Viewing Study NCT05216835

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Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug

Ignite Creation Date: 2025-12-24 @ 10:33 PM

Ignite Modification Date: 2025-12-28 @ 9:00 AM

Study NCT ID: NCT05216835

Status: COMPLETED

Last Update Posted: 2025-10-02

First Post: 2022-01-19

Is Gene Therapy: True

Has Adverse Events: True

Brief Title: Safety and Preliminary Efficacy Assessment of AZD7789 in Patients With Relapsed or Refractory Classical Hodgkin Lymphoma

Sponsor:

Organization:

Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['China', 'Germany']}, 'conditionBrowseModule': {'meshes': [{'id': 'D012008', 'term': 'Recurrence'}], 'ancestors': [{'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'information.center@astrazeneca.com', 'phone': '1-877-240-9479', 'title': 'Global Clinical Lead', 'organization': 'AstraZeneca'}, 'certainAgreement': {'otherDetails': 'No unpublished information contained herein may be disclosed without prior written approval from AstraZeneca.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Part A (dose escalation) of this study was completed and Part B (dose expansion) of this study was not initiated and therefore, data were not collected and analyzed for Part B of this study.'}}, 'adverseEventsModule': {'timeFrame': 'From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)', 'description': 'Safety set included all participants who received any amount of study intervention.', 'eventGroups': [{'id': 'EG000', 'title': 'Cohort A1', 'description': 'Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 2mg of sabestomig.', 'otherNumAtRisk': 1, 'deathsNumAtRisk': 1, 'otherNumAffected': 1, 'seriousNumAtRisk': 1, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Cohort A2', 'description': 'Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 7mg of sabestomig.', 'otherNumAtRisk': 1, 'deathsNumAtRisk': 1, 'otherNumAffected': 1, 'seriousNumAtRisk': 1, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Cohort A3', 'description': 'Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 22.5mg of sabestomig.', 'otherNumAtRisk': 1, 'deathsNumAtRisk': 1, 'otherNumAffected': 1, 'seriousNumAtRisk': 1, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Cohort A4', 'description': 'Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 75mg of sabestomig.', 'otherNumAtRisk': 1, 'deathsNumAtRisk': 1, 'otherNumAffected': 1, 'seriousNumAtRisk': 1, 'deathsNumAffected': 1, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Cohort A5', 'description': 'Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 225mg of sabestomig.', 'otherNumAtRisk': 5, 'deathsNumAtRisk': 5, 'otherNumAffected': 4, 'seriousNumAtRisk': 5, 'deathsNumAffected': 1, 'seriousNumAffected': 3}, {'id': 'EG005', 'title': 'Cohort A6', 'description': 'Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 750mg of sabestomig.', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 12, 'seriousNumAtRisk': 12, 'deathsNumAffected': 1, 'seriousNumAffected': 3}, {'id': 'EG006', 'title': 'Cohort A7', 'description': 'Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 1500mg of sabestomig.', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 10, 'seriousNumAtRisk': 12, 'deathsNumAffected': 1, 'seriousNumAffected': 4}, {'id': 'EG007', 'title': 'Cohort A8', 'description': 'Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 2000mg of sabestomig.', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 12, 'seriousNumAtRisk': 12, 'deathsNumAffected': 1, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 12, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v27.0)'}, {'term': 'Cystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v27.0)'}, {'term': 'Device related infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v27.0)'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v27.0)'}, {'term': 'Herpes zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v27.0)'}, {'term': 'Infected dermal cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v27.0)'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v27.0)'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 12, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 12, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v27.0)'}, {'term': 'Otitis externa', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v27.0)'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v27.0)'}, {'term': 'Respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v27.0)'}, {'term': 'Rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 12, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v27.0)'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v27.0)'}, {'term': 'Skin infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v27.0)'}, {'term': 'Tooth abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v27.0)'}, {'term': 'Tracheitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v27.0)'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v27.0)'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 12, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 12, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v27.0)'}, {'term': 'Lymphopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v27.0)'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v27.0)'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v27.0)'}, {'term': 'Acute graft versus host disease in skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1, 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'EG004', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v27.0)'}, {'term': 'Spinal compression fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v27.0)'}], 'seriousEvents': [{'term': 'Herpes zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v27.0)'}, {'term': 'Ophthalmic herpes zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v27.0)'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v27.0)'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v27.0)'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v27.0)'}, {'term': 'Febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v27.0)'}, {'term': 'Cytokine release syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v27.0)'}, {'term': 'Post herpetic neuralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v27.0)'}, {'term': 'Gastric perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v27.0)'}, {'term': 'Cholecystitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v27.0)'}, {'term': 'Exertional rhabdomyolysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v27.0)'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v27.0)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v27.0)'}, {'term': 'Infusion related reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v27.0)'}], 'frequencyThreshold': '3'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Part A (Dose Escalation): Number of Participants With Adverse Events (AEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '12', 'groupId': 'OG005'}, {'value': '12', 'groupId': 'OG006'}, {'value': '12', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort A1', 'description': 'Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 2mg of sabestomig.'}, {'id': 'OG001', 'title': 'Cohort A2', 'description': 'Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 7mg of sabestomig.'}, {'id': 'OG002', 'title': 'Cohort A3', 'description': 'Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 22.5mg of sabestomig.'}, {'id': 'OG003', 'title': 'Cohort A4', 'description': 'Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 75mg of sabestomig.'}, {'id': 'OG004', 'title': 'Cohort A5', 'description': 'Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 225mg of sabestomig.'}, {'id': 'OG005', 'title': 'Cohort A6', 'description': 'Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 750mg of sabestomig.'}, {'id': 'OG006', 'title': 'Cohort A7', 'description': 'Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 1500mg of sabestomig.'}, {'id': 'OG007', 'title': 'Cohort A8', 'description': 'Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 2000mg of sabestomig.'}], 'classes': [{'title': 'Any AE', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '12', 'groupId': 'OG005'}, {'value': '10', 'groupId': 'OG006'}, {'value': '12', 'groupId': 'OG007'}]}]}, {'title': 'Any AE possibly related to Sabestomig [a]', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '8', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}]}]}, {'title': 'Any AE of CTCAE grade 3 or higher', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}]}]}, {'title': 'Any AE of CTCAE grade 3 or higher, possibly related to Sabestomig [a]', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}]}]}, {'title': 'Any AE with outcome = death', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}, {'title': 'Any AE with outcome = death, possibly related to Sabestomig [a]', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}, {'title': 'Any SAE (including events with outcome = death)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}, {'title': 'Any SAE (including events with outcome = death), possibly related to Sabestomig [a]', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}, {'title': 'Any SAE leading to discontinuation of Sabestomig', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}, {'title': 'Any SAE leading to discontinuation of Sabestomig, possibly related to Sabestomig [a]', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}, {'title': 'Any AE leading to discontinuation of Sabestomig', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}]}]}, {'title': 'Any AE leading to discontinuation of Sabestomig, possibly related to Sabestomig [a]', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}]}]}, {'title': 'Any AE leading to cycle delay', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}]}]}, {'title': 'Any AE leading to cycle delay, possibly related to Sabestomig [a]', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}, {'title': 'Any AE of special interest [b]', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}, {'value': '7', 'groupId': 'OG006'}, {'value': '5', 'groupId': 'OG007'}]}]}, {'title': 'Any AE of special interest [b] also considered as an immune-mediated AE [a]', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}]}]}, {'title': 'Any AE of special interest [b], possibly related to Sabestomig [a]', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}]}]}, {'title': 'Any AE of special interest [b] also an immune-mediated AE, possibly related to Sabestomig [a]', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}]}]}, {'title': 'Any immune-mediated AE [a]', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}]}]}, {'title': 'Any immune-mediated AE, possibly related to Sabestomig [a]', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)', 'description': 'The safety and tolerability of sabestomig in participants with r/r cHL were assessed.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety set included all participants who received any amount of study intervention.\n\nCTCAE = Common Terminology Criteria for Adverse Events (version 5.0)\n\n1. = As assessed by the investigator.\n2. = AE of special interest derivations were programmed based on sponsor assessment of AE terms.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Part A (Dose Escalation): Number of Participants With Adverse Events of Special Interest (AESIs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '12', 'groupId': 'OG005'}, {'value': '12', 'groupId': 'OG006'}, {'value': '12', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort A1', 'description': 'Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 2mg of sabestomig.'}, {'id': 'OG001', 'title': 'Cohort A2', 'description': 'Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 7mg of sabestomig.'}, {'id': 'OG002', 'title': 'Cohort A3', 'description': 'Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 22.5mg of sabestomig.'}, {'id': 'OG003', 'title': 'Cohort A4', 'description': 'Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 75mg of sabestomig.'}, {'id': 'OG004', 'title': 'Cohort A5', 'description': 'Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 225mg of sabestomig.'}, {'id': 'OG005', 'title': 'Cohort A6', 'description': 'Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 750mg of sabestomig.'}, {'id': 'OG006', 'title': 'Cohort A7', 'description': 'Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 1500mg of sabestomig.'}, {'id': 'OG007', 'title': 'Cohort A8', 'description': 'Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 2000mg of sabestomig.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}, {'value': '7', 'groupId': 'OG006'}, {'value': '5', 'groupId': 'OG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From start of treatment [C1D1 (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)', 'description': 'The safety and tolerability of sabestomig in participants with r/r cHL were assessed.\n\nAn AESI was an AE of scientific and medical interest specific to understanding of a study intervention and may have required close monitoring and rapid communication to AstraZeneca by the Investigator.\n\nThe AESIs for sabestomig include events with a potential inflammatory or immune-mediated mechanism and which may require more frequent monitoring and/or interventions such as steroids, immunosuppressants and/or hormone replacement therapy.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety set included all participants who received any amount of study intervention.\n\nAE of special interest derivations were programmed based on sponsor assessment of AE terms.'}, {'type': 'PRIMARY', 'title': 'Part A (Dose Escalation): Number of Participants With Dose-limiting Toxicities (DLTs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '11', 'groupId': 'OG005'}, {'value': '12', 'groupId': 'OG006'}, {'value': '12', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort A1', 'description': 'Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 2mg of sabestomig.'}, {'id': 'OG001', 'title': 'Cohort A2', 'description': 'Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 7mg of sabestomig.'}, {'id': 'OG002', 'title': 'Cohort A3', 'description': 'Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 22.5mg of sabestomig.'}, {'id': 'OG003', 'title': 'Cohort A4', 'description': 'Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 75mg of sabestomig.'}, {'id': 'OG004', 'title': 'Cohort A5', 'description': 'Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 225mg of sabestomig.'}, {'id': 'OG005', 'title': 'Cohort A6', 'description': 'Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 750mg of sabestomig.'}, {'id': 'OG006', 'title': 'Cohort A7', 'description': 'Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 1500mg of sabestomig.'}, {'id': 'OG007', 'title': 'Cohort A8', 'description': 'Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 2000mg of sabestomig.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first dose (C1D1) until 28 days for each participant [within 28 days DLT period]', 'description': 'DLT was defined as any ≥Grade 3 AE as per NCI CTCAE version 5 unless unequivocally due to underlying malignancy or an extraneous cause.\n\nThe following conditions were considered as DLTs:\n\n* Any death not clearly due to the underlying disease or extraneous causes\n* Grade 4 imAE or anemia\n* Any ≥Grade 3 non-infectious pneumonitis or colitis of any duration\n* Specific liver transaminase elevation as per protocol\n* Any Grade 3 imAE, including rash, pruritus, or diarrhea, that does not downgrade to Grade 2 or less within 7 days\n* Grade 3 nausea, vomiting, or diarrhea that does not resolve to Grade 2 or less within 3 days of getting maximal supportive care\n* ≥Grade 3 neutropenia, without fever or systemic infection, that does not improve by at least one grade within 7 days\n* Grade 4 thrombocytopenia for more than 7 days or ≥Grade 3 thrombocytopenia along with Grade ≥2 bleeding\n* Grade 4 Cytokine Release Syndrome (CRS) of any duration or Grade 3 CRS not improving to Grade ≤2 within 72 hours', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety set included all participants who received any amount of study intervention.'}, {'type': 'PRIMARY', 'title': 'Part B (Dose Expansion): Cohort B1: Objective Response Rate (ORR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B', 'description': 'Participants with anti-PD-1/PD-L1 exposed r/r cHL were planned to receive sabestomig once the RP2D had been determined.'}], 'timeFrame': 'Up to approximately 2 years 90 days', 'description': 'The anti-tumor activity of sabestomig in participants with r/r cHL was planned to be assessed.\n\nORR was defined as the percentage of participants with an objective response \\[Best Overall Response of a complete response (CR) or partial response (PR)\\] as per modified Lugano criteria (Lugano 2014), with the denominator defined as the number of participants in the response-evaluable analysis set.\n\nDisease response was planned to be assessed according to Blinded Independent Central Review using modified Lugano criteria (Lugano 2014).', 'reportingStatus': 'POSTED', 'populationDescription': 'Part B was not initiated, therefore, no participant was enrolled and analyzed for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Part B (Dose Expansion): Cohort B2: Complete Response Rate (CRR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B', 'description': 'Participants with anti-PD-1/PD-L1 exposed r/r cHL were planned to receive sabestomig once the RP2D had been determined.'}], 'timeFrame': 'Up to approximately 2 years 90 days', 'description': 'The anti-tumor activity of sabestomig in participants with r/r cHL was planned to be assessed.\n\nThe CRR was defined as the percentage of participants with a CR as per modified Lugano criteria (Lugano 2014), with the denominator defined as the number of participants in the response-evaluable analysis set.\n\nDisease response was planned to be assessed according to Blinded Independent Central Review using modified Lugano criteria (Lugano 2014).', 'reportingStatus': 'POSTED', 'populationDescription': 'Part B was not initiated, therefore, no participant was enrolled and analyzed for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Part B (Dose Expansion): Number of Participants With AEs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B', 'description': 'Participants with anti-PD-1/PD-L1 exposed r/r cHL were planned to receive sabestomig once the RP2D had been determined.'}], 'timeFrame': 'Up to approximately 2 years 90 days', 'description': 'The safety and tolerability of sabestomig in participants with r/r cHL was planned to be assessed.', 'reportingStatus': 'POSTED', 'populationDescription': 'Part B was not initiated, therefore, no participant was enrolled and analyzed for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Part A (Dose Escalation): Complete Response Rate (CRR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '12', 'groupId': 'OG005'}, {'value': '12', 'groupId': 'OG006'}, {'value': '12', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort A1', 'description': 'Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 2mg of sabestomig.'}, {'id': 'OG001', 'title': 'Cohort A2', 'description': 'Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 7mg of sabestomig.'}, {'id': 'OG002', 'title': 'Cohort A3', 'description': 'Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 22.5mg of sabestomig.'}, {'id': 'OG003', 'title': 'Cohort A4', 'description': 'Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 75mg of sabestomig.'}, {'id': 'OG004', 'title': 'Cohort A5', 'description': 'Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 225mg of sabestomig.'}, {'id': 'OG005', 'title': 'Cohort A6', 'description': 'Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 750mg of sabestomig.'}, {'id': 'OG006', 'title': 'Cohort A7', 'description': 'Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 1500mg of sabestomig.'}, {'id': 'OG007', 'title': 'Cohort A8', 'description': 'Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 2000mg of sabestomig.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': "Here, 'NA' indicated that data were not analyzed due to presence of single participant during analysis as pre-specified in Statistical analysis plan (SAP).", 'groupId': 'OG000'}, {'value': 'NA', 'comment': "Here, 'NA' indicated that data were not analyzed due to presence of single participant during analysis as pre-specified in SAP.", 'groupId': 'OG001'}, {'value': 'NA', 'comment': "Here, 'NA' indicated that data were not analyzed due to presence of single participant during analysis as pre-specified in SAP.", 'groupId': 'OG002'}, {'value': 'NA', 'comment': "Here, 'NA' indicated that data were not analyzed due to presence of single participant during analysis as pre-specified in SAP.", 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '33.3', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From start of treatment [C1D1 (each cycle was 28 days)] until first documented disease progression, or last evaluable assessment in the absence of progression (up to 2 years 5 months)', 'description': 'The anti-tumor activity of sabestomig in participants with r/r cHL was assessed.\n\nThe CRR was defined as the percentage of participants with a CR as per modified Lugano criteria (Lugano 2014) as assessed by the Investigator, with the denominator defined as the number of participants in the response-evaluable analysis set.\n\nDisease response was assessed according to Investigator assessment using modified Lugano criteria (Lugano 2014).', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Response-evaluable set included all dosed participants who had measurable disease at baseline.'}, {'type': 'SECONDARY', 'title': 'Part A (Dose Escalation): Objective Response Rate (ORR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '12', 'groupId': 'OG005'}, {'value': '12', 'groupId': 'OG006'}, {'value': '12', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort A1', 'description': 'Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 2mg of sabestomig.'}, {'id': 'OG001', 'title': 'Cohort A2', 'description': 'Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 7mg of sabestomig.'}, {'id': 'OG002', 'title': 'Cohort A3', 'description': 'Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 22.5mg of sabestomig.'}, {'id': 'OG003', 'title': 'Cohort A4', 'description': 'Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 75mg of sabestomig.'}, {'id': 'OG004', 'title': 'Cohort A5', 'description': 'Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 225mg of sabestomig.'}, {'id': 'OG005', 'title': 'Cohort A6', 'description': 'Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 750mg of sabestomig.'}, {'id': 'OG006', 'title': 'Cohort A7', 'description': 'Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 1500mg of sabestomig.'}, {'id': 'OG007', 'title': 'Cohort A8', 'description': 'Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 2000mg of sabestomig.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': "Here, 'NA' indicated that data were not analyzed due to presence of single participant during analysis as pre-specified in SAP.", 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': "Here, 'NA' indicated that data were not analyzed due to presence of single participant during analysis as pre-specified in SAP.", 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': "Here, 'NA' indicated that data were not analyzed due to presence of single participant during analysis as pre-specified in SAP.", 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': "Here, 'NA' indicated that data were not analyzed due to presence of single participant during analysis as pre-specified in SAP.", 'groupId': 'OG003', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '0.0', 'comment': "Here, 'NA' indicated that the upper and lower limit of confidence interval did not cross the 50% probability of ORR.", 'groupId': 'OG004', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '50.0', 'groupId': 'OG005', 'lowerLimit': '21.1', 'upperLimit': '78.9'}, {'value': '25.0', 'groupId': 'OG006', 'lowerLimit': '5.5', 'upperLimit': '57.2'}, {'value': '16.7', 'groupId': 'OG007', 'lowerLimit': '2.1', 'upperLimit': '48.4'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From start of treatment [C1D1 (each cycle was 28 days)] until progression, or last evaluable assessment in the absence of progression (up to 2 years 5 months)', 'description': 'The anti-tumor activity of sabestomig in participants with r/r cHL was assessed.\n\nThe ORR was defined as the percentage of participants with an objective response (Best Overall Response of CR or PR) as per modified Lugano criteria (Lugano 2014), as assessed by the Investigator, with the denominator defined as the number of participants in the response-evaluable analysis set.\n\nDisease response was assessed according to Investigator assessment using modified Lugano criteria (Lugano 2014).', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Response-evaluable set included all dosed participants who had measurable disease at baseline.'}, {'type': 'SECONDARY', 'title': 'Part A (Dose Escalation): Duration of Response (DoR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort A1', 'description': 'Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 2mg of sabestomig.'}, {'id': 'OG001', 'title': 'Cohort A2', 'description': 'Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 7mg of sabestomig.'}, {'id': 'OG002', 'title': 'Cohort A3', 'description': 'Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 22.5mg of sabestomig.'}, {'id': 'OG003', 'title': 'Cohort A4', 'description': 'Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 75mg of sabestomig.'}, {'id': 'OG004', 'title': 'Cohort A5', 'description': 'Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 225mg of sabestomig.'}, {'id': 'OG005', 'title': 'Cohort A6', 'description': 'Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 750mg of sabestomig.'}, {'id': 'OG006', 'title': 'Cohort A7', 'description': 'Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 1500mg of sabestomig.'}, {'id': 'OG007', 'title': 'Cohort A8', 'description': 'Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 2000mg of sabestomig.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': "Here, 'NA' indicated that data were not analyzed due to presence of single participant during analysis as pre-specified in SAP.", 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': "Here, 'NA' indicated that data were not analyzed due to presence of single participant during analysis as pre-specified in SAP.", 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': "Here, 'NA' indicated that data were not analyzed due to presence of single participant during analysis as pre-specified in SAP.", 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': "Here, 'NA' indicated that data were not analyzed due to presence of single participant during analysis as pre-specified in SAP.", 'groupId': 'OG003', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': "Here, 'NA' indicated that the median and lower limit of confidence interval did not cross the 50% probability of DoR.", 'groupId': 'OG005', 'lowerLimit': '2.7', 'upperLimit': 'NA'}, {'value': '7.7', 'comment': "Here, 'NA' indicated that the lower limit of confidence interval did not cross the 50% probability of DoR.", 'groupId': 'OG006', 'lowerLimit': '7.1', 'upperLimit': 'NA'}, {'value': '6.3', 'comment': "Here, 'NA' indicated that the upper and lower limit of confidence interval did not cross the 50% probability of DoR.", 'groupId': 'OG007', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From first documented response until date of first documented disease progression or death from any cause, or data cut-off or end of study (whichever came first, assessed up to 2 years 5 months)', 'description': 'The anti-tumor activity of sabestomig in participants with r/r cHL was assessed.\n\nThe DoR was defined as the time from the date of first documented objective response (CR or PR), as assessed by Investigator, using the modified Lugano criteria (Lugano 2014), until the date of first documented disease progression or death (by any cause in the absence of disease progression).\n\nDisease response was assessed according to Investigator assessment using modified Lugano criteria (Lugano 2014).', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Response-evaluable set included all dosed participants who had measurable disease at baseline.\n\nNumber of participants analyzed were number of participants with objective response.'}, {'type': 'SECONDARY', 'title': 'Part A (Dose Escalation): Duration of Complete Response (DoCR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort A1', 'description': 'Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 2mg of sabestomig.'}, {'id': 'OG001', 'title': 'Cohort A2', 'description': 'Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 7mg of sabestomig.'}, {'id': 'OG002', 'title': 'Cohort A3', 'description': 'Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 22.5mg of sabestomig.'}, {'id': 'OG003', 'title': 'Cohort A4', 'description': 'Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 75mg of sabestomig.'}, {'id': 'OG004', 'title': 'Cohort A5', 'description': 'Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 225mg of sabestomig.'}, {'id': 'OG005', 'title': 'Cohort A6', 'description': 'Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 750mg of sabestomig.'}, {'id': 'OG006', 'title': 'Cohort A7', 'description': 'Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 1500mg of sabestomig.'}, {'id': 'OG007', 'title': 'Cohort A8', 'description': 'Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 2000mg of sabestomig.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': "Here, 'NA' indicated that data (DOCR) was not calculable due to low number of responders with CR events, as pre-specified in SAP.", 'groupId': 'OG005', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From first documented complete response until date of first documented disease progression or death from any cause, or data cut-off or end of study (whichever came first, assessed up to 2 years 5 months)', 'description': 'The anti-tumor activity of sabestomig in participants with r/r cHL was assessed.\n\nThe DoCR was defined as the time from first documented CR, as per modified Lugano criteria (Lugano 2014) as assessed by the Investigator, until the date of first documented relapse/progression or death due to any cause (in the absence of disease progression).\n\nDisease response was assessed according to Investigator assessment using modified Lugano criteria (Lugano 2014).', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Response-evaluable set included all dosed participants who had measurable disease at baseline.\n\nNumber of participants analyzed were number of participants with complete response.'}, {'type': 'SECONDARY', 'title': 'Part A (Dose Escalation): Progression-free Survival (PFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '12', 'groupId': 'OG005'}, {'value': '12', 'groupId': 'OG006'}, {'value': '12', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort A1', 'description': 'Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 2mg of sabestomig.'}, {'id': 'OG001', 'title': 'Cohort A2', 'description': 'Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 7mg of sabestomig.'}, {'id': 'OG002', 'title': 'Cohort A3', 'description': 'Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 22.5mg of sabestomig.'}, {'id': 'OG003', 'title': 'Cohort A4', 'description': 'Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 75mg of sabestomig.'}, {'id': 'OG004', 'title': 'Cohort A5', 'description': 'Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 225mg of sabestomig.'}, {'id': 'OG005', 'title': 'Cohort A6', 'description': 'Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 750mg of sabestomig.'}, {'id': 'OG006', 'title': 'Cohort A7', 'description': 'Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 1500mg of sabestomig.'}, {'id': 'OG007', 'title': 'Cohort A8', 'description': 'Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 2000mg of sabestomig.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': "Here, 'NA' indicated that data were not analyzed due to presence of single participant during analysis as pre-specified in SAP.", 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': "Here, 'NA' indicated that data were not analyzed due to presence of single participant during analysis as pre-specified in SAP.", 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': "Here, 'NA' indicated that data were not analyzed due to presence of single participant during analysis as pre-specified in SAP.", 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': "Here, 'NA' indicated that data were not analyzed due to presence of single participant during analysis as pre-specified in SAP.", 'groupId': 'OG003', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '1.9', 'comment': "Here, 'NA' indicated that the lower limit of confidence interval did not cross the 50% probability of PFS.", 'groupId': 'OG004', 'lowerLimit': '1.4', 'upperLimit': 'NA'}, {'value': '4.8', 'groupId': 'OG005', 'lowerLimit': '2.4', 'upperLimit': '11.9'}, {'value': '5.7', 'comment': "Here, 'NA' indicated that the lower limit of confidence interval did not cross the 50% probability of PFS.", 'groupId': 'OG006', 'lowerLimit': '1.8', 'upperLimit': 'NA'}, {'value': '2.1', 'groupId': 'OG007', 'lowerLimit': '1.6', 'upperLimit': '8.1'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From start of treatment [C1D1 (each cycle was 28 days)] until date of first documented disease progression or data cut-off or end of study (whichever came first, assessed up to 2 years 5 months)', 'description': 'The anti-tumor activity of sabestomig in participants with r/r cHL was assessed.\n\nPFS was defined as the time from first dose until the earlier of the date of first documented disease progression, as per modified Lugano criteria (Lugano 2014) as assessed by the Investigator, or death (by any cause in the absence of disease progression or subsequent anticancer treatment).\n\nDisease response was assessed according to Investigator assessment using modified Lugano criteria (Lugano 2014).', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set included all participants who received any amount of study intervention.'}, {'type': 'SECONDARY', 'title': 'Part A (Dose Escalation): Overall Survival (OS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '12', 'groupId': 'OG005'}, {'value': '12', 'groupId': 'OG006'}, {'value': '12', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort A1', 'description': 'Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 2mg of sabestomig.'}, {'id': 'OG001', 'title': 'Cohort A2', 'description': 'Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 7mg of sabestomig.'}, {'id': 'OG002', 'title': 'Cohort A3', 'description': 'Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 22.5mg of sabestomig.'}, {'id': 'OG003', 'title': 'Cohort A4', 'description': 'Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 75mg of sabestomig.'}, {'id': 'OG004', 'title': 'Cohort A5', 'description': 'Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 225mg of sabestomig.'}, {'id': 'OG005', 'title': 'Cohort A6', 'description': 'Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 750mg of sabestomig.'}, {'id': 'OG006', 'title': 'Cohort A7', 'description': 'Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 1500mg of sabestomig.'}, {'id': 'OG007', 'title': 'Cohort A8', 'description': 'Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 2000mg of sabestomig.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': "Here, 'NA' indicated that data were not analyzed due to presence of single participant during analysis as pre-specified in SAP.", 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': "Here, 'NA' indicated that data were not analyzed due to presence of single participant during analysis as pre-specified in SAP.", 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': "Here, 'NA' indicated that data were not analyzed due to presence of single participant during analysis as pre-specified in SAP.", 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': "Here, 'NA' indicated that data were not analyzed due to presence of single participant during analysis as pre-specified in SAP.", 'groupId': 'OG003', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': "Here, 'NA' indicated that the median and lower limit of confidence interval did not cross the 50% probability of OS.", 'groupId': 'OG004', 'lowerLimit': '1.4', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': "Here, 'NA' indicated that the median and confidence interval did not cross the 50% probability of OS.", 'groupId': 'OG005', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': "Here, 'NA' indicated that the median and confidence interval did not cross the 50% probability of OS.", 'groupId': 'OG006', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': "Here, 'NA' indicated that the median and lower limit of confidence interval did not cross the 50% probability of OS.", 'groupId': 'OG007', 'lowerLimit': '8.4', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From start of treatment [C1D1 (each cycle was 28 days)] until date of death due to any cause or data cut-off or end of study (whichever came first, assessed up to 2 years 5 months)', 'description': 'The anti-tumor activity of sabestomig in participants with r/r cHL was assessed.\n\nThe OS was defined as the time from the start of treatment until death due to any cause regardless of whether participant withdraws from treatment or receives another anti-lymphoma therapy.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set included all participants who received any amount of study intervention.'}, {'type': 'SECONDARY', 'title': 'Part A (Dose Escalation): Number of Participants With Positive Anti-drug Antibodies (ADA) Against Sabestomig in Serum', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '12', 'groupId': 'OG005'}, {'value': '12', 'groupId': 'OG006'}, {'value': '12', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort A1', 'description': 'Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 2mg of sabestomig.'}, {'id': 'OG001', 'title': 'Cohort A2', 'description': 'Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 7mg of sabestomig.'}, {'id': 'OG002', 'title': 'Cohort A3', 'description': 'Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 22.5mg of sabestomig.'}, {'id': 'OG003', 'title': 'Cohort A4', 'description': 'Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 75mg of sabestomig.'}, {'id': 'OG004', 'title': 'Cohort A5', 'description': 'Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 225mg of sabestomig.'}, {'id': 'OG005', 'title': 'Cohort A6', 'description': 'Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 750mg of sabestomig.'}, {'id': 'OG006', 'title': 'Cohort A7', 'description': 'Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 1500mg of sabestomig.'}, {'id': 'OG007', 'title': 'Cohort A8', 'description': 'Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 2000mg of sabestomig.'}], 'classes': [{'title': 'ADA prevalence', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}]}]}, {'title': 'Treatment-induced ADA positive', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}]}]}, {'title': 'Treatment-boosted ADA', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}]}]}, {'title': 'ADA incidence', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}]}]}, {'title': 'ADA positive at baseline and at least one post-baseline', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}, {'title': 'ADA positive at baseline and not positive at post-baseline', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}, {'title': 'ADA transient positive', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}, {'title': 'ADA persistently positive', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'On C1D1, C2D1, and until end of study [up to 2 years 5 months (each cycle was 28 days)]', 'description': 'The presence of ADA for sabestomig in treated participants with r/r cHL was assessed.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Immunogenicity analysis set included all participants who received at least 1 dose of study intervention with at least 1 reportable immunogenicity measurement.'}, {'type': 'SECONDARY', 'title': 'Part A (Dose Escalation): Maximum Observed Concentration (Cmax)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '12', 'groupId': 'OG005'}, {'value': '11', 'groupId': 'OG006'}, {'value': '11', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort A1', 'description': 'Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 2mg of sabestomig.'}, {'id': 'OG001', 'title': 'Cohort A2', 'description': 'Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 7mg of sabestomig.'}, {'id': 'OG002', 'title': 'Cohort A3', 'description': 'Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 22.5mg of sabestomig.'}, {'id': 'OG003', 'title': 'Cohort A4', 'description': 'Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 75mg of sabestomig.'}, {'id': 'OG004', 'title': 'Cohort A5', 'description': 'Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 225mg of sabestomig.'}, {'id': 'OG005', 'title': 'Cohort A6', 'description': 'Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 750mg of sabestomig.'}, {'id': 'OG006', 'title': 'Cohort A7', 'description': 'Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 1500mg of sabestomig.'}, {'id': 'OG007', 'title': 'Cohort A8', 'description': 'Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 2000mg of sabestomig.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': "Here, 'NA' indicated that median value was not calculated for a single participant as pre-specified in the SAP.", 'groupId': 'OG000', 'lowerLimit': '0.14', 'upperLimit': '0.14'}, {'value': 'NA', 'comment': "Here, 'NA' indicated that median value was not calculated for a single participant as pre-specified in the SAP.", 'groupId': 'OG001', 'lowerLimit': '1.41', 'upperLimit': '1.41'}, {'value': 'NA', 'comment': "Here, 'NA' indicated that median value was not calculated for a single participant as pre-specified in the SAP.", 'groupId': 'OG002', 'lowerLimit': '5.80', 'upperLimit': '5.80'}, {'value': 'NA', 'comment': "Here, 'NA' indicated that median value was not calculated for a single participant as pre-specified in the SAP.", 'groupId': 'OG003', 'lowerLimit': '15.40', 'upperLimit': '15.40'}, {'value': '52.49', 'groupId': 'OG004', 'lowerLimit': '39.60', 'upperLimit': '82.90'}, {'value': '256.00', 'groupId': 'OG005', 'lowerLimit': '172.00', 'upperLimit': '430.00'}, {'value': '516.00', 'groupId': 'OG006', 'lowerLimit': '364.00', 'upperLimit': '1480.00'}, {'value': '695.10', 'groupId': 'OG007', 'lowerLimit': '323.00', 'upperLimit': '1400.00'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From C1D1 [before start of infusion (SOI) and at end of infusion (EOI)] to end of study [up to 2 years 5 months (each cycle was 28 days)]', 'description': 'The Cmax of sabestomig in participants with r/r cHL was assessed.', 'unitOfMeasure': 'microgram (ug)/milliliter (mL)', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic (PK) set included all participants who received at least 1 dose of study intervention with at least 1 reportable concentration.'}, {'type': 'SECONDARY', 'title': 'Part A (Dose Escalation): Area Under the Concentration-time Curve (AUC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '11', 'groupId': 'OG005'}, {'value': '11', 'groupId': 'OG006'}, {'value': '11', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort A1', 'description': 'Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 2mg of sabestomig.'}, {'id': 'OG001', 'title': 'Cohort A2', 'description': 'Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 7mg of sabestomig.'}, {'id': 'OG002', 'title': 'Cohort A3', 'description': 'Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 22.5mg of sabestomig.'}, {'id': 'OG003', 'title': 'Cohort A4', 'description': 'Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 75mg of sabestomig.'}, {'id': 'OG004', 'title': 'Cohort A5', 'description': 'Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 225mg of sabestomig.'}, {'id': 'OG005', 'title': 'Cohort A6', 'description': 'Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 750mg of sabestomig.'}, {'id': 'OG006', 'title': 'Cohort A7', 'description': 'Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 1500mg of sabestomig.'}, {'id': 'OG007', 'title': 'Cohort A8', 'description': 'Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 2000mg of sabestomig.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': "Here, 'NA' indicated that median value was not calculated for a single participant as pre-specified in the SAP.", 'groupId': 'OG001', 'lowerLimit': '4.24', 'upperLimit': '4.24'}, {'value': 'NA', 'comment': "Here, 'NA' indicated that median value was not calculated for a single participant as pre-specified in the SAP.", 'groupId': 'OG002', 'lowerLimit': '28.50', 'upperLimit': '28.50'}, {'value': 'NA', 'comment': "Here, 'NA' indicated that median value was not calculated for a single participant as pre-specified in the SAP.", 'groupId': 'OG003', 'lowerLimit': '88.80', 'upperLimit': '88.80'}, {'value': '273.00', 'groupId': 'OG004', 'lowerLimit': '110.00', 'upperLimit': '518.00'}, {'value': '2256.00', 'groupId': 'OG005', 'lowerLimit': '1710.00', 'upperLimit': '4780.00'}, {'value': '4687.00', 'groupId': 'OG006', 'lowerLimit': '2740.00', 'upperLimit': '8370.00'}, {'value': '6883.00', 'groupId': 'OG007', 'lowerLimit': '2560.00', 'upperLimit': '8120.00'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From C1D1 (before SOI and at EOI) to end of study [up to 2 years 5 months (each cycle was 28 days)]', 'description': 'The AUC of sabestomig in participants with r/r cHL was assessed.', 'unitOfMeasure': 'Day*ug/mL', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'PK set included all participants who received at least 1 dose of study intervention with at least 1 reportable concentration.'}, {'type': 'SECONDARY', 'title': 'Part A (Dose Escalation): Clearance (CL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '11', 'groupId': 'OG005'}, {'value': '9', 'groupId': 'OG006'}, {'value': '11', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort A1', 'description': 'Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 2mg of sabestomig.'}, {'id': 'OG001', 'title': 'Cohort A2', 'description': 'Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 7mg of sabestomig.'}, {'id': 'OG002', 'title': 'Cohort A3', 'description': 'Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 22.5mg of sabestomig.'}, {'id': 'OG003', 'title': 'Cohort A4', 'description': 'Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 75mg of sabestomig.'}, {'id': 'OG004', 'title': 'Cohort A5', 'description': 'Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 225mg of sabestomig.'}, {'id': 'OG005', 'title': 'Cohort A6', 'description': 'Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 750mg of sabestomig.'}, {'id': 'OG006', 'title': 'Cohort A7', 'description': 'Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 1500mg of sabestomig.'}, {'id': 'OG007', 'title': 'Cohort A8', 'description': 'Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 2000mg of sabestomig.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': "Here, 'NA' indicated that median value was not calculated for a single participant as pre-specified in the SAP.", 'groupId': 'OG001', 'lowerLimit': '1.3200', 'upperLimit': '1.3200'}, {'value': 'NA', 'comment': "Here, 'NA' indicated that median value was not calculated for a single participant as pre-specified in the SAP.", 'groupId': 'OG002', 'lowerLimit': '0.7210', 'upperLimit': '0.7210'}, {'value': 'NA', 'comment': "Here, 'NA' indicated that median value was not calculated for a single participant as pre-specified in the SAP.", 'groupId': 'OG003', 'lowerLimit': '0.8160', 'upperLimit': '0.8160'}, {'value': '0.4925', 'groupId': 'OG004', 'lowerLimit': '0.2910', 'upperLimit': '1.9800'}, {'value': '0.2321', 'groupId': 'OG005', 'lowerLimit': '0.1030', 'upperLimit': '0.4200'}, {'value': '0.2211', 'groupId': 'OG006', 'lowerLimit': '0.1010', 'upperLimit': '0.3180'}, {'value': '0.2149', 'groupId': 'OG007', 'lowerLimit': '0.1280', 'upperLimit': '0.7020'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From C1D1 (before SOI and at EOI) to end of study [up to 2 years 5 months (each cycle was 28 days)]', 'description': 'The CL of sabestomig in participants with r/r cHL was assessed.', 'unitOfMeasure': 'Liter (L)/Day', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'PK set included all participants who received at least 1 dose of study intervention with at least 1 reportable concentration.'}, {'type': 'SECONDARY', 'title': 'Part A (Dose Escalation): Terminal Elimination Half-life (t½λz)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '11', 'groupId': 'OG005'}, {'value': '9', 'groupId': 'OG006'}, {'value': '11', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort A1', 'description': 'Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 2mg of sabestomig.'}, {'id': 'OG001', 'title': 'Cohort A2', 'description': 'Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 7mg of sabestomig.'}, {'id': 'OG002', 'title': 'Cohort A3', 'description': 'Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 22.5mg of sabestomig.'}, {'id': 'OG003', 'title': 'Cohort A4', 'description': 'Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 75mg of sabestomig.'}, {'id': 'OG004', 'title': 'Cohort A5', 'description': 'Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 225mg of sabestomig.'}, {'id': 'OG005', 'title': 'Cohort A6', 'description': 'Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 750mg of sabestomig.'}, {'id': 'OG006', 'title': 'Cohort A7', 'description': 'Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 1500mg of sabestomig.'}, {'id': 'OG007', 'title': 'Cohort A8', 'description': 'Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 2000mg of sabestomig.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': "Here, 'NA' indicated that median value was not calculated for a single participant as pre-specified in the SAP.", 'groupId': 'OG001', 'lowerLimit': '2.880', 'upperLimit': '2.880'}, {'value': 'NA', 'comment': "Here, 'NA' indicated that median value was not calculated for a single participant as pre-specified in the SAP.", 'groupId': 'OG002', 'lowerLimit': '8.980', 'upperLimit': '8.980'}, {'value': 'NA', 'comment': "Here, 'NA' indicated that median value was not calculated for a single participant as pre-specified in the SAP.", 'groupId': 'OG003', 'lowerLimit': '4.730', 'upperLimit': '4.730'}, {'value': '9.136', 'groupId': 'OG004', 'lowerLimit': '3.100', 'upperLimit': '25.000'}, {'value': '12.720', 'groupId': 'OG005', 'lowerLimit': '6.680', 'upperLimit': '42.800'}, {'value': '16.440', 'groupId': 'OG006', 'lowerLimit': '11.200', 'upperLimit': '22.600'}, {'value': '12.070', 'groupId': 'OG007', 'lowerLimit': '5.990', 'upperLimit': '21.000'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From C1D1 (before SOI and at EOI) to end of study [up to 2 years 5 months (each cycle was 28 days)]', 'description': 'The t½λz of sabestomig in participants with r/r cHL was assessed.', 'unitOfMeasure': 'Day', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'PK set included all participants who received at least 1 dose of study intervention with at least 1 reportable concentration.'}, {'type': 'SECONDARY', 'title': 'Part B (Dose Expansion): Duration of Response (DoR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B', 'description': 'Participants with anti-PD-1/PD-L1 exposed r/r cHL were planned to receive sabestomig once the RP2D had been determined.'}], 'timeFrame': 'Up to approximately 2 years 90 days', 'description': 'The DoR of sabestomig in participants with r/r cHL was planned to be assessed.', 'reportingStatus': 'POSTED', 'populationDescription': 'Part B was not initiated, therefore, no participant was enrolled and analyzed for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Part B (Dose Expansion): Duration of Complete Response (DoCR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B', 'description': 'Participants with anti-PD-1/PD-L1 exposed r/r cHL were planned to receive sabestomig once the RP2D had been determined.'}], 'timeFrame': 'Up to approximately 2 years 90 days', 'description': 'The DoCR of sabestomig in participants with r/r cHL was planned to be assessed.', 'reportingStatus': 'POSTED', 'populationDescription': 'Part B was not initiated, therefore, no participant was enrolled and analyzed for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Part B (Dose Expansion): Progression-free Survival (PFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B', 'description': 'Participants with anti-PD-1/PD-L1 exposed r/r cHL were planned to receive sabestomig once the RP2D had been determined.'}], 'timeFrame': 'Up to approximately 2 years 90 days', 'description': 'The anti-tumor activity of sabestomig in participants with r/r cHL was planned to be assessed.', 'reportingStatus': 'POSTED', 'populationDescription': 'Part B was not initiated, therefore, no participant was enrolled and analyzed for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Part B (Dose Expansion): Overall Survival (OS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B', 'description': 'Participants with anti-PD-1/PD-L1 exposed r/r cHL were planned to receive sabestomig once the RP2D had been determined.'}], 'timeFrame': 'Up to approximately 2 years 90 days', 'description': 'The anti-tumor activity of sabestomig in participants with r/r cHL was planned to be assessed.', 'reportingStatus': 'POSTED', 'populationDescription': 'Part B was not initiated, therefore, no participant was enrolled and analyzed for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Part B (Dose Expansion): Number of Participants With Positive ADA Against Sabestomig in Serum', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B', 'description': 'Participants with anti-PD-1/PD-L1 exposed r/r cHL were planned to receive sabestomig once the RP2D had been determined.'}], 'timeFrame': 'Up to approximately 2 years 90 days', 'description': 'The presence of ADA for sabestomig in treated participants with r/r cHL was planned to be assessed.', 'reportingStatus': 'POSTED', 'populationDescription': 'Part B was not initiated, therefore, no participant was enrolled and analyzed for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Part B (Dose Expansion): Maximum Observed Concentration (Cmax)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B', 'description': 'Participants with anti-PD-1/PD-L1 exposed r/r cHL were planned to receive sabestomig once the RP2D had been determined.'}], 'timeFrame': 'Up to approximately 2 years 90 days', 'description': 'The Cmax of sabestomig in participants with r/r cHL was planned to be assessed.', 'reportingStatus': 'POSTED', 'populationDescription': 'Part B was not initiated, therefore, no participant was enrolled and analyzed for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Part B (Dose Expansion): Area Under the Concentration-time Curve (AUC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B', 'description': 'Participants with anti-PD-1/PD-L1 exposed r/r cHL were planned to receive sabestomig once the RP2D had been determined.'}], 'timeFrame': 'Up to approximately 2 years 90 days', 'description': 'The AUC of sabestomig in participants with r/r cHL was planned to be assessed.', 'reportingStatus': 'POSTED', 'populationDescription': 'Part B was not initiated, therefore, no participant was enrolled and analyzed for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Part B (Dose Expansion): Terminal Elimination Half-life (t½λz)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B', 'description': 'Participants with anti-PD-1/PD-L1 exposed r/r cHL were planned to receive sabestomig once the RP2D had been determined.'}], 'timeFrame': 'Up to approximately 2 years 90 days', 'description': 'The t½λz of sabestomig in participants with r/r cHL was planned to be assessed.', 'reportingStatus': 'POSTED', 'populationDescription': 'Part B was not initiated, therefore, no participant was enrolled and analyzed for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Part B (Dose Expansion): Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B', 'description': 'Participants with anti-PD-1/PD-L1 exposed r/r cHL were planned to receive sabestomig once the RP2D had been determined.'}], 'timeFrame': 'Up to approximately 2 years 90 days', 'description': 'Proportion of participants reporting different levels of presence/magnitude/interference (as applicable) of diarrhea, rash, and fatigue over time based on PRO-CTCAE was planned to be evaluated.\n\nPRO-CTCAE was a PRO measurement system developed to evaluate symptomatic toxicity in participants on cancer clinical trials. The PRO-CTCAE Item Library included 124 items representing 78 symptomatic toxicities drawn from the CTCAE. PRO-CTCAE items were planned to evaluate the symptom attributes of frequency, severity, interference, amount, presence/absence. Each symptomatic AE was planned to be assessed by 1 to 3 attributes. Conditional branching logic was planned to be used with electronic data capture, thereby reducing respondent burden. The recall period was planned as the past 7 days and PRO-CTCAE responses were planned to score from 0 to 4 (or 0/1 for absent/present).', 'reportingStatus': 'POSTED', 'populationDescription': 'Part B was not initiated, therefore, no participant was enrolled and analyzed for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Part B (Dose Expansion): Pediatric Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (Peds-PRO-CTCAE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B', 'description': 'Participants with anti-PD-1/PD-L1 exposed r/r cHL were planned to receive sabestomig once the RP2D had been determined.'}], 'timeFrame': 'Up to approximately 2 years 90 days', 'description': "Proportion of participants reporting different levels of presence/magnitude/interference (as applicable) of diarrhea, rash, and fatigue over time based on peds-PRO-CTCAE was planned to be evaluated.\n\nThe pediatric module included 130 items representing 62 symptomatic toxicities and permitted self-reporting by children and adolescents aged 7 to 17 years. In this study, 17 symptomatic toxicities were planned for selection. Thus, the total number of questions that participants would have answered ranged from 17 (assuming that no branching questions were triggered, ie, the participant answered '0' to the initial question for each symptom) to 42 items (assuming that all possible branching questions were triggered for every symptom posed to the participant).", 'reportingStatus': 'POSTED', 'populationDescription': 'Part B was not initiated, therefore, no participant was enrolled and analyzed for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Part B (Dose Expansion): Patient Global Impression of Treatment Tolerability (PGI-TT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B', 'description': 'Participants with anti-PD-1/PD-L1 exposed r/r cHL were planned to receive sabestomig once the RP2D had been determined.'}], 'timeFrame': 'Up to approximately 2 years 90 days', 'description': 'Proportion of participants reporting different levels of overall side-effect bother over time based on the PGI-TT was planned to be evaluated.\n\nFor adult participants only, the PGI-TT item was included to assess how a participant perceived the overall burden of treatment-related side effects of cancer treatment over the past 7 days. Participants were planned to be asked to choose the response that best described the level of burden by the side effect of their cancer treatment over the past week. The planned response options were:"not at all", "a little bit", "somewhat", "quite a bit", and "very much".', 'reportingStatus': 'POSTED', 'populationDescription': 'Part B was not initiated, therefore, no participant was enrolled and analyzed for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Part B (Dose Expansion): European Organization for Research and Treatment of Cancer (EORTC) Item List (IL)XX QL2 [2-item Global Health-related Quality of Life (HRQoL)]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B', 'description': 'Participants with anti-PD-1/PD-L1 exposed r/r cHL were planned to receive sabestomig once the RP2D had been determined.'}], 'timeFrame': 'Up to approximately 2 years 90 days', 'description': 'Proportion of participants reporting different levels of quality of life/health over time based on the European Organization for Research and Treatment of Cancer Item List (EORTC) ILXX QL2 items was planned to be evaluated.\n\nEORTC QLQ-C30 was a 30-item self-administered questionnaire designed for all cancer types. Questions were grouped into 5 multi-item functional scales (physical, role, emotional, cognitive, and social), 3 multi-item symptom scales (fatigue, pain, and nausea/vomiting), 2-item global HRQoL (QL2) scale, 5 single items assessing additional symptoms commonly reported by participants with cancer (dyspnea, loss of appetite, insomnia, constipation, and diarrhea), and 1 item on the financial impact of the disease. Participants were planned to answer QLQ-C30 questions in reference to how they had been over the past week. Final scores were planned to transform to range from 0 to 100, where higher scores indicated better functioning, better HRQoL, or greater level of symptoms.', 'reportingStatus': 'POSTED', 'populationDescription': 'Part B was not initiated, therefore, no participant was enrolled and analyzed for this outcome measure.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Cohort A1', 'description': 'Participants with relapsed or refractory classical Hodgkin Lymphoma (r/r cHL) previously treated with anti-programmed cell death protein-1/programmed cell death-ligand 1 (anti-PD-1/PD-L1) based therapy received 2mg of sabestomig.'}, {'id': 'FG001', 'title': 'Cohort A2', 'description': 'Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 7mg of sabestomig.'}, {'id': 'FG002', 'title': 'Cohort A3', 'description': 'Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 22.5mg of sabestomig.'}, {'id': 'FG003', 'title': 'Cohort A4', 'description': 'Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 75mg of sabestomig.'}, {'id': 'FG004', 'title': 'Cohort A5', 'description': 'Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 225mg of sabestomig.'}, {'id': 'FG005', 'title': 'Cohort A6', 'description': 'Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 750mg of sabestomig.'}, {'id': 'FG006', 'title': 'Cohort A7', 'description': 'Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 1500mg of sabestomig.'}, {'id': 'FG007', 'title': 'Cohort A8', 'description': 'Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 2000mg of sabestomig.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '5'}, {'groupId': 'FG005', 'numSubjects': '12'}, {'groupId': 'FG006', 'numSubjects': '12'}, {'groupId': 'FG007', 'numSubjects': '12'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '5'}, {'groupId': 'FG005', 'numSubjects': '12'}, {'groupId': 'FG006', 'numSubjects': '12'}, {'groupId': 'FG007', 'numSubjects': '12'}]}], 'dropWithdraws': [{'type': 'Ongoing as of DCO (30 Aug 2024)', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '10'}, {'groupId': 'FG006', 'numSubjects': '10'}, {'groupId': 'FG007', 'numSubjects': '9'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '1'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'Study terminated by Sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '1'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Participants were enrolled in this study from 18 March 2022 (First subject in) and the analyses presented in this results form are based on a final data cut-off (DCO) of 30 August 2024.', 'preAssignmentDetails': 'Participants who met the inclusion criteria and none of the exclusion criteria were enrolled to the study. All study assessments were performed as per the schedule of assessment.\n\nPart B was not initiated, therefore, no participant was enrolled and analyzed for this part of the study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}, {'value': '12', 'groupId': 'BG005'}, {'value': '12', 'groupId': 'BG006'}, {'value': '12', 'groupId': 'BG007'}, {'value': '45', 'groupId': 'BG008'}]}], 'groups': [{'id': 'BG000', 'title': 'Cohort A1', 'description': 'Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 2mg of sabestomig.'}, {'id': 'BG001', 'title': 'Cohort A2', 'description': 'Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 7mg of sabestomig.'}, {'id': 'BG002', 'title': 'Cohort A3', 'description': 'Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 22.5mg of sabestomig.'}, {'id': 'BG003', 'title': 'Cohort A4', 'description': 'Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 75mg of sabestomig.'}, {'id': 'BG004', 'title': 'Cohort A5', 'description': 'Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 225mg of sabestomig.'}, {'id': 'BG005', 'title': 'Cohort A6', 'description': 'Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 750mg of sabestomig.'}, {'id': 'BG006', 'title': 'Cohort A7', 'description': 'Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 1500mg of sabestomig.'}, {'id': 'BG007', 'title': 'Cohort A8', 'description': 'Participants with r/r cHL previously treated with anti-PD-1/PD-L1 based therapy received 2000mg of sabestomig.'}, {'id': 'BG008', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': "Mean was not reported due to concerns with participant's confidentiality. Standard deviation was not calculable for a single participant.", 'groupId': 'BG000'}, {'value': 'NA', 'spread': 'NA', 'comment': "Mean was not reported due to concerns with participant's confidentiality. Standard deviation was not calculable for a single participant.", 'groupId': 'BG001'}, {'value': 'NA', 'spread': 'NA', 'comment': "Mean was not reported due to concerns with participant's confidentiality. Standard deviation was not calculable for a single participant.", 'groupId': 'BG002'}, {'value': 'NA', 'spread': 'NA', 'comment': "Mean was not reported due to concerns with participant's confidentiality. Standard deviation was not calculable for a single participant.", 'groupId': 'BG003'}, {'value': '45.8', 'spread': '17.6', 'groupId': 'BG004'}, {'value': '44.4', 'spread': '16.0', 'groupId': 'BG005'}, {'value': '38.6', 'spread': '14.5', 'groupId': 'BG006'}, {'value': '52.1', 'spread': '21.2', 'groupId': 'BG007'}, {'value': '44.0', 'spread': '17.4', 'groupId': 'BG008'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'Female', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}, {'value': '6', 'groupId': 'BG007'}, {'value': '14', 'groupId': 'BG008'}]}]}, {'title': 'Male', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '9', 'groupId': 'BG005'}, {'value': '10', 'groupId': 'BG006'}, {'value': '6', 'groupId': 'BG007'}, {'value': '27', 'groupId': 'BG008'}]}]}, {'title': 'All', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '4', 'groupId': 'BG008'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': "For single participant in a particular gender, the data was not reported under specific category, rather a customized option was used, and the data was reported as 'All' to maintain participant's confidentiality.", 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Hispanic or Latino', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}]}]}, {'title': 'Not Hispanic or Latino', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '12', 'groupId': 'BG005'}, {'value': '10', 'groupId': 'BG006'}, {'value': '10', 'groupId': 'BG007'}, {'value': '35', 'groupId': 'BG008'}]}]}, {'title': 'Missing', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '2', 'groupId': 'BG007'}, {'value': '5', 'groupId': 'BG008'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '5', 'groupId': 'BG008'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': "For single participant in a particular ethnicity, the data was not reported under specific category, rather a customized option was used, and the data was reported as 'Other' to maintain participant's confidentiality.", 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Full analysis set included all participants who received any amount of study intervention.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-05-07', 'size': 8852087, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-02-28T09:00', 'hasProtocol': True}, {'date': '2024-09-25', 'size': 7238253, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-02-28T09:00', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 45}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-03-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2025-09-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-18', 'studyFirstSubmitDate': '2022-01-19', 'resultsFirstSubmitDate': '2025-02-28', 'studyFirstSubmitQcDate': '2022-01-19', 'lastUpdatePostDateStruct': {'date': '2025-10-02', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-04-15', 'studyFirstPostDateStruct': {'date': '2022-02-01', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-05-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-08-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Part A (Dose Escalation): Number of Participants With Adverse Events of Special Interest (AESIs)', 'timeFrame': 'From start of treatment [C1D1 (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)', 'description': 'The safety and tolerability of sabestomig in participants with r/r cHL were assessed.\n\nAn AESI was an AE of scientific and medical interest specific to understanding of a study intervention and may have required close monitoring and rapid communication to AstraZeneca by the Investigator.\n\nThe AESIs for sabestomig include events with a potential inflammatory or immune-mediated mechanism and which may require more frequent monitoring and/or interventions such as steroids, immunosuppressants and/or hormone replacement therapy.'}], 'primaryOutcomes': [{'measure': 'Part A (Dose Escalation): Number of Participants With Adverse Events (AEs)', 'timeFrame': 'From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)', 'description': 'The safety and tolerability of sabestomig in participants with r/r cHL were assessed.'}, {'measure': 'Part A (Dose Escalation): Number of Participants With Dose-limiting Toxicities (DLTs)', 'timeFrame': 'From first dose (C1D1) until 28 days for each participant [within 28 days DLT period]', 'description': 'DLT was defined as any ≥Grade 3 AE as per NCI CTCAE version 5 unless unequivocally due to underlying malignancy or an extraneous cause.\n\nThe following conditions were considered as DLTs:\n\n* Any death not clearly due to the underlying disease or extraneous causes\n* Grade 4 imAE or anemia\n* Any ≥Grade 3 non-infectious pneumonitis or colitis of any duration\n* Specific liver transaminase elevation as per protocol\n* Any Grade 3 imAE, including rash, pruritus, or diarrhea, that does not downgrade to Grade 2 or less within 7 days\n* Grade 3 nausea, vomiting, or diarrhea that does not resolve to Grade 2 or less within 3 days of getting maximal supportive care\n* ≥Grade 3 neutropenia, without fever or systemic infection, that does not improve by at least one grade within 7 days\n* Grade 4 thrombocytopenia for more than 7 days or ≥Grade 3 thrombocytopenia along with Grade ≥2 bleeding\n* Grade 4 Cytokine Release Syndrome (CRS) of any duration or Grade 3 CRS not improving to Grade ≤2 within 72 hours'}, {'measure': 'Part B (Dose Expansion): Cohort B1: Objective Response Rate (ORR)', 'timeFrame': 'Up to approximately 2 years 90 days', 'description': 'The anti-tumor activity of sabestomig in participants with r/r cHL was planned to be assessed.\n\nORR was defined as the percentage of participants with an objective response \\[Best Overall Response of a complete response (CR) or partial response (PR)\\] as per modified Lugano criteria (Lugano 2014), with the denominator defined as the number of participants in the response-evaluable analysis set.\n\nDisease response was planned to be assessed according to Blinded Independent Central Review using modified Lugano criteria (Lugano 2014).'}, {'measure': 'Part B (Dose Expansion): Cohort B2: Complete Response Rate (CRR)', 'timeFrame': 'Up to approximately 2 years 90 days', 'description': 'The anti-tumor activity of sabestomig in participants with r/r cHL was planned to be assessed.\n\nThe CRR was defined as the percentage of participants with a CR as per modified Lugano criteria (Lugano 2014), with the denominator defined as the number of participants in the response-evaluable analysis set.\n\nDisease response was planned to be assessed according to Blinded Independent Central Review using modified Lugano criteria (Lugano 2014).'}, {'measure': 'Part B (Dose Expansion): Number of Participants With AEs', 'timeFrame': 'Up to approximately 2 years 90 days', 'description': 'The safety and tolerability of sabestomig in participants with r/r cHL was planned to be assessed.'}], 'secondaryOutcomes': [{'measure': 'Part A (Dose Escalation): Complete Response Rate (CRR)', 'timeFrame': 'From start of treatment [C1D1 (each cycle was 28 days)] until first documented disease progression, or last evaluable assessment in the absence of progression (up to 2 years 5 months)', 'description': 'The anti-tumor activity of sabestomig in participants with r/r cHL was assessed.\n\nThe CRR was defined as the percentage of participants with a CR as per modified Lugano criteria (Lugano 2014) as assessed by the Investigator, with the denominator defined as the number of participants in the response-evaluable analysis set.\n\nDisease response was assessed according to Investigator assessment using modified Lugano criteria (Lugano 2014).'}, {'measure': 'Part A (Dose Escalation): Objective Response Rate (ORR)', 'timeFrame': 'From start of treatment [C1D1 (each cycle was 28 days)] until progression, or last evaluable assessment in the absence of progression (up to 2 years 5 months)', 'description': 'The anti-tumor activity of sabestomig in participants with r/r cHL was assessed.\n\nThe ORR was defined as the percentage of participants with an objective response (Best Overall Response of CR or PR) as per modified Lugano criteria (Lugano 2014), as assessed by the Investigator, with the denominator defined as the number of participants in the response-evaluable analysis set.\n\nDisease response was assessed according to Investigator assessment using modified Lugano criteria (Lugano 2014).'}, {'measure': 'Part A (Dose Escalation): Duration of Response (DoR)', 'timeFrame': 'From first documented response until date of first documented disease progression or death from any cause, or data cut-off or end of study (whichever came first, assessed up to 2 years 5 months)', 'description': 'The anti-tumor activity of sabestomig in participants with r/r cHL was assessed.\n\nThe DoR was defined as the time from the date of first documented objective response (CR or PR), as assessed by Investigator, using the modified Lugano criteria (Lugano 2014), until the date of first documented disease progression or death (by any cause in the absence of disease progression).\n\nDisease response was assessed according to Investigator assessment using modified Lugano criteria (Lugano 2014).'}, {'measure': 'Part A (Dose Escalation): Duration of Complete Response (DoCR)', 'timeFrame': 'From first documented complete response until date of first documented disease progression or death from any cause, or data cut-off or end of study (whichever came first, assessed up to 2 years 5 months)', 'description': 'The anti-tumor activity of sabestomig in participants with r/r cHL was assessed.\n\nThe DoCR was defined as the time from first documented CR, as per modified Lugano criteria (Lugano 2014) as assessed by the Investigator, until the date of first documented relapse/progression or death due to any cause (in the absence of disease progression).\n\nDisease response was assessed according to Investigator assessment using modified Lugano criteria (Lugano 2014).'}, {'measure': 'Part A (Dose Escalation): Progression-free Survival (PFS)', 'timeFrame': 'From start of treatment [C1D1 (each cycle was 28 days)] until date of first documented disease progression or data cut-off or end of study (whichever came first, assessed up to 2 years 5 months)', 'description': 'The anti-tumor activity of sabestomig in participants with r/r cHL was assessed.\n\nPFS was defined as the time from first dose until the earlier of the date of first documented disease progression, as per modified Lugano criteria (Lugano 2014) as assessed by the Investigator, or death (by any cause in the absence of disease progression or subsequent anticancer treatment).\n\nDisease response was assessed according to Investigator assessment using modified Lugano criteria (Lugano 2014).'}, {'measure': 'Part A (Dose Escalation): Overall Survival (OS)', 'timeFrame': 'From start of treatment [C1D1 (each cycle was 28 days)] until date of death due to any cause or data cut-off or end of study (whichever came first, assessed up to 2 years 5 months)', 'description': 'The anti-tumor activity of sabestomig in participants with r/r cHL was assessed.\n\nThe OS was defined as the time from the start of treatment until death due to any cause regardless of whether participant withdraws from treatment or receives another anti-lymphoma therapy.'}, {'measure': 'Part A (Dose Escalation): Number of Participants With Positive Anti-drug Antibodies (ADA) Against Sabestomig in Serum', 'timeFrame': 'On C1D1, C2D1, and until end of study [up to 2 years 5 months (each cycle was 28 days)]', 'description': 'The presence of ADA for sabestomig in treated participants with r/r cHL was assessed.'}, {'measure': 'Part A (Dose Escalation): Maximum Observed Concentration (Cmax)', 'timeFrame': 'From C1D1 [before start of infusion (SOI) and at end of infusion (EOI)] to end of study [up to 2 years 5 months (each cycle was 28 days)]', 'description': 'The Cmax of sabestomig in participants with r/r cHL was assessed.'}, {'measure': 'Part A (Dose Escalation): Area Under the Concentration-time Curve (AUC)', 'timeFrame': 'From C1D1 (before SOI and at EOI) to end of study [up to 2 years 5 months (each cycle was 28 days)]', 'description': 'The AUC of sabestomig in participants with r/r cHL was assessed.'}, {'measure': 'Part A (Dose Escalation): Clearance (CL)', 'timeFrame': 'From C1D1 (before SOI and at EOI) to end of study [up to 2 years 5 months (each cycle was 28 days)]', 'description': 'The CL of sabestomig in participants with r/r cHL was assessed.'}, {'measure': 'Part A (Dose Escalation): Terminal Elimination Half-life (t½λz)', 'timeFrame': 'From C1D1 (before SOI and at EOI) to end of study [up to 2 years 5 months (each cycle was 28 days)]', 'description': 'The t½λz of sabestomig in participants with r/r cHL was assessed.'}, {'measure': 'Part B (Dose Expansion): Duration of Response (DoR)', 'timeFrame': 'Up to approximately 2 years 90 days', 'description': 'The DoR of sabestomig in participants with r/r cHL was planned to be assessed.'}, {'measure': 'Part B (Dose Expansion): Duration of Complete Response (DoCR)', 'timeFrame': 'Up to approximately 2 years 90 days', 'description': 'The DoCR of sabestomig in participants with r/r cHL was planned to be assessed.'}, {'measure': 'Part B (Dose Expansion): Progression-free Survival (PFS)', 'timeFrame': 'Up to approximately 2 years 90 days', 'description': 'The anti-tumor activity of sabestomig in participants with r/r cHL was planned to be assessed.'}, {'measure': 'Part B (Dose Expansion): Overall Survival (OS)', 'timeFrame': 'Up to approximately 2 years 90 days', 'description': 'The anti-tumor activity of sabestomig in participants with r/r cHL was planned to be assessed.'}, {'measure': 'Part B (Dose Expansion): Number of Participants With Positive ADA Against Sabestomig in Serum', 'timeFrame': 'Up to approximately 2 years 90 days', 'description': 'The presence of ADA for sabestomig in treated participants with r/r cHL was planned to be assessed.'}, {'measure': 'Part B (Dose Expansion): Maximum Observed Concentration (Cmax)', 'timeFrame': 'Up to approximately 2 years 90 days', 'description': 'The Cmax of sabestomig in participants with r/r cHL was planned to be assessed.'}, {'measure': 'Part B (Dose Expansion): Area Under the Concentration-time Curve (AUC)', 'timeFrame': 'Up to approximately 2 years 90 days', 'description': 'The AUC of sabestomig in participants with r/r cHL was planned to be assessed.'}, {'measure': 'Part B (Dose Expansion): Terminal Elimination Half-life (t½λz)', 'timeFrame': 'Up to approximately 2 years 90 days', 'description': 'The t½λz of sabestomig in participants with r/r cHL was planned to be assessed.'}, {'measure': 'Part B (Dose Expansion): Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)', 'timeFrame': 'Up to approximately 2 years 90 days', 'description': 'Proportion of participants reporting different levels of presence/magnitude/interference (as applicable) of diarrhea, rash, and fatigue over time based on PRO-CTCAE was planned to be evaluated.\n\nPRO-CTCAE was a PRO measurement system developed to evaluate symptomatic toxicity in participants on cancer clinical trials. The PRO-CTCAE Item Library included 124 items representing 78 symptomatic toxicities drawn from the CTCAE. PRO-CTCAE items were planned to evaluate the symptom attributes of frequency, severity, interference, amount, presence/absence. Each symptomatic AE was planned to be assessed by 1 to 3 attributes. Conditional branching logic was planned to be used with electronic data capture, thereby reducing respondent burden. The recall period was planned as the past 7 days and PRO-CTCAE responses were planned to score from 0 to 4 (or 0/1 for absent/present).'}, {'measure': 'Part B (Dose Expansion): Pediatric Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (Peds-PRO-CTCAE)', 'timeFrame': 'Up to approximately 2 years 90 days', 'description': "Proportion of participants reporting different levels of presence/magnitude/interference (as applicable) of diarrhea, rash, and fatigue over time based on peds-PRO-CTCAE was planned to be evaluated.\n\nThe pediatric module included 130 items representing 62 symptomatic toxicities and permitted self-reporting by children and adolescents aged 7 to 17 years. In this study, 17 symptomatic toxicities were planned for selection. Thus, the total number of questions that participants would have answered ranged from 17 (assuming that no branching questions were triggered, ie, the participant answered '0' to the initial question for each symptom) to 42 items (assuming that all possible branching questions were triggered for every symptom posed to the participant)."}, {'measure': 'Part B (Dose Expansion): Patient Global Impression of Treatment Tolerability (PGI-TT)', 'timeFrame': 'Up to approximately 2 years 90 days', 'description': 'Proportion of participants reporting different levels of overall side-effect bother over time based on the PGI-TT was planned to be evaluated.\n\nFor adult participants only, the PGI-TT item was included to assess how a participant perceived the overall burden of treatment-related side effects of cancer treatment over the past 7 days. Participants were planned to be asked to choose the response that best described the level of burden by the side effect of their cancer treatment over the past week. The planned response options were:"not at all", "a little bit", "somewhat", "quite a bit", and "very much".'}, {'measure': 'Part B (Dose Expansion): European Organization for Research and Treatment of Cancer (EORTC) Item List (IL)XX QL2 [2-item Global Health-related Quality of Life (HRQoL)]', 'timeFrame': 'Up to approximately 2 years 90 days', 'description': 'Proportion of participants reporting different levels of quality of life/health over time based on the European Organization for Research and Treatment of Cancer Item List (EORTC) ILXX QL2 items was planned to be evaluated.\n\nEORTC QLQ-C30 was a 30-item self-administered questionnaire designed for all cancer types. Questions were grouped into 5 multi-item functional scales (physical, role, emotional, cognitive, and social), 3 multi-item symptom scales (fatigue, pain, and nausea/vomiting), 2-item global HRQoL (QL2) scale, 5 single items assessing additional symptoms commonly reported by participants with cancer (dyspnea, loss of appetite, insomnia, constipation, and diarrhea), and 1 item on the financial impact of the disease. Participants were planned to answer QLQ-C30 questions in reference to how they had been over the past week. Final scores were planned to transform to range from 0 to 100, where higher scores indicated better functioning, better HRQoL, or greater level of symptoms.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pharmacokinetics', 'Classical Hodgkin Lymphoma (cHL)', 'Dose Expansion', 'Dose escalation', 'r/r cHL', 'programmed cell death protein-1 (PD-1)', 'Accelerated titration design (ATD)', 'T cell immunoglobulin and mucin domain-containing protein-3 (TIM-3)', 'Modified toxicity probability interval-2 (mTPI-2)', 'Bispecific antibody', 'Immunotherapy'], 'conditions': ['Relapsed or Refractory Classical Hodgkin Lymphoma']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=D9571C00001&attachmentIdentifier=facc246c-51a1-409b-9b50-7764ab4a0942&fileName=CSR_Synopsis_19_Dec_2024_D9571C00001_Final_Redacted_19Feb2025_watermark.pdf&versionIdentifier=', 'label': 'Redacted CSR synopsis'}, {'url': 'https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=D9571C00001&attachmentIdentifier=ca82868a-2ad5-4cad-bd7d-8d4760d75c48&fileName=d9571c00001-sap-ed-3_Final_Redacted_19Feb2025_watermark.pdf&versionIdentifier=', 'label': 'Redacted SAP'}, {'url': 'https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=D9571C00001&attachmentIdentifier=82ae7214-584d-4a02-9082-4f4ae1210c07&fileName=_Protocol_Main_5_07May2024_English__D9571C00001_Public_redacted.pdf&versionIdentifier=', 'label': 'Redacted CSP'}]}, 'descriptionModule': {'briefSummary': 'The study is intended to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of sabestomig (AZD7789) in patients with relapsed/refractory classical Hodgkin Lymphoma (r/r cHL).', 'detailedDescription': 'This is a Phase I/II, open-label multi-center study will have sabestomig administered via intravenous infusion on Cycle 1 Day 1 to adult/young adult patients with relapsed/refractory classical Hodgkin Lymphoma (r/r cHL). This study will have 2 parts: Phase 1 (Part A) Dose Escalation and Phase 2 (Part B) Dose Expansion.\n\nPatients will be treated with study intervention for a maximum of 35 cycles, or until disease progression, unacceptable toxicity, withdrawal of consent, or if other reasons to discontinue treatment occur.\n\nThe trial was intended to be Phase I/II trial (but the trial never moved forward to Phase 2). Hence, the study Phase was updated to Phase I.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '101 Years', 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ≥ 16 years of age at the time of obtaining informed consent\n* Eastern Cooperative Oncology Group performance status of 0 or 1 at screening\n* At least one positron emission tomography (PET)-avid measurable lesion according to Modified Lugano Criteria after the last line of therapy.\n* Confirmed histological diagnosis of active relapse/refractory cHL\n* Failed at least 2 prior lines of systemic therapy.\n* No previous treatment with anti-TIM-3.\n* Adequate organ and bone marrow function\n* Non-pregnant women and willingness of female patients to avoid pregnancy or male participants willing to avoid fathering children through highly effective methods of contraception\n* Minimum body weight ≥ 40 kg for all participants.\n\nExclusion Criteria:\n\n* Unresolved toxicities of ≥ Grade 2 from prior therapy\n* Any prior ≥ Grade 3 imAE while receiving prior checkpoint inhibitor immunotherapy\n* Patients with central nervous system (CNS) involvement or leptomeningeal disease.\n* History of allogeneic stem cell transplant or organ transplantation.\n* Any venous or arterial thromboembolic event within ≤ 6 months prior to the first dose of study intervention.\n* Active infection including Tuberculosis (TB), human immunodeficiency virus (HIV), hepatitis A, chronic or active hepatitis B, chronic or active hepatitis C, active COVID-19 infection\n* History of arrhythmia which is requires treatment, symptomatic or uncontrol led atrial fibrillation despite treatment, or asymptomatic sustained ventricular tachycardia\n* Uncontrolled intercurrent illness.\n* Active or prior documented pathologically confirmed autoimmune or inflammatory disorders.\n* Past medical history of interstitial lung disease (ILD), drug-induced ILD, radiation pneumonitis requiring steroid treatment, or any evidence of clinically active ILD\n* Other invasive malignancy within 2 years prior to screening\n* Congenital long QT syndrome or history of QT prolongation associated with other medications that cannot be changed or discontinued based on a cardiologist assessment\n* Current or prior use of immunosuppressive medication within 14 days prior to the first dose of study intervention\n* Any concurrent chemotherapy, radiotherapy, investigational, biologic, or hormonal therapy for cancer treatment.'}, 'identificationModule': {'nctId': 'NCT05216835', 'briefTitle': 'Safety and Preliminary Efficacy Assessment of AZD7789 in Patients With Relapsed or Refractory Classical Hodgkin Lymphoma', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'A Phase I/II Open-label, Multi-center Study to Assess Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of AZD7789, an Anti-PD-1 and Anti-TIM-3 Bispecific Antibody, in Patients With Relapsed or Refractory Classical Hodgkin Lymphoma.', 'orgStudyIdInfo': {'id': 'D9571C00001'}, 'secondaryIdInfos': [{'id': '2021-003569-36', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cohort A: Dose Escalation', 'description': 'Patients with anti-PD-1/PD-L1 exposed r/r cHL will receive sabestomig to determine the recommended phase 2 dose (RP2D).', 'interventionNames': ['Drug: Sabestomig (AZD7789)']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort B1: Dose Expansion', 'description': 'Patients with anti-PD-1/PD-L1 exposed r/r cHL will receive sabestomig once the RP2D has been determined.', 'interventionNames': ['Drug: Sabestomig (AZD7789)']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort B2: Dose Expansion', 'description': 'Patients with anti-PD-1/PD-L1 naïve r/r cHL will receive sabestomig once the RP2D has been determined.', 'interventionNames': ['Drug: Sabestomig (AZD7789)']}], 'interventions': [{'name': 'Sabestomig (AZD7789)', 'type': 'DRUG', 'description': 'Patients will receive sabestomig (PD-1/TIM-3 bispecific monoclonal antibody) via intravenous infusion.', 'armGroupLabels': ['Cohort A: Dose Escalation', 'Cohort B1: Dose Expansion', 'Cohort B2: Dose Expansion']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91010', 'city': 'Duarte', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 34.13945, 'lon': -117.97729}}, {'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'zip': '10065', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': 'M5G 1X6', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Research Site', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'H3T 1E2', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Research Site', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': '2100', 'city': 'København Ø', 'country': 'Denmark', 'facility': 'Research Site', 'geoPoint': {'lat': 55.70968, 'lon': 12.56862}}, {'zip': '59037', 'city': 'Lille', 'country': 'France', 'facility': 'Research Site', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'zip': '40138', 'city': 'Bologna', 'country': 'Italy', 'facility': 'Research Site', 'geoPoint': {'lat': 44.49381, 'lon': 11.33875}}, {'zip': '80131', 'city': 'Napoli', 'country': 'Italy', 'facility': 'Research Site', 'geoPoint': {'lat': 40.87618, 'lon': 14.5195}}, {'zip': '46010', 'city': 'Valencia', 'country': 'Spain', 'facility': 'Research Site', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}, {'zip': 'M20 4BX', 'city': 'Manchester', 'country': 'United Kingdom', 'facility': 'Research Site', 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}, {'zip': '0X3 7LJ', 'city': 'Oxford', 'country': 'United Kingdom', 'facility': 'Research Site', 'geoPoint': {'lat': 51.75222, 'lon': -1.25596}}]}, 'ipdSharingStatementModule': {'url': 'https://vivli.org/', 'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': 'AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.', 'ipdSharing': 'YES', 'description': 'Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All requests will be evaluated as per the AZ disclosure commitment:\n\nhttps://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.', 'accessCriteria': 'When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Parexel', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}