Ignite Creation Date:
2025-12-25 @ 12:22 AM
Ignite Modification Date:
2026-01-01 @ 7:29 PM
Study NCT ID:
NCT05064358
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-10-07
First Post:
2021-09-22
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study to Investigate Alternative Dosing Regimens of Belantamab Mafodotin in Participants With Relapsed or Refractory Multiple Myeloma
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2025-08-27', 'type': 'ESTIMATED'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D009101', 'term': 'Multiple Myeloma'}, {'id': 'D012008', 'term': 'Recurrence'}], 'ancestors': [{'id': 'D054219', 'term': 'Neoplasms, Plasma Cell'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D020141', 'term': 'Hemostatic Disorders'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010265', 'term': 'Paraproteinemias'}, {'id': 'D001796', 'term': 'Blood Protein Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D006474', 'term': 'Hemorrhagic Disorders'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000631691', 'term': 'belantamab mafodotin'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'GSKClinicalSupportHD@gsk.com', 'phone': '866-435-7343', 'title': 'GSK Response Center', 'organization': 'GlaxoSmithKline'}, 'certainAgreement': {'otherDetails': 'GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single site data not precede the primary publication of the entire clinical trial.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'All-cause mortality, Serious adverse events (SAEs) and non-serious AEs (Non SAEs) were collected up to 152 weeks.', 'description': 'All-cause mortality was collected based on ITT Population included all randomized participants, whether or not randomized treatment was administered. SAEs and non-SAEs were collected based on Safety Population included all randomized participants who received at least 1 dose of study treatment. The results presented are based on data cut-off date 30 Jan 2025 and additional safety results will be updated within a year of study completion.', 'eventGroups': [{'id': 'EG000', 'title': 'Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W)', 'description': 'Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose on Day 1 of every 3 weeks (Q3W) as a 30-60 minute intravenous (IV) infusion until confirmed disease progression, unacceptable toxicity or death.', 'otherNumAtRisk': 39, 'deathsNumAtRisk': 40, 'otherNumAffected': 38, 'seriousNumAtRisk': 39, 'deathsNumAffected': 23, 'seriousNumAffected': 17}, {'id': 'EG001', 'title': 'Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W', 'description': 'Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q3W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.', 'otherNumAtRisk': 40, 'deathsNumAtRisk': 40, 'otherNumAffected': 36, 'seriousNumAtRisk': 40, 'deathsNumAffected': 23, 'seriousNumAffected': 17}, {'id': 'EG002', 'title': 'Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W)', 'description': 'Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on Day 1 of every 6 weeks (Q6W) as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.', 'otherNumAtRisk': 39, 'deathsNumAtRisk': 40, 'otherNumAffected': 36, 'seriousNumAtRisk': 39, 'deathsNumAffected': 25, 'seriousNumAffected': 21}, {'id': 'EG003', 'title': 'Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W', 'description': 'Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q6W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.', 'otherNumAtRisk': 40, 'deathsNumAtRisk': 40, 'otherNumAffected': 40, 'seriousNumAtRisk': 40, 'deathsNumAffected': 21, 'seriousNumAffected': 16}, {'id': 'EG004', 'title': 'Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment)', 'description': 'Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q6W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death. For this arm, dose modification decisions were determined by the results of the Ocular Surface Disease Index (OSDI) questionnaire or VA assessments using Snellen chart. The OSDI scale assesses the severity of eye symptoms and their impact and Snellen chart is for the assessment of visual acuity.', 'otherNumAtRisk': 17, 'deathsNumAtRisk': 17, 'otherNumAffected': 16, 'seriousNumAtRisk': 17, 'deathsNumAffected': 5, 'seriousNumAffected': 4}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 16, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 15, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 39, 'numEvents': 13, 'numAffected': 12}, {'groupId': 'EG003', 'numAtRisk': 40, 'numEvents': 23, 'numAffected': 15}, {'groupId': 'EG004', 'numAtRisk': 17, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Iron deficiency anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 40, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Lymphopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 39, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 11, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 39, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 40, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG004', 'numAtRisk': 17, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 17, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 26, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 39, 'numEvents': 20, 'numAffected': 13}, {'groupId': 'EG003', 'numAtRisk': 40, 'numEvents': 14, 'numAffected': 10}, {'groupId': 'EG004', 'numAtRisk': 17, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 39, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 7, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 39, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 40, 'numEvents': 9, 'numAffected': 7}, {'groupId': 'EG004', 'numAtRisk': 17, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Corneal epithelial microcysts', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Corneal erosion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Dry eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 25, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 17, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 39, 'numEvents': 33, 'numAffected': 12}, {'groupId': 'EG003', 'numAtRisk': 40, 'numEvents': 17, 'numAffected': 12}, {'groupId': 'EG004', 'numAtRisk': 17, 'numEvents': 14, 'numAffected': 8}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Eye irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 20, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 19, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 39, 'numEvents': 32, 'numAffected': 11}, {'groupId': 'EG003', 'numAtRisk': 40, 'numEvents': 21, 'numAffected': 11}, {'groupId': 'EG004', 'numAtRisk': 17, 'numEvents': 11, 'numAffected': 5}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Eye pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 13, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 39, 'numEvents': 25, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 40, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 17, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Eye pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Eyelid irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Foreign body sensation in eyes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 12, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 14, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 39, 'numEvents': 35, 'numAffected': 11}, {'groupId': 'EG003', 'numAtRisk': 40, 'numEvents': 8, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 17, 'numEvents': 10, 'numAffected': 3}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Lacrimation increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 40, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Photophobia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 12, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 19, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 39, 'numEvents': 19, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 40, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 17, 'numEvents': 12, 'numAffected': 5}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Punctate keratitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Trichiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Ulcerative keratitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Vision blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 36, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 33, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 39, 'numEvents': 53, 'numAffected': 18}, {'groupId': 'EG003', 'numAtRisk': 40, 'numEvents': 19, 'numAffected': 11}, {'groupId': 'EG004', 'numAtRisk': 17, 'numEvents': 22, 'numAffected': 9}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 39, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 40, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Anal incontinence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 39, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 39, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 40, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 39, 'numEvents': 9, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 40, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 39, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 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'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Post procedural haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 39, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Subdural haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 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{'groupId': 'EG002', 'numAtRisk': 39, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Groin pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 1, 'numAffected': 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'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Photophobia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Drug-induced liver injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Jaundice cholestatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 39, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Cytokine release syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Blood lactate dehydrogenase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Spinal cord compression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 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{'term': 'Delirium', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 39, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 39, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Chronic kidney disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Haemoptysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 39, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 39, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Respiratory distress', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Pelvic venous thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 39, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 39, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}, {'term': 'Cardio-respiratory arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 39, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v27.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With Grade ≥2 Corneal Events Assessed by Keratopathy Visual Acuity (KVA) Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W)', 'description': 'Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose on Day 1 of every 3 weeks (Q3W) as a 30-60 minute intravenous (IV) infusion until confirmed disease progression, unacceptable toxicity or death.'}, {'id': 'OG001', 'title': 'Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W', 'description': 'Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q3W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.'}, {'id': 'OG002', 'title': 'Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W)', 'description': 'Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on Day 1 of every 6 weeks (Q6W) as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.'}, {'id': 'OG003', 'title': 'Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W', 'description': 'Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q6W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.'}], 'classes': [{'categories': [{'measurements': [{'value': '64', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '44', 'groupId': 'OG002'}, {'value': '38', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 29.5 months', 'description': 'The KVA scale is based on the evaluation of corneal changes using slit lamp examination. This scale provides a standardized approach for evaluating the relationship between corneal health and visual acuity. KVA scale is defined as Grade 0: No keratopathy, normal visual acuity with no corneal abnormalities; Grade 1: Mild changes to the cornea with no significant loss in visual acuity; Grade 2: Moderate corneal changes with noticeable visual acuity reduction; Grade 3: Severe corneal changes with substantial visual acuity impairment; Grade 4: Very severe corneal changes leading to significant vision loss. Higher grade indicates greater severity of corneal events.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population included all randomized participants who received at least 1 dose of study treatment. As outlined in the protocol, the objective was to examine the corneal events in Arms B to D, compared to Arm A; hence, Arm E was not included.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Corneal Events up to Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}, {'value': '17', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W)', 'description': 'Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose on Day 1 of every 3 weeks (Q3W) as a 30-60 minute intravenous (IV) infusion until confirmed disease progression, unacceptable toxicity or death.'}, {'id': 'OG001', 'title': 'Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W', 'description': 'Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q3W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.'}, {'id': 'OG002', 'title': 'Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W)', 'description': 'Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on Day 1 of every 6 weeks (Q6W) as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.'}, {'id': 'OG003', 'title': 'Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W', 'description': 'Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q6W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.'}, {'id': 'OG004', 'title': 'Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment)', 'description': 'Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q6W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death. For this arm, dose modification decisions were determined by the results of the Ocular Surface Disease Index (OSDI) questionnaire or VA assessments using Snellen chart. The OSDI scale assesses the severity of eye symptoms and their impact and Snellen chart is for the assessment of visual acuity.'}], 'classes': [{'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}, {'value': '24', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to week 16', 'description': 'The number of participants with corneal events were assessed using KVA scale. The KVA scale provides a standardized approach for evaluating the relationship between corneal health and visual acuity. KVA scale is defined as Grade 0: No keratopathy, normal visual acuity with no corneal abnormalities; Grade 1: Mild changes to the cornea with no significant loss in visual acuity; Grade 2: Moderate corneal changes with noticeable visual acuity reduction; Grade 3: Severe corneal changes with substantial visual acuity impairment; Grade 4: Very severe corneal changes leading to significant vision loss. Higher grade indicates greater severity of corneal events.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population.'}, {'type': 'SECONDARY', 'title': 'Incidence Rate of Corneal Events by Grade (KVA Scale)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W)', 'description': 'Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose on Day 1 of every 3 weeks (Q3W) as a 30-60 minute intravenous (IV) infusion until confirmed disease progression, unacceptable toxicity or death.'}, {'id': 'OG001', 'title': 'Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W', 'description': 'Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q3W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.'}, {'id': 'OG002', 'title': 'Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W)', 'description': 'Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on Day 1 of every 6 weeks (Q6W) as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.'}, {'id': 'OG003', 'title': 'Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W', 'description': 'Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q6W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.'}, {'id': 'OG004', 'title': 'Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment)', 'description': 'Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q6W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death. For this arm, dose modification decisions were determined by the results of the Ocular Surface Disease Index (OSDI) questionnaire or VA assessments using Snellen chart. The OSDI scale assesses the severity of eye symptoms and their impact and Snellen chart is for the assessment of visual acuity.'}], 'classes': [{'title': 'Grade 1', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}]}]}, {'title': 'Grade 2', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}]}]}, {'title': 'Grade 3', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}]}, {'title': 'Grade 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 152 weeks', 'description': 'Incidence rate of corneal events is defined as the percentage of participants with corneal events by grade according to the KVA scale. The KVA scale provides a standardized approach for evaluating the relationship between corneal health and visual acuity. KVA scale is defined as Grade 0: No keratopathy, normal visual acuity with no corneal abnormalities; Grade 1: Mild changes to the cornea with no significant loss in visual acuity; Grade 2: Moderate corneal changes with noticeable visual acuity reduction; Grade 3: Severe corneal changes with substantial visual acuity impairment; Grade 4: Very severe corneal changes leading to significant vision loss. Higher grade indicates greater severity of corneal events.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population. Only those participants with data available at specified time points have been analyzed.'}, {'type': 'SECONDARY', 'title': 'Exposure Adjusted Incidence Rate of Corneal Events as Per CTCAE Grade', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}, {'value': '17', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W)', 'description': 'Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose on Day 1 of every 3 weeks (Q3W) as a 30-60 minute intravenous (IV) infusion until confirmed disease progression, unacceptable toxicity or death.'}, {'id': 'OG001', 'title': 'Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W', 'description': 'Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q3W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.'}, {'id': 'OG002', 'title': 'Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W)', 'description': 'Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on Day 1 of every 6 weeks (Q6W) as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.'}, {'id': 'OG003', 'title': 'Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W', 'description': 'Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q6W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.'}, {'id': 'OG004', 'title': 'Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment)', 'description': 'Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q6W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death. For this arm, dose modification decisions were determined by the results of the Ocular Surface Disease Index (OSDI) questionnaire or VA assessments using Snellen chart. The OSDI scale assesses the severity of eye symptoms and their impact and Snellen chart is for the assessment of visual acuity.'}], 'classes': [{'title': 'Grade 3', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}]}]}, {'title': 'Grade 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Grade 5', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 152 weeks', 'description': 'Exposure adjusted incidence rate of corneal events is defined as the number of participants with corneal events divided by the total exposure time for all participants at risk in the treatment group. Incidence rate for corneal events was assessed using Common Terminology Criteria for Adverse Events (CTCAE). Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe or medically significant but not immediately life-threatening; Grade 4: Life-threatening consequences; Grade 5: Death related to AE. Higher grades indicate greater severity. The number of participants with Grades 3,4, and 5 are presented.', 'unitOfMeasure': 'Events per 100 patient years', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population'}, {'type': 'SECONDARY', 'title': 'Median Duration of All the Dose Delays', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}, {'value': '17', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W)', 'description': 'Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose on Day 1 of every 3 weeks (Q3W) as a 30-60 minute intravenous (IV) infusion until confirmed disease progression, unacceptable toxicity or death.'}, {'id': 'OG001', 'title': 'Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W', 'description': 'Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q3W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.'}, {'id': 'OG002', 'title': 'Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W)', 'description': 'Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on Day 1 of every 6 weeks (Q6W) as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.'}, {'id': 'OG003', 'title': 'Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W', 'description': 'Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q6W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.'}, {'id': 'OG004', 'title': 'Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment)', 'description': 'Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q6W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death. For this arm, dose modification decisions were determined by the results of the Ocular Surface Disease Index (OSDI) questionnaire or VA assessments using Snellen chart. The OSDI scale assesses the severity of eye symptoms and their impact and Snellen chart is for the assessment of visual acuity.'}], 'classes': [{'categories': [{'measurements': [{'value': '39.0', 'groupId': 'OG000', 'lowerLimit': '16', 'upperLimit': '144'}, {'value': '18.0', 'groupId': 'OG001', 'lowerLimit': '4', 'upperLimit': '125'}, {'value': '51.0', 'groupId': 'OG002', 'lowerLimit': '18', 'upperLimit': '163'}, {'value': '60.0', 'groupId': 'OG003', 'lowerLimit': '34', 'upperLimit': '103'}, {'value': '59.0', 'groupId': 'OG004', 'lowerLimit': '25', 'upperLimit': '88'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 152 weeks', 'description': 'Median duration of dose delays is defined as the median duration in time of all the dose delays in the respective treatment group. Duration of delays is defined as period from the expected start date of dose to actual start date of current dose.', 'unitOfMeasure': 'Days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Requiring Dose Reduction, Dose Interruption/Delay, Permanent Treatment Discontinuation Due to Corneal Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}, {'value': '24', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W)', 'description': 'Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose on Day 1 of every 3 weeks (Q3W) as a 30-60 minute intravenous (IV) infusion until confirmed disease progression, unacceptable toxicity or death.'}, {'id': 'OG001', 'title': 'Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W', 'description': 'Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q3W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.'}, {'id': 'OG002', 'title': 'Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W)', 'description': 'Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on Day 1 of every 6 weeks (Q6W) as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.'}, {'id': 'OG003', 'title': 'Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W', 'description': 'Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q6W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.'}, {'id': 'OG004', 'title': 'Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment)', 'description': 'Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q6W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death. For this arm, dose modification decisions were determined by the results of the Ocular Surface Disease Index (OSDI) questionnaire or VA assessments using Snellen chart. The OSDI scale assesses the severity of eye symptoms and their impact and Snellen chart is for the assessment of visual acuity.'}], 'classes': [{'title': 'Dose Reduction', 'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}, {'value': '23', 'groupId': 'OG003'}, {'value': '35', 'groupId': 'OG004'}]}]}, {'title': 'Dose Interruption/Delay', 'categories': [{'measurements': [{'value': '59', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '33', 'groupId': 'OG003'}, {'value': '29', 'groupId': 'OG004'}]}]}, {'title': 'Permanent Treatment Discontinuation', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 152 weeks', 'description': 'The percentage of participants that required dose reduction, dose interruption/delay, permanent treatment discontinuation due to corneal events were evaluated using KVA Scale. KVA scale is defined as Grade 0: No keratopathy, normal visual acuity with no corneal abnormalities; Grade 1: Mild changes to the cornea with no significant loss in visual acuity; Grade 2: Moderate corneal changes with noticeable visual acuity reduction; Grade 3: Severe corneal changes with substantial visual acuity impairment; Grade 4: Very severe corneal changes leading to significant vision loss. Higher grade indicates greater severity of corneal events.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population. Only those participants who experienced corneal events have been analyzed.'}, {'type': 'SECONDARY', 'title': 'Cumulative Incidence of Grade 2 or Above Corneal Events (KVA Scale)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W)', 'description': 'Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose on Day 1 of every 3 weeks (Q3W) as a 30-60 minute intravenous (IV) infusion until confirmed disease progression, unacceptable toxicity or death.'}, {'id': 'OG001', 'title': 'Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W', 'description': 'Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q3W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.'}, {'id': 'OG002', 'title': 'Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W)', 'description': 'Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on Day 1 of every 6 weeks (Q6W) as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.'}, {'id': 'OG003', 'title': 'Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W', 'description': 'Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q6W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.'}, {'id': 'OG004', 'title': 'Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment)', 'description': 'Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q6W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death. For this arm, dose modification decisions were determined by the results of the Ocular Surface Disease Index (OSDI) questionnaire or VA assessments using Snellen chart. The OSDI scale assesses the severity of eye symptoms and their impact and Snellen chart is for the assessment of visual acuity.'}], 'classes': [{'title': 'At 3 months', 'categories': [{'measurements': [{'value': '59', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}, {'value': '33', 'groupId': 'OG003'}, {'value': '53', 'groupId': 'OG004'}]}]}, {'title': 'At 6 months', 'categories': [{'measurements': [{'value': '64', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}, {'value': '38', 'groupId': 'OG003'}, {'value': '59', 'groupId': 'OG004'}]}]}, {'title': 'At 9 months', 'categories': [{'measurements': [{'value': '64', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}, {'value': '38', 'groupId': 'OG003'}, {'value': '59', 'groupId': 'OG004'}]}]}, {'title': 'At 12 months', 'categories': [{'measurements': [{'value': '64', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '44', 'groupId': 'OG002'}, {'value': '38', 'groupId': 'OG003'}, {'value': '59', 'groupId': 'OG004'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At 3 months, 6 months, 9 months and 12 months', 'description': 'Cumulative incidence of Grade 2 or above corneal events is defined as the percentage of corneal events of Grade 2 or above, as assessed using the KVA scale, within a specific time interval. KVA scale is defined as Grade 0: No keratopathy, normal visual acuity with no corneal abnormalities; Grade 1: Mild changes to the cornea with no significant loss in visual acuity; Grade 2: Moderate corneal changes with noticeable visual acuity reduction; Grade 3: Severe corneal changes with substantial visual acuity impairment; Grade 4: Very severe corneal changes leading to significant vision loss. Higher grade indicates greater severity of corneal events.', 'unitOfMeasure': 'Percentage of events', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population. Only those participants who experienced corneal events (KVA scale) of Grade 2 or above have been analyzed.'}, {'type': 'SECONDARY', 'title': 'Toxicity Index (TI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}, {'value': '17', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W)', 'description': 'Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose on Day 1 of every 3 weeks (Q3W) as a 30-60 minute intravenous (IV) infusion until confirmed disease progression, unacceptable toxicity or death.'}, {'id': 'OG001', 'title': 'Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W', 'description': 'Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q3W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.'}, {'id': 'OG002', 'title': 'Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W)', 'description': 'Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on Day 1 of every 6 weeks (Q6W) as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.'}, {'id': 'OG003', 'title': 'Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W', 'description': 'Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q6W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.'}, {'id': 'OG004', 'title': 'Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment)', 'description': 'Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q6W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death. For this arm, dose modification decisions were determined by the results of the Ocular Surface Disease Index (OSDI) questionnaire or VA assessments using Snellen chart. The OSDI scale assesses the severity of eye symptoms and their impact and Snellen chart is for the assessment of visual acuity.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.68', 'spread': '1.078', 'groupId': 'OG000'}, {'value': '3.83', 'spread': '1.017', 'groupId': 'OG001'}, {'value': '3.87', 'spread': '1.092', 'groupId': 'OG002'}, {'value': '3.43', 'spread': '1.031', 'groupId': 'OG003'}, {'value': '3.64', 'spread': '0.892', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 152 weeks', 'description': "Toxicity Index is a composite score derived from the severity grades of adverse events (AEs) reported during the study, based on the Common Terminology Criteria for Adverse Events (CTCAE). A participant's score is calculated as a function of the ordered toxicity grades, represented in descending order by sequence, on a scale of 0-6, where 0 represents no toxicity and 6 represents the highest toxicity. CTCAE grades are defined as follows: Grade 1 (Mild), Grade 2 (Moderate), Grade 3 (Severe or medically significant but not immediately life-threatening), Grade 4 (Life-threatening consequences), and Grade 5 (Death related to AE). Higher grades indicate greater toxicity severity.", 'unitOfMeasure': 'Score on scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population'}, {'type': 'SECONDARY', 'title': 'Duration of Corneal Events of Grade 2 or Above', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W)', 'description': 'Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose on Day 1 of every 3 weeks (Q3W) as a 30-60 minute intravenous (IV) infusion until confirmed disease progression, unacceptable toxicity or death.'}, {'id': 'OG001', 'title': 'Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W', 'description': 'Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q3W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.'}, {'id': 'OG002', 'title': 'Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W)', 'description': 'Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on Day 1 of every 6 weeks (Q6W) as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.'}, {'id': 'OG003', 'title': 'Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W', 'description': 'Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q6W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.'}, {'id': 'OG004', 'title': 'Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment)', 'description': 'Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q6W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death. For this arm, dose modification decisions were determined by the results of the Ocular Surface Disease Index (OSDI) questionnaire or VA assessments using Snellen chart. The OSDI scale assesses the severity of eye symptoms and their impact and Snellen chart is for the assessment of visual acuity.'}], 'classes': [{'categories': [{'measurements': [{'value': '63.0', 'groupId': 'OG000', 'lowerLimit': '22', 'upperLimit': '296'}, {'value': '67.5', 'groupId': 'OG001', 'lowerLimit': '13', 'upperLimit': '233'}, {'value': '46.5', 'groupId': 'OG002', 'lowerLimit': '20', 'upperLimit': '162'}, {'value': '53.5', 'groupId': 'OG003', 'lowerLimit': '20', 'upperLimit': '148'}, {'value': '44.0', 'groupId': 'OG004', 'lowerLimit': '21', 'upperLimit': '274'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 152 weeks', 'description': 'Duration of corneal events is defined for each participant as the sum of duration of all the corneal AEs. The duration is defined as time from onset of any corneal events (KVA scale) of Grade 2 or above to the first time resolution to baseline, Grade 1 or below. It required at least one day gap between the resolution of all events from first occurrence to the onset of next occurrence.', 'unitOfMeasure': 'Days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population. Only those participants who experienced corneal events (KVA Scale) of Grade 2 or above have been analyzed.'}, {'type': 'SECONDARY', 'title': 'Percentage of Time on Study With Grade 2 or Above Corneal Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W)', 'description': 'Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose on Day 1 of every 3 weeks (Q3W) as a 30-60 minute intravenous (IV) infusion until confirmed disease progression, unacceptable toxicity or death.'}, {'id': 'OG001', 'title': 'Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W', 'description': 'Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q3W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.'}, {'id': 'OG002', 'title': 'Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W)', 'description': 'Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on Day 1 of every 6 weeks (Q6W) as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.'}, {'id': 'OG003', 'title': 'Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W', 'description': 'Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q6W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.'}, {'id': 'OG004', 'title': 'Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment)', 'description': 'Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q6W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death. For this arm, dose modification decisions were determined by the results of the Ocular Surface Disease Index (OSDI) questionnaire or VA assessments using Snellen chart. The OSDI scale assesses the severity of eye symptoms and their impact and Snellen chart is for the assessment of visual acuity.'}], 'classes': [{'categories': [{'measurements': [{'value': '23.27', 'groupId': 'OG000', 'lowerLimit': '0.5', 'upperLimit': '76.7'}, {'value': '24.86', 'groupId': 'OG001', 'lowerLimit': '5.1', 'upperLimit': '69.1'}, {'value': '18.99', 'groupId': 'OG002', 'lowerLimit': '0.4', 'upperLimit': '78.1'}, {'value': '23.67', 'groupId': 'OG003', 'lowerLimit': '5.5', 'upperLimit': '85.6'}, {'value': '35.63', 'groupId': 'OG004', 'lowerLimit': '3.9', 'upperLimit': '61.6'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 152 weeks', 'description': 'It is defined as the percentage of time that a participant has corneal events out of the total time that a participant is on the study. Time with corneal events is defined as time from onset of any corneal events (KVA scale) of Grade 2 or above to the first-time resolution to baseline, Grade 1 or below.', 'unitOfMeasure': 'Percentage of Time', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population. Only those participants who experienced corneal events of Grade 2 or above have been analyzed.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Change in Best Corrected Visual Acuity Test (BCVA) Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W)', 'description': 'Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose on Day 1 of every 3 weeks (Q3W) as a 30-60 minute intravenous (IV) infusion until confirmed disease progression, unacceptable toxicity or death.'}, {'id': 'OG001', 'title': 'Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W', 'description': 'Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q3W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.'}, {'id': 'OG002', 'title': 'Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W)', 'description': 'Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on Day 1 of every 6 weeks (Q6W) as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.'}, {'id': 'OG003', 'title': 'Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W', 'description': 'Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q6W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.'}, {'id': 'OG004', 'title': 'Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment)', 'description': 'Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q6W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death. For this arm, dose modification decisions were determined by the results of the Ocular Surface Disease Index (OSDI) questionnaire or VA assessments using Snellen chart. The OSDI scale assesses the severity of eye symptoms and their impact and Snellen chart is for the assessment of visual acuity.'}], 'classes': [{'title': 'Left Eye', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}]}], 'categories': [{'title': 'No change', 'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '27', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}]}, {'title': 'Possible worsened vision', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}, {'title': 'Definite worsened vision', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}]}]}, {'title': 'Right Eye', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}]}], 'categories': [{'title': 'No change', 'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}, {'value': '27', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}]}, {'title': 'Possible worsened vision', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}, {'title': 'Definite worsened vision', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline (Day 1) and up to 152 weeks', 'description': 'Change in BCVA is defined as change in logarithm of the minimum angle of resolution (logMAR) units compared with baseline or the first visit after the cataract surgery. BCVA score was calculated based on the Logarithm of the Minimum Angle of Resolution (logMAR score). Any change from baseline categories is presented for right and left eyes. No change/improved vision is defined as a change from baseline \\<0.1; a possible worsened vision is defined as a change from baseline \\>=0.1 to \\<=0.3; a definite worsened vision is defined as a change from baseline \\>0.3 logMAR score. Improvement in BCVA is represented by a reduction in logMAR score from baseline, while worsening in BCVA is represented by an increase in logMAR score from baseline.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population. Only those participants with data available at specified time points have been analyzed.'}, {'type': 'SECONDARY', 'title': 'Objective Response Rate (ORR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}, {'value': '17', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W)', 'description': 'Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose on Day 1 of every 3 weeks (Q3W) as a 30-60 minute intravenous (IV) infusion until confirmed disease progression, unacceptable toxicity or death.'}, {'id': 'OG001', 'title': 'Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W', 'description': 'Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q3W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.'}, {'id': 'OG002', 'title': 'Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W)', 'description': 'Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on Day 1 of every 6 weeks (Q6W) as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.'}, {'id': 'OG003', 'title': 'Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W', 'description': 'Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q6W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.'}, {'id': 'OG004', 'title': 'Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment)', 'description': 'Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q6W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death. For this arm, dose modification decisions were determined by the results of the Ocular Surface Disease Index (OSDI) questionnaire or VA assessments using Snellen chart. The OSDI scale assesses the severity of eye symptoms and their impact and Snellen chart is for the assessment of visual acuity.'}], 'classes': [{'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000', 'lowerLimit': '18.6', 'upperLimit': '49.1'}, {'value': '25', 'groupId': 'OG001', 'lowerLimit': '12.7', 'upperLimit': '41.2'}, {'value': '28', 'groupId': 'OG002', 'lowerLimit': '14.6', 'upperLimit': '43.9'}, {'value': '25', 'groupId': 'OG003', 'lowerLimit': '12.7', 'upperLimit': '41.2'}, {'value': '18', 'groupId': 'OG004', 'lowerLimit': '3.8', 'upperLimit': '43.4'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 152 weeks', 'description': 'ORR was defined as the percentage of participants with a confirmed partial response (PR) or better (i.e., PR, very good partial response \\[VGPR\\], complete response \\[CR\\] and stringent complete response \\[sCR\\]), according to the International Myeloma Working Group (IMWG) Response Criteria. CR = negative immunofixation of serum and urine AND disappearance of any soft tissue plasmacytomas AND \\<5% plasmacytomas in the bone marrow; sCR=stringent complete response, CR as above PLUS normal serum free light-chain (FLC) assay ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence; VGPR = serum and urine M-component detectable by immunofixation but not on electrophoresis OR ≥ 90% reduction in serum M-component plus urine M-component \\<100 mg/24 h; PR = ≥50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥90% or to \\<200 mg/24 h.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat Population included all randomized participants, whether or not randomized treatment was administered.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With a Confirmed VGPR or Better (i.e., VGPR, CR, and sCR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}, {'value': '17', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W)', 'description': 'Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose on Day 1 of every 3 weeks (Q3W) as a 30-60 minute intravenous (IV) infusion until confirmed disease progression, unacceptable toxicity or death.'}, {'id': 'OG001', 'title': 'Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W', 'description': 'Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q3W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.'}, {'id': 'OG002', 'title': 'Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W)', 'description': 'Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on Day 1 of every 6 weeks (Q6W) as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.'}, {'id': 'OG003', 'title': 'Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W', 'description': 'Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q6W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.'}, {'id': 'OG004', 'title': 'Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment)', 'description': 'Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q6W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death. For this arm, dose modification decisions were determined by the results of the Ocular Surface Disease Index (OSDI) questionnaire or VA assessments using Snellen chart. The OSDI scale assesses the severity of eye symptoms and their impact and Snellen chart is for the assessment of visual acuity.'}], 'classes': [{'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000', 'lowerLimit': '12.7', 'upperLimit': '41.2'}, {'value': '18', 'groupId': 'OG001', 'lowerLimit': '7.3', 'upperLimit': '32.8'}, {'value': '8', 'groupId': 'OG002', 'lowerLimit': '1.6', 'upperLimit': '20.4'}, {'value': '15', 'groupId': 'OG003', 'lowerLimit': '5.7', 'upperLimit': '29.8'}, {'value': '18', 'groupId': 'OG004', 'lowerLimit': '3.8', 'upperLimit': '43.4'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 152 weeks', 'description': 'Percentage of participants with a confirmed VGPR or better defined as percentage of participant with confirmed VGPR, CR, and sCR, according to the 2016 IMWG response criteria. CR = negative immunofixation of serum and urine AND disappearance of any soft tissue plasmacytomas AND \\<5% plasmacytomas in the bone marrow; sCR=stringent complete response, CR as above PLUS normal serum free light-chain (FLC) assay ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence; VGPR = serum and urine M-component detectable by immunofixation but not on electrophoresis OR ≥ 90% reduction in serum M-component plus urine M-component \\<100 mg/24 h.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat Population'}, {'type': 'SECONDARY', 'title': 'Time to Response (TTR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W)', 'description': 'Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose on Day 1 of every 3 weeks (Q3W) as a 30-60 minute intravenous (IV) infusion until confirmed disease progression, unacceptable toxicity or death.'}, {'id': 'OG001', 'title': 'Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W', 'description': 'Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q3W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.'}, {'id': 'OG002', 'title': 'Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W)', 'description': 'Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on Day 1 of every 6 weeks (Q6W) as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.'}, {'id': 'OG003', 'title': 'Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W', 'description': 'Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q6W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.'}, {'id': 'OG004', 'title': 'Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment)', 'description': 'Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q6W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death. For this arm, dose modification decisions were determined by the results of the Ocular Surface Disease Index (OSDI) questionnaire or VA assessments using Snellen chart. The OSDI scale assesses the severity of eye symptoms and their impact and Snellen chart is for the assessment of visual acuity.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.8', 'groupId': 'OG000', 'lowerLimit': '0.7', 'upperLimit': '1.4'}, {'value': '1.1', 'groupId': 'OG001', 'lowerLimit': '0.7', 'upperLimit': '2.1'}, {'value': '0.7', 'groupId': 'OG002', 'lowerLimit': '0.7', 'upperLimit': '0.9'}, {'value': '0.8', 'groupId': 'OG003', 'lowerLimit': '0.7', 'upperLimit': '2.2'}, {'value': '1.5', 'comment': 'The upper limit of the 95% confidence interval was not estimable at the time of the final analysis due to an insufficient number of participants with events within the length of follow-up in assessing the number of events', 'groupId': 'OG004', 'lowerLimit': '0.8', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 152 weeks', 'description': 'TTR defined as the time between the date of randomization and the first documented evidence of response (PR or better), among participants who achieve a response (i.e., confirmed PR or better), according to the 2016 IMWG response criteria. PR = ≥50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥90% or to \\<200 mg/24 h.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat Population. Only those participants with confirmed partial response (PR) or better (i.e., PR, VGPR, CR and sCR) have been analyzed.'}, {'type': 'SECONDARY', 'title': 'Duration of Response (DoR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W)', 'description': 'Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose on Day 1 of every 3 weeks (Q3W) as a 30-60 minute intravenous (IV) infusion until confirmed disease progression, unacceptable toxicity or death.'}, {'id': 'OG001', 'title': 'Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W', 'description': 'Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q3W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.'}, {'id': 'OG002', 'title': 'Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W)', 'description': 'Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on Day 1 of every 6 weeks (Q6W) as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.'}, {'id': 'OG003', 'title': 'Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W', 'description': 'Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q6W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.'}, {'id': 'OG004', 'title': 'Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment)', 'description': 'Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q6W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death. For this arm, dose modification decisions were determined by the results of the Ocular Surface Disease Index (OSDI) questionnaire or VA assessments using Snellen chart. The OSDI scale assesses the severity of eye symptoms and their impact and Snellen chart is for the assessment of visual acuity.'}], 'classes': [{'categories': [{'measurements': [{'value': '15.9', 'groupId': 'OG000', 'lowerLimit': '4.9', 'upperLimit': '21.4'}, {'value': '22.1', 'comment': 'The upper limit of 95% confidence interval was not estimable at the time of the final analysis due to an insufficient number of participants with events within the length of follow-up in assessing the number of events', 'groupId': 'OG001', 'lowerLimit': '4.2', 'upperLimit': 'NA'}, {'value': '6.2', 'groupId': 'OG002', 'lowerLimit': '2.1', 'upperLimit': '20.7'}, {'value': '7.8', 'groupId': 'OG003', 'lowerLimit': '2.8', 'upperLimit': '13.3'}, {'value': '15.9', 'comment': 'The lower and upper limit 95% confidence interval were not estimable at the time of the final analysis due to an insufficient number of participants with events within the length of follow-up in assessing the number of events', 'groupId': 'OG004', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 152 weeks', 'description': 'DoR defined as the time from first documented evidence of PR or better until disease progression (PD) among responders according to the 2016 IMWG response criteria or death due to any cause. PR = ≥50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥90% or to \\<200 mg/24 h. PD= Increase of 25% from lowest confirmed response value in 1 or more of the following criteria: Serum M-protein with absolute increase of \\>= 0.5 g/dL; Serum M-protein increase \\>= 1 g/dL if the lowest M-component was \\>=5 g/dL; Urinary M-protein (absolute increase must be \\>= 200 mg per 24 h).', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat Population. Only those participants with confirmed PR or better (i.e., PR, VGPR, CR and sCR) have been analyzed.'}, {'type': 'SECONDARY', 'title': 'Time to Progression (TTP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '32', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W)', 'description': 'Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose on Day 1 of every 3 weeks (Q3W) as a 30-60 minute intravenous (IV) infusion until confirmed disease progression, unacceptable toxicity or death.'}, {'id': 'OG001', 'title': 'Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W', 'description': 'Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q3W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.'}, {'id': 'OG002', 'title': 'Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W)', 'description': 'Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on Day 1 of every 6 weeks (Q6W) as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.'}, {'id': 'OG003', 'title': 'Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W', 'description': 'Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q6W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.'}, {'id': 'OG004', 'title': 'Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment)', 'description': 'Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q6W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death. For this arm, dose modification decisions were determined by the results of the Ocular Surface Disease Index (OSDI) questionnaire or VA assessments using Snellen chart. The OSDI scale assesses the severity of eye symptoms and their impact and Snellen chart is for the assessment of visual acuity.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.0', 'groupId': 'OG000', 'lowerLimit': '2.8', 'upperLimit': '10.4'}, {'value': '2.1', 'groupId': 'OG001', 'lowerLimit': '1.0', 'upperLimit': '9.1'}, {'value': '2.8', 'groupId': 'OG002', 'lowerLimit': '1.7', 'upperLimit': '4.2'}, {'value': '2.7', 'groupId': 'OG003', 'lowerLimit': '1.9', 'upperLimit': '5.6'}, {'value': '2.9', 'groupId': 'OG004', 'lowerLimit': '0.8', 'upperLimit': '17.3'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 152 weeks', 'description': 'TTP defined as the time from randomization until the earliest date of documented PD or death due to PD, according to the 2016 IMWG response criteria. PD= Increase of 25% from lowest confirmed response value in 1 or more of the following criteria: Serum M-protein with absolute increase of \\>= 0.5 g/dL; Serum M-protein increase \\>= 1 g/dL if the lowest M-component was \\>=5 g/dL; Urinary M-protein (absolute increase must be \\>= 200 mg per 24 h).', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat Population. Only those participants with documented PD or death due to PD have been analyzed.'}, {'type': 'SECONDARY', 'title': 'Progression Free Survival (PFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}, {'value': '34', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W)', 'description': 'Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose on Day 1 of every 3 weeks (Q3W) as a 30-60 minute intravenous (IV) infusion until confirmed disease progression, unacceptable toxicity or death.'}, {'id': 'OG001', 'title': 'Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W', 'description': 'Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q3W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.'}, {'id': 'OG002', 'title': 'Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W)', 'description': 'Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on Day 1 of every 6 weeks (Q6W) as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.'}, {'id': 'OG003', 'title': 'Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W', 'description': 'Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q6W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.'}, {'id': 'OG004', 'title': 'Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment)', 'description': 'Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q6W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death. For this arm, dose modification decisions were determined by the results of the Ocular Surface Disease Index (OSDI) questionnaire or VA assessments using Snellen chart. The OSDI scale assesses the severity of eye symptoms and their impact and Snellen chart is for the assessment of visual acuity.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.7', 'groupId': 'OG000', 'lowerLimit': '2.8', 'upperLimit': '9.0'}, {'value': '2.1', 'groupId': 'OG001', 'lowerLimit': '1.0', 'upperLimit': '3.6'}, {'value': '2.8', 'groupId': 'OG002', 'lowerLimit': '1.4', 'upperLimit': '3.5'}, {'value': '2.7', 'groupId': 'OG003', 'lowerLimit': '1.9', 'upperLimit': '4.2'}, {'value': '2.8', 'groupId': 'OG004', 'lowerLimit': '0.8', 'upperLimit': '17.3'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 152 weeks', 'description': 'PFS defined as the time from randomization until the earliest date of documented PD, according to the 2016 IMWG response criteria, or death due to any cause. PD= Increase of 25% from lowest confirmed response value in 1 or more of the following criteria: Serum M-protein with absolute increase of \\>= 0.5 g/dL; Serum M-protein increase \\>= 1 g/dL if the lowest M-component was \\>=5 g/dL; Urinary M-protein (absolute increase must be \\>= 200 mg per 24 h).', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat Population. Only those participants with documented PD or death due to any cause have been analyzed.'}, {'type': 'SECONDARY', 'title': 'Overall Survival (OS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}, {'value': '21', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W)', 'description': 'Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose on Day 1 of every 3 weeks (Q3W) as a 30-60 minute intravenous (IV) infusion until confirmed disease progression, unacceptable toxicity or death.'}, {'id': 'OG001', 'title': 'Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W', 'description': 'Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q3W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.'}, {'id': 'OG002', 'title': 'Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W)', 'description': 'Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on Day 1 of every 6 weeks (Q6W) as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.'}, {'id': 'OG003', 'title': 'Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W', 'description': 'Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q6W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.'}, {'id': 'OG004', 'title': 'Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment)', 'description': 'Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q6W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death. For this arm, dose modification decisions were determined by the results of the Ocular Surface Disease Index (OSDI) questionnaire or VA assessments using Snellen chart. The OSDI scale assesses the severity of eye symptoms and their impact and Snellen chart is for the assessment of visual acuity.'}], 'classes': [{'categories': [{'measurements': [{'value': '20.9', 'comment': 'The upper limit of 95% confidence interval was not estimable at the time of the final analysis due to an insufficient number of participants with events within the length of follow-up in assessing the number of events.', 'groupId': 'OG000', 'lowerLimit': '8.1', 'upperLimit': 'NA'}, {'value': '15.0', 'groupId': 'OG001', 'lowerLimit': '7.6', 'upperLimit': '20.1'}, {'value': '13.5', 'groupId': 'OG002', 'lowerLimit': '7.5', 'upperLimit': '21.2'}, {'value': '14.5', 'comment': 'The upper limit of 95% confidence interval was not estimable at the time of the final analysis due to an insufficient number of participants with events within the length of follow-up in assessing the number of events.', 'groupId': 'OG003', 'lowerLimit': '7.7', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'The median and upper limit 95% confidence interval was not estimable at the time of the final analysis due to an insufficient number of participants with events within the length of follow-up in assessing the number of events.', 'groupId': 'OG004', 'lowerLimit': '4.8', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 152 weeks', 'description': 'OS defined as the time from randomization until the date of death due to any cause.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat Population. Only those participants with documented death due to any cause have been analyzed.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With AEs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}, {'value': '17', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W)', 'description': 'Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose on Day 1 of every 3 weeks (Q3W) as a 30-60 minute intravenous (IV) infusion until confirmed disease progression, unacceptable toxicity or death.'}, {'id': 'OG001', 'title': 'Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W', 'description': 'Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q3W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.'}, {'id': 'OG002', 'title': 'Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W)', 'description': 'Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on Day 1 of every 6 weeks (Q6W) as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.'}, {'id': 'OG003', 'title': 'Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W', 'description': 'Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q6W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.'}, {'id': 'OG004', 'title': 'Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment)', 'description': 'Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q6W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death. For this arm, dose modification decisions were determined by the results of the Ocular Surface Disease Index (OSDI) questionnaire or VA assessments using Snellen chart. The OSDI scale assesses the severity of eye symptoms and their impact and Snellen chart is for the assessment of visual acuity.'}], 'classes': [{'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}, {'value': '100', 'groupId': 'OG002'}, {'value': '100', 'groupId': 'OG003'}, {'value': '100', 'groupId': 'OG004'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 152 weeks', 'description': 'An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. AEs were coded using the standard Medical Dictionary for Regulatory Activities (MedDRA).', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Requiring Dose Reduction, Dose Interruption/Delay, Permanent Treatment Discontinuation Due to Any AEs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}, {'value': '17', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W)', 'description': 'Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose on Day 1 of every 3 weeks (Q3W) as a 30-60 minute intravenous (IV) infusion until confirmed disease progression, unacceptable toxicity or death.'}, {'id': 'OG001', 'title': 'Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W', 'description': 'Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q3W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.'}, {'id': 'OG002', 'title': 'Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W)', 'description': 'Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on Day 1 of every 6 weeks (Q6W) as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.'}, {'id': 'OG003', 'title': 'Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W', 'description': 'Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q6W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.'}, {'id': 'OG004', 'title': 'Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment)', 'description': 'Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q6W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death. For this arm, dose modification decisions were determined by the results of the Ocular Surface Disease Index (OSDI) questionnaire or VA assessments using Snellen chart. The OSDI scale assesses the severity of eye symptoms and their impact and Snellen chart is for the assessment of visual acuity.'}], 'classes': [{'title': 'Dose Reduction', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '18', 'groupId': 'OG004'}]}]}, {'title': 'Dose Interruption/Delay', 'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '35', 'groupId': 'OG004'}]}]}, {'title': 'Permanent Treatment Discontinuation', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '18', 'groupId': 'OG004'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 152 weeks', 'description': 'Percentage of participants requiring dose reduction, dose interruption/delay, permanent treatment discontinuation due to any AEs were presented. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. AEs were coded using the standard MedDRA.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}, {'value': '16', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W)', 'description': 'Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose on Day 1 of every 3 weeks (Q3W) as a 30-60 minute intravenous (IV) infusion until confirmed disease progression, unacceptable toxicity or death.'}, {'id': 'OG001', 'title': 'Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W', 'description': 'Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q3W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.'}, {'id': 'OG002', 'title': 'Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W)', 'description': 'Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on Day 1 of every 6 weeks (Q6W) as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.'}, {'id': 'OG003', 'title': 'Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W', 'description': 'Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q6W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.'}, {'id': 'OG004', 'title': 'Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment)', 'description': 'Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q6W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death. For this arm, dose modification decisions were determined by the results of the Ocular Surface Disease Index (OSDI) questionnaire or VA assessments using Snellen chart. The OSDI scale assesses the severity of eye symptoms and their impact and Snellen chart is for the assessment of visual acuity.'}], 'classes': [{'title': 'Eosinophilia, Increase to Grades 1 to 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Eosinophilia, Increase to Grades 2 to 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Eosinophilia, Increase to Grades 3 to 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Anemia, Increase to Grades 1 to 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}, {'value': '16', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}]}, {'title': 'Anemia, Increase to Grades 2 to 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}, {'value': '16', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}]}]}, {'title': 'Anemia, Increase to Grades 3 to 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}, {'value': '16', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}]}]}, {'title': 'Hemoglobin increased, Increase to Grades 1 to 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}, {'value': '16', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Hemoglobin increased, Increase to Grades 2 to 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}, {'value': '16', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Hemoglobin increased, Increase to Grades 3 to 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}, {'value': '16', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Leukocytosis, Increase to Grades 1 to 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}, {'value': '16', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Leukocytosis, Increase to Grades 2 to 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}, {'value': '16', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Leukocytosis, Increase to Grades 3 to 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}, {'value': '16', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'White blood cell decreased, Increase to Grades 1 to 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}, {'value': '16', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}]}]}, {'title': 'White blood cell decreased, Increase to Grades 2 to 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}, {'value': '16', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}]}, {'title': 'White blood cell decreased, Increase to Grades 3 to 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}, {'value': '16', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}]}]}, {'title': 'Lymphocyte count decreased, Increase to Grades 1 to 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}]}, {'title': 'Lymphocyte count decreased, Increase to Grades 2 to 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}]}]}, {'title': 'Lymphocyte count decreased, Increase to Grades 3 to 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}]}, {'title': 'Lymphocyte count increased, Increase to Grades 1 to 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Lymphocyte count increased, Increase to Grades 2 to 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Lymphocyte count increased, Increase to Grades 3 to 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Neutrophil count decreased, Increase to Grades 1 to 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}, {'value': '31', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}]}]}, {'title': 'Neutrophil count decreased, Increase to Grades 2 to 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}, {'value': '31', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}]}]}, {'title': 'Neutrophil count decreased, Increase to Grades 3 to 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}, {'value': '31', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}]}]}, {'title': 'Platelet count decreased, Increase to Grades 1 to 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}, {'value': '16', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}, {'value': '21', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}]}]}, {'title': 'Platelet count decreased, Increase to Grades 2 to 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}, {'value': '16', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}]}]}, {'title': 'Platelet count decreased, Increase to Grades 3 to 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}, {'value': '16', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 152 weeks', 'description': 'Blood samples were collected for the analysis of hematology parameters. The parameters were graded according to CTCAE grades. Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe or medically significant but not immediately life-threatening; Grade 4: Life-threatening consequences; Grade 5: Death related to AE. Higher grades indicate greater severity and an increase in CTCAE grade was defined relative to the Baseline grade. Any worst-case post baseline increases in grade 1/2/3 to a grade of 4 are presented.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population. Only those participants with data available for specified categories have been analyzed. Participants were counted more than once within some categories, so the percentages may not add to 100 percent (%).'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W)', 'description': 'Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose on Day 1 of every 3 weeks (Q3W) as a 30-60 minute intravenous (IV) infusion until confirmed disease progression, unacceptable toxicity or death.'}, {'id': 'OG001', 'title': 'Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W', 'description': 'Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q3W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.'}, {'id': 'OG002', 'title': 'Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W)', 'description': 'Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on Day 1 of every 6 weeks (Q6W) as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.'}, {'id': 'OG003', 'title': 'Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W', 'description': 'Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q6W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.'}, {'id': 'OG004', 'title': 'Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment)', 'description': 'Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q6W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death. For this arm, dose modification decisions were determined by the results of the Ocular Surface Disease Index (OSDI) questionnaire or VA assessments using Snellen chart. The OSDI scale assesses the severity of eye symptoms and their impact and Snellen chart is for the assessment of visual acuity.'}], 'classes': [{'title': 'Alanine aminotransferase increased, Increase to Grades 1 to 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}]}]}, {'title': 'Alanine aminotransferase increased, Increase to Grades 2 to 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Alanine aminotransferase increased, Increase to Grades 3 to 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Hypoalbuminemia, Increase to Grades 1 to 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}, {'value': '39', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}]}]}, {'title': 'Hypoalbuminemia, Increase to Grades 2 to 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}, {'value': '39', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}]}]}, {'title': 'Hypoalbuminemia, Increase to Grades 3 to 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}, {'value': '39', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Alkaline phosphatase increased, Increase to Grades 1 to 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}]}]}, {'title': 'Alkaline phosphatase increased, Increase to Grades 2 to 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Alkaline phosphatase increased, Increase to Grades 3 to 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Aspartate aminotransferase increased, Increase to Grades 1 to 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}]}]}, {'title': 'Aspartate aminotransferase increased, Increase to Grades 2 to 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Aspartate aminotransferase increased, Increase to Grades 3 to 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Blood bilirubin increased, Increase to Grades 1 to 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}]}]}, {'title': 'Blood bilirubin increased, Increase to Grades 2 to 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}]}, {'title': 'Blood bilirubin increased, Increase to Grades 3 to 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Hypercalcemia, Increase to Grades 1 to 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}, {'value': '39', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}]}]}, {'title': 'Hypercalcemia, Increase to Grades 2 to 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}, {'value': '39', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}]}, {'title': 'Hypercalcemia, Increase to Grades 3 to 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}, {'value': '39', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}]}, {'title': 'Hypocalcemia, Increase to Grades 1 to 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}, {'value': '39', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}]}, {'title': 'Hypocalcemia, Increase to Grades 2 to 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}, {'value': '39', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}]}, {'title': 'Hypocalcemia, Increase to Grades 3 to 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}, {'value': '39', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'CPK increased, Increase to Grades 1 to 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}, {'value': '38', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}]}]}, {'title': 'CPK increased, Increase to Grades 2 to 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}, {'value': '38', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'CPK increased, Increase to Grades 3 to 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}, {'value': '38', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Creatinine increased, Increase to Grades 1 to 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}]}]}, {'title': 'Creatinine increased, Increase to Grades 2 to 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}]}]}, {'title': 'Creatinine increased, Increase to Grades 3 to 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}]}, {'title': 'Chronic Kidney Disease, Increase to Grades 1 to 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}, {'value': '23', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}]}]}, {'title': 'Chronic Kidney Disease, Increase to Grades 2 to 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}, {'value': '23', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}]}]}, {'title': 'Chronic Kidney Disease, Increase to Grades 3 to 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}, {'value': '23', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}]}]}, {'title': 'GGT increased, Increase to Grades 1 to 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}, {'value': '13', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}]}]}, {'title': 'GGT increased, Increase to Grades 2 to 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}, {'value': '13', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}]}, {'title': 'GGT increased, Increase to Grades 3 to 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}, {'value': '13', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Blood lactate dehydrogenase increased, Increase to Grades 1 to 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}]}, {'title': 'Blood lactate dehydrogenase increased, Increase to Grades 2 to 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Blood lactate dehydrogenase increased, Increase to Grades 3 to 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Hypermagnesemia, Increase to Grades 1 to 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}, {'value': '39', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Hypermagnesemia, Increase to Grades 2 to 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}, {'value': '39', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Hypermagnesemia, Increase to Grades 3 to 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}, {'value': '39', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Hypomagnesemia, Increase to Grades 1 to 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}, {'value': '39', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}]}]}, {'title': 'Hypomagnesemia, Increase to Grades 2 to 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}, {'value': '39', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Hypomagnesemia, Increase to Grades 3 to 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}, {'value': '39', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Hyperkalemia, Increase to Grades 1 to 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}]}]}, {'title': 'Hyperkalemia, Increase to Grades 2 to 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Hyperkalemia, Increase to Grades 3 to 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Hypernatremia, Increase to Grades 1 to 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}]}]}, {'title': 'Hypernatremia, Increase to Grades 2 to 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}]}, {'title': 'Hypernatremia, Increase to Grades 3 to 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 152 weeks', 'description': 'Blood samples were collected for the analysis of clinical chemistry parameters. The parameters were graded according to CTCAE grades. Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe or medically significant but not immediately life-threatening; Grade 4: Life-threatening consequences; Grade 5: Death related to AE. Higher grades indicate greater severity and an increase in CTCAE grade was defined relative to the Baseline grade. Any worst-case post baseline increases in grade 1/2/3 to a grade of 4 are presented.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population. Only those participants with data available for specified categories have been analyzed. Participants were counted more than once within some categories, so the percentages may not add to 100 percent (%)'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Post-baseline Positive Anti-drug Antibodies (ADAs) Against Belantamab Mafodotin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}, {'value': '36', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W)', 'description': 'Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose on Day 1 of every 3 weeks (Q3W) as a 30-60 minute intravenous (IV) infusion until confirmed disease progression, unacceptable toxicity or death.'}, {'id': 'OG001', 'title': 'Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W', 'description': 'Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q3W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.'}, {'id': 'OG002', 'title': 'Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W)', 'description': 'Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on Day 1 of every 6 weeks (Q6W) as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.'}, {'id': 'OG003', 'title': 'Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W', 'description': 'Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q6W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.'}, {'id': 'OG004', 'title': 'Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment)', 'description': 'Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q6W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death. For this arm, dose modification decisions were determined by the results of the Ocular Surface Disease Index (OSDI) questionnaire or VA assessments using Snellen chart. The OSDI scale assesses the severity of eye symptoms and their impact and Snellen chart is for the assessment of visual acuity.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline (Day 1) and up to 152 weeks', 'description': 'Serum samples collected for the analysis of the presence of ADAs using validated immunoassays. All samples were tested in screening assay, and positive samples were further characterized for antibody titers. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population. Only those participants with data available at specified time points have been analyzed.'}, {'type': 'SECONDARY', 'title': 'Titers of ADAs Against Belantamab Mafodotin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W)', 'description': 'Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose on Day 1 of every 3 weeks (Q3W) as a 30-60 minute intravenous (IV) infusion until confirmed disease progression, unacceptable toxicity or death.'}, {'id': 'OG001', 'title': 'Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W', 'description': 'Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q3W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.'}, {'id': 'OG002', 'title': 'Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W)', 'description': 'Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on Day 1 of every 6 weeks (Q6W) as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.'}, {'id': 'OG003', 'title': 'Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W', 'description': 'Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q6W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.'}, {'id': 'OG004', 'title': 'Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment)', 'description': 'Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q6W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death. For this arm, dose modification decisions were determined by the results of the Ocular Surface Disease Index (OSDI) questionnaire or VA assessments using Snellen chart. The OSDI scale assesses the severity of eye symptoms and their impact and Snellen chart is for the assessment of visual acuity.'}], 'timeFrame': 'Up to 152 weeks', 'description': 'Serum samples collected for the analysis of the presence of ADAs using validated immunoassays. All samples were to be further tested in screening assay, and positive samples were further to be characterized for antibody titers.', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population. There were no participants with positive ADA results. Hence the titer (concentration) of ADA was not collected.'}, {'type': 'SECONDARY', 'title': 'Maximum Observed Concentration (Cmax) for Belantamab Mafodotin Antibody-drug Conjugate (ADC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}, {'value': '17', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W)', 'description': 'Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose on Day 1 of every 3 weeks (Q3W) as a 30-60 minute intravenous (IV) infusion until confirmed disease progression, unacceptable toxicity or death.'}, {'id': 'OG001', 'title': 'Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W', 'description': 'Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q3W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.'}, {'id': 'OG002', 'title': 'Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W)', 'description': 'Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on Day 1 of every 6 weeks (Q6W) as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.'}, {'id': 'OG003', 'title': 'Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W', 'description': 'Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q6W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.'}, {'id': 'OG004', 'title': 'Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment)', 'description': 'Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q6W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death. For this arm, dose modification decisions were determined by the results of the Ocular Surface Disease Index (OSDI) questionnaire or VA assessments using Snellen chart. The OSDI scale assesses the severity of eye symptoms and their impact and Snellen chart is for the assessment of visual acuity.'}], 'classes': [{'categories': [{'measurements': [{'value': '44.8', 'spread': '22.8', 'groupId': 'OG000'}, {'value': '33.1', 'spread': '23.2', 'groupId': 'OG001'}, {'value': '42.1', 'spread': '24.7', 'groupId': 'OG002'}, {'value': '33.1', 'spread': '18.3', 'groupId': 'OG003'}, {'value': '34.1', 'spread': '26.8', 'groupId': 'OG004'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle(C)1 Day(D) 1 Pre-dose, End of Infusion (EOI), Start of Infusion (SOI) + 2 hours (H); C1D2 SOI+24H; C1D4; C1D8-15', 'description': 'Plasma samples were collected for PK analysis for belantamab mafodotin antibody-drug conjugate (ADC).', 'unitOfMeasure': 'Microgram/ millilitre (ug/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic (PK) Population included all participants in the Safety Population from whom at least 1 post-treatment PK sample was obtained and analyzed. One Participant was randomized in Arm A but inadvertently given Arm B treatment at Cycle 1. Hence included in Arm B for PK analyses.'}, {'type': 'SECONDARY', 'title': 'Concentration at 21 Days for Belantamab Mafodotin ADC', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}, {'value': '17', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W)', 'description': 'Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose on Day 1 of every 3 weeks (Q3W) as a 30-60 minute intravenous (IV) infusion until confirmed disease progression, unacceptable toxicity or death.'}, {'id': 'OG001', 'title': 'Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W', 'description': 'Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q3W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.'}, {'id': 'OG002', 'title': 'Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W)', 'description': 'Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on Day 1 of every 6 weeks (Q6W) as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.'}, {'id': 'OG003', 'title': 'Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W', 'description': 'Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q6W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.'}, {'id': 'OG004', 'title': 'Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment)', 'description': 'Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q6W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death. For this arm, dose modification decisions were determined by the results of the Ocular Surface Disease Index (OSDI) questionnaire or VA assessments using Snellen chart. The OSDI scale assesses the severity of eye symptoms and their impact and Snellen chart is for the assessment of visual acuity.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.28', 'spread': '56.7', 'groupId': 'OG000'}, {'value': '1.5', 'spread': '62.4', 'groupId': 'OG001'}, {'value': '1.94', 'spread': '69.3', 'groupId': 'OG002'}, {'value': '1.69', 'spread': '50.2', 'groupId': 'OG003'}, {'value': '1.53', 'spread': '62.1', 'groupId': 'OG004'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At 21 days', 'description': 'Plasma samples were collected for PK analysis for belantamab mafodotin ADC.', 'unitOfMeasure': 'ug/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic (PK) Population. One Participant was randomized in Arm A but inadvertently given Arm B treatment at Cycle 1. Hence included in Arm B for PK analyses.'}, {'type': 'SECONDARY', 'title': 'Average Concentration Over 21 Days (Cavg) for Belantamab Mafodotin ADC', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}, {'value': '17', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W)', 'description': 'Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose on Day 1 of every 3 weeks (Q3W) as a 30-60 minute intravenous (IV) infusion until confirmed disease progression, unacceptable toxicity or death.'}, {'id': 'OG001', 'title': 'Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W', 'description': 'Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q3W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.'}, {'id': 'OG002', 'title': 'Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W)', 'description': 'Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on Day 1 of every 6 weeks (Q6W) as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.'}, {'id': 'OG003', 'title': 'Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W', 'description': 'Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q6W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.'}, {'id': 'OG004', 'title': 'Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment)', 'description': 'Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q6W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death. For this arm, dose modification decisions were determined by the results of the Ocular Surface Disease Index (OSDI) questionnaire or VA assessments using Snellen chart. The OSDI scale assesses the severity of eye symptoms and their impact and Snellen chart is for the assessment of visual acuity.'}], 'classes': [{'categories': [{'measurements': [{'value': '8.4', 'spread': '32.2', 'groupId': 'OG000'}, {'value': '5.98', 'spread': '34.6', 'groupId': 'OG001'}, {'value': '7.71', 'spread': '38.6', 'groupId': 'OG002'}, {'value': '6.3', 'spread': '27.1', 'groupId': 'OG003'}, {'value': '6.11', 'spread': '40.6', 'groupId': 'OG004'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'C1 D1 Pre-dose, EOI, SOI + 2H; C1D2 SOI+24H; C1D4; C1D8-15, D21', 'description': 'Plasma samples were collected for PK analysis for belantamab mafodotin ADC.', 'unitOfMeasure': 'ug/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic (PK) Population. One Participant was randomized in Arm A but inadvertently given Arm B treatment at Cycle 1. Hence included in Arm B for PK analyses.'}, {'type': 'SECONDARY', 'title': 'Area Under the Concentration-time Curve (AUC) (0-504h) of Belantamab Mafodotin ADC', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}, {'value': '17', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W)', 'description': 'Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose on Day 1 of every 3 weeks (Q3W) as a 30-60 minute intravenous (IV) infusion until confirmed disease progression, unacceptable toxicity or death.'}, {'id': 'OG001', 'title': 'Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W', 'description': 'Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q3W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.'}, {'id': 'OG002', 'title': 'Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W)', 'description': 'Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on Day 1 of every 6 weeks (Q6W) as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.'}, {'id': 'OG003', 'title': 'Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W', 'description': 'Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q6W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.'}, {'id': 'OG004', 'title': 'Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment)', 'description': 'Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q6W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death. For this arm, dose modification decisions were determined by the results of the Ocular Surface Disease Index (OSDI) questionnaire or VA assessments using Snellen chart. The OSDI scale assesses the severity of eye symptoms and their impact and Snellen chart is for the assessment of visual acuity.'}], 'classes': [{'categories': [{'measurements': [{'value': '4233', 'spread': '32.2', 'groupId': 'OG000'}, {'value': '3013', 'spread': '34.6', 'groupId': 'OG001'}, {'value': '3886', 'spread': '38.6', 'groupId': 'OG002'}, {'value': '3173', 'spread': '27.1', 'groupId': 'OG003'}, {'value': '3079', 'spread': '40.6', 'groupId': 'OG004'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'C1 D1 Pre-dose, EOI, SOI + 2H; C1D2 SOI+24H; C1D4; C1D8-15, D21', 'description': 'Plasma samples were collected to determine the area under the concentration-time curve (AUC) (0-504h) of Belantamab mafodotin ADC.', 'unitOfMeasure': 'micrograms* hour/ millilitre (ug*h/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic (PK) Population. One Participant was randomized in Arm A but inadvertently given Arm B treatment at Cycle 1. Hence included in Arm B for PK analyses.'}, {'type': 'SECONDARY', 'title': 'Half-life (t1/2) of Belantamab Mafodotin ADC', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}, {'value': '17', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W)', 'description': 'Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose on Day 1 of every 3 weeks (Q3W) as a 30-60 minute intravenous (IV) infusion until confirmed disease progression, unacceptable toxicity or death.'}, {'id': 'OG001', 'title': 'Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W', 'description': 'Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q3W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.'}, {'id': 'OG002', 'title': 'Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W)', 'description': 'Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on Day 1 of every 6 weeks (Q6W) as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.'}, {'id': 'OG003', 'title': 'Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W', 'description': 'Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q6W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.'}, {'id': 'OG004', 'title': 'Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment)', 'description': 'Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q6W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death. For this arm, dose modification decisions were determined by the results of the Ocular Surface Disease Index (OSDI) questionnaire or VA assessments using Snellen chart. The OSDI scale assesses the severity of eye symptoms and their impact and Snellen chart is for the assessment of visual acuity.'}], 'classes': [{'categories': [{'measurements': [{'value': '13', 'spread': '30.5', 'groupId': 'OG000'}, {'value': '12', 'spread': '32.1', 'groupId': 'OG001'}, {'value': '12', 'spread': '40', 'groupId': 'OG002'}, {'value': '12', 'spread': '34.2', 'groupId': 'OG003'}, {'value': '13', 'spread': '41.3', 'groupId': 'OG004'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'C1 D1 Pre-dose, EOI, SOI + 2H; C1D2 SOI+24H; C1D4; C1D8-15', 'description': 'Plasma samples were collected for PK analysis of Belantamab mafodotin ADC', 'unitOfMeasure': 'Days', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic (PK) Population. One Participant was randomized in Arm A but inadvertently given Arm B treatment at Cycle 1. Hence included in Arm B for PK analyses.'}, {'type': 'SECONDARY', 'title': 'Clearance (CL) for Belantamab Mafodotin ADC', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}, {'value': '17', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W)', 'description': 'Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose on Day 1 of every 3 weeks (Q3W) as a 30-60 minute intravenous (IV) infusion until confirmed disease progression, unacceptable toxicity or death.'}, {'id': 'OG001', 'title': 'Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W', 'description': 'Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q3W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.'}, {'id': 'OG002', 'title': 'Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W)', 'description': 'Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on Day 1 of every 6 weeks (Q6W) as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.'}, {'id': 'OG003', 'title': 'Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W', 'description': 'Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q6W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.'}, {'id': 'OG004', 'title': 'Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment)', 'description': 'Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q6W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death. For this arm, dose modification decisions were determined by the results of the Ocular Surface Disease Index (OSDI) questionnaire or VA assessments using Snellen chart. The OSDI scale assesses the severity of eye symptoms and their impact and Snellen chart is for the assessment of visual acuity.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.8', 'spread': '38.3', 'groupId': 'OG000'}, {'value': '0.83', 'spread': '57.1', 'groupId': 'OG001'}, {'value': '0.84', 'spread': '47.7', 'groupId': 'OG002'}, {'value': '0.74', 'spread': '53.3', 'groupId': 'OG003'}, {'value': '0.86', 'spread': '59.7', 'groupId': 'OG004'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'C1 D1 Pre-dose, EOI, SOI + 2H; C1D2 SOI+24H; C1D4; C1D8-15', 'description': 'Plasma samples were collected for PK analysis for belantamab mafodotin ADC.', 'unitOfMeasure': 'Liter/ days', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic (PK) Population. One Participant was randomized in Arm A but inadvertently given Arm B treatment at Cycle 1. Hence included in Arm B for PK analyses.'}, {'type': 'SECONDARY', 'title': 'Steady-state Volume of Distribution (Vss) for Belantamab Mafodotin ADC', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}, {'value': '17', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W)', 'description': 'Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose on Day 1 of every 3 weeks (Q3W) as a 30-60 minute intravenous (IV) infusion until confirmed disease progression, unacceptable toxicity or death.'}, {'id': 'OG001', 'title': 'Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W', 'description': 'Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q3W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.'}, {'id': 'OG002', 'title': 'Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W)', 'description': 'Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on Day 1 of every 6 weeks (Q6W) as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.'}, {'id': 'OG003', 'title': 'Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W', 'description': 'Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q6W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.'}, {'id': 'OG004', 'title': 'Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment)', 'description': 'Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q6W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death. For this arm, dose modification decisions were determined by the results of the Ocular Surface Disease Index (OSDI) questionnaire or VA assessments using Snellen chart. The OSDI scale assesses the severity of eye symptoms and their impact and Snellen chart is for the assessment of visual acuity.'}], 'classes': [{'categories': [{'measurements': [{'value': '10.0', 'spread': '19.6', 'groupId': 'OG000'}, {'value': '9.3', 'spread': '26.4', 'groupId': 'OG001'}, {'value': '9.4', 'spread': '26.9', 'groupId': 'OG002'}, {'value': '8.9', 'spread': '25.4', 'groupId': 'OG003'}, {'value': '10.0', 'spread': '16.1', 'groupId': 'OG004'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'C1 D1 Pre-dose, EOI, SOI + 2H; C1D2 SOI+24H; C1D4; C1D8-15', 'description': 'Plasma samples were collected for PK analysis for belantamab mafodotin ADC.', 'unitOfMeasure': 'Liter', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic (PK) Population. One Participant was randomized in Arm A but inadvertently given Arm B treatment at Cycle 1. Hence included in Arm B for PK analyses.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W)', 'description': 'Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose on Day 1 of every 3 weeks (Q3W) as a 30-60 minute intravenous (IV) infusion until confirmed disease progression, unacceptable toxicity or death.'}, {'id': 'FG001', 'title': 'Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W', 'description': 'Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q3W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.'}, {'id': 'FG002', 'title': 'Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W)', 'description': 'Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on Day 1 of every 6 weeks (Q6W) as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.'}, {'id': 'FG003', 'title': 'Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W', 'description': 'Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q6W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.'}, {'id': 'FG004', 'title': 'Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment)', 'description': 'Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q6W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death. For this arm, dose modification decisions were determined by the results of the Ocular Surface Disease Index (OSDI) questionnaire or VA assessments using Snellen chart. The OSDI scale assesses the severity of eye symptoms and their impact and Snellen chart is for the assessment of visual acuity.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'comment': 'Intent-to-Treat Population included all randomized participants, whether or not randomized treatment was administered.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '40'}, {'groupId': 'FG001', 'numSubjects': '40'}, {'groupId': 'FG002', 'numSubjects': '40'}, {'groupId': 'FG003', 'numSubjects': '40'}, {'groupId': 'FG004', 'numSubjects': '17'}]}, {'type': 'Safety', 'comment': 'All randomized participants who received at least 1 dose of study treatment.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '39'}, {'groupId': 'FG001', 'numSubjects': '40'}, {'groupId': 'FG002', 'numSubjects': '39'}, {'groupId': 'FG003', 'numSubjects': '40'}, {'groupId': 'FG004', 'numSubjects': '17'}]}, {'type': 'Pharmacokinetic', 'comment': 'All participants in the Safety Population from whom at least 1 post-treatment pharmacokinetic (PK) sample was obtained and analyzed.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '38'}, {'comment': '1 participant was randomized in Arm A but inadvertently given Arm B treatment at Cycle 1.', 'groupId': 'FG001', 'numSubjects': '41'}, {'groupId': 'FG002', 'numSubjects': '39'}, {'groupId': 'FG003', 'numSubjects': '40'}, {'groupId': 'FG004', 'numSubjects': '17'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '8'}, {'groupId': 'FG003', 'numSubjects': '9'}, {'groupId': 'FG004', 'numSubjects': '7'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '33'}, {'groupId': 'FG002', 'numSubjects': '32'}, {'groupId': 'FG003', 'numSubjects': '31'}, {'groupId': 'FG004', 'numSubjects': '10'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '23'}, {'groupId': 'FG001', 'numSubjects': '23'}, {'groupId': 'FG002', 'numSubjects': '25'}, {'groupId': 'FG003', 'numSubjects': '21'}, {'groupId': 'FG004', 'numSubjects': '5'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '6'}, {'groupId': 'FG004', 'numSubjects': '3'}]}, {'type': 'Ongoing at the time of analysis', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '2'}]}]}], 'preAssignmentDetails': 'The results presented are based on the data cut-off date of 30 Jan 2025. Those participants still benefiting from study drug in the opinion of their treating physician continued to receive study drug in the Post Analysis Continuation of Treatment (PACT) phase. Additional safety results will be provided within one year of study completion.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}, {'value': '40', 'groupId': 'BG003'}, {'value': '17', 'groupId': 'BG004'}, {'value': '177', 'groupId': 'BG005'}]}], 'groups': [{'id': 'BG000', 'title': 'Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W)', 'description': 'Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose on Day 1 of every 3 weeks (Q3W) as a 30-60 minute intravenous (IV) infusion until confirmed disease progression, unacceptable toxicity or death.'}, {'id': 'BG001', 'title': 'Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W', 'description': 'Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q3W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.'}, {'id': 'BG002', 'title': 'Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W)', 'description': 'Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on Day 1 of every 6 weeks (Q6W) as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.'}, {'id': 'BG003', 'title': 'Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W', 'description': 'Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q6W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.'}, {'id': 'BG004', 'title': 'Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment)', 'description': 'Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q6W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death. For this arm, dose modification decisions were determined by the results of the Ocular Surface Disease Index (OSDI) questionnaire or VA assessments using Snellen chart. The OSDI scale assesses the severity of eye symptoms and their impact and Snellen chart is for the assessment of visual acuity.'}, {'id': 'BG005', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '66.6', 'spread': '10.36', 'groupId': 'BG000'}, {'value': '63.0', 'spread': '9.02', 'groupId': 'BG001'}, {'value': '63.7', 'spread': '9.92', 'groupId': 'BG002'}, {'value': '65.4', 'spread': '8.87', 'groupId': 'BG003'}, {'value': '67.1', 'spread': '10.42', 'groupId': 'BG004'}, {'value': '64.9', 'spread': '9.66', 'groupId': 'BG005'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'YEARS', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}, {'value': '16', 'groupId': 'BG003'}, {'value': '8', 'groupId': 'BG004'}, {'value': '83', 'groupId': 'BG005'}]}, {'title': 'Male', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}, {'value': '24', 'groupId': 'BG003'}, {'value': '9', 'groupId': 'BG004'}, {'value': '94', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Hispanic or Latino', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}, {'value': '46', 'groupId': 'BG005'}]}]}, {'title': 'Not Hispanic or Latino', 'categories': [{'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}, {'value': '34', 'groupId': 'BG003'}, {'value': '11', 'groupId': 'BG004'}, {'value': '131', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-06-25', 'size': 3047685, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-08-06T08:45', 'hasProtocol': True}, {'date': '2024-09-18', 'size': 1048107, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-08-06T08:45', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'It is an open label study'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Belantamab mafodotin will be administered using various dosing regimens.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 177}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-03-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-01-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-18', 'studyFirstSubmitDate': '2021-09-22', 'resultsFirstSubmitDate': '2025-08-06', 'studyFirstSubmitQcDate': '2021-09-22', 'lastUpdatePostDateStruct': {'date': '2025-10-07', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-09-18', 'studyFirstPostDateStruct': {'date': '2021-10-01', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-10-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-08-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With Grade ≥2 Corneal Events Assessed by Keratopathy Visual Acuity (KVA) Scale', 'timeFrame': 'Up to 29.5 months', 'description': 'The KVA scale is based on the evaluation of corneal changes using slit lamp examination. This scale provides a standardized approach for evaluating the relationship between corneal health and visual acuity. KVA scale is defined as Grade 0: No keratopathy, normal visual acuity with no corneal abnormalities; Grade 1: Mild changes to the cornea with no significant loss in visual acuity; Grade 2: Moderate corneal changes with noticeable visual acuity reduction; Grade 3: Severe corneal changes with substantial visual acuity impairment; Grade 4: Very severe corneal changes leading to significant vision loss. Higher grade indicates greater severity of corneal events.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Corneal Events up to Week 16', 'timeFrame': 'Up to week 16', 'description': 'The number of participants with corneal events were assessed using KVA scale. The KVA scale provides a standardized approach for evaluating the relationship between corneal health and visual acuity. KVA scale is defined as Grade 0: No keratopathy, normal visual acuity with no corneal abnormalities; Grade 1: Mild changes to the cornea with no significant loss in visual acuity; Grade 2: Moderate corneal changes with noticeable visual acuity reduction; Grade 3: Severe corneal changes with substantial visual acuity impairment; Grade 4: Very severe corneal changes leading to significant vision loss. Higher grade indicates greater severity of corneal events.'}, {'measure': 'Incidence Rate of Corneal Events by Grade (KVA Scale)', 'timeFrame': 'Up to 152 weeks', 'description': 'Incidence rate of corneal events is defined as the percentage of participants with corneal events by grade according to the KVA scale. The KVA scale provides a standardized approach for evaluating the relationship between corneal health and visual acuity. KVA scale is defined as Grade 0: No keratopathy, normal visual acuity with no corneal abnormalities; Grade 1: Mild changes to the cornea with no significant loss in visual acuity; Grade 2: Moderate corneal changes with noticeable visual acuity reduction; Grade 3: Severe corneal changes with substantial visual acuity impairment; Grade 4: Very severe corneal changes leading to significant vision loss. Higher grade indicates greater severity of corneal events.'}, {'measure': 'Exposure Adjusted Incidence Rate of Corneal Events as Per CTCAE Grade', 'timeFrame': 'Up to 152 weeks', 'description': 'Exposure adjusted incidence rate of corneal events is defined as the number of participants with corneal events divided by the total exposure time for all participants at risk in the treatment group. Incidence rate for corneal events was assessed using Common Terminology Criteria for Adverse Events (CTCAE). Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe or medically significant but not immediately life-threatening; Grade 4: Life-threatening consequences; Grade 5: Death related to AE. Higher grades indicate greater severity. The number of participants with Grades 3,4, and 5 are presented.'}, {'measure': 'Median Duration of All the Dose Delays', 'timeFrame': 'Up to 152 weeks', 'description': 'Median duration of dose delays is defined as the median duration in time of all the dose delays in the respective treatment group. Duration of delays is defined as period from the expected start date of dose to actual start date of current dose.'}, {'measure': 'Percentage of Participants Requiring Dose Reduction, Dose Interruption/Delay, Permanent Treatment Discontinuation Due to Corneal Events', 'timeFrame': 'Up to 152 weeks', 'description': 'The percentage of participants that required dose reduction, dose interruption/delay, permanent treatment discontinuation due to corneal events were evaluated using KVA Scale. KVA scale is defined as Grade 0: No keratopathy, normal visual acuity with no corneal abnormalities; Grade 1: Mild changes to the cornea with no significant loss in visual acuity; Grade 2: Moderate corneal changes with noticeable visual acuity reduction; Grade 3: Severe corneal changes with substantial visual acuity impairment; Grade 4: Very severe corneal changes leading to significant vision loss. Higher grade indicates greater severity of corneal events.'}, {'measure': 'Cumulative Incidence of Grade 2 or Above Corneal Events (KVA Scale)', 'timeFrame': 'At 3 months, 6 months, 9 months and 12 months', 'description': 'Cumulative incidence of Grade 2 or above corneal events is defined as the percentage of corneal events of Grade 2 or above, as assessed using the KVA scale, within a specific time interval. KVA scale is defined as Grade 0: No keratopathy, normal visual acuity with no corneal abnormalities; Grade 1: Mild changes to the cornea with no significant loss in visual acuity; Grade 2: Moderate corneal changes with noticeable visual acuity reduction; Grade 3: Severe corneal changes with substantial visual acuity impairment; Grade 4: Very severe corneal changes leading to significant vision loss. Higher grade indicates greater severity of corneal events.'}, {'measure': 'Toxicity Index (TI)', 'timeFrame': 'Up to 152 weeks', 'description': "Toxicity Index is a composite score derived from the severity grades of adverse events (AEs) reported during the study, based on the Common Terminology Criteria for Adverse Events (CTCAE). A participant's score is calculated as a function of the ordered toxicity grades, represented in descending order by sequence, on a scale of 0-6, where 0 represents no toxicity and 6 represents the highest toxicity. CTCAE grades are defined as follows: Grade 1 (Mild), Grade 2 (Moderate), Grade 3 (Severe or medically significant but not immediately life-threatening), Grade 4 (Life-threatening consequences), and Grade 5 (Death related to AE). Higher grades indicate greater toxicity severity."}, {'measure': 'Duration of Corneal Events of Grade 2 or Above', 'timeFrame': 'Up to 152 weeks', 'description': 'Duration of corneal events is defined for each participant as the sum of duration of all the corneal AEs. The duration is defined as time from onset of any corneal events (KVA scale) of Grade 2 or above to the first time resolution to baseline, Grade 1 or below. It required at least one day gap between the resolution of all events from first occurrence to the onset of next occurrence.'}, {'measure': 'Percentage of Time on Study With Grade 2 or Above Corneal Events', 'timeFrame': 'Up to 152 weeks', 'description': 'It is defined as the percentage of time that a participant has corneal events out of the total time that a participant is on the study. Time with corneal events is defined as time from onset of any corneal events (KVA scale) of Grade 2 or above to the first-time resolution to baseline, Grade 1 or below.'}, {'measure': 'Number of Participants With Change in Best Corrected Visual Acuity Test (BCVA) Scores', 'timeFrame': 'Baseline (Day 1) and up to 152 weeks', 'description': 'Change in BCVA is defined as change in logarithm of the minimum angle of resolution (logMAR) units compared with baseline or the first visit after the cataract surgery. BCVA score was calculated based on the Logarithm of the Minimum Angle of Resolution (logMAR score). Any change from baseline categories is presented for right and left eyes. No change/improved vision is defined as a change from baseline \\<0.1; a possible worsened vision is defined as a change from baseline \\>=0.1 to \\<=0.3; a definite worsened vision is defined as a change from baseline \\>0.3 logMAR score. Improvement in BCVA is represented by a reduction in logMAR score from baseline, while worsening in BCVA is represented by an increase in logMAR score from baseline.'}, {'measure': 'Objective Response Rate (ORR)', 'timeFrame': 'Up to 152 weeks', 'description': 'ORR was defined as the percentage of participants with a confirmed partial response (PR) or better (i.e., PR, very good partial response \\[VGPR\\], complete response \\[CR\\] and stringent complete response \\[sCR\\]), according to the International Myeloma Working Group (IMWG) Response Criteria. CR = negative immunofixation of serum and urine AND disappearance of any soft tissue plasmacytomas AND \\<5% plasmacytomas in the bone marrow; sCR=stringent complete response, CR as above PLUS normal serum free light-chain (FLC) assay ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence; VGPR = serum and urine M-component detectable by immunofixation but not on electrophoresis OR ≥ 90% reduction in serum M-component plus urine M-component \\<100 mg/24 h; PR = ≥50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥90% or to \\<200 mg/24 h.'}, {'measure': 'Percentage of Participants With a Confirmed VGPR or Better (i.e., VGPR, CR, and sCR)', 'timeFrame': 'Up to 152 weeks', 'description': 'Percentage of participants with a confirmed VGPR or better defined as percentage of participant with confirmed VGPR, CR, and sCR, according to the 2016 IMWG response criteria. CR = negative immunofixation of serum and urine AND disappearance of any soft tissue plasmacytomas AND \\<5% plasmacytomas in the bone marrow; sCR=stringent complete response, CR as above PLUS normal serum free light-chain (FLC) assay ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence; VGPR = serum and urine M-component detectable by immunofixation but not on electrophoresis OR ≥ 90% reduction in serum M-component plus urine M-component \\<100 mg/24 h.'}, {'measure': 'Time to Response (TTR)', 'timeFrame': 'Up to 152 weeks', 'description': 'TTR defined as the time between the date of randomization and the first documented evidence of response (PR or better), among participants who achieve a response (i.e., confirmed PR or better), according to the 2016 IMWG response criteria. PR = ≥50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥90% or to \\<200 mg/24 h.'}, {'measure': 'Duration of Response (DoR)', 'timeFrame': 'Up to 152 weeks', 'description': 'DoR defined as the time from first documented evidence of PR or better until disease progression (PD) among responders according to the 2016 IMWG response criteria or death due to any cause. PR = ≥50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥90% or to \\<200 mg/24 h. PD= Increase of 25% from lowest confirmed response value in 1 or more of the following criteria: Serum M-protein with absolute increase of \\>= 0.5 g/dL; Serum M-protein increase \\>= 1 g/dL if the lowest M-component was \\>=5 g/dL; Urinary M-protein (absolute increase must be \\>= 200 mg per 24 h).'}, {'measure': 'Time to Progression (TTP)', 'timeFrame': 'Up to 152 weeks', 'description': 'TTP defined as the time from randomization until the earliest date of documented PD or death due to PD, according to the 2016 IMWG response criteria. PD= Increase of 25% from lowest confirmed response value in 1 or more of the following criteria: Serum M-protein with absolute increase of \\>= 0.5 g/dL; Serum M-protein increase \\>= 1 g/dL if the lowest M-component was \\>=5 g/dL; Urinary M-protein (absolute increase must be \\>= 200 mg per 24 h).'}, {'measure': 'Progression Free Survival (PFS)', 'timeFrame': 'Up to 152 weeks', 'description': 'PFS defined as the time from randomization until the earliest date of documented PD, according to the 2016 IMWG response criteria, or death due to any cause. PD= Increase of 25% from lowest confirmed response value in 1 or more of the following criteria: Serum M-protein with absolute increase of \\>= 0.5 g/dL; Serum M-protein increase \\>= 1 g/dL if the lowest M-component was \\>=5 g/dL; Urinary M-protein (absolute increase must be \\>= 200 mg per 24 h).'}, {'measure': 'Overall Survival (OS)', 'timeFrame': 'Up to 152 weeks', 'description': 'OS defined as the time from randomization until the date of death due to any cause.'}, {'measure': 'Percentage of Participants With AEs', 'timeFrame': 'Up to 152 weeks', 'description': 'An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. AEs were coded using the standard Medical Dictionary for Regulatory Activities (MedDRA).'}, {'measure': 'Percentage of Participants Requiring Dose Reduction, Dose Interruption/Delay, Permanent Treatment Discontinuation Due to Any AEs', 'timeFrame': 'Up to 152 weeks', 'description': 'Percentage of participants requiring dose reduction, dose interruption/delay, permanent treatment discontinuation due to any AEs were presented. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. AEs were coded using the standard MedDRA.'}, {'measure': 'Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline', 'timeFrame': 'Up to 152 weeks', 'description': 'Blood samples were collected for the analysis of hematology parameters. The parameters were graded according to CTCAE grades. Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe or medically significant but not immediately life-threatening; Grade 4: Life-threatening consequences; Grade 5: Death related to AE. Higher grades indicate greater severity and an increase in CTCAE grade was defined relative to the Baseline grade. Any worst-case post baseline increases in grade 1/2/3 to a grade of 4 are presented.'}, {'measure': 'Number of Participants With Worst-Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline', 'timeFrame': 'Up to 152 weeks', 'description': 'Blood samples were collected for the analysis of clinical chemistry parameters. The parameters were graded according to CTCAE grades. Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe or medically significant but not immediately life-threatening; Grade 4: Life-threatening consequences; Grade 5: Death related to AE. Higher grades indicate greater severity and an increase in CTCAE grade was defined relative to the Baseline grade. Any worst-case post baseline increases in grade 1/2/3 to a grade of 4 are presented.'}, {'measure': 'Number of Participants With Post-baseline Positive Anti-drug Antibodies (ADAs) Against Belantamab Mafodotin', 'timeFrame': 'Baseline (Day 1) and up to 152 weeks', 'description': 'Serum samples collected for the analysis of the presence of ADAs using validated immunoassays. All samples were tested in screening assay, and positive samples were further characterized for antibody titers. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.'}, {'measure': 'Titers of ADAs Against Belantamab Mafodotin', 'timeFrame': 'Up to 152 weeks', 'description': 'Serum samples collected for the analysis of the presence of ADAs using validated immunoassays. All samples were to be further tested in screening assay, and positive samples were further to be characterized for antibody titers.'}, {'measure': 'Maximum Observed Concentration (Cmax) for Belantamab Mafodotin Antibody-drug Conjugate (ADC)', 'timeFrame': 'Cycle(C)1 Day(D) 1 Pre-dose, End of Infusion (EOI), Start of Infusion (SOI) + 2 hours (H); C1D2 SOI+24H; C1D4; C1D8-15', 'description': 'Plasma samples were collected for PK analysis for belantamab mafodotin antibody-drug conjugate (ADC).'}, {'measure': 'Concentration at 21 Days for Belantamab Mafodotin ADC', 'timeFrame': 'At 21 days', 'description': 'Plasma samples were collected for PK analysis for belantamab mafodotin ADC.'}, {'measure': 'Average Concentration Over 21 Days (Cavg) for Belantamab Mafodotin ADC', 'timeFrame': 'C1 D1 Pre-dose, EOI, SOI + 2H; C1D2 SOI+24H; C1D4; C1D8-15, D21', 'description': 'Plasma samples were collected for PK analysis for belantamab mafodotin ADC.'}, {'measure': 'Area Under the Concentration-time Curve (AUC) (0-504h) of Belantamab Mafodotin ADC', 'timeFrame': 'C1 D1 Pre-dose, EOI, SOI + 2H; C1D2 SOI+24H; C1D4; C1D8-15, D21', 'description': 'Plasma samples were collected to determine the area under the concentration-time curve (AUC) (0-504h) of Belantamab mafodotin ADC.'}, {'measure': 'Half-life (t1/2) of Belantamab Mafodotin ADC', 'timeFrame': 'C1 D1 Pre-dose, EOI, SOI + 2H; C1D2 SOI+24H; C1D4; C1D8-15', 'description': 'Plasma samples were collected for PK analysis of Belantamab mafodotin ADC'}, {'measure': 'Clearance (CL) for Belantamab Mafodotin ADC', 'timeFrame': 'C1 D1 Pre-dose, EOI, SOI + 2H; C1D2 SOI+24H; C1D4; C1D8-15', 'description': 'Plasma samples were collected for PK analysis for belantamab mafodotin ADC.'}, {'measure': 'Steady-state Volume of Distribution (Vss) for Belantamab Mafodotin ADC', 'timeFrame': 'C1 D1 Pre-dose, EOI, SOI + 2H; C1D2 SOI+24H; C1D4; C1D8-15', 'description': 'Plasma samples were collected for PK analysis for belantamab mafodotin ADC.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Antibody drug conjugate', 'Belantamab mafodotin', 'BLENREP', 'DREAMM14', 'GSK2857916', 'Alternative dosing', 'Relapsed or refractory multiple myeloma', 'RRMM'], 'conditions': ['Multiple Myeloma']}, 'descriptionModule': {'briefSummary': 'This study aims to evaluate alternative dosing regimens of single-agent belantamab mafodotin in participants with relapsed or refractory multiple myeloma (RRMM) to determine if an improved overall benefit/risk profile can be achieved by modifying the belantamab mafodotin dose, schedule, or both.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Participant must be 18 years of age inclusive at the time of signing the informed consent form (ICF).\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.\n* Histologically or cytologically confirmed diagnosis of MM and a. Has undergone stem cell transplant or is considered transplant ineligible, and b. Has failed at least 3 prior lines of anti-myeloma therapies, including an anti-cluster of differentiation (CD)38 antibody (e.g., daratumumab) alone or in combination and is refractory to an immunomodulatory agent (e.g., lenalidomide, pomalidomide) and a proteasome inhibitor (e.g., bortezomib, ixazomib, carfilzomib).\n* France specific: participants have failed at least 4 prior lines of anti-myeloma therapies\n* Participant has measurable disease per modified IMWG criteria.\n* Life expectancy of at least 6 months, in the opinion of the investigator.\n* Male and female participants agree to abide by protocol-defined contraceptive requirements.\n* Participant is capable of giving signed informed consent.\n* Participant meets country-specific inclusion criteria described in the protocol.\n\nExclusion Criteria:\n\n* Symptomatic amyloidosis, active POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, myeloma protein, and skin changes), or active plasma cell leukemia at the time of screening.\n* Current corneal epithelial disease, except nonconfluent superficial punctate keratitis (SPK).\n* Evidence of active mucosal or internal bleeding.\n* Presence of an active renal condition.\n* Any serious and/or unstable pre-existing medical condition, psychiatric disorder, or other conditions that could interfere with the participant's safety, obtaining informed consent, or compliance with the study procedures.\n* Malignancies other than the disease under study, except for any other malignancy from which the participant has been disease free for \\>2 years and, will not affect the evaluation of the effects of the study treatment on the currently targeted malignancy (MM). Participants with curatively treated non-melanoma skin cancer may be enrolled without a 2-year restriction.\n* Evidence of cardiovascular risk as per the protocol criteria.\n* Pregnant or lactating female.\n* Active infection requiring antibiotic, antiviral, or antifungal treatment.\n* Known human immunodeficiency virus (HIV) infection, unless the criteria in protocol can be met.\n* Hepatitis B and C will be excluded unless the criteria in protocol can be met.\n* Cirrhosis or current unstable liver or biliary disease.\n* Alanine aminotransferase (ALT) \\>2.5× upper limit of normal (ULN).\n* Total Bilirubin \\>1.5×ULN.\n* Systemic anti-MM therapy within \\<=14 days or 5 half-lives, whichever is shorter.\n* Systemic therapy with high dose steroids within \\<=14 days before the first dose of study treatment.\n* Prior allogenic stem cell transplant.\n* Prior treatment with a monoclonal antibody \\<=30 days before the first dose of study treatment. Use of monoclonal antibodies for serious conditions unrelated to multiple myeloma, such as COVID, may be permitted.\n* Prior treatment with an anti-B cell maturation antigen (BCMA) targeted therapy or hypersensitivity reactions to any components of the study treatment.\n* Treatment with an antibody-drug conjugate.\n* Participant has received any major surgery \\<=4 weeks before the first dose of study treatment. An exception may be allowed for bone stabilizing surgery.\n* Inadequate bone marrow reserve or organ functions as demonstrated by any of the following: a. Absolute neutrophil count \\<1.0×10\\^9/L, b. Hemoglobin \\<8 gram/deciliter (g/dL), c. Platelet count \\<50×10\\^9/L, d. Spot urine (albumin/creatinine ratio) \\>500 milligram/gram (mg/g), e. Estimated glomerular filtration rate (eGFR) \\<30 milliliter per minute per 1.73 meter square (mL/min/1.73m\\^2).\n* UK specific: a. Absolute neutrophil count \\<1.5×10\\^9/L, c. Platelet count \\<75×10\\^9/L"}, 'identificationModule': {'nctId': 'NCT05064358', 'acronym': 'DREAMM 14', 'briefTitle': 'Study to Investigate Alternative Dosing Regimens of Belantamab Mafodotin in Participants With Relapsed or Refractory Multiple Myeloma', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': 'A Phase 2, Randomized, Parallel, Open-label Study to Investigate the Safety, Efficacy, and Pharmacokinetics of Various Dosing Regimens of Single-agent Belantamab Mafodotin (GSK2857916) in Participants With Relapsed or Refractory Multiple Myeloma (DREAMM-14)', 'orgStudyIdInfo': {'id': '209628'}, 'secondaryIdInfos': [{'id': '2021-004151-16', 'type': 'EUDRACT_NUMBER'}, {'id': '2023-508213-16', 'type': 'REGISTRY', 'domain': 'CTIS'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cohort 1: Participants receiving belantamab mafodotin at dose level (DL) 1', 'interventionNames': ['Drug: Belantamab mafodotin']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 2: Participants receiving belantamab mafodotin at DL 2', 'interventionNames': ['Drug: Belantamab mafodotin']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 3: Participants receiving belantamab mafodotin at DL 3', 'interventionNames': ['Drug: Belantamab mafodotin']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 4: Participants receiving belantamab mafodotin at DL 4', 'interventionNames': ['Drug: Belantamab mafodotin']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 5: Participants receiving belantamab mafodotin at DL4 with alternative dose modification', 'interventionNames': ['Drug: Belantamab mafodotin']}], 'interventions': [{'name': 'Belantamab mafodotin', 'type': 'DRUG', 'description': 'Belantamab mafodotin will be administered.', 'armGroupLabels': ['Cohort 1: Participants receiving belantamab mafodotin at dose level (DL) 1', 'Cohort 2: Participants receiving belantamab mafodotin at DL 2', 'Cohort 3: Participants receiving belantamab mafodotin at DL 3', 'Cohort 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