Ignite Creation Date:
2025-12-24 @ 4:54 PM
Ignite Modification Date:
2026-01-25 @ 3:11 PM
Study NCT ID:
NCT03727750
Status:
COMPLETED
Last Update Posted:
2022-03-25
First Post:
2018-09-28
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Evaluating QTc, PK, Safety of Gemtuzumab Ozogamicin (GO) in Patients With CD33+ R/R AML
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000079982', 'term': 'Gemtuzumab'}], 'ancestors': [{'id': 'D000080084', 'term': 'Calicheamicins'}, {'id': 'D000617', 'term': 'Aminoglycosides'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov_Inquiries@pfizer.com', 'phone': '1-800-718-1021', 'title': 'Pfizer ClinicalTrials.gov Call Center', 'organization': 'Pfizer Inc.'}, 'certainAgreement': {'otherDetails': 'Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From first dose of study drug up to 36 days after last dose (up to a maximum of 12 months)', 'description': 'Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all enrolled participants who received at least 1 dose of study medication.', 'eventGroups': [{'id': 'EG000', 'title': 'Gemtuzumab Ozogamicin (GO)', 'description': 'Participants with confirmed diagnosis of refractory or relapsed CD33-positive Acute Myeloid Leukemia (AML) aged \\>= 18 years received three doses of Gemtuzumab Ozogamicin, 3 mg/m\\^2 as IV infusion on Days 1, 4 and 7 of Cycle 1 and 2.', 'otherNumAtRisk': 50, 'deathsNumAtRisk': 50, 'otherNumAffected': 36, 'seriousNumAtRisk': 50, 'deathsNumAffected': 45, 'seriousNumAffected': 34}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 5}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Febrile Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 9}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 5}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 9}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Abdominal Pain Upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Gingival Bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Infusion Related Reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Alanine Aminotransferase Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Aspartate Aminotransferase Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 5}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Gamma-Glutamyltransferase Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 9}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Hypomagnesaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 5}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Acute Kidney Injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 3}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}], 'seriousEvents': [{'term': 'Febrile Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 11}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Atrial Fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Supraventricular Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Vitreous Floaters', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Gastric Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Disease Progression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Multiple Organ Dysfunction Syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Atypical Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Covid-19 Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Escherichia Urinary Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Eye Infection Fungal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Neutropenic Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Pneumonia Klebsiella', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Pneumonia Respiratory Syncytial Viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Traumatic Intracranial Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Acute Myeloid Leukaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Respiratory Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Capillary Leak Syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': "Change From Baseline in Corrected QT Interval for Heart Rate Using Fridericia's Formula (QTcF) at Cycle 1 Day 1: 1 Hour", 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Gemtuzumab Ozogamicin (GO)', 'description': 'Participants with confirmed diagnosis of refractory or relapsed CD33-positive Acute Myeloid Leukemia (AML) aged \\>= 18 years received three doses of Gemtuzumab Ozogamicin, 3 mg/m\\^2 as IV infusion on Days 1, 4 and 7 of Cycle 1 and 2.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.90', 'groupId': 'OG000', 'lowerLimit': '2.48', 'upperLimit': '7.32'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Cycle 1 Day 1: 1 Hour', 'description': "Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and average was calculated. QT interval was the time between the start of the Q wave and the end of the T wave in the cardiac electrical cycle. QTcF was the QT interval corrected for heart rate using Fridericia's formula: QTcF = QT divided by cube root of 60/heart rate. Change from baseline in QT interval corrected for heart rate using Fridericia's formula was reported.", 'unitOfMeasure': 'milliseconds', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "QTc analysis set included all the participants in the safety analysis set who had a baseline ECG and at least 1 post-dose ECG. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure."}, {'type': 'PRIMARY', 'title': "Change From Baseline in Corrected QT Interval for Heart Rate Using Fridericia's Formula (QTcF) at Cycle 1 Day 1: 2 Hours", 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Gemtuzumab Ozogamicin (GO)', 'description': 'Participants with confirmed diagnosis of refractory or relapsed CD33-positive Acute Myeloid Leukemia (AML) aged \\>= 18 years received three doses of Gemtuzumab Ozogamicin, 3 mg/m\\^2 as IV infusion on Days 1, 4 and 7 of Cycle 1 and 2.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.25', 'groupId': 'OG000', 'lowerLimit': '1.66', 'upperLimit': '6.84'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Cycle 1 Day 1: 2 Hours', 'description': "Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and average was calculated. QT interval was the time between the start of the Q wave and the end of the T wave in the cardiac electrical cycle. QTcF was the QT interval corrected for heart rate using Fridericia's formula: QTcF = QT divided by cube root of 60/heart rate. Change from baseline in QT interval corrected for heart rate using Fridericia's formula was reported.", 'unitOfMeasure': 'milliseconds', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "QTc analysis set included all the participants in the safety analysis set who had a baseline ECG and at least 1 post-dose ECG. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure."}, {'type': 'PRIMARY', 'title': "Change From Baseline in Corrected QT Interval for Heart Rate Using Fridericia's Formula (QTcF) at Cycle 1 Day 1: 4 Hours", 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Gemtuzumab Ozogamicin (GO)', 'description': 'Participants with confirmed diagnosis of refractory or relapsed CD33-positive Acute Myeloid Leukemia (AML) aged \\>= 18 years received three doses of Gemtuzumab Ozogamicin, 3 mg/m\\^2 as IV infusion on Days 1, 4 and 7 of Cycle 1 and 2.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.10', 'groupId': 'OG000', 'lowerLimit': '2.15', 'upperLimit': '8.06'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Cycle 1 Day 1: 4 Hours', 'description': "Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and average was calculated. QT interval was the time between the start of the Q wave and the end of the T wave in the cardiac electrical cycle. QTcF was the QT interval corrected for heart rate using Fridericia's formula: QTcF = QT divided by cube root of 60/heart rate. Change from baseline in QT interval corrected for heart rate using Fridericia's formula was reported.", 'unitOfMeasure': 'milliseconds', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "QTc analysis set included all the participants in the safety analysis set who had a baseline ECG and at least 1 post-dose ECG. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure."}, {'type': 'PRIMARY', 'title': "Change From Baseline in Corrected QT Interval for Heart Rate Using Fridericia's Formula (QTcF) at Cycle 1 Day 4: 0 Hour", 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Gemtuzumab Ozogamicin (GO)', 'description': 'Participants with confirmed diagnosis of refractory or relapsed CD33-positive Acute Myeloid Leukemia (AML) aged \\>= 18 years received three doses of Gemtuzumab Ozogamicin, 3 mg/m\\^2 as IV infusion on Days 1, 4 and 7 of Cycle 1 and 2.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.44', 'groupId': 'OG000', 'lowerLimit': '-5.98', 'upperLimit': '1.09'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Cycle 1 Day 4: 0 Hour', 'description': "Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and average was calculated. QT interval was the time between the start of the Q wave and the end of the T wave in the cardiac electrical cycle. QTcF was the QT interval corrected for heart rate using Fridericia's formula: QTcF = QT divided by cube root of 60/heart rate. Change from baseline in QT interval corrected for heart rate using Fridericia's formula was reported.", 'unitOfMeasure': 'milliseconds', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "QTc analysis set included all the participants in the safety analysis set who had a baseline ECG and at least 1 post-dose ECG. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure."}, {'type': 'PRIMARY', 'title': "Change From Baseline in Corrected QT Interval for Heart Rate Using Fridericia's Formula (QTcF) at Cycle 1 Day 4: 2 Hours", 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Gemtuzumab Ozogamicin (GO)', 'description': 'Participants with confirmed diagnosis of refractory or relapsed CD33-positive Acute Myeloid Leukemia (AML) aged \\>= 18 years received three doses of Gemtuzumab Ozogamicin, 3 mg/m\\^2 as IV infusion on Days 1, 4 and 7 of Cycle 1 and 2.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.45', 'groupId': 'OG000', 'lowerLimit': '-3.98', 'upperLimit': '3.07'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Cycle 1 Day 4: 2 Hours', 'description': "Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and average was calculated. QT interval was the time between the start of the Q wave and the end of the T wave in the cardiac electrical cycle. QTcF was the QT interval corrected for heart rate using Fridericia's formula: QTcF = QT divided by cube root of 60/heart rate. Change from baseline in QT interval corrected for heart rate using Fridericia's formula was reported.", 'unitOfMeasure': 'milliseconds', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "QTc analysis set included all the participants in the safety analysis set who had a baseline ECG and at least 1 post-dose ECG. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure."}, {'type': 'PRIMARY', 'title': "Change From Baseline in Corrected QT Interval for Heart Rate Using Fridericia's Formula (QTcF) at Cycle 1 Day 7: 0 Hour", 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Gemtuzumab Ozogamicin (GO)', 'description': 'Participants with confirmed diagnosis of refractory or relapsed CD33-positive Acute Myeloid Leukemia (AML) aged \\>= 18 years received three doses of Gemtuzumab Ozogamicin, 3 mg/m\\^2 as IV infusion on Days 1, 4 and 7 of Cycle 1 and 2.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.00', 'groupId': 'OG000', 'lowerLimit': '-4.59', 'upperLimit': '2.58'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Cycle 1 Day 7: 0 Hour', 'description': "Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and average was calculated. QT interval was the time between the start of the Q wave and the end of the T wave in the cardiac electrical cycle. QTcF was the QT interval corrected for heart rate using Fridericia's formula: QTcF = QT divided by cube root of 60/heart rate. Change from baseline in QT interval corrected for heart rate using Fridericia's formula was reported.", 'unitOfMeasure': 'milliseconds', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "QTc analysis set included all the participants in the safety analysis set who had a baseline ECG and at least 1 post-dose ECG. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure."}, {'type': 'PRIMARY', 'title': "Change From Baseline in Corrected QT Interval for Heart Rate Using Fridericia's Formula (QTcF) at Cycle 1 Day 7: 2 Hours", 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Gemtuzumab Ozogamicin (GO)', 'description': 'Participants with confirmed diagnosis of refractory or relapsed CD33-positive Acute Myeloid Leukemia (AML) aged \\>= 18 years received three doses of Gemtuzumab Ozogamicin, 3 mg/m\\^2 as IV infusion on Days 1, 4 and 7 of Cycle 1 and 2.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.29', 'groupId': 'OG000', 'lowerLimit': '0.88', 'upperLimit': '7.70'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Cycle 1 Day 7: 2 Hours', 'description': "Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and average was calculated. QT interval was the time between the start of the Q wave and the end of the T wave in the cardiac electrical cycle. QTcF was the QT interval corrected for heart rate using Fridericia's formula: QTcF = QT divided by cube root of 60/heart rate. Change from baseline in QT interval corrected for heart rate using Fridericia's formula was reported.", 'unitOfMeasure': 'milliseconds', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "QTc analysis set included all the participants in the safety analysis set who had a baseline ECG and at least 1 post-dose ECG. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure."}, {'type': 'PRIMARY', 'title': "Change From Baseline in Corrected QT Interval for Heart Rate Using Fridericia's Formula (QTcF) at Cycle 1 Day 7: 4 Hours", 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Gemtuzumab Ozogamicin (GO)', 'description': 'Participants with confirmed diagnosis of refractory or relapsed CD33-positive Acute Myeloid Leukemia (AML) aged \\>= 18 years received three doses of Gemtuzumab Ozogamicin, 3 mg/m\\^2 as IV infusion on Days 1, 4 and 7 of Cycle 1 and 2.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.19', 'groupId': 'OG000', 'lowerLimit': '0.45', 'upperLimit': '7.93'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Cycle 1 Day 7: 4 Hours', 'description': "Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and average was calculated. QT interval was the time between the start of the Q wave and the end of the T wave in the cardiac electrical cycle. QTcF was the QT interval corrected for heart rate using Fridericia's formula: QTcF = QT divided by cube root of 60/heart rate. Change from baseline in QT interval corrected for heart rate using Fridericia's formula was reported.", 'unitOfMeasure': 'milliseconds', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "QTc analysis set included all the participants in the safety analysis set who had a baseline ECG and at least 1 post-dose ECG. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure."}, {'type': 'PRIMARY', 'title': "Change From Baseline in Corrected QT Interval for Heart Rate Using Fridericia's Formula (QTcF) at Cycle 1 Day 7: 6 Hours", 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Gemtuzumab Ozogamicin (GO)', 'description': 'Participants with confirmed diagnosis of refractory or relapsed CD33-positive Acute Myeloid Leukemia (AML) aged \\>= 18 years received three doses of Gemtuzumab Ozogamicin, 3 mg/m\\^2 as IV infusion on Days 1, 4 and 7 of Cycle 1 and 2.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.03', 'groupId': 'OG000', 'lowerLimit': '-2.88', 'upperLimit': '4.93'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Cycle 1 Day 7: 6 Hours', 'description': "Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and average was calculated. QT interval was the time between the start of the Q wave and the end of the T wave in the cardiac electrical cycle. QTcF was the QT interval corrected for heart rate using Fridericia's formula: QTcF = QT divided by cube root of 60/heart rate. Change from baseline in QT interval corrected for heart rate using Fridericia's formula was reported.", 'unitOfMeasure': 'milliseconds', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "QTc analysis set included all the participants in the safety analysis set who had a baseline ECG and at least 1 post-dose ECG. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure."}, {'type': 'PRIMARY', 'title': "Change From Baseline in Corrected QT Interval for Heart Rate Using Fridericia's Formula (QTcF) at Cycle 2 Day 1: 0 Hour", 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Gemtuzumab Ozogamicin (GO)', 'description': 'Participants with confirmed diagnosis of refractory or relapsed CD33-positive Acute Myeloid Leukemia (AML) aged \\>= 18 years received three doses of Gemtuzumab Ozogamicin, 3 mg/m\\^2 as IV infusion on Days 1, 4 and 7 of Cycle 1 and 2.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.0', 'spread': '11.32', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Cycle 2 Day 1: 0 Hour', 'description': "Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and average was calculated. QT interval was the time between the start of the Q wave and the end of the T wave in the cardiac electrical cycle. QTcF was the QT interval corrected for heart rate using Fridericia's formula: QTcF = QT divided by cube root of 60/heart rate. Change from baseline in QT interval corrected for heart rate using Fridericia's formula was reported.", 'unitOfMeasure': 'milliseconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "QTc analysis set included all the participants in the safety analysis set who had a baseline ECG and at least 1 post-dose ECG. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure."}, {'type': 'PRIMARY', 'title': "Change From Baseline in Corrected QT Interval for Heart Rate Using Fridericia's Formula (QTcF) at Cycle 2 Day 1: 2 Hours", 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Gemtuzumab Ozogamicin (GO)', 'description': 'Participants with confirmed diagnosis of refractory or relapsed CD33-positive Acute Myeloid Leukemia (AML) aged \\>= 18 years received three doses of Gemtuzumab Ozogamicin, 3 mg/m\\^2 as IV infusion on Days 1, 4 and 7 of Cycle 1 and 2.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.3', 'spread': '9.12', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Cycle 2 Day 1: 2 Hours', 'description': "Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and average was calculated. QT interval was the time between the start of the Q wave and the end of the T wave in the cardiac electrical cycle. QTcF was the QT interval corrected for heart rate using Fridericia's formula: QTcF = QT divided by cube root of 60/heart rate. Change from baseline in QT interval corrected for heart rate using Fridericia's formula was reported.", 'unitOfMeasure': 'milliseconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "QTc analysis set included all the participants in the safety analysis set who had a baseline ECG and at least 1 post-dose ECG. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure."}, {'type': 'PRIMARY', 'title': "Change From Baseline in Corrected QT Interval for Heart Rate Using Fridericia's Formula (QTcF) at Cycle 2 Day 7: 0 Hour", 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Gemtuzumab Ozogamicin (GO)', 'description': 'Participants with confirmed diagnosis of refractory or relapsed CD33-positive Acute Myeloid Leukemia (AML) aged \\>= 18 years received three doses of Gemtuzumab Ozogamicin, 3 mg/m\\^2 as IV infusion on Days 1, 4 and 7 of Cycle 1 and 2.'}], 'classes': [{'categories': [{'measurements': [{'value': '-5.4', 'spread': '7.58', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Cycle 2 Day 7: 0 Hour', 'description': "Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and average was calculated. QT interval was the time between the start of the Q wave and the end of the T wave in the cardiac electrical cycle. QTcF was the QT interval corrected for heart rate using Fridericia's formula: QTcF = QT divided by cube root of 60/heart rate. Change from baseline in QT interval corrected for heart rate using Fridericia's formula was reported.", 'unitOfMeasure': 'milliseconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "QTc analysis set included all the participants in the safety analysis set who had a baseline ECG and at least 1 post-dose ECG. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure."}, {'type': 'PRIMARY', 'title': "Change From Baseline in Corrected QT Interval for Heart Rate Using Fridericia's Formula (QTcF) at Cycle 2 Day 7: 2 Hours", 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Gemtuzumab Ozogamicin (GO)', 'description': 'Participants with confirmed diagnosis of refractory or relapsed CD33-positive Acute Myeloid Leukemia (AML) aged \\>= 18 years received three doses of Gemtuzumab Ozogamicin, 3 mg/m\\^2 as IV infusion on Days 1, 4 and 7 of Cycle 1 and 2.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.6', 'spread': '10.69', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Cycle 2 Day 7: 2 Hours', 'description': "Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and average was calculated. QT interval was the time between the start of the Q wave and the end of the T wave in the cardiac electrical cycle. QTcF was the QT interval corrected for heart rate using Fridericia's formula: QTcF = QT divided by cube root of 60/heart rate. Change from baseline in QT interval corrected for heart rate using Fridericia's formula was reported.", 'unitOfMeasure': 'milliseconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "QTc analysis set included all the participants in the safety analysis set who had a baseline ECG and at least 1 post-dose ECG. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure."}, {'type': 'PRIMARY', 'title': "Change From Baseline in Corrected QT Interval for Heart Rate Using Fridericia's Formula (QTcF) at Cycle 2 Day 7: 6 Hours", 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Gemtuzumab Ozogamicin (GO)', 'description': 'Participants with confirmed diagnosis of refractory or relapsed CD33-positive Acute Myeloid Leukemia (AML) aged \\>= 18 years received three doses of Gemtuzumab Ozogamicin, 3 mg/m\\^2 as IV infusion on Days 1, 4 and 7 of Cycle 1 and 2.'}], 'classes': [{'categories': [{'measurements': [{'value': '-8.8', 'spread': '14.43', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Cycle 2 Day 7: 6 Hours', 'description': "Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and average was calculated. QT interval was the time between the start of the Q wave and the end of the T wave in the cardiac electrical cycle. QTcF was the QT interval corrected for heart rate using Fridericia's formula: QTcF = QT divided by cube root of 60/heart rate. Change from baseline in QT interval corrected for heart rate using Fridericia's formula was reported.", 'unitOfMeasure': 'milliseconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "QTc analysis set included all the participants in the safety analysis set who had a baseline ECG and at least 1 post-dose ECG. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Clearance (CL) of Gemtuzumab Ozogamicin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Gemtuzumab Ozogamicin (GO)', 'description': 'Participants with confirmed diagnosis of refractory or relapsed CD33-positive Acute Myeloid Leukemia (AML) aged \\>= 18 years received three doses of Gemtuzumab Ozogamicin, 3 mg/m\\^2 as IV infusion on Days 1, 4 and 7 of Cycle 1 and 2.'}], 'classes': [{'title': 'AC-CL-184538', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '15.02', 'spread': '112', 'groupId': 'OG000'}]}]}, {'title': 'CL-184538', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4246', 'spread': '177', 'groupId': 'OG000'}]}]}, {'title': 'Total HP67.6 Antibody', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.3212', 'spread': '153', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre dose, 2, 4, 6, 72, 192 and 336 hours post dose on Cycle 1 Day 7', 'description': 'Clearance of a drug was measure of the rate at which the drug was metabolized or eliminated by normal biological processes.', 'unitOfMeasure': 'Liters/hour', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': "Pharmacokinetic (PK) analysis set included all the participants who were treated with GO and contributed at least 1 PK sample. Here, 'Number Analyzed' = participants evaluable for this outcome measure for specified rows."}, {'type': 'SECONDARY', 'title': 'Volume of Distribution of Gemtuzumab Ozogamicin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Gemtuzumab Ozogamicin (GO)', 'description': 'Participants with confirmed diagnosis of refractory or relapsed CD33-positive Acute Myeloid Leukemia (AML) aged \\>= 18 years received three doses of Gemtuzumab Ozogamicin, 3 mg/m\\^2 as IV infusion on Days 1, 4 and 7 of Cycle 1 and 2.'}], 'timeFrame': 'Pre dose, 2, 4, 6, 72, 192 and 336 hours post dose on Cycle 1 Day 7', 'description': 'Volume of distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug.', 'reportingStatus': 'POSTED', 'populationDescription': 'This outcome measure could not be estimated due to insufficient concentration-time data by non-compartmental analysis.'}, {'type': 'SECONDARY', 'title': 'Maximum Observed Plasma Concentration (Cmax): AC-CL-184538 and CL-184538', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Gemtuzumab Ozogamicin (GO)', 'description': 'Participants with confirmed diagnosis of refractory or relapsed CD33-positive Acute Myeloid Leukemia (AML) aged \\>= 18 years received three doses of Gemtuzumab Ozogamicin, 3 mg/m\\^2 as IV infusion on Days 1, 4 and 7 of Cycle 1 and 2.'}], 'classes': [{'title': 'Cycle 1 Day 1: AC-CL-184538', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '6457', 'spread': '81', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 1 Day 1: CL-184538', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '45.69', 'spread': '51', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 1 Day 7: AC-CL-184538', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '11740', 'spread': '79', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 1 Day 7: CL-184538', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '58.76', 'spread': '70', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre dose, 1, 2, 4, 6, 24 and 72 hours post dose on Cycle 1 Day 1; and Pre dose, 2, 4, 6, 72, 192 and 336 hours post dose on Cycle 1 Day 7', 'description': 'Cmax was defined as the maximum observed plasma concentration of GO. Calicheamicin (conjugated calicheamicin ac-CL-184538 and unconjugated CL-184538) analyte were used to determined the Cmax in this outcome measure.', 'unitOfMeasure': 'picogram/milliliter', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': "PK analysis set included all the participants who were treated with GO and contributed at least 1 PK sample. Here, 'Number Analyzed' = participants evaluable for this outcome measure for specified rows."}, {'type': 'SECONDARY', 'title': 'Maximum Observed Plasma Concentration (Cmax): Total HP67.6 Antibody', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Gemtuzumab Ozogamicin (GO)', 'description': 'Participants with confirmed diagnosis of refractory or relapsed CD33-positive Acute Myeloid Leukemia (AML) aged \\>= 18 years received three doses of Gemtuzumab Ozogamicin, 3 mg/m\\^2 as IV infusion on Days 1, 4 and 7 of Cycle 1 and 2.'}], 'classes': [{'title': 'Cycle 1 Day 1: Total HP67.6 Antibody', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '282.1', 'spread': '77', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 1 Day 7: Total HP67.6 Antibody', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '585.6', 'spread': '105', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre dose, 1, 2, 4, 6, 24 and 72 hours post dose on Cycle 1 Day 1; and Pre dose, 2, 4, 6, 72, 192 and 336 hours post dose on Cycle 1 Day 7', 'description': 'Cmax was defined as the maximum observed plasma concentration of GO. Total HP67.6 antibodies analyte was used to determined the Cmax in this outcome measure.', 'unitOfMeasure': 'nanogram/milliliter', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': "PK analysis set included all the participants who were treated with GO and contributed at least 1 PK sample. Here, 'Number Analyzed' = participants evaluable for this outcome measure for specified rows."}, {'type': 'SECONDARY', 'title': 'Time to Reach Maximum Observed Plasma Concentration (Tmax)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Gemtuzumab Ozogamicin (GO)', 'description': 'Participants with confirmed diagnosis of refractory or relapsed CD33-positive Acute Myeloid Leukemia (AML) aged \\>= 18 years received three doses of Gemtuzumab Ozogamicin, 3 mg/m\\^2 as IV infusion on Days 1, 4 and 7 of Cycle 1 and 2.'}], 'classes': [{'title': 'Cycle 1 Day 1: AC-CL-184538', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.080', 'groupId': 'OG000', 'lowerLimit': '0.933', 'upperLimit': '5.83'}]}]}, {'title': 'Cycle 1 Day 1: CL-184538', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.170', 'groupId': 'OG000', 'lowerLimit': '1.00', 'upperLimit': '6.08'}]}]}, {'title': 'Cycle 1 Day 1: Total HP67.6 Antibody', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.080', 'groupId': 'OG000', 'lowerLimit': '0.933', 'upperLimit': '4.25'}]}]}, {'title': 'Cycle 1 Day 7: AC-CL-184538', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.130', 'groupId': 'OG000', 'lowerLimit': '0.000', 'upperLimit': '6.25'}]}]}, {'title': 'Cycle 1 Day 7: CL-184538', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.920', 'groupId': 'OG000', 'lowerLimit': '1.85', 'upperLimit': '6.10'}]}]}, {'title': 'Cycle 1 Day 7: Total HP67.6 Antibody', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.170', 'groupId': 'OG000', 'lowerLimit': '1.92', 'upperLimit': '6.40'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Pre dose, 1, 2, 4, 6, 24 and 72 hours post dose on Cycle 1 Day 1; and Pre dose, 2, 4, 6, 72, 192 and 336 hours post dose on Cycle 1 Day 7', 'description': 'Tmax = time (hours) to maximum plasma concentration (Cmax).', 'unitOfMeasure': 'hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': "PK analysis set included all the participants who were treated with GO and contributed at least 1 PK sample. Here, 'Number Analyzed' = participants evaluable for this outcome measure for specified rows."}, {'type': 'SECONDARY', 'title': 'Area Under the Plasma Concentration-time Profile From Time Zero to the Time of Last Quantifiable Concentration (AUClast): AC-CL-184538 and CL-184538', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Gemtuzumab Ozogamicin (GO)', 'description': 'Participants with confirmed diagnosis of refractory or relapsed CD33-positive Acute Myeloid Leukemia (AML) aged \\>= 18 years received three doses of Gemtuzumab Ozogamicin, 3 mg/m\\^2 as IV infusion on Days 1, 4 and 7 of Cycle 1 and 2.'}], 'classes': [{'title': 'Cycle 1 Day 1: AC-CL-184538', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '93260', 'spread': '83', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 1 Day 1: CL-184538', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '99.83', 'spread': '171', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 1 Day 7: AC-CL-184538', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '453900', 'spread': '120', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 1 Day 7: CL-184538', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '242.0', 'spread': '283', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre dose, 1, 2, 4, 6, 24 and 72 hours post dose on Cycle 1 Day 1; and Pre dose, 2, 4, 6, 72, 192 and 336 hours post dose on Cycle 1 Day 7', 'description': 'Area under the plasma concentration-time curve from time zero to the time of the last measurable concentration (AUClast). Calicheamicin (conjugated calicheamicin ac-CL-184538 and unconjugated CL-184538) analytes were used to determined the AUClast in this outcome measure.', 'unitOfMeasure': 'picogram*hour/milliliter', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': "PK analysis set included all the participants who were treated with GO and contributed at least 1 PK sample. Here, 'Number Analyzed' = participants evaluable for this outcome measure for specified rows."}, {'type': 'SECONDARY', 'title': 'Area Under the Plasma Concentration-time Profile From Time Zero to the Time of Last Quantifiable Concentration (AUClast): Total HP67.6 Antibody', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Gemtuzumab Ozogamicin (GO)', 'description': 'Participants with confirmed diagnosis of refractory or relapsed CD33-positive Acute Myeloid Leukemia (AML) aged \\>= 18 years received three doses of Gemtuzumab Ozogamicin, 3 mg/m\\^2 as IV infusion on Days 1, 4 and 7 of Cycle 1 and 2.'}], 'classes': [{'title': 'Cycle 1 Day 1: Total HP67.6 Antibody', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2496', 'spread': '210', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 1 Day 7: Total HP67.6 Antibody', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '14740', 'spread': '388', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre dose, 1, 2, 4, 6, 24 and 72 hours post dose on Cycle 1 Day 1; and Pre dose, 2, 4, 6, 72, 192 and 336 hours post dose on Cycle 1 Day 7', 'description': 'Area under the plasma concentration-time curve from time zero to the time of the last measurable concentration (AUClast). Total HP67.6 antibodies analyte was used to determined the AUClast in this outcome measure.', 'unitOfMeasure': 'nanogram*hour/milliliter', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': "PK analysis set included all the participants who were treated with GO and contributed at least 1 PK sample. Here, 'Number Analyzed' = participants evaluable for this outcome measure for specified rows."}, {'type': 'SECONDARY', 'title': 'Area Under the Plasma Concentration-time Profile From Time Zero to Time 72 Hours (AUC0-72): AC-CL-184538 and CL-184538', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Gemtuzumab Ozogamicin (GO)', 'description': 'Participants with confirmed diagnosis of refractory or relapsed CD33-positive Acute Myeloid Leukemia (AML) aged \\>= 18 years received three doses of Gemtuzumab Ozogamicin, 3 mg/m\\^2 as IV infusion on Days 1, 4 and 7 of Cycle 1 and 2.'}], 'classes': [{'title': 'AC-CL-184538', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '93490', 'spread': '82', 'groupId': 'OG000'}]}]}, {'title': 'CL-184538', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '247.8', 'spread': '176', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre dose, 1, 2, 4, 6, 24 and 72 hours post dose on Cycle 1 Day 1', 'description': 'Area under the plasma concentration-time curve from time zero to the time 72 hours (AUC0-72). Calicheamicin (conjugated calicheamicin ac-CL-184538 and unconjugated CL-184538) analytes were used to determined the AUC0-72 in this outcome measure.', 'unitOfMeasure': 'picogram*hour/milliliter', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': "PK analysis set included all the participants who were treated with GO and contributed at least 1 PK sample. Here, 'Number Analyzed' = participants evaluable for this outcome measure for specified rows."}, {'type': 'SECONDARY', 'title': 'Area Under the Plasma Concentration-time Profile From Time Zero to Time 72 Hours (AUC0-72): Total HP67.6 Antibody', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Gemtuzumab Ozogamicin (GO)', 'description': 'Participants with confirmed diagnosis of refractory or relapsed CD33-positive Acute Myeloid Leukemia (AML) aged \\>= 18 years received three doses of Gemtuzumab Ozogamicin, 3 mg/m\\^2 as IV infusion on Days 1, 4 and 7 of Cycle 1 and 2.'}], 'classes': [{'categories': [{'measurements': [{'value': '3797', 'spread': '135', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre dose, 1, 2, 4, 6, 24 and 72 hours post dose on Cycle 1 Day 1', 'description': 'Area under the plasma concentration-time curve from time zero to the time 72 hours (AUC0-72). Total HP67.6 antibodies analyte was used to determined the AUC0-72 in this outcome measure.', 'unitOfMeasure': 'nanogram*hour/milliliter', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': "PK analysis set included all the participants who were treated with GO and contributed at least 1 PK sample. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Area Under the Plasma Concentration-time Profile From Time Zero to Time 336 Hours (AUC0-336): AC-CL-184538 and CL-184538', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Gemtuzumab Ozogamicin (GO)', 'description': 'Participants with confirmed diagnosis of refractory or relapsed CD33-positive Acute Myeloid Leukemia (AML) aged \\>= 18 years received three doses of Gemtuzumab Ozogamicin, 3 mg/m\\^2 as IV infusion on Days 1, 4 and 7 of Cycle 1 and 2.'}], 'classes': [{'title': 'AC-CL-184538', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '461500', 'spread': '121', 'groupId': 'OG000'}]}]}, {'title': 'CL-184538', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1639', 'spread': '181', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre dose, 2, 4, 6, 72, 192 and 336 hours post dose on Cycle 1 Day 7', 'description': 'Area under the plasma concentration-time curve from time zero to the time 336 hours (AUC0-336). Calicheamicin (conjugated calicheamicin ac-CL-184538 and unconjugated CL-184538) analytes were used to determined the AUC0-336 in this outcome measure.', 'unitOfMeasure': 'picogram*hour/milliliter', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': "PK analysis set included all the participants who were treated with GO and contributed at least 1 PK sample. Here, 'Number Analyzed' = participants evaluable for this outcome measure for specified rows."}, {'type': 'SECONDARY', 'title': 'Area Under the Plasma Concentration-time Profile From Time Zero to Time 336 Hours (AUC0-336): Total HP67.6 Antibody', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Gemtuzumab Ozogamicin (GO)', 'description': 'Participants with confirmed diagnosis of refractory or relapsed CD33-positive Acute Myeloid Leukemia (AML) aged \\>= 18 years received three doses of Gemtuzumab Ozogamicin, 3 mg/m\\^2 as IV infusion on Days 1, 4 and 7 of Cycle 1 and 2.'}], 'classes': [{'categories': [{'measurements': [{'value': '26820', 'spread': '131', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre dose, 2, 4, 6, 72, 192 and 336 hours post dose on Cycle 1 Day 7', 'description': 'Area under the plasma concentration-time curve from time zero to the time 336 hours (AUC0-336). Total HP67.6 antibodies analyte was used to determined the AUC0-336 in this outcome measure.', 'unitOfMeasure': 'nanogram*hour/milliliter', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': "PK analysis set included all the participants who were treated with GO and contributed at least 1 PK sample. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Gemtuzumab Ozogamicin (GO)', 'description': 'Participants with confirmed diagnosis of refractory or relapsed CD33-positive Acute Myeloid Leukemia (AML) aged \\>= 18 years received three doses of Gemtuzumab Ozogamicin, 3 mg/m\\^2 as IV infusion on Days 1, 4 and 7 of Cycle 1 and 2.'}], 'classes': [{'title': 'TEAEs', 'categories': [{'measurements': [{'value': '49', 'groupId': 'OG000'}]}]}, {'title': 'SAEs', 'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first dose of study drug up to 36 days after last dose (up to a maximum of 12 months)', 'description': 'An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; medically important events. A treatment emergent AE was defined as an event between first dose of study drug and up to 36 days after the last dose of study drug, that was absent before treatment, or that worsened during the treatment period relative to the pretreatment state. AEs included all serious and non-serious adverse events.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set included all enrolled participants who received at least 1 dose of study medication.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Shift From Grade <=2 at Baseline to Grade 3 or 4 Post-Baseline in Clinical Laboratory Abnormalities- Hematology and Coagulation Parameters', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Gemtuzumab Ozogamicin (GO)', 'description': 'Participants with confirmed diagnosis of refractory or relapsed CD33-positive Acute Myeloid Leukemia (AML) aged \\>= 18 years received three doses of Gemtuzumab Ozogamicin, 3 mg/m\\^2 as IV infusion on Days 1, 4 and 7 of Cycle 1 and 2.'}], 'classes': [{'categories': [{'measurements': [{'value': '43', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first dose of study drug up to 36 days after last dose (up to a maximum of 12 months)', 'description': 'Laboratory parameters included hematological and coagulation parameters. These included activated partial thromboplastin time prolonged, anemia, fibrinogen decreased, hemoglobin increased, international normalized ratio increased, leukocytosis, lymphocyte count decreased, lymphocyte count increased, neutrophil count decreased, platelet count decreased, white blood cell decreased. Number of participants with hematological and coagulation abnormalities by grades (as per Common Terminology Criteria for Adverse Events (CTCAE version 4.03) were reported. Grade 1= mild; Grade 2= moderate; Grade 3= severe and Grade 4= life-threatening or disabling.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set included all enrolled participants who received at least 1 dose of study medication.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Shift From Grade <=2 at Baseline to Grade 3 or 4 Post-Baseline in Clinical Laboratory Abnormalities- Chemistry Parameters', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Gemtuzumab Ozogamicin (GO)', 'description': 'Participants with confirmed diagnosis of refractory or relapsed CD33-positive Acute Myeloid Leukemia (AML) aged \\>= 18 years received three doses of Gemtuzumab Ozogamicin, 3 mg/m\\^2 as IV infusion on Days 1, 4 and 7 of Cycle 1 and 2.'}], 'classes': [{'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first dose of study drug up to 36 days after last dose (up to a maximum of 12 months)', 'description': 'Laboratory parameters included chemistry parameters. These included: alanine aminotransferase increased, alkaline phosphatase increased, aspartate aminotransferase increased, blood bilirubin increased, creatinine increased, hypercalcemia, hyperglycemia, hyperkalemia, hypermagnesemia, hypernatremia, hypoalbuminemia, hypocalcemia, hypoglycemia, hypokalemia, hypomagnesemia, and hyponatremia. Number of participants with chemistry test abnormalities by grades (CTCAE version 4.03) were reported. Grade 1= mild; Grade 2= moderate; Grade 3= severe and Grade 4= life-threatening or disabling.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set included all enrolled participants who received at least 1 dose of study medication.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Positive Anti-Drug Antibody (ADA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Gemtuzumab Ozogamicin (GO)', 'description': 'Participants with confirmed diagnosis of refractory or relapsed CD33-positive Acute Myeloid Leukemia (AML) aged \\>= 18 years received three doses of Gemtuzumab Ozogamicin, 3 mg/m\\^2 as IV infusion on Days 1, 4 and 7 of Cycle 1 and 2.'}], 'classes': [{'title': 'Treatment-induced ADA Positive', 'categories': [{'measurements': [{'value': '12.0', 'groupId': 'OG000'}]}]}, {'title': 'Treatment-boosted ADA Positive', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From first dose of study drug up to maximum of 12 months', 'description': 'Percentage of participants with treatment-induced ADA positive (post baseline-positive only) and treatment-boosted ADA positive (baseline ADA titer that was boosted to a 9-fold or higher level following drug administration) were reported in this outcome measure.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Immunogenicity analysis set included all participants in the safety analysis set who had at least 1 immunogenicity sample with results.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Positive Neutralizing Antibodies (NAb)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Gemtuzumab Ozogamicin (GO)', 'description': 'Participants with confirmed diagnosis of refractory or relapsed CD33-positive Acute Myeloid Leukemia (AML) aged \\>= 18 years received three doses of Gemtuzumab Ozogamicin, 3 mg/m\\^2 as IV infusion on Days 1, 4 and 7 of Cycle 1 and 2.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From first dose of study drug up to maximum of 12 months', 'description': 'Percentage of participants with either treatment-induced NAb or treatment-boosted NAb were reported.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Immunogenicity analysis set included all participants in the safety analysis set who had at least 1 immunogenicity sample with results.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Achieved Complete Remission (CR) and Complete Remission With Incomplete Hematologic Recovery (CRi)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Gemtuzumab Ozogamicin (GO)', 'description': 'Participants with confirmed diagnosis of refractory or relapsed CD33-positive Acute Myeloid Leukemia (AML) aged \\>= 18 years received three doses of Gemtuzumab Ozogamicin, 3 mg/m\\^2 as IV infusion on Days 1, 4 and 7 of Cycle 1 and 2.'}], 'classes': [{'categories': [{'measurements': [{'value': '9.8', 'groupId': 'OG000', 'lowerLimit': '3.3', 'upperLimit': '21.4'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From first dose of study drug to 36 days after last dose (maximum up to of 12 months)', 'description': 'Percentage of participants with first dose of study drug to best overall response with CR and CRi were reported. CR was defined as the disappearance of leukemia indicated by less than (\\<) 5 percent (%) bone marrow blasts, absence of circulating blasts with auer rods and absence of extramedullary disease, with recovery of hematopoiesis defined by absolute neutrophil count (ANC) greater than or equal to (\\>=)1000 per microliter (1000/mcL) and platelets \\>=100,000/mcL. CRi was defined as all CR criteria except residual neutropenia; ANC \\<1000/mcL or thrombocytopenia and platelet count \\<100,000/mcL.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set included all enrolled participants.'}, {'type': 'SECONDARY', 'title': 'Overall Survival (OS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Gemtuzumab Ozogamicin (GO)', 'description': 'Participants with confirmed diagnosis of refractory or relapsed CD33-positive Acute Myeloid Leukemia (AML) aged \\>= 18 years received three doses of Gemtuzumab Ozogamicin, 3 mg/m\\^2 as IV infusion on Days 1, 4 and 7 of Cycle 1 and 2.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.8', 'groupId': 'OG000', 'lowerLimit': '1.7', 'upperLimit': '4.2'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From the first dose of study treatment to the date of death or date of censored, whichever occurred first (maximum up to 12 months)', 'description': 'OS was defined as the time (in months) from the start date (first dose) of study treatment to the date of death due to any cause. Participants last known to be alive were censored at date of last contact. Analysis was performed using Kaplan-Meier method.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set included all enrolled participants.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Gemtuzumab Ozogamicin (GO)', 'description': 'Participants with confirmed diagnosis of refractory or relapsed cluster of differentiation (CD33)- positive Acute Myeloid Leukemia (AML) aged greater than or equal to (\\>=) 18 years received three doses of Gemtuzumab Ozogamicin, 3 milligram per meter square (mg/m\\^2) as intravenous (IV) infusion on Days 1, 4 and 7 of Cycle 1 and 2.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '51'}]}, {'type': 'Safety Set', 'achievements': [{'groupId': 'FG000', 'numSubjects': '50'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '49'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '45'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}], 'preAssignmentDetails': 'A total 66 participants signed the informed consent form and were screened. Out of 66 participants, 15 participants were screen failed and 51 participants were enrolled into the study'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Gemtuzumab Ozogamicin (GO)', 'description': 'Participants with confirmed diagnosis of refractory or relapsed CD33-positive Acute Myeloid Leukemia (AML) aged \\>= 18 years received three doses of Gemtuzumab Ozogamicin, 3 mg/m\\^2 as IV infusion on Days 1, 4 and 7 of Cycle 1 and 2.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '64.9', 'spread': '11.4', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '20', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '31', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '40', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '39', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Full analysis set included all enrolled participants included in the study.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-06-27', 'size': 4184316, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2022-02-28T14:58', 'hasProtocol': True}, {'date': '2021-04-21', 'size': 1149633, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2022-02-28T14:58', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'open-label'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Single arm, open-label, interventional'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 51}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-07-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2021-04-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-02-28', 'studyFirstSubmitDate': '2018-09-28', 'resultsFirstSubmitDate': '2022-02-28', 'studyFirstSubmitQcDate': '2018-10-30', 'lastUpdatePostDateStruct': {'date': '2022-03-25', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-02-28', 'studyFirstPostDateStruct': {'date': '2018-11-01', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-03-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-04-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Change From Baseline in Corrected QT Interval for Heart Rate Using Fridericia's Formula (QTcF) at Cycle 1 Day 1: 1 Hour", 'timeFrame': 'Baseline, Cycle 1 Day 1: 1 Hour', 'description': "Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and average was calculated. QT interval was the time between the start of the Q wave and the end of the T wave in the cardiac electrical cycle. QTcF was the QT interval corrected for heart rate using Fridericia's formula: QTcF = QT divided by cube root of 60/heart rate. Change from baseline in QT interval corrected for heart rate using Fridericia's formula was reported."}, {'measure': "Change From Baseline in Corrected QT Interval for Heart Rate Using Fridericia's Formula (QTcF) at Cycle 1 Day 1: 2 Hours", 'timeFrame': 'Baseline, Cycle 1 Day 1: 2 Hours', 'description': "Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and average was calculated. QT interval was the time between the start of the Q wave and the end of the T wave in the cardiac electrical cycle. QTcF was the QT interval corrected for heart rate using Fridericia's formula: QTcF = QT divided by cube root of 60/heart rate. Change from baseline in QT interval corrected for heart rate using Fridericia's formula was reported."}, {'measure': "Change From Baseline in Corrected QT Interval for Heart Rate Using Fridericia's Formula (QTcF) at Cycle 1 Day 1: 4 Hours", 'timeFrame': 'Baseline, Cycle 1 Day 1: 4 Hours', 'description': "Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and average was calculated. QT interval was the time between the start of the Q wave and the end of the T wave in the cardiac electrical cycle. QTcF was the QT interval corrected for heart rate using Fridericia's formula: QTcF = QT divided by cube root of 60/heart rate. Change from baseline in QT interval corrected for heart rate using Fridericia's formula was reported."}, {'measure': "Change From Baseline in Corrected QT Interval for Heart Rate Using Fridericia's Formula (QTcF) at Cycle 1 Day 4: 0 Hour", 'timeFrame': 'Baseline, Cycle 1 Day 4: 0 Hour', 'description': "Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and average was calculated. QT interval was the time between the start of the Q wave and the end of the T wave in the cardiac electrical cycle. QTcF was the QT interval corrected for heart rate using Fridericia's formula: QTcF = QT divided by cube root of 60/heart rate. Change from baseline in QT interval corrected for heart rate using Fridericia's formula was reported."}, {'measure': "Change From Baseline in Corrected QT Interval for Heart Rate Using Fridericia's Formula (QTcF) at Cycle 1 Day 4: 2 Hours", 'timeFrame': 'Baseline, Cycle 1 Day 4: 2 Hours', 'description': "Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and average was calculated. QT interval was the time between the start of the Q wave and the end of the T wave in the cardiac electrical cycle. QTcF was the QT interval corrected for heart rate using Fridericia's formula: QTcF = QT divided by cube root of 60/heart rate. Change from baseline in QT interval corrected for heart rate using Fridericia's formula was reported."}, {'measure': "Change From Baseline in Corrected QT Interval for Heart Rate Using Fridericia's Formula (QTcF) at Cycle 1 Day 7: 0 Hour", 'timeFrame': 'Baseline, Cycle 1 Day 7: 0 Hour', 'description': "Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and average was calculated. QT interval was the time between the start of the Q wave and the end of the T wave in the cardiac electrical cycle. QTcF was the QT interval corrected for heart rate using Fridericia's formula: QTcF = QT divided by cube root of 60/heart rate. Change from baseline in QT interval corrected for heart rate using Fridericia's formula was reported."}, {'measure': "Change From Baseline in Corrected QT Interval for Heart Rate Using Fridericia's Formula (QTcF) at Cycle 1 Day 7: 2 Hours", 'timeFrame': 'Baseline, Cycle 1 Day 7: 2 Hours', 'description': "Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and average was calculated. QT interval was the time between the start of the Q wave and the end of the T wave in the cardiac electrical cycle. QTcF was the QT interval corrected for heart rate using Fridericia's formula: QTcF = QT divided by cube root of 60/heart rate. Change from baseline in QT interval corrected for heart rate using Fridericia's formula was reported."}, {'measure': "Change From Baseline in Corrected QT Interval for Heart Rate Using Fridericia's Formula (QTcF) at Cycle 1 Day 7: 4 Hours", 'timeFrame': 'Baseline, Cycle 1 Day 7: 4 Hours', 'description': "Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and average was calculated. QT interval was the time between the start of the Q wave and the end of the T wave in the cardiac electrical cycle. QTcF was the QT interval corrected for heart rate using Fridericia's formula: QTcF = QT divided by cube root of 60/heart rate. Change from baseline in QT interval corrected for heart rate using Fridericia's formula was reported."}, {'measure': "Change From Baseline in Corrected QT Interval for Heart Rate Using Fridericia's Formula (QTcF) at Cycle 1 Day 7: 6 Hours", 'timeFrame': 'Baseline, Cycle 1 Day 7: 6 Hours', 'description': "Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and average was calculated. QT interval was the time between the start of the Q wave and the end of the T wave in the cardiac electrical cycle. QTcF was the QT interval corrected for heart rate using Fridericia's formula: QTcF = QT divided by cube root of 60/heart rate. Change from baseline in QT interval corrected for heart rate using Fridericia's formula was reported."}, {'measure': "Change From Baseline in Corrected QT Interval for Heart Rate Using Fridericia's Formula (QTcF) at Cycle 2 Day 1: 0 Hour", 'timeFrame': 'Baseline, Cycle 2 Day 1: 0 Hour', 'description': "Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and average was calculated. QT interval was the time between the start of the Q wave and the end of the T wave in the cardiac electrical cycle. QTcF was the QT interval corrected for heart rate using Fridericia's formula: QTcF = QT divided by cube root of 60/heart rate. Change from baseline in QT interval corrected for heart rate using Fridericia's formula was reported."}, {'measure': "Change From Baseline in Corrected QT Interval for Heart Rate Using Fridericia's Formula (QTcF) at Cycle 2 Day 1: 2 Hours", 'timeFrame': 'Baseline, Cycle 2 Day 1: 2 Hours', 'description': "Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and average was calculated. QT interval was the time between the start of the Q wave and the end of the T wave in the cardiac electrical cycle. QTcF was the QT interval corrected for heart rate using Fridericia's formula: QTcF = QT divided by cube root of 60/heart rate. Change from baseline in QT interval corrected for heart rate using Fridericia's formula was reported."}, {'measure': "Change From Baseline in Corrected QT Interval for Heart Rate Using Fridericia's Formula (QTcF) at Cycle 2 Day 7: 0 Hour", 'timeFrame': 'Baseline, Cycle 2 Day 7: 0 Hour', 'description': "Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and average was calculated. QT interval was the time between the start of the Q wave and the end of the T wave in the cardiac electrical cycle. QTcF was the QT interval corrected for heart rate using Fridericia's formula: QTcF = QT divided by cube root of 60/heart rate. Change from baseline in QT interval corrected for heart rate using Fridericia's formula was reported."}, {'measure': "Change From Baseline in Corrected QT Interval for Heart Rate Using Fridericia's Formula (QTcF) at Cycle 2 Day 7: 2 Hours", 'timeFrame': 'Baseline, Cycle 2 Day 7: 2 Hours', 'description': "Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and average was calculated. QT interval was the time between the start of the Q wave and the end of the T wave in the cardiac electrical cycle. QTcF was the QT interval corrected for heart rate using Fridericia's formula: QTcF = QT divided by cube root of 60/heart rate. Change from baseline in QT interval corrected for heart rate using Fridericia's formula was reported."}, {'measure': "Change From Baseline in Corrected QT Interval for Heart Rate Using Fridericia's Formula (QTcF) at Cycle 2 Day 7: 6 Hours", 'timeFrame': 'Baseline, Cycle 2 Day 7: 6 Hours', 'description': "Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and average was calculated. QT interval was the time between the start of the Q wave and the end of the T wave in the cardiac electrical cycle. QTcF was the QT interval corrected for heart rate using Fridericia's formula: QTcF = QT divided by cube root of 60/heart rate. Change from baseline in QT interval corrected for heart rate using Fridericia's formula was reported."}], 'secondaryOutcomes': [{'measure': 'Clearance (CL) of Gemtuzumab Ozogamicin', 'timeFrame': 'Pre dose, 2, 4, 6, 72, 192 and 336 hours post dose on Cycle 1 Day 7', 'description': 'Clearance of a drug was measure of the rate at which the drug was metabolized or eliminated by normal biological processes.'}, {'measure': 'Volume of Distribution of Gemtuzumab Ozogamicin', 'timeFrame': 'Pre dose, 2, 4, 6, 72, 192 and 336 hours post dose on Cycle 1 Day 7', 'description': 'Volume of distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug.'}, {'measure': 'Maximum Observed Plasma Concentration (Cmax): AC-CL-184538 and CL-184538', 'timeFrame': 'Pre dose, 1, 2, 4, 6, 24 and 72 hours post dose on Cycle 1 Day 1; and Pre dose, 2, 4, 6, 72, 192 and 336 hours post dose on Cycle 1 Day 7', 'description': 'Cmax was defined as the maximum observed plasma concentration of GO. Calicheamicin (conjugated calicheamicin ac-CL-184538 and unconjugated CL-184538) analyte were used to determined the Cmax in this outcome measure.'}, {'measure': 'Maximum Observed Plasma Concentration (Cmax): Total HP67.6 Antibody', 'timeFrame': 'Pre dose, 1, 2, 4, 6, 24 and 72 hours post dose on Cycle 1 Day 1; and Pre dose, 2, 4, 6, 72, 192 and 336 hours post dose on Cycle 1 Day 7', 'description': 'Cmax was defined as the maximum observed plasma concentration of GO. Total HP67.6 antibodies analyte was used to determined the Cmax in this outcome measure.'}, {'measure': 'Time to Reach Maximum Observed Plasma Concentration (Tmax)', 'timeFrame': 'Pre dose, 1, 2, 4, 6, 24 and 72 hours post dose on Cycle 1 Day 1; and Pre dose, 2, 4, 6, 72, 192 and 336 hours post dose on Cycle 1 Day 7', 'description': 'Tmax = time (hours) to maximum plasma concentration (Cmax).'}, {'measure': 'Area Under the Plasma Concentration-time Profile From Time Zero to the Time of Last Quantifiable Concentration (AUClast): AC-CL-184538 and CL-184538', 'timeFrame': 'Pre dose, 1, 2, 4, 6, 24 and 72 hours post dose on Cycle 1 Day 1; and Pre dose, 2, 4, 6, 72, 192 and 336 hours post dose on Cycle 1 Day 7', 'description': 'Area under the plasma concentration-time curve from time zero to the time of the last measurable concentration (AUClast). Calicheamicin (conjugated calicheamicin ac-CL-184538 and unconjugated CL-184538) analytes were used to determined the AUClast in this outcome measure.'}, {'measure': 'Area Under the Plasma Concentration-time Profile From Time Zero to the Time of Last Quantifiable Concentration (AUClast): Total HP67.6 Antibody', 'timeFrame': 'Pre dose, 1, 2, 4, 6, 24 and 72 hours post dose on Cycle 1 Day 1; and Pre dose, 2, 4, 6, 72, 192 and 336 hours post dose on Cycle 1 Day 7', 'description': 'Area under the plasma concentration-time curve from time zero to the time of the last measurable concentration (AUClast). Total HP67.6 antibodies analyte was used to determined the AUClast in this outcome measure.'}, {'measure': 'Area Under the Plasma Concentration-time Profile From Time Zero to Time 72 Hours (AUC0-72): AC-CL-184538 and CL-184538', 'timeFrame': 'Pre dose, 1, 2, 4, 6, 24 and 72 hours post dose on Cycle 1 Day 1', 'description': 'Area under the plasma concentration-time curve from time zero to the time 72 hours (AUC0-72). Calicheamicin (conjugated calicheamicin ac-CL-184538 and unconjugated CL-184538) analytes were used to determined the AUC0-72 in this outcome measure.'}, {'measure': 'Area Under the Plasma Concentration-time Profile From Time Zero to Time 72 Hours (AUC0-72): Total HP67.6 Antibody', 'timeFrame': 'Pre dose, 1, 2, 4, 6, 24 and 72 hours post dose on Cycle 1 Day 1', 'description': 'Area under the plasma concentration-time curve from time zero to the time 72 hours (AUC0-72). Total HP67.6 antibodies analyte was used to determined the AUC0-72 in this outcome measure.'}, {'measure': 'Area Under the Plasma Concentration-time Profile From Time Zero to Time 336 Hours (AUC0-336): AC-CL-184538 and CL-184538', 'timeFrame': 'Pre dose, 2, 4, 6, 72, 192 and 336 hours post dose on Cycle 1 Day 7', 'description': 'Area under the plasma concentration-time curve from time zero to the time 336 hours (AUC0-336). Calicheamicin (conjugated calicheamicin ac-CL-184538 and unconjugated CL-184538) analytes were used to determined the AUC0-336 in this outcome measure.'}, {'measure': 'Area Under the Plasma Concentration-time Profile From Time Zero to Time 336 Hours (AUC0-336): Total HP67.6 Antibody', 'timeFrame': 'Pre dose, 2, 4, 6, 72, 192 and 336 hours post dose on Cycle 1 Day 7', 'description': 'Area under the plasma concentration-time curve from time zero to the time 336 hours (AUC0-336). Total HP67.6 antibodies analyte was used to determined the AUC0-336 in this outcome measure.'}, {'measure': 'Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)', 'timeFrame': 'From first dose of study drug up to 36 days after last dose (up to a maximum of 12 months)', 'description': 'An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; medically important events. A treatment emergent AE was defined as an event between first dose of study drug and up to 36 days after the last dose of study drug, that was absent before treatment, or that worsened during the treatment period relative to the pretreatment state. AEs included all serious and non-serious adverse events.'}, {'measure': 'Number of Participants With Shift From Grade <=2 at Baseline to Grade 3 or 4 Post-Baseline in Clinical Laboratory Abnormalities- Hematology and Coagulation Parameters', 'timeFrame': 'From first dose of study drug up to 36 days after last dose (up to a maximum of 12 months)', 'description': 'Laboratory parameters included hematological and coagulation parameters. These included activated partial thromboplastin time prolonged, anemia, fibrinogen decreased, hemoglobin increased, international normalized ratio increased, leukocytosis, lymphocyte count decreased, lymphocyte count increased, neutrophil count decreased, platelet count decreased, white blood cell decreased. Number of participants with hematological and coagulation abnormalities by grades (as per Common Terminology Criteria for Adverse Events (CTCAE version 4.03) were reported. Grade 1= mild; Grade 2= moderate; Grade 3= severe and Grade 4= life-threatening or disabling.'}, {'measure': 'Number of Participants With Shift From Grade <=2 at Baseline to Grade 3 or 4 Post-Baseline in Clinical Laboratory Abnormalities- Chemistry Parameters', 'timeFrame': 'From first dose of study drug up to 36 days after last dose (up to a maximum of 12 months)', 'description': 'Laboratory parameters included chemistry parameters. These included: alanine aminotransferase increased, alkaline phosphatase increased, aspartate aminotransferase increased, blood bilirubin increased, creatinine increased, hypercalcemia, hyperglycemia, hyperkalemia, hypermagnesemia, hypernatremia, hypoalbuminemia, hypocalcemia, hypoglycemia, hypokalemia, hypomagnesemia, and hyponatremia. Number of participants with chemistry test abnormalities by grades (CTCAE version 4.03) were reported. Grade 1= mild; Grade 2= moderate; Grade 3= severe and Grade 4= life-threatening or disabling.'}, {'measure': 'Percentage of Participants With Positive Anti-Drug Antibody (ADA)', 'timeFrame': 'From first dose of study drug up to maximum of 12 months', 'description': 'Percentage of participants with treatment-induced ADA positive (post baseline-positive only) and treatment-boosted ADA positive (baseline ADA titer that was boosted to a 9-fold or higher level following drug administration) were reported in this outcome measure.'}, {'measure': 'Percentage of Participants With Positive Neutralizing Antibodies (NAb)', 'timeFrame': 'From first dose of study drug up to maximum of 12 months', 'description': 'Percentage of participants with either treatment-induced NAb or treatment-boosted NAb were reported.'}, {'measure': 'Percentage of Participants Who Achieved Complete Remission (CR) and Complete Remission With Incomplete Hematologic Recovery (CRi)', 'timeFrame': 'From first dose of study drug to 36 days after last dose (maximum up to of 12 months)', 'description': 'Percentage of participants with first dose of study drug to best overall response with CR and CRi were reported. CR was defined as the disappearance of leukemia indicated by less than (\\<) 5 percent (%) bone marrow blasts, absence of circulating blasts with auer rods and absence of extramedullary disease, with recovery of hematopoiesis defined by absolute neutrophil count (ANC) greater than or equal to (\\>=)1000 per microliter (1000/mcL) and platelets \\>=100,000/mcL. CRi was defined as all CR criteria except residual neutropenia; ANC \\<1000/mcL or thrombocytopenia and platelet count \\<100,000/mcL.'}, {'measure': 'Overall Survival (OS)', 'timeFrame': 'From the first dose of study treatment to the date of death or date of censored, whichever occurred first (maximum up to 12 months)', 'description': 'OS was defined as the time (in months) from the start date (first dose) of study treatment to the date of death due to any cause. Participants last known to be alive were censored at date of last contact. Analysis was performed using Kaplan-Meier method.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['gemtuzumab ozogamicin', 'Mylotarg', 'QT interval prolongation', 'Pharmacokinetics', 'Safety', 'Veno-occlusive disease', 'Anti-drug antibody'], 'conditions': ['ECG', 'Pharmacokinetics', 'Safety']}, 'referencesModule': {'references': [{'pmid': '36892676', 'type': 'DERIVED', 'citation': 'Montesinos P, Kota V, Brandwein J, Bousset P, Benner RJ, Vandendries E, Chen Y, McMullin MF. A phase IV study evaluating QT interval, pharmacokinetics, and safety following fractionated dosing of gemtuzumab ozogamicin in patients with relapsed/refractory CD33-positive acute myeloid leukemia. Cancer Chemother Pharmacol. 2023 May;91(5):441-446. doi: 10.1007/s00280-023-04516-9. Epub 2023 Mar 9.'}], 'seeAlsoLinks': [{'url': 'https://pmiform.com/clinical-trial-info-request?StudyID=B1761031', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'This is a single-arm, open-label, Phase 4 study evaluating the effect of GO on the QTc, pharmacokinetics, safety, and immunogenicity of GO as a single-agent monotherapy in adult and pediatric patients with relapsed or refractory CD33-positive AML.', 'detailedDescription': "This is a single-arm, open-label, Phase 4 study evaluating the effect of GO on the QTc, pharmacokinetics, safety, and immunogenicity of GO as a single-agent monotherapy in adult and pediatric patients with relapsed or refractory CD33-positive AML. Approximately 50 adult (age \\>=18 years) and 6 pediatric (12 years =\\< age =\\< 17 years) patients who satisfy the study eligibility criteria will be enrolled. Enrolled patients will receive GO 3 mg/m2 up to 2 cycles on Days 1, 4, and 7 at each cycle. The impact of GO on VOD/SOS in the context of previous and subsequent HSCT will also be assessed. Patients enrolled in the study will receive three doses of GO 3 mg/m2 (up to one vial) as a 2-hour intravenous infusion on Cycle 1 Days 1, 4, and 7. A second cycle of GO 3mg/m² (up to one vial) on Cycle 2 Days 1, 4, and 7 will be allowed at the investigator's discretion for patients who meet the following criteria after Cycle 1: Bone marrow with a decrease of blast percentage to at least 25% or a decrease of pretreatment blast percentage by at least 50%; and Blood count with neutrophils \\>=1,000/µL, and platelets \\>=50,000/µL, except in patients with the bone marrow blasts \\>=5%, the decrease in neutrophils and platelets thought to be due to the underlying leukemia. After GO treatment, subsequent anticancer therapy such as consolidation or conditioning regimen and/or HSCT could be considered at the investigator's discretion. A minimum interval of 2 months is recommended between the last dose of GO and HSCT."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\n* Refractory or relapsed (ie, bone marrow blasts \\>5%) CD33-positive AML.\n* Age \\>=12 years.\n* Eastern Cooperative Oncology Group (ECOG) Performance Status 0 to 2.\n* Initial peripheral white blood cells (WBC) counts \\>=30,000/mL; patients with a higher WBC count should undergo cytoreduction.\n* Adequate renal/hepatic functions\n\nExclusion Criteria\n\n* Patients with prior treatment with gemtuzumab ozogamicin (GO).\n* Patients with prior history of VOD/SOS.\n* Prior HSCT is not allowed, if it was conducted within 2 months prior to study enrollment.\n* Patients with known active central nervous system (CNS) leukemia.\n* Uncontrolled or active infectious status.\n* Uncontrolled cardiac dysrhythmias of NCI CTCAE Grade 2, uncontrolled atrial fibrillation of any grade.\n* Sero-positivity to human immunodeficieny virus (HIV).\n* Active hepatitis B or hepatitis C infection\n* Chemotherapy, radiotherapy, or other anti-cancer therapy (except hydroxyurea as cytoreduction) within 2 weeks prior to enrollment in the study.\n* Major surgery within 4 weeks prior to enrollment.\n* QTc interval \\>470 milliseconds (msec) using the Fridericia (QTcF), family or personal history of long or short QT syndrome, Brugada syndrome or known history of QTc prolongation, or Torsade de Pointes (TdP).\n* The use of medications known to predispose to Torsades de Pointes within 2 weeks prior to enrollment\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to gemtuzumab ozogamicin (GO).'}, 'identificationModule': {'nctId': 'NCT03727750', 'briefTitle': 'Evaluating QTc, PK, Safety of Gemtuzumab Ozogamicin (GO) in Patients With CD33+ R/R AML', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A SINGLE ARM, OPEN-LABEL, PHASE 4 STUDY EVALUATING QT INTERVAL, PHARMACOKINETICS, AND SAFETY OF GEMTUZUMAB OZOGAMICIN (MYLOTARG (TRADEMARKER)) AS A SINGLE-AGENT REGIMEN IN PATIENTS WITH RELAPSED OR REFRACTORY CD33-POSITIVE ACUTE MYELOID LEUKEMIA', 'orgStudyIdInfo': {'id': 'B1761031'}, 'secondaryIdInfos': [{'id': '2018-002619-89', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Gemtuzumab Ozogamicin (GO)', 'description': "Patients will receive three doses of Gemtuzumab Ozogamicin (GO) 3 mg/m2 (up to one vial) as a 2 hour intravenous infusion on Cycle 1 Days 1, 4, and 7. A second cycle of GO 3mg/m² (up to one vial) on Cycle 2 Days 1, 4, and 7 will be allowed at the investigator's discretion for patients who meet the criteria", 'interventionNames': ['Drug: Gemtuzumab Ozogamicin']}], 'interventions': [{'name': 'Gemtuzumab Ozogamicin', 'type': 'DRUG', 'description': "Three doses of GO 3 mg/m2 (up to one vial) as a 2 hour intravenous infusion on Cycle 1 Days 1, 4, and 7. A second cycle of GO 3mg/m² (up to one vial) on Cycle 2 Days 1, 4, and 7 will be allowed at the investigator's discretion for patients who meet the criteria", 'armGroupLabels': ['Gemtuzumab Ozogamicin (GO)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30912', 'city': 'Augusta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Augusta University Medical Center Clinical Research Pharmacy', 'geoPoint': {'lat': 33.47097, 'lon': -81.97484}}, {'zip': '30912', 'city': 'Augusta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Georgia Cancer Center at Augusta University', 'geoPoint': {'lat': 33.47097, 'lon': -81.97484}}, {'zip': '27834', 'city': 'Greenville', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Brody School of Medicine at East Carolina University', 'geoPoint': {'lat': 35.61266, 'lon': -77.36635}}, {'zip': '27834', 'city': 'Greenville', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Vidant Medical Center', 'geoPoint': {'lat': 35.61266, 'lon': -77.36635}}, {'zip': 'T6G 2B7', 'city': 'Edmonton', 'state': 'Alberta', 'country': 'Canada', 'facility': 'University of Alberta Hospital', 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}, {'zip': 'T6G 2V2', 'city': 'Edmonton', 'state': 'Alberta', 'country': 'Canada', 'facility': 'Research Transition Facility', 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}, {'zip': 'T6G1Z1', 'city': 'Edmonton', 'state': 'Alberta', 'country': 'Canada', 'facility': 'Kaye Edmonton Clinic', 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}, {'zip': 'L8V 1C3', 'city': 'Hamilton', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Hamilton Health Sciences, Juravinski Hospital', 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}, {'zip': 'L8V 5C2', 'city': 'Hamilton', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Juravinski Cancer Centre', 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}, {'zip': '1083', 'city': 'Budapest', 'country': 'Hungary', 'facility': 'Semmelweis Egyetem I.sz Belgyogyaszati Klinika, Hematologiai Osztaly', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}, {'zip': '4032', 'city': 'Debrecen', 'country': 'Hungary', 'facility': 'Debreceni Egyetem Klinikai Kozpont Belgyogyaszati Klinika', 'geoPoint': {'lat': 47.53167, 'lon': 21.62444}}, {'zip': '9024', 'city': 'Győr', 'country': 'Hungary', 'facility': 'Petz Aladar Megyei Oktato Korhaz, II. Belgyogyaszat - Hematologiai Osztaly', 'geoPoint': {'lat': 47.68333, 'lon': 17.63512}}, {'zip': '7400', 'city': 'Kaposvár', 'country': 'Hungary', 'facility': 'Somogy Megyei Kaposi Mor Oktato Korhaz', 'geoPoint': {'lat': 46.36667, 'lon': 17.8}}, {'zip': '80-214', 'city': 'Gdansk', 'country': 'Poland', 'facility': 'Klinika Hematologii i Transplantologii', 'geoPoint': {'lat': 54.35227, 'lon': 18.64912}}, {'zip': '80-214', 'city': 'Gdansk', 'country': 'Poland', 'facility': 'Uniwersyteckie Centrum Kliniczne', 'geoPoint': {'lat': 54.35227, 'lon': 18.64912}}, {'zip': '50-367', 'city': 'Wroclaw', 'country': 'Poland', 'facility': 'Klinika Hematologii, Nowotworow Krwi i Transplantacji Szpiku', 'geoPoint': {'lat': 51.10286, 'lon': 17.03006}}, {'zip': '50-369', 'city': 'Wroclaw', 'country': 'Poland', 'facility': 'Pracownia Tomografii Komputerowej i Pracownia Rezonansu Magnetycznego', 'geoPoint': {'lat': 51.10286, 'lon': 17.03006}}, {'zip': '08025', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital de la Santa Creu i Sant Pau', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '14004', 'city': 'Córdoba', 'country': 'Spain', 'facility': 'Hospital Universitario Reina Sofía', 'geoPoint': {'lat': 37.89155, 'lon': -4.77275}}, {'zip': '28007', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital General Universitario Gregorio Maranon', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '46026', 'city': 'Valencia', 'country': 'Spain', 'facility': 'Hospital Universitari i Politecnic La Fe', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}, {'zip': 'BH7 7DW', 'city': 'Bournemouth', 'state': 'Dorset', 'country': 'United Kingdom', 'facility': 'The Royal Bournemouth and Christchurch NHS Foundation Trust', 'geoPoint': {'lat': 50.72048, 'lon': -1.8795}}, {'zip': 'BT9 7AB', 'city': 'Belfast', 'country': 'United Kingdom', 'facility': 'Belfast Health and Social Care Trust', 'geoPoint': {'lat': 54.59682, 'lon': -5.92541}}, {'zip': 'L7 8XP', 'city': 'Liverpool', 'country': 'United Kingdom', 'facility': 'Clatterbridge Cancer Center NHS Foundation Trust', 'geoPoint': {'lat': 53.41058, 'lon': -2.97794}}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'ipdSharingStatementModule': {'url': 'https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests', 'ipdSharing': 'YES', 'description': "Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\\_trials/trial\\_data\\_and\\_results/data\\_requests."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}