId': 'FG000', 'numSubjects': '804'}, {'groupId': 'FG001', 'numSubjects': '141'}, {'groupId': 'FG002', 'numSubjects': '2666'}, {'groupId': 'FG003', 'numSubjects': '38'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '563'}, {'groupId': 'FG001', 'numSubjects': '108'}, {'groupId': 'FG002', 'numSubjects': '1758'}, {'groupId': 'FG003', 'numSubjects': '23'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '241'}, {'groupId': 'FG001', 'numSubjects': '33'}, {'groupId': 'FG002', 'numSubjects': '908'}, {'groupId': 'FG003', 'numSubjects': '87'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '91'}, {'groupId': 'FG001', 'numSubjects': '14'}, {'groupId': 'FG002', 'numSubjects': '351'}, {'groupId': 'FG003', 'numSubjects': '2'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '65'}, {'groupId': 'FG001', 'numSubjects': '16'}, {'groupId': 'FG002', 'numSubjects': '360'}, {'groupId': 'FG003', 'numSubjects': '5'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '64'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '134'}, {'groupId': 'FG003', 'numSubjects': '6'}]}, {'type': 'Participant request', 'reasons': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '33'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Sponsor request', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '30'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Never Initiated Treatment', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '72'}]}]}], 'recruitmentDetails': 'Participants who were newly diagnosed (received no treatment at the time of study registration) or previously diagnosed with essential thrombocythemia (ET), receiving or continuing previous cytoreductive therapy were recruited in the study', 'preAssignmentDetails': 'Due to the non-interventional nature of the study, participants could be receiving XAGRID, XAGRID+Other (Cytoreductives), other (cytoreductives) and no essential thrombocythemia (ET) therapy. During the study participants could change the treatments.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '804', 'groupId': 'BG000'}, {'value': '141', 'groupId': 'BG001'}, {'value': '2664', 'groupId': 'BG002'}, {'value': '38', 'groupId': 'BG003'}, {'value': '3647', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'XAGRID Only', 'description': "Participants who received XAGRID at a dose and mode of administration managed as per investigator's discretion and the relevant Summary of Product Characteristics (SmPC) at the time of registering into the study for a 5 year observation period, during which participants were able to switch treatments per investigator's discretion."}, {'id': 'BG001', 'title': 'XAGRID+Other (Cytoreductives)', 'description': "Participants who received XAGRID along with Other cytoreductives drugs at a dose and mode of administration managed as per investigator's discretion and the relevant SmPC at the time of registering into the study for a 5 year observation period, during which participants were able to switch treatments per investigator's discretion. Other Cytoreductives included Hydroxyurea, Interferon- alpha, Pegylated interferon, Busulphan, Pipobroman, Sodium phosphate P32."}, {'id': 'BG002', 'title': 'Other (Cytoreductives)', 'description': "Participants who received other (Cytoreductives) at a dose and mode of administration managed as per investigator's discretion and the relevant SmPC at the time of registering into the study for a 5 year observation period, during which participants were able to switch treatments per investigator's discretion. Other Cytoreductives included Hydroxyurea, Interferon- alpha, Pegylated interferon, Busulphan, Pipobroman, Sodium phosphate P32."}, {'id': 'BG003', 'title': 'No Essential Thrombocythemia (ET) Therapy', 'description': "Participants who were not receiving any cytoreductive treatment for at least 28 consecutive days at the time of registering into the study for a 5 year observation period, during which participants were able to switch treatments per investigator's discretion."}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '55.4', 'spread': '14.99', 'groupId': 'BG000'}, {'value': '59.9', 'spread': '13.74', 'groupId': 'BG001'}, {'value': '67.4', 'spread': '13.05', 'groupId': 'BG002'}, {'value': '64.3', 'spread': '14.26', 'groupId': 'BG003'}, {'value': '64.4', 'spread': '14.43', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'title': 'Less than (<) 65 years', 'categories': [{'measurements': [{'value': '575', 'groupId': 'BG000'}, {'value': '89', 'groupId': 'BG001'}, {'value': '913', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}, {'value': '1591', 'groupId': 'BG004'}]}]}, {'title': '65-<75 years', 'categories': [{'measurements': [{'value': '133', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '897', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}, {'value': '1073', 'groupId': 'BG004'}]}]}, {'title': 'Greater than equal to (>=)75 years', 'categories': [{'measurements': [{'value': '96', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '854', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}, {'value': '983', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '501', 'groupId': 'BG000'}, {'value': '80', 'groupId': 'BG001'}, {'value': '1632', 'groupId': 'BG002'}, {'value': '25', 'groupId': 'BG003'}, {'value': '2238', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '303', 'groupId': 'BG000'}, {'value': '61', 'groupId': 'BG001'}, {'value': '1032', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}, {'value': '1409', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'First Treatment Safety Population included all participants who received at least 1 dose of cytoreductive treatment. Data of 2 participants were missing in the Other (Cytoreductives) treatment arm.'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3647}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-05-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2014-04-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-05-25', 'studyFirstSubmitDate': '2007-12-04', 'resultsFirstSubmitDate': '2015-03-25', 'studyFirstSubmitQcDate': '2007-12-04', 'lastUpdatePostDateStruct': {'date': '2021-06-09', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2015-10-15', 'studyFirstPostDateStruct': {'date': '2007-12-05', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-11-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With At Least One Pre-Defined Event (PDE), Deaths, Pregnancies', 'timeFrame': 'Up to 5 years', 'description': 'Pre-defined events (PDEs) were evaluated whenever an event occurred and was defined by a panel of independent qualified physicians, blinded to cytoreductive therapy, validated all PDEs prior to analysis (Event Validation Panel). Non-PDE death only included deaths not recorded as outcome of another PDE.'}, {'measure': 'Number of Participants With Suspected Serious Adverse Reaction (SSAR) Events', 'timeFrame': 'Up to 5 years', 'description': 'SSAR: serious adverse event (SAE) that was considered related to cytoreductive therapy. SAE: any untoward medical occurrence that at any dose resulted in death, life-threatening (at the time of the event), in-patient hospitalization/prolongation of existing hospitalization (elective hospitalizations/procedures for pre-existing conditions that had not worsened were excluded), resulted in persistent or significant disability/incapacity or congenital abnormality/birth defect. Relatedness (suspected/not suspected) to XAGRID or other cytoreductive theraphy was determined by the investigator. As for SSARs, it was important to consider whether the events were related to XAGRID or other cytoreductive therapy. A participant was included in Xagrid or other treatment group based on treatment exposure, participants received Xagrid + Other was counted both in Xagrid and other treatment group.'}], 'secondaryOutcomes': [{'measure': 'Event Rate of Thrombohaemorrhagic Events', 'timeFrame': 'Up to 5 years', 'description': 'Event Rate of Thrombohaemorrhagic Events was calculated by dividing number of participants with events by total patient-year exposure. The reporting unit is per 100 participant-years of treatment exposure. Thrombohaemorrhagic Events is a composite endpoint of the PDEs myocardial infarction, angina, stroke, transient ischaemic attack, venous thromboembolic events, intermittent claudication/digital ischaemia, and major haemorrhagic events.'}, {'measure': 'Platelet Count', 'timeFrame': 'Baseline, Month 6,12,18, 24, 30, 36, 42, 48, 54, 60'}, {'measure': 'Duration of Exposure for Each Essential Thrombocythemia (ET) Therapy', 'timeFrame': 'Up to 5 years', 'description': 'Total duration for each participant = sum of \\[stop date - start date + 1\\] across all periods of time where the specific treatment was taken during the study, where start date = registration/consent date for treatments started before registration/consent date and/or stop date withdrawal/final date for treatments ongoing at the time of withdrawal/end of study. Where a participant has multiple records of the same therapy on the same day, the therapy is counted once for that day.'}, {'measure': 'Cumulative Dose for Each Essential Thrombocythemia (ET) Therapy', 'timeFrame': 'Up to 5 years', 'description': 'Since the study is observational nature, interpreting the table is difficult due to inconsistencies in reporting the units of the dose.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Thrombocythemia, Essential']}, 'referencesModule': {'references': [{'pmid': '29079600', 'type': 'DERIVED', 'citation': 'Birgegard G, Besses C, Griesshammer M, Gugliotta L, Harrison CN, Hamdani M, Wu J, Achenbach H, Kiladjian JJ. Treatment of essential thrombocythemia in Europe: a prospective long-term observational study of 3649 high-risk patients in the Evaluation of Anagrelide Efficacy and Long-term Safety study. Haematologica. 2018 Jan;103(1):51-60. doi: 10.3324/haematol.2017.174672. Epub 2017 Oct 27.'}, {'pmid': '24334294', 'type': 'DERIVED', 'citation': 'Gugliotta L, Besses C, Griesshammer M, Harrison C, Kiladjian JJ, Coll R, Smith J, Abhyankar B, Birgegard G. Combination therapy of hydroxycarbamide with anagrelide in patients with essential thrombocythemia in the evaluation of Xagrid(R) efficacy and long-term safety study. Haematologica. 2014 Apr;99(4):679-87. doi: 10.3324/haematol.2012.083097. Epub 2013 Dec 13.'}, {'pmid': '23199894', 'type': 'DERIVED', 'citation': 'Besses C, Kiladjian JJ, Griesshammer M, Gugliotta L, Harrison C, Coll R, Smith J, Abhyankar B, Birgegard G. Cytoreductive treatment patterns for essential thrombocythemia in Europe. Analysis of 3643 patients in the EXELS study. Leuk Res. 2013 Feb;37(2):162-8. doi: 10.1016/j.leukres.2012.11.004. Epub 2012 Nov 29.'}, {'pmid': '23184668', 'type': 'DERIVED', 'citation': 'Kiladjian JJ, Besses C, Griesshammer M, Gugliotta L, Harrison C, Coll R, Smith J, Birgegard G. Efficacy and safety of cytoreductive therapies in patients with essential thrombocythaemia aged >80 years: an interim analysis of the EXELS study. Clin Drug Investig. 2013 Jan;33(1):55-63. doi: 10.1007/s40261-012-0042-0.'}]}, 'descriptionModule': {'briefSummary': 'This is an observational safety study being conducted in Europe comparing patients taking Xagrid to patients taking other cytoreductive treatments. The plan is to enrol at least 750 subjects taking Xagrid with up to 3000 subjects taking other cytoreductive therapies. The study will collect follow up data for 5 years for each patient enrolled that will focus on collecting data related to pre-defined events (PDEs) and Suspected Serious Adverse Reactions (SSARs).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients receiving cytoreductive therapy for the treatment of at-risk essential thrombocytopenia (ET).', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* High risk ET patients\n* Subjects who can give written informed consent.\n* Subjects taking cytoreductive therapy\n\nExclusion Criteria:\n\n* Contraindications listed by the product being used.\n* Patient cannot be participating in another clinical trial.'}, 'identificationModule': {'nctId': 'NCT00567502', 'briefTitle': 'Safety and Pregnancy Outcomes in Thrombocythemia Patients Exposed to XAGRID® (Anagrelide Hydrochloride) Compared to Other Treatments', 'organization': {'class': 'INDUSTRY', 'fullName': 'Takeda'}, 'officialTitle': 'A Non-Interventional, Post Authorisation Safety Study, to Continuously Monitor Safety and Pregnancy Outcomes in a Cohort of At-Risk Essential Thrombocythaemia (ET) Subjects Exposed to Xagrid Compared to Other Conventional Cytoreductive Treatments', 'orgStudyIdInfo': {'id': 'SPD422-401'}}, 'armsInterventionsModule': {'armGroups': [{'label': '1', 'description': 'XAGRID® (anagrelide hydrochloride)'}, {'label': '2', 'description': 'Xagrid + Other cytoreductive'}, {'label': '3', 'description': 'Other cytoreductive'}]}, 'contactsLocationsModule': {'locations': [{'zip': '3304', 'city': 'Limassol', 'country': 'Cyprus', 'facility': 'Clinic of Haematology', 'geoPoint': {'lat': 34.68406, 'lon': 33.03794}}, {'zip': '2100', 'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'Rigshospitalet', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}, {'zip': '6700', 'city': 'Esbjerg', 'country': 'Denmark', 'facility': 'SUS-Esbjerg Maematologisk afdelning', 'geoPoint': {'lat': 55.47028, 'lon': 8.45187}}, {'zip': '2500', 'city': 'Herlev', 'country': 'Denmark', 'facility': 'Herlev Hospital', 'geoPoint': {'lat': 55.72366, 'lon': 12.43998}}, {'zip': '5000', 'city': 'Odense', 'country': 'Denmark', 'facility': 'Odense University Hospital', 'geoPoint': {'lat': 55.39594, 'lon': 10.38831}}, {'zip': '4000', 'city': 'Roskilde', 'country': 'Denmark', 'facility': 'Roskilde Sygehus', 'geoPoint': {'lat': 55.64152, 'lon': 12.08035}}, {'zip': '7000', 'city': 'Vejle', 'country': 'Denmark', 'facility': 'Vejle Sygehus', 'geoPoint': {'lat': 55.70927, 'lon': 9.5357}}, {'zip': '8800', 'city': 'Viborg', 'country': 'Denmark', 'facility': 'Viborg Hospital', 'geoPoint': {'lat': 56.45319, 'lon': 9.40201}}, {'zip': '00029', 'city': 'Helsinki', 'country': 'Finland', 'facility': 'Helsinki University Hospital', 'geoPoint': {'lat': 60.16952, 'lon': 24.93545}}, {'zip': '40620', 'city': 'Jyväskylä', 'country': 'Finland', 'facility': 'Jyvaskyla Central Hospital', 'geoPoint': {'lat': 62.24147, 'lon': 25.72088}}, {'zip': '70211', 'city': 'Kuopio', 'country': 'Finland', 'facility': 'Kuopio University Hospital', 'geoPoint': {'lat': 62.89238, 'lon': 27.67703}}, {'zip': '95170', 'city': 'Argenteuil', 'country': 'France', 'facility': 'Centre Hospitalier Victor Dupouy', 'geoPoint': {'lat': 48.94788, 'lon': 2.24744}}, {'zip': '60021', 'city': 'Beauvais', 'country': 'France', 'facility': 'Centre Hospitalier de Beauvais', 'geoPoint': {'lat': 49.43333, 'lon': 2.08333}}, {'city': 'Bobigny', 'country': 'France', 'facility': 'Hopital Avicenne', 'geoPoint': {'lat': 48.90982, 'lon': 2.45012}}, {'zip': '29609', 'city': 'Brest', 'country': 'France', 'facility': 'Hopital de la Cavale Blanche', 'geoPoint': {'lat': 48.39029, 'lon': -4.48628}}, {'zip': '14033', 'city': 'Caen', 'country': 'France', 'facility': 'CHU Clemenceau', 'geoPoint': {'lat': 49.18585, 'lon': -0.35912}}, {'zip': '94100', 'city': 'Créteil', 'country': 'France', 'facility': 'Hopital Henri Mondor', 'geoPoint': {'lat': 48.79266, 'lon': 2.46569}}, {'zip': '21000', 'city': 'Dijon', 'country': 'France', 'facility': 'Cabinet Medical', 'geoPoint': {'lat': 47.31344, 'lon': 5.01391}}, {'zip': '95602', 'city': 'Eaubonne', 'country': 'France', 'facility': 'Hopital Simone Veil', 'geoPoint': {'lat': 48.99712, 'lon': 2.28249}}, {'zip': '38043', 'city': 'Grenoble', 'country': 'France', 'facility': 'CHU de Grenoble Hopital Albert Michallon', 'geoPoint': {'lat': 45.17869, 'lon': 5.71479}}, {'zip': '62307', 'city': 'Lens', 'country': 'France', 'facility': 'Centre Hospitalier de Lens', 'geoPoint': {'lat': 50.43302, 'lon': 2.82791}}, {'zip': '59020', 'city': 'Lille', 'country': 'France', 'facility': 'Hopital Saint Vincent de Paul', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'zip': '59037', 'city': 'Lille', 'country': 'France', 'facility': 'CHRU de Lille - 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