Study of Single Agent Belantamab Mafodotin Versus Pomalid... | NCT04162210

ID	Type	Description	Link
2018-004252-38	EudraCT Number

Label	Type	Description	Intervention Names
Participants receiving Belantamab mafodotin	Experimental	Participants will receive belantamab mafodotin single agent dose on Day 1 of Q3W	Drug: Belantamab mafodotin
Participants receiving pom/dex	Active Comparator	Participants will receive pomalidomide daily on Days 1 to 21 of each 28-day cycle, with dexamethasone once weekly on Days 1, 8, 15 and 22.	Drug: Pom/dex (Pomalidomide plus low dose Dexamethasone)

Name	Type	Description	Arm Group Labels	Other Names
Belantamab mafodotin	Drug	Belantamab mafodotin will be administered.	Participants receiving Belantamab mafodotin

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Progression-Free Survival (PFS) Based on Investigator-Assessed Response as Per International Myeloma Working Group (IMWG)	PFS is time from randomization until earliest date of progressive disease (PD), or death due to any cause per investigator-assessed response per IMWG. PD is ≥25% increase from nadir in any of following: serum M-protein (absolute increase ≥0.5 gram per deciliter [g/dL]),urine M-protein(absolute increase ≥200 mg/24hr),difference between involved/uninvolved FLC levels (absolute increase >10 mg/dL) in patients without measurable serum and urine M-protein levels, or bone marrow plasma-cell percentage irrespective of baseline status (absolute increase ≥10%) in patients without measurable serum and urine M-protein levels and without measurable involved FLC levels; appearance of new lesion,≥50% increase in longest diameter of a lesion previously measured >1cm in short axis, or ≥50% increase from nadir in sum of products of two longest perpendicular diameters of more than 1 lesion; ≥50% increase in circulating plasma cells (minimum of 200 cells/microliter) if this is only measure of disease.	Up to 27 months

Secondary Outcomes

Measure	Description	Time Frame
Overall Survival (OS)	OS is defined as the time from randomization until death due to any cause.	Up to approximately 263 weeks
Overall Response Rate (ORR)	Overall Response Rate is 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. PR: ≥50% reduction of serum M-protein and reduction in 24-hour (h) urinary M-protein by ≥90% or to <200 mg/24-h; 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; 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.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Capable of giving signed informed consent.
Participants must be 18 or older, at the time of signing the informed consent. In Republic of Korea, participants must be over 19 years of age inclusive, at the time of signing informed consent.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
Histologically or cytologically confirmed diagnosis of Multiple myeloma (MM) as defined according to IMWG, and : Has undergone autologous stem cell transplant (SCT), or is considered transplant ineligible; Has received at least 2 prior lines of anti-myeloma treatments, including at least 2 consecutive cycles of both lenalidomide and a proteasome inhibitor (given separately or in combination), and must have documented disease progression on, or within 60 days of, completion of the last treatment or must be non-responsive while on last treatment, where non-responsive is defined as not achieving at least Minimal Response (MR) after 2 complete treatment cycles. In such cases lack of achieving of at least MR must be determined no earlier than at least 4 weeks after the last treatment.
Has measurable disease with at least one of the following: Serum M-protein >=0.5 gram per deciliter (g/dL) (>=5 gram per Liter); Urine M-protein >=200 mg/24 hours; Serum free light chain (FLC) assay: Involved FLC level >=10 milligram per deciliter (mg/dL) (>=100 mg/L) and an abnormal serum FLC ratio (<0.26 or >1.65).
Participants with a history of autologous SCT are eligible for study participation provided the following eligibility criteria are met: Transplant was >100 days prior to initiating study treatment; No active infection(s).
Adequate organ system functions as defined: Absolute neutrophil count (ANC) >=1.0*10^9/L; Hemoglobin >= 8.0 g/dL; Platelets >= 50x10^9/L; Total bilirubin <=1.5* Upper limit of normal (ULN) (isolated bilirubin >1.5*ULN is acceptable if bilirubin is fractionated and direct bilirubin <35 percent); ALT <=2.5*ULN; Estimated glomerular filtration rate (eGFR) >=30 milliliter per minute per 1.73 square meter (mL/min/1.73 m^2); Spot urine (albumin/creatinine ratios) <=500 milligram per gram (mg/g) (56 milligram per millimoles [mg/mmol]).
Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. Male participants are eligible to participate if they agree to the following during the intervention period and until 6 months after the last dose of study intervention to allow for clearance of any altered sperm: Refrain from donating sperm PLUS, either: Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent OR Must agree to use contraception/barrier as detailed below depending on whether they are randomised to Arm 1 (belantamab mafodotin) or Arm 2 (pom/dex), even if they have undergone a successful vasectomy: Agree to use a male condom throughout study treatment including the 6 month follow-up period even if they have undergone a successful vasectomy and a female partner to use an additional highly effective contraceptive method with a failure rate of <1 percent per year when having sexual intercourse with a pregnant woman or a woman of childbearing potential who is not currently pregnant. Four weeks for male participants on Treatment Arm 2 (pom/dex).
A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies: Is not a woman of childbearing potential (WOCBP) OR Is a WOCBP and agrees to abide by the following: Arm 1 (belantamab mafodotin): Use a contraceptive method that is highly effective (with a failure rate of <1 percent per year) which includes abstinence, preferably with low user dependency during the intervention period and for 4 months after the last dose of study treatment. Arm 2 (pom/dex): Due to pomalidomide being a thalidomide analogue with risk for embryofetal toxicity and prescribed under a pregnancy prevention/controlled distribution program, WOCBP participants will be eligible if they commit either to abstain continuously from heterosexual sexual intercourse or to use two methods of reliable birth control (one method that is highly effective), beginning 4 weeks prior to initiating treatment with pomalidomide, during therapy, during dose interruptions and continuing for at least 4 weeks following discontinuation of pomalidomide treatment. Two negative pregnancy tests must be obtained prior to initiating therapy. The first test should be performed within 10-14 days and the second test within 24 hours prior to prescribing pomalidomide therapy. And agrees not to donate eggs (ova, oocytes) for the purpose of reproduction during this period. The investigator should confirm the effectiveness of the contraceptive method(s) ahead of the first dose of study intervention.
All prior treatment-related toxicities (defined by National Cancer Institute- Common Toxicity Criteria for Adverse Events [NCI-CTCAE], version 5.0, 2017) must be <=Grade 1 at the time of enrollment, except for alopecia and Grade 2 peripheral neuropathy.

Exclusion Criteria:

Symptomatic amyloidosis, active POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, myeloma protein, and skin changes); active plasma cell leukemia at the time of screening.
Systemic anti-myeloma therapy or use of an investigational drug within <14 days or 5 half-lives, whichever is shorter, before the first dose of study intervention.
Prior treatment with an anti-MM monoclonal antibody within 30 days prior to receiving the first dose of study intervention.
Prior B cell maturation antigen (BCMA)-targeted therapy or prior pomalidomide treatment.
Plasmapheresis within 7 days prior to the first dose of study intervention.
Prior allogeneic stem cell transplant. (Participants who have undergone syngeneic transplant will be allowed only if no history of, or currently active, Graft-Versus-Host Disease [GvHD]).
Any major surgery within the last 4 weeks.
Presence of active renal condition (infection, requirement for dialysis or any other condition that could affect participant's safety). Participants with isolated proteinuria resulting from MM are eligible, provided they fulfil criteria as described in inclusion criteria.
Any serious and/or unstable pre-existing medical, psychiatric disorder, or other conditions (including lab abnormalities) that could interfere with participant's safety, obtaining informed consent, or compliance with study procedures.
History of (non-infectious) pneumonitis that required steroids, or current pneumonitis.
Evidence of active mucosal or internal bleeding.
Current unstable liver or biliary disease per investigator assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminaemia, esophageal or gastric varices, persistent jaundice, or cirrhosis. (Stable chronic liver disease [including Gilbert's syndrome or asymptomatic gallstones] or hepatobiliary involvement of malignancy is acceptable if participant otherwise meets entry criteria)
Participants with previous or concurrent malignancies other than multiple myeloma are excluded, unless the second malignancy has been considered medically stable for at least 2 years. The participant must not be receiving active therapy, other than hormonal therapy for this disease. (Participants with curatively treated non-melanoma skin cancer are allowed without a 2-year restriction).
Evidence of cardiovascular risk including any of the following: Evidence of current clinically significant uncontrolled arrhythmias including clinically significant electrocardiogram (ECG) abnormalities including 2nd degree (Mobitz Type II) or 3rd degree atrioventricular block; History of myocardial infarction, acute coronary syndromes (including unstable angina), coronary angioplasty, or stenting or bypass grafting within 3 months of Screening; Class III or IV heart failure as defined by the New York Heart Association (NYHA) functional classification system; Uncontrolled hypertension.
Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to belantamab mafodotin, pomalidomide, dexamethasone or any of the components of the study intervention.
Pregnant or lactating female.
Active infection requiring treatment.
Known human immunodeficiency virus (HIV), unless the participant can meet all of the following criteria: Established anti-retroviral therapy (ART) for at least 4 weeks and HIV viral load <400 copies/mL; CD4+ T-cell (CD4+) counts ≥350 cells/uL; No history of AIDS-defining opportunistic infections within the last 12 months.(Consideration must be given to ART and prophylactic antimicrobials that may have a drug-drug interaction and/or overlapping toxicities with belantamab mafodotin or other combination products as relevant)
Participants with Hepatitis B will be excluded unless the following criteria can be met: If the participant is hepatitis B core antibody (HbcAb) positive or hepatitis B surface antigen (HbsAg) negative, then hepatitis B virus (HBV) deoxyribonucleic acid (DNA) should be undectectable at the time of screening; If HbsAg+ at screening or <=3 months prior to first dose of study treatment, then HBV DNA should be undetectable, highly effective antiviral treatment should be started ≥4 weeks prior to first dose of study treatment, exclusion of participants with cirrhosis and participants in Japan must test hepatitis B e antigen (HBeAg) and hepatitis B e antibody (HBeAb ).
Positive hepatitis C antibody test result or positive hepatitis C Ribonucleic acid (RNA) test result at screening or within 3 months prior to first dose of study treatment unless the participant can meet the following criteria: Hepatitis C RNA test negative at Screening and successful anti-viral treatment (usually 8 weeks duration) is required, followed by a negative HCV RNA test after a washout period of at least 4 weeks (Hepatitis RNA is optional and participants with negative Hepatitis C antibody test are not required to also undergo Hepatitis C RNA testing).
Participants unable to tolerate thromboembolic prophylaxis.
Current corneal epithelial disease except for mild punctate keratopathy.

Name	Affiliation	Role
GSK Clinical Trials	GlaxoSmithKline	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
GSK Investigational Site		Tucson	Arizona	85715	United States
GSK Investigational Site

PubMed Identifier	Type	Citation	Retractions
37793771	Derived	Dimopoulos MA, Hungria VTM, Radinoff A, Delimpasi S, Mikala G, Masszi T, Li J, Capra M, Maiolino A, Pappa V, Chraniuk D, Osipov I, Leleu X, Low M, Matsumoto M, Sule N, Li M, McKeown A, He W, Bright S, Currie B, Perera S, Boyle J, Roy-Ghanta S, Opalinska J, Weisel K. Efficacy and safety of single-agent belantamab mafodotin versus pomalidomide plus low-dose dexamethasone in patients with relapsed or refractory multiple myeloma (DREAMM-3): a phase 3, open-label, randomised study. Lancet Haematol. 2023 Oct;10(10):e801-e812. doi: 10.1016/S2352-3026(23)00243-0.

ID	Title	Description
FG000	Belantamab Mafodotin	Participants with relapsed/refractory multiple myeloma (RRMM) received 30 minutes intravenous infusion of 2.5 milligram/kilogram (mg/kg) belantamab mafodotin on day 1 of each 21-day cycle
FG001	Pomalidomide Plus Dexamethasone

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Oct 30, 2024	Apr 21, 2026

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Secondary

Overall Survival (OS)

OS is defined as the time from randomization until death due to any cause.

ITT Population

Posted

Median

95% Confidence Interval

Months

Up to approximately 263 weeks

ID	Title	Description
OG000	Belantamab Mafodotin	Participants with relapsed/refractory multiple myeloma (RRMM) received 30 minutes intravenous infusion of 2.5 milligram/kilogram (mg/kg) belantamab mafodotin on day 1 of each 21-day cycle
OG001	Pomalidomide Plus Dexamethasone	Participants with RRMM received 4 mg pomalidomide capsule daily on Days 1 to 21 of each 28-day cycle, along with 40 mg or at lower 20 mg (for participants >75 years of age) dose of dexamethasone tablet once weekly (Days 1, 8, 15 and 22)

Units	Counts
Participants	OG000218 OG001107

Title

Denominators

Categories

Title	Measurements
	OG00024.0(19.4 to 33.2) OG00122.9(16.0 to 29.3)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Log Rank	One-sided p-value from stratified log-rank test were adjusted for previous treatment with anti-CD38, ISS staging and number of prior lines of therapy.	0.440		Hazard Ratio (HR)	0.98			2-Sided	95	0.73	1.30					Other

Secondary

Overall Response Rate (ORR)

Overall Response Rate is 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. PR: ≥50% reduction of serum M-protein and reduction in 24-hour (h) urinary M-protein by ≥90% or to <200 mg/24-h; 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; 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.

ITT Population

Posted

Number

95% Confidence Interval

Percentage of Participants

Up to approximately 263 weeks

ID	Title	Description
OG000	Belantamab Mafodotin	Participants with relapsed/refractory multiple myeloma (RRMM) received 30 minutes intravenous infusion of 2.5 milligram/kilogram (mg/kg) belantamab mafodotin on day 1 of each 21-day cycle
OG001	Pomalidomide Plus Dexamethasone	Participants with RRMM received 4 mg pomalidomide capsule daily on Days 1 to 21 of each 28-day cycle, along with 40 mg or at lower 20 mg (for participants >75 years of age) dose of dexamethasone tablet once weekly (Days 1, 8, 15 and 22)

Secondary

Clinical Benefit Rate (CBR)

Clinical benefit rate is defined as the percentage of participants with a confirmed minimal response (MR) or better according to the IMWG Response Criteria. MR is >= 25% but < 49% reduction of serum M-protein and reduction in 24-hour urinary M-protein by 50-89%.

ITT Population

Posted

Number

95% Confidence Interval

Percentage of Participants

Up to approximately 263 weeks

ID	Title	Description
OG000	Belantamab Mafodotin	Participants with relapsed/refractory multiple myeloma (RRMM) received 30 minutes intravenous infusion of 2.5 milligram/kilogram (mg/kg) belantamab mafodotin on day 1 of each 21-day cycle
OG001	Pomalidomide Plus Dexamethasone	Participants with RRMM received 4 mg pomalidomide capsule daily on Days 1 to 21 of each 28-day cycle, along with 40 mg or at lower 20 mg (for participants >75 years of age) dose of dexamethasone tablet once weekly (Days 1, 8, 15 and 22)

Units	Counts
Participants

Secondary

Duration of Response (DoR)

Duration of response is defined as the time from first documented evidence of PR or better, to the time when disease progression (PD) is documented per IMWG response criteria; or death due to PD occurs among participants who achieve an overall response, i.e. confirmed PR or better. 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). PR = ≥50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥ 90% or to <200 mg/24 h.

ITT Population. Only participants who achieved confirmed CR or PR as the best overall response were evaluated.

Posted

Median

95% Confidence Interval

Months

Up to approximately 263 weeks

ID	Title	Description
OG000	Belantamab Mafodotin	Participants with relapsed/refractory multiple myeloma (RRMM) received 30 minutes intravenous infusion of 2.5 milligram/kilogram (mg/kg) belantamab mafodotin on day 1 of each 21-day cycle
OG001	Pomalidomide Plus Dexamethasone	Participants with RRMM received 4 mg pomalidomide capsule daily on Days 1 to 21 of each 28-day cycle, along with 40 mg or at lower 20 mg (for participants >75 years of age) dose of dexamethasone tablet once weekly (Days 1, 8, 15 and 22)

Secondary

Time to Response (TTR)

TTR is defined as the time between the date of randomization and the first documented evidence of response (PR or better) among participants who achieve confirmed PR or better. PR: >=50% reduction of serum M-protein & reduction in 24h urinary M-protein by >=90%/<200mg/24 h.

ITT Population. Only participants who achieved confirmed CR or PR as the best overall response were evaluated.

Posted

Median

Inter-Quartile Range

Months

Up to approximately 263 weeks

ID	Title	Description
OG000	Belantamab Mafodotin	Participants with relapsed/refractory multiple myeloma (RRMM) received 30 minutes intravenous infusion of 2.5 milligram/kilogram (mg/kg) belantamab mafodotin on day 1 of each 21-day cycle
OG001	Pomalidomide Plus Dexamethasone	Participants with RRMM received 4 mg pomalidomide capsule daily on Days 1 to 21 of each 28-day cycle, along with 40 mg or at lower 20 mg (for participants >75 years of age) dose of dexamethasone tablet once weekly (Days 1, 8, 15 and 22)

Units	Counts
Participants

Secondary

Time to Progression (TTP)

TTP is defined as the time from the date of randomization until the earliest date of documented PD (per IMWG Response Criteria) or death due to PD. PD: increase of >=25% from lowest confirmed value in any 1 of following criteria: serum M-protein (absolute increase must be >=0.5 g/dL), serum M-protein increase >=1g/dL if lowest M component was >=5g/dL; urine M-component (absolute increase must be >=200mg/24 hour),appearance of new lesion(s), >=50% increase from nadir in Sum of the Products of the maximal perpendicular Diameters of measured lesions (SPD) of >1 lesion, or >=50% increase in the longest diameter of previous lesion >1 cm in short axis.

ITT Population

Posted

Median

95% Confidence Interval

Months

Up to approximately 263 weeks

ID	Title	Description
OG000	Belantamab Mafodotin	Participants with relapsed/refractory multiple myeloma (RRMM) received 30 minutes intravenous infusion of 2.5 milligram/kilogram (mg/kg) belantamab mafodotin on day 1 of each 21-day cycle
OG001	Pomalidomide Plus Dexamethasone	Participants with RRMM received 4 mg pomalidomide capsule daily on Days 1 to 21 of each 28-day cycle, along with 40 mg or at lower 20 mg (for participants >75 years of age) dose of dexamethasone tablet once weekly (Days 1, 8, 15 and 22)

Secondary

Number of Participants With Treatment Emergent Adverse Events (TEAEs)

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. TEAE is an event that emerged during treatment having been absent pre-treatment or worsened relative to the pre-treatment state. AEs were to be coded using the Medical Dictionary for Regulatory Activities (MedDRA) coding system.

Safety Population included all randomized participants who took at least 1 dose of study intervention

Posted

Count of Participants

Participants

Up to approximately 263 weeks

ID	Title	Description
OG000	Belantamab Mafodotin	Participants with relapsed/refractory multiple myeloma (RRMM) received 30 minutes intravenous infusion of 2.5 milligram/kilogram (mg/kg) belantamab mafodotin on day 1 of each 21-day cycle
OG001	Pomalidomide Plus Dexamethasone	Participants with RRMM received 4 mg pomalidomide capsule daily on Days 1 to 21 of each 28-day cycle, along with 40 mg or at lower 20 mg (for participants >75 years of age) dose of dexamethasone tablet once weekly (Days 1, 8, 15 and 22)

Units

Secondary

Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-baseline Relative to Baseline

Blood samples were collected for evaluation of hematology parameters. The summaries of worst-case change from Baseline with respect to normal range have been presented for only those laboratory tests that are gradable by CTCAE v5.0. The number of participants with decreases to low from baseline, changes to normal or no changes from baseline, and increases to high values have been presented. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. [Basophils (Baso), Mean Corpuscular Hemoglobin Concentration (MCHC), Mean Corpuscular Hemoglobin (MCH), Mean Corpuscular Volume (MCV), Erythrocytes (Ery), Hematocrit (Hct), Monocytes (Mono), Reticulocytes (Ret), Leukocytes (Leu), Eosinophils (Eosi), Lymphocytes (Lym), Neutrophils (Neu)]

Safety Population. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified categories. Participants were counted twice if participant had values that changed To Low and To High, so percentages may not add to 100%

Posted

Count of Participants

Participants

Baseline (Day 1) and up to approximately 263 weeks

ID	Title	Description
OG000	Belantamab Mafodotin	Participants with relapsed/refractory multiple myeloma (RRMM) received 30 minutes intravenous infusion of 2.5 milligram/kilogram (mg/kg) belantamab mafodotin on day 1 of each 21-day cycle

Secondary

Number of Participants With Maximum Grade Increase Post-Baseline Relative to Baseline in Hematology

Blood samples were collected for evaluation of hematology parameters. The summaries of maximum grade increase from Baseline with respect to normal range have been presented for only those laboratory tests that are gradable by CTCAE version 5.0. Grade 1 (G1): mild; Grade 2 (G2): moderate; Grade 3 (G3): severe; Grade 4 (G4) life-threatening or disabling. Higher grade indicates greater severity and an increase in CTCAE grade was defined relative to the Baseline grade. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. [White Blood Cells (WBC)]

Safety Population. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified categories. Participants were counted more than once within some categories, hence the percentages may not add up to 100%.

Posted

Count of Participants

Participants

Baseline (Day 1) and up to approximately 263 weeks

ID	Title	Description
OG000	Belantamab Mafodotin	Participants with relapsed/refractory multiple myeloma (RRMM) received 30 minutes intravenous infusion of 2.5 milligram/kilogram (mg/kg) belantamab mafodotin on day 1 of each 21-day cycle
OG001	Pomalidomide Plus Dexamethasone

Secondary

Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-baseline Relative to Baseline

Blood samples were collected for evaluation of clinical chemistry parameters. The summaries of worst-case change from Baseline with respect to normal range have been presented for only those laboratory tests that are gradable by CTCAE v5.0. The number of participants with decreases to low from baseline, changes to normal or no changes from baseline, and increases to high values have been presented. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. [Kappa Light (K Lt), Lambda (λ),Monoclonal (Mc), Protein (P), Change (Cge), Alpha (α), Beta (β), Creatine Kinase (CK), Gamma (γ) ,Immunoglobulin (I-Globulin), Indirect (In.)]

Safety Population. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified categories. Participants were counted more than once within some categories, hence the percentages may not add up to 100%.

Posted

Count of Participants

Participants

Baseline (Day 1) and up to approximately 263 weeks

ID	Title	Description
OG000	Belantamab Mafodotin	Participants with relapsed/refractory multiple myeloma (RRMM) received 30 minutes intravenous infusion of 2.5 milligram/kilogram (mg/kg) belantamab mafodotin on day 1 of each 21-day cycle
OG001	Pomalidomide Plus Dexamethasone

Secondary

Number of Participants With Maximum Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry

Blood samples were collected for evaluation of clinical chemistry parameters. The summaries of maximum grade increase from Baseline with respect to normal range have been presented for only those laboratory tests that are gradable by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.Grade 1 (G1): mild; Grade 2 (G2): moderate; Grade 3 (G3): severe; Grade 4 (G4) life-threatening or disabling. Higher grade indicates greater severity and an increase in CTCAE grade was defined relative to the Baseline grade. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. [Alanine aminotransferase (ALT), Alkaline phosphatase (ALP), Aspartate Aminotransferase (AST), Creatine Kinase (CPK), Gamma Glutamyl Transferase (GGT)]

Safety Population.Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified categories. Participants were counted more than once within some categories, hence the percentages may not add up to 100%.

Posted

Count of Participants

Participants

Baseline (Day 1) and Up to approximately 263 weeks

ID	Title	Description
OG000	Belantamab Mafodotin	Participants with relapsed/refractory multiple myeloma (RRMM) received 30 minutes intravenous infusion of 2.5 milligram/kilogram (mg/kg) belantamab mafodotin on day 1 of each 21-day cycle

Secondary

Number of Participants With Shift in Urine Albumin Creatinine Ratio From Baseline to Worst Post-Baseline

Urine samples were analyzed for spot urine albumin/creatinine ratio (UACR)[milligrams/grams (mg/g)]. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. The "worst post-baseline value" is defined as the highest UACR measurement recorded for a participant after the baseline assessment and up to the end of the study observation period. The "shift" will be calculated as the difference between this worst post-baseline UACR value and the baseline UACR value (Worst Post-Baseline UACR - Baseline UACR). Each category is reported as "Baseline category, Worst post-baseline category." Ranges are inclusive and expressed as [lower-upper].

Safety Population

Posted

Count of Participants

Participants

Baseline (Day 1) and Up to approximately 263 weeks

ID	Title	Description
OG000	Belantamab Mafodotin	Participants with relapsed/refractory multiple myeloma (RRMM) received 30 minutes intravenous infusion of 2.5 milligram/kilogram (mg/kg) belantamab mafodotin on day 1 of each 21-day cycle
OG001	Pomalidomide Plus Dexamethasone	Participants with RRMM received 4 mg pomalidomide capsule daily on Days 1 to 21 of each 28-day cycle, along with 40 mg or at lower 20 mg (for participants >75 years of age) dose of dexamethasone tablet once weekly (Days 1, 8, 15 and 22)

Secondary

Number of Participants With Maximum Worst-case Change From Baseline in Best Corrected Visual Acuity Test (BCVA) Scores

BCVA score was assessed individually for each eye. BCVA score was calculated based on the Logarithm of the Minimum Angle of Resolution (logMAR score). Any worst-case change from baseline categories are presented for right and left eyes. BCVA test scores were categorized as no change/improved vision, possible worsened vision and definite worsened vision. No change/improved vision was defined as a change from baseline <0.12 logMAR score; a possible worsened vision was defined as a change from baseline >=0.12 to <0.3 logMAR score; a definite worsened vision was defined as a change from baseline >=0.3 logMAR score. Baseline (Day 1) was defined as latest pre-dose assessment with non-missing value, including unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.

Posted

Count of Participants

Participants

Baseline (Day 1) and up to approximately 263 weeks

ID	Title	Description
OG000	Belantamab Mafodotin	Participants with relapsed/refractory multiple myeloma (RRMM) received 30 minutes intravenous infusion of 2.5 milligram/kilogram (mg/kg) belantamab mafodotin on day 1 of each 21-day cycle
OG001

Secondary

Observed Plasma Concentrations of Belantamab Mafodotin- Antibody-drug Conjugate (ADC)

Blood samples were collected at indicated time points for pharmacokinetic analysis of belantamab mafodotin

Pharmacokinetic population included all participants in the safety analysis set who had at least 1 non-missing PK assessment. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified time points

Posted

Mean

Standard Deviation

Micrograms per milliliter (ug/mL)

Pre-dose on Day (D)1 of Cycles(C)1,2,3,4,6,9,12,18,24,30,36,42; End of Infusion (EOI) on D1 of C1,2,3,4&6; Start of infusion (SOI) + 2 hours(h) on D1,SOI + 24 h on D1; D4,D8-15,D22 of C1&C3; D1 of C2,3,4&6; C3D2; & End of Treatment(EOT) (~242 weeks)

ID	Title	Description
OG000	Belantamab Mafodotin	Participants with relapsed/refractory multiple myeloma (RRMM) received 30 minutes intravenous infusion of 2.5 milligram/kilogram (mg/kg) belantamab mafodotin on day 1 of each 21-day cycle

Units	Counts
Participants	OG000

Secondary

Observed Plasma Concentrations of Belantamab Mafodotin- Total Monoclonal Antibody (mAb)

Blood samples were collected at indicated time points for pharmacokinetic analysis of belantamab mafodotin

Pharmacokinetic population. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified time points.

Posted

Mean

Standard Deviation

ug/mL

Pre-dose on Day (D)1 of Cycles (C)1,2,3,4,6,9,12,18,24,30,36,42; EOI on D1 of C1,2,3, 4 & 6; SOI + 24h on D1&2 of C1&3; D4, D8-15, D22 of C1&3; D1of C2,3,4 & 6; D2 of C3; and EOT (~242 weeks)

ID	Title	Description
OG000	Belantamab Mafodotin	Participants with relapsed/refractory multiple myeloma (RRMM) received 30 minutes intravenous infusion of 2.5 milligram/kilogram (mg/kg) belantamab mafodotin on day 1 of each 21-day cycle

Units	Counts
Participants	OG000

Secondary

Observed Plasma Concentrations of Belantamab Mafodotin-Cys-mc Microtubular Inhibitor Monomethyl Auristatin-F (MMAF)

Blood samples were collected at indicated time points for pharmacokinetic analysis of belantamab mafodotin

Posted

Mean

Standard Deviation

ug/mL

Pre-dose on Day (D)1 of Cycles (C)1,2,3,4,6,9,12,18,24,30,36,42; EOI on D1 of C1,2,3, 4 & 6; D1 SOI + 2 h of C1&3; D2 SOI + 24h of C1&3; D4, D8-15, D22 of C1&3; D1 of C2,3,4,6,9,12,18,24 & 30; D2 of C3; and EOT (~242 weeks)

ID	Title	Description
OG000	Belantamab Mafodotin	Participants with relapsed/refractory multiple myeloma (RRMM) received 30 minutes intravenous infusion of 2.5 milligram/kilogram (mg/kg) belantamab mafodotin on day 1 of each 21-day cycle

Units	Counts
Participants	OG000

Secondary

Number of Participants With Post-baseline Positive Anti-Drug Antibody (ADAs) Against Belantamab Mafodotin

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.

Safety Population.

Posted

Count of Participants

Participants

Upto approximately 263 weeks

ID	Title	Description
OG000	Belantamab Mafodotin	Participants with relapsed/refractory multiple myeloma (RRMM) received 30 minutes intravenous infusion of 2.5 milligram/kilogram (mg/kg) belantamab mafodotin on day 1 of each 21-day cycle

Units	Counts
Participants	OG000

Secondary

Titers of ADAs Against Belantamab Mafodotin

Serum samples were collected and tested for the presence of antibodies against belantamab mafodotin . Confirmed positive ADA samples were further analyzed to obtain the titer of the antibodies. Titers of anti-drug antibodies against belantamab mafodotin is presented.

Safety Population. Data for only that participant with positive ADA results is presented.

Posted

Median

Full Range

Titer

Up to approximately 263 weeks

ID	Title	Description
OG000	Belantamab Mafodotin	Participants with relapsed/refractory multiple myeloma (RRMM) received 30 minutes intravenous infusion of 2.5 milligram/kilogram (mg/kg) belantamab mafodotin on day 1 of each 21-day cycle

Units	Counts
Participants	OG000

Secondary

Number of Participants With Symptomatic Adverse Effects as Measured by the Patient Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)

PRO-CTCAE is a patient-reported outcome measure developed to evaluate symptomatic toxicity in participants on cancer clinical trials. The PRO-CTCAE includes an item library of 124 items representing 78 symptomatic toxicities drawn from the CTCAE. It includes symptomatic toxicities drawn from the CTCAE like blurred vision, chills, constipation, decreased appetite, fatigue, general pain, mouth/throat sores, nausea, nosebleed, shortness of breath, vomiting, watery eyes, cough, itchy, loose/watery stools, Numb/Tingling Hands/Feet (N/T H/F), Pain/Burning (P/B) and Problems Tasting Food/Drink (Prob Tasting F/D) . Items are scored individually on a 0 to 4 scale for severity, frequency and interference. A score of 0 indicates no symptom or interference, while higher score of 4 signify increasing severity, frequency, and interference with daily activities.

ITT Population. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified categories.

Posted

Count of Participants

Participants

Up to approximately 263 weeks

ID	Title	Description
OG000	Belantamab Mafodotin	Participants with relapsed/refractory multiple myeloma (RRMM) received 30 minutes intravenous infusion of 2.5 milligram/kilogram (mg/kg) belantamab mafodotin on day 1 of each 21-day cycle

Secondary

Change From Baseline (CFB) in Ocular Surface Disease Index (OSDI) Total Score

OSDI is 12-item patient-reported outcomes questionnaire designed to provide rapid assessment of range of ocular surface symptoms, including symptoms related to chronic dry eye, severity, and impact on patient's ability to function. In addition to an overall score, there are three subscales of OSDI: ocular symptoms, vision-related function, and environmental triggers. OSDI items are scored on a 0 to 4 Likert-type scale, where 0 = None of the time and 4 = All of the time. Total OSDI score = ([sum of scores for all questions answered×100]/[total number of questions answered×4]). Subscale scores are computed similarly with only questions from each subscale used to generate its own score. Any subscales analyzed separately would also have a maximum possible score of 100. A score of 100=to complete disability, while a score of 0=to no disability. Decrease in score from baseline means improvement

Safety Population. Only participants with data available at specific timepoints have been analyzed.

Posted

Mean

Standard Deviation

Scores on Scale

Baseline (Day 1) and Up to approximately 263 weeks

ID	Title	Description
OG000	Belantamab Mafodotin	Participants with relapsed/refractory multiple myeloma (RRMM) received 30 minutes intravenous infusion of 2.5 milligram/kilogram (mg/kg) belantamab mafodotin on day 1 of each 21-day cycle
OG001	Pomalidomide Plus Dexamethasone

Secondary

Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score.

The EORTC QLQ-C30 includes 30-items with single and multi-item scales. These included five functional scales (physical functioning [PF], role functioning [RF], emotional functioning [EF] cognitive functioning [CF] and social functioning [SF]), three symptom scales (fatigue, nausea/vomiting [N/V] and pain), a global health status (GHS)/ Quality-of-Life (QoL) scale, and six single items (dyspnea, insomnia, appetite loss [AL], constipation, diarrhea and financial difficulties [FD]). Response options are 1 to 4. Scores were averaged and transformed to 0 to 100, a high score for functional scales/ GHS/QoL represent better functioning ability or health-related quality-of-life (HRQoL), whereas a high score for symptom scales/ single items represent significant symptomatology. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.

Posted

Mean

Standard Deviation

Scores on Scale

Baseline (Day 1), every three weeks(Q3W) starting from week 4 until week 238, End of Treatment (~242 weeks) and Follow up (~ 263 weeks)

ID	Title	Description
OG000	Belantamab Mafodotin	Participants with relapsed/refractory multiple myeloma (RRMM) received 30 minutes intravenous infusion of 2.5 milligram/kilogram (mg/kg) belantamab mafodotin on day 1 of each 21-day cycle

Secondary

Change From Baseline (CFB) in EORTC QLQ 20-item Multiple Myeloma Module (MY20) Score

The EORTC QLQ-MY20 is a supplement to the QLQ-C30 instrument used in participants with multiple myeloma. The module comprised of 20 questions that addressed four myeloma-specific HRQoL domains: disease symptoms (DS), side effects of treatment (SET), future perspective (FP) and body image (BI). Responses are 1 to 4. Scores were averaged and scales were transformed to 0 to 100 scale. A high score for disease symptoms and side effects of treatment represented a high level of symptomatology or problems, whereas a high score for future perspective and body image represented better outcomes. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.

ITT Population. Only those participants with data available in specified timepoints have been presented. Rows and Arms/Groups with 0 participants analyzed represent time points at which no participant data was available from within the respective Arms/Groups.

Posted

Mean

Standard Deviation

Scores on Scale

Baseline (Day 1), every three weeks(Q3W) starting from week 4 until week 238, End of Treatment (~242 weeks) and Follow up (~263 weeks)

ID	Title	Description
OG000	Belantamab Mafodotin	Participants with relapsed/refractory multiple myeloma (RRMM) received 30 minutes intravenous infusion of 2.5 milligram/kilogram (mg/kg) belantamab mafodotin on day 1 of each 21-day cycle
OG001	Pomalidomide Plus Dexamethasone

Secondary

Change From Baseline (CFB) in EORTC IL52 Score

European Organization for Research and Treatment of Cancer Item Library 52 (EORTC-QLQ-IL52) is disease symptoms domain from EORTC Quality of Life Questionnaire 20-item Multiple Myeloma module) (EORTC QLQ-MY20). Disease symptoms domain of IL52 contain 6 items covering following concepts: bone aches or pain, back pain, hip pain, arm or shoulder pain, chest pain, and pain increasing with activity. IL52 items are scored on 1 to 4 Likert-type scale, where 1 = Not at all, 2 = A little, 3 = Quite a bit, and 4 = Very much. A raw score is then calculated as mean of completed item responses across 6 disease symptom items. For symptom scales, this raw score is linearly transformed to a 0 to 100 scale using the formula: [(raw score - 1) / 3] × 100. Under this approach, a score of 0 indicates no symptoms across items, while a score of 100 indicates the highest level of symptom burden. Accordingly, higher scores indicate greater symptom burden or worse disease symptoms

Posted

Least Squares Mean

95% Confidence Interval

Scores on Scale

Baseline (Day 1), every three weeks(Q3W) starting from week 4 until week 238

ID	Title	Description
OG000	Belantamab Mafodotin	Participants with relapsed/refractory multiple myeloma (RRMM) received 30 minutes intravenous infusion of 2.5 milligram/kilogram (mg/kg) belantamab mafodotin on day 1 of each 21-day cycle

Secondary

Number of Participants With Minimal Residual Disease (MRD) Negativity Rate

MRD negativity rate is defined as the percentage of participants who are MRD negative by Next generation sequencing (NGS) method. The number of participants with MRD negativity has been presented

ITT Population

Posted

Count of Participants

Participants

Up to approximately 263 weeks

ID	Title	Description
OG000	Belantamab Mafodotin	Participants with relapsed/refractory multiple myeloma (RRMM) received 30 minutes intravenous infusion of 2.5 milligram/kilogram (mg/kg) belantamab mafodotin on day 1 of each 21-day cycle
OG001	Pomalidomide Plus Dexamethasone	Participants with RRMM received 4 mg pomalidomide capsule daily on Days 1 to 21 of each 28-day cycle, along with 40 mg or at lower 20 mg (for participants >75 years of age) dose of dexamethasone tablet once weekly (Days 1, 8, 15 and 22)

Units	Counts
Participants	OG000

Primary

Progression-Free Survival (PFS) Based on Investigator-Assessed Response as Per International Myeloma Working Group (IMWG)

PFS is time from randomization until earliest date of progressive disease (PD), or death due to any cause per investigator-assessed response per IMWG. PD is ≥25% increase from nadir in any of following: serum M-protein (absolute increase ≥0.5 gram per deciliter [g/dL]),urine M-protein(absolute increase ≥200 mg/24hr),difference between involved/uninvolved FLC levels (absolute increase >10 mg/dL) in patients without measurable serum and urine M-protein levels, or bone marrow plasma-cell percentage irrespective of baseline status (absolute increase ≥10%) in patients without measurable serum and urine M-protein levels and without measurable involved FLC levels; appearance of new lesion,≥50% increase in longest diameter of a lesion previously measured >1cm in short axis, or ≥50% increase from nadir in sum of products of two longest perpendicular diameters of more than 1 lesion; ≥50% increase in circulating plasma cells (minimum of 200 cells/microliter) if this is only measure of disease.

Intent-to-treat (ITT) population included all randomized participants whether or not randomized treatment was administered.

Posted

Median

95% Confidence Interval

Months

Up to 27 months

ID	Title	Description
OG000	Belantamab Mafodotin	Participants with relapsed/refractory multiple myeloma (RRMM) received 30 minutes intravenous infusion of 2.5 milligram/kilogram (mg/kg) belantamab mafodotin on day 1 of each 21-day cycle
OG001	Pomalidomide Plus Dexamethasone

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Pneumonia	Infections and infestations	MedDRA v27.1	Systematic Assessment	EG0007 events7 affected217 at risk EG00112 events10 affected102 at risk
COVID-19	Infections and infestations	MedDRA v27.1	Systematic Assessment	EG0005 events5 affected217 at risk EG0014 events4 affected102 at risk
Urinary tract infection	Infections and infestations	MedDRA v27.1	Systematic Assessment	EG0005 events4 affected217 at risk EG0010 events0 affected102 at risk
COVID-19 pneumonia	Infections and infestations	MedDRA v27.1	Systematic Assessment	EG0003 events3 affected217 at risk EG0015 events5 affected102 at risk
Septic shock	Infections and infestations	MedDRA v27.1	Systematic Assessment	EG0003 events3 affected217 at risk EG0011 events1 affected102 at risk
Lower respiratory tract infection	Infections and infestations	MedDRA v27.1	Systematic Assessment	EG0002 events2 affected217 at risk EG0010 events0 affected102 at risk
Osteomyelitis	Infections and infestations	MedDRA v27.1	Systematic Assessment	EG0002 events2 affected217 at risk EG0010 events0 affected102 at risk
Sepsis	Infections and infestations	MedDRA v27.1	Systematic Assessment	EG0002 events2 affected217 at risk EG0013 events3 affected102 at risk
Acute hepatitis B	Infections and infestations	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected217 at risk EG0010 events0 affected102 at risk
Cellulitis	Infections and infestations	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected217 at risk EG0010 events0 affected102 at risk
Meningitis	Infections and infestations	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected217 at risk EG0010 events0 affected102 at risk
Pneumonia influenzal	Infections and infestations	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected217 at risk EG0010 events0 affected102 at risk
Pneumonia pneumococcal	Infections and infestations	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected217 at risk EG0010 events0 affected102 at risk
Postoperative wound infection	Infections and infestations	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected217 at risk EG0010 events0 affected102 at risk
Pseudomembranous colitis	Infections and infestations	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected217 at risk EG0010 events0 affected102 at risk
Respiratory tract infection	Infections and infestations	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected217 at risk EG0012 events2 affected102 at risk
Rhinovirus infection	Infections and infestations	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected217 at risk EG0011 events1 affected102 at risk
Sepsis syndrome	Infections and infestations	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected217 at risk EG0010 events0 affected102 at risk
Spontaneous bacterial peritonitis	Infections and infestations	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected217 at risk EG0010 events0 affected102 at risk
Tooth infection	Infections and infestations	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected217 at risk EG0010 events0 affected102 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected217 at risk EG0010 events0 affected102 at risk
Arthritis infective	Infections and infestations	MedDRA v27.1	Systematic Assessment	EG0000 events0 affected217 at risk EG0011 events1 affected102 at risk
Coronavirus infection	Infections and infestations	MedDRA v27.1	Systematic Assessment	EG0000 events0 affected217 at risk EG0011 events1 affected102 at risk
Cytomegalovirus infection	Infections and infestations	MedDRA v27.1	Systematic Assessment	EG0000 events0 affected217 at risk EG0011 events1 affected102 at risk
Diverticulitis	Infections and infestations	MedDRA v27.1	Systematic Assessment	EG0000 events0 affected217 at risk EG0011 events1 affected102 at risk
Gastroenteritis rotavirus	Infections and infestations	MedDRA v27.1	Systematic Assessment	EG0000 events0 affected217 at risk EG0011 events1 affected102 at risk
Influenza	Infections and infestations	MedDRA v27.1	Systematic Assessment	EG0000 events0 affected217 at risk EG0011 events1 affected102 at risk
Neutropenic sepsis	Infections and infestations	MedDRA v27.1	Systematic Assessment	EG0000 events0 affected217 at risk EG0011 events1 affected102 at risk
Perineal abscess	Infections and infestations	MedDRA v27.1	Systematic Assessment	EG0000 events0 affected217 at risk EG0011 events1 affected102 at risk
Pneumocystis jirovecii pneumonia	Infections and infestations	MedDRA v27.1	Systematic Assessment	EG0000 events0 affected217 at risk EG0011 events1 affected102 at risk
Pulmonary nocardiosis	Infections and infestations	MedDRA v27.1	Systematic Assessment	EG0000 events0 affected217 at risk EG0011 events1 affected102 at risk
Sinusitis	Infections and infestations	MedDRA v27.1	Systematic Assessment	EG0000 events0 affected217 at risk EG0011 events1 affected102 at risk
Staphylococcal bacteraemia	Infections and infestations	MedDRA v27.1	Systematic Assessment	EG0000 events0 affected217 at risk EG0011 events1 affected102 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA v27.1	Systematic Assessment	EG0009 events9 affected217 at risk EG0011 events1 affected102 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA v27.1	Systematic Assessment	EG0008 events6 affected217 at risk EG0011 events1 affected102 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected217 at risk EG0015 events5 affected102 at risk
Lymphadenopathy	Blood and lymphatic system disorders	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected217 at risk EG0010 events0 affected102 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected217 at risk EG0011 events1 affected102 at risk
Myelosuppression	Blood and lymphatic system disorders	MedDRA v27.1	Systematic Assessment	EG0000 events0 affected217 at risk EG0011 events1 affected102 at risk
Pancytopenia	Blood and lymphatic system disorders	MedDRA v27.1	Systematic Assessment	EG0000 events0 affected217 at risk EG0011 events1 affected102 at risk
Infusion related reaction	Injury, poisoning and procedural complications	MedDRA v27.1	Systematic Assessment	EG0004 events4 affected217 at risk EG0010 events0 affected102 at risk
Fall	Injury, poisoning and procedural complications	MedDRA v27.1	Systematic Assessment	EG0003 events3 affected217 at risk EG0010 events0 affected102 at risk
Femur fracture	Injury, poisoning and procedural complications	MedDRA v27.1	Systematic Assessment	EG0003 events3 affected217 at risk EG0010 events0 affected102 at risk
Subdural haematoma	Injury, poisoning and procedural complications	MedDRA v27.1	Systematic Assessment	EG0003 events3 affected217 at risk EG0011 events1 affected102 at risk
Hip fracture	Injury, poisoning and procedural complications	MedDRA v27.1	Systematic Assessment	EG0002 events2 affected217 at risk EG0011 events1 affected102 at risk
Clavicle fracture	Injury, poisoning and procedural complications	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected217 at risk EG0010 events0 affected102 at risk
Concussion	Injury, poisoning and procedural complications	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected217 at risk EG0010 events0 affected102 at risk
Dislocation of vertebra	Injury, poisoning and procedural complications	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected217 at risk EG0010 events0 affected102 at risk
Head injury	Injury, poisoning and procedural complications	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected217 at risk EG0010 events0 affected102 at risk
Road traffic accident	Injury, poisoning and procedural complications	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected217 at risk EG0010 events0 affected102 at risk
Spinal compression fracture	Injury, poisoning and procedural complications	MedDRA v27.1	Systematic Assessment	EG0000 events0 affected217 at risk EG0011 events1 affected102 at risk
Spinal fracture	Injury, poisoning and procedural complications	MedDRA v27.1	Systematic Assessment	EG0000 events0 affected217 at risk EG0011 events1 affected102 at risk
Pathological fracture	Musculoskeletal and connective tissue disorders	MedDRA v27.1	Systematic Assessment	EG0003 events3 affected217 at risk EG0010 events0 affected102 at risk
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA v27.1	Systematic Assessment	EG0002 events2 affected217 at risk EG0010 events0 affected102 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA v27.1	Systematic Assessment	EG0002 events1 affected217 at risk EG0011 events1 affected102 at risk
Myopathy	Musculoskeletal and connective tissue disorders	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected217 at risk EG0010 events0 affected102 at risk
Osteonecrosis	Musculoskeletal and connective tissue disorders	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected217 at risk EG0010 events0 affected102 at risk
Osteonecrosis of jaw	Musculoskeletal and connective tissue disorders	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected217 at risk EG0010 events0 affected102 at risk
Spinal stenosis	Musculoskeletal and connective tissue disorders	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected217 at risk EG0010 events0 affected102 at risk
Vertebral lesion	Musculoskeletal and connective tissue disorders	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected217 at risk EG0010 events0 affected102 at risk
Immobilisation syndrome	Musculoskeletal and connective tissue disorders	MedDRA v27.1	Systematic Assessment	EG0000 events0 affected217 at risk EG0011 events1 affected102 at risk
Joint effusion	Musculoskeletal and connective tissue disorders	MedDRA v27.1	Systematic Assessment	EG0000 events0 affected217 at risk EG0011 events1 affected102 at risk
Spinal cord compression	Nervous system disorders	MedDRA v27.1	Systematic Assessment	EG0003 events3 affected217 at risk EG0010 events0 affected102 at risk
Cerebral haemorrhage	Nervous system disorders	MedDRA v27.1	Systematic Assessment	EG0002 events2 affected217 at risk EG0010 events0 affected102 at risk
Encephalopathy	Nervous system disorders	MedDRA v27.1	Systematic Assessment	EG0002 events2 affected217 at risk EG0010 events0 affected102 at risk
Cauda equina syndrome	Nervous system disorders	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected217 at risk EG0010 events0 affected102 at risk
Epilepsy	Nervous system disorders	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected217 at risk EG0010 events0 affected102 at risk
Haemorrhagic stroke	Nervous system disorders	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected217 at risk EG0010 events0 affected102 at risk
Hyperammonaemic encephalopathy	Nervous system disorders	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected217 at risk EG0010 events0 affected102 at risk
Peripheral motor neuropathy	Nervous system disorders	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected217 at risk EG0010 events0 affected102 at risk
Radicular pain	Nervous system disorders	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected217 at risk EG0010 events0 affected102 at risk
Transient global amnesia	Nervous system disorders	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected217 at risk EG0010 events0 affected102 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected217 at risk EG0010 events0 affected102 at risk
Atrial fibrillation	Cardiac disorders	MedDRA v27.1	Systematic Assessment	EG0003 events3 affected217 at risk EG0010 events0 affected102 at risk
Cardiac failure	Cardiac disorders	MedDRA v27.1	Systematic Assessment	EG0002 events2 affected217 at risk EG0011 events1 affected102 at risk
Angina pectoris	Cardiac disorders	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected217 at risk EG0010 events0 affected102 at risk
Cardio-respiratory arrest	Cardiac disorders	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected217 at risk EG0010 events0 affected102 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA v27.1	Systematic Assessment	EG0000 events0 affected217 at risk EG0011 events1 affected102 at risk
Cardiac arrest	Cardiac disorders	MedDRA v27.1	Systematic Assessment	EG0000 events0 affected217 at risk EG0011 events1 affected102 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA v27.1	Systematic Assessment	EG0000 events0 affected217 at risk EG0011 events1 affected102 at risk
Plasma cell myeloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v27.1	Systematic Assessment	EG0002 events2 affected217 at risk EG0010 events0 affected102 at risk
Acute myeloid leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected217 at risk EG0011 events1 affected102 at risk
Bone neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected217 at risk EG0010 events0 affected102 at risk
Malignant melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected217 at risk EG0010 events0 affected102 at risk
Renal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected217 at risk EG0010 events0 affected102 at risk
Transitional cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected217 at risk EG0010 events0 affected102 at risk
Bowen's disease	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v27.1	Systematic Assessment	EG0000 events0 affected217 at risk EG0011 events1 affected102 at risk
Breast cancer stage I	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v27.1	Systematic Assessment	EG0000 events0 affected217 at risk EG0011 events1 affected102 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA v27.1	Systematic Assessment	EG0003 events2 affected217 at risk EG0010 events0 affected102 at risk
Vomiting	Gastrointestinal disorders	MedDRA v27.1	Systematic Assessment	EG0002 events2 affected217 at risk EG0010 events0 affected102 at risk
Abdominal compartment syndrome	Gastrointestinal disorders	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected217 at risk EG0010 events0 affected102 at risk
Colitis	Gastrointestinal disorders	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected217 at risk EG0010 events0 affected102 at risk
Gastric haemorrhage	Gastrointestinal disorders	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected217 at risk EG0010 events0 affected102 at risk
Haematochezia	Gastrointestinal disorders	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected217 at risk EG0010 events0 affected102 at risk
Small intestinal haemorrhage	Gastrointestinal disorders	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected217 at risk EG0010 events0 affected102 at risk
Inguinal hernia	Gastrointestinal disorders	MedDRA v27.1	Systematic Assessment	EG0000 events0 affected217 at risk EG0011 events1 affected102 at risk
Pyrexia	General disorders	MedDRA v27.1	Systematic Assessment	EG00010 events8 affected217 at risk EG0010 events0 affected102 at risk
Platelet count decreased	Investigations	MedDRA v27.1	Systematic Assessment	EG0004 events4 affected217 at risk EG0010 events0 affected102 at risk
Neutrophil count decreased	Investigations	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected217 at risk EG0011 events1 affected102 at risk
Alanine aminotransferase increased	Investigations	MedDRA v27.1	Systematic Assessment	EG0000 events0 affected217 at risk EG0011 events1 affected102 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA v27.1	Systematic Assessment	EG0002 events2 affected217 at risk EG0010 events0 affected102 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected217 at risk EG0010 events0 affected102 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected217 at risk EG0010 events0 affected102 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected217 at risk EG0010 events0 affected102 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected217 at risk EG0010 events0 affected102 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA v27.1	Systematic Assessment	EG0002 events2 affected217 at risk EG0010 events0 affected102 at risk
Haematuria	Renal and urinary disorders	MedDRA v27.1	Systematic Assessment	EG0002 events2 affected217 at risk EG0010 events0 affected102 at risk
Renal failure	Renal and urinary disorders	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected217 at risk EG0010 events0 affected102 at risk
Hypercalcaemia	Metabolism and nutrition disorders	MedDRA v27.1	Systematic Assessment	EG0002 events2 affected217 at risk EG0010 events0 affected102 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected217 at risk EG0010 events0 affected102 at risk
Deep vein thrombosis	Vascular disorders	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected217 at risk EG0010 events0 affected102 at risk
Hypertensive crisis	Vascular disorders	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected217 at risk EG0010 events0 affected102 at risk
Shock haemorrhagic	Vascular disorders	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected217 at risk EG0010 events0 affected102 at risk
Adrenal insufficiency	Endocrine disorders	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected217 at risk EG0010 events0 affected102 at risk
Cholecystitis acute	Hepatobiliary disorders	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected217 at risk EG0010 events0 affected102 at risk
Cytokine release syndrome	Immune system disorders	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected217 at risk EG0010 events0 affected102 at risk
Device extrusion	Product Issues	MedDRA v27.1	Systematic Assessment	EG0000 events0 affected217 at risk EG0011 events1 affected102 at risk
Confusional state	Psychiatric disorders	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected217 at risk EG0010 events0 affected102 at risk
Angioedema	Skin and subcutaneous tissue disorders	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected217 at risk EG0010 events0 affected102 at risk
Loss of personal independence in daily activities	Social circumstances	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected217 at risk EG0010 events0 affected102 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA v27.1	Systematic Assessment	EG000113 events72 affected217 at risk EG00183 events35 affected102 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA v27.1	Systematic Assessment	EG00080 events63 affected217 at risk EG00150 events35 affected102 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA v27.1	Systematic Assessment	EG00064 events27 affected217 at risk EG001107 events41 affected102 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA v27.1	Systematic Assessment	EG00014 events9 affected217 at risk EG00138 events10 affected102 at risk
Lymphopenia	Blood and lymphatic system disorders	MedDRA v27.1	Systematic Assessment	EG0009 events6 affected217 at risk EG00136 events8 affected102 at risk
Vision blurred	Eye disorders	MedDRA v27.1	Systematic Assessment	EG000370 events105 affected217 at risk EG0017 events7 affected102 at risk
Dry eye	Eye disorders	MedDRA v27.1	Systematic Assessment	EG000204 events82 affected217 at risk EG0013 events3 affected102 at risk
Foreign body sensation in eyes	Eye disorders	MedDRA v27.1	Systematic Assessment	EG000259 events80 affected217 at risk EG0015 events5 affected102 at risk
Eye irritation	Eye disorders	MedDRA v27.1	Systematic Assessment	EG000159 events63 affected217 at risk EG0015 events3 affected102 at risk
Photophobia	Eye disorders	MedDRA v27.1	Systematic Assessment	EG000152 events63 affected217 at risk EG0014 events4 affected102 at risk
Eye pain	Eye disorders	MedDRA v27.1	Systematic Assessment	EG000124 events49 affected217 at risk EG0010 events0 affected102 at risk
Visual acuity reduced	Eye disorders	MedDRA v27.1	Systematic Assessment	EG00085 events40 affected217 at risk EG0011 events1 affected102 at risk
Keratopathy	Eye disorders	MedDRA v27.1	Systematic Assessment	EG00024 events22 affected217 at risk EG0011 events1 affected102 at risk
Punctate keratitis	Eye disorders	MedDRA v27.1	Systematic Assessment	EG00039 events22 affected217 at risk EG0010 events0 affected102 at risk
Visual impairment	Eye disorders	MedDRA v27.1	Systematic Assessment	EG00023 events15 affected217 at risk EG0010 events0 affected102 at risk
Cataract	Eye disorders	MedDRA v27.1	Systematic Assessment	EG00016 events14 affected217 at risk EG0016 events5 affected102 at risk
Keratitis	Eye disorders	MedDRA v27.1	Systematic Assessment	EG00015 events13 affected217 at risk EG0010 events0 affected102 at risk
Lacrimation increased	Eye disorders	MedDRA v27.1	Systematic Assessment	EG00021 events13 affected217 at risk EG0010 events0 affected102 at risk
Aspartate aminotransferase increased	Investigations	MedDRA v27.1	Systematic Assessment	EG00043 events36 affected217 at risk EG00110 events6 affected102 at risk
Blood lactate dehydrogenase increased	Investigations	MedDRA v27.1	Systematic Assessment	EG00048 events35 affected217 at risk EG0011 events1 affected102 at risk
Platelet count decreased	Investigations	MedDRA v27.1	Systematic Assessment	EG00042 events32 affected217 at risk EG00126 events13 affected102 at risk
Gamma-glutamyltransferase increased	Investigations	MedDRA v27.1	Systematic Assessment	EG00034 events30 affected217 at risk EG0016 events6 affected102 at risk
Alanine aminotransferase increased	Investigations	MedDRA v27.1	Systematic Assessment	EG00024 events19 affected217 at risk EG00121 events9 affected102 at risk
Neutrophil count decreased	Investigations	MedDRA v27.1	Systematic Assessment	EG00044 events19 affected217 at risk EG00182 events15 affected102 at risk
White blood cell count decreased	Investigations	MedDRA v27.1	Systematic Assessment	EG00028 events14 affected217 at risk EG00148 events11 affected102 at risk
Blood creatinine increased	Investigations	MedDRA v27.1	Systematic Assessment	EG00017 events13 affected217 at risk EG0019 events6 affected102 at risk
Blood alkaline phosphatase increased	Investigations	MedDRA v27.1	Systematic Assessment	EG00016 events12 affected217 at risk EG0014 events2 affected102 at risk
Lymphocyte count decreased	Investigations	MedDRA v27.1	Systematic Assessment	EG00021 events11 affected217 at risk EG00126 events9 affected102 at risk
Pyrexia	General disorders	MedDRA v27.1	Systematic Assessment	EG00061 events39 affected217 at risk EG00117 events14 affected102 at risk
Fatigue	General disorders	MedDRA v27.1	Systematic Assessment	EG00027 events23 affected217 at risk EG00115 events15 affected102 at risk
Chills	General disorders	MedDRA v27.1	Systematic Assessment	EG00017 events14 affected217 at risk EG0012 events2 affected102 at risk
Asthenia	General disorders	MedDRA v27.1	Systematic Assessment	EG00011 events10 affected217 at risk EG0017 events6 affected102 at risk
Oedema peripheral	General disorders	MedDRA v27.1	Systematic Assessment	EG0009 events8 affected217 at risk EG00114 events12 affected102 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA v27.1	Systematic Assessment	EG00035 events29 affected217 at risk EG00115 events12 affected102 at risk
Nausea	Gastrointestinal disorders	MedDRA v27.1	Systematic Assessment	EG00038 events25 affected217 at risk EG0017 events5 affected102 at risk
Vomiting	Gastrointestinal disorders	MedDRA v27.1	Systematic Assessment	EG00028 events17 affected217 at risk EG0012 events2 affected102 at risk
Constipation	Gastrointestinal disorders	MedDRA v27.1	Systematic Assessment	EG00015 events13 affected217 at risk EG00113 events10 affected102 at risk
COVID-19	Infections and infestations	MedDRA v27.1	Systematic Assessment	EG00036 events33 affected217 at risk EG00116 events13 affected102 at risk
Urinary tract infection	Infections and infestations	MedDRA v27.1	Systematic Assessment	EG00018 events13 affected217 at risk EG0012 events2 affected102 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA v27.1	Systematic Assessment	EG00016 events10 affected217 at risk EG0016 events6 affected102 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA v27.1	Systematic Assessment	EG00025 events20 affected217 at risk EG0019 events9 affected102 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA v27.1	Systematic Assessment	EG00021 events16 affected217 at risk EG00111 events10 affected102 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA v27.1	Systematic Assessment	EG00018 events16 affected217 at risk EG0017 events7 affected102 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA v27.1	Systematic Assessment	EG00013 events12 affected217 at risk EG0012 events2 affected102 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA v27.1	Systematic Assessment	EG00011 events9 affected217 at risk EG00114 events8 affected102 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA v27.1	Systematic Assessment	EG00019 events17 affected217 at risk EG0019 events4 affected102 at risk
Hypercalcaemia	Metabolism and nutrition disorders	MedDRA v27.1	Systematic Assessment	EG00012 events11 affected217 at risk EG0012 events2 affected102 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA v27.1	Systematic Assessment	EG0008 events7 affected217 at risk EG0019 events8 affected102 at risk
Insomnia	Psychiatric disorders	MedDRA v27.1	Systematic Assessment	EG00012 events12 affected217 at risk EG0017 events7 affected102 at risk
Hypertension	Vascular disorders	MedDRA v27.1	Systematic Assessment	EG00014 events14 affected217 at risk EG0013 events3 affected102 at risk
Infusion related reaction	Injury, poisoning and procedural complications	MedDRA v27.1	Systematic Assessment	EG00025 events15 affected217 at risk EG0011 events1 affected102 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA v27.1	Systematic Assessment	EG0007 events7 affected217 at risk EG00110 events7 affected102 at risk
Hepatic function abnormal	Hepatobiliary disorders	MedDRA v27.1	Systematic Assessment	EG00019 events13 affected217 at risk EG0010 events0 affected102 at risk

ID	Term
D054219	Neoplasms, Plasma Cell
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D020141	Hemostatic Disorders
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D010265	Paraproteinemias
D001796	Blood Protein Disorders
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases
D006474	Hemorrhagic Disorders
D008232	Lymphoproliferative Disorders
D007160	Immunoproliferative Disorders
D007154	Immune System Diseases

ID	Term
D011246	Pregnadienetriols
D011245	Pregnadienes
D011278	Pregnanes
D013256	Steroids
D000072473	Fused-Ring Compounds
D011083	Polycyclic Compounds
D013259	Steroids, Fluorinated

ID	Title	Description
BG000	Belantamab Mafodotin	Participants with relapsed/refractory multiple myeloma (RRMM) received 30 minutes intravenous infusion of 2.5 milligram/kilogram (mg/kg) belantamab mafodotin on day 1 of each 21-day cycle
BG001	Pomalidomide Plus Dexamethasone	Participants with RRMM received 4 mg pomalidomide capsule daily on Days 1 to 21 of each 28-day cycle, along with 40 mg or at lower 20 mg (for participants >75 years of age) dose of dexamethasone tablet once weekly (Days 1, 8, 15 and 22)
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Belantamab Mafodotin	Participants with relapsed/refractory multiple myeloma (RRMM) received 30 minutes intravenous infusion of 2.5 milligram/kilogram (mg/kg) belantamab mafodotin on day 1 of each 21-day cycle	139	217	101	217	205	217
EG001	Pomalidomide Plus Dexamethasone	Participants with RRMM received 4 mg pomalidomide capsule daily on Days 1 to 21 of each 28-day cycle, along with 40 mg or at lower 20 mg (for participants >75 years of age) dose of dexamethasone tablet once weekly (Days 1, 8, 15 and 22)	71	102	45	102	93	102

ID	Term
C000631691	belantamab mafodotin
C467566	pomalidomide
D003907	Dexamethasone