Sub-study of Belantamab Mafodotin (GSK2857916) in Combina... | NCT07084896 | Trialant
NCT07084896
Sponsor
GlaxoSmithKline
Status
Active, not recruiting
Last Update Posted
May 6, 2026Actual
Enrollment
106Actual
Phase
Phase 1Phase 2
Conditions
Multiple Myeloma
Interventions
Belantamab mafodotin
Nirogacestat
Countries
United States
Australia
Canada
France
Germany
Greece
Netherlands
Norway
Poland
Russia
South Korea
Spain
Sweden
Protocol Section
Identification Module
NCT ID
NCT07084896
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
208887 Sub Study 3
Secondary IDs
ID
Type
Description
Link
2023-509550-55
Other Identifier
EUCT number
Brief Title
Sub-study of Belantamab Mafodotin (GSK2857916) in Combination With Nirogacestat in Participants With RRMM
Official Title
A Phase I/II, Randomized, Open-label Platform Study Utilizing a Master Protocol to Study Belantamab Mafodotin (GSK2857916) as Monotherapy and in Combination With Anti-Cancer Treatments in Participants With Relapsed/Refractory Multiple Myeloma (RRMM)-DREAMM5 - Sub-study 3 - Belantamab Mafodotin and Nirogacestat in Combination
Acronym
Not provided
Organization
GlaxoSmithKlineINDUSTRY
Status Module
Record Verification Date
Apr 2026
Overall Recruitment Status or Expanded Access Status
Active, not recruiting
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
YesNCT03763370Available
Start Date
Jun 8, 2020Actual
Primary Completion Date
Apr 17, 2025Actual
Completion Date
Mar 11, 2027Estimated
First Submitted Date
Jul 22, 2025
First Submission Date that Met QC Criteria
Jul 22, 2025
First Posted Date
Jul 25, 2025Actual
Results Waived
Not provided
Results First Submitted Date
Apr 15, 2026
Results First Submitted that Met QC Criteria
Apr 15, 2026
Results First Posted Date
May 6, 2026Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Apr 15, 2026
Last Update Posted Date
May 6, 2026Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
GlaxoSmithKlineINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The primary purpose is to determine the safety and tolerability of belantamab mafodotin in combination with nirogacestat and to establish the recommended Phase 2 dose for combination treatment to explore in the cohort expansion (CE) phase in participants with RRMM. This study is a sub study of the Master protocol (NCT04126200).
Detailed Description
Not provided
Conditions Module
Conditions
Multiple Myeloma
Keywords
Belantamab Mafodotin
Nirogacestat
GSK2857916
Multiple myeloma
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 1Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
106Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Belantamab mafodotin + Nirogacestat
Experimental
Drug: Belantamab mafodotin
Drug: Nirogacestat
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Belantamab mafodotin
Drug
Belantamab mafodotin will be administered.
Belantamab mafodotin + Nirogacestat
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
DE Phase: Number of Participants With Dose Limiting Toxicities (DLTs)
Criteria for dose-limiting toxicity (DLT) included hematologic indicators such as Grade 3-5 febrile neutropenia and thrombocytopenia with bleeding. Non-hematologic criteria, excluding corneal toxicity, comprise Grade 3-5 toxicities, with exceptions for manageable nausea, vomiting, or diarrhea, controlled Grade 3 hypertension, and events linked to disease progression. Tumor lysis syndrome (TLS) of Grade 3 or 4, successfully managed within 7 days without end-organ damage, was considered. Corneal toxicity, assessed by the GSK corneal grading scale at Grade 4, is a DLT. Other organ-specific toxicities, notably liver toxicity meeting GSK stopping criteria, also qualified as DLTs. Severity was graded using National Cancer Institute (NCI) - Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0.
Up to 28 days
DE Phase: Number of Participants With Adverse Events (AEs)
An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) coding system.
Up to approximately 253 weeks
DE Phase: Number of Participants With Worst-case Hematology Results by Maximum Grade Increase Post - Baseline Relative to Baseline
Blood samples were collected for evaluation of hematology parameters including Anemia (An), Hemoglobin increased (HbI), Lymphocyte count decreased (LyD), Lymphocytes count increased (LyI), Neutrophils count decreased (NeuD), Platelet count decreased (PD), Leukocytosis (LC) and White blood cell decreased (WBCD). The laboratory parameters were graded according to CTCAE v5.0. Grade 1 (G1): mild; Grade 2 (G2): moderate; Grade 3 (G3): severe; Grade 4 (G4) life-threatening or disabling. Higher grade indicates greater severity and an increase in CTCAE grade was defined relative to the Baseline grade. Any worst-case post baseline increases to G1, G2, G3, and G4 are presented. Baseline value was defined as the most recent, non-missing value from a local laboratory prior to the first dose of study treatment.
Secondary Outcomes
Measure
Description
Time Frame
DE Phase: Overall Response Rate (ORR)
Overall Response Rate (ORR) was defined as the percentage of participants with a confirmed Partial Response (PR) or better as the best overall response (i.e., PR, Very Good Partial Response [VGPR], Complete Response [CR], and stringent Complete Response [sCR]), as assessed by the investigator per international myeloma working group (IMWG) (2016). PR is defined as ≥50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥90% or to <200 mg/24 h. VGPR is defined as serum and urine M-component detectable by immunofixation but not on electrophoresis OR ≥ 90% reduction in serum M-component plus urine M-component <100 mg/24 h. CR is defined as negative immunofixation of serum and urine AND disappearance of any soft tissue plasmacytomas AND <5% plasmacytomas in the bone marrow. sCR is defined as CR as above PLUS normal serum free light-chain (FLC) assay ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Participant must be 18 years of age inclusive or older, at the time of signing the informed consent.
Participants must have histologically or cytologically confirmed diagnosis of Multiple Myeloma (MM), as defined by the IMWG.
Participants having at least 3 prior lines of prior anti-myeloma treatments including an immunomodulating agent (IMID) a proteasome inhibitor (PI) and an anti-CD38 monoclonal antibody.
Participants with a history of autologous stem cell transplant are eligible for study participation when, transplant was >100 days prior to study enrolment and with no active infection(s).
Participants with Eastern Cooperative Oncology Group (ECOG) performance status of 0-1, unless ECOG less than equal to (<=)2 is due solely to skeletal complications and/or skeletal pain due to MM.
Participants with measurable disease defined as at least one of the following: Serum M-protein greater than equal to (>=)0.5 gram per deciliter (>=5 gram per liter) or Urine M-protein >=200 milligrams (mg) per 24 hours or Serum free light chain (FLC) assay: Involved FLC level >=10 mg per deciliter (>=100 mg per Liter) and an abnormal serum FLC ratio (<0.26 or >1.65).
Participants who have tested positive for Hepatitis B core antibody (HBcAb) can be enrolled if the following criteria are met: Serology result HBcAb+, Hepatitis B surface antigen (HBsAg)-; HBV deoxyribonucleic acid (DNA) undetectable during screening.
Participants who are currently receiving physiological doses oral steroids (<10 mg/day), inhaled steroids or ophthalmological steroids.
Exclusion Criteria:
Participants with current corneal epithelial disease except mild punctate keratopathy.
Participants with evidence of cardiovascular risk.
Participants with known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to belantamab mafodotin or any of the components of the study treatment. History of severe hypersensitivity to other mAb.
Participants with active infection requiring antibiotic, antiviral, or antifungal treatment.
Participants with other monoclonal antibodies within 30 days or systemic anti-myeloma therapy within <14 days.
Participants with prior radiotherapy within 2 weeks of start of study therapy.
Participants with prior allogeneic transplant are prohibited.
Participants who have received prior Chimeric Antigen T cell therapy (CAR-T) therapy with lymphodepletion with chemotherapy within 3 months of screening.
Participants with any major surgery (other than bone-stabilizing surgery) within the last 30 days.
Participants with prior treatment with an investigational agent within 14 days or 5 half-lives of receiving the first dose of study drugs, whichever is shorter.
Participants with >=grade 3 toxicity considered related to prior check-point inhibitors and that led to treatment discontinuation.
Participants who have received transfusion of blood products within 2 weeks before the first dose of study drug.
Participants must not receive live attenuated vaccines within 30 days prior to first dose of study treatment or whilst receiving belantamab mafodotin +- partner agent in any sub-study arm of the platform trial and for at least 70 days following last study treatment.
Participants with presence of active renal condition (infection, requirement for dialysis or any other condition that could affect participant's safety). Participants with isolated proteinuria resulting from MM.
Participants with known human immunodeficiency virus (HIV) infection, unless the participant can meet all criteria: a) established anti-retroviral therapy for at least 4 weeks and HIV viral load<400 copies/milliliter (mL) b) cluster of differentiation 4 plus (CD4+) T-cell (CD4+) counts >= 350 cells/microliter (µL) c) No history of Acquired immunodeficiency syndrome (AIDS)-defining opportunistic infections within the last 12 months in which case the participant would be eligible for CE Phase only.
Participants with uncontrolled small and/or large intestinal disease.
Participants with uncontrolled skin disease.
Participants with any condition causing hypophosphatemia, hypokalemia or hypomagnesemia which is refractory to electrolyte replacement.
Participants with previous administration of a gamma secretase inhibitor.
Participants with concomitant administration of a strong CYP3A4 inhibitor or inducer.
The results presented are based on the data cut-off date of 17 Apr 2025. Those participants still benefiting from study drug in the opinion of their treating physician continue to receive study drug in Post Analysis Continuation of Treatment (PACT) phase and their safety data will be provided within a year of study completion.
Recruitment Details
This is a sub-study of the master study NCT04126200. The sub-study included two phases - Dose Escalation (DE) and Cohort Expansion (CE).
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
DE Phase: 0.95 mg/kg Belantamab Mafodotin + Nirogacestat
In DE Phase, participants with Relapsed/Refractory Multiple Myeloma (RRMM) received 0.95 milligram (mg)/kilogram (kg) belantamab mafodotin intravenous (IV) infusion as powder for solution once every 3 weeks (Q3W) infused over 30- 60 minutes on day 1 of 21-day cycles in combination with 100 mg nirogacestat administered twice a day (BID) on day 1, 4, 8 and 15 of 21-day cycles. Treatment was administered until disease progression, intolerable toxicity, informed consent withdrawal, the end of the sub-study or death.
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
Sep 3, 2024
Apr 15, 2026
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
N/A
Intervention Model
Single Group Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
GSK2857916
Nirogacestat
Drug
Nirogacestat will be administered.
Belantamab mafodotin + Nirogacestat
Baseline (Day 1) and up to approximately 253 weeks
DE Phase: Number of Participants With Worst-Case Chemistry Results by Maximum Grade Increase Post - Baseline Relative to Baseline
Blood samples were collected for evaluation of clinical chemistry parameters including Hypoglycemia (HG), Hypoalbuminemia (HA), Creatinine Kinase increased (CPKi), Hyperkalemia (HK), Blood lactate dehydrogenase Increased (BLDi), Hypermagnesemia (HyperM), Hypomagnesemia (HypoM), Hypernatremia (HyperN), Hypercalcemia (HyperC), Hypocalcemia (HypoC) and Chronic Kidney Disease (CKD). The laboratory parameters were graded according to CTCAE version 5. G1: mild; G2: moderate; G3: severe; Grade 4 (G4) life-threatening or disabling. Higher grade indicates greater severity and an increase in CTCAE grade was defined relative to the Baseline grade. Any worst-case post baseline increase to G1, G2, G3, and G4 are presented. Baseline value was defined as the most recent, non-missing value from a local laboratory prior to the first dose of study treatment.
Baseline (Day 1) and up to approximately 253 weeks
CE Phase: Overall Response Rate (ORR)
Overall Response Rate (ORR) was defined as the percentage of participants with a confirmed Partial Response (PR) or better as the best overall response (i.e., PR, Very Good Partial Response [VGPR], Complete Response [CR], and stringent Complete Response [sCR]), as assessed by the investigator per international myeloma working group (IMWG) (2016). PR is defined as ≥50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥90% or to <200 mg/24 h. VGPR is defined as serum and urine M-component detectable by immunofixation but not on electrophoresis OR ≥ 90% reduction in serum M-component plus urine M-component <100 mg/24 h. CR is defined as negative immunofixation of serum and urine AND disappearance of any soft tissue plasmacytomas AND <5% plasmacytomas in the bone marrow. sCR is defined as CR as above PLUS normal serum free light-chain (FLC) assay ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence.
Up to approximately 253 weeks
Up to approximately 253 weeks
CE Phase: Clinical Benefit Rate (CBR)
Clinical benefit rate was defined as the percentage of participants with a confirmed minimal response (MR) or better according to the IMWG Response Criteria. MR is defined as >= 25% but < 49% reduction of serum M-protein and reduction in 24-hour urinary M-protein by 50-89%.
Up to approximately 253 weeks
DE Phase: Number of Participants Achieving Stringent Complete Response (SCR), Complete Response (CR), Very Good Partial Response (VGPR) and Partial Response (PR)
Partial Response [PR], Very Good Partial Response [VGPR], Complete Response [CR], and stringent Complete Response [sCR] as assessed by the investigator per IMWG (2016). PR is defined as ≥50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥90% or to <200 mg/24 h. VGPR is defined as serum and urine M-component detectable by immunofixation but not on electrophoresis OR ≥ 90% reduction in serum M-component plus urine M-component <100 mg/24 h. CR is defined as negative immunofixation of serum and urine AND disappearance of any soft tissue plasmacytomas AND <5% plasmacytomas in the bone marrow. sCR is defined as CR as above PLUS normal serum free light-chain (FLC) assay ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence.
Up to approximately 253 weeks
CE Phase: Number of Participants Achieving SCR, CR, VGPR and PR
Partial Response [PR], Very Good Partial Response [VGPR], Complete Response [CR], and stringent Complete Response [sCR] as assessed by the investigator per IMWG (2016). PR is defined as ≥50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥90% or to <200 mg/24 h. VGPR is defined as serum and urine M-component detectable by immunofixation but not on electrophoresis OR ≥ 90% reduction in serum M-component plus urine M-component <100 mg/24 h. CR is defined as negative immunofixation of serum and urine AND disappearance of any soft tissue plasmacytomas AND <5% plasmacytomas in the bone marrow. sCR is defined as CR as above PLUS normal serum free light-chain (FLC) assay ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence.
Up to approximately 253 weeks
DE Phase: Plasma Concentrations of Belantamab Mafodotin Antibody-Drug Conjugate (ADC)
Blood samples were collected for PK analysis of belantamab mafodotin Antibody-Drug Conjugate (ADC). Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified timepoints.
PRE-DOSE(PD), END OF INFUSION (EOI), EOI+2 HOURS(H), EOI+ 24H on Day(D) 1 of Cycle (C) 1; ANYTIME on C1 D4, D8, D22, and D29 ; PD and EOI on D1 of C2, C4, C6, C9, C12; PD on D1 of C18 and C30; End of Treatment (approximately 157 weeks)
CE Phase: Plasma Concentrations of Belantamab Mafodotin Antibody-Drug Conjugate (ADC)
Blood samples were collected for PK analysis of belantamab mafodotin Antibody-Drug Conjugate (ADC).
PRE-DOSE(PD), END OF INFUSION (EOI), EOI+2 HOURS(H), EOI+ 24H on Day(D) 1 of Cycle (C) 1; ANYTIME on C1 D4, D8, and D22 ; PD and EOI on D1 of C2, C4, C6, C9, C12; PD on D1 of C18; End of Treatment (approximately 157 weeks)
DE Phase: Plasma Concentration of Belantamab Mafodotin Total Antibody
Blood samples were collected for PK analysis of Belantamab mafodotin total antibody.
PRE-DOSE(PD), END OF INFUSION (EOI), EOI+2 HOURS(H), EOI+ 24H on Day(D) 1 of Cycle (C) 1; ANYTIME on C1 D4, D8, D22, and D29; PD and EOI on D1 of C2, C4, C6, C9, C12; PD on D1 of C18 and C30; End of Treatment (approximately 157 weeks)
CE Phase: Plasma Concentration of Belantamab Mafodotin Plasma Total Antibody
Blood samples were collected for PK analysis of Belantamab mafodotin total antibody.
PRE-DOSE(PD), END OF INFUSION (EOI), EOI+2 HOURS(H), EOI+ 24H on Day(D) 1 of Cycle (C) 1; ANYTIME on C1 D4, D8, and D22; PD and EOI on D1 of C2, C4, C6, C9, C12; PD on D1 of C18; End of Treatment (appoximately 157 weeks)
DE Phase: Plasma Concentrations of Belantamab Mafodotin Cys- Monomethyl Auristatin-F (Cys-mcMMAF)
Blood samples were collected for PK analysis of belantamab mafodotin cys- monomethyl auristatin-F (cys-mcMMAF).
PRE-DOSE(PD), END OF INFUSION (EOI), EOI+2 HOURS(H), EOI+ 24H on Day(D) 1 of Cycle (C) 1; ANYTIME on C1 D4, D8, D22, and D29; PD and EOI on D1 of C2, C4, C6, C9, C12; PD on D1 of C18 and C30; End of Treatment (approximately 157 weeks)
CE Phase: Plasma Concentrations of Belantamab Mafodotin Cys- Monomethyl Auristatin-F (Cys-mcMMAF)
Blood samples were collected for PK analysis of belantamab mafodotin cys- monomethyl auristatin-F (cys-mcMMAF).
PRE-DOSE(PD), END OF INFUSION (EOI), EOI+2 HOURS(H), EOI+ 24H on Day(D) 1 of Cycle (C) 1; ANYTIME on C1 D4, D8, D22 ; PD and EOI on D1 of C2, C4, C6, C9, C12; PD on D1 of C18; End of Treatment (approximately 157 weeks)
DE Phase: Plasma Concentration of Nirogacestat When Administered in Combination With Belantamab Mafodotin
Blood samples were collected for PK analysis of Nirogacestat when administered orally in combination with belantamab mafodotin.
PRE-DOSE (PD), Post-dose 30 Minutes, 1H, 2H, and 4H on Cycle (C) 1 Day (D) -2; PRE-DOSE (PD), Post-dose 30 Minutes, 1H, 2H, 4H, 8H on C1D1; PD on C1D4 and D8 ; PD, Post-dose 30 Minutes, 1H, 2H, 4H, 8H on C2D1
CE Phase: Plasma Concentration of Nirogacestat When Administered in Combination With Belantamab Mafodotin
Blood samples were collected for PK analysis of Nirogacestat when administered orally in combination with belantamab mafodotin.
PRE-DOSE (PD), Post-dose 30 Minutes, 1H, 2H, 4H, 8H on C1D1; PD on C1D4 and D8 ; PD, Post-dose 30 Minutes, 1H, 2H, 4H, 8H on C2D1
DE Phase: Number of Participants With Post-baseline Positive Anti-drug Antibodies (ADAs) Against Belantamab Mafodotin
Serum samples were collected for the analysis of the presence of ADAs using validated immunoassays. All samples were tested in screening assay, and positive samples were further characterized for antibody titers.
C2 D1, C4 D1, C6 D1, C9 D1, C12 D1, C18 D1, C30 D1, End of Treatment (approximately 157 weeks)
CE Phase: Number of Participants With Post-baseline Positive ADAs Against Belantamab Mafodotin
Serum samples were collected for the analysis of the presence of ADAs using validated immunoassays. All samples were tested in screening assay, and positive samples were further characterized for antibody titers.
C2 D1, C4 D1, C6 D1, C9 D1, C12 D1, C18 D1, End of Treatment (approximately 157 weeks)
DE Phase: Titer of ADAs Against Belantamab Mafodotin
Serum samples were collected for the analysis of the presence of ADAs using validated immunoassays. All samples were to be further tested in screening assay, and positive samples were further to be characterized for antibody titers.
Up to approximately 157 weeks.
CE Phase: Titer of ADAs Against Belantamab Mafodotin
Serum samples were collected for the analysis of the presence of ADAs using validated immunoassays. All samples were further tested in screening assay, and positive samples were further characterized for antibody titers.
C2 D1 and at End of Treatment (approximately 157 weeks)
DE Phase: Number of Participants With Adverse Events of Special Interest (AESI) for Belantamab Mafodotin
An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Adverse Events of Special Interest (whether serious or non serious) were collected.
Up to approximately 253 weeks
CE Phase: Number of Participants With Adverse Events of Special Interest (AESI) for Belantamab Mafodotin
An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Adverse Events of Special Interest (whether serious or non serious) were collected.
Up to approximately 253 weeks
DE Phase: Number of Participants With Any Corneal Event by Maximum Grade as Per CTCAE Grade
The corneal events were graded according to CTCAE version 5. Grade 1: mild; Grade 2: moderate; Grade 3: severe or medically significant. Grade 4: Life-threatening consequences; Grade 5: Death related to AE. Higher grade indicates greater severity and an increase in CTCAE grade was defined relative to the Baseline grade. Results are presented for number of participants with any corneal events by maximum grade as per CTCAE grade v5.0.
Up to approximately 253 weeks
CE Phase: Number of Participants With Any Corneal Event by Maximum Grade as Per CTCAE Grade
The corneal events were graded according to CTCAE version 5. Grade 1: mild; Grade 2: moderate; Grade 3: severe or medically significant. Grade 4: Life-threatening consequences; Grade 5: Death related to AE. Higher grade indicates greater severity and an increase in CTCAE grade was defined relative to the Baseline grade. Results are presented for number of participants with any corneal events by maximum grade as per CTCAE grade v5.0.
Up to approximately 253 weeks
CE Phase: Progression-free Survival (PFS)
PFS is defined as the time from randomization until the earliest date of confirmed progressive disease (PD) per IMWG, or death due to any cause.
Up to approximately 253 weeks
CE Phase: Duration of Response (DoR)
DoR is defined as the time from first documented evidence or PR or better until progressive disease per IMWG or death due to progressive disease among participants who achieve confirmed partial response or better.
Up to approximately 253 weeks
CE Phase: Time to Response (TTR)
TTR is defined as the time between the date of randomization and the first documented evidence of response (PR or better), among participants who achieve a response (confirmed PR or better).
Up to approximately 253 weeks
CE Phase: Overall Survival (OS)
OS is defined as the time from randomization until death due to any cause.
Up to approximately 253 weeks
CE Phase: Number of Participants With AEs and SAEs
An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that; results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, other situations judged by physician, is associated with liver injury and impaired liver function. AEs and SAEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) coding system.
Up to approximately 253 weeks
CE Phase: Number of Participants With AEs Leading to Discontinuation
An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Number of participants with AEs leading to discontinuation were evaluated.
Up to approximately 253 weeks
CE Phase: Number of Participants With Adverse Events Leading to Dose Reduction or Delay
Number of participants with adverse events leading to dose reduction or delay were evaluated.
Up to approximately 253 weeks
CE Phase: Number of Participants With Worst-case Hematology Results by Maximum Grade Increase Post - Baseline Relative to Baseline
Blood samples were collected for evaluation of hematology parameters including Anemia (An), Hemoglobin increased (HbI), Lymphocyte count decreased (LyD), Lymphocytes count increased (LyI), Neutrophils count decreased (NeuD), Platelet count decreased (PD), Leukocytosis (LC) and White blood cell decreased (WBCD). The laboratory parameters were graded according to CTCAE version 5. Grade 1 (G1): mild; Grade 2 (G2): moderate; Grade 3 (G3): severe; Grade 4 (G4) life-threatening or disabling. Higher grade indicates greater severity and an increase in CTCAE grade was defined relative to the Baseline grade. Any worst-case post baseline increases to G1, G2, G3, and G4 are presented. Baseline value was defined as the most recent, non-missing value from a local laboratory prior to the first dose of study treatment.
Baseline (Day 1) and up to approximately 253 weeks
CE Phase: Number of Participants With Worst-Case Chemistry Results by Maximum Grade Increase Post - Baseline Relative to Baseline
Blood samples were collected for evaluation of clinical chemistry parameters including Hypoglycemia (HG), Hypoalbuminemia (HA), Creatinine Kinase increased (CPKi), Hyperkalemia (HK), Blood lactate dehydrogenase Increased (BLDi), Hypermagnesemia (HyperM), Hypomagnesemia (HypoM), Hypernatremia (HyperN), Hypercalcemia (HyperC), Hypocalcemia (HypoC) and Chronic Kidney Disease (CKD). The laboratory parameters were graded according to CTCAE version 5. G1: mild; G2: moderate; G3: severe; Grade 4 (G4) life-threatening or disabling. Higher grade indicates greater severity and an increase in CTCAE grade was defined relative to the Baseline grade. Any worst-case post baseline increase to G1, G2, G3, and G4 are presented. Baseline value was defined as the most recent, non-missing value from a local laboratory prior to the first dose of study treatment.
Baseline (Day 1) and up to approximately 253 weeks
Boston
Massachusetts
02215
United States
251164
Grand Rapids
Michigan
49546
United States
239015
Madison
Wisconsin
53792
United States
GSK Investigational Site
Fitzroy
Victoria
3065
Australia
GSK Investigational Site
Vancouver
British Columbia
V5Z1M9
Canada
GSK Investigational Site
Halifax
Nova Scotia
B3H 1V7
Canada
GSK Investigational Site
Lille
59037
France
GSK Investigational Site
Villejuif
94805
France
GSK Investigational Site
Frankfurt
60590
Germany
GSK Investigational Site
Kiel
24105
Germany
GSK Investigational Site
Leipzig
04103
Germany
GSK Investigational Site
Athens
11528
Greece
GSK Investigational Site
Utrecht
3584 CX
Netherlands
GSK Investigational Site
Oslo
0450
Norway
GSK Investigational Site
Katowice
40-519
Poland
GSK Investigational Site
Lodz
93-513
Poland
GSK Investigational Site
Lublin
20-081
Poland
GSK Investigational Site
Moscow
125284
Russia
GSK Investigational Site
Incheon
21565
South Korea
GSK Investigational Site
Seoul
06351
South Korea
GSK Investigational Site
Seoul
06591
South Korea
GSK Investigational Site
Ulsan
44033
South Korea
GSK Investigational Site
Badalona
08916
Spain
GSK Investigational Site
Madrid
28041
Spain
GSK Investigational Site
Madrid
31008
Spain
GSK Investigational Site
Pozuelo de AlarcOn Madr
28223
Spain
GSK Investigational Site
Falun
SE-791 82
Sweden
GSK Investigational Site
Stockholm
SE-141 86
Sweden
FG001
DE Phase: 1.9 mg/kg Belantamab Mafodotin+ Nirogacestat
In DE Phase, participants with RRMM received 1.9 mg/ kg belantamab mafodotin IV infusion as powder for solution once Q3W infused over 30- 60 minutes on day 1 of 21-day cycles in combination with 100 mg nirogacestat administered BID on day 1, 4, 8 and 15 of 21-day cycles. Treatment was administered until disease progression, intolerable toxicity, informed consent withdrawal, the end of the sub-study or death.
FG002
DE Phase: 1.0 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID
In DE Phase, participants with RRMM received 1.0 mg/ kg belantamab mafodotin IV infusion as powder for solution once every 4 weeks (Q4W) for Cycle 1-2 and then once every 8 weeks (Q8W) from Cycle 2 onwards, infused over 30- 60 minutes on day 1 of 28-day cycles in Q4W and 56-day cycle in Q8W in combination with 100 mg nirogacestat BID on day 1, 4, 8 and 15 of 21-day cycles. Treatment was administered until disease progression, intolerable toxicity, informed consent withdrawal, the end of the sub-study or death.
FG003
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID
In DE Phase, participants with RRMM received 1.4 mg/ kg belantamab mafodotin IV infusion as powder for solution Q4W for Cycle 1 and then Q8W from Cycle2 onwards, infused over 30- 60 minutes on day 1 of 21-day cycles in combination with 100 mg nirogacestat BID on day 1, 4, 8 and 15 of 21-day cycles. Treatment was administered until disease progression, intolerable toxicity, informed consent withdrawal, the end of the sub-study or death.
FG004
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W + Nirogacestat BID
In DE Phase, participants with RRMM received 1.4 mg/ kg belantamab mafodotin IV infusion as powder for solution Q4W, infused over 30- 60 minutes on day 1 of 28-day cycles in combination with 100 mg nirogacestat BID on day 1, 4, 8 and 15 of 21-day cycles. Treatment was administered until disease progression, intolerable toxicity, informed consent withdrawal, the end of the sub-study or death.
FG005
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat
In CE Phase, Participants with RRMM received 0.95 mg/ kg belantamab mafodotin IV infusion as powder for solution once every 3 weeks (Q3W), infused over 30- 60 minutes on day 1 of 21-day cycles in combination with 100 mg nirogacestat BID on day 1, 4, 8 and 15 of 21-day cycles. Treatment was administered until disease progression, intolerable toxicity, informed consent withdrawal, the end of the sub-study or death.
FG006
CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W
In CE Phase, Participants with RRMM received 2.5 mg/ kg belantamab mafodotin IV infusion as powder for solution Q3W, infused over 30- 60 minutes on day 1 of 21-day cycles until disease progression, intolerable toxicity, informed consent withdrawal, the end of the sub-study or death.
FG00010 subjects
FG0014 subjects
FG00210 subjects
FG00310 subjects
FG0041 subjects
FG00534 subjects
FG00637 subjects
DLT Evaluable Population
DLT Evaluable Population included participants in DE phase who have received at least 80% of all components of the intended dose of treatment in cycle 1 and were followed up for a period of one cycle length or withdrawn within the first cycle due to an AE meeting the definition of a DLT.
FG0008 subjects
FG0013 subjects
FG0026 subjects
FG0037 subjects
FG0041 subjects
FG00528 subjects
FG00636 subjects
Safety Population
Safety population included all participants who received at least 1 dose of any component of the combination therapy.
FG00010 subjects
FG0014 subjects
FG00210 subjects
FG00310 subjects
FG0041 subjects
FG00534 subjects
FG00637 subjects
Pharmacokinetic Population
Pharmacokinetic population included all participants in the safety population from whom at least one PK sample has been obtained and analysed.
FG00010 subjects
FG0014 subjects
FG00210 subjects
FG00310 subjects
FG0041 subjects
FG00534 subjects
FG00637 subjects
COMPLETED
FG0008 subjects
FG0014 subjects
FG0026 subjects
FG0038 subjects
FG0040 subjects
FG00524 subjects
FG00624 subjects
NOT COMPLETED
FG0002 subjects
FG0010 subjects
FG0024 subjects
FG0032 subjects
FG0041 subjects
FG00510 subjects
FG00613 subjects
Type
Comment
Reasons
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0061 subjects
Physician Decision
FG0001 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
Withdrawal by Subject
FG0001 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
Ongoing at the time of analysis
FG0000 subjects
FG0010 subjects
FG0022 subjects
FG0032 subjects
FG004
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
DE Phase: 0.95 mg/kg Belantamab Mafodotin + Nirogacestat
In DE Phase, participants with Relapsed/Refractory Multiple Myeloma (RRMM) received 0.95 milligram (mg)/kilogram (kg) belantamab mafodotin intravenous (IV) infusion as powder for solution once every 3 weeks (Q3W) infused over 30- 60 minutes on day 1 of 21-day cycles in combination with 100 mg nirogacestat administered twice a day (BID) on day 1, 4, 8 and 15 of 21-day cycles. Treatment was administered until disease progression, intolerable toxicity, informed consent withdrawal, the end of the sub-study or death.
BG001
DE Phase: 1.9 mg/kg Belantamab Mafodotin+ Nirogacestat
In DE Phase, participants with RRMM received 1.9 mg/ kg belantamab mafodotin IV infusion as powder for solution once Q3W infused over 30- 60 minutes on day 1 of 21-day cycles in combination with 100 mg nirogacestat administered BID on day 1, 4, 8 and 15 of 21-day cycles. Treatment was administered until disease progression, intolerable toxicity, informed consent withdrawal, the end of the sub-study or death.
BG002
DE Phase: 1.0 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID
In DE Phase, participants with RRMM received 1.0 mg/ kg belantamab mafodotin IV infusion as powder for solution once every 4 weeks (Q4W) for Cycle 1-2 and then once every 8 weeks (Q8W) from Cycle 2 onwards, infused over 30- 60 minutes on day 1 of 28-day cycles in Q4W and 56-day cycle in Q8W in combination with 100 mg nirogacestat BID on day 1, 4, 8 and 15 of 21-day cycles. Treatment was administered until disease progression, intolerable toxicity, informed consent withdrawal, the end of the sub-study or death.
BG003
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID
In DE Phase, participants with RRMM received 1.4 mg/ kg belantamab mafodotin IV infusion as powder for solution Q4W for Cycle 1 and then Q8W from Cycle2 onwards, infused over 30- 60 minutes on day 1 of 21-day cycles in combination with 100 mg nirogacestat BID on day 1, 4, 8 and 15 of 21-day cycles. Treatment was administered until disease progression, intolerable toxicity, informed consent withdrawal, the end of the sub-study or death.
BG004
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W + Nirogacestat BID
In DE Phase, participants with RRMM received 1.4 mg/ kg belantamab mafodotin IV infusion as powder for solution Q4W, infused over 30- 60 minutes on day 1 of 28-day cycles in combination with 100 mg nirogacestat BID on day 1, 4, 8 and 15 of 21-day cycles. Treatment was administered until disease progression, intolerable toxicity, informed consent withdrawal, the end of the sub-study or death.
BG005
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat
In CE Phase, Participants with RRMM received 0.95 mg/ kg belantamab mafodotin IV infusion as powder for solution once every 3 weeks (Q3W), infused over 30- 60 minutes on day 1 of 21-day cycles in combination with 100 mg nirogacestat BID on day 1, 4, 8 and 15 of 21-day cycles. Treatment was administered until disease progression, intolerable toxicity, informed consent withdrawal, the end of the sub-study or death.
BG006
CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W
In CE Phase, Participants with RRMM received 2.5 mg/ kg belantamab mafodotin IV infusion as powder for solution Q3W, infused over 30- 60 minutes on day 1 of 21-day cycles until disease progression, intolerable toxicity, informed consent withdrawal, the end of the sub-study or death.
BG007
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00010
BG0014
BG00210
BG00310
BG0041
BG00534
BG00637
BG007106
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Customized
Count of Participants
Participants
Title
Denominators
Categories
18 years to >=75 years
Title
Measurements
BG00010
BG0014
BG00210
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0005
BG0012
BG002
Race/Ethnicity, Customized
Race categories ('Asian', 'Black or African American' and 'White') are combined into 'All Other Races' category as the study is evaluating participants with rare disease.
Count of Participants
Participants
Title
Denominators
Categories
All other races
Title
Measurements
BG00010
BG001
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
DE Phase: Number of Participants With Dose Limiting Toxicities (DLTs)
Criteria for dose-limiting toxicity (DLT) included hematologic indicators such as Grade 3-5 febrile neutropenia and thrombocytopenia with bleeding. Non-hematologic criteria, excluding corneal toxicity, comprise Grade 3-5 toxicities, with exceptions for manageable nausea, vomiting, or diarrhea, controlled Grade 3 hypertension, and events linked to disease progression. Tumor lysis syndrome (TLS) of Grade 3 or 4, successfully managed within 7 days without end-organ damage, was considered. Corneal toxicity, assessed by the GSK corneal grading scale at Grade 4, is a DLT. Other organ-specific toxicities, notably liver toxicity meeting GSK stopping criteria, also qualified as DLTs. Severity was graded using National Cancer Institute (NCI) - Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0.
DLT Evaluable Population included participants in DE phase who have received at least 80% of all components of the intended dose of treatment in cycle 1 and were followed up for a period of one cycle length or withdrawn within the first cycle due to an AE meeting the definition of a DLT.
Posted
Count of Participants
Participants
Up to 28 days
ID
Title
Description
OG000
DE Phase: 0.95 mg/kg Belantamab Mafodotin + Nirogacestat
In DE Phase, participants with Relapsed/Refractory Multiple Myeloma (RRMM) received 0.95 milligram (mg)/kilogram (kg) belantamab mafodotin intravenous (IV) infusion as powder for solution once every 3 weeks (Q3W) infused over 30- 60 minutes on day 1 of 21-day cycles in combination with 100 mg nirogacestat administered twice a day (BID) on day 1, 4, 8 and 15 of 21-day cycles. Treatment was administered until disease progression, intolerable toxicity, informed consent withdrawal, the end of the sub-study or death.
OG001
DE Phase: 1.9 mg/kg Belantamab Mafodotin+ Nirogacestat
In DE Phase, participants with RRMM received 1.9 mg/ kg belantamab mafodotin IV infusion as powder for solution once Q3W infused over 30- 60 minutes on day 1 of 21-day cycles in combination with 100 mg nirogacestat administered BID on day 1, 4, 8 and 15 of 21-day cycles. Treatment was administered until disease progression, intolerable toxicity, informed consent withdrawal, the end of the sub-study or death.
OG002
DE Phase: 1.0 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID
In DE Phase, participants with RRMM received 1.0 mg/ kg belantamab mafodotin IV infusion as powder for solution once every 4 weeks (Q4W) for Cycle 1-2 and then once every 8 weeks (Q8W) from Cycle 2 onwards, infused over 30- 60 minutes on day 1 of 28-day cycles in Q4W and 56-day cycle in Q8W in combination with 100 mg nirogacestat BID on day 1, 4, 8 and 15 of 21-day cycles. Treatment was administered until disease progression, intolerable toxicity, informed consent withdrawal, the end of the sub-study or death.
OG003
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID
In DE Phase, participants with RRMM received 1.4 mg/ kg belantamab mafodotin IV infusion as powder for solution Q4W for Cycle 1 and then Q8W from Cycle2 onwards, infused over 30- 60 minutes on day 1 of 21-day cycles in combination with 100 mg nirogacestat BID on day 1, 4, 8 and 15 of 21-day cycles. Treatment was administered until disease progression, intolerable toxicity, informed consent withdrawal, the end of the sub-study or death.
Units
Counts
Participants
OG0008
OG0013
OG0026
OG003
Title
Denominators
Categories
Title
Measurements
OG0001
OG0012
OG0020
OG003
Primary
DE Phase: Number of Participants With Adverse Events (AEs)
An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) coding system.
Safety population included all participants who received at least 1 dose of any component of the combination therapy.
Posted
Count of Participants
Participants
Up to approximately 253 weeks
ID
Title
Description
OG000
DE Phase: 0.95 mg/kg Belantamab Mafodotin + Nirogacestat
In DE Phase, participants with Relapsed/Refractory Multiple Myeloma (RRMM) received 0.95 milligram (mg)/kilogram (kg) belantamab mafodotin intravenous (IV) infusion as powder for solution once every 3 weeks (Q3W) infused over 30- 60 minutes on day 1 of 21-day cycles in combination with 100 mg nirogacestat administered twice a day (BID) on day 1, 4, 8 and 15 of 21-day cycles. Treatment was administered until disease progression, intolerable toxicity, informed consent withdrawal, the end of the sub-study or death.
OG001
DE Phase: 1.9 mg/kg Belantamab Mafodotin+ Nirogacestat
In DE Phase, participants with RRMM received 1.9 mg/ kg belantamab mafodotin IV infusion as powder for solution once Q3W infused over 30- 60 minutes on day 1 of 21-day cycles in combination with 100 mg nirogacestat administered BID on day 1, 4, 8 and 15 of 21-day cycles. Treatment was administered until disease progression, intolerable toxicity, informed consent withdrawal, the end of the sub-study or death.
Primary
DE Phase: Number of Participants With Worst-case Hematology Results by Maximum Grade Increase Post - Baseline Relative to Baseline
Blood samples were collected for evaluation of hematology parameters including Anemia (An), Hemoglobin increased (HbI), Lymphocyte count decreased (LyD), Lymphocytes count increased (LyI), Neutrophils count decreased (NeuD), Platelet count decreased (PD), Leukocytosis (LC) and White blood cell decreased (WBCD). The laboratory parameters were graded according to CTCAE v5.0. Grade 1 (G1): mild; Grade 2 (G2): moderate; Grade 3 (G3): severe; Grade 4 (G4) life-threatening or disabling. Higher grade indicates greater severity and an increase in CTCAE grade was defined relative to the Baseline grade. Any worst-case post baseline increases to G1, G2, G3, and G4 are presented. Baseline value was defined as the most recent, non-missing value from a local laboratory prior to the first dose of study treatment.
Safety Population.
Posted
Count of Participants
Participants
Baseline (Day 1) and up to approximately 253 weeks
ID
Title
Description
OG000
DE Phase: 0.95 mg/kg Belantamab Mafodotin + Nirogacestat
In DE Phase, participants with Relapsed/Refractory Multiple Myeloma (RRMM) received 0.95 milligram (mg)/kilogram (kg) belantamab mafodotin intravenous (IV) infusion as powder for solution once every 3 weeks (Q3W) infused over 30- 60 minutes on day 1 of 21-day cycles in combination with 100 mg nirogacestat administered twice a day (BID) on day 1, 4, 8 and 15 of 21-day cycles. Treatment was administered until disease progression, intolerable toxicity, informed consent withdrawal, the end of the sub-study or death.
Primary
DE Phase: Number of Participants With Worst-Case Chemistry Results by Maximum Grade Increase Post - Baseline Relative to Baseline
Blood samples were collected for evaluation of clinical chemistry parameters including Hypoglycemia (HG), Hypoalbuminemia (HA), Creatinine Kinase increased (CPKi), Hyperkalemia (HK), Blood lactate dehydrogenase Increased (BLDi), Hypermagnesemia (HyperM), Hypomagnesemia (HypoM), Hypernatremia (HyperN), Hypercalcemia (HyperC), Hypocalcemia (HypoC) and Chronic Kidney Disease (CKD). The laboratory parameters were graded according to CTCAE version 5. G1: mild; G2: moderate; G3: severe; Grade 4 (G4) life-threatening or disabling. Higher grade indicates greater severity and an increase in CTCAE grade was defined relative to the Baseline grade. Any worst-case post baseline increase to G1, G2, G3, and G4 are presented. Baseline value was defined as the most recent, non-missing value from a local laboratory prior to the first dose of study treatment.
Safety Population. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified categories.
Posted
Count of Participants
Participants
Baseline (Day 1) and up to approximately 253 weeks
ID
Title
Description
OG000
DE Phase: 0.95 mg/kg Belantamab Mafodotin + Nirogacestat
In DE Phase, participants with Relapsed/Refractory Multiple Myeloma (RRMM) received 0.95 milligram (mg)/kilogram (kg) belantamab mafodotin intravenous (IV) infusion as powder for solution once every 3 weeks (Q3W) infused over 30- 60 minutes on day 1 of 21-day cycles in combination with 100 mg nirogacestat administered twice a day (BID) on day 1, 4, 8 and 15 of 21-day cycles. Treatment was administered until disease progression, intolerable toxicity, informed consent withdrawal, the end of the sub-study or death.
Primary
CE Phase: Overall Response Rate (ORR)
Overall Response Rate (ORR) was defined as the percentage of participants with a confirmed Partial Response (PR) or better as the best overall response (i.e., PR, Very Good Partial Response [VGPR], Complete Response [CR], and stringent Complete Response [sCR]), as assessed by the investigator per international myeloma working group (IMWG) (2016). PR is defined as ≥50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥90% or to <200 mg/24 h. VGPR is defined as serum and urine M-component detectable by immunofixation but not on electrophoresis OR ≥ 90% reduction in serum M-component plus urine M-component <100 mg/24 h. CR is defined as negative immunofixation of serum and urine AND disappearance of any soft tissue plasmacytomas AND <5% plasmacytomas in the bone marrow. sCR is defined as CR as above PLUS normal serum free light-chain (FLC) assay ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence.
Safety Population
Posted
Number
95% Confidence Interval
Percentage of participants
Up to approximately 253 weeks
ID
Title
Description
OG000
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat
In CE Phase, Participants with RRMM received 0.95 mg/ kg belantamab mafodotin IV infusion as powder for solution once every 3 weeks (Q3W), infused over 30- 60 minutes on day 1 of 21-day cycles in combination with 100 mg nirogacestat BID on day 1, 4, 8 and 15 of 21-day cycles. Treatment was administered until disease progression, intolerable toxicity, informed consent withdrawal, the end of the sub-study or death.
Secondary
DE Phase: Overall Response Rate (ORR)
Overall Response Rate (ORR) was defined as the percentage of participants with a confirmed Partial Response (PR) or better as the best overall response (i.e., PR, Very Good Partial Response [VGPR], Complete Response [CR], and stringent Complete Response [sCR]), as assessed by the investigator per international myeloma working group (IMWG) (2016). PR is defined as ≥50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥90% or to <200 mg/24 h. VGPR is defined as serum and urine M-component detectable by immunofixation but not on electrophoresis OR ≥ 90% reduction in serum M-component plus urine M-component <100 mg/24 h. CR is defined as negative immunofixation of serum and urine AND disappearance of any soft tissue plasmacytomas AND <5% plasmacytomas in the bone marrow. sCR is defined as CR as above PLUS normal serum free light-chain (FLC) assay ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence.
Safety Population
Posted
Number
95% Confidence Interval
Percentage of participants
Up to approximately 253 weeks
ID
Title
Description
OG000
DE Phase: 0.95 mg/kg Belantamab Mafodotin + Nirogacestat
In DE Phase, participants with Relapsed/Refractory Multiple Myeloma (RRMM) received 0.95 milligram (mg)/kilogram (kg) belantamab mafodotin intravenous (IV) infusion as powder for solution once every 3 weeks (Q3W) infused over 30- 60 minutes on day 1 of 21-day cycles in combination with 100 mg nirogacestat administered twice a day (BID) on day 1, 4, 8 and 15 of 21-day cycles. Treatment was administered until disease progression, intolerable toxicity, informed consent withdrawal, the end of the sub-study or death.
Secondary
CE Phase: Clinical Benefit Rate (CBR)
Clinical benefit rate was defined as the percentage of participants with a confirmed minimal response (MR) or better according to the IMWG Response Criteria. MR is defined as >= 25% but < 49% reduction of serum M-protein and reduction in 24-hour urinary M-protein by 50-89%.
Safety Population
Posted
Number
95% Confidence Interval
Percentage of participants
Up to approximately 253 weeks
ID
Title
Description
OG000
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat
In CE Phase, Participants with RRMM received 0.95 mg/ kg belantamab mafodotin IV infusion as powder for solution once every 3 weeks (Q3W), infused over 30- 60 minutes on day 1 of 21-day cycles in combination with 100 mg nirogacestat BID on day 1, 4, 8 and 15 of 21-day cycles. Treatment was administered until disease progression, intolerable toxicity, informed consent withdrawal, the end of the sub-study or death.
OG001
CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W
In CE Phase, Participants with RRMM received 2.5 mg/ kg belantamab mafodotin IV infusion as powder for solution Q3W, infused over 30- 60 minutes on day 1 of 21-day cycles until disease progression, intolerable toxicity, informed consent withdrawal, the end of the sub-study or death.
Secondary
DE Phase: Number of Participants Achieving Stringent Complete Response (SCR), Complete Response (CR), Very Good Partial Response (VGPR) and Partial Response (PR)
Partial Response [PR], Very Good Partial Response [VGPR], Complete Response [CR], and stringent Complete Response [sCR] as assessed by the investigator per IMWG (2016). PR is defined as ≥50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥90% or to <200 mg/24 h. VGPR is defined as serum and urine M-component detectable by immunofixation but not on electrophoresis OR ≥ 90% reduction in serum M-component plus urine M-component <100 mg/24 h. CR is defined as negative immunofixation of serum and urine AND disappearance of any soft tissue plasmacytomas AND <5% plasmacytomas in the bone marrow. sCR is defined as CR as above PLUS normal serum free light-chain (FLC) assay ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence.
Safety Population
Posted
Number
Count of participants
Up to approximately 253 weeks
ID
Title
Description
OG000
DE Phase: 0.95 mg/kg Belantamab Mafodotin + Nirogacestat
In DE Phase, participants with Relapsed/Refractory Multiple Myeloma (RRMM) received 0.95 milligram (mg)/kilogram (kg) belantamab mafodotin intravenous (IV) infusion as powder for solution once every 3 weeks (Q3W) infused over 30- 60 minutes on day 1 of 21-day cycles in combination with 100 mg nirogacestat administered twice a day (BID) on day 1, 4, 8 and 15 of 21-day cycles. Treatment was administered until disease progression, intolerable toxicity, informed consent withdrawal, the end of the sub-study or death.
Secondary
CE Phase: Number of Participants Achieving SCR, CR, VGPR and PR
Partial Response [PR], Very Good Partial Response [VGPR], Complete Response [CR], and stringent Complete Response [sCR] as assessed by the investigator per IMWG (2016). PR is defined as ≥50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥90% or to <200 mg/24 h. VGPR is defined as serum and urine M-component detectable by immunofixation but not on electrophoresis OR ≥ 90% reduction in serum M-component plus urine M-component <100 mg/24 h. CR is defined as negative immunofixation of serum and urine AND disappearance of any soft tissue plasmacytomas AND <5% plasmacytomas in the bone marrow. sCR is defined as CR as above PLUS normal serum free light-chain (FLC) assay ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence.
Safety Population
Posted
Number
Count of participants
Up to approximately 253 weeks
ID
Title
Description
OG000
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat
In CE Phase, Participants with RRMM received 0.95 mg/ kg belantamab mafodotin IV infusion as powder for solution once every 3 weeks (Q3W), infused over 30- 60 minutes on day 1 of 21-day cycles in combination with 100 mg nirogacestat BID on day 1, 4, 8 and 15 of 21-day cycles. Treatment was administered until disease progression, intolerable toxicity, informed consent withdrawal, the end of the sub-study or death.
OG001
CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W
Secondary
DE Phase: Plasma Concentrations of Belantamab Mafodotin Antibody-Drug Conjugate (ADC)
Blood samples were collected for PK analysis of belantamab mafodotin Antibody-Drug Conjugate (ADC). Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified timepoints.
Pharmacokinetic population included all participants in the safety population from whom at least one PK sample has been obtained and analysed. 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
Median
Full Range
Nanogram/millilitre (ng/mL)
PRE-DOSE(PD), END OF INFUSION (EOI), EOI+2 HOURS(H), EOI+ 24H on Day(D) 1 of Cycle (C) 1; ANYTIME on C1 D4, D8, D22, and D29 ; PD and EOI on D1 of C2, C4, C6, C9, C12; PD on D1 of C18 and C30; End of Treatment (approximately 157 weeks)
ID
Title
Description
OG000
DE Phase: 0.95 mg/kg Belantamab Mafodotin + Nirogacestat
In DE Phase, participants with Relapsed/Refractory Multiple Myeloma (RRMM) received 0.95 milligram (mg)/kilogram (kg) belantamab mafodotin intravenous (IV) infusion as powder for solution once every 3 weeks (Q3W) infused over 30- 60 minutes on day 1 of 21-day cycles in combination with 100 mg nirogacestat administered twice a day (BID) on day 1, 4, 8 and 15 of 21-day cycles. Treatment was administered until disease progression, intolerable toxicity, informed consent withdrawal, the end of the sub-study or death.
Secondary
CE Phase: Plasma Concentrations of Belantamab Mafodotin Antibody-Drug Conjugate (ADC)
Blood samples were collected for PK analysis of belantamab mafodotin Antibody-Drug Conjugate (ADC).
Pharmacokinetic population. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified 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
Median
Full Range
ng/mL
PRE-DOSE(PD), END OF INFUSION (EOI), EOI+2 HOURS(H), EOI+ 24H on Day(D) 1 of Cycle (C) 1; ANYTIME on C1 D4, D8, and D22 ; PD and EOI on D1 of C2, C4, C6, C9, C12; PD on D1 of C18; End of Treatment (approximately 157 weeks)
ID
Title
Description
OG000
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat
In CE Phase, Participants with RRMM received 0.95 mg/ kg belantamab mafodotin IV infusion as powder for solution once every 3 weeks (Q3W), infused over 30- 60 minutes on day 1 of 21-day cycles in combination with 100 mg nirogacestat BID on day 1, 4, 8 and 15 of 21-day cycles. Treatment was administered until disease progression, intolerable toxicity, informed consent withdrawal, the end of the sub-study or death.
OG001
CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W
In CE Phase, Participants with RRMM received 2.5 mg/ kg belantamab mafodotin IV infusion as powder for solution Q3W, infused over 30- 60 minutes on day 1 of 21-day cycles until disease progression, intolerable toxicity, informed consent withdrawal, the end of the sub-study or death.
Secondary
DE Phase: Plasma Concentration of Belantamab Mafodotin Total Antibody
Blood samples were collected for PK analysis of Belantamab mafodotin total antibody.
Pharmacokinetic population. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified 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
Median
Full Range
ng/mL
PRE-DOSE(PD), END OF INFUSION (EOI), EOI+2 HOURS(H), EOI+ 24H on Day(D) 1 of Cycle (C) 1; ANYTIME on C1 D4, D8, D22, and D29; PD and EOI on D1 of C2, C4, C6, C9, C12; PD on D1 of C18 and C30; End of Treatment (approximately 157 weeks)
ID
Title
Description
OG000
DE Phase: 0.95 mg/kg Belantamab Mafodotin + Nirogacestat
In DE Phase, participants with Relapsed/Refractory Multiple Myeloma (RRMM) received 0.95 milligram (mg)/kilogram (kg) belantamab mafodotin intravenous (IV) infusion as powder for solution once every 3 weeks (Q3W) infused over 30- 60 minutes on day 1 of 21-day cycles in combination with 100 mg nirogacestat administered twice a day (BID) on day 1, 4, 8 and 15 of 21-day cycles. Treatment was administered until disease progression, intolerable toxicity, informed consent withdrawal, the end of the sub-study or death.
OG001
DE Phase: 1.9 mg/kg Belantamab Mafodotin+ Nirogacestat
Secondary
CE Phase: Plasma Concentration of Belantamab Mafodotin Plasma Total Antibody
Blood samples were collected for PK analysis of Belantamab mafodotin total antibody.
Pharmacokinetic population. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified 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
Median
Full Range
ng/mL
PRE-DOSE(PD), END OF INFUSION (EOI), EOI+2 HOURS(H), EOI+ 24H on Day(D) 1 of Cycle (C) 1; ANYTIME on C1 D4, D8, and D22; PD and EOI on D1 of C2, C4, C6, C9, C12; PD on D1 of C18; End of Treatment (appoximately 157 weeks)
ID
Title
Description
OG000
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat
In CE Phase, Participants with RRMM received 0.95 mg/ kg belantamab mafodotin IV infusion as powder for solution once every 3 weeks (Q3W), infused over 30- 60 minutes on day 1 of 21-day cycles in combination with 100 mg nirogacestat BID on day 1, 4, 8 and 15 of 21-day cycles. Treatment was administered until disease progression, intolerable toxicity, informed consent withdrawal, the end of the sub-study or death.
OG001
CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W
In CE Phase, Participants with RRMM received 2.5 mg/ kg belantamab mafodotin IV infusion as powder for solution Q3W, infused over 30- 60 minutes on day 1 of 21-day cycles until disease progression, intolerable toxicity, informed consent withdrawal, the end of the sub-study or death.
Secondary
DE Phase: Plasma Concentrations of Belantamab Mafodotin Cys- Monomethyl Auristatin-F (Cys-mcMMAF)
Blood samples were collected for PK analysis of belantamab mafodotin cys- monomethyl auristatin-F (cys-mcMMAF).
Pharmacokinetic population. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified 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
Median
Full Range
Picogram / millilitre (pg/mL)
PRE-DOSE(PD), END OF INFUSION (EOI), EOI+2 HOURS(H), EOI+ 24H on Day(D) 1 of Cycle (C) 1; ANYTIME on C1 D4, D8, D22, and D29; PD and EOI on D1 of C2, C4, C6, C9, C12; PD on D1 of C18 and C30; End of Treatment (approximately 157 weeks)
ID
Title
Description
OG000
DE Phase: 0.95 mg/kg Belantamab Mafodotin + Nirogacestat
In DE Phase, participants with Relapsed/Refractory Multiple Myeloma (RRMM) received 0.95 milligram (mg)/kilogram (kg) belantamab mafodotin intravenous (IV) infusion as powder for solution once every 3 weeks (Q3W) infused over 30- 60 minutes on day 1 of 21-day cycles in combination with 100 mg nirogacestat administered twice a day (BID) on day 1, 4, 8 and 15 of 21-day cycles. Treatment was administered until disease progression, intolerable toxicity, informed consent withdrawal, the end of the sub-study or death.
OG001
DE Phase: 1.9 mg/kg Belantamab Mafodotin+ Nirogacestat
Secondary
CE Phase: Plasma Concentrations of Belantamab Mafodotin Cys- Monomethyl Auristatin-F (Cys-mcMMAF)
Blood samples were collected for PK analysis of belantamab mafodotin cys- monomethyl auristatin-F (cys-mcMMAF).
Pharmacokinetic population. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified timepoints.
Posted
Median
Full Range
pg/mL
PRE-DOSE(PD), END OF INFUSION (EOI), EOI+2 HOURS(H), EOI+ 24H on Day(D) 1 of Cycle (C) 1; ANYTIME on C1 D4, D8, D22 ; PD and EOI on D1 of C2, C4, C6, C9, C12; PD on D1 of C18; End of Treatment (approximately 157 weeks)
ID
Title
Description
OG000
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat
In CE Phase, Participants with RRMM received 0.95 mg/ kg belantamab mafodotin IV infusion as powder for solution once every 3 weeks (Q3W), infused over 30- 60 minutes on day 1 of 21-day cycles in combination with 100 mg nirogacestat BID on day 1, 4, 8 and 15 of 21-day cycles. Treatment was administered until disease progression, intolerable toxicity, informed consent withdrawal, the end of the sub-study or death.
OG001
CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W
In CE Phase, Participants with RRMM received 2.5 mg/ kg belantamab mafodotin IV infusion as powder for solution Q3W, infused over 30- 60 minutes on day 1 of 21-day cycles until disease progression, intolerable toxicity, informed consent withdrawal, the end of the sub-study or death.
Secondary
DE Phase: Plasma Concentration of Nirogacestat When Administered in Combination With Belantamab Mafodotin
Blood samples were collected for PK analysis of Nirogacestat when administered orally in combination with belantamab mafodotin.
Pharmacokinetic population. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified 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
Median
Full Range
ng/mL
PRE-DOSE (PD), Post-dose 30 Minutes, 1H, 2H, and 4H on Cycle (C) 1 Day (D) -2; PRE-DOSE (PD), Post-dose 30 Minutes, 1H, 2H, 4H, 8H on C1D1; PD on C1D4 and D8 ; PD, Post-dose 30 Minutes, 1H, 2H, 4H, 8H on C2D1
ID
Title
Description
OG000
DE Phase: 0.95 mg/kg Belantamab Mafodotin + Nirogacestat
In DE Phase, participants with Relapsed/Refractory Multiple Myeloma (RRMM) received 0.95 milligram (mg)/kilogram (kg) belantamab mafodotin intravenous (IV) infusion as powder for solution once every 3 weeks (Q3W) infused over 30- 60 minutes on day 1 of 21-day cycles in combination with 100 mg nirogacestat administered twice a day (BID) on day 1, 4, 8 and 15 of 21-day cycles. Treatment was administered until disease progression, intolerable toxicity, informed consent withdrawal, the end of the sub-study or death.
OG001
DE Phase: 1.9 mg/kg Belantamab Mafodotin+ Nirogacestat
Secondary
CE Phase: Plasma Concentration of Nirogacestat When Administered in Combination With Belantamab Mafodotin
Blood samples were collected for PK analysis of Nirogacestat when administered orally in combination with belantamab mafodotin.
Pharmacokinetic population. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified timepoints.
Posted
Median
Full Range
ng/mL
PRE-DOSE (PD), Post-dose 30 Minutes, 1H, 2H, 4H, 8H on C1D1; PD on C1D4 and D8 ; PD, Post-dose 30 Minutes, 1H, 2H, 4H, 8H on C2D1
ID
Title
Description
OG000
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat
In CE Phase, Participants with RRMM received 0.95 mg/ kg belantamab mafodotin IV infusion as powder for solution once every 3 weeks (Q3W), infused over 30- 60 minutes on day 1 of 21-day cycles in combination with 100 mg nirogacestat BID on day 1, 4, 8 and 15 of 21-day cycles. Treatment was administered until disease progression, intolerable toxicity, informed consent withdrawal, the end of the sub-study or death.
Units
Counts
Participants
Secondary
DE Phase: Number of Participants With Post-baseline Positive Anti-drug Antibodies (ADAs) Against Belantamab Mafodotin
Serum samples were collected for the analysis of the presence of ADAs using validated immunoassays. All samples were tested in screening assay, and positive samples were further characterized for antibody titers.
Safety Population. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified 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
Count of Participants
Participants
C2 D1, C4 D1, C6 D1, C9 D1, C12 D1, C18 D1, C30 D1, End of Treatment (approximately 157 weeks)
ID
Title
Description
OG000
DE Phase: 0.95 mg/kg Belantamab Mafodotin + Nirogacestat
In DE Phase, participants with Relapsed/Refractory Multiple Myeloma (RRMM) received 0.95 milligram (mg)/kilogram (kg) belantamab mafodotin intravenous (IV) infusion as powder for solution once every 3 weeks (Q3W) infused over 30- 60 minutes on day 1 of 21-day cycles in combination with 100 mg nirogacestat administered twice a day (BID) on day 1, 4, 8 and 15 of 21-day cycles. Treatment was administered until disease progression, intolerable toxicity, informed consent withdrawal, the end of the sub-study or death.
OG001
DE Phase: 1.9 mg/kg Belantamab Mafodotin+ Nirogacestat
Secondary
CE Phase: Number of Participants With Post-baseline Positive ADAs Against Belantamab Mafodotin
Serum samples were collected for the analysis of the presence of ADAs using validated immunoassays. All samples were tested in screening assay, and positive samples were further characterized for antibody titers.
Safety Population. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified timepoints.
Posted
Count of Participants
Participants
C2 D1, C4 D1, C6 D1, C9 D1, C12 D1, C18 D1, End of Treatment (approximately 157 weeks)
ID
Title
Description
OG000
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat
In CE Phase, Participants with RRMM received 0.95 mg/ kg belantamab mafodotin IV infusion as powder for solution once every 3 weeks (Q3W), infused over 30- 60 minutes on day 1 of 21-day cycles in combination with 100 mg nirogacestat BID on day 1, 4, 8 and 15 of 21-day cycles. Treatment was administered until disease progression, intolerable toxicity, informed consent withdrawal, the end of the sub-study or death.
OG001
CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W
In CE Phase, Participants with RRMM received 2.5 mg/ kg belantamab mafodotin IV infusion as powder for solution Q3W, infused over 30- 60 minutes on day 1 of 21-day cycles until disease progression, intolerable toxicity, informed consent withdrawal, the end of the sub-study or death.
Secondary
DE Phase: Titer of ADAs Against Belantamab Mafodotin
Serum samples were collected for the analysis of the presence of ADAs using validated immunoassays. All samples were to be further tested in screening assay, and positive samples were further to be characterized for antibody titers.
Safety Population. No participants were found positive for ADAs, hence participants were not analyzed for titers of ADAs.
Posted
Up to approximately 157 weeks.
ID
Title
Description
OG000
DE Phase: 0.95 mg/kg Belantamab Mafodotin + Nirogacestat
In DE Phase, participants with Relapsed/Refractory Multiple Myeloma (RRMM) received 0.95 milligram (mg)/kilogram (kg) belantamab mafodotin intravenous (IV) infusion as powder for solution once every 3 weeks (Q3W) infused over 30- 60 minutes on day 1 of 21-day cycles in combination with 100 mg nirogacestat administered twice a day (BID) on day 1, 4, 8 and 15 of 21-day cycles. Treatment was administered until disease progression, intolerable toxicity, informed consent withdrawal, the end of the sub-study or death.
OG001
DE Phase: 1.9 mg/kg Belantamab Mafodotin+ Nirogacestat
In DE Phase, participants with RRMM received 1.9 mg/ kg belantamab mafodotin IV infusion as powder for solution once Q3W infused over 30- 60 minutes on day 1 of 21-day cycles in combination with 100 mg nirogacestat administered BID on day 1, 4, 8 and 15 of 21-day cycles. Treatment was administered until disease progression, intolerable toxicity, informed consent withdrawal, the end of the sub-study or death.
Secondary
CE Phase: Titer of ADAs Against Belantamab Mafodotin
Serum samples were collected for the analysis of the presence of ADAs using validated immunoassays. All samples were further tested in screening assay, and positive samples were further characterized for antibody titers.
Safety Population. Only those participants with positive ADA data available at the specified timepoint is presented.
Posted
Median
Full Range
Titer
C2 D1 and at End of Treatment (approximately 157 weeks)
ID
Title
Description
OG000
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat
In CE Phase, Participants with RRMM received 0.95 mg/ kg belantamab mafodotin IV infusion as powder for solution once every 3 weeks (Q3W), infused over 30- 60 minutes on day 1 of 21-day cycles in combination with 100 mg nirogacestat BID on day 1, 4, 8 and 15 of 21-day cycles. Treatment was administered until disease progression, intolerable toxicity, informed consent withdrawal, the end of the sub-study or death.
OG001
CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W
In CE Phase, Participants with RRMM received 2.5 mg/ kg belantamab mafodotin IV infusion as powder for solution Q3W, infused over 30- 60 minutes on day 1 of 21-day cycles until disease progression, intolerable toxicity, informed consent withdrawal, the end of the sub-study or death.
Secondary
DE Phase: Number of Participants With Adverse Events of Special Interest (AESI) for Belantamab Mafodotin
An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Adverse Events of Special Interest (whether serious or non serious) were collected.
Safety Population
Posted
Count of Participants
Participants
Up to approximately 253 weeks
ID
Title
Description
OG000
DE Phase: 0.95 mg/kg Belantamab Mafodotin + Nirogacestat
In DE Phase, participants with Relapsed/Refractory Multiple Myeloma (RRMM) received 0.95 milligram (mg)/kilogram (kg) belantamab mafodotin intravenous (IV) infusion as powder for solution once every 3 weeks (Q3W) infused over 30- 60 minutes on day 1 of 21-day cycles in combination with 100 mg nirogacestat administered twice a day (BID) on day 1, 4, 8 and 15 of 21-day cycles. Treatment was administered until disease progression, intolerable toxicity, informed consent withdrawal, the end of the sub-study or death.
OG001
DE Phase: 1.9 mg/kg Belantamab Mafodotin+ Nirogacestat
In DE Phase, participants with RRMM received 1.9 mg/ kg belantamab mafodotin IV infusion as powder for solution once Q3W infused over 30- 60 minutes on day 1 of 21-day cycles in combination with 100 mg nirogacestat administered BID on day 1, 4, 8 and 15 of 21-day cycles. Treatment was administered until disease progression, intolerable toxicity, informed consent withdrawal, the end of the sub-study or death.
Secondary
CE Phase: Number of Participants With Adverse Events of Special Interest (AESI) for Belantamab Mafodotin
An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Adverse Events of Special Interest (whether serious or non serious) were collected.
Safety Population
Posted
Count of Participants
Participants
Up to approximately 253 weeks
ID
Title
Description
OG000
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat
In CE Phase, Participants with RRMM received 0.95 mg/ kg belantamab mafodotin IV infusion as powder for solution once every 3 weeks (Q3W), infused over 30- 60 minutes on day 1 of 21-day cycles in combination with 100 mg nirogacestat BID on day 1, 4, 8 and 15 of 21-day cycles. Treatment was administered until disease progression, intolerable toxicity, informed consent withdrawal, the end of the sub-study or death.
OG001
CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W
In CE Phase, Participants with RRMM received 2.5 mg/ kg belantamab mafodotin IV infusion as powder for solution Q3W, infused over 30- 60 minutes on day 1 of 21-day cycles until disease progression, intolerable toxicity, informed consent withdrawal, the end of the sub-study or death.
Secondary
DE Phase: Number of Participants With Any Corneal Event by Maximum Grade as Per CTCAE Grade
The corneal events were graded according to CTCAE version 5. Grade 1: mild; Grade 2: moderate; Grade 3: severe or medically significant. Grade 4: Life-threatening consequences; Grade 5: Death related to AE. Higher grade indicates greater severity and an increase in CTCAE grade was defined relative to the Baseline grade. Results are presented for number of participants with any corneal events by maximum grade as per CTCAE grade v5.0.
Safety Population
Posted
Count of Participants
Participants
Up to approximately 253 weeks
ID
Title
Description
OG000
DE Phase: 0.95 mg/kg Belantamab Mafodotin + Nirogacestat
In DE Phase, participants with Relapsed/Refractory Multiple Myeloma (RRMM) received 0.95 milligram (mg)/kilogram (kg) belantamab mafodotin intravenous (IV) infusion as powder for solution once every 3 weeks (Q3W) infused over 30- 60 minutes on day 1 of 21-day cycles in combination with 100 mg nirogacestat administered twice a day (BID) on day 1, 4, 8 and 15 of 21-day cycles. Treatment was administered until disease progression, intolerable toxicity, informed consent withdrawal, the end of the sub-study or death.
OG001
DE Phase: 1.9 mg/kg Belantamab Mafodotin+ Nirogacestat
In DE Phase, participants with RRMM received 1.9 mg/ kg belantamab mafodotin IV infusion as powder for solution once Q3W infused over 30- 60 minutes on day 1 of 21-day cycles in combination with 100 mg nirogacestat administered BID on day 1, 4, 8 and 15 of 21-day cycles. Treatment was administered until disease progression, intolerable toxicity, informed consent withdrawal, the end of the sub-study or death.
Secondary
CE Phase: Number of Participants With Any Corneal Event by Maximum Grade as Per CTCAE Grade
The corneal events were graded according to CTCAE version 5. Grade 1: mild; Grade 2: moderate; Grade 3: severe or medically significant. Grade 4: Life-threatening consequences; Grade 5: Death related to AE. Higher grade indicates greater severity and an increase in CTCAE grade was defined relative to the Baseline grade. Results are presented for number of participants with any corneal events by maximum grade as per CTCAE grade v5.0.
Safety Population
Posted
Count of Participants
Participants
Up to approximately 253 weeks
ID
Title
Description
OG000
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat
In CE Phase, Participants with RRMM received 0.95 mg/ kg belantamab mafodotin IV infusion as powder for solution once every 3 weeks (Q3W), infused over 30- 60 minutes on day 1 of 21-day cycles in combination with 100 mg nirogacestat BID on day 1, 4, 8 and 15 of 21-day cycles. Treatment was administered until disease progression, intolerable toxicity, informed consent withdrawal, the end of the sub-study or death.
OG001
CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W
In CE Phase, Participants with RRMM received 2.5 mg/ kg belantamab mafodotin IV infusion as powder for solution Q3W, infused over 30- 60 minutes on day 1 of 21-day cycles until disease progression, intolerable toxicity, informed consent withdrawal, the end of the sub-study or death.
Secondary
CE Phase: Progression-free Survival (PFS)
PFS is defined as the time from randomization until the earliest date of confirmed progressive disease (PD) per IMWG, or death due to any cause.
Safety Population
Posted
Median
95% Confidence Interval
Months
Up to approximately 253 weeks
ID
Title
Description
OG000
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat
In CE Phase, Participants with RRMM received 0.95 mg/ kg belantamab mafodotin IV infusion as powder for solution once every 3 weeks (Q3W), infused over 30- 60 minutes on day 1 of 21-day cycles in combination with 100 mg nirogacestat BID on day 1, 4, 8 and 15 of 21-day cycles. Treatment was administered until disease progression, intolerable toxicity, informed consent withdrawal, the end of the sub-study or death.
OG001
CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W
In CE Phase, Participants with RRMM received 2.5 mg/ kg belantamab mafodotin IV infusion as powder for solution Q3W, infused over 30- 60 minutes on day 1 of 21-day cycles until disease progression, intolerable toxicity, informed consent withdrawal, the end of the sub-study or death.
Units
Counts
Secondary
CE Phase: Duration of Response (DoR)
DoR is defined as the time from first documented evidence or PR or better until progressive disease per IMWG or death due to progressive disease among participants who achieve confirmed partial response or better.
Safety Population. Only those participants with a confirmed PR or better as the best overall response (i.e., PR, VGPR, CR, and sCR) were assessed for this endpoint.
Posted
Median
95% Confidence Interval
Months
Up to approximately 253 weeks
ID
Title
Description
OG000
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat
In CE Phase, Participants with RRMM received 0.95 mg/ kg belantamab mafodotin IV infusion as powder for solution once every 3 weeks (Q3W), infused over 30- 60 minutes on day 1 of 21-day cycles in combination with 100 mg nirogacestat BID on day 1, 4, 8 and 15 of 21-day cycles. Treatment was administered until disease progression, intolerable toxicity, informed consent withdrawal, the end of the sub-study or death.
OG001
CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W
In CE Phase, Participants with RRMM received 2.5 mg/ kg belantamab mafodotin IV infusion as powder for solution Q3W, infused over 30- 60 minutes on day 1 of 21-day cycles until disease progression, intolerable toxicity, informed consent withdrawal, the end of the sub-study or death.
Secondary
CE Phase: Time to Response (TTR)
TTR is defined as the time between the date of randomization and the first documented evidence of response (PR or better), among participants who achieve a response (confirmed PR or better).
Safety Population. Only those participants with a confirmed PR or better as the best overall response (i.e., PR, VGPR, CR, and sCR) were assessed for this endpoint.
Posted
Median
95% Confidence Interval
Months
Up to approximately 253 weeks
ID
Title
Description
OG000
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat
In CE Phase, Participants with RRMM received 0.95 mg/ kg belantamab mafodotin IV infusion as powder for solution once every 3 weeks (Q3W), infused over 30- 60 minutes on day 1 of 21-day cycles in combination with 100 mg nirogacestat BID on day 1, 4, 8 and 15 of 21-day cycles. Treatment was administered until disease progression, intolerable toxicity, informed consent withdrawal, the end of the sub-study or death.
OG001
CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W
In CE Phase, Participants with RRMM received 2.5 mg/ kg belantamab mafodotin IV infusion as powder for solution Q3W, infused over 30- 60 minutes on day 1 of 21-day cycles until disease progression, intolerable toxicity, informed consent withdrawal, the end of the sub-study or death.
Secondary
CE Phase: Overall Survival (OS)
OS is defined as the time from randomization until death due to any cause.
Safety Population
Posted
Median
95% Confidence Interval
Months
Up to approximately 253 weeks
ID
Title
Description
OG000
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat
In CE Phase, Participants with RRMM received 0.95 mg/ kg belantamab mafodotin IV infusion as powder for solution once every 3 weeks (Q3W), infused over 30- 60 minutes on day 1 of 21-day cycles in combination with 100 mg nirogacestat BID on day 1, 4, 8 and 15 of 21-day cycles. Treatment was administered until disease progression, intolerable toxicity, informed consent withdrawal, the end of the sub-study or death.
OG001
CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W
In CE Phase, Participants with RRMM received 2.5 mg/ kg belantamab mafodotin IV infusion as powder for solution Q3W, infused over 30- 60 minutes on day 1 of 21-day cycles until disease progression, intolerable toxicity, informed consent withdrawal, the end of the sub-study or death.
Units
Counts
Participants
Secondary
CE Phase: Number of Participants With AEs and SAEs
An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that; results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, other situations judged by physician, is associated with liver injury and impaired liver function. AEs and SAEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) coding system.
Safety Population
Posted
Count of Participants
Participants
Up to approximately 253 weeks
ID
Title
Description
OG000
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat
In CE Phase, Participants with RRMM received 0.95 mg/ kg belantamab mafodotin IV infusion as powder for solution once every 3 weeks (Q3W), infused over 30- 60 minutes on day 1 of 21-day cycles in combination with 100 mg nirogacestat BID on day 1, 4, 8 and 15 of 21-day cycles. Treatment was administered until disease progression, intolerable toxicity, informed consent withdrawal, the end of the sub-study or death.
OG001
CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W
In CE Phase, Participants with RRMM received 2.5 mg/ kg belantamab mafodotin IV infusion as powder for solution Q3W, infused over 30- 60 minutes on day 1 of 21-day cycles until disease progression, intolerable toxicity, informed consent withdrawal, the end of the sub-study or death.
Secondary
CE Phase: Number of Participants With AEs Leading to Discontinuation
An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Number of participants with AEs leading to discontinuation were evaluated.
Safety Population
Posted
Count of Participants
Participants
Up to approximately 253 weeks
ID
Title
Description
OG000
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat
In CE Phase, Participants with RRMM received 0.95 mg/ kg belantamab mafodotin IV infusion as powder for solution once every 3 weeks (Q3W), infused over 30- 60 minutes on day 1 of 21-day cycles in combination with 100 mg nirogacestat BID on day 1, 4, 8 and 15 of 21-day cycles. Treatment was administered until disease progression, intolerable toxicity, informed consent withdrawal, the end of the sub-study or death.
OG001
CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W
In CE Phase, Participants with RRMM received 2.5 mg/ kg belantamab mafodotin IV infusion as powder for solution Q3W, infused over 30- 60 minutes on day 1 of 21-day cycles until disease progression, intolerable toxicity, informed consent withdrawal, the end of the sub-study or death.
Secondary
CE Phase: Number of Participants With Adverse Events Leading to Dose Reduction or Delay
Number of participants with adverse events leading to dose reduction or delay were evaluated.
Safety Population
Posted
Count of Participants
Participants
Up to approximately 253 weeks
ID
Title
Description
OG000
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat
In CE Phase, Participants with RRMM received 0.95 mg/ kg belantamab mafodotin IV infusion as powder for solution once every 3 weeks (Q3W), infused over 30- 60 minutes on day 1 of 21-day cycles in combination with 100 mg nirogacestat BID on day 1, 4, 8 and 15 of 21-day cycles. Treatment was administered until disease progression, intolerable toxicity, informed consent withdrawal, the end of the sub-study or death.
OG001
CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W
In CE Phase, Participants with RRMM received 2.5 mg/ kg belantamab mafodotin IV infusion as powder for solution Q3W, infused over 30- 60 minutes on day 1 of 21-day cycles until disease progression, intolerable toxicity, informed consent withdrawal, the end of the sub-study or death.
Units
Counts
Secondary
CE Phase: Number of Participants With Worst-case Hematology Results by Maximum Grade Increase Post - Baseline Relative to Baseline
Blood samples were collected for evaluation of hematology parameters including Anemia (An), Hemoglobin increased (HbI), Lymphocyte count decreased (LyD), Lymphocytes count increased (LyI), Neutrophils count decreased (NeuD), Platelet count decreased (PD), Leukocytosis (LC) and White blood cell decreased (WBCD). The laboratory parameters were graded according to CTCAE version 5. Grade 1 (G1): mild; Grade 2 (G2): moderate; Grade 3 (G3): severe; Grade 4 (G4) life-threatening or disabling. Higher grade indicates greater severity and an increase in CTCAE grade was defined relative to the Baseline grade. Any worst-case post baseline increases to G1, G2, G3, and G4 are presented. Baseline value was defined as the most recent, non-missing value from a local laboratory prior to the first dose of study treatment.
Safety Population. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified categories.
Posted
Count of Participants
Participants
Baseline (Day 1) and up to approximately 253 weeks
ID
Title
Description
OG000
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat
In CE Phase, Participants with RRMM received 0.95 mg/ kg belantamab mafodotin IV infusion as powder for solution once every 3 weeks (Q3W), infused over 30- 60 minutes on day 1 of 21-day cycles in combination with 100 mg nirogacestat BID on day 1, 4, 8 and 15 of 21-day cycles. Treatment was administered until disease progression, intolerable toxicity, informed consent withdrawal, the end of the sub-study or death.
Secondary
CE Phase: Number of Participants With Worst-Case Chemistry Results by Maximum Grade Increase Post - Baseline Relative to Baseline
Blood samples were collected for evaluation of clinical chemistry parameters including Hypoglycemia (HG), Hypoalbuminemia (HA), Creatinine Kinase increased (CPKi), Hyperkalemia (HK), Blood lactate dehydrogenase Increased (BLDi), Hypermagnesemia (HyperM), Hypomagnesemia (HypoM), Hypernatremia (HyperN), Hypercalcemia (HyperC), Hypocalcemia (HypoC) and Chronic Kidney Disease (CKD). The laboratory parameters were graded according to CTCAE version 5. G1: mild; G2: moderate; G3: severe; Grade 4 (G4) life-threatening or disabling. Higher grade indicates greater severity and an increase in CTCAE grade was defined relative to the Baseline grade. Any worst-case post baseline increase to G1, G2, G3, and G4 are presented. Baseline value was defined as the most recent, non-missing value from a local laboratory prior to the first dose of study treatment.
Safety Population. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified categories.
Posted
Count of Participants
Participants
Baseline (Day 1) and up to approximately 253 weeks
ID
Title
Description
OG000
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat
In CE Phase, Participants with RRMM received 0.95 mg/ kg belantamab mafodotin IV infusion as powder for solution once every 3 weeks (Q3W), infused over 30- 60 minutes on day 1 of 21-day cycles in combination with 100 mg nirogacestat BID on day 1, 4, 8 and 15 of 21-day cycles. Treatment was administered until disease progression, intolerable toxicity, informed consent withdrawal, the end of the sub-study or death.
Time Frame
All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 253 weeks.
Description
Safety set included all participants who received at least 1 dose of any component of the combination therapy. The results presented are based on data cut-off date 17 Apr 2025. Safety data collection is still ongoing and will be provided within a year of study completion.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
DE Phase: 0.95 mg/kg Belantamab Mafodotin + Nirogacestat
In DE Phase, participants with Relapsed/Refractory Multiple Myeloma (RRMM) received 0.95 milligram (mg)/kilogram (kg) belantamab mafodotin intravenous (IV) infusion as powder for solution once every 3 weeks (Q3W) infused over 30- 60 minutes on day 1 of 21-day cycles in combination with 100 mg nirogacestat administered twice a day (BID) on day 1, 4, 8 and 15 of 21-day cycles. Treatment was administered until disease progression, intolerable toxicity, informed consent withdrawal, the end of the sub-study or death.
7
10
8
10
10
10
EG001
DE Phase: 1.9 mg/kg Belantamab Mafodotin+ Nirogacestat
In DE Phase, participants with RRMM received 1.9 mg/ kg belantamab mafodotin IV infusion as powder for solution once Q3W infused over 30- 60 minutes on day 1 of 21-day cycles in combination with 100 mg nirogacestat administered BID on day 1, 4, 8 and 15 of 21-day cycles. Treatment was administered until disease progression, intolerable toxicity, informed consent withdrawal, the end of the sub-study or death.
2
4
2
4
4
4
EG002
DE Phase: 1.0 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID
In DE Phase, participants with RRMM received 1.0 mg/ kg belantamab mafodotin IV infusion as powder for solution once every 4 weeks (Q4W) for Cycle 1-2 and then once every 8 weeks (Q8W) from Cycle 2 onwards, infused over 30- 60 minutes on day 1 of 28-day cycles in Q4W and 56-day cycle in Q8W in combination with 100 mg nirogacestat BID on day 1, 4, 8 and 15 of 21-day cycles. Treatment was administered until disease progression, intolerable toxicity, informed consent withdrawal, the end of the sub-study or death.
3
10
3
10
10
10
EG003
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID
In DE Phase, participants with RRMM received 1.4 mg/ kg belantamab mafodotin IV infusion as powder for solution Q4W for Cycle 1 and then Q8W from Cycle2 onwards, infused over 30- 60 minutes on day 1 of 21-day cycles in combination with 100 mg nirogacestat BID on day 1, 4, 8 and 15 of 21-day cycles. Treatment was administered until disease progression, intolerable toxicity, informed consent withdrawal, the end of the sub-study or death.
2
10
2
10
10
10
EG004
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W + Nirogacestat BID
In DE Phase, participants with RRMM received 1.4 mg/ kg belantamab mafodotin IV infusion as powder for solution Q4W, infused over 30- 60 minutes on day 1 of 28-day cycles in combination with 100 mg nirogacestat BID on day 1, 4, 8 and 15 of 21-day cycles. Treatment was administered until disease progression, intolerable toxicity, informed consent withdrawal, the end of the sub-study or death.
0
1
0
1
0
1
EG005
CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat
In CE Phase, Participants with RRMM received 0.95 mg/ kg belantamab mafodotin IV infusion as powder for solution once every 3 weeks (Q3W), infused over 30- 60 minutes on day 1 of 21-day cycles in combination with 100 mg nirogacestat BID on day 1, 4, 8 and 15 of 21-day cycles. Treatment was administered until disease progression, intolerable toxicity, informed consent withdrawal, the end of the sub-study or death.
13
34
16
34
27
34
EG006
CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W
In CE Phase, Participants with RRMM received 2.5 mg/ kg belantamab mafodotin IV infusion as powder for solution Q3W, infused over 30- 60 minutes on day 1 of 21-day cycles until disease progression, intolerable toxicity, informed consent withdrawal, the end of the sub-study or death.
11
37
13
37
34
37
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Febrile neutropenia
Blood and lymphatic system disorders
MedDRA v28.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected10 at risk
EG0031 events1 affected10 at risk
EG0040 events0 affected1 at risk
EG0051 events1 affected34 at risk
EG0061 events1 affected37 at risk
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA v28.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected10 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA v28.0
Systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected10 at risk
EG003
Cardiac arrest
Cardiac disorders
MedDRA v28.0
Systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected10 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA v28.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected10 at risk
EG003
Retroperitoneal haematoma
Gastrointestinal disorders
MedDRA v28.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected10 at risk
EG003
Asthenia
General disorders
MedDRA v28.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected10 at risk
EG003
General physical health deterioration
General disorders
MedDRA v28.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected10 at risk
EG003
Hyperthermia
General disorders
MedDRA v28.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected10 at risk
EG003
Localised oedema
General disorders
MedDRA v28.0
Systematic Assessment
EG0002 events1 affected10 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected10 at risk
EG003
Multiple organ dysfunction syndrome
General disorders
MedDRA v28.0
Systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected10 at risk
EG003
Oedema peripheral
General disorders
MedDRA v28.0
Systematic Assessment
EG0002 events1 affected10 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected10 at risk
EG003
Pyrexia
General disorders
MedDRA v28.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected10 at risk
EG003
Systemic inflammatory response syndrom
General disorders
MedDRA v28.0
Systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected10 at risk
EG003
Alpha haemolytic streptococcal infecti
Infections and infestations
MedDRA v28.0
Systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected10 at risk
EG003
Bacteraemia
Infections and infestations
MedDRA v28.0
Systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected10 at risk
EG003
COVID-19
Infections and infestations
MedDRA v28.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected10 at risk
EG003
COVID-19 pneumonia
Infections and infestations
MedDRA v28.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected10 at risk
EG003
Herpes simplex reactivation
Infections and infestations
MedDRA v28.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected10 at risk
EG003
Influenza
Infections and infestations
MedDRA v28.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected10 at risk
EG003
Localised infection
Infections and infestations
MedDRA v28.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected10 at risk
EG003
Pneumonia
Infections and infestations
MedDRA v28.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected10 at risk
EG003
Pneumonia klebsiella
Infections and infestations
MedDRA v28.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected10 at risk
EG003
Pneumonia pneumococcal
Infections and infestations
MedDRA v28.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected10 at risk
EG003
Sepsis
Infections and infestations
MedDRA v28.0
Systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected10 at risk
EG003
Sinusitis
Infections and infestations
MedDRA v28.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected10 at risk
EG003
Streptococcal infection
Infections and infestations
MedDRA v28.0
Systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected10 at risk
EG003
Streptococcal sepsis
Infections and infestations
MedDRA v28.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected10 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA v28.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0011 events1 affected4 at risk
EG0020 events0 affected10 at risk
EG003
Compression fracture
Injury, poisoning and procedural complications
MedDRA v28.0
Systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected10 at risk
EG003
Femur fracture
Injury, poisoning and procedural complications
MedDRA v28.0
Systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected10 at risk
EG003
Humerus fracture
Injury, poisoning and procedural complications
MedDRA v28.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected10 at risk
EG003
Infusion related reaction
Injury, poisoning and procedural complications
MedDRA v28.0
Systematic Assessment
EG0002 events2 affected10 at risk
EG0011 events1 affected4 at risk
EG0020 events0 affected10 at risk
EG003
Pelvic fracture
Injury, poisoning and procedural complications
MedDRA v28.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected10 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA v28.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected10 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA v28.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected10 at risk
EG003
Electrocardiogram QT prolonged
Investigations
MedDRA v28.0
Systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected10 at risk
EG003
Electrocardiogram T wave abnormal
Investigations
MedDRA v28.0
Systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected10 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA v28.0
Systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected10 at risk
EG003
Pathological fracture
Musculoskeletal and connective tissue disorders
MedDRA v28.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected10 at risk
EG003
Acute myeloid leukaemia
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA v28.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected10 at risk
EG003
Adenocarcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA v28.0
Systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected10 at risk
EG003
Basal cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA v28.0
Systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected10 at risk
EG003
Colorectal adenocarcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA v28.0
Systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected10 at risk
EG003
Squamous cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA v28.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected10 at risk
EG003
Haemorrhage intracranial
Nervous system disorders
MedDRA v28.0
Systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected10 at risk
EG003
Metabolic encephalopathy
Nervous system disorders
MedDRA v28.0
Systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected10 at risk
EG003
Delirium
Psychiatric disorders
MedDRA v28.0
Systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected10 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA v28.0
Systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected10 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA v28.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected10 at risk
EG003
Prostatitis
Reproductive system and breast disorders
MedDRA v28.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected10 at risk
EG003
Acute respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA v28.0
Systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected10 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA v28.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected10 at risk
EG003
Lung disorder
Respiratory, thoracic and mediastinal disorders
MedDRA v28.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected10 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA v28.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected10 at risk
EG003
Respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA v28.0
Systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected10 at risk
EG003
Arteriovenous fistula
Vascular disorders
MedDRA v28.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected10 at risk
EG003
Hypotension
Vascular disorders
MedDRA v28.0
Systematic Assessment
EG0002 events1 affected10 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected10 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA v28.0
Systematic Assessment
EG0004 events4 affected10 at risk
EG0011 events1 affected4 at risk
EG0021 events1 affected10 at risk
EG0032 events2 affected10 at risk
EG0040 events0 affected1 at risk
EG00510 events5 affected34 at risk
EG00615 events9 affected37 at risk
Eosinophilia
Blood and lymphatic system disorders
MedDRA v28.0
Systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected10 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA v28.0
Systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected10 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA v28.0
Systematic Assessment
EG0005 events4 affected10 at risk
EG0014 events3 affected4 at risk
EG0021 events1 affected10 at risk
EG003
Tachycardia
Cardiac disorders
MedDRA v28.0
Systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected10 at risk
EG003
Blepharitis
Eye disorders
MedDRA v28.0
Systematic Assessment
EG0003 events3 affected10 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected10 at risk
EG003
Cataract
Eye disorders
MedDRA v28.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected10 at risk
EG003
Cataract nuclear
Eye disorders
MedDRA v28.0
Systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected10 at risk
EG003
Cataract subcapsular
Eye disorders
MedDRA v28.0
Systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected10 at risk
EG003
Conjunctivochalasis
Eye disorders
MedDRA v28.0
Systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected10 at risk
EG003
Corneal cyst
Eye disorders
MedDRA v28.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected10 at risk
EG003
Corneal epithelial microcysts
Eye disorders
MedDRA v28.0
Systematic Assessment
EG00010 events2 affected10 at risk
EG0011 events1 affected4 at risk
EG0020 events0 affected10 at risk
EG003
Corneal epithelium defect
Eye disorders
MedDRA v28.0
Systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected10 at risk
EG003
Dermatochalasis
Eye disorders
MedDRA v28.0
Systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected10 at risk
EG003
Diplopia
Eye disorders
MedDRA v28.0
Systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected10 at risk
EG003
Dry eye
Eye disorders
MedDRA v28.0
Systematic Assessment
EG0006 events3 affected10 at risk
EG0012 events2 affected4 at risk
EG0028 events4 affected10 at risk
EG003
Exophthalmos
Eye disorders
MedDRA v28.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected10 at risk
EG003
Eye disorder
Eye disorders
MedDRA v28.0
Systematic Assessment
EG0004 events3 affected10 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected10 at risk
EG003
Eye irritation
Eye disorders
MedDRA v28.0
Systematic Assessment
EG0005 events3 affected10 at risk
EG0010 events0 affected4 at risk
EG0024 events4 affected10 at risk
EG003
Eye pain
Eye disorders
MedDRA v28.0
Systematic Assessment
EG0005 events4 affected10 at risk
EG0010 events0 affected4 at risk
EG0022 events2 affected10 at risk
EG003
Eye pruritus
Eye disorders
MedDRA v28.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected10 at risk
EG003
Foreign body sensation in eyes
Eye disorders
MedDRA v28.0
Systematic Assessment
EG0004 events2 affected10 at risk
EG0010 events0 affected4 at risk
EG0023 events3 affected10 at risk
EG003
Keratitis
Eye disorders
MedDRA v28.0
Systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected10 at risk
EG003
Keratopathy
Eye disorders
MedDRA v28.0
Systematic Assessment
EG0002 events1 affected10 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected10 at risk
EG003
Lacrimation increased
Eye disorders
MedDRA v28.0
Systematic Assessment
EG0002 events1 affected10 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected10 at risk
EG003
Meibomian gland dysfunction
Eye disorders
MedDRA v28.0
Systematic Assessment
EG0003 events2 affected10 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected10 at risk
EG003
Ocular hyperaemia
Eye disorders
MedDRA v28.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected10 at risk
EG003
Periorbital disorder
Eye disorders
MedDRA v28.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected10 at risk
EG003
Photophobia
Eye disorders
MedDRA v28.0
Systematic Assessment
EG0003 events3 affected10 at risk
EG0011 events1 affected4 at risk
EG0023 events3 affected10 at risk
EG003
Photopsia
Eye disorders
MedDRA v28.0
Systematic Assessment
EG0003 events1 affected10 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected10 at risk
EG003
Punctate keratitis
Eye disorders
MedDRA v28.0
Systematic Assessment
EG0004 events1 affected10 at risk
EG0012 events1 affected4 at risk
EG0020 events0 affected10 at risk
EG003
Uveitis
Eye disorders
MedDRA v28.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0012 events1 affected4 at risk
EG0020 events0 affected10 at risk
EG003
Vision blurred
Eye disorders
MedDRA v28.0
Systematic Assessment
EG0005 events3 affected10 at risk
EG0012 events2 affected4 at risk
EG0023 events3 affected10 at risk
EG003
Visual acuity reduced
Eye disorders
MedDRA v28.0
Systematic Assessment
EG0003 events2 affected10 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected10 at risk
EG003
Visual impairment
Eye disorders
MedDRA v28.0
Systematic Assessment
EG0002 events2 affected10 at risk
EG0011 events1 affected4 at risk
EG0020 events0 affected10 at risk
EG003
Vitreous floaters
Eye disorders
MedDRA v28.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected10 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA v28.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected10 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA v28.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0011 events1 affected4 at risk
EG0021 events1 affected10 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA v28.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected10 at risk
EG003
Colon dysplasia
Gastrointestinal disorders
MedDRA v28.0
Systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected10 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA v28.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0012 events1 affected4 at risk
EG0021 events1 affected10 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA v28.0
Systematic Assessment
EG0008 events7 affected10 at risk
EG0014 events2 affected4 at risk
EG0029 events8 affected10 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA v28.0
Systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected10 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA v28.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected10 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA v28.0
Systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected10 at risk
EG003
Haemorrhoids
Gastrointestinal disorders
MedDRA v28.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected10 at risk
EG003
Haemorrhoids thrombosed
Gastrointestinal disorders
MedDRA v28.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected10 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA v28.0
Systematic Assessment
EG0003 events3 affected10 at risk
EG0013 events2 affected4 at risk
EG0020 events0 affected10 at risk
EG003
Oral disorder
Gastrointestinal disorders
MedDRA v28.0
Systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected10 at risk
EG003
Oral pain
Gastrointestinal disorders
MedDRA v28.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0011 events1 affected4 at risk
EG0020 events0 affected10 at risk
EG003
Tongue erythema
Gastrointestinal disorders
MedDRA v28.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected10 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA v28.0
Systematic Assessment
EG0001 events1 affected10 at risk
EG0011 events1 affected4 at risk
EG0023 events2 affected10 at risk
EG003
Asthenia
General disorders
MedDRA v28.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0011 events1 affected4 at risk
EG0020 events0 affected10 at risk
EG003
Axillary pain
General disorders
MedDRA v28.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0012 events1 affected4 at risk
EG0020 events0 affected10 at risk
EG003
Chest pain
General disorders
MedDRA v28.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0011 events1 affected4 at risk
EG0020 events0 affected10 at risk
EG003
Chills
General disorders
MedDRA v28.0
Systematic Assessment
EG0001 events1 affected10 at risk
EG0011 events1 affected4 at risk
EG0021 events1 affected10 at risk
EG003
Fatigue
General disorders
MedDRA v28.0
Systematic Assessment
EG0001 events1 affected10 at risk
EG0011 events1 affected4 at risk
EG0023 events3 affected10 at risk
EG003
Ill-defined disorder
General disorders
MedDRA v28.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected10 at risk
EG003
Influenza like illness
General disorders
MedDRA v28.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected10 at risk
EG003
Localised oedema
General disorders
MedDRA v28.0
Systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected10 at risk
EG003
Nodule
General disorders
MedDRA v28.0
Systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected10 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA v28.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected10 at risk
EG003
Pain
General disorders
MedDRA v28.0
Systematic Assessment
EG0002 events2 affected10 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected10 at risk
EG003
Pyrexia
General disorders
MedDRA v28.0
Systematic Assessment
EG0001 events1 affected10 at risk
EG0012 events1 affected4 at risk
EG0020 events0 affected10 at risk
EG003
Biliary colic
Hepatobiliary disorders
MedDRA v28.0
Systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected10 at risk
EG003
Cholestasis
Hepatobiliary disorders
MedDRA v28.0
Systematic Assessment
EG0002 events1 affected10 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected10 at risk
EG003
Cytokine release syndrome
Immune system disorders
MedDRA v28.0
Systematic Assessment
EG0002 events2 affected10 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected10 at risk
EG003
Bronchitis
Infections and infestations
MedDRA v28.0
Systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected10 at risk
EG003
COVID-19
Infections and infestations
MedDRA v28.0
Systematic Assessment
EG0002 events2 affected10 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected10 at risk
EG003
Conjunctivitis
Infections and infestations
MedDRA v28.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected10 at risk
EG003
Fungal infection
Infections and infestations
MedDRA v28.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected10 at risk
EG003
Herpes simplex
Infections and infestations
MedDRA v28.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected10 at risk
EG003
Herpes zoster
Infections and infestations
MedDRA v28.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected10 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA v28.0
Systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected10 at risk
EG003
Pneumonia
Infections and infestations
MedDRA v28.0
Systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected10 at risk
EG003
Septic shock
Infections and infestations
MedDRA v28.0
Systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected10 at risk
EG003
Sinusitis
Infections and infestations
MedDRA v28.0
Systematic Assessment
EG0003 events1 affected10 at risk
EG0010 events0 affected4 at risk
EG0022 events2 affected10 at risk
EG003
Streptococcal bacteraemia
Infections and infestations
MedDRA v28.0
Systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected10 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA v28.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected4 at risk
EG0023 events3 affected10 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA v28.0
Systematic Assessment
EG0001 events1 affected10 at risk
EG0011 events1 affected4 at risk
EG0020 events0 affected10 at risk
EG003
Viral infection
Infections and infestations
MedDRA v28.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected10 at risk
EG003
Viral pharyngitis
Infections and infestations
MedDRA v28.0
Systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected10 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA v28.0
Systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected10 at risk
EG003
Hip fracture
Injury, poisoning and procedural complications
MedDRA v28.0
Systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected10 at risk
EG003
Infusion related reaction
Injury, poisoning and procedural complications
MedDRA v28.0
Systematic Assessment
EG0002 events2 affected10 at risk
EG0011 events1 affected4 at risk
EG0020 events0 affected10 at risk
EG003
Jaw fracture
Injury, poisoning and procedural complications
MedDRA v28.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected10 at risk
EG003
Procedural pain
Injury, poisoning and procedural complications
MedDRA v28.0
Systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected10 at risk
EG003
Scapula fracture
Injury, poisoning and procedural complications
MedDRA v28.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0011 events1 affected4 at risk
EG0020 events0 affected10 at risk
EG003
Tooth fracture
Injury, poisoning and procedural complications
MedDRA v28.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0011 events1 affected4 at risk
EG0020 events0 affected10 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA v28.0
Systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected10 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA v28.0
Systematic Assessment
EG0004 events2 affected10 at risk
EG0012 events1 affected4 at risk
EG0021 events1 affected10 at risk
EG003
Blood alkaline phosphatase increased
Investigations
MedDRA v28.0
Systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected10 at risk
EG003
Blood creatine increased
Investigations
MedDRA v28.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected10 at risk
EG003
Blood creatine phosphokinase increased
Investigations
MedDRA v28.0
Systematic Assessment
EG0002 events2 affected10 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected10 at risk
EG003
Blood creatinine increased
Investigations
MedDRA v28.0
Systematic Assessment
EG0003 events2 affected10 at risk
EG0011 events1 affected4 at risk
EG0020 events0 affected10 at risk
EG003
Blood lactate dehydrogenase increased
Investigations
MedDRA v28.0
Systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected10 at risk
EG003
Blood lactic acid increased
Investigations
MedDRA v28.0
Systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected10 at risk
EG003
Brain natriuretic peptide increased
Investigations
MedDRA v28.0
Systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected10 at risk
EG003
Gamma-glutamyltransferase increased
Investigations
MedDRA v28.0
Systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected10 at risk
EG003
Lymphocyte count decreased
Investigations
MedDRA v28.0
Systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected10 at risk
EG003
N-terminal prohormone brain natriureti
Investigations
MedDRA v28.0
Systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected10 at risk
EG003
Neutrophil count decreased
Investigations
MedDRA v28.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected10 at risk
EG003
Platelet count decreased
Investigations
MedDRA v28.0
Systematic Assessment
EG0001 events1 affected10 at risk
EG0014 events1 affected4 at risk
EG0023 events3 affected10 at risk
EG003
Troponin I increased
Investigations
MedDRA v28.0
Systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected10 at risk
EG003
Visual acuity tests abnormal
Investigations
MedDRA v28.0
Systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected10 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA v28.0
Systematic Assessment
EG0001 events1 affected10 at risk
EG0012 events2 affected4 at risk
EG0022 events2 affected10 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
MedDRA v28.0
Systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected10 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA v28.0
Systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected10 at risk
EG003
Hyperphosphataemia
Metabolism and nutrition disorders
MedDRA v28.0
Systematic Assessment
EG0002 events1 affected10 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected10 at risk
EG003
Hyperuricaemia
Metabolism and nutrition disorders
MedDRA v28.0
Systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected10 at risk
EG003
Hypervolaemia
Metabolism and nutrition disorders
MedDRA v28.0
Systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected10 at risk
EG003
Hypoalbuminaemia
Metabolism and nutrition disorders
MedDRA v28.0
Systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected10 at risk
EG003
Hypocalcaemia
Metabolism and nutrition disorders
MedDRA v28.0
Systematic Assessment
EG0003 events2 affected10 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected10 at risk
EG003
Hypoglycaemia
Metabolism and nutrition disorders
MedDRA v28.0
Systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected10 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA v28.0
Systematic Assessment
EG0004 events4 affected10 at risk
EG0011 events1 affected4 at risk
EG0021 events1 affected10 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA v28.0
Systematic Assessment
EG0003 events1 affected10 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected10 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA v28.0
Systematic Assessment
EG0002 events1 affected10 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected10 at risk
EG003
Hypophosphataemia
Metabolism and nutrition disorders
MedDRA v28.0
Systematic Assessment
EG00013 events7 affected10 at risk
EG0016 events3 affected4 at risk
EG0026 events5 affected10 at risk
EG003
Hypovolaemia
Metabolism and nutrition disorders
MedDRA v28.0
Systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected10 at risk
EG003
Iron deficiency
Metabolism and nutrition disorders
MedDRA v28.0
Systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected10 at risk
EG003
Metabolic acidosis
Metabolism and nutrition disorders
MedDRA v28.0
Systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected10 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA v28.0
Systematic Assessment
EG0004 events2 affected10 at risk
EG0012 events1 affected4 at risk
EG0020 events0 affected10 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA v28.0
Systematic Assessment
EG0002 events2 affected10 at risk
EG0012 events1 affected4 at risk
EG0020 events0 affected10 at risk
EG003
Bone pain
Musculoskeletal and connective tissue disorders
MedDRA v28.0
Systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected10 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA v28.0
Systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected10 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA v28.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected10 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA v28.0
Systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected10 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA v28.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected10 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA v28.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0011 events1 affected4 at risk
EG0020 events0 affected10 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA v28.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0011 events1 affected4 at risk
EG0022 events2 affected10 at risk
EG003
Rotator cuff syndrome
Musculoskeletal and connective tissue disorders
MedDRA v28.0
Systematic Assessment
EG0002 events2 affected10 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected10 at risk
EG003
Basal cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA v28.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected10 at risk
EG003
Keratoacanthoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA v28.0
Systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected10 at risk
EG003
Squamous cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA v28.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected10 at risk
EG003
Burning sensation
Nervous system disorders
MedDRA v28.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0011 events1 affected4 at risk
EG0020 events0 affected10 at risk
EG003
Depressed level of consciousness
Nervous system disorders
MedDRA v28.0
Systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected10 at risk
EG003
Dizziness
Nervous system disorders
MedDRA v28.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected10 at risk
EG003
Headache
Nervous system disorders
MedDRA v28.0
Systematic Assessment
EG0002 events2 affected10 at risk
EG0012 events2 affected4 at risk
EG0021 events1 affected10 at risk
EG003
Neuropathy peripheral
Nervous system disorders
MedDRA v28.0
Systematic Assessment
EG0002 events2 affected10 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected10 at risk
EG003
Peripheral sensory neuropathy
Nervous system disorders
MedDRA v28.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected10 at risk
EG003
Taste disorder
Nervous system disorders
MedDRA v28.0
Systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected10 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA v28.0
Systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected10 at risk
EG003
Confusional state
Psychiatric disorders
MedDRA v28.0
Systematic Assessment
EG0002 events1 affected10 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected10 at risk
EG003
Delirium
Psychiatric disorders
MedDRA v28.0
Systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected10 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA v28.0
Systematic Assessment
EG0003 events3 affected10 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected10 at risk
EG003
Mental status changes
Psychiatric disorders
MedDRA v28.0
Systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected10 at risk
EG003
Dysuria
Renal and urinary disorders
MedDRA v28.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected10 at risk
EG003
Glycosuria
Renal and urinary disorders
MedDRA v28.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected10 at risk
EG003
Microalbuminuria
Renal and urinary disorders
MedDRA v28.0
Systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected10 at risk
EG003
Pollakiuria
Renal and urinary disorders
MedDRA v28.0
Systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected10 at risk
EG003
Proteinuria
Renal and urinary disorders
MedDRA v28.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected10 at risk
EG003
Urinary incontinence
Renal and urinary disorders
MedDRA v28.0
Systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected10 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA v28.0
Systematic Assessment
EG0001 events1 affected10 at risk
EG0011 events1 affected4 at risk
EG0024 events4 affected10 at risk
EG003
Dysphonia
Respiratory, thoracic and mediastinal disorders
MedDRA v28.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected10 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA v28.0
Systematic Assessment
EG0002 events2 affected10 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected10 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA v28.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0012 events1 affected4 at risk
EG0020 events0 affected10 at risk
EG003
Lung disorder
Respiratory, thoracic and mediastinal disorders
MedDRA v28.0
Systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected10 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA v28.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected10 at risk
EG003
Nasal dryness
Respiratory, thoracic and mediastinal disorders
MedDRA v28.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0011 events1 affected4 at risk
EG0020 events0 affected10 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA v28.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected4 at risk
EG0022 events2 affected10 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA v28.0
Systematic Assessment
EG0003 events3 affected10 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected10 at risk
EG003
Rhinitis allergic
Respiratory, thoracic and mediastinal disorders
MedDRA v28.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0011 events1 affected4 at risk
EG0020 events0 affected10 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA v28.0
Systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected4 at risk
EG0021 events1 affected10 at risk
EG003
Sinus disorder
Respiratory, thoracic and mediastinal disorders
MedDRA v28.0
Systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected10 at risk
EG003
Upper-airway cough syndrome
Respiratory, thoracic and mediastinal disorders
MedDRA v28.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0011 events1 affected4 at risk
EG0020 events0 affected10 at risk
EG003
Decubitus ulcer
Skin and subcutaneous tissue disorders
MedDRA v28.0
Systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected10 at risk
EG003
Dermatitis acneiform
Skin and subcutaneous tissue disorders
MedDRA v28.0
Systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected10 at risk
EG003
Hyperhidrosis
Skin and subcutaneous tissue disorders
MedDRA v28.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected10 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA v28.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0011 events1 affected4 at risk
EG0021 events1 affected10 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA v28.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0011 events1 affected4 at risk
EG0020 events0 affected10 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
MedDRA v28.0
Systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected10 at risk
EG003
Sensitive skin
Skin and subcutaneous tissue disorders
MedDRA v28.0
Systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected10 at risk
EG003
Urticaria
Skin and subcutaneous tissue disorders
MedDRA v28.0
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected10 at risk
EG003
Hypertension
Vascular disorders
MedDRA v28.0
Systematic Assessment
EG0001 events1 affected10 at risk
EG0011 events1 affected4 at risk
EG0020 events0 affected10 at risk
EG003
Hypotension
Vascular disorders
MedDRA v28.0
Systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected4 at risk
EG0020 events0 affected10 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single site data not precede the primary publication of the entire clinical trial.
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W + Nirogacestat BID
In DE Phase, participants with RRMM received 1.4 mg/ kg belantamab mafodotin IV infusion as powder for solution Q4W, infused over 30- 60 minutes on day 1 of 28-day cycles in combination with 100 mg nirogacestat BID on day 1, 4, 8 and 15 of 21-day cycles. Treatment was administered until disease progression, intolerable toxicity, informed consent withdrawal, the end of the sub-study or death.
7
OG0041
0
OG0040
OG002
DE Phase: 1.0 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID
In DE Phase, participants with RRMM received 1.0 mg/ kg belantamab mafodotin IV infusion as powder for solution once every 4 weeks (Q4W) for Cycle 1-2 and then once every 8 weeks (Q8W) from Cycle 2 onwards, infused over 30- 60 minutes on day 1 of 28-day cycles in Q4W and 56-day cycle in Q8W in combination with 100 mg nirogacestat BID on day 1, 4, 8 and 15 of 21-day cycles. Treatment was administered until disease progression, intolerable toxicity, informed consent withdrawal, the end of the sub-study or death.
OG003
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID
In DE Phase, participants with RRMM received 1.4 mg/ kg belantamab mafodotin IV infusion as powder for solution Q4W for Cycle 1 and then Q8W from Cycle2 onwards, infused over 30- 60 minutes on day 1 of 21-day cycles in combination with 100 mg nirogacestat BID on day 1, 4, 8 and 15 of 21-day cycles. Treatment was administered until disease progression, intolerable toxicity, informed consent withdrawal, the end of the sub-study or death.
OG004
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W + Nirogacestat BID
In DE Phase, participants with RRMM received 1.4 mg/ kg belantamab mafodotin IV infusion as powder for solution Q4W, infused over 30- 60 minutes on day 1 of 28-day cycles in combination with 100 mg nirogacestat BID on day 1, 4, 8 and 15 of 21-day cycles. Treatment was administered until disease progression, intolerable toxicity, informed consent withdrawal, the end of the sub-study or death.
Units
Counts
Participants
OG00010
OG0014
OG00210
OG00310
OG0041
Title
Denominators
Categories
Title
Measurements
OG00010
OG0014
OG00210
OG00310
OG0040
OG001
DE Phase: 1.9 mg/kg Belantamab Mafodotin+ Nirogacestat
In DE Phase, participants with RRMM received 1.9 mg/ kg belantamab mafodotin IV infusion as powder for solution once Q3W infused over 30- 60 minutes on day 1 of 21-day cycles in combination with 100 mg nirogacestat administered BID on day 1, 4, 8 and 15 of 21-day cycles. Treatment was administered until disease progression, intolerable toxicity, informed consent withdrawal, the end of the sub-study or death.
OG002
DE Phase: 1.0 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID
In DE Phase, participants with RRMM received 1.0 mg/ kg belantamab mafodotin IV infusion as powder for solution once every 4 weeks (Q4W) for Cycle 1-2 and then once every 8 weeks (Q8W) from Cycle 2 onwards, infused over 30- 60 minutes on day 1 of 28-day cycles in Q4W and 56-day cycle in Q8W in combination with 100 mg nirogacestat BID on day 1, 4, 8 and 15 of 21-day cycles. Treatment was administered until disease progression, intolerable toxicity, informed consent withdrawal, the end of the sub-study or death.
OG003
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID
In DE Phase, participants with RRMM received 1.4 mg/ kg belantamab mafodotin IV infusion as powder for solution Q4W for Cycle 1 and then Q8W from Cycle2 onwards, infused over 30- 60 minutes on day 1 of 21-day cycles in combination with 100 mg nirogacestat BID on day 1, 4, 8 and 15 of 21-day cycles. Treatment was administered until disease progression, intolerable toxicity, informed consent withdrawal, the end of the sub-study or death.
OG004
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W + Nirogacestat BID
In DE Phase, participants with RRMM received 1.4 mg/ kg belantamab mafodotin IV infusion as powder for solution Q4W, infused over 30- 60 minutes on day 1 of 28-day cycles in combination with 100 mg nirogacestat BID on day 1, 4, 8 and 15 of 21-day cycles. Treatment was administered until disease progression, intolerable toxicity, informed consent withdrawal, the end of the sub-study or death.
Units
Counts
Participants
OG00010
OG0014
OG00210
OG00310
OG0041
Title
Denominators
Categories
An, Increase to Grade 1
Title
Measurements
OG0002
OG0010
OG0021
OG0031
OG0040
An, Increase to Grade 2
Title
Measurements
OG0002
OG0011
OG0021
OG003
An, Increase to Grade 3
Title
Measurements
OG0003
OG0011
OG0021
OG003
An, Increase to Grade 4
Title
Measurements
OG0000
OG0010
OG0020
OG003
HbI, Increase to Grade 1
Title
Measurements
OG0000
OG0010
OG0020
OG003
HbI, Increase to Grade 2
Title
Measurements
OG0000
OG0010
OG0020
OG003
HbI, Increase to Grade 3
Title
Measurements
OG0000
OG0010
OG0020
OG003
HbI, Increase to Grade 4
Title
Measurements
OG0000
OG0010
OG0020
OG003
LyD, Increase to Grade 1
Title
Measurements
OG0000
OG0011
OG0020
OG003
LyD, Increase to Grade 2
Title
Measurements
OG0002
OG0010
OG0024
OG003
LyD, Increase to Grade 3
Title
Measurements
OG0005
OG0012
OG0022
OG003
LyD, Increase to Grade 4
Title
Measurements
OG0001
OG0010
OG0021
OG003
LyI, Increase to Grade 1
Title
Measurements
OG0000
OG0010
OG0020
OG003
LyI, Increase to Grade 2
Title
Measurements
OG0000
OG0010
OG0022
OG003
LyI, Increase to Grade 3
Title
Measurements
OG0000
OG0010
OG0020
OG003
LyI, Increase to Grade 4
Title
Measurements
OG0000
OG0010
OG0020
OG003
NeuD, Increase to Grade 1
Title
Measurements
OG0003
OG0010
OG0023
OG003
NeuD, Increase to Grade 2
Title
Measurements
OG0002
OG0010
OG0021
OG003
NeuD, Increase to Grade 3
Title
Measurements
OG0001
OG0010
OG0020
OG003
NeuD, Increase to Grade 4
Title
Measurements
OG0000
OG0010
OG0020
OG003
PD, Increase to Grade 1
Title
Measurements
OG0001
OG0010
OG0021
OG003
PD, Increase to Grade 2
Title
Measurements
OG0002
OG0012
OG0022
OG003
PD, Increase to Grade 3
Title
Measurements
OG0002
OG0010
OG0021
OG003
PD, Increase to Grade 4
Title
Measurements
OG0001
OG0012
OG0020
OG003
LC, Increase to Grade 1
Title
Measurements
OG0001
OG0010
OG0020
OG003
LC, Increase to Grade 2
Title
Measurements
OG0000
OG0010
OG0020
OG003
LC, Increase to Grade 3
Title
Measurements
OG0000
OG0010
OG0020
OG003
LC, Increase to Grade 4
Title
Measurements
OG0000
OG0010
OG0020
OG003
WBCD, Increase to Grade 1
Title
Measurements
OG0001
OG0011
OG0022
OG003
WBCD, Increase to Grade 2
Title
Measurements
OG0005
OG0010
OG0023
OG003
WBCD, Increase to Grade 3
Title
Measurements
OG0001
OG0010
OG0020
OG003
WBCD, Increase to Grade 4
Title
Measurements
OG0000
OG0010
OG0020
OG003
OG001
DE Phase: 1.9 mg/kg Belantamab Mafodotin+ Nirogacestat
In DE Phase, participants with RRMM received 1.9 mg/ kg belantamab mafodotin IV infusion as powder for solution once Q3W infused over 30- 60 minutes on day 1 of 21-day cycles in combination with 100 mg nirogacestat administered BID on day 1, 4, 8 and 15 of 21-day cycles. Treatment was administered until disease progression, intolerable toxicity, informed consent withdrawal, the end of the sub-study or death.
OG002
DE Phase: 1.0 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID
In DE Phase, participants with RRMM received 1.0 mg/ kg belantamab mafodotin IV infusion as powder for solution once every 4 weeks (Q4W) for Cycle 1-2 and then once every 8 weeks (Q8W) from Cycle 2 onwards, infused over 30- 60 minutes on day 1 of 28-day cycles in Q4W and 56-day cycle in Q8W in combination with 100 mg nirogacestat BID on day 1, 4, 8 and 15 of 21-day cycles. Treatment was administered until disease progression, intolerable toxicity, informed consent withdrawal, the end of the sub-study or death.
OG003
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID
In DE Phase, participants with RRMM received 1.4 mg/ kg belantamab mafodotin IV infusion as powder for solution Q4W for Cycle 1 and then Q8W from Cycle2 onwards, infused over 30- 60 minutes on day 1 of 21-day cycles in combination with 100 mg nirogacestat BID on day 1, 4, 8 and 15 of 21-day cycles. Treatment was administered until disease progression, intolerable toxicity, informed consent withdrawal, the end of the sub-study or death.
OG004
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W + Nirogacestat BID
In DE Phase, participants with RRMM received 1.4 mg/ kg belantamab mafodotin IV infusion as powder for solution Q4W, infused over 30- 60 minutes on day 1 of 28-day cycles in combination with 100 mg nirogacestat BID on day 1, 4, 8 and 15 of 21-day cycles. Treatment was administered until disease progression, intolerable toxicity, informed consent withdrawal, the end of the sub-study or death.
Units
Counts
Participants
OG00010
OG0014
OG00210
OG00310
OG0041
Title
Denominators
Categories
HG, Increase to Grade 1
ParticipantsOG00010
ParticipantsOG0014
ParticipantsOG00210
ParticipantsOG00310
ParticipantsOG0041
Title
Measurements
OG0002
OG0010
OG0021
OG003
HG, Increase to Grade 2
ParticipantsOG00010
ParticipantsOG0014
ParticipantsOG00210
ParticipantsOG00310
HG, Increase to Grade 3
ParticipantsOG00010
ParticipantsOG0014
ParticipantsOG00210
ParticipantsOG00310
HG, Increase to Grade 4
ParticipantsOG00010
ParticipantsOG0014
ParticipantsOG00210
ParticipantsOG00310
HA, Increase to Grade 1
ParticipantsOG00010
ParticipantsOG0014
ParticipantsOG00210
ParticipantsOG00310
HA, Increase to Grade 2
ParticipantsOG00010
ParticipantsOG0014
ParticipantsOG00210
ParticipantsOG00310
HA, Increase to Grade 3
ParticipantsOG00010
ParticipantsOG0014
ParticipantsOG00210
ParticipantsOG00310
HA, Increase to Grade 4
ParticipantsOG00010
ParticipantsOG0014
ParticipantsOG00210
ParticipantsOG00310
CPKi, Increase to Grade 1
ParticipantsOG00010
ParticipantsOG0014
ParticipantsOG00210
ParticipantsOG00310
CPKi, Increase to Grade 2
ParticipantsOG00010
ParticipantsOG0014
ParticipantsOG00210
ParticipantsOG00310
CPKi, Increase to Grade 3
ParticipantsOG00010
ParticipantsOG0014
ParticipantsOG00210
ParticipantsOG00310
CPKi, Increase to Grade 4
ParticipantsOG00010
ParticipantsOG0014
ParticipantsOG00210
ParticipantsOG00310
HK, Increase to Grade 1
ParticipantsOG00010
ParticipantsOG0014
ParticipantsOG00210
ParticipantsOG00310
HK, Increase to Grade 2
ParticipantsOG00010
ParticipantsOG0014
ParticipantsOG00210
ParticipantsOG00310
HK, Increase to Grade 3
ParticipantsOG00010
ParticipantsOG0014
ParticipantsOG00210
ParticipantsOG00310
HK, Increase to Grade 4
ParticipantsOG00010
ParticipantsOG0014
ParticipantsOG00210
ParticipantsOG00310
BLDi, Increase to Grade 1
ParticipantsOG00010
ParticipantsOG0014
ParticipantsOG00210
ParticipantsOG00310
BLDi, Increase to Grade 2
ParticipantsOG00010
ParticipantsOG0014
ParticipantsOG00210
ParticipantsOG00310
BLDi, Increase to Grade 3
ParticipantsOG00010
ParticipantsOG0014
ParticipantsOG00210
ParticipantsOG00310
BLDi, Increase to Grade 4
ParticipantsOG00010
ParticipantsOG0014
ParticipantsOG00210
ParticipantsOG00310
HyperM, Increase to Grade 1
ParticipantsOG00010
ParticipantsOG0014
ParticipantsOG00210
ParticipantsOG00310
HyperM, Increase to Grade 2
ParticipantsOG00010
ParticipantsOG0014
ParticipantsOG00210
ParticipantsOG00310
HyperM, Increase to Grade 3
ParticipantsOG00010
ParticipantsOG0014
ParticipantsOG00210
ParticipantsOG00310
HyperM, Increase to Grade 4
ParticipantsOG00010
ParticipantsOG0014
ParticipantsOG00210
ParticipantsOG00310
HypoM, Increase to Grade 1
ParticipantsOG00010
ParticipantsOG0014
ParticipantsOG00210
ParticipantsOG00310
HypoM, Increase to Grade 2
ParticipantsOG00010
ParticipantsOG0014
ParticipantsOG00210
ParticipantsOG00310
HypoM, Increase to Grade 3
ParticipantsOG00010
ParticipantsOG0014
ParticipantsOG00210
ParticipantsOG00310
HypoM, Increase to Grade 4
ParticipantsOG00010
ParticipantsOG0014
ParticipantsOG00210
ParticipantsOG00310
HyperN, Increase to Grade 1
ParticipantsOG00010
ParticipantsOG0014
ParticipantsOG00210
ParticipantsOG00310
HyperN, Increase to Grade 2
ParticipantsOG00010
ParticipantsOG0014
ParticipantsOG00210
ParticipantsOG00310
HyperN, Increase to Grade 3
ParticipantsOG00010
ParticipantsOG0014
ParticipantsOG00210
ParticipantsOG00310
HyperN, Increase to Grade 4
ParticipantsOG00010
ParticipantsOG0014
ParticipantsOG00210
ParticipantsOG00310
HyperC, Increase to Grade 1
ParticipantsOG00010
ParticipantsOG0014
ParticipantsOG00210
ParticipantsOG00310
HyperC, Increase to Grade 2
ParticipantsOG00010
ParticipantsOG0014
ParticipantsOG00210
ParticipantsOG00310
HyperC, Increase to Grade 3
ParticipantsOG00010
ParticipantsOG0014
ParticipantsOG00210
ParticipantsOG00310
HyperC, Increase to Grade 4
ParticipantsOG00010
ParticipantsOG0014
ParticipantsOG00210
ParticipantsOG00310
HypoC, Increase to Grade 1
ParticipantsOG00010
ParticipantsOG0014
ParticipantsOG00210
ParticipantsOG00310
HypoC, Increase to Grade 2
ParticipantsOG00010
ParticipantsOG0014
ParticipantsOG00210
ParticipantsOG00310
HypoC, Increase to Grade 3
ParticipantsOG00010
ParticipantsOG0014
ParticipantsOG00210
ParticipantsOG00310
HypoC, Increase to Grade 4
ParticipantsOG00010
ParticipantsOG0014
ParticipantsOG00210
ParticipantsOG00310
CKD, Increase to Grade 1
ParticipantsOG0009
ParticipantsOG0014
ParticipantsOG0029
ParticipantsOG0039
CKD, Increase to Grade 2
ParticipantsOG0009
ParticipantsOG0014
ParticipantsOG0029
ParticipantsOG0039
CKD, Increase to Grade 3
ParticipantsOG0009
ParticipantsOG0014
ParticipantsOG0029
ParticipantsOG0039
CKD, Increase to Grade 4
ParticipantsOG0009
ParticipantsOG0014
ParticipantsOG0029
ParticipantsOG0039
OG001
CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W
In CE Phase, Participants with RRMM received 2.5 mg/ kg belantamab mafodotin IV infusion as powder for solution Q3W, infused over 30- 60 minutes on day 1 of 21-day cycles until disease progression, intolerable toxicity, informed consent withdrawal, the end of the sub-study or death.
Units
Counts
Participants
OG00034
OG00137
Title
Denominators
Categories
Title
Measurements
OG00029(15.1 to 47.5)
OG00138(22.5 to 55.2)
OG001
DE Phase: 1.9 mg/kg Belantamab Mafodotin+ Nirogacestat
In DE Phase, participants with RRMM received 1.9 mg/ kg belantamab mafodotin IV infusion as powder for solution once Q3W infused over 30- 60 minutes on day 1 of 21-day cycles in combination with 100 mg nirogacestat administered BID on day 1, 4, 8 and 15 of 21-day cycles. Treatment was administered until disease progression, intolerable toxicity, informed consent withdrawal, the end of the sub-study or death.
OG002
DE Phase: 1.0 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID
In DE Phase, participants with RRMM received 1.0 mg/ kg belantamab mafodotin IV infusion as powder for solution once every 4 weeks (Q4W) for Cycle 1-2 and then once every 8 weeks (Q8W) from Cycle 2 onwards, infused over 30- 60 minutes on day 1 of 28-day cycles in Q4W and 56-day cycle in Q8W in combination with 100 mg nirogacestat BID on day 1, 4, 8 and 15 of 21-day cycles. Treatment was administered until disease progression, intolerable toxicity, informed consent withdrawal, the end of the sub-study or death.
OG003
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID
In DE Phase, participants with RRMM received 1.4 mg/ kg belantamab mafodotin IV infusion as powder for solution Q4W for Cycle 1 and then Q8W from Cycle2 onwards, infused over 30- 60 minutes on day 1 of 21-day cycles in combination with 100 mg nirogacestat BID on day 1, 4, 8 and 15 of 21-day cycles. Treatment was administered until disease progression, intolerable toxicity, informed consent withdrawal, the end of the sub-study or death.
OG004
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W + Nirogacestat BID
In DE Phase, participants with RRMM received 1.4 mg/ kg belantamab mafodotin IV infusion as powder for solution Q4W, infused over 30- 60 minutes on day 1 of 28-day cycles in combination with 100 mg nirogacestat BID on day 1, 4, 8 and 15 of 21-day cycles. Treatment was administered until disease progression, intolerable toxicity, informed consent withdrawal, the end of the sub-study or death.
Units
Counts
Participants
OG00010
OG0014
OG00210
OG00310
OG0041
Title
Denominators
Categories
Title
Measurements
OG00060(26.2 to 87.8)
OG0010(0.0 to 60.2)
OG00240(12.2 to 73.8)
OG00350(18.7 to 81.3)
OG0040(0.0 to 97.5)
Units
Counts
Participants
OG00034
OG00137
Title
Denominators
Categories
Title
Measurements
OG00035(19.7 to 53.5)
OG00149(31.9 to 65.6)
OG001
DE Phase: 1.9 mg/kg Belantamab Mafodotin+ Nirogacestat
In DE Phase, participants with RRMM received 1.9 mg/ kg belantamab mafodotin IV infusion as powder for solution once Q3W infused over 30- 60 minutes on day 1 of 21-day cycles in combination with 100 mg nirogacestat administered BID on day 1, 4, 8 and 15 of 21-day cycles. Treatment was administered until disease progression, intolerable toxicity, informed consent withdrawal, the end of the sub-study or death.
OG002
DE Phase: 1.0 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID
In DE Phase, participants with RRMM received 1.0 mg/ kg belantamab mafodotin IV infusion as powder for solution once every 4 weeks (Q4W) for Cycle 1-2 and then once every 8 weeks (Q8W) from Cycle 2 onwards, infused over 30- 60 minutes on day 1 of 28-day cycles in Q4W and 56-day cycle in Q8W in combination with 100 mg nirogacestat BID on day 1, 4, 8 and 15 of 21-day cycles. Treatment was administered until disease progression, intolerable toxicity, informed consent withdrawal, the end of the sub-study or death.
OG003
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID
In DE Phase, participants with RRMM received 1.4 mg/ kg belantamab mafodotin IV infusion as powder for solution Q4W for Cycle 1 and then Q8W from Cycle2 onwards, infused over 30- 60 minutes on day 1 of 21-day cycles in combination with 100 mg nirogacestat BID on day 1, 4, 8 and 15 of 21-day cycles. Treatment was administered until disease progression, intolerable toxicity, informed consent withdrawal, the end of the sub-study or death.
OG004
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W + Nirogacestat BID
In DE Phase, participants with RRMM received 1.4 mg/ kg belantamab mafodotin IV infusion as powder for solution Q4W, infused over 30- 60 minutes on day 1 of 28-day cycles in combination with 100 mg nirogacestat BID on day 1, 4, 8 and 15 of 21-day cycles. Treatment was administered until disease progression, intolerable toxicity, informed consent withdrawal, the end of the sub-study or death.
Units
Counts
Participants
OG00010
OG0014
OG00210
OG00310
OG0041
Title
Denominators
Categories
Stringent Complete Response (sCR)
Title
Measurements
OG0000
OG0010
OG0020
OG0031
OG0040
Complete Response (CR)
Title
Measurements
OG0000
OG0010
OG0020
OG003
Very Good Partial Response (VGPR)
Title
Measurements
OG0003
OG0010
OG0020
OG003
Partial Response (PR)
Title
Measurements
OG0003
OG0010
OG0024
OG003
In CE Phase, Participants with RRMM received 2.5 mg/ kg belantamab mafodotin IV infusion as powder for solution Q3W, infused over 30- 60 minutes on day 1 of 21-day cycles until disease progression, intolerable toxicity, informed consent withdrawal, the end of the sub-study or death.
Units
Counts
Participants
OG00034
OG00137
Title
Denominators
Categories
Stringent Complete Response (sCR)
Title
Measurements
OG0000
OG0012
Complete Response (CR)
Title
Measurements
OG0001
OG0011
Very Good Partial Response (VGPR)
Title
Measurements
OG0005
OG0015
Partial Response (PR)
Title
Measurements
OG0004
OG0016
OG001
DE Phase: 1.9 mg/kg Belantamab Mafodotin+ Nirogacestat
In DE Phase, participants with RRMM received 1.9 mg/ kg belantamab mafodotin IV infusion as powder for solution once Q3W infused over 30- 60 minutes on day 1 of 21-day cycles in combination with 100 mg nirogacestat administered BID on day 1, 4, 8 and 15 of 21-day cycles. Treatment was administered until disease progression, intolerable toxicity, informed consent withdrawal, the end of the sub-study or death.
OG002
DE Phase: 1.0 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID
In DE Phase, participants with RRMM received 1.0 mg/ kg belantamab mafodotin IV infusion as powder for solution once every 4 weeks (Q4W) for Cycle 1-2 and then once every 8 weeks (Q8W) from Cycle 2 onwards, infused over 30- 60 minutes on day 1 of 28-day cycles in Q4W and 56-day cycle in Q8W in combination with 100 mg nirogacestat BID on day 1, 4, 8 and 15 of 21-day cycles. Treatment was administered until disease progression, intolerable toxicity, informed consent withdrawal, the end of the sub-study or death.
OG003
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID
In DE Phase, participants with RRMM received 1.4 mg/ kg belantamab mafodotin IV infusion as powder for solution Q4W for Cycle 1 and then Q8W from Cycle2 onwards, infused over 30- 60 minutes on day 1 of 21-day cycles in combination with 100 mg nirogacestat BID on day 1, 4, 8 and 15 of 21-day cycles. Treatment was administered until disease progression, intolerable toxicity, informed consent withdrawal, the end of the sub-study or death.
OG004
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W + Nirogacestat BID
In DE Phase, participants with RRMM received 1.4 mg/ kg belantamab mafodotin IV infusion as powder for solution Q4W, infused over 30- 60 minutes on day 1 of 28-day cycles in combination with 100 mg nirogacestat BID on day 1, 4, 8 and 15 of 21-day cycles. Treatment was administered until disease progression, intolerable toxicity, informed consent withdrawal, the end of the sub-study or death.
Units
Counts
Participants
OG00010
OG0014
OG00210
OG00310
OG0041
Title
Denominators
Categories
CYCLE 1 DAY 1, PRE-DOSE
ParticipantsOG0008
ParticipantsOG0013
ParticipantsOG0029
ParticipantsOG00310
ParticipantsOG0041
Title
Measurements
OG0000.0(0 to 0)
OG0010.0(0 to 0)
OG0020.0(0 to 0)
OG003
CYCLE 1 DAY 1, END OF INFUSION
ParticipantsOG00010
ParticipantsOG0014
ParticipantsOG00210
ParticipantsOG00310
CYCLE 1 DAY 1, 2 HOURS
ParticipantsOG00010
ParticipantsOG0014
ParticipantsOG00210
ParticipantsOG00310
CYCLE 1 DAY 1, 24 HOURS
ParticipantsOG00010
ParticipantsOG0012
ParticipantsOG0020
ParticipantsOG0030
CYCLE 1 DAY 4, ANYTIME SAMPLE
ParticipantsOG0009
ParticipantsOG0014
ParticipantsOG00210
ParticipantsOG0039
CYCLE 1 DAY 8, ANYTIME SAMPLE
ParticipantsOG0009
ParticipantsOG0014
ParticipantsOG0028
ParticipantsOG0039
CYCLE 1 DAY 22, ANYTIME SAMPLE
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0032
CYCLE 1 DAY 29, ANYTIME SAMPLE
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0024
ParticipantsOG0031
CYCLE 2 DAY 1, PRE-DOSE
ParticipantsOG0007
ParticipantsOG0013
ParticipantsOG0026
ParticipantsOG0038
CYCLE 2 DAY 1, END OF INFUSION
ParticipantsOG0009
ParticipantsOG0014
ParticipantsOG0027
ParticipantsOG0038
CYCLE 4 DAY 1, PRE-DOSE
ParticipantsOG0006
ParticipantsOG0011
ParticipantsOG0026
ParticipantsOG0034
CYCLE 4 DAY 1, END OF INFUSION
ParticipantsOG0006
ParticipantsOG0011
ParticipantsOG0026
ParticipantsOG0034
CYCLE 6 DAY 1, PRE-DOSE
ParticipantsOG0006
ParticipantsOG0011
ParticipantsOG0025
ParticipantsOG0034
CYCLE 6 DAY 1, END OF INFUSION
ParticipantsOG0006
ParticipantsOG0011
ParticipantsOG0025
ParticipantsOG0034
CYCLE 9 DAY 1, PRE-DOSE
ParticipantsOG0005
ParticipantsOG0011
ParticipantsOG0022
ParticipantsOG0032
CYCLE 9 DAY 1, END OF INFUSION
ParticipantsOG0005
ParticipantsOG0011
ParticipantsOG0022
ParticipantsOG0032
CYCLE 12 DAY 1, PRE-DOSE
ParticipantsOG0004
ParticipantsOG0011
ParticipantsOG0020
ParticipantsOG0032
CYCLE 12 DAY 1, END OF INFUSION
ParticipantsOG0005
ParticipantsOG0011
ParticipantsOG0020
ParticipantsOG0032
CYCLE 18 DAY 1, PRE-DOSE
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
CYCLE 30 DAY 1, PRE-DOSE
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
END OF TREATMENT (~157 weeks),
ParticipantsOG0006
ParticipantsOG0014
ParticipantsOG0026
ParticipantsOG0036
Units
Counts
Participants
OG00034
OG00137
Title
Denominators
Categories
CYCLE 1 DAY 1, PRE-DOSE
ParticipantsOG00026
ParticipantsOG00130
Title
Measurements
OG0000.0(0 to 0)
OG0010.0(0 to 40500)
CYCLE 1 DAY 1, END OF INFUSION
ParticipantsOG00034
ParticipantsOG00135
Title
Measurements
OG00019150.0(0 to 40700)
OG001
CYCLE 1 DAY 1, 2 HOURS
ParticipantsOG00033
ParticipantsOG00136
Title
Measurements
OG00017400.0(10500 to 53200)
OG001
CYCLE 1 DAY 1, 24 HOURS
ParticipantsOG00030
ParticipantsOG00134
Title
Measurements
OG00011300.0(3000 to 26500)
OG001
CYCLE 1 DAY 4, ANYTIME SAMPLE
ParticipantsOG00032
ParticipantsOG00137
Title
Measurements
OG0006320.0(552 to 16300)
OG001
CYCLE 1 DAY 8, ANYTIME SAMPLE
ParticipantsOG00030
ParticipantsOG00135
Title
Measurements
OG0002735.0(0 to 5000)
OG001
CYCLE 1 DAY 22, ANYTIME SAMPLE
ParticipantsOG0000
ParticipantsOG0016
Title
Measurements
OG0012955.0(1700 to 4130)
CYCLE 2 DAY 1, PRE-DOSE
ParticipantsOG00024
ParticipantsOG00128
Title
Measurements
OG000561.0(0 to 17600)
OG001
CYCLE 2 DAY 1, END OF INFUSION
ParticipantsOG00028
ParticipantsOG00131
Title
Measurements
OG00021400.0(0 to 34900)
OG001
CYCLE 4 DAY 1, PRE-DOSE
ParticipantsOG00019
ParticipantsOG00117
Title
Measurements
OG000522.0(0 to 3030)
OG001
CYCLE 4 DAY 1, END OF INFUSION
ParticipantsOG00022
ParticipantsOG00116
Title
Measurements
OG00019050.0(9300 to 40600)
OG001
CYCLE 6 DAY 1, PRE-DOSE
ParticipantsOG00013
ParticipantsOG00114
Title
Measurements
OG0000.0(0 to 4950)
OG001
CYCLE 6 DAY 1, END OF INFUSION
ParticipantsOG00013
ParticipantsOG00114
Title
Measurements
OG00018700.0(7970 to 36000)
OG001
CYCLE 9 DAY 1, PRE-DOSE
ParticipantsOG0006
ParticipantsOG0019
Title
Measurements
OG0002590.0(692 to 3570)
OG001
CYCLE 9 DAY 1, END OF INFUSION
ParticipantsOG0006
ParticipantsOG0019
Title
Measurements
OG00022350.0(19400 to 32200)
OG001
CYCLE 12 DAY 1, PRE-DOSE
ParticipantsOG0005
ParticipantsOG0018
Title
Measurements
OG0002920.0(1010 to 4030)
OG001
CYCLE 12 DAY 1, END OF INFUSION
ParticipantsOG0005
ParticipantsOG0018
Title
Measurements
OG00021500.0(14200 to 37200)
OG001
CYCLE 18 DAY 1, PRE-DOSE
ParticipantsOG0004
ParticipantsOG0016
Title
Measurements
OG0002105.0(933 to 4780)
OG001
END OF TREATMENT (~157 weeks)
ParticipantsOG00022
ParticipantsOG00118
Title
Measurements
OG000857.0(0 to 11900)
OG001
In DE Phase, participants with RRMM received 1.9 mg/ kg belantamab mafodotin IV infusion as powder for solution once Q3W infused over 30- 60 minutes on day 1 of 21-day cycles in combination with 100 mg nirogacestat administered BID on day 1, 4, 8 and 15 of 21-day cycles. Treatment was administered until disease progression, intolerable toxicity, informed consent withdrawal, the end of the sub-study or death.
OG002
DE Phase: 1.0 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID
In DE Phase, participants with RRMM received 1.0 mg/ kg belantamab mafodotin IV infusion as powder for solution once every 4 weeks (Q4W) for Cycle 1-2 and then once every 8 weeks (Q8W) from Cycle 2 onwards, infused over 30- 60 minutes on day 1 of 28-day cycles in Q4W and 56-day cycle in Q8W in combination with 100 mg nirogacestat BID on day 1, 4, 8 and 15 of 21-day cycles. Treatment was administered until disease progression, intolerable toxicity, informed consent withdrawal, the end of the sub-study or death.
OG003
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID
In DE Phase, participants with RRMM received 1.4 mg/ kg belantamab mafodotin IV infusion as powder for solution Q4W for Cycle 1 and then Q8W from Cycle2 onwards, infused over 30- 60 minutes on day 1 of 21-day cycles in combination with 100 mg nirogacestat BID on day 1, 4, 8 and 15 of 21-day cycles. Treatment was administered until disease progression, intolerable toxicity, informed consent withdrawal, the end of the sub-study or death.
OG004
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W + Nirogacestat BID
In DE Phase, participants with RRMM received 1.4 mg/ kg belantamab mafodotin IV infusion as powder for solution Q4W, infused over 30- 60 minutes on day 1 of 28-day cycles in combination with 100 mg nirogacestat BID on day 1, 4, 8 and 15 of 21-day cycles. Treatment was administered until disease progression, intolerable toxicity, informed consent withdrawal, the end of the sub-study or death.
Units
Counts
Participants
OG00010
OG0014
OG00210
OG00310
OG0041
Title
Denominators
Categories
CYCLE 1 DAY 1, PRE-DOSE
ParticipantsOG0005
ParticipantsOG0012
ParticipantsOG0028
ParticipantsOG0039
ParticipantsOG0041
Title
Measurements
OG0000.0(0 to 0)
OG0010.0(0 to 0)
OG0020.0(0 to 0)
OG003
CYCLE 1 DAY 1, END OF INFUSION
ParticipantsOG0009
ParticipantsOG0014
ParticipantsOG00210
ParticipantsOG00310
CYCLE 1 DAY 1, 2 HOURS
ParticipantsOG0009
ParticipantsOG0014
ParticipantsOG00210
ParticipantsOG00310
CYCLE 1 DAY 1, 24 HOURS
ParticipantsOG00010
ParticipantsOG0012
ParticipantsOG0020
ParticipantsOG0030
CYCLE 1 DAY 4, ANYTIME SAMPLE
ParticipantsOG0009
ParticipantsOG0014
ParticipantsOG00210
ParticipantsOG0039
CYCLE 1 DAY 8, ANYTIME SAMPLE
ParticipantsOG00010
ParticipantsOG0014
ParticipantsOG0028
ParticipantsOG0039
CYCLE 1 DAY 22, ANYTIME SAMPLE
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0032
CYCLE 1 DAY 29, ANYTIME SAMPLE
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0023
ParticipantsOG0031
CYCLE 2 DAY 1, PRE-DOSE
ParticipantsOG0006
ParticipantsOG0013
ParticipantsOG0026
ParticipantsOG0038
CYCLE 2 DAY 1, END OF INFUSION
ParticipantsOG0008
ParticipantsOG0014
ParticipantsOG0027
ParticipantsOG0038
CYCLE 4 DAY 1, PRE-DOSE
ParticipantsOG0006
ParticipantsOG0011
ParticipantsOG0026
ParticipantsOG0034
CYCLE 4 DAY 1, END OF INFUSION
ParticipantsOG0006
ParticipantsOG0011
ParticipantsOG0026
ParticipantsOG0034
CYCLE 6 DAY 1, PRE-DOSE
ParticipantsOG0006
ParticipantsOG0011
ParticipantsOG0025
ParticipantsOG0034
CYCLE 6 DAY 1, END OF INFUSION
ParticipantsOG0006
ParticipantsOG0011
ParticipantsOG0025
ParticipantsOG0034
CYCLE 9 DAY 1, PRE-DOSE
ParticipantsOG0005
ParticipantsOG0011
ParticipantsOG0022
ParticipantsOG0032
CYCLE 9 DAY 1, END OF INFUSION
ParticipantsOG0005
ParticipantsOG0011
ParticipantsOG0022
ParticipantsOG0032
CYCLE 12 DAY 1, PRE-DOSE
ParticipantsOG0004
ParticipantsOG0011
ParticipantsOG0020
ParticipantsOG0032
CYCLE 12 DAY 1, END OF INFUSION
ParticipantsOG0005
ParticipantsOG0011
ParticipantsOG0020
ParticipantsOG0032
CYCLE 18 DAY 1, PRE-DOSE
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
CYCLE 30 DAY 1, PRE-DOSE
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
END OF TREATMENT (~157 weeks)
ParticipantsOG0007
ParticipantsOG0014
ParticipantsOG0025
ParticipantsOG0036
Units
Counts
Participants
OG00034
OG00137
Title
Denominators
Categories
CYCLE 1 DAY 1, PRE-DOSE
ParticipantsOG00023
ParticipantsOG00120
Title
Measurements
OG0000.0(0 to 5050)
OG0010.0(0 to 4580)
CYCLE 1 DAY 1, END OF INFUSION
ParticipantsOG00034
ParticipantsOG00136
Title
Measurements
OG00017000.0(0 to 36700)
OG001
CYCLE 1 DAY 1, 2 HOURS
ParticipantsOG00032
ParticipantsOG00136
Title
Measurements
OG00017000.0(9690 to 41100)
OG001
CYCLE 1 DAY 1, 24 HOURS
ParticipantsOG00030
ParticipantsOG00134
Title
Measurements
OG00012050.0(4060 to 27500)
OG001
CYCLE 1 DAY 4, ANYTIME SAMPLE
ParticipantsOG00032
ParticipantsOG00136
Title
Measurements
OG0008005.0(750 to 22500)
OG001
CYCLE 1 DAY 8, ANYTIME SAMPLE
ParticipantsOG00029
ParticipantsOG00136
Title
Measurements
OG0003970.0(0 to 14000)
OG001
CYCLE 1 DAY 22, ANYTIME SAMPLE
ParticipantsOG0000
ParticipantsOG0016
Title
Measurements
OG00110630.0(4670 to 13800)
CYCLE 2 DAY 1, PRE-DOSE
ParticipantsOG00025
ParticipantsOG00129
Title
Measurements
OG0001760.0(0 to 16700)
OG001
CYCLE 2 DAY 1, END OF INFUSION
ParticipantsOG00028
ParticipantsOG00131
Title
Measurements
OG00021600.0(0 to 38100)
OG001
CYCLE 4 DAY 1, PRE-DOSE
ParticipantsOG00018
ParticipantsOG00117
Title
Measurements
OG0001935.0(0 to 15700)
OG001
CYCLE 4 DAY 1, END OF INFUSION
ParticipantsOG00022
ParticipantsOG00116
Title
Measurements
OG00020050.0(7070 to 61500)
OG001
CYCLE 6 DAY 1, PRE-DOSE
ParticipantsOG00013
ParticipantsOG00114
Title
Measurements
OG0001110.0(0 to 8320)
OG001
CYCLE 6 DAY 1, END OF INFUSION
ParticipantsOG00013
ParticipantsOG00114
Title
Measurements
OG00020200.0(9470 to 32500)
OG001
CYCLE 9 DAY 1, PRE-DOSE
ParticipantsOG0006
ParticipantsOG0019
Title
Measurements
OG0006550.0(3800 to 13300)
OG001
CYCLE 9 DAY 1, END OF INFUSION
ParticipantsOG0006
ParticipantsOG0019
Title
Measurements
OG00029350.0(16600 to 37100)
OG001
CYCLE 12 DAY 1, PRE-DOSE
ParticipantsOG0005
ParticipantsOG0018
Title
Measurements
OG0007910.0(1550 to 16600)
OG001
CYCLE 12 DAY 1, END OF INFUSION
ParticipantsOG0005
ParticipantsOG0018
Title
Measurements
OG00033700.0(10500 to 38700)
OG001
CYCLE 18 DAY 1, PRE-DOSE
ParticipantsOG0004
ParticipantsOG0015
Title
Measurements
OG0006165.0(4090 to 8820)
OG001
END OF TREATMENT (~157 weeks)
ParticipantsOG00022
ParticipantsOG00120
Title
Measurements
OG0002570.0(0 to 16200)
OG001
In DE Phase, participants with RRMM received 1.9 mg/ kg belantamab mafodotin IV infusion as powder for solution once Q3W infused over 30- 60 minutes on day 1 of 21-day cycles in combination with 100 mg nirogacestat administered BID on day 1, 4, 8 and 15 of 21-day cycles. Treatment was administered until disease progression, intolerable toxicity, informed consent withdrawal, the end of the sub-study or death.
OG002
DE Phase: 1.0 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID
In DE Phase, participants with RRMM received 1.0 mg/ kg belantamab mafodotin IV infusion as powder for solution once every 4 weeks (Q4W) for Cycle 1-2 and then once every 8 weeks (Q8W) from Cycle 2 onwards, infused over 30- 60 minutes on day 1 of 28-day cycles in Q4W and 56-day cycle in Q8W in combination with 100 mg nirogacestat BID on day 1, 4, 8 and 15 of 21-day cycles. Treatment was administered until disease progression, intolerable toxicity, informed consent withdrawal, the end of the sub-study or death.
OG003
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID
In DE Phase, participants with RRMM received 1.4 mg/ kg belantamab mafodotin IV infusion as powder for solution Q4W for Cycle 1 and then Q8W from Cycle2 onwards, infused over 30- 60 minutes on day 1 of 21-day cycles in combination with 100 mg nirogacestat BID on day 1, 4, 8 and 15 of 21-day cycles. Treatment was administered until disease progression, intolerable toxicity, informed consent withdrawal, the end of the sub-study or death.
OG004
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W + Nirogacestat BID
In DE Phase, participants with RRMM received 1.4 mg/ kg belantamab mafodotin IV infusion as powder for solution Q4W, infused over 30- 60 minutes on day 1 of 28-day cycles in combination with 100 mg nirogacestat BID on day 1, 4, 8 and 15 of 21-day cycles. Treatment was administered until disease progression, intolerable toxicity, informed consent withdrawal, the end of the sub-study or death.
Units
Counts
Participants
OG00010
OG0014
OG00210
OG00310
OG0041
Title
Denominators
Categories
CYCLE 1 DAY 1, PRE-DOSE
ParticipantsOG00010
ParticipantsOG0014
ParticipantsOG0027
ParticipantsOG00310
ParticipantsOG0041
Title
Measurements
OG0000.00(0.0 to 0.0)
OG0010.00(0.0 to 0.0)
OG0020.00(0.0 to 0.0)
OG003
CYCLE 1 DAY 1, END OF INFUSION
ParticipantsOG00010
ParticipantsOG0014
ParticipantsOG0028
ParticipantsOG00310
CYCLE 1 DAY 1, 2 HOURS
ParticipantsOG00010
ParticipantsOG0014
ParticipantsOG0028
ParticipantsOG00310
CYCLE 1 DAY 1, 24 HOURS
ParticipantsOG00010
ParticipantsOG0012
ParticipantsOG0020
ParticipantsOG0030
CYCLE 1 DAY 4, ANYTIME SAMPLE
ParticipantsOG0009
ParticipantsOG0014
ParticipantsOG0025
ParticipantsOG0039
CYCLE 1 DAY 8, ANYTIME SAMPLE
ParticipantsOG00010
ParticipantsOG0014
ParticipantsOG0024
ParticipantsOG0039
CYCLE 1 DAY 22, ANYTIME SAMPLE
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0032
CYCLE 1 DAY 29, ANYTIME SAMPLE
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0022
ParticipantsOG0031
CYCLE 2 DAY 1, PRE-DOSE
ParticipantsOG0009
ParticipantsOG0014
ParticipantsOG0025
ParticipantsOG0038
CYCLE 2 DAY 1, END OF INFUSION
ParticipantsOG0009
ParticipantsOG0014
ParticipantsOG0025
ParticipantsOG0038
CYCLE 4 DAY 1, PRE-DOSE
ParticipantsOG0006
ParticipantsOG0011
ParticipantsOG0026
ParticipantsOG0032
CYCLE 4 DAY 1, END OF INFUSION
ParticipantsOG0006
ParticipantsOG0011
ParticipantsOG0026
ParticipantsOG0032
CYCLE 6 DAY 1, PRE-DOSE
ParticipantsOG0006
ParticipantsOG0011
ParticipantsOG0025
ParticipantsOG0034
CYCLE 6 DAY 1, END OF INFUSION
ParticipantsOG0006
ParticipantsOG0011
ParticipantsOG0025
ParticipantsOG0034
CYCLE 9 DAY 1, PRE-DOSE
ParticipantsOG0005
ParticipantsOG0011
ParticipantsOG0022
ParticipantsOG0032
CYCLE 9 DAY 1, END OF INFUSION
ParticipantsOG0005
ParticipantsOG0011
ParticipantsOG0022
ParticipantsOG0032
CYCLE 12 DAY 1, PRE-DOSE
ParticipantsOG0005
ParticipantsOG0011
ParticipantsOG0020
ParticipantsOG0032
CYCLE 12 DAY 1, END OF INFUSION
ParticipantsOG0004
ParticipantsOG0011
ParticipantsOG0020
ParticipantsOG0032
CYCLE 18 DAY 1, PRE-DOSE
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
CYCLE 30 DAY 1, PRE-DOSE
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
END OF TREATMENT (~157 weeks)
ParticipantsOG0007
ParticipantsOG0014
ParticipantsOG0027
ParticipantsOG0036
Units
Counts
Participants
OG00034
OG00137
Title
Denominators
Categories
CYCLE 1 DAY 1, PRE-DOSE
ParticipantsOG00033
ParticipantsOG00137
Title
Measurements
OG0000.00(0.0 to 0.0)
OG0010.00(0.0 to 0.0)
CYCLE 1 DAY 1, END OF INFUSION
ParticipantsOG00034
ParticipantsOG00135
Title
Measurements
OG000143.00(0.0 to 550.0)
OG001
CYCLE 1 DAY 1, 2 HOURS
ParticipantsOG00033
ParticipantsOG00135
Title
Measurements
OG000179.00(69.3 to 675.0)
OG001
CYCLE 1 DAY 1, 24 HOURS
ParticipantsOG00031
ParticipantsOG00132
Title
Measurements
OG000291.00(137.0 to 4960.0)
OG001
CYCLE 1 DAY 4, ANYTIME SAMPLE
ParticipantsOG00033
ParticipantsOG00136
Title
Measurements
OG000237.00(98.5 to 1470.0)
OG001
CYCLE 1 DAY 8, ANYTIME SAMPLE
ParticipantsOG00032
ParticipantsOG00135
Title
Measurements
OG00061.20(0.0 to 629.0)
OG001
CYCLE 1 DAY 22, ANYTIME SAMPLE
ParticipantsOG0001
ParticipantsOG0015
Title
Measurements
OG0000.00(NA to NA)Full range is not applicable as only a single participant was analyzed. Median value presented here is the actual concentration for this single participant.
OG001
CYCLE 2 DAY 1, PRE-DOSE
ParticipantsOG00028
ParticipantsOG00131
Title
Measurements
OG0000.00(0.0 to 94.2)
OG001
CYCLE 2 DAY 1, END OF INFUSION
ParticipantsOG00028
ParticipantsOG00131
Title
Measurements
OG000126.00(0.0 to 698.0)
OG001
CYCLE 4 DAY 1, PRE-DOSE
ParticipantsOG00022
ParticipantsOG00117
Title
Measurements
OG0000.00(0.0 to 0.0)
OG001
CYCLE 4 DAY 1, END OF INFUSION
ParticipantsOG00022
ParticipantsOG00116
Title
Measurements
OG000128.50(0.0 to 293.0)
OG001
CYCLE 6 DAY 1, PRE-DOSE
ParticipantsOG00013
ParticipantsOG00113
Title
Measurements
OG0000.00(0.0 to 0.0)
OG001
CYCLE 6 DAY 1, END OF INFUSION
ParticipantsOG00013
ParticipantsOG00113
Title
Measurements
OG000113.00(54.4 to 199.0)
OG001
CYCLE 9 DAY 1, PRE-DOSE
ParticipantsOG0005
ParticipantsOG0019
Title
Measurements
OG0000.00(0.0 to 0.0)
OG001
CYCLE 9 DAY 1, END OF INFUSION
ParticipantsOG0005
ParticipantsOG0019
Title
Measurements
OG000137.00(59.6 to 179.0)
OG001
CYCLE 12 DAY 1, PRE-DOSE
ParticipantsOG0005
ParticipantsOG0018
Title
Measurements
OG0000.00(0.0 to 0.0)
OG001
CYCLE 12 DAY 1, END OF INFUSION
ParticipantsOG0005
ParticipantsOG0017
Title
Measurements
OG000112.00(71.1 to 210.0)
OG001
CYCLE 18 DAY 1, PRE-DOSE
ParticipantsOG0004
ParticipantsOG0016
Title
Measurements
OG0000.00(0.0 to 0.0)
OG001
END OF TREATMENT (~157 weeks)
ParticipantsOG00026
ParticipantsOG00120
Title
Measurements
OG0000.00(0.0 to 276.0)
OG001
In DE Phase, participants with RRMM received 1.9 mg/ kg belantamab mafodotin IV infusion as powder for solution once Q3W infused over 30- 60 minutes on day 1 of 21-day cycles in combination with 100 mg nirogacestat administered BID on day 1, 4, 8 and 15 of 21-day cycles. Treatment was administered until disease progression, intolerable toxicity, informed consent withdrawal, the end of the sub-study or death.
OG002
DE Phase: 1.0 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID
In DE Phase, participants with RRMM received 1.0 mg/ kg belantamab mafodotin IV infusion as powder for solution once every 4 weeks (Q4W) for Cycle 1-2 and then once every 8 weeks (Q8W) from Cycle 2 onwards, infused over 30- 60 minutes on day 1 of 28-day cycles in Q4W and 56-day cycle in Q8W in combination with 100 mg nirogacestat BID on day 1, 4, 8 and 15 of 21-day cycles. Treatment was administered until disease progression, intolerable toxicity, informed consent withdrawal, the end of the sub-study or death.
OG003
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID
In DE Phase, participants with RRMM received 1.4 mg/ kg belantamab mafodotin IV infusion as powder for solution Q4W for Cycle 1 and then Q8W from Cycle2 onwards, infused over 30- 60 minutes on day 1 of 21-day cycles in combination with 100 mg nirogacestat BID on day 1, 4, 8 and 15 of 21-day cycles. Treatment was administered until disease progression, intolerable toxicity, informed consent withdrawal, the end of the sub-study or death.
OG004
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W + Nirogacestat BID
In DE Phase, participants with RRMM received 1.4 mg/ kg belantamab mafodotin IV infusion as powder for solution Q4W, infused over 30- 60 minutes on day 1 of 28-day cycles in combination with 100 mg nirogacestat BID on day 1, 4, 8 and 15 of 21-day cycles. Treatment was administered until disease progression, intolerable toxicity, informed consent withdrawal, the end of the sub-study or death.
Units
Counts
Participants
OG00010
OG0014
OG00210
OG00310
OG0041
Title
Denominators
Categories
CYCLE 1 DAY -2, PRE-DOSE
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0029
ParticipantsOG00310
ParticipantsOG0041
Title
Measurements
OG0020.00(0.0 to 0.0)
OG0030.00(0.0 to 579.0)
OG0040.00(NA to NA)Full range is not applicable as only a single participant was analyzed. Median value presented here is the actual concentration for this single participant.
CYCLE 1 DAY -2, 30 MINUTES
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0029
ParticipantsOG00310
CYCLE 1 DAY -2, 1 HOUR
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0029
ParticipantsOG00310
CYCLE 1 DAY -2, 2 HOURS
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0029
ParticipantsOG00310
CYCLE 1 DAY -2, 4 HOURS
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0029
ParticipantsOG00310
CYCLE 1 DAY 1, PRE-DOSE
ParticipantsOG00010
ParticipantsOG0014
ParticipantsOG00210
ParticipantsOG00310
CYCLE 1 DAY 1, 30 MINUTES
ParticipantsOG00010
ParticipantsOG0014
ParticipantsOG0021
ParticipantsOG0036
CYCLE 1 DAY 1, 1 HOUR
ParticipantsOG00010
ParticipantsOG0013
ParticipantsOG0021
ParticipantsOG0036
CYCLE 1 DAY 1, 2 HOURS
ParticipantsOG00010
ParticipantsOG0014
ParticipantsOG0021
ParticipantsOG0036
CYCLE 1 DAY 1, 4 HOURS
ParticipantsOG0009
ParticipantsOG0014
ParticipantsOG0021
ParticipantsOG0036
CYCLE 1 DAY 1, 8 HOURS
ParticipantsOG0007
ParticipantsOG0013
ParticipantsOG0020
ParticipantsOG0030
CYCLE 1 DAY 4, PRE-DOSE
ParticipantsOG0009
ParticipantsOG0014
ParticipantsOG0029
ParticipantsOG0038
CYCLE 1 DAY 8, PRE-DOSE
ParticipantsOG00010
ParticipantsOG0014
ParticipantsOG0028
ParticipantsOG0039
CYCLE 2 DAY 1, PRE-DOSE
ParticipantsOG0009
ParticipantsOG0014
ParticipantsOG0027
ParticipantsOG0038
CYCLE 2 DAY 1, 30 MINUTES
ParticipantsOG0008
ParticipantsOG0013
ParticipantsOG0027
ParticipantsOG0038
CYCLE 2 DAY 1, 1 HOUR
ParticipantsOG0009
ParticipantsOG0014
ParticipantsOG0027
ParticipantsOG0038
CYCLE 2 DAY 1, 2 HOURS
ParticipantsOG0008
ParticipantsOG0013
ParticipantsOG0027
ParticipantsOG0038
CYCLE 2 DAY 1, 4 HOURS
ParticipantsOG0008
ParticipantsOG0013
ParticipantsOG0027
ParticipantsOG0038
CYCLE 2 DAY 1, 8 HOURS
ParticipantsOG0004
ParticipantsOG0013
ParticipantsOG0020
ParticipantsOG0030
OG000
34
Title
Denominators
Categories
CYCLE 1 DAY 1, PRE-DOSE
ParticipantsOG00032
Title
Measurements
OG0000.00(0.0 to 0.0)
CYCLE 1 DAY 1, 30 MINUTES
ParticipantsOG00033
Title
Measurements
OG000146.00(0.0 to 1510.0)
CYCLE 1 DAY 1, 1 HOUR
ParticipantsOG00034
Title
Measurements
OG000487.00(14.1 to 1570.0)
CYCLE 1 DAY 1, 2 HOURS
ParticipantsOG00034
Title
Measurements
OG000353.00(21.2 to 826.0)
CYCLE 1 DAY 1, 4 HOURS
ParticipantsOG00032
Title
Measurements
OG000192.00(0.6 to 774.0)
CYCLE 1 DAY 1, 8 HOURS
ParticipantsOG00031
Title
Measurements
OG00087.80(0.0 to 337.0)
CYCLE 1 DAY 4, PRE-DOSE
ParticipantsOG00033
Title
Measurements
OG000231.00(57.4 to 1220.0)
CYCLE 1 DAY 8, PRE-DOSE
ParticipantsOG00032
Title
Measurements
OG000246.50(62.1 to 988.0)
CYCLE 2 DAY 1, PRE-DOSE
ParticipantsOG00025
Title
Measurements
OG000142.00(0.0 to 557.0)
CYCLE 2 DAY 1, 30 MINUTES
ParticipantsOG00025
Title
Measurements
OG000390.00(33.5 to 1250.0)
CYCLE 2 DAY 1, 1 HOUR
ParticipantsOG00025
Title
Measurements
OG000448.00(39.8 to 1640.0)
CYCLE 2 DAY 1, 2 HOURS
ParticipantsOG00025
Title
Measurements
OG000444.00(153.0 to 1290.0)
CYCLE 2 DAY 1, 4 HOURS
ParticipantsOG00023
Title
Measurements
OG000247.00(84.8 to 881.0)
CYCLE 2 DAY 1, 8 HOURS
ParticipantsOG00025
Title
Measurements
OG000154.00(1.0 to 756.0)
In DE Phase, participants with RRMM received 1.9 mg/ kg belantamab mafodotin IV infusion as powder for solution once Q3W infused over 30- 60 minutes on day 1 of 21-day cycles in combination with 100 mg nirogacestat administered BID on day 1, 4, 8 and 15 of 21-day cycles. Treatment was administered until disease progression, intolerable toxicity, informed consent withdrawal, the end of the sub-study or death.
OG002
DE Phase: 1.0 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID
In DE Phase, participants with RRMM received 1.0 mg/ kg belantamab mafodotin IV infusion as powder for solution once every 4 weeks (Q4W) for Cycle 1-2 and then once every 8 weeks (Q8W) from Cycle 2 onwards, infused over 30- 60 minutes on day 1 of 28-day cycles in Q4W and 56-day cycle in Q8W in combination with 100 mg nirogacestat BID on day 1, 4, 8 and 15 of 21-day cycles. Treatment was administered until disease progression, intolerable toxicity, informed consent withdrawal, the end of the sub-study or death.
OG003
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID
In DE Phase, participants with RRMM received 1.4 mg/ kg belantamab mafodotin IV infusion as powder for solution Q4W for Cycle 1 and then Q8W from Cycle2 onwards, infused over 30- 60 minutes on day 1 of 21-day cycles in combination with 100 mg nirogacestat BID on day 1, 4, 8 and 15 of 21-day cycles. Treatment was administered until disease progression, intolerable toxicity, informed consent withdrawal, the end of the sub-study or death.
OG004
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W + Nirogacestat BID
In DE Phase, participants with RRMM received 1.4 mg/ kg belantamab mafodotin IV infusion as powder for solution Q4W, infused over 30- 60 minutes on day 1 of 28-day cycles in combination with 100 mg nirogacestat BID on day 1, 4, 8 and 15 of 21-day cycles. Treatment was administered until disease progression, intolerable toxicity, informed consent withdrawal, the end of the sub-study or death.
Units
Counts
Participants
OG00010
OG0014
OG00210
OG00310
OG0041
Title
Denominators
Categories
CYCLE 2 DAY 1
ParticipantsOG0009
ParticipantsOG0014
ParticipantsOG0027
ParticipantsOG0038
ParticipantsOG0041
Title
Measurements
OG0000
OG0010
OG0020
OG003
CYCLE 4 DAY 1
ParticipantsOG0005
ParticipantsOG0011
ParticipantsOG0026
ParticipantsOG0034
CYCLE 6 DAY 1
ParticipantsOG0006
ParticipantsOG0011
ParticipantsOG0024
ParticipantsOG0034
CYCLE 9 DAY 1
ParticipantsOG0005
ParticipantsOG0011
ParticipantsOG0022
ParticipantsOG0032
CYCLE 12 DAY 1
ParticipantsOG0005
ParticipantsOG0011
ParticipantsOG0020
ParticipantsOG0032
CYCLE 18 DAY 1
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
CYCLE 30 DAY 1
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
END OF TREATMENT (~157 weeks)
ParticipantsOG0007
ParticipantsOG0014
ParticipantsOG0027
ParticipantsOG0036
Units
Counts
Participants
OG00034
OG00137
Title
Denominators
Categories
CYCLE 2 DAY 1
ParticipantsOG00028
ParticipantsOG00131
Title
Measurements
OG0000
OG0011
CYCLE 4 DAY 1
ParticipantsOG00022
ParticipantsOG00118
Title
Measurements
OG0000
OG001
CYCLE 6 DAY 1
ParticipantsOG00013
ParticipantsOG00114
Title
Measurements
OG0000
OG001
CYCLE 9 DAY 1
ParticipantsOG0007
ParticipantsOG0019
Title
Measurements
OG0000
OG001
CYCLE 12 DAY 1
ParticipantsOG0005
ParticipantsOG0018
Title
Measurements
OG0000
OG001
CYCLE 18 DAY 1
ParticipantsOG0004
ParticipantsOG0016
Title
Measurements
OG0000
OG001
END OF TREATMENT (~157 weeks)
ParticipantsOG00026
ParticipantsOG00121
Title
Measurements
OG0001
OG001
OG002
DE Phase: 1.0 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID
In DE Phase, participants with RRMM received 1.0 mg/ kg belantamab mafodotin IV infusion as powder for solution once every 4 weeks (Q4W) for Cycle 1-2 and then once every 8 weeks (Q8W) from Cycle 2 onwards, infused over 30- 60 minutes on day 1 of 28-day cycles in Q4W and 56-day cycle in Q8W in combination with 100 mg nirogacestat BID on day 1, 4, 8 and 15 of 21-day cycles. Treatment was administered until disease progression, intolerable toxicity, informed consent withdrawal, the end of the sub-study or death.
OG003
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID
In DE Phase, participants with RRMM received 1.4 mg/ kg belantamab mafodotin IV infusion as powder for solution Q4W for Cycle 1 and then Q8W from Cycle2 onwards, infused over 30- 60 minutes on day 1 of 21-day cycles in combination with 100 mg nirogacestat BID on day 1, 4, 8 and 15 of 21-day cycles. Treatment was administered until disease progression, intolerable toxicity, informed consent withdrawal, the end of the sub-study or death.
OG004
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W + Nirogacestat BID
In DE Phase, participants with RRMM received 1.4 mg/ kg belantamab mafodotin IV infusion as powder for solution Q4W, infused over 30- 60 minutes on day 1 of 28-day cycles in combination with 100 mg nirogacestat BID on day 1, 4, 8 and 15 of 21-day cycles. Treatment was administered until disease progression, intolerable toxicity, informed consent withdrawal, the end of the sub-study or death.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
OG0040
Units
Counts
Participants
OG0001
OG0011
Title
Denominators
Categories
Cycle 2 Day 1
ParticipantsOG0000
ParticipantsOG0011
Title
Measurements
OG001100(NA to NA)Full range is not applicable as only a single participant was analyzed. Median value presented here is the actual titer value for this single participant.
End of Treatment (~157 weeks)
ParticipantsOG0001
ParticipantsOG0010
Title
Measurements
OG000400.0(NA to NA)Full range is not applicable as only a single participant was analyzed. Median value presented here is the actual titer value for this single participant.
OG002
DE Phase: 1.0 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID
In DE Phase, participants with RRMM received 1.0 mg/ kg belantamab mafodotin IV infusion as powder for solution once every 4 weeks (Q4W) for Cycle 1-2 and then once every 8 weeks (Q8W) from Cycle 2 onwards, infused over 30- 60 minutes on day 1 of 28-day cycles in Q4W and 56-day cycle in Q8W in combination with 100 mg nirogacestat BID on day 1, 4, 8 and 15 of 21-day cycles. Treatment was administered until disease progression, intolerable toxicity, informed consent withdrawal, the end of the sub-study or death.
OG003
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID
In DE Phase, participants with RRMM received 1.4 mg/ kg belantamab mafodotin IV infusion as powder for solution Q4W for Cycle 1 and then Q8W from Cycle2 onwards, infused over 30- 60 minutes on day 1 of 21-day cycles in combination with 100 mg nirogacestat BID on day 1, 4, 8 and 15 of 21-day cycles. Treatment was administered until disease progression, intolerable toxicity, informed consent withdrawal, the end of the sub-study or death.
OG004
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W + Nirogacestat BID
In DE Phase, participants with RRMM received 1.4 mg/ kg belantamab mafodotin IV infusion as powder for solution Q4W, infused over 30- 60 minutes on day 1 of 28-day cycles in combination with 100 mg nirogacestat BID on day 1, 4, 8 and 15 of 21-day cycles. Treatment was administered until disease progression, intolerable toxicity, informed consent withdrawal, the end of the sub-study or death.
Units
Counts
Participants
OG00010
OG0014
OG00210
OG00310
OG0041
Title
Denominators
Categories
Title
Measurements
OG00010
OG0014
OG0029
OG00310
OG0040
Units
Counts
Participants
OG00034
OG00137
Title
Denominators
Categories
Title
Measurements
OG00028
OG00131
OG002
DE Phase: 1.0 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID
In DE Phase, participants with RRMM received 1.0 mg/ kg belantamab mafodotin IV infusion as powder for solution once every 4 weeks (Q4W) for Cycle 1-2 and then once every 8 weeks (Q8W) from Cycle 2 onwards, infused over 30- 60 minutes on day 1 of 28-day cycles in Q4W and 56-day cycle in Q8W in combination with 100 mg nirogacestat BID on day 1, 4, 8 and 15 of 21-day cycles. Treatment was administered until disease progression, intolerable toxicity, informed consent withdrawal, the end of the sub-study or death.
OG003
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID
In DE Phase, participants with RRMM received 1.4 mg/ kg belantamab mafodotin IV infusion as powder for solution Q4W for Cycle 1 and then Q8W from Cycle2 onwards, infused over 30- 60 minutes on day 1 of 21-day cycles in combination with 100 mg nirogacestat BID on day 1, 4, 8 and 15 of 21-day cycles. Treatment was administered until disease progression, intolerable toxicity, informed consent withdrawal, the end of the sub-study or death.
OG004
DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W + Nirogacestat BID
In DE Phase, participants with RRMM received 1.4 mg/ kg belantamab mafodotin IV infusion as powder for solution Q4W, infused over 30- 60 minutes on day 1 of 28-day cycles in combination with 100 mg nirogacestat BID on day 1, 4, 8 and 15 of 21-day cycles. Treatment was administered until disease progression, intolerable toxicity, informed consent withdrawal, the end of the sub-study or death.
Units
Counts
Participants
OG00010
OG0014
OG00210
OG00310
OG0041
Title
Denominators
Categories
Grade 1
Title
Measurements
OG0001
OG0011
OG0022
OG0032
OG0040
Grade 2
Title
Measurements
OG0001
OG0011
OG0023
OG003
Grade 3
Title
Measurements
OG0003
OG0010
OG0020
OG003
Grade 4
Title
Measurements
OG0000
OG0010
OG0020
OG003
Grade 5
Title
Measurements
OG0000
OG0010
OG0020
OG003
Units
Counts
Participants
OG00034
OG00137
Title
Denominators
Categories
Grade 1
Title
Measurements
OG0009
OG0019
Grade 2
Title
Measurements
OG0003
OG0015
Grade 3
Title
Measurements
OG0000
OG0012
Grade 4
Title
Measurements
OG0000
OG0010
Grade 5
Title
Measurements
OG0000
OG0010
Participants
OG00034
OG00137
Title
Denominators
Categories
Title
Measurements
OG0003.5(1.4 to 8.6)
OG0019.6(4.2 to 20.2)
Units
Counts
Participants
OG00010
OG00114
Title
Denominators
Categories
Title
Measurements
OG000NA(4.2 to NA)Median and upper limit of 95% Confidence interval were not estimable at the time of the final analysis due to an insufficient number of participants with events within the length of follow-up in assessing the number of events.
OG00122.2(4.9 to NA)Upper limit of 95% Confidence interval was not estimable at the time of the final analysis due to an insufficient number of participants with events within the length of follow-up in assessing the number of events.
Units
Counts
Participants
OG00010
OG00114
Title
Denominators
Categories
Title
Measurements
OG0001.1(0.7 to 1.4)
OG0011.4(0.7 to 2.1)
OG00034
OG00137
Title
Denominators
Categories
Title
Measurements
OG000NA(11.7 to NA)Median and upper limit of 95% Confidence interval were not estimable at the time of the final analysis due to an insufficient number of participants with events within the length of follow-up in assessing the number of events.
OG001NA(19.9 to NA)Median and upper limit of 95% Confidence interval were not estimable at the time of the final analysis due to an insufficient number of participants with events within the length of follow-up in assessing the number of events.
Units
Counts
Participants
OG00034
OG00137
Title
Denominators
Categories
AE
Title
Measurements
OG00034
OG00135
SAE
Title
Measurements
OG00016
OG00113
Units
Counts
Participants
OG00034
OG00137
Title
Denominators
Categories
Title
Measurements
OG0002
OG0011
Participants
OG00034
OG00137
Title
Denominators
Categories
Title
Measurements
OG00020
OG00112
OG001
CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W
In CE Phase, Participants with RRMM received 2.5 mg/ kg belantamab mafodotin IV infusion as powder for solution Q3W, infused over 30- 60 minutes on day 1 of 21-day cycles until disease progression, intolerable toxicity, informed consent withdrawal, the end of the sub-study or death.
Units
Counts
Participants
OG00034
OG00137
Title
Denominators
Categories
An, Increase to Grade 1
ParticipantsOG00032
ParticipantsOG00137
Title
Measurements
OG0001
OG0015
An, Increase to Grade 2
ParticipantsOG00032
ParticipantsOG00137
Title
Measurements
OG0006
OG001
An, Increase to Grade 3
ParticipantsOG00032
ParticipantsOG00137
Title
Measurements
OG0006
OG001
An, Increase to Grade 4
ParticipantsOG00032
ParticipantsOG00137
Title
Measurements
OG0000
OG001
HbI, Increase to Grade 1
ParticipantsOG00032
ParticipantsOG00137
Title
Measurements
OG0001
OG001
HbI, Increase to Grade 2
ParticipantsOG00032
ParticipantsOG00137
Title
Measurements
OG0000
OG001
HbI, Increase to Grade 3
ParticipantsOG00032
ParticipantsOG00137
Title
Measurements
OG0001
OG001
HbI, Increase to Grade 4
ParticipantsOG00032
ParticipantsOG00137
Title
Measurements
OG0000
OG001
LyD, Increase to Grade 1
ParticipantsOG00032
ParticipantsOG00136
Title
Measurements
OG0005
OG001
LyD, Increase to Grade 2
ParticipantsOG00032
ParticipantsOG00136
Title
Measurements
OG0008
OG001
LyD, Increase to Grade 3
ParticipantsOG00032
ParticipantsOG00136
Title
Measurements
OG0005
OG001
LyD, Increase to Grade 4
ParticipantsOG00032
ParticipantsOG00136
Title
Measurements
OG0002
OG001
LyI, Increase to Grade 1
ParticipantsOG00032
ParticipantsOG00136
Title
Measurements
OG0000
OG001
LyI, Increase to Grade 2
ParticipantsOG00032
ParticipantsOG00136
Title
Measurements
OG0003
OG001
LyI, Increase to Grade 3
ParticipantsOG00032
ParticipantsOG00136
Title
Measurements
OG0000
OG001
LyI, Increase to Grade 4
ParticipantsOG00032
ParticipantsOG00136
Title
Measurements
OG0000
OG001
NeuD, Increase to Grade 1
ParticipantsOG00032
ParticipantsOG00137
Title
Measurements
OG0002
OG001
NeuD, Increase to Grade 2
ParticipantsOG00032
ParticipantsOG00137
Title
Measurements
OG0005
OG001
NeuD, Increase to Grade 3
ParticipantsOG00032
ParticipantsOG00137
Title
Measurements
OG0003
OG001
NeuD, Increase to Grade 4
ParticipantsOG00032
ParticipantsOG00137
Title
Measurements
OG0002
OG001
PD, Increase to Grade 1
ParticipantsOG00032
ParticipantsOG00137
Title
Measurements
OG00012
OG001
PD, Increase to Grade 2
ParticipantsOG00032
ParticipantsOG00137
Title
Measurements
OG0004
OG001
PD, Increase to Grade 3
ParticipantsOG00032
ParticipantsOG00137
Title
Measurements
OG0005
OG001
PD, Increase to Grade 4
ParticipantsOG00032
ParticipantsOG00137
Title
Measurements
OG0003
OG001
LC, Increase to Grade 1
ParticipantsOG00032
ParticipantsOG00137
Title
Measurements
OG0000
OG001
LC, Increase to Grade 2
ParticipantsOG00032
ParticipantsOG00137
Title
Measurements
OG0000
OG001
LC, Increase to Grade 3
ParticipantsOG00032
ParticipantsOG00137
Title
Measurements
OG0000
OG001
LC, Increase to Grade 4
ParticipantsOG00032
ParticipantsOG00137
Title
Measurements
OG0000
OG001
WBCD, Increase to Grade 1
ParticipantsOG00032
ParticipantsOG00137
Title
Measurements
OG0008
OG001
WBCD, Increase to Grade 2
ParticipantsOG00032
ParticipantsOG00137
Title
Measurements
OG0002
OG001
WBCD, Increase to Grade 3
ParticipantsOG00032
ParticipantsOG00137
Title
Measurements
OG0002
OG001
WBCD, Increase to Grade 4
ParticipantsOG00032
ParticipantsOG00137
Title
Measurements
OG0001
OG001
OG001
CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W
In CE Phase, Participants with RRMM received 2.5 mg/ kg belantamab mafodotin IV infusion as powder for solution Q3W, infused over 30- 60 minutes on day 1 of 21-day cycles until disease progression, intolerable toxicity, informed consent withdrawal, the end of the sub-study or death.
Units
Counts
Participants
OG00034
OG00137
Title
Denominators
Categories
HG, Increase to Grade 1
ParticipantsOG00032
ParticipantsOG00136
Title
Measurements
OG0007
OG0012
HG, Increase to Grade 2
ParticipantsOG00032
ParticipantsOG00136
Title
Measurements
OG0000
OG001
HG, Increase to Grade 3
ParticipantsOG00032
ParticipantsOG00136
Title
Measurements
OG0000
OG001
HG, Increase to Grade 4
ParticipantsOG00032
ParticipantsOG00136
Title
Measurements
OG0000
OG001
HA, Increase to Grade 1
ParticipantsOG00032
ParticipantsOG00136
Title
Measurements
OG0002
OG001
HA, Increase to Grade 2
ParticipantsOG00032
ParticipantsOG00136
Title
Measurements
OG0003
OG001
HA, Increase to Grade 3
ParticipantsOG00032
ParticipantsOG00136
Title
Measurements
OG0000
OG001
HA, Increase to Grade 4
ParticipantsOG00032
ParticipantsOG00136
Title
Measurements
OG0000
OG001
CPKi, Increase to Grade 1
ParticipantsOG00031
ParticipantsOG00133
Title
Measurements
OG0007
OG001
CPKi, Increase to Grade 2
ParticipantsOG00031
ParticipantsOG00133
Title
Measurements
OG0001
OG001
CPKi, Increase to Grade 3
ParticipantsOG00031
ParticipantsOG00133
Title
Measurements
OG0000
OG001
CPKi, Increase to Grade 4
ParticipantsOG00031
ParticipantsOG00133
Title
Measurements
OG0001
OG001
HK, Increase to Grade 1
ParticipantsOG00032
ParticipantsOG00136
Title
Measurements
OG0005
OG001
HK, Increase to Grade 2
ParticipantsOG00032
ParticipantsOG00136
Title
Measurements
OG0000
OG001
HK, Increase to Grade 3
ParticipantsOG00032
ParticipantsOG00136
Title
Measurements
OG0001
OG001
HK, Increase to Grade 4
ParticipantsOG00032
ParticipantsOG00136
Title
Measurements
OG0000
OG001
BLDi, Increase to Grade 1
ParticipantsOG00032
ParticipantsOG00136
Title
Measurements
OG00018
OG001
BLDi, Increase to Grade 2
ParticipantsOG00032
ParticipantsOG00136
Title
Measurements
OG0000
OG001
BLDi, Increase to Grade 3
ParticipantsOG00032
ParticipantsOG00136
Title
Measurements
OG0000
OG001
BLDi, Increase to Grade 4
ParticipantsOG00032
ParticipantsOG00136
Title
Measurements
OG0000
OG001
HyperM, Increase to Grade 1
ParticipantsOG00032
ParticipantsOG00136
Title
Measurements
OG0006
OG001
HyperM, Increase to Grade 2
ParticipantsOG00032
ParticipantsOG00136
Title
Measurements
OG0000
OG001
HyperM, Increase to Grade 3
ParticipantsOG00032
ParticipantsOG00136
Title
Measurements
OG0001
OG001
HyperM, Increase to Grade 4
ParticipantsOG00032
ParticipantsOG00136
Title
Measurements
OG0000
OG001
HypoM, Increase to Grade 1
ParticipantsOG00032
ParticipantsOG00136
Title
Measurements
OG0006
OG001
HypoM, Increase to Grade 2
ParticipantsOG00032
ParticipantsOG00136
Title
Measurements
OG0001
OG001
HypoM, Increase to Grade 3
ParticipantsOG00032
ParticipantsOG00136
Title
Measurements
OG0000
OG001
HypoM, Increase to Grade 4
ParticipantsOG00032
ParticipantsOG00136
Title
Measurements
OG0000
OG001
HyperN, Increase to Grade 1
ParticipantsOG00032
ParticipantsOG00136
Title
Measurements
OG0007
OG001
HyperN, Increase to Grade 2
ParticipantsOG00032
ParticipantsOG00136
Title
Measurements
OG0000
OG001
HyperN, Increase to Grade 3
ParticipantsOG00032
ParticipantsOG00136
Title
Measurements
OG0000
OG001
HyperN, Increase to Grade 4
ParticipantsOG00032
ParticipantsOG00136
Title
Measurements
OG0000
OG001
HyperC, Increase to Grade 1
ParticipantsOG00032
ParticipantsOG00136
Title
Measurements
OG0004
OG001
HyperC, Increase to Grade 2
ParticipantsOG00032
ParticipantsOG00136
Title
Measurements
OG0002
OG001
HyperC, Increase to Grade 3
ParticipantsOG00032
ParticipantsOG00136
Title
Measurements
OG0000
OG001
HyperC, Increase to Grade 4
ParticipantsOG00032
ParticipantsOG00136
Title
Measurements
OG0000
OG001
HypoC, Increase to Grade 1
ParticipantsOG00032
ParticipantsOG00136
Title
Measurements
OG00010
OG001
HypoC, Increase to Grade 2
ParticipantsOG00032
ParticipantsOG00136
Title
Measurements
OG0002
OG001
HypoC, Increase to Grade 3
ParticipantsOG00032
ParticipantsOG00136
Title
Measurements
OG0001
OG001
HypoC, Increase to Grade 4
ParticipantsOG00032
ParticipantsOG00136
Title
Measurements
OG0001
OG001
CKD, Increase to Grade 1
ParticipantsOG00024
ParticipantsOG00127
Title
Measurements
OG0000
OG001
CKD, Increase to Grade 2
ParticipantsOG00024
ParticipantsOG00127
Title
Measurements
OG0002
OG001
CKD, Increase to Grade 3
ParticipantsOG00024
ParticipantsOG00127
Title
Measurements
OG0006
OG001
CKD, Increase to Grade 4
ParticipantsOG00024
ParticipantsOG00127
Title
Measurements
OG0001
OG001
0 events
0 affected
10 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected34 at risk
EG0061 events1 affected37 at risk
0 events
0 affected
10 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected34 at risk
EG0060 events0 affected37 at risk
0 events
0 affected
10 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected34 at risk
EG0060 events0 affected37 at risk
0 events
0 affected
10 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected34 at risk
EG0061 events1 affected37 at risk
0 events
0 affected
10 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected34 at risk
EG0060 events0 affected37 at risk
0 events
0 affected
10 at risk
EG0040 events0 affected1 at risk
EG0051 events1 affected34 at risk
EG0060 events0 affected37 at risk
0 events
0 affected
10 at risk
EG0040 events0 affected1 at risk
EG0051 events1 affected34 at risk
EG0061 events1 affected37 at risk
0 events
0 affected
10 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected34 at risk
EG0061 events1 affected37 at risk
0 events
0 affected
10 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected34 at risk
EG0060 events0 affected37 at risk
0 events
0 affected
10 at risk
EG0040 events0 affected1 at risk
EG0051 events1 affected34 at risk
EG0060 events0 affected37 at risk
0 events
0 affected
10 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected34 at risk
EG0060 events0 affected37 at risk
0 events
0 affected
10 at risk
EG0040 events0 affected1 at risk
EG0053 events3 affected34 at risk
EG0062 events2 affected37 at risk
0 events
0 affected
10 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected34 at risk
EG0060 events0 affected37 at risk
0 events
0 affected
10 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected34 at risk
EG0060 events0 affected37 at risk
0 events
0 affected
10 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected34 at risk
EG0060 events0 affected37 at risk
0 events
0 affected
10 at risk
EG0040 events0 affected1 at risk
EG0051 events1 affected34 at risk
EG0063 events3 affected37 at risk
0 events
0 affected
10 at risk
EG0040 events0 affected1 at risk
EG0051 events1 affected34 at risk
EG0061 events1 affected37 at risk
0 events
0 affected
10 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected34 at risk
EG0061 events1 affected37 at risk
0 events
0 affected
10 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected34 at risk
EG0061 events1 affected37 at risk
0 events
0 affected
10 at risk
EG0040 events0 affected1 at risk
EG0051 events1 affected34 at risk
EG0060 events0 affected37 at risk
1 events
1 affected
10 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected34 at risk
EG0063 events2 affected37 at risk
0 events
0 affected
10 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected34 at risk
EG0061 events1 affected37 at risk
0 events
0 affected
10 at risk
EG0040 events0 affected1 at risk
EG0051 events1 affected34 at risk
EG0060 events0 affected37 at risk
0 events
0 affected
10 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected34 at risk
EG0060 events0 affected37 at risk
0 events
0 affected
10 at risk
EG0040 events0 affected1 at risk
EG0051 events1 affected34 at risk
EG0060 events0 affected37 at risk
0 events
0 affected
10 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected34 at risk
EG0060 events0 affected37 at risk
0 events
0 affected
10 at risk
EG0040 events0 affected1 at risk
EG0051 events1 affected34 at risk
EG0060 events0 affected37 at risk
0 events
0 affected
10 at risk
EG0040 events0 affected1 at risk
EG0051 events1 affected34 at risk
EG0060 events0 affected37 at risk
0 events
0 affected
10 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected34 at risk
EG0060 events0 affected37 at risk
0 events
0 affected
10 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected34 at risk
EG0060 events0 affected37 at risk
0 events
0 affected
10 at risk
EG0040 events0 affected1 at risk
EG0051 events1 affected34 at risk
EG0060 events0 affected37 at risk
0 events
0 affected
10 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected34 at risk
EG0061 events1 affected37 at risk
0 events
0 affected
10 at risk
EG0040 events0 affected1 at risk
EG0051 events1 affected34 at risk
EG0060 events0 affected37 at risk
0 events
0 affected
10 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected34 at risk
EG0061 events1 affected37 at risk
0 events
0 affected
10 at risk
EG0040 events0 affected1 at risk
EG0051 events1 affected34 at risk
EG0060 events0 affected37 at risk
0 events
0 affected
10 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected34 at risk
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10 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected34 at risk
EG0062 events2 affected37 at risk
0 events
0 affected
10 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected34 at risk
EG0060 events0 affected37 at risk
1 events
1 affected
10 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected34 at risk
EG0060 events0 affected37 at risk
1 events
1 affected
10 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected34 at risk
EG0060 events0 affected37 at risk
0 events
0 affected
10 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected34 at risk
EG0060 events0 affected37 at risk
1 events
1 affected
10 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected34 at risk
EG0060 events0 affected37 at risk
2 events
2 affected
10 at risk
EG0040 events0 affected1 at risk
EG0054 events3 affected34 at risk
EG0062 events2 affected37 at risk
0 events
0 affected
10 at risk
EG0040 events0 affected1 at risk
EG0050 events0 affected34 at risk
EG0060 events0 affected37 at risk
3
OG0040
0
OG0040
0
OG0040
0
OG0040
0
OG0040
0
OG0040
0
OG0040
1
OG0040
1
OG0040
2
OG0040
0
OG0040
0
OG0040
1
OG0040
0
OG0040
0
OG0040
1
OG0040
1
OG0041
1
OG0040
0
OG0040
3
OG0040
2
OG0041
2
OG0040
1
OG0040
0
OG0040
0
OG0040
0
OG0040
0
OG0040
0
OG0040
2
OG0040
0
OG0040
0
OG0040
1
OG0040
ParticipantsOG0041
Title
Measurements
OG0000
OG0010
OG0021
OG0030
OG0040
ParticipantsOG0041
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
ParticipantsOG0041
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
ParticipantsOG0041
Title
Measurements
OG0000
OG0010
OG0021
OG0030
OG0040
ParticipantsOG0041
Title
Measurements
OG0001
OG0012
OG0021
OG0030
OG0040
ParticipantsOG0041
Title
Measurements
OG0001
OG0010
OG0020
OG0030
OG0040
ParticipantsOG0041
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
ParticipantsOG0041
Title
Measurements
OG0003
OG0011
OG0021
OG0033
OG0041
ParticipantsOG0041
Title
Measurements
OG0002
OG0010
OG0020
OG0030
OG0040
ParticipantsOG0041
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
ParticipantsOG0041
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
ParticipantsOG0041
Title
Measurements
OG0000
OG0010
OG0021
OG0030
OG0040
ParticipantsOG0041
Title
Measurements
OG0001
OG0010
OG0020
OG0030
OG0040
ParticipantsOG0041
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
ParticipantsOG0041
Title
Measurements
OG0001
OG0010
OG0020
OG0030
OG0040
ParticipantsOG0041
Title
Measurements
OG0003
OG0013
OG0025
OG0038
OG0041
ParticipantsOG0041
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
ParticipantsOG0041
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
ParticipantsOG0041
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
ParticipantsOG0041
Title
Measurements
OG0001
OG0010
OG0021
OG0031
OG0040
ParticipantsOG0041
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
ParticipantsOG0041
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
ParticipantsOG0041
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
ParticipantsOG0041
Title
Measurements
OG0002
OG0011
OG0021
OG0031
OG0040
ParticipantsOG0041
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
ParticipantsOG0041
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
ParticipantsOG0041
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
ParticipantsOG0041
Title
Measurements
OG0000
OG0010
OG0020
OG0032
OG0040
ParticipantsOG0041
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
ParticipantsOG0041
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
ParticipantsOG0041
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
ParticipantsOG0041
Title
Measurements
OG0000
OG0010
OG0021
OG0031
OG0040
ParticipantsOG0041
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
ParticipantsOG0041
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
ParticipantsOG0041
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
ParticipantsOG0041
Title
Measurements
OG0001
OG0010
OG0024
OG0036
OG0041
ParticipantsOG0041
Title
Measurements
OG0001
OG0010
OG0020
OG0030
OG0040
ParticipantsOG0041
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
ParticipantsOG0041
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
ParticipantsOG0041
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
ParticipantsOG0041
Title
Measurements
OG0004
OG0011
OG0020
OG0031
OG0040
ParticipantsOG0041
Title
Measurements
OG0000
OG0010
OG0020
OG0031
OG0040
ParticipantsOG0041
Title
Measurements
OG0000
OG0011
OG0020
OG0030
OG0040
0
OG0040
1
OG0040
3
OG0040
0.0
(0 to 0)
OG0040.0(NA to NA)Full range is not applicable as only a single participant was analyzed. Median value presented here is the actual concentration for this single participant.
ParticipantsOG0041
Title
Measurements
OG00015750.0(12300 to 24200)
OG00155350.0(30800 to 73900)
OG00221750.0(11000 to 38300)
OG00333400.0(16800 to 49400)
OG00427600.0(NA to NA)Full range is not applicable as only a single participant was analyzed. Median value presented here is the actual concentration for this single participant.
ParticipantsOG0041
Title
Measurements
OG00016550.0(11100 to 24100)
OG00150300.0(26100 to 67500)
OG00221100.0(11000 to 47200)
OG00329300.0(17100 to 50700)
OG00426900.0(NA to NA)Full range is not applicable as only a single participant was analyzed. Median value presented here is the actual concentration for this single participant.
ParticipantsOG0040
Title
Measurements
OG0009235.0(6320 to 14500)
OG00127150.0(16800 to 37500)
ParticipantsOG0041
Title
Measurements
OG0004680.0(1720 to 9580)
OG00113000.0(7800 to 17900)
OG0027370.0(3580 to 13900)
OG00310000.0(2400 to 23500)
OG00413300.0(NA to NA)Full range is not applicable as only a single participant was analyzed. Median value presented here is the actual concentration for this single participant.
ParticipantsOG0041
Title
Measurements
OG0002320.0(1290 to 5080)
OG0015545.0(3800 to 6760)
OG0023910.0(1520 to 5930)
OG0034690.0(1700 to 11100)
OG0044870.0(NA to NA)Full range is not applicable as only a single participant was analyzed. Median value presented here is the actual concentration for this single participant.
ParticipantsOG0040
Title
Measurements
OG003476.0(0 to 952)
ParticipantsOG0040
Title
Measurements
OG002570.0(0 to 1270)
OG0032350.0(NA to NA)Full range is not applicable as only a single participant was analyzed. Median value presented here is the actual concentration for this single participant.
ParticipantsOG0041
Title
Measurements
OG0000.0(0 to 6520)
OG0011230.0(525 to 1600)
OG002326.5(0 to 1510)
OG003308.5(0 to 1880)
OG0040.0(NA to NA)Full range is not applicable as only a single participant was analyzed. Median value presented here is the actual concentration for this single participant.
ParticipantsOG0041
Title
Measurements
OG00016900.0(0 to 25800)
OG00147150.0(27000 to 65900)
OG00223100.0(14000 to 28600)
OG00330350.0(20500 to 64700)
OG00431400.0(NA to NA)Full range is not applicable as only a single participant was analyzed. Median value presented here is the actual concentration for this single participant.
ParticipantsOG0040
Title
Measurements
OG0001380.0(863 to 2980)
OG0011390.0(NA to NA)Full range is not applicable as only a single participant was analyzed. Median value presented here is the actual concentration for this single participant.
OG0020.0(0 to 28900)
OG003287.5(0 to 1150)
ParticipantsOG0040
Title
Measurements
OG00020300.0(13600 to 26300)
OG00156600.0(NA to NA)Full range is not applicable as only a single participant was analyzed. Median value presented here is the actual concentration for this single participant.
OG00222450.0(17700 to 27700)
OG00320050.0(3440 to 32200)
ParticipantsOG0040
Title
Measurements
OG0002495.0(1450 to 3570)
OG0011430.0(NA to NA)Full range is not applicable as only a single participant was analyzed. Median value presented here is the actual concentration for this single participant.
OG0020.0(0 to 523)
OG003780.0(0 to 1280)
ParticipantsOG0040
Title
Measurements
OG00020050.0(14300 to 30600)
OG00155900.0(NA to NA)Full range is not applicable as only a single participant was analyzed. Median value presented here is the actual concentration for this single participant.
OG00224600.0(20100 to 27700)
OG00322450.0(16700 to 29000)
ParticipantsOG0040
Title
Measurements
OG0002810.0(0 to 5190)
OG0011570.0(NA to NA)Full range is not applicable as only a single participant was analyzed. Median value presented here is the actual concentration for this single participant.
OG0020.0(0 to 0)
OG003530.0(507 to 553)
ParticipantsOG0040
Title
Measurements
OG00019100.0(15900 to 30100)
OG00153200.0(NA to NA)Full range is not applicable as only a single participant was analyzed. Median value presented here is the actual concentration for this single participant.
OG00221550.0(20300 to 22800)
OG0037950.0(0 to 15900)
ParticipantsOG0040
Title
Measurements
OG0002225.0(1160 to 4790)
OG0012510.0(NA to NA)Full range is not applicable as only a single participant was analyzed. Median value presented here is the actual concentration for this single participant.
OG0031010.0(0 to 2020)
ParticipantsOG0040
Title
Measurements
OG00027000.0(19400 to 31600)
OG00135000.0(NA to NA)Full range is not applicable as only a single participant was analyzed. Median value presented here is the actual concentration for this single participant.
OG00310735.0(7670 to 13800)
ParticipantsOG0040
Title
Measurements
OG0001500.0(NA to NA)Full range is not applicable as only a single participant was analyzed. Median value presented here is the actual concentration for this single participant.
ParticipantsOG0040
Title
Measurements
OG000790.0(NA to NA)Full range is not applicable as only a single participant was analyzed. Median value presented here is the actual concentration for this single participant.
ParticipantsOG0041
Title
Measurements
OG000570.0(0 to 6240)
OG0011130.0(0 to 4070)
OG002994.5(0 to 2380)
OG003302.5(0 to 1850)
OG0040.0(NA to NA)Full range is not applicable as only a single participant was analyzed. Median value presented here is the actual concentration for this single participant.
53800.0
(1800 to 91200)
52900.0
(23300 to 87100)
31400.0
(13000 to 65500)
16700.0
(5480 to 41000)
7990.0
(2890 to 16600)
1860.0
(0 to 3540)
50600.0
(15500 to 97300)
1840.0
(0 to 7460)
46500.0
(26700 to 94300)
1265.0
(0 to 33700)
40600.0
(1240 to 89700)
2300.0
(0 to 22000)
30300.0
(11800 to 73000)
2140.0
(0 to 15100)
29750.0
(1350 to 39600)
2330.0
(0 to 6690)
1485.0
(0 to 8260)
0.0
(0 to 2330)
OG0040.0(NA to NA)Full range is not applicable as only a single participant was analyzed. Median value presented here is the actual concentration for this single participant.
ParticipantsOG0041
Title
Measurements
OG00016500.0(10100 to 26800)
OG00137750.0(27800 to 43400)
OG00221300.0(8730 to 32000)
OG00327850.0(12700 to 46200)
OG00432500.0(NA to NA)Full range is not applicable as only a single participant was analyzed. Median value presented here is the actual concentration for this single participant.
ParticipantsOG0041
Title
Measurements
OG00016900.0(12800 to 26700)
OG00135450.0(26800 to 43900)
OG00221800.0(9260 to 28400)
OG00327250.0(9940 to 50600)
OG00433800.0(NA to NA)Full range is not applicable as only a single participant was analyzed. Median value presented here is the actual concentration for this single participant.
ParticipantsOG0040
Title
Measurements
OG00010950.0(8130 to 18400)
OG00121300.0(16600 to 26000)
ParticipantsOG0041
Title
Measurements
OG0006220.0(3630 to 13200)
OG00113400.0(10100 to 18400)
OG0028500.0(5060 to 14100)
OG00313600.0(3370 to 34600)
OG00418800.0(NA to NA)Full range is not applicable as only a single participant was analyzed. Median value presented here is the actual concentration for this single participant.
ParticipantsOG0041
Title
Measurements
OG0003565.0(2280 to 8570)
OG0019320.0(6930 to 9640)
OG0025335.0(3620 to 7870)
OG0038300.0(1470 to 16700)
OG0047210.0(NA to NA)Full range is not applicable as only a single participant was analyzed. Median value presented here is the actual concentration for this single participant.
ParticipantsOG0040
Title
Measurements
OG0031605.0(1230 to 1980)
ParticipantsOG0040
Title
Measurements
OG0023030.0(759 to 3070)
OG0037020.0(NA to NA)Full range is not applicable as only a single participant was analyzed. Median value presented here is the actual concentration for this single participant.
ParticipantsOG0041
Title
Measurements
OG0001700.0(823 to 3490)
OG0012310.0(1440 to 3120)
OG0021440.0(0 to 6350)
OG0032060.0(0 to 3830)
OG0041600.0(NA to NA)Full range is not applicable as only a single participant was analyzed. Median value presented here is the actual concentration for this single participant.
ParticipantsOG0041
Title
Measurements
OG00021250.0(747 to 29400)
OG00132900.0(24500 to 35600)
OG00225200.0(13800 to 34700)
OG00326700.0(14400 to 42800)
OG00425200.0(NA to NA)Full range is not applicable as only a single participant was analyzed. Median value presented here is the actual concentration for this single participant.
ParticipantsOG0040
Title
Measurements
OG0004860.0(3180 to 9250)
OG0013730.0(NA to NA)Full range is not applicable as only a single participant was analyzed. Median value presented here is the actual concentration for this single participant.
OG002792.0(0 to 1440)
OG0031898.5(778 to 5610)
ParticipantsOG0040
Title
Measurements
OG00023200.0(18200 to 33300)
OG00140200.0(NA to NA)Full range is not applicable as only a single participant was analyzed. Median value presented here is the actual concentration for this single participant.
OG00225300.0(13100 to 33800)
OG00324550.0(4240 to 39700)
ParticipantsOG0040
Title
Measurements
OG0008600.0(4290 to 10200)
OG0013450.0(NA to NA)Full range is not applicable as only a single participant was analyzed. Median value presented here is the actual concentration for this single participant.
OG0021310.0(0 to 1560)
OG0032115.0(1320 to 5490)
ParticipantsOG0040
Title
Measurements
OG00027400.0(20200 to 36800)
OG00135500.0(NA to NA)Full range is not applicable as only a single participant was analyzed. Median value presented here is the actual concentration for this single participant.
OG00220800.0(15500 to 23500)
OG00321400.0(14700 to 29700)
ParticipantsOG0040
Title
Measurements
OG00012200.0(0 to 18100)
OG0014990.0(NA to NA)Full range is not applicable as only a single participant was analyzed. Median value presented here is the actual concentration for this single participant.
OG002373.0(0 to 746)
OG0032220.0(1180 to 3260)
ParticipantsOG0040
Title
Measurements
OG00033200.0(15300 to 44800)
OG00148200.0(NA to NA)Full range is not applicable as only a single participant was analyzed. Median value presented here is the actual concentration for this single participant.
OG00219250.0(18600 to 19900)
OG00310475.0(1250 to 19700)
ParticipantsOG0040
Title
Measurements
OG0008765.0(2780 to 17200)
OG0017560.0(NA to NA)Full range is not applicable as only a single participant was analyzed. Median value presented here is the actual concentration for this single participant.
OG0032958.5(897 to 5020)
ParticipantsOG0040
Title
Measurements
OG00035600.0(16100 to 48200)
OG00150500.0(NA to NA)Full range is not applicable as only a single participant was analyzed. Median value presented here is the actual concentration for this single participant.
OG00312335.0(6870 to 17800)
ParticipantsOG0040
Title
Measurements
OG0002340.0(NA to NA)Full range is not applicable as only a single participant was analyzed. Median value presented here is the actual concentration for this single participant.
ParticipantsOG0040
Title
Measurements
OG0002370.0(NA to NA)Full range is not applicable as only a single participant was analyzed. Median value presented here is the actual concentration for this single participant.
ParticipantsOG0041
Title
Measurements
OG0001890.0(0 to 24300)
OG0012980.0(0 to 9290)
OG0022390.0(2030 to 4720)
OG0031285.0(0 to 3170)
OG0040.0(NA to NA)Full range is not applicable as only a single participant was analyzed. Median value presented here is the actual concentration for this single participant.
45150.0
(7000 to 81500)
46800.0
(29800 to 75900)
36200.0
(17100 to 73100)
22050.0
(9900 to 39000)
15150.0
(5590 to 30600)
5460.0
(0 to 25900)
48400.0
(16500 to 93000)
8090.0
(1080 to 26600)
46250.0
(22100 to 196000)
3680.0
(629 to 44500)
37100.0
(2490 to 77300)
9030.0
(1060 to 60400)
29600.0
(14900 to 66300)
6915.0
(723 to 17700)
27950.0
(15100 to 47600)
6760.0
(914 to 42500)
4050.0
(1180 to 22100)
0.00
(0.0 to 0.0)
OG0040.00(NA to NA)Full range is not applicable as only a single participant was analyzed. Median value presented here is the actual concentration for this single participant.
ParticipantsOG0041
Title
Measurements
OG000163.50(99.4 to 338.0)
OG001175.00(168.0 to 317.0)
OG00296.55(68.2 to 190.0)
OG003165.50(99.3 to 1040.0)
OG004155.00(NA to NA)Full range is not applicable as only a single participant was analyzed. Median value presented here is the actual concentration for this single participant.
ParticipantsOG0041
Title
Measurements
OG000191.00(119.0 to 351.0)
OG001322.00(225.0 to 388.0)
OG002137.50(86.9 to 270.0)
OG003299.00(156.0 to 1150.0)
OG004113.00(NA to NA)Full range is not applicable as only a single participant was analyzed. Median value presented here is the actual concentration for this single participant.
ParticipantsOG0040
Title
Measurements
OG000387.50(196.0 to 855.0)
OG0011697.50(675.0 to 2720.0)
ParticipantsOG0041
Title
Measurements
OG000232.00(145.0 to 711.0)
OG001528.50(393.0 to 909.0)
OG002144.00(115.0 to 358.0)
OG003432.00(202.0 to 2950.0)
OG004244.00(NA to NA)Full range is not applicable as only a single participant was analyzed. Median value presented here is the actual concentration for this single participant.
ParticipantsOG0040
Title
Measurements
OG00071.20(0.0 to 122.0)
OG001177.00(163.0 to 193.0)
OG00288.45(63.3 to 137.0)
OG003132.00(71.4 to 245.0)
ParticipantsOG0040
Title
Measurements
OG0030.00(0.0 to 0.0)
ParticipantsOG0040
Title
Measurements
OG0020.00(0.0 to 0.0)
OG0030.00(NA to NA)Full range is not applicable as only a single participant was analyzed. Median value presented here is the actual concentration for this single participant.
ParticipantsOG0041
Title
Measurements
OG0000.00(0.0 to 122.0)
OG0010.00(0.0 to 0.0)
OG0020.00(0.0 to 0.0)
OG0030.00(0.0 to 0.0)
OG0040.00(NA to NA)Full range is not applicable as only a single participant was analyzed. Median value presented here is the actual concentration for this single participant.
ParticipantsOG0041
Title
Measurements
OG000131.00(0.0 to 330.0)
OG001291.50(201.0 to 369.0)
OG002142.00(0.0 to 152.0)
OG003231.50(126.0 to 907.0)
OG004122.00(NA to NA)Full range is not applicable as only a single participant was analyzed. Median value presented here is the actual concentration for this single participant.
ParticipantsOG0040
Title
Measurements
OG0000.00(0.0 to 0.0)
OG0010.00(NA to NA)Full range is not applicable as only a single participant was analyzed. Median value presented here is the actual concentration for this single participant.
OG0020.00(0.0 to 0.0)
OG0030.00(0.0 to 0.0)
ParticipantsOG0040
Title
Measurements
OG000190.00(113.0 to 312.0)
OG0015620.00(NA to NA)Full range is not applicable as only a single participant was analyzed. Median value presented here is the actual concentration for this single participant.
OG00291.70(0.0 to 121.0)
OG00388.00(0.0 to 176.0)
ParticipantsOG0040
Title
Measurements
OG0000.00(0.0 to 0.0)
OG0010.00(NA to NA)Full range is not applicable as only a single participant was analyzed. Median value presented here is the actual concentration for this single participant.
OG0020.00(0.0 to 0.0)
OG0030.00(0.0 to 0.0)
ParticipantsOG0040
Title
Measurements
OG000164.50(84.2 to 301.0)
OG001226.00(NA to NA)Full range is not applicable as only a single participant was analyzed. Median value presented here is the actual concentration for this single participant.
OG002145.00(81.0 to 171.0)
OG003133.50(102.0 to 214.0)
ParticipantsOG0040
Title
Measurements
OG0000.00(0.0 to 0.0)
OG0010.00(NA to NA)Full range is not applicable as only a single participant was analyzed. Median value presented here is the actual concentration for this single participant.
OG0020.00(0.0 to 0.0)
OG0030.00(0.0 to 0.0)
ParticipantsOG0040
Title
Measurements
OG000128.00(113.0 to 223.0)
OG001243.00(NA to NA)Full range is not applicable as only a single participant was analyzed. Median value presented here is the actual concentration for this single participant.
OG002100.85(90.7 to 111.0)
OG00355.50(0.0 to 111.0)
ParticipantsOG0040
Title
Measurements
OG0000.00(0.0 to 188.0)
OG0010.00(NA to NA)Full range is not applicable as only a single participant was analyzed. Median value presented here is the actual concentration for this single participant.
OG0030.00(0.0 to 0.0)
ParticipantsOG0040
Title
Measurements
OG000166.00(114.0 to 229.0)
OG001285.00(NA to NA)Full range is not applicable as only a single participant was analyzed. Median value presented here is the actual concentration for this single participant.
OG003100.50(0.0 to 201.0)
ParticipantsOG0040
Title
Measurements
OG0000.00(NA to NA)Full range is not applicable as only a single participant was analyzed. Median value presented here is the actual concentration for this single participant.
ParticipantsOG0040
Title
Measurements
OG0000.00(NA to NA)Full range is not applicable as only a single participant was analyzed. Median value presented here is the actual concentration for this single participant.
ParticipantsOG0041
Title
Measurements
OG0000.00(0.0 to 74.6)
OG0010.00(0.0 to 73.8)
OG0020.00(0.0 to 0.0)
OG0030.00(0.0 to 71.2)
OG0040.00(NA to NA)Full range is not applicable as only a single participant was analyzed. Median value presented here is the actual concentration for this single participant.
453.00
(0.0 to 1360.0)
513.00
(175.0 to 2590.0)
778.00
(436.0 to 5970.0)
548.00
(235.0 to 2530.0)
200.00
(81.9 to 548.0)
0.00
(0.0 to 0.0)
0.00
(0.0 to 55.0)
329.00
(0.0 to 684.0)
0.00
(0.0 to 0.0)
351.50
(119.0 to 987.0)
0.00
(0.0 to 115.0)
213.00
(0.0 to 492.0)
0.00
(0.0 to 0.0)
172.00
(0.0 to 533.0)
0.00
(0.0 to 52.5)
261.00
(0.0 to 2120.0)
0.00
(0.0 to 0.0)
0.00
(0.0 to 162.0)
ParticipantsOG0041
Title
Measurements
OG002377.00(0.0 to 769.0)
OG003251.50(0.8 to 1270.0)
OG004272.00(NA to NA)Full range is not applicable as only a single participant was analyzed. Median value presented here is the actual concentration for this single participant.
ParticipantsOG0041
Title
Measurements
OG002371.00(4.3 to 804.0)
OG003343.50(21.2 to 968.0)
OG004345.00(NA to NA)Full range is not applicable as only a single participant was analyzed. Median value presented here is the actual concentration for this single participant.
ParticipantsOG0041
Title
Measurements
OG002307.00(19.3 to 688.0)
OG003319.00(124.0 to 1360.0)
OG004153.00(NA to NA)Full range is not applicable as only a single participant was analyzed. Median value presented here is the actual concentration for this single participant.
ParticipantsOG0041
Title
Measurements
OG002168.00(75.3 to 278.0)
OG003161.50(67.1 to 611.0)
OG00452.30(NA to NA)Full range is not applicable as only a single participant was analyzed. Median value presented here is the actual concentration for this single participant.
ParticipantsOG0040
Title
Measurements
OG0000.00(0.0 to 0.0)
OG0010.00(0.0 to 0.0)
OG00298.55(34.7 to 564.0)
OG00388.25(41.3 to 1000.0)
ParticipantsOG0041
Title
Measurements
OG000244.00(7.9 to 1560.0)
OG001348.00(78.5 to 914.0)
OG002253.00(NA to NA)Full range is not applicable as only a single participant was analyzed. Median value presented here is the actual concentration for this single participant.
OG003670.00(188.0 to 998.0)
OG004585.00(NA to NA)Full range is not applicable as only a single participant was analyzed. Median value presented here is the actual concentration for this single participant.
ParticipantsOG0041
Title
Measurements
OG000306.50(122.0 to 1680.0)
OG001490.00(108.0 to 923.0)
OG002465.00(NA to NA)Full range is not applicable as only a single participant was analyzed. Median value presented here is the actual concentration for this single participant.
OG003651.00(389.0 to 1240.0)
OG004547.00(NA to NA)Full range is not applicable as only a single participant was analyzed. Median value presented here is the actual concentration for this single participant.
ParticipantsOG0041
Title
Measurements
OG000265.50(126.0 to 1060.0)
OG001325.00(252.0 to 369.0)
OG002726.00(NA to NA)Full range is not applicable as only a single participant was analyzed. Median value presented here is the actual concentration for this single participant.
OG003413.50(217.0 to 1100.0)
OG004207.00(NA to NA)Full range is not applicable as only a single participant was analyzed. Median value presented here is the actual concentration for this single participant.
ParticipantsOG0041
Title
Measurements
OG000110.00(58.4 to 431.0)
OG001127.00(50.6 to 149.0)
OG002366.00(NA to NA)Full range is not applicable as only a single participant was analyzed. Median value presented here is the actual concentration for this single participant.
OG003215.00(103.0 to 625.0)
OG004113.00(NA to NA)Full range is not applicable as only a single participant was analyzed. Median value presented here is the actual concentration for this single participant.
ParticipantsOG0040
Title
Measurements
OG00050.90(32.7 to 254.0)
OG00174.80(30.4 to 102.0)
ParticipantsOG0041
Title
Measurements
OG000176.00(93.5 to 409.0)
OG001161.00(72.3 to 309.0)
OG002152.00(42.9 to 339.0)
OG003171.50(80.0 to 1390.0)
OG004138.00(NA to NA)Full range is not applicable as only a single participant was analyzed. Median value presented here is the actual concentration for this single participant.
ParticipantsOG0041
Title
Measurements
OG000129.00(60.5 to 490.0)
OG001379.50(20.6 to 1070.0)
OG002174.50(53.9 to 403.0)
OG003218.00(144.0 to 1140.0)
OG004117.00(NA to NA)Full range is not applicable as only a single participant was analyzed. Median value presented here is the actual concentration for this single participant.
ParticipantsOG0041
Title
Measurements
OG00086.60(38.3 to 761.0)
OG00163.73(2.1 to 195.0)
OG0021.83(0.0 to 149.0)
OG00354.30(0.0 to 724.0)
OG00424.00(NA to NA)Full range is not applicable as only a single participant was analyzed. Median value presented here is the actual concentration for this single participant.
ParticipantsOG0041
Title
Measurements
OG000228.00(37.3 to 1830.0)
OG00112.70(6.2 to 789.0)
OG002122.00(1.2 to 550.0)
OG003484.50(58.7 to 1190.0)
OG00474.00(NA to NA)Full range is not applicable as only a single participant was analyzed. Median value presented here is the actual concentration for this single participant.
ParticipantsOG0041
Title
Measurements
OG000253.00(78.6 to 2260.0)
OG001186.50(33.9 to 773.0)
OG002220.00(13.6 to 726.0)
OG003422.00(81.8 to 1330.0)
OG004171.00(NA to NA)Full range is not applicable as only a single participant was analyzed. Median value presented here is the actual concentration for this single participant.
ParticipantsOG0041
Title
Measurements
OG000236.50(102.0 to 1400.0)
OG001162.00(54.9 to 704.0)
OG002274.00(81.9 to 523.0)
OG003334.50(119.0 to 472.0)
OG004124.00(NA to NA)Full range is not applicable as only a single participant was analyzed. Median value presented here is the actual concentration for this single participant.
ParticipantsOG0041
Title
Measurements
OG000170.00(64.5 to 941.0)
OG001357.00(173.0 to 400.0)
OG002196.00(48.0 to 426.0)
OG003179.50(109.0 to 326.0)
OG00458.20(NA to NA)Full range is not applicable as only a single participant was analyzed. Median value presented here is the actual concentration for this single participant.