A Study of Belantamab Mafodotin Monotherapy in Multiple M... | NCT04398745

Label	Type	Description	Intervention Names
Part 1: Participants with normal/mild impaired renal function	Experimental	Participants with normal or mildly impaired renal function (Normal: individual glomerular filtration rate [iGFR]: >=90 milliliter per minute; Mild impairment: iGFR: 60-89 mL/min will be administered with belantamab mafodotin 2.5 mg/kg as an intravenous infusion over 30 minutes Q3W on Day 1 of every 21- day cycle until confirmed disease progression, death, unacceptable toxicity, withdrawal of consent, or end of study, whichever occurs first.	Drug: Belantamab mafodotin
Part 1: Participants with severe renal impairment	Experimental	Participants with severely impaired renal function (iGFR: 15-29 mL/min) will be administered with belantamab mafodotin 2.5 mg/kg as an intravenous infusion over 30 minutes Q3W on Day 1 of every 21- day cycle until confirmed disease progression, death, unacceptable toxicity, withdrawal of consent, or end of study, whichever occurs first.	Drug: Belantamab mafodotin
Part 2: Participants with ESRD (not on dialysis)	Experimental	Participants with ESRD (iGFR: <15 mL/min) not on dialysis will be administered with belantamab mafodotin either 2.5 mg/kg or 1.9 mg/kg (or other adjusted dose) as an intravenous infusion over 30 minutes Q3W on Day 1 of every 21- day cycle until confirmed disease progression, death, unacceptable toxicity, withdrawal of consent, or end of study, whichever occurs first. In Part 2, the dose will be decided after evaluation of pharmacokinetic and safety data of Part 1.	Drug: Belantamab mafodotin
Part 2: Participants with ESRD (on hemodialysis)

Name	Type	Description	Arm Group Labels	Other Names
Belantamab mafodotin	Drug	Belantamab mafodotin will be provided as lyophilized powder which will be available as 100 milligrams per vial (mg/vial) in single-use vial for reconstitution. Lyophilized belantamab mafodotin will reconstituted using water for injection, dilute with normal 0.9 % saline before use.

Measure	Description	Time Frame
Part 1: Area Under the Concentration-time Curve to Last Quantifiable Timepoint (AUC(0-tlast)) Following Administration of Belantamab Mafodotin (Antibody-drug Conjugate (ADC))	Blood samples were collected for PK analysis of belantamab mafodotin ADC. As pre-specified in protocol, only specified treatment arms were planned to be analyzed for this outcome measure. As first dose of belantamab mafodotin was administered on Day 1, cycle length correlates to Day 1 plus 21 days i.e., Day 22 in timeframe. Only those participants who were measured and analyzed (i.e., contributed to data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified timepoints.	Pre-dose, end of infusion (EOI), start of infusion (SOI)+2hour (h), SOI+4h, SOI+8h and SOI+24h on Cycle(C) 1 Day(D) 1 and C3D1; Anytime on C1 D4, D8, D15, D22; Anytime on C3 D4, D8, D15, D22; Pre-dose on C2D1 and C4D1.
Part 1: Area Under the Concentration-time Curve During the Dosing Interval (AUC(0-tau)) Following Administration of Belantamab Mafodotin (ADC)	Blood samples were collected for PK analysis of belantamab mafodotin ADC. As pre-specified in protocol, only specified treatment arms were planned to be analyzed for this outcome measure. As first dose of belantamab mafodotin was administered on Day 1, cycle length correlates to Day 1 plus 21 days i.e., Day 22 in timeframe.	Pre-dose, end of infusion (EOI), start of infusion (SOI)+2hour (h), SOI+4h, SOI+8h and SOI+24h on Cycle(C) 1 Day(D) 1 and C3D1; Anytime on C1 D4, D8, D15, D22; Anytime on C3 D4, D8, D15, D22; Pre-dose on C2D1 and C4D1.
Part 1: Observed Plasma Concentration at the End of Infusion (C-EOI) Following Administration of Belantamab Mafodotin (ADC)	Blood samples were collected for PK analysis of belantamab mafodotin ADC. As pre-specified in protocol, only specified treatment arms were planned to be analyzed for this outcome measure.	End of infusion on C1D1 and C3D1
Part 1: Maximum Observed Concentration (Cmax) Following Administration of Belantamab Mafodotin (ADC)

Measure	Description	Time Frame
Part 1 and Part 2: Change From Baseline (CFB) in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)	Blood pressures (DBP and SBP) were measured after resting for at least 5 minutes in a supine or semi-recumbent position. Baseline (Day 1) was defined as latest pre-dose assessment with a non-missing value, including unscheduled visits. Change from Baseline was calculated as post-dose visit value minus Baseline value. The "0" participants analyzed represents that data was not collected or available for analysis at that particular time point for the respective Arms/Groups.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Participants are capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the Informed Consent Form.
Male and/or female participants must be 18 years of age or older, at the time of signing the informed consent. In Republic of Korea, participants must be 19 years of age or older at the time of signing informed consent.
Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
Participants with histologically or cytologically confirmed diagnosis of MM, as defined in International Myeloma Working Group criteria: 1. Has undergone autologous stem cell transplant (SCT) or is considered transplant-ineligible; 2. Has failed at least 2 prior lines of anti-myeloma treatments, including an immunomodulatory drug (example [e.g.], lenalidomide or pomalidomide) and a proteasome inhibitor (e.g., bortezomib, ixazomib or carfilzomib). In Republic of Korea, participants should also have relapsed or refractory disease after treatment with an anti-CD38 antibody, if accessible to patients, or other suitable local standard of care.
Participants have measurable disease with at least one of the following: Serum M-protein >=0.5 grams per deciliter (g/dL) (>=5 grams per liter [g/L]); Urine M-protein >=200 milligrams (mg) per 24 hours (mg/24 h); and Serum free light chain (FLC) assay: Involved FLC level >=10 milligrams per deciliter (mg/dL) (>=100 milligrams per liter [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: 1. Transplant was >100 days prior to study enrollment, 2. No active infection(s), and 3. Participant meets the remainder of the eligibility criteria outlined in this protocol.
Participants with adequate organ system functions as defined follows: Absolute neutrophil count >=1.0 x 10^9 per liter (/L); Hemoglobin >=7.0 g/dL or 4.9 millimoles per liter (mmol/L); Platelets >= 50 x 10^9/L; Total bilirubin <=1.5 x Upper limit of normal (ULN) (Isolated bilirubin >=1.5 x ULN is acceptable if bilirubin is fractionated and direct bilirubin <35 percent [%]); Alanine aminotransferase <=2.5 x ULN; iGFR, Group 1: normal/ mildly impaired >=60milliliter per minute (mL/min); Group 2: severe 15-29 mL/min; Group 3: ESRD (not on dialysis) <15 mL/min; Group 4: ESRD (on dialysis) <15 mL/min; and left ventricular ejection fraction by echocardiograms >=40%.
Main additional inclusion criteria in Group 1 (matched control participants): Matched to at least one severely renal impaired participant by Baseline body weight (+/-20%) and Baseline albumin levels (+/-10%).
Female participants: Contraceptive use by women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. 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 using a contraceptive method that is highly effective (with a failure rate of <1% per year), preferably with low user dependency, during the intervention period and for at least 4 months after the last dose of study intervention and agrees not to donate eggs (ova, oocytes) for the purpose of reproduction during this period. The investigator should evaluate the effectiveness of the contraceptive method in relationship to the first dose of study intervention. A WOCBP must have a negative highly sensitive serum pregnancy test within 72 hours of dosing on Cycle 1 Day 1 and agree to use highly effective contraception during the study and for 4 months after the last dose of study medication. The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy.
Male participants: Contraceptive use by men 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 from the time of first dose of study until 6 months after the last dose of study treatment to allow for clearance of any altered sperm: Refrain from donating sperm and 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 a male condom even if they have undergone a successful vasectomy and female partner to use an additional highly effective contraceptive method with a failure rate of <1% per year as when having sexual intercourse with a WOCBP (including pregnant females).

Exclusion Criteria:

Participants with active plasma cell leukemia at the time of screening. Symptomatic amyloidosis, active POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, myeloma protein and skin changes), Waldenstroem Macroglobulinemia
Participants had a prior allogeneic stem cell transplant. . Participants who have undergone a syngeneic bone marrow transplant will be allowed only if there is no history of, or no currently active graft-versus-host-diseases (GvHD).
Participant has received an investigational drug within 14 days or 5 half-lives whichever is shorter, preceding the first dose of study drug. This includes prior treatment with a monoclonal antibody. The only exception is emergency use of a short course of systemic corticosteroids (equivalent to, or less than: dexamethasone 40 milligrams per day [mg/day] for a maximum of 4 days) before treatment.
Prior belantamab mafodotin therapy.
Participant has received a strong Organic-anion transporting polypeptide inhibitor within 14 days or 5 half-lives, whichever is shorter, preceding the first dose of study drug.
Systemic active infection requiring treatment.
Any unresolved toxicity >=Grade 2 from previous treatment except for alopecia, or peripheral neuropathy up to Grade 2.
Plasmapheresis within 7 days prior to the first dose of study drug. Screening laboratory values must be performed after last plasmapheresis.
Any major surgery within the last 4 weeks prior to Day 1 of Screening.
Any serious and/or unstable pre-existing medical, psychiatric disorder or other conditions (including lab abnormalities except renal impairment) that could interfere with participant's safety, obtaining informed consent or compliance to the study procedures.
Evidence of active mucosal or internal bleeding.
Current unstable liver or biliary disease per investigator assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, 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 MM are excluded, unless the prior 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 untreated arrhythmias, including clinically significant electrocardiogram abnormalities such as second degree (Mobitz Type II) or third degree atrioventricular block; History of myocardial infarction (within prior 18 months), 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 functional classification system and uncontrolled hypertension.
Known immediate or delayed hypersensitivity reaction or idiosyncratic reaction to drugs chemically related to belantamab mafodotin, or any of the components of the study treatment.
Known human immunodeficiency virus infection, 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 prior to first dose; CD4+ T-cell (CD4+) counts ≥350 cells/ L and no history of AIDS-defining opportunistic infections within the last 12 months
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. Participants with cirrhosis are excluded.
Positive hepatitis C antibody test result or positive hepatitis C ribonucleic acid test result at Screening or within 3 months prior to first dose of study treatment unless the participant can meet the following criteria: RNA test negative 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 prior to first dose.
Participants with renal impairment due to hepatic disease (hepatorenal syndrome).
Current corneal epithelial disease except for mild punctuate keratopathy.
Participant is a woman who is pregnant or breastfeeding.

Name	Affiliation	Role
GSK Clinical Trials	GlaxoSmithKline	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
GSK Investigational Site		Athens		10676	Greece
GSK Investigational Site

ID	Title	Description
FG000	Part 1: Belantamab Mafodotin 2.5 mg/kg (Normal/Mildly Impaired Renal Function)	Participants with Relapsed/Refractory Multiple Myeloma (RRMM) who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and normal/mildly impaired renal function received intravenous (IV) infusion of 2.5 milligram (mg)/kilogram (kg) belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to adverse event (AE), lost to follow-up, death, whichever occurs first.

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Jun 15, 2022	Apr 17, 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

Primary

Part 1: Area Under the Concentration-time Curve to Last Quantifiable Timepoint (AUC(0-tlast)) Following Administration of Belantamab Mafodotin (Antibody-drug Conjugate (ADC))

Blood samples were collected for PK analysis of belantamab mafodotin ADC. As pre-specified in protocol, only specified treatment arms were planned to be analyzed for this outcome measure. As first dose of belantamab mafodotin was administered on Day 1, cycle length correlates to Day 1 plus 21 days i.e., Day 22 in timeframe. Only those participants who were measured and analyzed (i.e., contributed to data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified timepoints.

Pharmacokinetic Evaluable population included all participants in the safety analysis set who had at least 80% non-missing expected plasma PK data during the Cycle 1 profile (i.e., all Cycle 1 timepoints and Cycle 2 Day 1 pre-dose). 'Cycle 1' and 'Cycle 3' include the full first and third cycles, along with Day 1 of Cycle 2 (C2D1) and Cycle 4 (C4D1) Predose periods, respectively.

Posted

Geometric Mean

Geometric Coefficient of Variation

hour*microgram/millitre(h*ug/mL)

Pre-dose, end of infusion (EOI), start of infusion (SOI)+2hour (h), SOI+4h, SOI+8h and SOI+24h on Cycle(C) 1 Day(D) 1 and C3D1; Anytime on C1 D4, D8, D15, D22; Anytime on C3 D4, D8, D15, D22; Pre-dose on C2D1 and C4D1.

ID	Title	Description
OG000	Part 1: Belantamab Mafodotin 2.5 mg/kg (Normal/Mildly Impaired Renal Function)	Participants with Relapsed/Refractory Multiple Myeloma (RRMM) who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and normal/mildly impaired renal function received intravenous (IV) infusion of 2.5 milligram (mg)/kilogram (kg) belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to adverse event (AE), lost to follow-up, death, whichever occurs first.
OG001	Part 1: Belantamab Mafodotin 2.5 mg/kg (Severely Impaired Renal Function)	Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and severe renal impairment renal function received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.

Units	Counts
Participants	OG0008 OG0018

Title

Denominators

Categories

Cycle 1

- ParticipantsOG0008
- ParticipantsOG0018

Title	Measurements
	OG0004021.3± 54.3

Primary

Part 1: Area Under the Concentration-time Curve During the Dosing Interval (AUC(0-tau)) Following Administration of Belantamab Mafodotin (ADC)

Pharmacokinetic Evaluable population. 'Cycle 1' and 'Cycle 3' include the full first and third cycles, along with the Day 1 of Cycle 2 (C2D1) and Cycle 4 (C4D1) Predose periods, respectively. Only those participants who were measured and analyzed (i.e., contributed to data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified timepoints.

Posted

Geometric Mean

Geometric Coefficient of Variation

h*ug/mL

ID	Title	Description
OG000	Part 1: Belantamab Mafodotin 2.5 mg/kg (Normal/Mildly Impaired Renal Function)	Participants with Relapsed/Refractory Multiple Myeloma (RRMM) who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and normal/mildly impaired renal function received intravenous (IV) infusion of 2.5 milligram (mg)/kilogram (kg) belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to adverse event (AE), lost to follow-up, death, whichever occurs first.

Primary

Part 1: Observed Plasma Concentration at the End of Infusion (C-EOI) Following Administration of Belantamab Mafodotin (ADC)

Blood samples were collected for PK analysis of belantamab mafodotin ADC. As pre-specified in protocol, only specified treatment arms were planned to be analyzed for this outcome measure.

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

Posted

Geometric Mean

Geometric Coefficient of Variation

ug/mL

End of infusion on C1D1 and C3D1

ID	Title	Description
OG000	Part 1: Belantamab Mafodotin 2.5 mg/kg (Normal/Mildly Impaired Renal Function)	Participants with Relapsed/Refractory Multiple Myeloma (RRMM) who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and normal/mildly impaired renal function received intravenous (IV) infusion of 2.5 milligram (mg)/kilogram (kg) belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to adverse event (AE), lost to follow-up, death, whichever occurs first.
OG001	Part 1: Belantamab Mafodotin 2.5 mg/kg (Severely Impaired Renal Function)	Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and severe renal impairment renal function received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.

Primary

Part 1: Maximum Observed Concentration (Cmax) Following Administration of Belantamab Mafodotin (ADC)

Posted

Geometric Mean

Geometric Coefficient of Variation

ug/mL

ID	Title	Description
OG000	Part 1: Belantamab Mafodotin 2.5 mg/kg (Normal/Mildly Impaired Renal Function)	Participants with Relapsed/Refractory Multiple Myeloma (RRMM) who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and normal/mildly impaired renal function received intravenous (IV) infusion of 2.5 milligram (mg)/kilogram (kg) belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to adverse event (AE), lost to follow-up, death, whichever occurs first.

Primary

Part 1: Time to Reach Cmax (Tmax) Following Administration of Belantamab Mafodotin (ADC)

Posted

Median

Full Range

Hour

ID	Title	Description
OG000	Part 1: Belantamab Mafodotin 2.5 mg/kg (Normal/Mildly Impaired Renal Function)	Participants with Relapsed/Refractory Multiple Myeloma (RRMM) who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and normal/mildly impaired renal function received intravenous (IV) infusion of 2.5 milligram (mg)/kilogram (kg) belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to adverse event (AE), lost to follow-up, death, whichever occurs first.

Primary

Part 1: Trough Concentration Prior to the Next Dose for Each Cycle (Ctrough) Following Administration of Belantamab Mafodotin (ADC)

Posted

Geometric Mean

Geometric Coefficient of Variation

ug/mL

ID	Title	Description
OG000	Part 1: Belantamab Mafodotin 2.5 mg/kg (Normal/Mildly Impaired Renal Function)	Participants with Relapsed/Refractory Multiple Myeloma (RRMM) who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and normal/mildly impaired renal function received intravenous (IV) infusion of 2.5 milligram (mg)/kilogram (kg) belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to adverse event (AE), lost to follow-up, death, whichever occurs first.

Primary

Part 1: Time of Last Observed Quantifiable Concentration (Tlast) Following Administration of Belantamab Mafodotin (ADC)

Blood samples were collected for PK analysis of belantamab mafodotin ADC. As pre-specified in protocol, only specified treatment arms were planned to be analyzed for this outcome measure. As first dose of belantamab mafodotin was administered on Day 1, cycle length correlates to Day 1 plus 21 days i.e., Day 22 in timeframe. For some participants, dosing in Cycle 2 or Cycle 4 was delayed, resulting in the pre-dose samples in these cycles (C2D1 or C4D1) being collected later than the protocol-defined planned days after dosing in C1D1 or C3D1. Consequently, the last PK samples for these participants were collected outside the pre-defined protocol time points, and certain Tlast values in the data table extend beyond the original protocol-defined Time Frame.

Posted

Median

Full Range

Hour

ID	Title	Description
OG000	Part 1: Belantamab Mafodotin 2.5 mg/kg (Normal/Mildly Impaired Renal Function)

Primary

Part 1: Area Under the Concentration-time Curve to Last Quantifiable Timepoint (AUC(0-tlast)) Following Administration of Belantamab Mafodotin (Total Antibody)

Posted

Geometric Mean

Geometric Coefficient of Variation

h*ug/mL

ID	Title	Description
OG000	Part 1: Belantamab Mafodotin 2.5 mg/kg (Normal/Mildly Impaired Renal Function)	Participants with Relapsed/Refractory Multiple Myeloma (RRMM) who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and normal/mildly impaired renal function received intravenous (IV) infusion of 2.5 milligram (mg)/kilogram (kg) belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to adverse event (AE), lost to follow-up, death, whichever occurs first.

Primary

Part 1: Area Under the Concentration-time Curve During the Dosing Interval (AUC(0-tau)) Following Administration of Belantamab Mafodotin (Total Antibody)

Blood samples were collected for PK analysis of belantamab mafodotin total Antibody. As pre-specified in protocol, only specified treatment arms were planned to be analyzed for this outcome measure. As first dose of belantamab mafodotin was administered on Day 1, cycle length correlates to Day 1 plus 21 days i.e., Day 22 in timeframe.

Posted

Geometric Mean

Geometric Coefficient of Variation

h*ug/mL

ID	Title	Description
OG000	Part 1: Belantamab Mafodotin 2.5 mg/kg (Normal/Mildly Impaired Renal Function)	Participants with Relapsed/Refractory Multiple Myeloma (RRMM) who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and normal/mildly impaired renal function received intravenous (IV) infusion of 2.5 milligram (mg)/kilogram (kg) belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to adverse event (AE), lost to follow-up, death, whichever occurs first.

Primary

Part 1: Observed Plasma Concentration at the End of Infusion (C-EOI) Following Administration of Belantamab Mafodotin (Total Antibody)

Blood samples were collected for PK analysis of belantamab mafodotin Total Antibody. As pre-specified in protocol, only specified treatment arms were planned to be analyzed for this outcome measure.

Posted

Geometric Mean

Geometric Coefficient of Variation

ug/mL

End of infusion on C1D1 and C3D1

ID	Title	Description
OG000	Part 1: Belantamab Mafodotin 2.5 mg/kg (Normal/Mildly Impaired Renal Function)	Participants with Relapsed/Refractory Multiple Myeloma (RRMM) who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and normal/mildly impaired renal function received intravenous (IV) infusion of 2.5 milligram (mg)/kilogram (kg) belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to adverse event (AE), lost to follow-up, death, whichever occurs first.
OG001	Part 1: Belantamab Mafodotin 2.5 mg/kg (Severely Impaired Renal Function)	Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and severe renal impairment renal function received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.

Primary

Part 1: Maximum Observed Concentration (Cmax) Following Administration of Belantamab Mafodotin (Total Antibody)

Posted

Geometric Mean

Geometric Coefficient of Variation

ug/mL

ID	Title	Description
OG000	Part 1: Belantamab Mafodotin 2.5 mg/kg (Normal/Mildly Impaired Renal Function)	Participants with Relapsed/Refractory Multiple Myeloma (RRMM) who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and normal/mildly impaired renal function received intravenous (IV) infusion of 2.5 milligram (mg)/kilogram (kg) belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to adverse event (AE), lost to follow-up, death, whichever occurs first.

Primary

Part 1: Time to Reach Cmax (Tmax) Following Administration of Belantamab Mafodotin (Total Antibody)

Blood samples were collected for PK analysis of belantamab mafodotin total antibody. As pre-specified in protocol, only specified treatment arms were planned to be analyzed for this outcome measure. As first dose of belantamab mafodotin was administered on Day 1, cycle length correlates to Day 1 plus 21 days i.e., Day 22 in timeframe.

Posted

Median

Full Range

Hour

ID	Title	Description
OG000	Part 1: Belantamab Mafodotin 2.5 mg/kg (Normal/Mildly Impaired Renal Function)	Participants with Relapsed/Refractory Multiple Myeloma (RRMM) who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and normal/mildly impaired renal function received intravenous (IV) infusion of 2.5 milligram (mg)/kilogram (kg) belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to adverse event (AE), lost to follow-up, death, whichever occurs first.

Primary

Part 1: Trough Concentration Prior to the Next Dose for Each Cycle (Ctrough) Following Administration of Belantamab Mafodotin (Total Antibody)

Posted

Geometric Mean

Geometric Coefficient of Variation

ug/mL

ID	Title	Description
OG000	Part 1: Belantamab Mafodotin 2.5 mg/kg (Normal/Mildly Impaired Renal Function)	Participants with Relapsed/Refractory Multiple Myeloma (RRMM) who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and normal/mildly impaired renal function received intravenous (IV) infusion of 2.5 milligram (mg)/kilogram (kg) belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to adverse event (AE), lost to follow-up, death, whichever occurs first.

Primary

Part 1: Time of Last Observed Quantifiable Concentration (Tlast) Following Administration of Belantamab Mafodotin (Total Antibody)

Blood samples were collected for PK analysis of belantamab mafodotin Total Antibody. As pre-specified in protocol, only specified treatment arms were planned to be analyzed for this outcome measure. As first dose of belantamab mafodotin was administered on Day 1, cycle length correlates to Day 1 plus 21 days i.e., Day 22 in timeframe. For some participants, dosing in Cycle 2 or Cycle 4 was delayed, resulting in the pre-dose samples in these cycles (C2D1 or C4D1) being collected later than the protocol-defined planned days after dosing in C1D1 or C3D1. Consequently, the last PK samples for these participants were collected outside the pre-defined protocol time points, and certain Tlast values in the data table extend beyond the original protocol-defined Time Frame.

Posted

Median

Full Range

Hour

ID	Title	Description
OG000	Part 1: Belantamab Mafodotin 2.5 mg/kg (Normal/Mildly Impaired Renal Function)

Primary

Part 1: Area Under the Concentration-time Curve to Last Quantifiable Timepoint (AUC(0-tlast)) Following Administration of Belantamab Mafodotin (Cysteine Maleimidocaproyl Monomethyl Auristatin F (Cys-mcMMAF))

Blood samples were collected for PK analysis of belantamab mafodotin Cys-mcMMAF. As pre-specified in protocol, only specified treatment arms were planned to be analyzed for this outcome measure. As first dose of belantamab mafodotin was administered on Day 1, cycle length correlates to Day 1 plus 21 days i.e., Day 22 in timeframe.

Posted

Geometric Mean

Geometric Coefficient of Variation

h*ng/mL

ID	Title	Description
OG000	Part 1: Belantamab Mafodotin 2.5 mg/kg (Normal/Mildly Impaired Renal Function)	Participants with Relapsed/Refractory Multiple Myeloma (RRMM) who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and normal/mildly impaired renal function received intravenous (IV) infusion of 2.5 milligram (mg)/kilogram (kg) belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to adverse event (AE), lost to follow-up, death, whichever occurs first.

Primary

Part 1: Area Under the Concentration-time Curve During the Dosing Interval up to 168 Hours (AUC (0-168h)) Following Administration of Belantamab Mafodotin (Cys-mcMMAF)

Blood samples were collected for PK analysis of belantamab mafodotin Cys-mcMMAF. As pre-specified in protocol, only specified treatment arms were planned to be analyzed for this outcome measure. In cases where the nominal Day 8 sample was collected prior to 168 hours and earlier time points did not permit reliable extrapolation to 168 hours, a later sample (e.g., Day 15) with a measurable concentration was used to support estimation of the concentration at 168 hours. Outcome data are reported only for AUC over 0-168 hours.

Posted

Geometric Mean

Geometric Coefficient of Variation

h*ng/mL

Pre-dose, end of infusion (EOI), start of infusion (SOI)+2hour (h), SOI+4h, SOI+8h and SOI+24h on Cycle(C) 1 Day(D) 1 and C3D1; Anytime on C1 D4, D8, and D15; Anytime on C3 D4, D8, and D15

ID	Title	Description
OG000	Part 1: Belantamab Mafodotin 2.5 mg/kg (Normal/Mildly Impaired Renal Function)	Participants with Relapsed/Refractory Multiple Myeloma (RRMM) who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and normal/mildly impaired renal function received intravenous (IV) infusion of 2.5 milligram (mg)/kilogram (kg) belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to adverse event (AE), lost to follow-up, death, whichever occurs first.

Primary

Part 1: Observed Plasma Concentration at the End of Infusion (C-EOI) Following Administration of Belantamab Mafodotin (Cys-mcMMAF)

Blood samples were collected for PK analysis of belantamab mafodotin Cys-mcMMAF. As pre-specified in protocol, only specified treatment arms were planned to be analyzed for this outcome measure.

Posted

Geometric Mean

Geometric Coefficient of Variation

ng/mL

End of infusion on C1D1 and C3D1

ID	Title	Description
OG000	Part 1: Belantamab Mafodotin 2.5 mg/kg (Normal/Mildly Impaired Renal Function)	Participants with Relapsed/Refractory Multiple Myeloma (RRMM) who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and normal/mildly impaired renal function received intravenous (IV) infusion of 2.5 milligram (mg)/kilogram (kg) belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to adverse event (AE), lost to follow-up, death, whichever occurs first.
OG001	Part 1: Belantamab Mafodotin 2.5 mg/kg (Severely Impaired Renal Function)	Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and severe renal impairment renal function received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.

Primary

Part 1: Maximum Observed Concentration (Cmax) Following Administration of Belantamab Mafodotin (Cys-mcMMAF)

Blood samples were collected for PK analysis of belantamab mafodotin Cys-mcMMAF. As pre-specified in protocol, only specified treatment arms were planned to be analyzed for this outcome measure. As first dose of belantamab mafodotin was administered on Day 1, cycle length correlates to Day 1 plus 21 days i.e., Day 22 in timeframe.

Posted

Geometric Mean

Geometric Coefficient of Variation

ng/mL

ID	Title	Description
OG000	Part 1: Belantamab Mafodotin 2.5 mg/kg (Normal/Mildly Impaired Renal Function)	Participants with Relapsed/Refractory Multiple Myeloma (RRMM) who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and normal/mildly impaired renal function received intravenous (IV) infusion of 2.5 milligram (mg)/kilogram (kg) belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to adverse event (AE), lost to follow-up, death, whichever occurs first.

Primary

Part 1: Time to Reach Cmax (Tmax) Following Administration of Belantamab Mafodotin (Cys-mcMMAF)

Blood samples were collected for PK analysis of belantamab mafodotin Cys-mcMMAF. As pre-specified in protocol, only specified treatment arms were planned to be analyzed for this outcome measure. As first dose of belantamab mafodotin was administered on Day 1, cycle length correlates to Day 1 plus 21 days i.e., Day 22 in timeframe.

Posted

Median

Full Range

Hour

ID	Title	Description
OG000	Part 1: Belantamab Mafodotin 2.5 mg/kg (Normal/Mildly Impaired Renal Function)	Participants with Relapsed/Refractory Multiple Myeloma (RRMM) who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and normal/mildly impaired renal function received intravenous (IV) infusion of 2.5 milligram (mg)/kilogram (kg) belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to adverse event (AE), lost to follow-up, death, whichever occurs first.

Primary

Part 1: Time of Last Observed Quantifiable Concentration (Tlast) Following Administration of Belantamab Mafodotin (Cys-mcMMAF)

Blood samples were collected for PK analysis of belantamab mafodotin Cys-mcMMAF. As pre-specified in protocol, only specified treatment arms were planned to be analyzed for this outcome measure. As first dose of belantamab mafodotin was administered on Day 1, cycle length correlates to Day 1 plus 21 days i.e., Day 22 in timeframe.

Posted

Median

Full Range

Hour

ID	Title	Description
OG000	Part 1: Belantamab Mafodotin 2.5 mg/kg (Normal/Mildly Impaired Renal Function)	Participants with Relapsed/Refractory Multiple Myeloma (RRMM) who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and normal/mildly impaired renal function received intravenous (IV) infusion of 2.5 milligram (mg)/kilogram (kg) belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to adverse event (AE), lost to follow-up, death, whichever occurs first.

Primary

Part 2: Area Under the Concentration-time Curve to Last Quantifiable Timepoint (AUC(0-tlast)) Following Administration of Belantamab Mafodotin (Antibody-drug Conjugate (ADC))

Posted

Geometric Mean

Geometric Coefficient of Variation

h*ug/mL

ID	Title	Description
OG000	Part 2: Belantamab Mafodotin 2.5 mg/kg End Stage Renal Disease (Not on Dialysis)	Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and end stage renal disease (ESRD) (not on hemodialysis) received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.

Primary

Part 2: Area Under the Concentration-time Curve During the Dosing Interval (AUC(0-tau)) Following Administration of Belantamab Mafodotin (ADC)

Posted

Geometric Mean

Geometric Coefficient of Variation

h*ug/mL

ID	Title	Description
OG000	Part 2: Belantamab Mafodotin 2.5 mg/kg End Stage Renal Disease (Not on Dialysis)	Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and end stage renal disease (ESRD) (not on hemodialysis) received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.

Primary

Part 2: Observed Plasma Concentration at the End of Infusion (C-EOI) Following Administration of Belantamab Mafodotin (ADC)

Blood samples were collected for PK analysis of belantamab mafodotin ADC.

Posted

Geometric Mean

Geometric Coefficient of Variation

ug/mL

End of infusion on C1D1 and C3D1

ID	Title	Description
OG000	Part 2: Belantamab Mafodotin 2.5 mg/kg End Stage Renal Disease (Not on Dialysis)	Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and end stage renal disease (ESRD) (not on hemodialysis) received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.
OG001	Part 2: Belantamab Mafodotin 2.5 mg/kg ESRD (On Dialysis)	Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and ESRD (on hemodialysis) received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.

Primary

Part 2: Maximum Observed Concentration (Cmax) Following Administration of Belantamab Mafodotin (ADC)

Posted

Geometric Mean

Geometric Coefficient of Variation

ug/mL

ID	Title	Description
OG000	Part 2: Belantamab Mafodotin 2.5 mg/kg End Stage Renal Disease (Not on Dialysis)	Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and end stage renal disease (ESRD) (not on hemodialysis) received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.
OG001

Primary

Part 2: Time to Reach Cmax (Tmax) Following Administration of Belantamab Mafodotin (ADC)

Posted

Median

Full Range

Hour

ID	Title	Description
OG000	Part 2: Belantamab Mafodotin 2.5 mg/kg End Stage Renal Disease (Not on Dialysis)	Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and end stage renal disease (ESRD) (not on hemodialysis) received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.
OG001	Part 2: Belantamab Mafodotin 2.5 mg/kg ESRD (On Dialysis)

Primary

Part 2: Trough Concentration Prior to the Next Dose for Each Cycle (Ctrough) Following Administration of Belantamab Mafodotin (ADC)

Posted

Geometric Mean

Geometric Coefficient of Variation

ug/mL

ID	Title	Description
OG000	Part 2: Belantamab Mafodotin 2.5 mg/kg End Stage Renal Disease (Not on Dialysis)	Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and end stage renal disease (ESRD) (not on hemodialysis) received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.

Primary

Part 2: Time of Last Observed Quantifiable Concentration (Tlast) Following Administration of Belantamab Mafodotin (ADC)

Blood samples were collected for PK analysis of belantamab mafodotin ADC. As first dose of belantamab mafodotin was administered on Day 1, cycle length correlates to Day 1 plus 21 days i.e., Day 22 in timeframe. For some participants, dosing in Cycle 2 or Cycle 4 was delayed, resulting in the pre-dose samples in these cycles (C2D1 or C4D1) being collected later than the protocol-defined planned days after dosing in C1D1 or C3D1. Consequently, the last PK samples for these participants were collected outside the pre-defined protocol time points, and certain Tlast values in the data table extend beyond the original protocol-defined Time Frame.

Posted

Median

Full Range

Hour

ID	Title	Description
OG000	Part 2: Belantamab Mafodotin 2.5 mg/kg End Stage Renal Disease (Not on Dialysis)	Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and end stage renal disease (ESRD) (not on hemodialysis) received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.

Primary

Part 2: Area Under the Concentration-time Curve to Last Quantifiable Timepoint (AUC(0-tlast)) Following Administration of Belantamab Mafodotin (Total Antibody)

Posted

Geometric Mean

Geometric Coefficient of Variation

h*ug/mL

ID	Title	Description
OG000	Part 2: Belantamab Mafodotin 2.5 mg/kg End Stage Renal Disease (Not on Dialysis)	Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and end stage renal disease (ESRD) (not on hemodialysis) received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.

Primary

Part 2: Area Under the Concentration-time Curve During the Dosing Interval (AUC(0-tau)) Following Administration of Belantamab Mafodotin (Total Antibody)

Posted

Geometric Mean

Geometric Coefficient of Variation

h*ug/mL

ID	Title	Description
OG000	Part 2: Belantamab Mafodotin 2.5 mg/kg End Stage Renal Disease (Not on Dialysis)	Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and end stage renal disease (ESRD) (not on hemodialysis) received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.

Primary

Part 2: Observed Plasma Concentration at the End of Infusion (C-EOI) Following Administration of Belantamab Mafodotin (Total Antibody)

Blood samples were collected for PK analysis of belantamab mafodotin Total Antibody.

Posted

Geometric Mean

Geometric Coefficient of Variation

ug/mL

End of infusion on C1D1 and C3D1

ID	Title	Description
OG000	Part 2: Belantamab Mafodotin 2.5 mg/kg End Stage Renal Disease (Not on Dialysis)	Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and end stage renal disease (ESRD) (not on hemodialysis) received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.
OG001	Part 2: Belantamab Mafodotin 2.5 mg/kg ESRD (On Dialysis)	Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and ESRD (on hemodialysis) received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.

Primary

Part 2: Maximum Observed Concentration (Cmax) Following Administration of Belantamab Mafodotin (Total Antibody)

Posted

Geometric Mean

Geometric Coefficient of Variation

ug/mL

ID	Title	Description
OG000	Part 2: Belantamab Mafodotin 2.5 mg/kg End Stage Renal Disease (Not on Dialysis)	Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and end stage renal disease (ESRD) (not on hemodialysis) received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.

Primary

Part 2: Time to Reach Cmax (Tmax) Following Administration of Belantamab Mafodotin (Total Antibody)

Posted

Median

Full Range

Hour

ID	Title	Description
OG000	Part 2: Belantamab Mafodotin 2.5 mg/kg End Stage Renal Disease (Not on Dialysis)	Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and end stage renal disease (ESRD) (not on hemodialysis) received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.
OG001

Primary

Part 2: Trough Concentration Prior to the Next Dose for Each Cycle (Ctrough) Following Administration of Belantamab Mafodotin (Total Antibody)

Posted

Geometric Mean

Geometric Coefficient of Variation

ug/mL

ID	Title	Description
OG000	Part 2: Belantamab Mafodotin 2.5 mg/kg End Stage Renal Disease (Not on Dialysis)	Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and end stage renal disease (ESRD) (not on hemodialysis) received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.

Primary

Part 2: Time of Last Observed Quantifiable Concentration (Tlast) Following Administration of Belantamab Mafodotin (Total Antibody)

Blood samples were collected for PK analysis of belantamab mafodotin Total Antibody. As first dose of belantamab mafodotin was administered on Day 1, cycle length correlates to Day 1 plus 21 days i.e., Day 22 in timeframe. For some participants, dosing in Cycle 2 or Cycle 4 was delayed, resulting in the pre-dose samples in these cycles (C2D1 or C4D1) being collected later than the protocol-defined planned days after dosing in C1D1 or C3D1. Consequently, the last PK samples for these participants were collected outside the pre-defined protocol time points, and certain Tlast values in the data table extend beyond the original protocol-defined Time Frame.

Posted

Median

Full Range

Hour

ID	Title	Description
OG000	Part 2: Belantamab Mafodotin 2.5 mg/kg End Stage Renal Disease (Not on Dialysis)	Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and end stage renal disease (ESRD) (not on hemodialysis) received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.

Primary

Part 2: Area Under the Concentration-time Curve to Last Quantifiable Timepoint (AUC(0-tlast)) Following Administration of Belantamab Mafodotin (Cysteine Maleimidocaproyl Monomethyl Auristatin F (Cys-mcMMAF))

Blood samples were collected for PK analysis of belantamab mafodotin Cys-mcMMAF. As first dose of belantamab mafodotin was administered on Day 1, cycle length correlates to Day 1 plus 21 days i.e., Day 22 in timeframe.

Posted

Geometric Mean

Geometric Coefficient of Variation

h*ng/mL

ID	Title	Description
OG000	Part 2: Belantamab Mafodotin 2.5 mg/kg End Stage Renal Disease (Not on Dialysis)	Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and end stage renal disease (ESRD) (not on hemodialysis) received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.

Primary

Part 2: Area Under the Concentration-time Curve During the Dosing Interval up to 168 Hours (AUC (0-168h)) Following Administration of Belantamab Mafodotin (Cys-mcMMAF)

Blood samples were collected for PK analysis of belantamab mafodotin Cys-mcMMAF. In cases where the nominal Day 8 sample was collected prior to 168 hours and earlier time points did not permit reliable extrapolation to 168 hours, a later sample (e.g., Day 15) with a measurable concentration was used to support estimation of the concentration at 168 hours. Outcome data are reported only for AUC over 0-168 hours.

Posted

Geometric Mean

Geometric Coefficient of Variation

h*ng/mL

Pre-dose, end of infusion (EOI), start of infusion (SOI)+2hour (h), SOI+4h, SOI+8h and SOI+24h on Cycle(C) 1 Day(D) 1 and C3D1; Anytime on C1 D4, D8, and D15; Anytime on C3 D4, D8, and D15

ID	Title	Description
OG000	Part 2: Belantamab Mafodotin 2.5 mg/kg End Stage Renal Disease (Not on Dialysis)	Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and end stage renal disease (ESRD) (not on hemodialysis) received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.

Primary

Part 2: Observed Plasma Concentration at the End of Infusion (C-EOI) Following Administration of Belantamab Mafodotin (Cys-mcMMAF)

Blood samples were collected for PK analysis of belantamab mafodotin Cys-mcMMAF.

Posted

Geometric Mean

Geometric Coefficient of Variation

ng/mL

End of infusion on C1D1 and C3D1

ID	Title	Description
OG000	Part 2: Belantamab Mafodotin 2.5 mg/kg End Stage Renal Disease (Not on Dialysis)	Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and end stage renal disease (ESRD) (not on hemodialysis) received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.
OG001	Part 2: Belantamab Mafodotin 2.5 mg/kg ESRD (On Dialysis)	Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and ESRD (on hemodialysis) received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.

Primary

Part 2: Maximum Observed Concentration (Cmax) Following Administration of Belantamab Mafodotin (Cys-mcMMAF)

Posted

Geometric Mean

Geometric Coefficient of Variation

ng/mL

ID	Title	Description
OG000	Part 2: Belantamab Mafodotin 2.5 mg/kg End Stage Renal Disease (Not on Dialysis)	Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and end stage renal disease (ESRD) (not on hemodialysis) received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.

Primary

Part 2: Time to Reach Cmax (Tmax) Following Administration of Belantamab Mafodotin (Cys-mcMMAF)

Posted

Median

Full Range

Hour

ID	Title	Description
OG000	Part 2: Belantamab Mafodotin 2.5 mg/kg End Stage Renal Disease (Not on Dialysis)	Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and end stage renal disease (ESRD) (not on hemodialysis) received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.
OG001

Primary

Part 2: Time of Last Observed Quantifiable Concentration (Tlast) Following Administration of Belantamab Mafodotin (Cys-mcMMAF)

Posted

Median

Full Range

Hour

ID	Title	Description
OG000	Part 2: Belantamab Mafodotin 2.5 mg/kg End Stage Renal Disease (Not on Dialysis)	Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and end stage renal disease (ESRD) (not on hemodialysis) received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.
OG001

Secondary

Part 1 and Part 2: Change From Baseline (CFB) in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)

Blood pressures (DBP and SBP) were measured after resting for at least 5 minutes in a supine or semi-recumbent position. Baseline (Day 1) was defined as latest pre-dose assessment with a non-missing value, including unscheduled visits. Change from Baseline was calculated as post-dose visit value minus Baseline value. The "0" participants analyzed represents that data was not collected or available for analysis at that particular time point for the respective Arms/Groups.

Safety population included all enrolled participants who received at least 1 dose of belantamab mafodotin. Only those participants who were measured and analyzed (i.e., contributed to data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified timepoints.

Posted

Mean

Standard Deviation

Millimeters of mercury (mmHg)

Baseline (Day 1) and up to approx. 236 weeks

ID	Title	Description
OG000	Part 1: Belantamab Mafodotin 2.5 mg/kg (Normal/Mildly Impaired Renal Function)	Participants with Relapsed/Refractory Multiple Myeloma (RRMM) who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and normal/mildly impaired renal function received intravenous (IV) infusion of 2.5 milligram (mg)/kilogram (kg) belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to adverse event (AE), lost to follow-up, death, whichever occurs first.

Secondary

Part 1 and Part 2: Change From Baseline (CFB) in Vital Signs: Heart Rate

Heart rate was measured after resting for at least 5 minutes in a supine or semi-recumbent position. Baseline (Day 1) was defined as latest pre-dose assessment with a non-missing value, including unscheduled visits. Change from Baseline was calculated as post-dose visit value minus Baseline value.

Safety population. Only those participants who were measured and analyzed (i.e., contributed to data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified timepoints. The "0" participants analyzed represents that data was not collected or available for analysis at that particular time point for the respective Arms/Groups.

Posted

Mean

Standard Deviation

Beats per minute

Baseline (Day 1) and up to approx. 236 weeks

ID	Title	Description
OG000	Part 1: Belantamab Mafodotin 2.5 mg/kg (Normal/Mildly Impaired Renal Function)	Participants with Relapsed/Refractory Multiple Myeloma (RRMM) who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and normal/mildly impaired renal function received intravenous (IV) infusion of 2.5 milligram (mg)/kilogram (kg) belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to adverse event (AE), lost to follow-up, death, whichever occurs first.
OG001	Part 1: Belantamab Mafodotin 2.5 mg/kg (Severely Impaired Renal Function)

Secondary

Part 1 and Part 2: Number of Participants With Adverse Events (AEs)

An AE is defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) coding system.

Safety population

Posted

Count of Participants

Participants

Up to approximately 236 weeks

ID	Title	Description
OG000	Part 1: Belantamab Mafodotin 2.5 mg/kg (Normal/Mildly Impaired Renal Function)	Participants with Relapsed/Refractory Multiple Myeloma (RRMM) who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and normal/mildly impaired renal function received intravenous (IV) infusion of 2.5 milligram (mg)/kilogram (kg) belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to adverse event (AE), lost to follow-up, death, whichever occurs first.
OG001	Part 1: Belantamab Mafodotin 2.5 mg/kg (Severely Impaired Renal Function)	Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and severe renal impairment renal function received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.

Secondary

Part 1 and Part 2: Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline

Blood samples were collected for the analysis of hematology parameters and are categorized in alignment with Common Terminology Criteria for Adverse Events (CTCAE) version 5 as Grade 1: mild; Grade 2: moderate; Grade 3: severe or medically significant; and Grade 4: life-threatening consequences. Higher grade indicates greater severity. An increase in grade was defined relative to the Baseline grade. Participants with missing baseline values are assumed to have baseline value of grade 0. Increase to a maximum grade of 3 and 4 is presented. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Worst Case Post-Baseline includes all scheduled and unscheduled visits post baseline.

Posted

Count of Participants

Participants

Baseline (Day 1) and up to approx. 236 weeks

ID	Title	Description
OG000	Part 1: Belantamab Mafodotin 2.5 mg/kg (Normal/Mildly Impaired Renal Function)	Participants with Relapsed/Refractory Multiple Myeloma (RRMM) who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and normal/mildly impaired renal function received intravenous (IV) infusion of 2.5 milligram (mg)/kilogram (kg) belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to adverse event (AE), lost to follow-up, death, whichever occurs first.

Secondary

Part 1 and Part 2: Number of Participants With Worst Case Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline

Blood samples were collected for the analysis of clinical chemistry parameters and are categorized in alignment with Common Terminology Criteria for Adverse Events (CTCAE) version 5 as Grade 1: mild; Grade 2: moderate; Grade 3: severe or medically significant; and Grade 4: life-threatening consequences. Higher grade indicates greater severity. An increase in grade was defined relative to the Baseline grade. Participants with missing baseline values are assumed to have baseline value of grade 0. Increase to a maximum grade of 3 and 4 is presented. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Worst Case Post-Baseline includes all scheduled and unscheduled visits post baseline.

Posted

Count of Participants

Participants

Baseline (Day 1) and up to approx. 236 weeks

ID	Title	Description
OG000	Part 1: Belantamab Mafodotin 2.5 mg/kg (Normal/Mildly Impaired Renal Function)	Participants with Relapsed/Refractory Multiple Myeloma (RRMM) who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and normal/mildly impaired renal function received intravenous (IV) infusion of 2.5 milligram (mg)/kilogram (kg) belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to adverse event (AE), lost to follow-up, death, whichever occurs first.

Secondary

Part 1 and Part 2: Change From Baseline (CFB) in Weight

Physical examination parameter weight was assessed. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Worst Case Post-Baseline includes all scheduled and unscheduled visits post baseline

Posted

Mean

Standard Deviation

Kilogram (Kg)

Baseline (Day 1) and up to approx. 236 weeks

ID	Title	Description
OG000	Part 1: Belantamab Mafodotin 2.5 mg/kg (Normal/Mildly Impaired Renal Function)	Participants with Relapsed/Refractory Multiple Myeloma (RRMM) who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and normal/mildly impaired renal function received intravenous (IV) infusion of 2.5 milligram (mg)/kilogram (kg) belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to adverse event (AE), lost to follow-up, death, whichever occurs first.
OG001	Part 1: Belantamab Mafodotin 2.5 mg/kg (Severely Impaired Renal Function)

Secondary

Part 1 and Part 2: Number of Participants With Worst Case Urinalysis Results Post-Baseline Relative to Baseline

Urine samples were collected to assess occult blood and protein in urine by dipstick method. Data is presented as "No Change/Decreased" and "Any Increase" that includes Increase to TRACE, Increase to 1+, Increase to 2+ and Increase to 3+ indicating proportional concentrations in the urine sample. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Worst Case Post-Baseline includes all scheduled and unscheduled visits post baseline.

Safety population. Only those participants who were measured and analyzed (i.e., contributed to data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified categories. The "0" participants analyzed represents that data was not collected or available for analysis at that particular time point for the respective Arms/Groups.

Posted

Count of Participants

Participants

Baseline (Day 1) and up to approx. 236 weeks

ID	Title	Description
OG000	Part 1: Belantamab Mafodotin 2.5 mg/kg (Normal/Mildly Impaired Renal Function)	Participants with Relapsed/Refractory Multiple Myeloma (RRMM) who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and normal/mildly impaired renal function received intravenous (IV) infusion of 2.5 milligram (mg)/kilogram (kg) belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to adverse event (AE), lost to follow-up, death, whichever occurs first.

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
COVID-19 pneumonia	Infections and infestations	MedDRA V28.0	Systematic Assessment	EG0001 events1 affected10 at risk EG0011 events1 affected9 at risk EG0020 events0 affected4 at risk EG0030 events0 affected5 at risk EG0040 events0 affected8 at risk
Pneumonia	Infections and infestations	MedDRA V28.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0011 events1 affected9 at risk EG0020 events0 affected4 at risk EG003
Atypical pneumonia	Infections and infestations	MedDRA V28.0	Systematic Assessment	EG0001 events1 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected4 at risk EG003
COVID-19	Infections and infestations	MedDRA V28.0	Systematic Assessment	EG0001 events1 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected4 at risk EG003
Enterobacter sepsis	Infections and infestations	MedDRA V28.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected4 at risk EG003
Metapneumovirus pneumonia	Infections and infestations	MedDRA V28.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected4 at risk EG003
Septic shock	Infections and infestations	MedDRA V28.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected4 at risk EG003
Chronic kidney disease	Renal and urinary disorders	MedDRA V28.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0012 events2 affected9 at risk EG0020 events0 affected4 at risk EG003
Acute kidney injury	Renal and urinary disorders	MedDRA V28.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0011 events1 affected9 at risk EG0021 events1 affected4 at risk EG003
Gastritis	Gastrointestinal disorders	MedDRA V28.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0011 events1 affected9 at risk EG0020 events0 affected4 at risk EG003
Intestinal ischaemia	Gastrointestinal disorders	MedDRA V28.0	Systematic Assessment	EG0001 events1 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected4 at risk EG003
Oesophagitis	Gastrointestinal disorders	MedDRA V28.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected4 at risk EG003
Multiple organ dysfunction syndrome	General disorders	MedDRA V28.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0011 events1 affected9 at risk EG0020 events0 affected4 at risk EG003
Asthenia	General disorders	MedDRA V28.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected4 at risk EG003
Sudden death	General disorders	MedDRA V28.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected4 at risk EG003
Arteriovenous fistula occlusion	Injury, poisoning and procedural complications	MedDRA V28.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected4 at risk EG003
Fall	Injury, poisoning and procedural complications	MedDRA V28.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected9 at risk EG0021 events1 affected4 at risk EG003
Fracture	Injury, poisoning and procedural complications	MedDRA V28.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected9 at risk EG0021 events1 affected4 at risk EG003
Humerus fracture	Injury, poisoning and procedural complications	MedDRA V28.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected4 at risk EG003
Lung neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA V28.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected4 at risk EG003
Plasma cell myeloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA V28.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected4 at risk EG003
Anaemia	Blood and lymphatic system disorders	MedDRA V28.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0012 events1 affected9 at risk EG0020 events0 affected4 at risk EG003
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA V28.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0011 events1 affected9 at risk EG0020 events0 affected4 at risk EG003
Hypertransaminasaemia	Hepatobiliary disorders	MedDRA V28.0	Systematic Assessment	EG0001 events1 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected4 at risk EG003
SARS-CoV-2 test positive	Investigations	MedDRA V28.0	Systematic Assessment	EG0001 events1 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected4 at risk EG003
Lactic acidosis	Metabolism and nutrition disorders	MedDRA V28.0	Systematic Assessment	EG0001 events1 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected4 at risk EG003
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA V28.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected4 at risk EG003
Cerebral haemorrhage	Nervous system disorders	MedDRA V28.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0011 events1 affected9 at risk EG0020 events0 affected4 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Vision blurred	Eye disorders	MedDRA V28.0	Systematic Assessment	EG00025 events6 affected10 at risk EG00116 events5 affected9 at risk EG0026 events1 affected4 at risk EG0036 events3 affected5 at risk EG0048 events3 affected8 at risk
Dry eye	Eye disorders	MedDRA V28.0	Systematic Assessment	EG00020 events5 affected10 at risk EG0018 events4 affected9 at risk EG00210 events2 affected4 at risk EG003
Eye irritation	Eye disorders	MedDRA V28.0	Systematic Assessment	EG00019 events5 affected10 at risk EG0018 events3 affected9 at risk EG0026 events1 affected4 at risk EG003
Photophobia	Eye disorders	MedDRA V28.0	Systematic Assessment	EG00014 events3 affected10 at risk EG0016 events3 affected9 at risk EG0022 events1 affected4 at risk EG003
Foreign body sensation in eyes	Eye disorders	MedDRA V28.0	Systematic Assessment	EG00026 events5 affected10 at risk EG0014 events2 affected9 at risk EG0029 events1 affected4 at risk EG003
Cataract	Eye disorders	MedDRA V28.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0012 events1 affected9 at risk EG0020 events0 affected4 at risk EG003
Eye pain	Eye disorders	MedDRA V28.0	Systematic Assessment	EG00019 events4 affected10 at risk EG0012 events1 affected9 at risk EG0020 events0 affected4 at risk EG003
Blepharitis	Eye disorders	MedDRA V28.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected9 at risk EG0022 events1 affected4 at risk EG003
Cataract cortical	Eye disorders	MedDRA V28.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected4 at risk EG003
Cataract nuclear	Eye disorders	MedDRA V28.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected4 at risk EG003
Cataract subcapsular	Eye disorders	MedDRA V28.0	Systematic Assessment	EG0002 events1 affected10 at risk EG0010 events0 affected9 at risk EG0021 events1 affected4 at risk EG003
Diplopia	Eye disorders	MedDRA V28.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected4 at risk EG003
Dry age-related macular degeneration	Eye disorders	MedDRA V28.0	Systematic Assessment	EG0002 events1 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected4 at risk EG003
Lacrimation increased	Eye disorders	MedDRA V28.0	Systematic Assessment	EG0002 events1 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected4 at risk EG003
Ocular discomfort	Eye disorders	MedDRA V28.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected9 at risk EG0022 events1 affected4 at risk EG003
Posterior capsule opacification	Eye disorders	MedDRA V28.0	Systematic Assessment	EG0003 events2 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected4 at risk EG003
Retinal haemorrhage	Eye disorders	MedDRA V28.0	Systematic Assessment	EG0001 events1 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected4 at risk EG003
Visual acuity reduced	Eye disorders	MedDRA V28.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected4 at risk EG003
Visual impairment	Eye disorders	MedDRA V28.0	Systematic Assessment	EG0005 events3 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected4 at risk EG003
Vitreous detachment	Eye disorders	MedDRA V28.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected9 at risk EG0021 events1 affected4 at risk EG003
Vitreous floaters	Eye disorders	MedDRA V28.0	Systematic Assessment	EG0002 events1 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected4 at risk EG003
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA V28.0	Systematic Assessment	EG00051 events2 affected10 at risk EG00112 events3 affected9 at risk EG0020 events0 affected4 at risk EG003
Anaemia	Blood and lymphatic system disorders	MedDRA V28.0	Systematic Assessment	EG0004 events4 affected10 at risk EG0014 events1 affected9 at risk EG0021 events1 affected4 at risk EG003
Leukopenia	Blood and lymphatic system disorders	MedDRA V28.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected9 at risk EG0021 events1 affected4 at risk EG003
Pancytopenia	Blood and lymphatic system disorders	MedDRA V28.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected9 at risk EG0021 events1 affected4 at risk EG003
Fatigue	General disorders	MedDRA V28.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0012 events1 affected9 at risk EG0021 events1 affected4 at risk EG003
Pyrexia	General disorders	MedDRA V28.0	Systematic Assessment	EG0002 events2 affected10 at risk EG0012 events1 affected9 at risk EG0021 events1 affected4 at risk EG003
Asthenia	General disorders	MedDRA V28.0	Systematic Assessment	EG0001 events1 affected10 at risk EG0010 events0 affected9 at risk EG0021 events1 affected4 at risk EG003
Chills	General disorders	MedDRA V28.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected9 at risk EG0022 events2 affected4 at risk EG003
Mass	General disorders	MedDRA V28.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected4 at risk EG003
Oedema peripheral	General disorders	MedDRA V28.0	Systematic Assessment	EG0003 events2 affected10 at risk EG0010 events0 affected9 at risk EG0021 events1 affected4 at risk EG003
Pain	General disorders	MedDRA V28.0	Systematic Assessment	EG0002 events1 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected4 at risk EG003
Peripheral swelling	General disorders	MedDRA V28.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected4 at risk EG003
Abdominal pain upper	Gastrointestinal disorders	MedDRA V28.0	Systematic Assessment	EG0001 events1 affected10 at risk EG0011 events1 affected9 at risk EG0020 events0 affected4 at risk EG003
Anal fissure	Gastrointestinal disorders	MedDRA V28.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0011 events1 affected9 at risk EG0020 events0 affected4 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA V28.0	Systematic Assessment	EG0001 events1 affected10 at risk EG0012 events1 affected9 at risk EG0020 events0 affected4 at risk EG003
Abdominal distension	Gastrointestinal disorders	MedDRA V28.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected4 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA V28.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected4 at risk EG003
Ascites	Gastrointestinal disorders	MedDRA V28.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected4 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA V28.0	Systematic Assessment	EG0001 events1 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected4 at risk EG003
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA V28.0	Systematic Assessment	EG0001 events1 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected4 at risk EG003
Gingival bleeding	Gastrointestinal disorders	MedDRA V28.0	Systematic Assessment	EG0001 events1 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected4 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA V28.0	Systematic Assessment	EG0004 events2 affected10 at risk EG0010 events0 affected9 at risk EG0021 events1 affected4 at risk EG003
Oral pain	Gastrointestinal disorders	MedDRA V28.0	Systematic Assessment	EG0002 events1 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected4 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA V28.0	Systematic Assessment	EG0001 events1 affected10 at risk EG0010 events0 affected9 at risk EG0021 events1 affected4 at risk EG003
COVID-19	Infections and infestations	MedDRA V28.0	Systematic Assessment	EG0003 events2 affected10 at risk EG0012 events1 affected9 at risk EG0020 events0 affected4 at risk EG003
Lower respiratory tract infection	Infections and infestations	MedDRA V28.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0011 events1 affected9 at risk EG0020 events0 affected4 at risk EG003
Bacteraemia	Infections and infestations	MedDRA V28.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected4 at risk EG003
Bacterial infection	Infections and infestations	MedDRA V28.0	Systematic Assessment	EG0001 events1 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected4 at risk EG003
Cryptococcosis	Infections and infestations	MedDRA V28.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected4 at risk EG003
Fungal skin infection	Infections and infestations	MedDRA V28.0	Systematic Assessment	EG0001 events1 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected4 at risk EG003
Hepatitis B reactivation	Infections and infestations	MedDRA V28.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected4 at risk EG003
Herpes simplex reactivation	Infections and infestations	MedDRA V28.0	Systematic Assessment	EG0001 events1 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected4 at risk EG003
Oral herpes	Infections and infestations	MedDRA V28.0	Systematic Assessment	EG0001 events1 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected4 at risk EG003
Parainfluenzae virus infection	Infections and infestations	MedDRA V28.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected4 at risk EG003
Periodontitis	Infections and infestations	MedDRA V28.0	Systematic Assessment	EG0001 events1 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected4 at risk EG003
Pneumonia	Infections and infestations	MedDRA V28.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected4 at risk EG003
Pneumonia aspiration	Infections and infestations	MedDRA V28.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected4 at risk EG003
Purulent discharge	Infections and infestations	MedDRA V28.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected9 at risk EG0021 events1 affected4 at risk EG003
Respiratory tract infection	Infections and infestations	MedDRA V28.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected4 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA V28.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected4 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA V28.0	Systematic Assessment	EG0004 events1 affected10 at risk EG0010 events0 affected9 at risk EG0021 events1 affected4 at risk EG003
Hypokalaemia	Metabolism and nutrition disorders	MedDRA V28.0	Systematic Assessment	EG0003 events2 affected10 at risk EG0012 events2 affected9 at risk EG0021 events1 affected4 at risk EG003
Hyperuricaemia	Metabolism and nutrition disorders	MedDRA V28.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0011 events1 affected9 at risk EG0020 events0 affected4 at risk EG003
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA V28.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0011 events1 affected9 at risk EG0020 events0 affected4 at risk EG003
Tumour lysis syndrome	Metabolism and nutrition disorders	MedDRA V28.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0011 events1 affected9 at risk EG0020 events0 affected4 at risk EG003
Decreased appetite	Metabolism and nutrition disorders	MedDRA V28.0	Systematic Assessment	EG0001 events1 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected4 at risk EG003
Dyslipidaemia	Metabolism and nutrition disorders	MedDRA V28.0	Systematic Assessment	EG0001 events1 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected4 at risk EG003
Hypercalcaemia	Metabolism and nutrition disorders	MedDRA V28.0	Systematic Assessment	EG0001 events1 affected10 at risk EG0010 events0 affected9 at risk EG0022 events2 affected4 at risk EG003
Hypoalbuminaemia	Metabolism and nutrition disorders	MedDRA V28.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected4 at risk EG003
Hypophosphataemia	Metabolism and nutrition disorders	MedDRA V28.0	Systematic Assessment	EG0002 events1 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected4 at risk EG003
Metabolic acidosis	Metabolism and nutrition disorders	MedDRA V28.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected9 at risk EG0021 events1 affected4 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA V28.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0013 events1 affected9 at risk EG0020 events0 affected4 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA V28.0	Systematic Assessment	EG0001 events1 affected10 at risk EG0011 events1 affected9 at risk EG0020 events0 affected4 at risk EG003
Bronchitis chronic	Respiratory, thoracic and mediastinal disorders	MedDRA V28.0	Systematic Assessment	EG0001 events1 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected4 at risk EG003
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA V28.0	Systematic Assessment	EG0001 events1 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected4 at risk EG003
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA V28.0	Systematic Assessment	EG0003 events2 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected4 at risk EG003
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA V28.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected4 at risk EG003
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA V28.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected4 at risk EG003
Pneumonitis aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA V28.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected4 at risk EG003
Rhinalgia	Respiratory, thoracic and mediastinal disorders	MedDRA V28.0	Systematic Assessment	EG0001 events1 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected4 at risk EG003
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA V28.0	Systematic Assessment	EG0001 events1 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected4 at risk EG003
Amylase increased	Investigations	MedDRA V28.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0011 events1 affected9 at risk EG0020 events0 affected4 at risk EG003
Alanine aminotransferase increased	Investigations	MedDRA V28.0	Systematic Assessment	EG0001 events1 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected4 at risk EG003
Aspartate aminotransferase increased	Investigations	MedDRA V28.0	Systematic Assessment	EG0001 events1 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected4 at risk EG003
Blood lactate dehydrogenase increased	Investigations	MedDRA V28.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected4 at risk EG003
Blood potassium decreased	Investigations	MedDRA V28.0	Systematic Assessment	EG0002 events1 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected4 at risk EG003
Blood urea increased	Investigations	MedDRA V28.0	Systematic Assessment	EG0001 events1 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected4 at risk EG003
Candida test positive	Investigations	MedDRA V28.0	Systematic Assessment	EG0001 events1 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected4 at risk EG003
Gamma-glutamyltransferase increased	Investigations	MedDRA V28.0	Systematic Assessment	EG0001 events1 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected4 at risk EG003
Hepatic enzyme increased	Investigations	MedDRA V28.0	Systematic Assessment	EG0001 events1 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected4 at risk EG003
Lymphocyte count decreased	Investigations	MedDRA V28.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected4 at risk EG003
Neutrophil count decreased	Investigations	MedDRA V28.0	Systematic Assessment	EG0003 events1 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected4 at risk EG003
Platelet count decreased	Investigations	MedDRA V28.0	Systematic Assessment	EG0001 events1 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected4 at risk EG003
White blood cell count decreased	Investigations	MedDRA V28.0	Systematic Assessment	EG0002 events2 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected4 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA V28.0	Systematic Assessment	EG0001 events1 affected10 at risk EG0011 events1 affected9 at risk EG0020 events0 affected4 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA V28.0	Systematic Assessment	EG0003 events2 affected10 at risk EG0011 events1 affected9 at risk EG0020 events0 affected4 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA V28.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected4 at risk EG003
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA V28.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected4 at risk EG003
Muscle tightness	Musculoskeletal and connective tissue disorders	MedDRA V28.0	Systematic Assessment	EG0001 events1 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected4 at risk EG003
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA V28.0	Systematic Assessment	EG0001 events1 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected4 at risk EG003
Musculoskeletal stiffness	Musculoskeletal and connective tissue disorders	MedDRA V28.0	Systematic Assessment	EG0001 events1 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected4 at risk EG003
Neuropathy peripheral	Nervous system disorders	MedDRA V28.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0012 events1 affected9 at risk EG0020 events0 affected4 at risk EG003
Sciatica	Nervous system disorders	MedDRA V28.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0011 events1 affected9 at risk EG0020 events0 affected4 at risk EG003
Uraemic encephalopathy	Nervous system disorders	MedDRA V28.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0011 events1 affected9 at risk EG0020 events0 affected4 at risk EG003
Dizziness	Nervous system disorders	MedDRA V28.0	Systematic Assessment	EG0001 events1 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected4 at risk EG003
Dysgeusia	Nervous system disorders	MedDRA V28.0	Systematic Assessment	EG0001 events1 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected4 at risk EG003
Headache	Nervous system disorders	MedDRA V28.0	Systematic Assessment	EG0002 events2 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected4 at risk EG003
Paraesthesia	Nervous system disorders	MedDRA V28.0	Systematic Assessment	EG0001 events1 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected4 at risk EG003
Infusion related reaction	Injury, poisoning and procedural complications	MedDRA V28.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0011 events1 affected9 at risk EG0020 events0 affected4 at risk EG003
Arteriovenous fistula site haemorrhage	Injury, poisoning and procedural complications	MedDRA V28.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected4 at risk EG003
Fall	Injury, poisoning and procedural complications	MedDRA V28.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected4 at risk EG003
Humerus fracture	Injury, poisoning and procedural complications	MedDRA V28.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected4 at risk EG003
Pelvic fracture	Injury, poisoning and procedural complications	MedDRA V28.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected4 at risk EG003
Procedural pain	Injury, poisoning and procedural complications	MedDRA V28.0	Systematic Assessment	EG0002 events1 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected4 at risk EG003
Radius fracture	Injury, poisoning and procedural complications	MedDRA V28.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected4 at risk EG003
Skin laceration	Injury, poisoning and procedural complications	MedDRA V28.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected4 at risk EG003
Chronic kidney disease	Renal and urinary disorders	MedDRA V28.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0011 events1 affected9 at risk EG0020 events0 affected4 at risk EG003
Acute kidney injury	Renal and urinary disorders	MedDRA V28.0	Systematic Assessment	EG0001 events1 affected10 at risk EG0010 events0 affected9 at risk EG0021 events1 affected4 at risk EG003
Albuminuria	Renal and urinary disorders	MedDRA V28.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected4 at risk EG003
Haematuria	Renal and urinary disorders	MedDRA V28.0	Systematic Assessment	EG0001 events1 affected10 at risk EG0010 events0 affected9 at risk EG0021 events1 affected4 at risk EG003
Hydronephrosis	Renal and urinary disorders	MedDRA V28.0	Systematic Assessment	EG0001 events1 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected4 at risk EG003
Hypertension	Vascular disorders	MedDRA V28.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0011 events1 affected9 at risk EG0021 events1 affected4 at risk EG003
Hypotension	Vascular disorders	MedDRA V28.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0011 events1 affected9 at risk EG0020 events0 affected4 at risk EG003
Confusional state	Psychiatric disorders	MedDRA V28.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected4 at risk EG003
Atrial fibrillation	Cardiac disorders	MedDRA V28.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected4 at risk EG003
Cerumen impaction	Ear and labyrinth disorders	MedDRA V28.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0011 events1 affected9 at risk EG0020 events0 affected4 at risk EG003
Hepatic failure	Hepatobiliary disorders	MedDRA V28.0	Systematic Assessment	EG0000 events0 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected4 at risk EG003
Hypogammaglobulinaemia	Immune system disorders	MedDRA V28.0	Systematic Assessment	EG0001 events1 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected4 at risk EG003
Nail deformation	Skin and subcutaneous tissue disorders	MedDRA V28.0	Systematic Assessment	EG0001 events1 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected4 at risk EG003
Pruritus	Skin and subcutaneous tissue disorders	MedDRA V28.0	Systematic Assessment	EG0001 events1 affected10 at risk EG0010 events0 affected9 at risk EG0020 events0 affected4 at risk EG003

ID	Term
D009101	Multiple Myeloma
D007676	Kidney Failure, Chronic
D051437	Renal Insufficiency

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
D051436	Renal Insufficiency, Chronic
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases
D052801	Male Urogenital Diseases
D002908	Chronic Disease
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

ID	Title	Description
BG000	Part 1: Belantamab Mafodotin 2.5 mg/kg (Normal/Mildly Impaired Renal Function)	Participants with Relapsed/Refractory Multiple Myeloma (RRMM) who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and normal/mildly impaired renal function received intravenous (IV) infusion of 2.5 milligram (mg)/kilogram (kg) belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to adverse event (AE), lost to follow-up, death, whichever occurs first.
BG001	Part 1: Belantamab Mafodotin 2.5 mg/kg (Severely Impaired Renal Function)	Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and severe renal impairment renal function received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.
BG002	Part 1: Belantamab Mafodotin 2.5 mg/kg (Other Renal Function)	Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and other renal impairment renal function received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.
BG003	Part 2: Belantamab Mafodotin 2.5 mg/kg End Stage Renal Disease (Not on Dialysis)	Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and end stage renal disease (ESRD) (not on hemodialysis) received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.
BG004	Part 2: Belantamab Mafodotin 2.5 mg/kg ESRD (On Dialysis)	Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and ESRD (on hemodialysis) received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.
BG005	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	Part 1: Belantamab Mafodotin 2.5 mg/kg (Normal/Mildly Impaired Renal Function)	Participants with Relapsed/Refractory Multiple Myeloma (RRMM) who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and normal/mildly impaired renal function received intravenous (IV) infusion of 2.5 milligram (mg)/kilogram (kg) belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to adverse event (AE), lost to follow-up, death, whichever occurs first.	2	10	4	10	10	10
EG001	Part 1: Belantamab Mafodotin 2.5 mg/kg (Severely Impaired Renal Function)	Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and severe renal impairment renal function received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.	3	9	4	9	9	9
EG002	Part 1: Belantamab Mafodotin 2.5 mg/kg (Other Renal Function)	Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and other renal impairment renal function received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.	0	4	2	4	3	4
EG003	Part 2: Belantamab Mafodotin 2.5 mg/kg End Stage Renal Disease (Not on Dialysis)	Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and end stage renal disease (ESRD) (not on hemodialysis) received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.	1	5	3	5	5	5
EG004	Part 2: Belantamab Mafodotin 2.5 mg/kg ESRD (On Dialysis)	Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and ESRD (on hemodialysis) received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.	3	8	4	8	8	8