Phase 1/2 Dose Escalation and Efficacy Study of Anti-CD38... | NCT01084252 | Trialant
NCT01084252
Sponsor
Sanofi
Status
Completed
Last Update Posted
Nov 1, 2024Actual
Enrollment
351Actual
Phase
Phase 1Phase 2
Conditions
Hematological Malignancy
Interventions
Isatuximab SAR650984
Dexamethasone
Dexamethasone
Countries
United States
Argentina
Belgium
Brazil
Chile
Finland
France
Greece
Israel
Italy
Mexico
Peru
Russia
Spain
Turkey (Türkiye)
Ukraine
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT01084252
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
TED10893
Secondary IDs
ID
Type
Description
Link
U1111-1116-5472
Registry Identifier
ICTRP
2013-001418-13
EudraCT Number
Brief Title
Phase 1/2 Dose Escalation and Efficacy Study of Anti-CD38 Monoclonal Antibody in Patients With Selected CD38+ Hematological Malignancies
Official Title
A Phase I/2 Dose Escalation Safety, Pharmacokinetic and Efficacy Study of Multiple Intravenous Administrations of a Humanized Monoclonal Antibody (SAR650984) Against CD38 in Patients With Selected CD38+ Hematological Malignancies
Acronym
Not provided
Organization
SanofiINDUSTRY
Status Module
Record Verification Date
Oct 2024
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
May 11, 2010Actual
Primary Completion Date
Dec 21, 2018Actual
Completion Date
Jul 13, 2023Actual
First Submitted Date
Mar 9, 2010
First Submission Date that Met QC Criteria
Mar 9, 2010
First Posted Date
Mar 10, 2010Estimated
Results Waived
Not provided
Results First Submitted Date
Mar 31, 2020
Results First Submitted that Met QC Criteria
Mar 31, 2020
Results First Posted Date
Apr 15, 2020Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Dec 7, 2019
Certification/Extension First Submitted that Passed QC Review
Dec 7, 2019
Certification/Extension First Posted Date
Dec 10, 2019Actual
Last Update Submitted Date
Oct 22, 2024
Last Update Posted Date
Nov 1, 2024Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
SanofiINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
Not provided
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
Primary Objective:
Phase 1:
To determine the maximum tolerated dose (MTD)/maximum administered dose (MAD) of SAR650984 (Isatuximab).
Phase 2 (stage 1):
To evaluate the activity of single-agent Isatuximab at different doses/schedules and to select dose and regimen to further evaluate the overall response rate (ORR) of Isatuximab as single agent or in combination with dexamethasone.
Phase 2 (stage 2):
To evaluate the activity in terms of overall response rate (ORR) of Isatuximab at the selected dose/schedule from stage1, as single agent (ISA arm) and in combination with dexamethasone (ISAdex arm).
Secondary Objectives:
Phase 1:
To characterize the global safety profile including cumulative toxicities.
To evaluate the pharmacokinetic (PK) profile of Isatuximab in the proposed dosing schedule(s).
To assess the pharmacodynamics (PD), immune response, and preliminary disease response.
Phase 2 (stage 1): to evaluate the following objectives for Isatuximab as single agent:
Safety
Efficacy as measured by duration of response, clinical benefit rate, progression free survival, overall survival.
Phase 2 (stage 2): to evaluate the following objectives in each arm (ISA and ISAdex):
Safety
Efficacy as measured by duration of response, clinical benefit rate, progression free survival, overall survival.
Participant-reported changes in health-related quality of life, symptoms of multiple myeloma and generic health status.
Pharmacokinetic profile of Isatuximab.
Immunogenicity of Isatuximab.
Investigate the relationship between CD38 receptor density and CD38 receptor occupancy (Stage 1 only) on multiple myeloma cells and parameters of clinical response.
Detailed Description
The Phase 1 study duration for an individual participant included a screening period for inclusion of up to 2 weeks, treatment with Isatuximab QW (every week) or Q2W (every 2 weeks) unless discontinued earlier due to safety or disease progression. Participants were followed for a minimum of 30 days following the last use of study drug or more than 30 days in case of unresolved toxicity, or up to initiation of another anticancer treatment.
The Phase 2 study duration for an individual participant included a screening period for inclusion of up to 3 weeks, then a treatment period and a follow up period. Treatment was continued until disease progression, unacceptable adverse reactions or other reasons for discontinuation. Participants were followed every 3 months following the last use of study drug until death or study cutoff, whichever came first.
Conditions Module
Conditions
Hematological Malignancy
Keywords
Anti-CD38 monoclonal antibody
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
351Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Phase 1:Isatuximab <=1 mg/kg Q2W
Experimental
Participants with CD38+ hematological malignancies (HM), received Isatuximab at any one of the dose less than or equal to (<=) 1 milligram per kilogram (mg/kg) (i.e. either 0.0001 mg/kg or 0.001 mg/kg or 0.01 mg/kg or 0.03 mg/kg or 0.1 mg/kg or 0.3 mg/kg or 1 mg/kg) as intravenous (IV) infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal by participant, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
Drug: Isatuximab SAR650984
Phase 1: Isatuximab 3mg/kg Q2W
Experimental
Participants with CD38+ HM, received Isatuximab 3 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
Drug: Isatuximab SAR650984
Phase 1: Isatuximab 5 mg/kg Q2W
Experimental
Participants with CD38+ HM, received Isatuximab 5 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
Drug: Isatuximab SAR650984
Phase1:Isatuximab (CD38+HM and Standard Risk Multiple Myeloma)
Experimental
Participants with CD38+ HM along with participants with standard risk multiple myeloma were included this arm and, received Isatuximab 10 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Isatuximab SAR650984
Drug
Pharmaceutical form: solution for infusion
Route of administration: intravenous
Phase 1: Isatuximab 10 mg/kg QW
Phase 1: Isatuximab 20 mg/kg Q2W
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Phase 1: Number of Participants With Dose Limiting Toxicities (DLTs)
DLTs were assessed using the national cancer institute common terminology criteria for adverse events (NCI-CTCAE) version 4.03. DLTs were defined as any Grade 3 or higher non-hematological toxicity (with the exception of allergic reaction/hypersensitivity), Grade 4 neutropenia and/or Grade 4 thrombocytopenia lasting longer than 5 days, attributed to isatuximab. Any other toxicity that the Investigator and the Sponsor deemed to be dose-limiting, regardless of the grade, was also considered as DLT.
Day 1 of Cycle 1 up to Day 14 of Cycle 2
Phase 1: Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Adverse event (AE) was defined as any untoward medical occurrence in a participant who received study drug and did not necessarily have to have a causal relationship with the treatment. TEAEs were defined as AEs that developed or worsened during the on-treatment period which was defined as the period from the time of first dose of study treatment until 30 days after the last dose of study treatment.
From Baseline up to 30 days after the last dose (maximum duration: 120 weeks )
Phase 2 Stage 1: Percentage of Participants With Overall Response (OR) According to International Myeloma Working Group (IMWG) Uniform Response Criteria
OR defined as participants with stringent complete response (sCR) or complete response (CR) or very good partial response (VGPR) or partial response (PR) . Based on IMWG, CR: Negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and <=5% plasma cells in bone marrow; sCR: CR and normal free light chain (FLC) ratio and no clonal cells in bone marrow; VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or >=90% reduction in serum M-protein and urine M-protein level <100 mg/24 hours; PR: >=50% reduction of serum M-Protein and reduction in urinary M-protein by >=90% or to <200 mg/24 hours; >=50% decrease in the difference between involved and uninvolved FLC levels in place of the M-protein criteria or a >=50% reduction in plasma cells in place of M-protein if present at baseline.
From the date of randomization until disease progression or death or data cut-off (maximum duration: 77 weeks for Stage 1a arms and 53 weeks for Stage 1b arm)
Secondary Outcomes
Measure
Description
Time Frame
Pharmacokinetic (PK) Assessment: Phase 1: Plasma Concentration of Isatuximab Observed at the End of an Intravenous Infusion (Ceoi)
Ceoi was defined as the plasma concentration of Isatuximab at end of infusion. Data for this outcome measure was planned to be collected and analyzed separately for dose 0.3 mg/kg, 1 mg/kg and not for 0.0001, 0.001, 0.01, 0.03 and 0.1 dose levels (reported under one arm, i.e. Phase 1: Isatuximab <=1mg/kg in participant flow). Analysis was performed on PK population: participants who gave informed consent, received at least one dose (even if incomplete) of isatuximab, had an assessable PK parameter.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion criteria:
Phase 1:
For dose escalation cohorts, participants with confirmed selected CD38+ hematological malignancies as specified below who had progressed on after standard therapy or for whom there was no effective standard therapy (refractory/relapsed participants). B-cell Non-Hodgkin-lymphoma/leukemia (NHL) participants with at least 1 measurable lesion. Multiple myeloma (MM) participants with measurable M-protein serum and/or 24-hour urine. Acute myeloid leukemia (AML) participants, all types except M3 based on French-American-British (FAB) classification. Acute Lymphoblastic Leukemia (B-cell ALL) participants. Chronic lymphocytic leukemia (CLL) participants.
For expansion cohorts, participants with relapsed/refractory MM with measurable M-protein (serum M-protein of >0.5 g/dL and/or urine M-protein of >200 mg (24-hr urine)) or elevated serum free light chains (FLC) >10 mg/dL with abnormal FLC ratio) who had progressed on or after standard therapy that included an Immunomodulatory drug (IMiD) and a proteasome inhibitor and who met the protocol defined criteria for standard risk or high risk.
Phase 2:
Participants had a known diagnosis of multiple myeloma with evidence of measurable disease, and have evidence of disease progression based on International Myeloma Working Group (IMWG) criteria: Serum M-protein ≥1 g/dL, or urine M-protein >=200 mg/24 hours or in the absence of measurable m-protein, serum FLC >=10 mg/dL, and abnormal serum immunoglobulin kappa lambda FLC ratio (<0.26 or >1.65).
Participants who received at least three prior lines of therapy for MM and had treatment with an IMiD (for >=2 cycles or >=2 months of treatment) and a proteasome inhibitor (PI) (for >=2 cycles or >=2 months of treatment) OR participants whose disease was double refractory to an IMiD and a PI. For participants who had received more than 1 type of IMiD and PI, their disease must be refractory to the most recent one.
Participants who had achieved a minimal response or better to at least one prior line of therapy.
Participants who had received an alkylating agent (>=2 cycles or >=2 months) either alone or in combination with other MM treatments.
Stage 2 only: Participants who had evidence of disease progression on or after the most recent prior regimen based on IMWG criteria.
Exclusion criteria:
Phase 1:
Karnofsky performance status <60
Poor bone marrow reserve
Poor organ function
Known intolerance to infused protein products, sucrose, histidine, polysorbate 80 or known hypersensitivity to any of the components of the study therapy that was not amenable to pre-medication with steroids and H2 blockers
Any serious active disease (including clinically significant infection that was chronic, recurrent, or active) or co-morbid condition, which, in the opinion of the investigator, interfered with the safety, the compliance with the study or with the interpretation of the results
Any severe underlying medical conditions including presence of laboratory abnormalities, which could impair the ability to participate in the study or the interpretation of its results
Phase 2:
Participants with multiple myeloma immunoglobulin M (IgM) subtype
Previous treatment with any anti-CD38 therapy
Participants with concurrent plasma cell leukemia
Participants with known or suspected amyloidosis
Karnofsky performance status <60 (stage 1)/Eastern Cooperative Oncology Group (ECOG) Performance status >2 (stage 2).
Poor bone marrow reserve
Poor organ function
Known intolerance to infused protein products, sucrose, histidine, polysorbate 80 or known hypersensitivity to any of the components of the study therapy that was not amenable to pre-medication with steroids and H2 blockers
Any serious active disease (including clinically significant infection that was chronic, recurrent, or active) or co-morbid condition, which, in the opinion of the investigator, interfered with the safety, the compliance with the study or with the interpretation of the results
Any severe underlying medical conditions including presence of laboratory abnormalities, which impaired the ability to participate in the study or the interpretation of its results
The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Dimopoulos M, Bringhen S, Anttila P, Capra M, Cavo M, Cole C, Gasparetto C, Hungria V, Jenner M, Vorobyev V, Ruiz EY, Yin JY, Saleem R, Hellet M, Mace S, Paiva B, Vij R. Isatuximab as monotherapy and combined with dexamethasone in patients with relapsed/refractory multiple myeloma. Blood. 2021 Mar 4;137(9):1154-1165. doi: 10.1182/blood.2020008209.
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
Types
Not provided
Time Frame
Not provided
Access Criteria
Not provided
URL
Not provided
Results Section
Participant Flow Module
Pre-assignment Details
Study consisted 2 phases: Phase 1 and Phase 2. Phase 1 was a dose escalation part of isatuximab to determine maximum tolerated dose (MTD). Phase 2 was conducted for efficacy and safety evaluation of isatuximab with or without dexamethasone. It consisted of 2 stages: Stage 1 (comprised of 1a and 1b) and Stage 2.
Recruitment Details
Study participants were involved in the study from 11 May 2010 at 59 centers in 18 countries. A total of 418 participants were screened, of which 351 participants were enrolled. A total of 67 participants had screen failures due to failure to meet inclusion criteria.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Phase1: Isatuximab <=1 mg/kg Every 2 Weeks (Q2W)
Participants with CD38+ hematological malignancies (HM), received Isatuximab at any one of the dose less than or equal to (<=) 1 milligram per kilogram (mg/kg) (i.e. either 0.0001 mg/kg or 0.001 mg/kg or 0.01 mg/kg or 0.03 mg/kg, or 0.1 mg/kg or 0.3 mg/kg or 1 mg/kg) as intravenous (IV) infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal by participant, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
Periods
Title
Milestones
Reasons Not Completed
Phase 1 (120 Weeks)
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
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
Jul 22, 2020
Jun 27, 2024
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Austria
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Parallel 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
Drug: Isatuximab SAR650984
Phase 1:Isatuximab (CD38 + HM and High Risk Multiple Myeloma)
Experimental
Participants with CD38+ HM along with participants with high risk multiple myeloma, received Isatuximab 10 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
Drug: Isatuximab SAR650984
Phase 1: Isatuximab 10 mg/kg QW
Experimental
Participants with CD38+ HM, received Isatuximab 10 mg/kg, as IV infusion QW, i.e. on Day 1 and 8 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
Drug: Isatuximab SAR650984
Phase 1: Isatuximab 20 mg/kg Q2W
Experimental
Participants with CD38+ HM, received Isatuximab 20 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
Drug: Isatuximab SAR650984
Phase 1: Isatuximab 20 mg/kg QW
Experimental
Participants with CD38+ HM, received Isatuximab 20 mg/kg, as IV infusion QW, i.e. on Day 1 and 8 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
Drug: Isatuximab SAR650984
Phase 2 Stage 1a: Isatuximab 3 mg/kg Q2W
Experimental
Participants with multiple Myeloma received Isatuximab 3 mg/kg, as IV infusion on Day 1 and Day 15 of each 28-day cycle until unacceptable adverse event (AE), disease progression, poor compliance to the study protocol, study termination or lost to follow up (maximum exposure: 414 weeks).
Drug: Isatuximab SAR650984
Phase 2 Stage 1a: Isatuximab 10 mg/kg Q2W
Experimental
Participants with multiple Myeloma received Isatuximab 10 mg/kg, as IV infusion on Day 1 and Day 15 of each 28-day cycle until unacceptable AE, disease progression, poor compliance to the study protocol, study termination or lost to follow up (maximum exposure: 414 weeks).
Drug: Isatuximab SAR650984
Phase2 Stage1a:Isatuximab 10mg/kg Q2W; Then Q4W
Experimental
Participants with multiple Myeloma received Isatuximab 10 mg/kg, as IV infusion Q2W, i.e. on Day 1 and Day 15 of Cycle 1 and 2 (each cycle 28 days), then every 4 week (Q4W), i.e. on Day 1 of each 28-days cycle until unacceptable AE, disease progression, poor compliance to the study protocol, study termination or lost to follow up (maximum exposure: 414 weeks).
Drug: Isatuximab SAR650984
Phase 2 Stage 1b: Isatuximab 20mg/kg QW and Then Q2W
Experimental
Participants with multiple Myeloma received Isatuximab 20 mg/kg, as IV infusion QW, i.e. on Day 1, 8, 15 and 22 of Cycle 1 and 2 (each cycle 28 days), then Q2W, i.e. on Day 1 and Day 15 of each 28-days cycle until unacceptable AE, disease progression, poor compliance to the study protocol, study termination or lost to follow up (maximum exposure: 92 weeks).
Drug: Isatuximab SAR650984
Phase 2 Stage 2: Isatuximab Alone
Experimental
Participants with relapsed or relapsed/refractory multiple myeloma (RRMM), received Isatuximab 20 mg/kg, as IV infusion on Day 1, 8, 15 and Day 22 of Cycle 1 (28 days) and then on Day 1 and 15 of each subsequent 28-day cycles until unacceptable AE, disease progression, poor compliance to the study protocol, study termination, lost to follow up or investigator's decision (maximum exposure: 301 weeks).
Drug: Isatuximab SAR650984
Phase 2 Stage 2: Isatuximab + Dexamethasone
Experimental
Participants with relapsed or RRMM, received Isatuximab 20 mg/kg, as IV infusion on Day 1, 8, 15 and Day 22 of Cycle 1 (28 days) and then on Day 1 and 15 of each subsequent 28-day cycles along with dexamethasone: tablet or as IV infusion (40 mg/day for less than [<] 75 years of age; 20 mg/day [greater than or equal to [>=] for 75 years of age) on Days 1, 8, 15 and 22 of each 28 days cycle until unacceptable AE, disease progression, poor compliance to the study protocol, study termination, lost to follow up or investigator's decision (maximum exposure: 301 weeks).](streamdown:incomplete-link)
Drug: Isatuximab SAR650984
Drug: Dexamethasone
Phase 1: Isatuximab 20 mg/kg QW
Phase 1: Isatuximab 3mg/kg Q2W
Phase 1: Isatuximab 5 mg/kg Q2W
Phase 1:Isatuximab (CD38 + HM and High Risk Multiple Myeloma)
Phase 1:Isatuximab <=1 mg/kg Q2W
Phase 2 Stage 1a: Isatuximab 10 mg/kg Q2W
Phase 2 Stage 1a: Isatuximab 3 mg/kg Q2W
Phase 2 Stage 1b: Isatuximab 20mg/kg QW and Then Q2W
Phase 2 Stage 2: Isatuximab + Dexamethasone
Phase 2 Stage 2: Isatuximab Alone
Phase1:Isatuximab (CD38+HM and Standard Risk Multiple Myeloma)
Phase2 Stage1a:Isatuximab 10mg/kg Q2W; Then Q4W
Sarclisa
Dexamethasone
Drug
Pharmaceutical form: solution for infusion
Route of administration: intravenous
Phase 2 Stage 2: Isatuximab + Dexamethasone
Dexamethasone
Drug
Pharmaceutical form: tablet
Route of administration: oral
Phase 2 Stage 2: Isatuximab + Dexamethasone
Phase 2 Stage 2: Percentage of Participants With Overall Response According to Updated IMWG Response Criteria
OR: participants with sCR or CR or VGPR or PR. As per updated IMWG, CR: Negative immunofixation on serum and urine, disappearance of any soft tissue plasmacytomas and <=5% plasma cells in bone marrow; normal FLC ratio of 0.26-1.65 in participants with only FLC disease; sCR: CR and normal FLC ratio and no clonal cells in bone marrow; VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or >=90% reduction in serum M-protein and urine M-protein level <100 mg/24 hours, >90% decrease in the difference between involved and uninvolved FLC levels; PR: >=50% reduction of serum M-Protein and reduction in urinary M-protein by >=90% or to <200 mg/24 hours; >=50% decrease in the difference between involved and uninvolved FLC levels in place of M-protein criteria or >=50% reduction in plasma cells in place of M-protein if present at baseline.
From the date of randomization to date of death from any cause (maximum duration: 97 weeks)
Cycle 1 Day 1 and Cycle 3 Day 1: At the end of infusion
PK Assessment: Phase 1: Maximum Observed Plasma Concentration (Cmax) of Isatuximab
Data for this outcome measure was planned to be collected and analyzed separately for dose 0.3 mg/kg, 1 mg/kg and not for 0.0001, 0.001, 0.01, 0.03 and 0.1 dose levels (reported under one arm, i.e. Phase 1: Isatuximab <=1mg/kg in participant flow). Analysis was performed on PK population.
For Q2W:Cycle 1,Day 1: pre-dose, 15 min after start of infusion, at the end of infusion, 3, 7, 24, 48 and 168 hr post-infusion; For QW: Cycle 1,Day 1: pre-dose, 15 min after start of infusion, at the end of infusion, 4, 24, 48, 72 and 168 hr post-infusion
PK Assessment: Phase 1: Time to Reach Maximum Plasma Concentration Observed (Tmax) of Isatuximab
Data for this outcome measure was planned to be collected and analyzed separately for dose 0.3 mg/kg, 1 mg/kg and not for 0.0001, 0.001, 0.01, 0.03 and 0.1 dose levels (reported under one arm, i.e. Phase 1: Isatuximab <=1mg/kg in participant flow). Analysis was performed on PK population.
For Q2W:Cycle 1,Day 1: pre-dose, 15 min after start of infusion, at the end of infusion, 3, 7, 24, 48 and 168 hr post-infusion; For QW: Cycle 1,Day 1: pre-dose, 15 min after start of infusion, at the end of infusion, 4, 24, 48, 72 and 168 hr post-infusion
PK Assessment: Phase 1: Plasma Concentration of Isatuximab at Week 1, 2 and 3
Data for this outcome measure was planned to be collected and analyzed only for dose 1 mg/kg and not for 0.0001, 0.001, 0.01, 0.03, 0.1 and 0.3 mg/kg dose levels (reported under one arm, i.e. Phase 1: Isatuximab <=1mg/kg in participant flow).
Week 1, 2 and 3
PK Assessment: Phase 1: Predicted Cumulative Area Under the Plasma Concentration Curve (AUC) of Isatuximab Over the First Week (0-168 Hours) (AUC1W)
Data for this outcome measure was planned to be collected and analyzed only for dose 1 mg/kg and not for 0.0001, 0.001, 0.01, 0.03, 0.1 and 0.3 mg/kg dose levels (reported under one arm, i.e. Phase 1: Isatuximab <=1mg/kg in participant flow).
For Q2W:Cycle 1,Day 1: pre-dose, 15 min after start of infusion, at the end of infusion, 3, 7, 24, 48 and 168 hr post-infusion; For QW: Cycle 1,Day 1: pre-dose, 15 min after start of infusion, at the end of infusion, 4, 24, 48, 72 and 168 hr post-infusion
PK Assessment: Phase 1: Predicted Cumulative Area Under the Plasma Concentration Curve (AUC) of Isatuximab Over the First 2 Weeks (0-336 Hours) (AUC2W)
Data for this outcome measure was planned to be collected and analyzed only for dose 1 mg/kg and not for 0.0001, 0.001, 0.01, 0.03, 0.1 and 0.3 mg/kg dose levels (reported under one arm, i.e. Phase 1: Isatuximab <=1mg/kg in participant flow).
For Q2W:Cycle 1,Day 1: pre-dose, 15 min after start of infusion, at the end of infusion, 3, 7, 24, 48 and 336 hr post-infusion; For QW: Cycle 1,Day 1: pre-dose, 15 min after start of infusion, at the end of infusion, 4, 24, 48, 72 and 336 hr post-infusion
Pharmacodynamic (PD) Assessment: Phase 1: Change From Baseline in Serum/Plasma Markers
Serum/plasma markers included: tumor necrosis factor alpha (TNF-α), interleukin-1β (IL-1-β), interleukin 6 (IL-6) and interferon-gamma (IFN-Gamma). Due to change in planned analysis, data for high-sensitivity C-reactive protein (hs-CRP) and CD38 was not collected and analyzed.
Cycle 1 Day 1
Immunogenicity Assessment: Phase 1: Number of Participants With Treatment-Emergent And Treatment-Boosted Anti-drug Antibodies (ADA) Response
ADA response was categorized as: treatment induced and treatment boosted response. Treatment-induced ADA was defined as ADA that developed at any time during the ADA on-study observation period (defined as the time from the first isatuximab administration until end of Phase 1) in participants without preexisting ADA (defined as: ADA that were present in samples drawn before treatment), including participants without pre-treatment (before treatment) samples. Treatment boosted ADA was defined as pre-existing ADA that increased at least 2 titer steps between pre-treatment (before treatment) and post-treatment.
Up to 120 weeks
Clinical Assessment: Phase 1: Percentage of Participants With Overall Response and Clinical Benefit: Assessed Using European Society for Blood and Marrow Transplantation (EBMT) Criteria
OR defined as participants with complete response (CR) or partial response (PR) as best overall response (BOR). Clinical benefit: participants with minimal response (MR) or better as BOR. BOR: best sequential response from start of treatment through the entire study excluding any time point following start of other treatment. CR: negative immunofixation on serum and urine, disappearance of any soft tissue plasmacytomas, <5% plasma cells in bone marrow aspirates, no increase in size or number of lytic bone lesions. PR: >=50% reduction of serum M-protein, reduction in 24 h urinary M-protein by >=90% or <200mg, >=50% reduction in size/number of soft tissue plasmacytomas, no increase in size or number of lytic bone lesions. MR: 25 to 49% reduction in serum M-protein, 50-89% reduction in 24h urine M-protein, 25-49% reduction in size of soft tissue plasmacytomas, no increase in size or number of lytic bone lesions.
From the date of randomization to the date of first documentation of progression or death (due to any cause) (maximum duration: 120 weeks)
Clinical Assessment: Phase 1: Duration of Response (DOR)
DOR: time from first response (PR or better) to first documented tumor progression/death. Progression as per EBMT: >25% increase in serum monoclonal paraprotein level, which must also be an absolute increase of >= 5 g/l: confirmed by >=1 repeated investigation; >25% increase in 24h urinary light chain excretion, which must also be an absolute increase of >=200 mg/24 h:confirmed by >=1 repeated investigation; >25% increase in plasma cells in a bone marrow aspirate/on trephine biopsy, which must also be an absolute increase of >= 10%; definite increase in size of existing bone lesions/soft tissue plasmacytomas; development of new bone lesions/soft tissue plasmacytomas; development of hypercalcemia (corrected serum calcium >11·5 mg/dl or 2·8 mmol/l) not attributable to any other cause. PR: >=50% reduction of serum M-protein, reduction in 24h urinary M-protein by >=90% or <200mg, >=50% reduction in size/number of soft tissue plasmacytomas, no increase in size/number of lytic bone lesions.
From the date of first response to the date of first documentation of progression or death (due to any cause) (maximum duration: 120 weeks)
Clinical Assessment: Phase 1: Time to First Response (TTR)
TTR was defined as the time from first dose of isatuximab to first response (PR or better). PR: >=50% reduction of serum M-protein, reduction in 24 h urinary M-protein by >=90% or <200mg, >=50% reduction in size/number of soft tissue plasmacytomas, no increase in size or number of lytic bone lesions.
From the date of first dose administration to the date of first response or death (due to any cause) (maximum duration: 120 weeks)
Clinical Assessment: Phase 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) (Karnofsky Performance Status)-Shift From Baseline Value to Best Value During Treatment
ECOG performance status was measured on a 4 point scale to assess participant's performance status. 0=Normal, fully functional; 1=Fatigue without significant decrease in daily activity; 2=Fatigue with significant impairment of daily activities or bed rest <50% of waking hours; 3=Bed rest/sitting >50% of waking hours; 4=Bedridden or unable to care for self, where lower score indicated good performance status. Number of participants with Baseline ECOG PS score and corresponding changes to the best values (categorized as: Baseline ECOG 1, During Treatment ECOG 0; Baseline ECOG 2, During Treatment ECOG 0; Baseline ECOG 2, During Treatment ECOG 1) are reported.
At baseline, during treatment (Day 1 up to 120 weeks)
Clinical Assessment: Phase 1: Number of Participants With Eastern Cooperative Oncology Group Performance Status (Karnofsky Performance Status)-Shift From Baseline Value to Worst Value During Treatment
ECOG performance status was measured on a 4 point scale to assess participant's performance status. 0=Normal, fully functional; 1=Fatigue without significant decrease in daily activity; 2=Fatigue with significant impairment of daily activities or bed rest <50% of waking hours; 3=Bed rest/sitting>50% of waking hours; 4=Bedridden or unable to care for self, where higher score indicated worst performance status. Number of participants with Baseline ECOG PS score and corresponding changes to the worst values (categorized as: Baseline ECOG 0, During Treatment ECOG 1; Baseline ECOG 2, During Treatment ECOG 1; Baseline ECOG 0, During Treatment ECOG 2; Baseline ECOG 1, During Treatment ECOG 2; Baseline ECOG 0, During Treatment ECOG 3; Baseline ECOG 1, During Treatment ECOG 3; Baseline ECOG 2, During Treatment ECOG 3) are reported.
At baseline, during treatment (up to 120 weeks)
Phase 2 Stage 1: Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Adverse event (AE) was defined as any untoward medical occurrence in a participant who received study drug and did not necessarily have to have a causal relationship with the treatment. TEAEs were defined as AEs that developed or worsened during the on-treatment period which was defined as the period from the time of first dose of study treatment until 30 days after the last dose of study treatment.
From Baseline up to 30 days after the last dose (maximum duration: 414 weeks for Stage 1a and 92 weeks for Stage 1b)
Phase 2 Stage 2: Number of Participants With Treatment Emergent Adverse Events (TEAEs)
AE was defined as any untoward medical occurrence in a participant who received study drug and did not necessarily have to have a causal relationship with the treatment. TEAEs were defined as AEs that developed or worsened during the on-treatment period which was defined as the period from the time of first dose of study treatment until 30 days after the last dose of study treatment.
From Baseline up to 30 days after the last dose (maximum duration: 301 weeks)
Phase 2 Stage 1: Duration of Response
DOR:Time from date of 1st IAC determined response (>= PR) that was subsequently confirmed, to date of first IAC determined PD/death, whichever happened earlier. updated IMWG criteria- PR:>=50% decrease in difference between involved and uninvolved FLC levels in place of M-protein criteria or a >=50% reduction in plasma cells in place of M-protein if baseline was ≥30%. If present at baseline a >=50% reduction in size of soft tissue plasmacytomas; PD: Increase of 25% from lowest response value in any of following: Serum M-protein >=0.5 g/dL absolute increase and/or urine M-protein >=200 mg/24 hours absolute increase and/or >10 mg/dL absolute increase in difference between involved and uninvolved FLC levels, >=10% bone marrow plasma cells (PCs), development of new bone lesions/soft tissue plasmacytomas or definite increase in size of existing bone lesions/soft tissue plasmacytomas, development of hypercalcemia (corrected serum calcium >11·5 mg/dl) attributed to PC proliferation disorder.
From the date of first response until disease progression or death or data cut-off (maximum duration: 77 weeks for Stage 1a arms and 53 weeks for stage 1b arm)
Phase 2 Stage 2: Duration of Response
DOR: Time from date of 1st IAC determined response (>= PR) that was subsequently confirmed, to date of 1st IAC determined PD or death, whichever happened earlier. As per updated IMWG criteria-PR: ≥50% reduction of serum M-Protein and reduction in urinary M-protein by ≥90% or to <200 mg/24 hours. ≥50% decrease in difference between involved and uninvolved FLC levels in place of M-protein criteria or ≥50% reduction in plasma cells in place of M-protein if baseline was ≥30%. If present at baseline ≥50% reduction in size of soft tissue plasmacytomas; PD: Increase of >25% from lowest response value in any one of following: Serum M-component (absolute increase must be >0.5 g/dL)4 and/or Urine M-component (absolute increase must be >200 mg/24 h) and/or >10 mg/dL absolute increase in difference between involved and uninvolved FLC levels, >=10% bone marrow plasma cell, development of hypercalcemia (corrected serum calcium >11.5 mg/dL) attributed solely to plasma cell proliferative disorder.
From the date of first response until disease progression or death or data cut-off (maximum duration: 97 weeks)
Phase 2 Stage 1: Percentage of Participants With Clinical Benefit
Clinical benefit: participants with sCR, CR, VGPR, PR or MR as per IMWG criteria, determined by IAC. CR: negative immunofixation on serum & urine, disappearance of any soft tissue plasmacytomas,<5% PCs in bone marrow aspirates. sCR: CR + normal FLC ratio (0.26-1.65), absence of clonal cells in bone marrow biopsy. VGPR: serum & urine M-component detectable by immunofixation, not on electrophoresis/,>=90% reduction in serum M-component plus urine M-component level <100mg/24hours; PR: ≥50% reduction of serum M-Protein and reduction in urinary M-protein by ≥90% or to <200 mg/24 hours, ≥50% decrease in the difference between involved and uninvolved FLC levels in place of the M-protein criteria or a ≥50% reduction in plasma cells in place of M-protein if baseline was ≥30%. If present at baseline, ≥50% size reduction in soft tissue plasmacytomas. MR:>=25 but <49% reduction in serum M-protein, reduction in 24h urine M-protein by 50-89%, 25-49% size reduction in soft tissue plasmacytomas.
From the date of randomization to the date of first documentation of progression or death (maximum duration: 77 weeks for Stage 1a arms and 53 weeks for stage 1b arm)
Phase 2 Stage 2: Percentage of Participants With Clinical Benefit
Clinical benefit:participants with sCR, CR, VGPR, PR or MR, per IMWG criteria, determined by IAC. CR:negative immunofixation on serum & urine, disappearance of any soft tissue plasmacytomas,<5% plasma cells in bone marrow aspirates,normal FLC ratio(0.26-1.65) in participants with only FLC disease.sCR:CR+normal FLC ratio, absence of clonal cells in bone marrow biopsy.VGPR:serum & urine M-component detectable by immunofixation, not on electrophoresis/,>=90% reduction in serum M-component plus urine M-component level <100mg/24h/,>=90% decrease in difference between involved and uninvolved FLC levels; PR:>=50% reduction of serum M-protein, reduction in 24h urinary M-protein by >=90%/<200mg/24h,>50% decrease in difference between involved and uninvolved FLC in place of M-protein criteria, >=50% reduction in size/number of soft tissue plasmacytomas. MR:>=25 but <49% reduction in serum M-protein,reduction in 24h urine M-protein by 50-89%, 25-49% reduction in size of soft tissue plasmacytomas
From the date of randomization to the date of first documentation of progression or death (maximum duration: 97 weeks )
Phase 2 Stage 1: Progression Free Survival (PFS)
PFS was defined as the time interval from the date of first isatuximab administration to the date of the first IAC-confirmed disease progression (PD) or date of death due to any cause, whichever came first. As per IMWG criteria, PD: Increase of > 25% from lowest response value in any one or more of the following: Serum M-component and/or (the absolute increase must be > 0.5 g/dL), Urine M-component and/or (the absolute increase must be > 200 mg/24 h), > 10mg/dL decrease in the difference between involved and uninvolved FLC levels in place of the M-protein criteria, >10% absolute percentage of bone marrow plasma cell, definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas, development of hypercalcemia (corrected serum calcium > 11.5 mg/dL or 2.65 mmol/L) that attributed solely to the plasma cell proliferative disorder. Analysis was performed by Kaplan-Meier method.
From the date of the first dose administration until progression or death, whichever occurred first (maximum duration: 77 weeks for Stage 1a arms and 53 weeks for stage 1b arm)
Phase 2 Stage 2: Progression Free Survival
PFS was defined as the time interval from the date of first isatuximab administration to the date of the first IAC-confirmed disease progression or the date of death due to any cause, whichever came first. As per IMWG criteria, PD: Increase of >25% from lowest response value in any one of the following: Serum M-component (the absolute increase must be >0.5 g/dL)4 and/or Urine M-component (the absolute increase must be >200 mg/24 h) and/or >10 mg/dL decrease in the difference between involved and uninvolved FLC levels in place of the M-protein criteria, ≥10% bone marrow plasma cell, development of hypercalcemia (corrected serum calcium >11.5 mg/dL) attributed solely to the plasma cell proliferative disorder. Analysis was performed by Kaplan-Meier method.
From the date of the first dose administration until progression or death, whichever occurred first (maximum duration: 97 weeks)
Phase 2 Stage 1: Overall Survival (OS)
OS was defined as the time interval from the date of first Isatuximab administration to death from any cause. Analysis was performed by Kaplan-Meier method.
From the date of randomization to date of death from any cause (maximum duration 77 weeks for Stage 1a arms and 53 weeks for stage 1b arm)
Phase 2 Stage 2: Overall Survival
OS was defined as the time interval from the date of first Isatuximab administration to death from any cause. Analysis was performed by Kaplan-Meier method.
From the date of randomization to date of death from any cause (maximum duration: 97 weeks)
Phase 2 Stage 1: Change From Baseline in Health Related Quality of Life (HRQL) European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Scores: Global Health Status
EORTC-QLQ-C30 is a cancer-specific instrument with 30 questions for evaluation of new chemotherapy and provides an assessment of participant reported outcome dimensions. First 28 questions used 4-point scale (1=not at all,2=a little,3=quite a bit,4=very much) for evaluating 5 functional scales (physical, role, emotional, cognitive, social), 3 symptom scales (fatigue, nausea/vomiting, pain) & other single items. For each item, high score = high level of symptomatology/problem. Last 2 questions represented participant's assessment of overall health & quality of life, coded on 7-point scale (1=very poor to 7=excellent). EORTC QLQ-C30 observed values and change from baseline for global health status (scoring of questions 29 & 30) and 5 functional scales, 3 symptom scales and other single items (scoring of questions 1 to 28). Answers were converted into grading scale, with values between 0 and 100. A high score represented a favorable outcome with a best quality of life for participant.
Baseline, Day 1 of Cycles 2, 3, 4, 5, 6, 7, 8, 9, 10 and End of Treatment (EOT: anytime up to 77 weeks for Stage 1a arms and 53 weeks for stage 1b arm)
Phase 2 Stage 1: Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Multiple Myeloma Specific Module With 20 Items (EORTC QLQ-MY20) Scores: Disease Symptom Subscale Score
EORTC QLQ-MY20 is a validated questionnaire to assess the overall quality of life in participants with MM. It has 4 subscales: body image, future perspective), and 2 symptoms scales (disease symptoms and side-effects of treatment). Disease symptoms subscale used 4-point scale ranged from 1= 'Not at All' to 4= 'Very Much'. Scores were averaged, and transformed to 0 -100 scale, where higher scores = more symptoms and lower health-related quality of life (HRQL) and lower score = less symptoms and more HRQL.
Baseline, Day 1 of Cycles 2, 3, 4, 5, 6, 7, 8, 9, 10 and EOT (anytime up to 77 weeks for Stage 1a arms and 53 weeks for stage 1b arm)
Phase 2 Stage 1: Change From Baseline in Euro Quality of Life 5 Dimension (EQ-5D) Generic Health Status - Visual Analogue Scale Scores
EQ-5D was a standardized HRQL questionnaire consisting of EQ-5D descriptive system and Visual Analogue Scale (VAS). EQ-5D VAS was used to record a participant's rating for his/her current health-related quality of life state and captured on a vertical VAS (0-100), where 0 = worst imaginable health state and 100 = best imaginable health state.
Baseline, Day 1 of Cycles 4, 7, 10, 13, 16, 19, and EOT (anytime up to 77 weeks for Stage 1a arms and 53 weeks for stage 1b arm)
Pharmacokinetic Assessment: Phase 2 Stage 2: Area Under the Plasma Concentration Versus Time Curve of Isatuximab Over 1 Week Interval
Pre-dose, at the end of infusion, 1 hour and 168 hours post dose on Day 1 of Cycle 1
Pharmacokinetic Assessment: Phase 2 Stage 2: Area Under the Plasma Concentration Versus Time Curve of Isatuximab Over 2 Weeks Interval
Cycle 1, Day 1: pre-dose, at the end of infusion, 168 and 336 hours post-infusion
Pharmacokinetic Assessment: Phase 2 Stage 2: Area Under the Plasma Concentration Versus Time Curve of Isatuximab Over 4 Weeks Interval
Cycle 1, Day 1: pre-dose, at the end of infusion, 168, 336, and 672 hours post-infusion
Pharmacokinetic Assessment: Phase 2 Stage 2: Plasma Concentration of Isatuximab Before Treatment Administration (Ctrough)
At Days 7, 14 and 28
Pharmacokinetic Assessment: Phase 2 Stage 2: Accumulation Ratio of Isatuximab Based on Ctrough
Ctrough is the plasma concentration observed before treatment administration. For 1st category, the accumulation ratio was calculated by dividing Ctrough value of Cycle 2 Day 1 by Cycle 1 Day 8 and for second category, accumulation ratio was calculated by dividing Ctrough value of Cycle 4 Day 1 by Cycle 1 Day 8.
Cycle 2, Day 1; Cycle 1, Day 8; Cycle 4, Day 1
Immunogenicity Assessment: Phase 2 Stage 2: Number of Participants With Anti-drug Antibodies to Isatuximab
ADA response was categorized as: treatment induced and treatment boosted response. Treatment-induced ADA was defined as ADA that developed at any time during the ADA on-study observation period (defined as the time from the first isatuximab administration until end of Phase 2 Stage 2) in participants without preexisting ADA (defined as: ADA that were present in samples drawn before treatment), including participants without pre-treatment (before treatment) samples. Treatment boosted ADA was defined as pre-existing ADA that increased at least 2 titer steps between pre-treatment (before treatment) and post-treatment.
Up to 97 weeks
San Francisco
California
94117
United States
Emory University Site Number : 840009
Atlanta
Georgia
30322
United States
University of Chicago Site Number : 840010
Chicago
Illinois
60637
United States
The University Of Michigan Site Number : 840022
Ann Arbor
Michigan
48109-0759
United States
Karmanos Cancer Center Site Number : 840027
Detroit
Michigan
48201
United States
Mayo Clinic of Rochester Site Number : 840018
Rochester
Minnesota
55905
United States
Washington University School of Medicine Site Number : 840013
St Louis
Missouri
63110
United States
The Cancer Center At Hackensack University Medical Site Number : 840011
Hackensack
New Jersey
07601
United States
Memorial Sloan-Kettering Cancer Center Site Number : 840014
New York
New York
10021
United States
Duke University Medical College Site Number : 840016
Durham
North Carolina
27707
United States
University of Cincinnati Site Number : 840004
Cincinnati
Ohio
45267-0542
United States
Vanderbilt University Site Number : 840001
Nashville
Tennessee
37232
United States
Huntsman Cancer Institute at the University of Utah Site Number : 840002
Salt Lake City
Utah
84112-5550
United States
Fred Hutchinson Cancer Research Center Site Number : 840012
Seattle
Washington
98109
United States
Medical College of Wisconsin Site Number : 840017
Milwaukee
Wisconsin
53226
United States
Investigational Site Number : 032003
Capital Federal
Buenos Aires
C1425ASS
Argentina
Investigational Site Number : 032002
Ciudad Autonoma de Buenos Aires
Buenos Aires
C1181ACH
Argentina
Investigational Site Number : 032001
Ciudad de Buenos Aires
Buenos Aires
C1426ANZ
Argentina
Investigational Site Number : 056001
Antwerp
2060
Belgium
Hospital Mae de Deus Site Number : 076003
Porto Alegre
Rio Grande do Sul
90110-270
Brazil
Hospital de Amor - Hospital do Cancer de Barretos - Fundacao Pio XII Site Number : 076001
Barretos
São Paulo
14784-400
Brazil
Clínica São Germano Site Number : 076002
São Paulo
São Paulo
04537-081
Brazil
Instituto COI de Educacao e Pesquisa Site Number : 076004
Rio de Janeiro
22775-002
Brazil
Investigational Site Number : 152001
Temuco
La Araucanía
4810469
Chile
Investigational Site Number : 246001
Helsinki
00029
Finland
Investigational Site Number : 246002
Turku
20520
Finland
Investigational Site Number : 250003
Nantes
44093
France
Investigational Site Number : 250004
Pierre-Bénite
69495
France
Investigational Site Number : 250001
Toulouse
31059
France
Investigational Site Number : 300001
Athens
11528
Greece
Investigational Site Number : 376004
Jerusalem
91120
Israel
Investigational Site Number : 376002
Tel Litwinsky
52621
Israel
Investigational Site Number : 380001
Bologna
40138
Italy
Investigational Site Number : 380002
Torino
10126
Italy
Investigational Site Number : 484003
San Luis Potosí City
San Luis Potosí
78419
Mexico
Investigational Site Number : 484001
Monterrey
64460
Mexico
Investigational Site Number : 604001
Arequipa
Peru
Investigational Site Number : 604002
Lima
34
Peru
Investigational Site Number : 643002
Moscow
125284
Russia
Investigational Site Number : 643003
Novosibirsk
630087
Russia
Investigational Site Number : 643001
Petrozavodsk
185019
Russia
Investigational Site Number : 643004
Saint Petersburg
194291
Russia
Investigational Site Number : 724005
Barcelona
Barcelona [Barcelona]
08036
Spain
Investigational Site Number : 724007
Badalona
Catalunya [Cataluña]
08916
Spain
Investigational Site Number : 724002
Pamplona
Navarre
31008
Spain
Investigational Site Number : 724006
Valencia
Valenciana, Comunidad
46017
Spain
Investigational Site Number : 724004
Madrid
28041
Spain
Investigational Site Number : 724001
Salamanca
37007
Spain
Investigational Site Number : 724008
Seville
41013
Spain
Investigational Site Number : 792002
Ankara
06200
Turkey (Türkiye)
Investigational Site Number : 792005
Ankara
06500
Turkey (Türkiye)
Investigational Site Number : 792001
Istanbul
Turkey (Türkiye)
Investigational Site Number : 792004
Samsun
55139
Turkey (Türkiye)
Investigational Site Number : 804001
Kyiv
04112
Ukraine
Investigational Site Number : 804004
Vinnytsia
21001
Ukraine
Investigational Site Number : 804002
Zaporizhzhya
69600
Ukraine
Investigational Site Number : 826002
Southampton
Hampshire
SO16 6YD
United Kingdom
Investigational Site Number : 826001
Nottingham
Nottinghamshire
NG5 1PB
United Kingdom
Derived
Mikhael J, Richter J, Vij R, Cole C, Zonder J, Kaufman JL, Bensinger W, Dimopoulos M, Lendvai N, Hari P, Ocio EM, Gasparetto C, Kumar S, Oprea C, Chiron M, Brillac C, Charpentier E, San-Miguel J, Martin T. A dose-finding Phase 2 study of single agent isatuximab (anti-CD38 mAb) in relapsed/refractory multiple myeloma. Leukemia. 2020 Dec;34(12):3298-3309. doi: 10.1038/s41375-020-0857-2. Epub 2020 May 14.
FG001
Phase 1: Isatuximab 3mg/kg Q2W
Participants with CD38+ HM, received Isatuximab 3 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
FG002
Phase 1: Isatuximab 5 mg/kg Q2W
Participants with CD38+ HM, received Isatuximab 5 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
FG003
Phase1:Isatuximab (CD38+HM and Standard Risk Multiple Myeloma)
Participants with CD38+ HM along with participants with standard risk multiple myeloma were included in this arm and, received Isatuximab 10 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
FG004
Phase 1: Isatuximab (CD38 + HM and High Risk Multiple Myeloma)
Participants with CD38+ HM along with participants with high risk multiple myeloma were included in this arm and, received Isatuximab 10 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
FG005
Phase 1: Isatuximab 10 mg/kg Every Week (QW)
Participants with CD38+ HM, received Isatuximab 10 mg/kg, as IV infusion QW, i.e. on Day 1 and 8 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
FG006
Phase 1: Isatuximab 20 mg/kg Q2W
Participants with CD38+ HM, received Isatuximab 20 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
FG007
Phase 1: Isatuximab 20 mg/kg QW
Participants with CD38+ HM, received Isatuximab 20 mg/kg, as IV infusion QW, i.e. on Day 1 and 8 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
FG008
Phase 2 Stage 1a: Isatuximab 3 mg/kg Q2W
Participants with multiple Myeloma received Isatuximab 3 mg/kg, as IV infusion on Day 1 and Day 15 of each 28-day cycle until unacceptable AE, disease progression, poor compliance to the study protocol, study termination or lost to follow up (maximum exposure: 414 weeks).
FG009
Phase 2 Stage 1a: Isatuximab 10 mg/kg Q2W
Participants with multiple Myeloma received Isatuximab 10 mg/kg, as IV infusion on Day 1 and Day 15 of each 28-day cycle until unacceptable AE, disease progression, poor compliance to the study protocol, study termination or lost to follow up (maximum exposure: 414 weeks).
FG010
Phase 2 Stage 1a: Isatuximab 10mg/kg Q2W; Then Q4W
Participants with multiple Myeloma received Isatuximab 10 mg/kg, as IV infusion Q2W, i.e. on Day 1 and Day 15 of Cycle 1 and 2 (each cycle 28 days), then every 4 weeks (Q4W), i.e. on Day 1 of each 28-days cycle until unacceptable AE, disease progression, poor compliance to the study protocol, study termination or lost to follow up (maximum exposure: 414 weeks).
FG011
Phase 2 Stage 1b: Isatuximab 20mg/kg QW and Then Q2W
Participants with multiple Myeloma received Isatuximab 20 mg/kg, as IV infusion QW, i.e. on Day 1, 8, 15 and 22 of Cycle 1 and 2 (each cycle 28 days), then Q2W, i.e. on Day 1 and Day 15 of each 28-days cycle until unacceptable AE, disease progression, poor compliance to the study protocol, study termination or lost to follow up (maximum exposure: 92 weeks).
FG012
Phase 2 Stage 2: Isatuximab Alone
Participants with relapsed or relapsed/refractory multiple myeloma (RRMM), received Isatuximab 20 mg/kg, as IV infusion on Day 1, 8, 15 and Day 22 of Cycle 1 (28 days) and then on Day 1 and 15 of each subsequent 28-day cycles until unacceptable AE, disease progression, poor compliance to the study protocol, study termination, lost to follow up or investigator's decision (maximum exposure: 301 weeks).
FG013
Phase 2 Stage 2: Isatuximab + Dexamethasone
Participants with relapsed or RRMM, received Isatuximab 20 mg/kg, as IV infusion on Day 1, 8, 15 and Day 22 of Cycle 1 (28 days) and then on Day 1 and 15 of each subsequent 28-day cycles along with dexamethasone: tablet or as IV infusion (40 mg/day for less than [<] 75 years of age; 20 mg/day for greater than or equal to [>=] 75 years of age) on Days 1, 8, 15 and 22 of each 28 days cycle until unacceptable AE, disease progression, poor compliance to the study protocol, study termination, lost to follow up or investigator's decision (maximum exposure: 301 weeks).
FG00016 subjects
FG0016 subjects
FG0023 subjects
FG00326 subjects
FG00418 subjects
FG0056 subjects
FG0067 subjects
FG0077 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
All Treated (AT) Population
Participants who signed informed consent & received at least 1 dose/even incomplete of isatuximab.
FG00016 subjects
FG0016 subjects
FG0023 subjects
FG00326 subjects
FG00418 subjects
FG0056 subjects
FG0067 subjects
FG0077 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
COMPLETED
Participants with end of treatment or death from any cause forms completed.
FG00016 subjects
FG0016 subjects
FG0023 subjects
FG00326 subjects
FG00418 subjects
FG0056 subjects
FG0067 subjects
FG0077 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
Phase 2 Stage 1(1a-414Weeks;1b-92Weeks)
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG00823 subjectsPhase 1, Phase 2 Stage 1 and Phase 2 Stage 2 were separate populations.
FG00924 subjectsPhase 1, Phase 2 Stage 1 and Phase 2 Stage 2 were separate populations.
FG01025 subjectsPhase 1, Phase 2 Stage 1 and Phase 2 Stage 2 were separate populations.
FG01125 subjectsPhase 1, Phase 2 Stage 1 and Phase 2 Stage 2 were separate populations.
FG0120 subjects
FG0130 subjects
AT Population
Participants who signed informed consent & received at least 1 dose/even incomplete of isatuximab.
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
COMPLETED
Participants with end of treatment or death from any cause forms completed.
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Phase 2 Stage 2 (301 Weeks)
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG012110 subjectsPhase 1, Phase 2 Stage 1 and Phase 2 Stage 2 were separate populations.
FG01355 subjectsPhase 1, Phase 2 Stage 1 and Phase 2 Stage 2 were separate populations.
AT Population
Participants who signed informed consent & received at least 1 dose/even incomplete of isatuximab.
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
COMPLETED
Participants with end of treatment or death from any cause forms completed.
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Enrolled, but not treated
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Analysis was performed on AT population.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Phase 1:Isatuximab <=1 mg/kg Q2W
Participants with CD38+ HM, received Isatuximab at any one of the dose <= 1 mg/kg (i.e. either 0.0001 mg/kg or 0.001 mg/kg or 0.01 mg/kg or 0.03 mg/kg, or 0.1 mg/kg or 0.3 mg/kg or 1 mg/kg) as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal by participant, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
BG001
Phase 1: Isatuximab 3mg/kg Q2W
Participants with CD38+ HM, received Isatuximab 3 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
BG002
Phase 1: Isatuximab 5 mg/kg Q2W
Participants with CD38+ HM, received Isatuximab 5 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
BG003
Phase1:Isatuximab (CD38+HM and Standard Risk Multiple Myeloma)
Participants with CD38+ HM along with participants with standard risk multiple myeloma were included in this arm and, received Isatuximab 10 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
BG004
Phase 1: Isatuximab (CD38 + HM and High Risk Multiple Myeloma)
Participants with CD38+ HM along with participants with high risk multiple myeloma were included in this arm and, received Isatuximab 10 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
BG005
Phase 1: Isatuximab 10 mg/kg QW
Participants with CD38+ HM, received Isatuximab 10 mg/kg, as IV infusion QW, i.e. on Day 1 and 8 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
BG006
Phase 1: Isatuximab 20 mg/kg Q2W
Participants with CD38+ HM, received Isatuximab 20 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
BG007
Phase 1: Isatuximab 20 mg/kg QW
Participants with CD38+ HM, received Isatuximab 20 mg/kg, as IV infusion QW, i.e. on Day 1 and 8 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
BG008
Phase 2 Stage 1a: Isatuximab 3 mg/kg Q2W
Participants with multiple Myeloma received Isatuximab 3 mg/kg, as IV infusion on Day 1 and Day 15 of each 28-day cycle until unacceptable AE, disease progression, poor compliance to the study protocol, study termination or lost to follow up (maximum exposure: 414 weeks).
BG009
Phase 2 Stage 1a: Isatuximab 10 mg/kg Q2W
Participants with multiple Myeloma received Isatuximab 10 mg/kg, as IV infusion on Day 1 and Day 15 of each 28-day cycle until unacceptable AE, disease progression, poor compliance to the study protocol, study termination or lost to follow up (maximum exposure: 414 weeks).
BG010
Phase 2 Stage 1a: Isatuximab 10mg/kg Q2W; Then Q4W
Participants with multiple Myeloma received Isatuximab 10 mg/kg, as IV infusion Q2W, i.e. on Day 1 and Day 15 of Cycle 1 and 2 (each cycle 28 days), then every 4 weeks (Q4W), i.e. on Day 1 of each 28-days cycle until unacceptable AE, disease progression, poor compliance to the study protocol, study termination or lost to follow up (maximum exposure: 414 weeks).
BG011
Phase 2 Stage 1b: Isatuximab 20mg/kg QW and Then Q2W
Participants with multiple Myeloma received Isatuximab 20 mg/kg, as IV infusion QW, i.e. on Day 1, 8, 15 and 22 of Cycle 1 and 2 (each cycle 28 days), then Q2W, i.e. on Day 1 and Day 15 of each 28-days cycle until unacceptable AE, disease progression, poor compliance to the study protocol, study termination or lost to follow up (maximum exposure: 92 weeks).
BG012
Phase 2 Stage 2: Isatuximab Alone
Participants with relapsed or relapsed/refractory multiple myeloma (RRMM), received Isatuximab 20 mg/kg, as IV infusion on Day 1, 8, 15 and Day 22 of Cycle 1 (28 days) and then on Day 1 and 15 of each subsequent 28-day cycles until unacceptable AE, disease progression, poor compliance to the study protocol, study termination, lost to follow up or investigator's decision (maximum exposure: 301 weeks).
BG013
Phase 2 Stage 2: Isatuximab + Dexamethasone
Participants with relapsed or RRMM, received Isatuximab 20 mg/kg, as IV infusion on Day 1, 8, 15 and Day 22 of Cycle 1 (28 days) and then on Day 1 and 15 of each subsequent 28-day cycles along with dexamethasone: tablet or as IV infusion (40 mg/day for less than [<] 75 years of age; 20 mg/day for greater than or equal to [>=] 75 years of age) on Days 1, 8, 15 and 22 of each 28 days cycle until unacceptable AE, disease progression, poor compliance to the study protocol, study termination, lost to follow up or investigator's decision (maximum exposure: 301 weeks).
BG014
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00016
BG0016
BG0023
BG00326
BG00418
BG0056
BG0067
BG0077
BG00823
BG00924
BG01025
BG01125
BG012109
BG01355
BG014350
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00064.9± 11.6
BG00163.5± 6.2
BG00262.0± 3.5
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0005
BG0013
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG002
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
Phase 1: Number of Participants With Dose Limiting Toxicities (DLTs)
DLTs were assessed using the national cancer institute common terminology criteria for adverse events (NCI-CTCAE) version 4.03. DLTs were defined as any Grade 3 or higher non-hematological toxicity (with the exception of allergic reaction/hypersensitivity), Grade 4 neutropenia and/or Grade 4 thrombocytopenia lasting longer than 5 days, attributed to isatuximab. Any other toxicity that the Investigator and the Sponsor deemed to be dose-limiting, regardless of the grade, was also considered as DLT.
DLT evaluable population included participants who gave their informed consent, received at least 1 dose of isatuximab during Phase 1 and had a DLT assessment at the end of Cycle 2. Data was planned not to be collected and analyzed for the arm: Phase 1: Isatuximab (CD38 + HM and High Risk Multiple Myeloma).
Posted
Count of Participants
Participants
Day 1 of Cycle 1 up to Day 14 of Cycle 2
ID
Title
Description
OG000
Phase 1:Isatuximab <=1 mg/kg Q2W
Participants with CD38+ HM, received Isatuximab at any one of the dose <= 1 mg/kg (i.e. either 0.0001 mg/kg or 0.001 mg/kg or 0.01 mg/kg or 0.03 mg/kg, or 0.1 mg/kg or 0.3 mg/kg or 1 mg/kg) as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal by participant, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
OG001
Phase 1: Isatuximab 3mg/kg Q2W
Participants with CD38+ HM, received Isatuximab 3 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
OG002
Phase 1: Isatuximab 5mg/kg Q2W
Participants with CD38+ HM, received Isatuximab 5 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
OG003
Phase1:Isatuximab (CD38+HM and Standard Risk Multiple Myeloma)
Participants with CD38+ HM along with participants with standard risk multiple myeloma were included in this arm and, received Isatuximab 10 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
OG004
Phase 1: Isatuximab 10 mg/kg QW
Participants with CD38+ HM, received Isatuximab 10 mg/kg, as IV infusion QW, i.e. on Day 1 and 8 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
OG005
Phase 1: Isatuximab 20mg/kg Q2W
Participants with CD38+ HM, received Isatuximab 20 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
OG006
Phase 1: Isatuximab 20mg/kg QW
Participants with CD38+ HM, received Isatuximab 20 mg/kg, as IV infusion QW, i.e. on Day 1 and 8 of each 14-day treatment cycle until occurrence of DLT, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
Units
Counts
Participants
OG00014
OG0016
OG0023
OG003
Title
Denominators
Categories
Title
Measurements
OG0001
OG0011
OG0020
OG003
Primary
Phase 1: Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Adverse event (AE) was defined as any untoward medical occurrence in a participant who received study drug and did not necessarily have to have a causal relationship with the treatment. TEAEs were defined as AEs that developed or worsened during the on-treatment period which was defined as the period from the time of first dose of study treatment until 30 days after the last dose of study treatment.
Analysis was performed on AT population which included participants who signed informed consent and received at least 1 dose/even incomplete of isatuximab.
Posted
Count of Participants
Participants
From Baseline up to 30 days after the last dose (maximum duration: 120 weeks )
ID
Title
Description
OG000
Phase 1: Isatuximab <=1mg/kg Q2W
Participants with CD38+ HM, received Isatuximab at any one of the dose <= 1 mg/kg (i.e. either 0.0001 mg/kg or 0.001 mg/kg or 0.01 mg/kg or 0.03 mg/kg, or 0.1 mg/kg or 0.3 mg/kg or 1 mg/kg) as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal by participant, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
OG001
Phase 1: Isatuximab 3mg/kg Q2W
Participants with CD38+ HM, received Isatuximab 3 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
Primary
Phase 2 Stage 1: Percentage of Participants With Overall Response (OR) According to International Myeloma Working Group (IMWG) Uniform Response Criteria
OR defined as participants with stringent complete response (sCR) or complete response (CR) or very good partial response (VGPR) or partial response (PR) . Based on IMWG, CR: Negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and <=5% plasma cells in bone marrow; sCR: CR and normal free light chain (FLC) ratio and no clonal cells in bone marrow; VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or >=90% reduction in serum M-protein and urine M-protein level <100 mg/24 hours; PR: >=50% reduction of serum M-Protein and reduction in urinary M-protein by >=90% or to <200 mg/24 hours; >=50% decrease in the difference between involved and uninvolved FLC levels in place of the M-protein criteria or a >=50% reduction in plasma cells in place of M-protein if present at baseline.
Analysis was performed on AT population which included participants who signed informed consent and received at least 1 dose/even incomplete of isatuximab.
Posted
Number
percentage of participants
From the date of randomization until disease progression or death or data cut-off (maximum duration: 77 weeks for Stage 1a arms and 53 weeks for Stage 1b arm)
ID
Title
Description
OG000
Phase 2 Stage 1a: Isatuximab 3 mg/kg
Participants with multiple Myeloma received Isatuximab 3 mg/kg, as IV infusion on Day 1 and Day 15 of each 28-day cycle until unacceptable AE, disease progression, poor compliance to the study protocol, study termination or lost to follow up (maximum exposure: 77 weeks).
Primary
Phase 2 Stage 2: Percentage of Participants With Overall Response According to Updated IMWG Response Criteria
OR: participants with sCR or CR or VGPR or PR. As per updated IMWG, CR: Negative immunofixation on serum and urine, disappearance of any soft tissue plasmacytomas and <=5% plasma cells in bone marrow; normal FLC ratio of 0.26-1.65 in participants with only FLC disease; sCR: CR and normal FLC ratio and no clonal cells in bone marrow; VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or >=90% reduction in serum M-protein and urine M-protein level <100 mg/24 hours, >90% decrease in the difference between involved and uninvolved FLC levels; PR: >=50% reduction of serum M-Protein and reduction in urinary M-protein by >=90% or to <200 mg/24 hours; >=50% decrease in the difference between involved and uninvolved FLC levels in place of M-protein criteria or >=50% reduction in plasma cells in place of M-protein if present at baseline.
Analysis was performed on AT population which included participants who signed informed consent & received at least 1 dose/even incomplete of isatuximab.
Posted
Number
percentage of participants
From the date of randomization to date of death from any cause (maximum duration: 97 weeks)
ID
Title
Description
OG000
Phase 2 Stage 2: Isatuximab Alone
Participants with relapsed or relapsed/refractory multiple myeloma (RRMM), received Isatuximab 20 mg/kg, as IV infusion on Day 1, 8, 15 and Day 22 of Cycle 1 (28 days) and then on Day 1 and 15 of each subsequent 28-day cycles until unacceptable AE, disease progression, poor compliance to the study protocol, study termination, lost to follow up or investigator's decision (maximum exposure: 97 weeks).
Secondary
Pharmacokinetic (PK) Assessment: Phase 1: Plasma Concentration of Isatuximab Observed at the End of an Intravenous Infusion (Ceoi)
Ceoi was defined as the plasma concentration of Isatuximab at end of infusion. Data for this outcome measure was planned to be collected and analyzed separately for dose 0.3 mg/kg, 1 mg/kg and not for 0.0001, 0.001, 0.01, 0.03 and 0.1 dose levels (reported under one arm, i.e. Phase 1: Isatuximab <=1mg/kg in participant flow). Analysis was performed on PK population: participants who gave informed consent, received at least one dose (even if incomplete) of isatuximab, had an assessable PK parameter.
Here, "Overall Number of Participants Analyzed"=participants evaluable for this outcome measure and "0" in "number analyzed" field signifies none of the participant were evaluable because at Cycle 3, Day 1, only data for reporting arms "Phase 1: Isatuximab 10mg/kg QW" and "Phase 1: Isatuximab 20mg/kg QW" was planned to be collected and analyzed.
Posted
Mean
Standard Deviation
microgram per milliliter (mcg/mL)
Cycle 1 Day 1 and Cycle 3 Day 1: At the end of infusion
ID
Title
Description
OG000
Phase 1: Isatuximab 0.3 mg/kg Q2W
Participants with CD38+ HM, received Isatuximab 0.3 mg/kg, as IV infusion on Day 1of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
OG001
Phase 1: Isatuximab 1 mg/kg Q2W
Secondary
PK Assessment: Phase 1: Maximum Observed Plasma Concentration (Cmax) of Isatuximab
Data for this outcome measure was planned to be collected and analyzed separately for dose 0.3 mg/kg, 1 mg/kg and not for 0.0001, 0.001, 0.01, 0.03 and 0.1 dose levels (reported under one arm, i.e. Phase 1: Isatuximab <=1mg/kg in participant flow). Analysis was performed on PK population.
Here, "Overall Number of Participants Analyzed"=participants evaluable for this outcome measure and "0" in "number analyzed" field signifies none of the participant were evaluable because at Cycle 3, Day 1, only data for reporting arms "Phase 1: Isatuximab 10mg/kg QW" and "Phase 1: Isatuximab 20mg/kg QW" was planned to be collected and analyzed.
Posted
Geometric Mean
Geometric Coefficient of Variation
mcg/mL
For Q2W:Cycle 1,Day 1: pre-dose, 15 min after start of infusion, at the end of infusion, 3, 7, 24, 48 and 168 hr post-infusion; For QW: Cycle 1,Day 1: pre-dose, 15 min after start of infusion, at the end of infusion, 4, 24, 48, 72 and 168 hr post-infusion
ID
Title
Description
OG000
Phase 1: Isatuximab 0.3 mg/kg Q2W
Participants with CD38+ HM, received Isatuximab 0.3 mg/kg, as IV infusion on Day 1of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
OG001
Phase 1: Isatuximab 1 mg/kg Q2W
Participants with CD38+ HM, received Isatuximab 1 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal by participant, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
Secondary
PK Assessment: Phase 1: Time to Reach Maximum Plasma Concentration Observed (Tmax) of Isatuximab
Data for this outcome measure was planned to be collected and analyzed separately for dose 0.3 mg/kg, 1 mg/kg and not for 0.0001, 0.001, 0.01, 0.03 and 0.1 dose levels (reported under one arm, i.e. Phase 1: Isatuximab <=1mg/kg in participant flow). Analysis was performed on PK population.
Here, "Overall Number of Participants Analyzed"=participants evaluable for this outcome measure and "0" in "number analyzed" field signifies none of the participant were evaluable because at Cycle 3, Day 1, only data for reporting arms "Phase 1: Isatuximab 10mg/kg QW" and "Phase 1: Isatuximab 20mg/kg QW" was planned to be collected and analyzed.
Posted
Median
Full Range
hours
For Q2W:Cycle 1,Day 1: pre-dose, 15 min after start of infusion, at the end of infusion, 3, 7, 24, 48 and 168 hr post-infusion; For QW: Cycle 1,Day 1: pre-dose, 15 min after start of infusion, at the end of infusion, 4, 24, 48, 72 and 168 hr post-infusion
ID
Title
Description
OG000
Phase 1: Isatuximab 0.3 mg/kg Q2W
Participants with CD38+ HM, received Isatuximab 0.3 mg/kg, as IV infusion on Day 1of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
OG001
Phase 1: Isatuximab 1 mg/kg Q2W
Participants with CD38+ HM, received Isatuximab 1 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal by participant, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
Secondary
PK Assessment: Phase 1: Plasma Concentration of Isatuximab at Week 1, 2 and 3
Data for this outcome measure was planned to be collected and analyzed only for dose 1 mg/kg and not for 0.0001, 0.001, 0.01, 0.03, 0.1 and 0.3 mg/kg dose levels (reported under one arm, i.e. Phase 1: Isatuximab <=1mg/kg in participant flow).
Analysis was performed on PK population. Here, 'number analyzed' = number of participants with available data for each category.
Posted
Geometric Mean
Geometric Coefficient of Variation
mcg/mL
Week 1, 2 and 3
ID
Title
Description
OG000
Phase 1: Isatuximab 1 mg/kg Q2W
Participants with CD38+ HM, received Isatuximab 1 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal by participant, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
OG001
Phase 1: Isatuximab 3mg/kg Q2W
Participants with CD38+ HM, received Isatuximab 3 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
OG002
Phase 1: 5mg/kg Q2W
Secondary
PK Assessment: Phase 1: Predicted Cumulative Area Under the Plasma Concentration Curve (AUC) of Isatuximab Over the First Week (0-168 Hours) (AUC1W)
Data for this outcome measure was planned to be collected and analyzed only for dose 1 mg/kg and not for 0.0001, 0.001, 0.01, 0.03, 0.1 and 0.3 mg/kg dose levels (reported under one arm, i.e. Phase 1: Isatuximab <=1mg/kg in participant flow).
Analysis was performed on PK population. Here, "Overall Number of Participants Analyzed" = participants evaluable for this outcome measure.
Posted
Geometric Mean
Geometric Coefficient of Variation
mcg*hour/mL
For Q2W:Cycle 1,Day 1: pre-dose, 15 min after start of infusion, at the end of infusion, 3, 7, 24, 48 and 168 hr post-infusion; For QW: Cycle 1,Day 1: pre-dose, 15 min after start of infusion, at the end of infusion, 4, 24, 48, 72 and 168 hr post-infusion
ID
Title
Description
OG000
Phase 1: Isatuximab 1 mg/kg Q2W
Participants with CD38+ HM, received Isatuximab 1 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal by participant, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
OG001
Phase 1: Isatuximab 3mg/kg Q2W
Participants with CD38+ HM, received Isatuximab 3 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
Secondary
PK Assessment: Phase 1: Predicted Cumulative Area Under the Plasma Concentration Curve (AUC) of Isatuximab Over the First 2 Weeks (0-336 Hours) (AUC2W)
Data for this outcome measure was planned to be collected and analyzed only for dose 1 mg/kg and not for 0.0001, 0.001, 0.01, 0.03, 0.1 and 0.3 mg/kg dose levels (reported under one arm, i.e. Phase 1: Isatuximab <=1mg/kg in participant flow).
Analysis was performed on PK population. Here, "Overall Number of Participants Analyzed" = participants evaluable for this outcome measure.
Posted
Geometric Mean
Geometric Coefficient of Variation
mcg*hour/mL
For Q2W:Cycle 1,Day 1: pre-dose, 15 min after start of infusion, at the end of infusion, 3, 7, 24, 48 and 336 hr post-infusion; For QW: Cycle 1,Day 1: pre-dose, 15 min after start of infusion, at the end of infusion, 4, 24, 48, 72 and 336 hr post-infusion
ID
Title
Description
OG000
Phase 1: Isatuximab 1 mg/kg Q2W
Participants with CD38+ HM, received Isatuximab 1 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal by participant, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
OG001
Phase 1: Isatuximab 3mg/kg Q2W
Participants with CD38+ HM, received Isatuximab 3 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
Secondary
Pharmacodynamic (PD) Assessment: Phase 1: Change From Baseline in Serum/Plasma Markers
Serum/plasma markers included: tumor necrosis factor alpha (TNF-α), interleukin-1β (IL-1-β), interleukin 6 (IL-6) and interferon-gamma (IFN-Gamma). Due to change in planned analysis, data for high-sensitivity C-reactive protein (hs-CRP) and CD38 was not collected and analyzed.
Analysis was performed on all randomized participants who gave their informed consent, had received at least 1 dose (even incomplete) of isatuximab and had an assessable PD parameter. Here, 'number analyzed' = number of participants with available data for each category.
Posted
Mean
Standard Deviation
picogram/milliliter (pg/mL)
Cycle 1 Day 1
ID
Title
Description
OG000
Phase 1:Isatuximab <=1 mg/kg Q2W
Participants with CD38+ HM, received Isatuximab at any one of the dose <= 1 mg/kg (i.e. either 0.0001 mg/kg or 0.001 mg/kg or 0.01 mg/kg or 0.03 mg/kg, or 0.1 mg/kg or 0.3 mg/kg or 1 mg/kg) as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal by participant, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
OG001
Phase 1: Isatuximab 3mg/kg Q2W
Participants with CD38+ HM, received Isatuximab 3 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
Secondary
Immunogenicity Assessment: Phase 1: Number of Participants With Treatment-Emergent And Treatment-Boosted Anti-drug Antibodies (ADA) Response
ADA response was categorized as: treatment induced and treatment boosted response. Treatment-induced ADA was defined as ADA that developed at any time during the ADA on-study observation period (defined as the time from the first isatuximab administration until end of Phase 1) in participants without preexisting ADA (defined as: ADA that were present in samples drawn before treatment), including participants without pre-treatment (before treatment) samples. Treatment boosted ADA was defined as pre-existing ADA that increased at least 2 titer steps between pre-treatment (before treatment) and post-treatment.
Analysis was performed on ADA evaluable population which included all treated participants with at least one ADA assessment with a reportable result during the ADA on-study observation period.
Posted
Count of Participants
Participants
Up to 120 weeks
ID
Title
Description
OG000
Phase 1:Isatuximab <=1 mg/kg Q2W
Participants with CD38+ HM, received Isatuximab at any one of the dose <= 1 mg/kg (i.e. either 0.0001 mg/kg or 0.001 mg/kg or 0.01 mg/kg or 0.03 mg/kg, or 0.1 mg/kg or 0.3 mg/kg or 1 mg/kg) as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal by participant, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
OG001
Phase 1: Isatuximab 3mg/kg Q2W
Secondary
Clinical Assessment: Phase 1: Percentage of Participants With Overall Response and Clinical Benefit: Assessed Using European Society for Blood and Marrow Transplantation (EBMT) Criteria
OR defined as participants with complete response (CR) or partial response (PR) as best overall response (BOR). Clinical benefit: participants with minimal response (MR) or better as BOR. BOR: best sequential response from start of treatment through the entire study excluding any time point following start of other treatment. CR: negative immunofixation on serum and urine, disappearance of any soft tissue plasmacytomas, <5% plasma cells in bone marrow aspirates, no increase in size or number of lytic bone lesions. PR: >=50% reduction of serum M-protein, reduction in 24 h urinary M-protein by >=90% or <200mg, >=50% reduction in size/number of soft tissue plasmacytomas, no increase in size or number of lytic bone lesions. MR: 25 to 49% reduction in serum M-protein, 50-89% reduction in 24h urine M-protein, 25-49% reduction in size of soft tissue plasmacytomas, no increase in size or number of lytic bone lesions.
Analysis was performed on all-treated population. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure.
Posted
Number
percentage of participants
From the date of randomization to the date of first documentation of progression or death (due to any cause) (maximum duration: 120 weeks)
ID
Title
Description
OG000
Phase 1: Isatuximab 1mg/kg Q2W
Participants with CD38+ HM, received Isatuximab 1 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal by participant, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
Secondary
Clinical Assessment: Phase 1: Duration of Response (DOR)
DOR: time from first response (PR or better) to first documented tumor progression/death. Progression as per EBMT: >25% increase in serum monoclonal paraprotein level, which must also be an absolute increase of >= 5 g/l: confirmed by >=1 repeated investigation; >25% increase in 24h urinary light chain excretion, which must also be an absolute increase of >=200 mg/24 h:confirmed by >=1 repeated investigation; >25% increase in plasma cells in a bone marrow aspirate/on trephine biopsy, which must also be an absolute increase of >= 10%; definite increase in size of existing bone lesions/soft tissue plasmacytomas; development of new bone lesions/soft tissue plasmacytomas; development of hypercalcemia (corrected serum calcium >11·5 mg/dl or 2·8 mmol/l) not attributable to any other cause. PR: >=50% reduction of serum M-protein, reduction in 24h urinary M-protein by >=90% or <200mg, >=50% reduction in size/number of soft tissue plasmacytomas, no increase in size/number of lytic bone lesions.
Analysis was performed only on subset of participants who had response in Phase 1 and not for the reporting group with no response.
Posted
Mean
Standard Deviation
months
From the date of first response to the date of first documentation of progression or death (due to any cause) (maximum duration: 120 weeks)
ID
Title
Description
OG000
Phase 1: Isatuximab 1mg/kg Q2W
Participants with CD38+ HM, received Isatuximab 1 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal by participant, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
Secondary
Clinical Assessment: Phase 1: Time to First Response (TTR)
TTR was defined as the time from first dose of isatuximab to first response (PR or better). PR: >=50% reduction of serum M-protein, reduction in 24 h urinary M-protein by >=90% or <200mg, >=50% reduction in size/number of soft tissue plasmacytomas, no increase in size or number of lytic bone lesions.
Analysis was performed only on subset of participants who had response in Phase 1 and not for the reporting group with no response.
Posted
Mean
Standard Deviation
months
From the date of first dose administration to the date of first response or death (due to any cause) (maximum duration: 120 weeks)
ID
Title
Description
OG000
Phase 1: Isatuximab 1mg/kg Q2W
Participants with CD38+ HM, received Isatuximab 1 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal by participant, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
OG001
Phase 1: Isatuximab 5mg/kg Q2W
Participants with CD38+ HM, received Isatuximab 5 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
Secondary
Clinical Assessment: Phase 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) (Karnofsky Performance Status)-Shift From Baseline Value to Best Value During Treatment
ECOG performance status was measured on a 4 point scale to assess participant's performance status. 0=Normal, fully functional; 1=Fatigue without significant decrease in daily activity; 2=Fatigue with significant impairment of daily activities or bed rest <50% of waking hours; 3=Bed rest/sitting >50% of waking hours; 4=Bedridden or unable to care for self, where lower score indicated good performance status. Number of participants with Baseline ECOG PS score and corresponding changes to the best values (categorized as: Baseline ECOG 1, During Treatment ECOG 0; Baseline ECOG 2, During Treatment ECOG 0; Baseline ECOG 2, During Treatment ECOG 1) are reported.
Analysis was performed on AT population. Data for this outcome measure was planned to be collected and analyzed for a combined arm of overall Phase 1 AT population.
Posted
Count of Participants
Participants
At baseline, during treatment (Day 1 up to 120 weeks)
ID
Title
Description
OG000
Phase 1: Isatuximab
All participants who were enrolled in Phase 1 and received Isatuximab.
Units
Counts
Participants
Secondary
Clinical Assessment: Phase 1: Number of Participants With Eastern Cooperative Oncology Group Performance Status (Karnofsky Performance Status)-Shift From Baseline Value to Worst Value During Treatment
ECOG performance status was measured on a 4 point scale to assess participant's performance status. 0=Normal, fully functional; 1=Fatigue without significant decrease in daily activity; 2=Fatigue with significant impairment of daily activities or bed rest <50% of waking hours; 3=Bed rest/sitting>50% of waking hours; 4=Bedridden or unable to care for self, where higher score indicated worst performance status. Number of participants with Baseline ECOG PS score and corresponding changes to the worst values (categorized as: Baseline ECOG 0, During Treatment ECOG 1; Baseline ECOG 2, During Treatment ECOG 1; Baseline ECOG 0, During Treatment ECOG 2; Baseline ECOG 1, During Treatment ECOG 2; Baseline ECOG 0, During Treatment ECOG 3; Baseline ECOG 1, During Treatment ECOG 3; Baseline ECOG 2, During Treatment ECOG 3) are reported.
Analysis was performed on AT population. Data for this outcome measure was planned to be collected and analyzed for a combined arm of overall Phase 1 AT population.
Posted
Count of Participants
Participants
At baseline, during treatment (up to 120 weeks)
ID
Title
Description
OG000
Phase 1: Isatuximab
All participants who were enrolled in Phase 1 and received Isatuximab.
Units
Counts
Secondary
Phase 2 Stage 1: Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Adverse event (AE) was defined as any untoward medical occurrence in a participant who received study drug and did not necessarily have to have a causal relationship with the treatment. TEAEs were defined as AEs that developed or worsened during the on-treatment period which was defined as the period from the time of first dose of study treatment until 30 days after the last dose of study treatment.
Analysis was performed on AT population which included Participants who signed informed consent & received at least 1 dose/even incomplete of isatuximab.
Posted
Count of Participants
Participants
From Baseline up to 30 days after the last dose (maximum duration: 414 weeks for Stage 1a and 92 weeks for Stage 1b)
ID
Title
Description
OG000
Phase 2 Stage 1a: Isatuximab 3mg/kg Q2W
Participants with multiple Myeloma received Isatuximab 3 mg/kg, as IV infusion on Day 1 and Day 15 of each 28-day cycle until unacceptable AE, disease progression, poor compliance to the study protocol, study termination or lost to follow up (maximum exposure: 414 weeks).
OG001
Phase 2 Stage 1a: Isatuximab 10mg/kg Q2W
Participants with multiple Myeloma received Isatuximab 10 mg/kg, as IV infusion on Day 1 and Day 15 of each 28-day cycle until unacceptable AE, disease progression, poor compliance to the study protocol, study termination or lost to follow up (maximum exposure: 414 weeks).
Secondary
Phase 2 Stage 2: Number of Participants With Treatment Emergent Adverse Events (TEAEs)
AE was defined as any untoward medical occurrence in a participant who received study drug and did not necessarily have to have a causal relationship with the treatment. TEAEs were defined as AEs that developed or worsened during the on-treatment period which was defined as the period from the time of first dose of study treatment until 30 days after the last dose of study treatment.
Analysis was performed on AT population which included participants who signed informed consent & received at least 1 dose/even incomplete of isatuximab.
Posted
Count of Participants
Participants
From Baseline up to 30 days after the last dose (maximum duration: 301 weeks)
ID
Title
Description
OG000
Phase 2 Stage 2: Isatuximab Alone
Participants with relapsed or relapsed/refractory multiple myeloma (RRMM), received Isatuximab 20 mg/kg, as IV infusion on Day 1, 8, 15 and Day 22 of Cycle 1 (28 days) and then on Day 1 and 15 of each subsequent 28-day cycles until unacceptable AE, disease progression, poor compliance to the study protocol, study termination, lost to follow up or investigator's decision (maximum exposure: 301 weeks).
OG001
Phase 2 Stage 2: Isatuximab + Dexamethasone
Participants with relapsed or RRMM, received Isatuximab 20 mg/kg, as IV infusion on Day 1, 8, 15 and Day 22 of Cycle 1 (28 days) and then on Day 1 and 15 of each subsequent 28-day cycles along with dexamethasone: tablet or as IV infusion (40 mg/day for less than [<] 75 years of age; 20 mg/day for greater than or equal to [>=] 75 years of age) on Days 1, 8, 15 and 22 of each 28 days cycle until unacceptable AE, disease progression, poor compliance to the study protocol, study termination, lost to follow up or investigator's decision (maximum exposure: 301 weeks).
Secondary
Phase 2 Stage 1: Duration of Response
DOR:Time from date of 1st IAC determined response (>= PR) that was subsequently confirmed, to date of first IAC determined PD/death, whichever happened earlier. updated IMWG criteria- PR:>=50% decrease in difference between involved and uninvolved FLC levels in place of M-protein criteria or a >=50% reduction in plasma cells in place of M-protein if baseline was ≥30%. If present at baseline a >=50% reduction in size of soft tissue plasmacytomas; PD: Increase of 25% from lowest response value in any of following: Serum M-protein >=0.5 g/dL absolute increase and/or urine M-protein >=200 mg/24 hours absolute increase and/or >10 mg/dL absolute increase in difference between involved and uninvolved FLC levels, >=10% bone marrow plasma cells (PCs), development of new bone lesions/soft tissue plasmacytomas or definite increase in size of existing bone lesions/soft tissue plasmacytomas, development of hypercalcemia (corrected serum calcium >11·5 mg/dl) attributed to PC proliferation disorder.
Analysis was performed only on subset of population who had response in Phase 2 stage 1.
Posted
Mean
Standard Deviation
months
From the date of first response until disease progression or death or data cut-off (maximum duration: 77 weeks for Stage 1a arms and 53 weeks for stage 1b arm)
ID
Title
Description
OG000
Phase 2 Stage 1a: Isatuximab 3mg/kg Q2W
Participants with multiple Myeloma received Isatuximab 3 mg/kg, as IV infusion on Day 1 and Day 15 of each 28-day cycle until unacceptable AE, disease progression, poor compliance to the study protocol, study termination or lost to follow up (maximum exposure: 77 weeks).
Secondary
Phase 2 Stage 2: Duration of Response
DOR: Time from date of 1st IAC determined response (>= PR) that was subsequently confirmed, to date of 1st IAC determined PD or death, whichever happened earlier. As per updated IMWG criteria-PR: ≥50% reduction of serum M-Protein and reduction in urinary M-protein by ≥90% or to <200 mg/24 hours. ≥50% decrease in difference between involved and uninvolved FLC levels in place of M-protein criteria or ≥50% reduction in plasma cells in place of M-protein if baseline was ≥30%. If present at baseline ≥50% reduction in size of soft tissue plasmacytomas; PD: Increase of >25% from lowest response value in any one of following: Serum M-component (absolute increase must be >0.5 g/dL)4 and/or Urine M-component (absolute increase must be >200 mg/24 h) and/or >10 mg/dL absolute increase in difference between involved and uninvolved FLC levels, >=10% bone marrow plasma cell, development of hypercalcemia (corrected serum calcium >11.5 mg/dL) attributed solely to plasma cell proliferative disorder.
Analysis was performed only on subset of population who had response in Phase 2 stage 2.
Posted
Mean
Standard Deviation
months
From the date of first response until disease progression or death or data cut-off (maximum duration: 97 weeks)
ID
Title
Description
OG000
Phase 2 Stage 2: Isatuximab Alone
Participants with relapsed or relapsed/refractory multiple myeloma (RRMM), received Isatuximab 20 mg/kg, as IV infusion on Day 1, 8, 15 and Day 22 of Cycle 1 (28 days) and then on Day 1 and 15 of each subsequent 28-day cycles until unacceptable AE, disease progression, poor compliance to the study protocol, study termination, lost to follow up or investigator's decision (maximum exposure: 97 weeks).
Secondary
Phase 2 Stage 1: Percentage of Participants With Clinical Benefit
Clinical benefit: participants with sCR, CR, VGPR, PR or MR as per IMWG criteria, determined by IAC. CR: negative immunofixation on serum & urine, disappearance of any soft tissue plasmacytomas,<5% PCs in bone marrow aspirates. sCR: CR + normal FLC ratio (0.26-1.65), absence of clonal cells in bone marrow biopsy. VGPR: serum & urine M-component detectable by immunofixation, not on electrophoresis/,>=90% reduction in serum M-component plus urine M-component level <100mg/24hours; PR: ≥50% reduction of serum M-Protein and reduction in urinary M-protein by ≥90% or to <200 mg/24 hours, ≥50% decrease in the difference between involved and uninvolved FLC levels in place of the M-protein criteria or a ≥50% reduction in plasma cells in place of M-protein if baseline was ≥30%. If present at baseline, ≥50% size reduction in soft tissue plasmacytomas. MR:>=25 but <49% reduction in serum M-protein, reduction in 24h urine M-protein by 50-89%, 25-49% size reduction in soft tissue plasmacytomas.
Analysis was performed on AT population.
Posted
Number
percentage of participants
From the date of randomization to the date of first documentation of progression or death (maximum duration: 77 weeks for Stage 1a arms and 53 weeks for stage 1b arm)
ID
Title
Description
OG000
Phase 2 Stage 1a: Isatuximab 3mg/kg Q2W
Participants with multiple Myeloma received Isatuximab 3 mg/kg, as IV infusion on Day 1 and Day 15 of each 28-day cycle until unacceptable AE, disease progression, poor compliance to the study protocol, study termination or lost to follow up (maximum exposure: 77 weeks).
Secondary
Phase 2 Stage 2: Percentage of Participants With Clinical Benefit
Clinical benefit:participants with sCR, CR, VGPR, PR or MR, per IMWG criteria, determined by IAC. CR:negative immunofixation on serum & urine, disappearance of any soft tissue plasmacytomas,<5% plasma cells in bone marrow aspirates,normal FLC ratio(0.26-1.65) in participants with only FLC disease.sCR:CR+normal FLC ratio, absence of clonal cells in bone marrow biopsy.VGPR:serum & urine M-component detectable by immunofixation, not on electrophoresis/,>=90% reduction in serum M-component plus urine M-component level <100mg/24h/,>=90% decrease in difference between involved and uninvolved FLC levels; PR:>=50% reduction of serum M-protein, reduction in 24h urinary M-protein by >=90%/<200mg/24h,>50% decrease in difference between involved and uninvolved FLC in place of M-protein criteria, >=50% reduction in size/number of soft tissue plasmacytomas. MR:>=25 but <49% reduction in serum M-protein,reduction in 24h urine M-protein by 50-89%, 25-49% reduction in size of soft tissue plasmacytomas
Analysis was performed on AT population.
Posted
Number
percentage of participants
From the date of randomization to the date of first documentation of progression or death (maximum duration: 97 weeks )
ID
Title
Description
OG000
Phase 2 Stage 2: Isatuximab Alone
Participants with relapsed or relapsed/refractory multiple myeloma (RRMM), received Isatuximab 20 mg/kg, as IV infusion on Day 1, 8, 15 and Day 22 of Cycle 1 (28 days) and then on Day 1 and 15 of each subsequent 28-day cycles until unacceptable AE, disease progression, poor compliance to the study protocol, study termination, lost to follow up or investigator's decision (maximum exposure: 97 weeks).
Secondary
Phase 2 Stage 1: Progression Free Survival (PFS)
PFS was defined as the time interval from the date of first isatuximab administration to the date of the first IAC-confirmed disease progression (PD) or date of death due to any cause, whichever came first. As per IMWG criteria, PD: Increase of > 25% from lowest response value in any one or more of the following: Serum M-component and/or (the absolute increase must be > 0.5 g/dL), Urine M-component and/or (the absolute increase must be > 200 mg/24 h), > 10mg/dL decrease in the difference between involved and uninvolved FLC levels in place of the M-protein criteria, >10% absolute percentage of bone marrow plasma cell, definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas, development of hypercalcemia (corrected serum calcium > 11.5 mg/dL or 2.65 mmol/L) that attributed solely to the plasma cell proliferative disorder. Analysis was performed by Kaplan-Meier method.
Analysis was performed on AT population.
Posted
Median
95% Confidence Interval
months
From the date of the first dose administration until progression or death, whichever occurred first (maximum duration: 77 weeks for Stage 1a arms and 53 weeks for stage 1b arm)
ID
Title
Description
OG000
Phase 2 Stage 1a: Isatuximab 3mg/kg Q2W
Participants with multiple Myeloma received Isatuximab 3 mg/kg, as IV infusion on Day 1 and Day 15 of each 28-day cycle until unacceptable AE, disease progression, poor compliance to the study protocol, study termination or lost to follow up (maximum exposure: 77 weeks).
Secondary
Phase 2 Stage 2: Progression Free Survival
PFS was defined as the time interval from the date of first isatuximab administration to the date of the first IAC-confirmed disease progression or the date of death due to any cause, whichever came first. As per IMWG criteria, PD: Increase of >25% from lowest response value in any one of the following: Serum M-component (the absolute increase must be >0.5 g/dL)4 and/or Urine M-component (the absolute increase must be >200 mg/24 h) and/or >10 mg/dL decrease in the difference between involved and uninvolved FLC levels in place of the M-protein criteria, ≥10% bone marrow plasma cell, development of hypercalcemia (corrected serum calcium >11.5 mg/dL) attributed solely to the plasma cell proliferative disorder. Analysis was performed by Kaplan-Meier method.
Analysis was performed on AT population.
Posted
Median
95% Confidence Interval
months
From the date of the first dose administration until progression or death, whichever occurred first (maximum duration: 97 weeks)
ID
Title
Description
OG000
Phase 2 Stage 2: Isatuximab Alone
Participants with relapsed or relapsed/refractory multiple myeloma (RRMM), received Isatuximab 20 mg/kg, as IV infusion on Day 1, 8, 15 and Day 22 of Cycle 1 (28 days) and then on Day 1 and 15 of each subsequent 28-day cycles until unacceptable AE, disease progression, poor compliance to the study protocol, study termination, lost to follow up or investigator's decision (maximum exposure: 97 weeks).
OG001
Phase 2 Stage 2: Isatuximab + Dexamethasone
Secondary
Phase 2 Stage 1: Overall Survival (OS)
OS was defined as the time interval from the date of first Isatuximab administration to death from any cause. Analysis was performed by Kaplan-Meier method.
Analysis was performed on AT population.
Posted
Median
95% Confidence Interval
months
From the date of randomization to date of death from any cause (maximum duration 77 weeks for Stage 1a arms and 53 weeks for stage 1b arm)
ID
Title
Description
OG000
Phase 2 Stage 1a: Isatuximab 3mg/kg Q2W
Participants with multiple Myeloma received Isatuximab 3 mg/kg, as IV infusion on Day 1 and Day 15 of each 28-day cycle until unacceptable AE, disease progression, poor compliance to the study protocol, study termination or lost to follow up (maximum exposure: 77 weeks).
OG001
Phase 2 Stage 1a: Isatuximab 10mg/kg Q2W
Participants with multiple Myeloma received Isatuximab 10 mg/kg, as IV infusion on Day 1 and Day 15 of each 28-day cycle until unacceptable AE, disease progression, poor compliance to the study protocol, study termination or lost to follow up (maximum exposure: 77 weeks).
OG002
Phase 2 Stage 1a: Isatuximab 10mg/kg Q2W; Then Q4W
Participants with multiple Myeloma received Isatuximab 10 mg/kg, as IV infusion Q2W, i.e. on Day 1 and Day 15 of Cycle 1 and 2 (each cycle 28 days), then every 4 weeks (Q4W), i.e. on Day 1 of each 28-days cycle until unacceptable AE, disease progression, poor compliance to the study protocol, study termination or lost to follow up (maximum exposure: 77 weeks).
Secondary
Phase 2 Stage 2: Overall Survival
OS was defined as the time interval from the date of first Isatuximab administration to death from any cause. Analysis was performed by Kaplan-Meier method.
Analysis was performed on AT population.
Posted
Median
95% Confidence Interval
months
From the date of randomization to date of death from any cause (maximum duration: 97 weeks)
ID
Title
Description
OG000
Phase 2 Stage 2: Isatuximab Alone
Participants with relapsed or relapsed/refractory multiple myeloma (RRMM), received Isatuximab 20 mg/kg, as IV infusion on Day 1, 8, 15 and Day 22 of Cycle 1 (28 days) and then on Day 1 and 15 of each subsequent 28-day cycles until unacceptable AE, disease progression, poor compliance to the study protocol, study termination, lost to follow up or investigator's decision (maximum exposure: 97 weeks).
OG001
Phase 2 Stage 2: Isatuximab + Dexamethasone
Participants with relapsed or RRMM, received Isatuximab 20 mg/kg, as IV infusion on Day 1, 8, 15 and Day 22 of Cycle 1 (28 days) and then on Day 1 and 15 of each subsequent 28-day cycles along with dexamethasone: tablet or as IV infusion (40 mg/day for less than [<] 75 years of age; 20 mg/day for greater than or equal to [>=] 75 years of age) on Days 1, 8, 15 and 22 of each 28 days cycle until unacceptable AE, disease progression, poor compliance to the study protocol, study termination, lost to follow up or investigator's decision (maximum exposure: 97 weeks).
Secondary
Phase 2 Stage 1: Change From Baseline in Health Related Quality of Life (HRQL) European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Scores: Global Health Status
EORTC-QLQ-C30 is a cancer-specific instrument with 30 questions for evaluation of new chemotherapy and provides an assessment of participant reported outcome dimensions. First 28 questions used 4-point scale (1=not at all,2=a little,3=quite a bit,4=very much) for evaluating 5 functional scales (physical, role, emotional, cognitive, social), 3 symptom scales (fatigue, nausea/vomiting, pain) & other single items. For each item, high score = high level of symptomatology/problem. Last 2 questions represented participant's assessment of overall health & quality of life, coded on 7-point scale (1=very poor to 7=excellent). EORTC QLQ-C30 observed values and change from baseline for global health status (scoring of questions 29 & 30) and 5 functional scales, 3 symptom scales and other single items (scoring of questions 1 to 28). Answers were converted into grading scale, with values between 0 and 100. A high score represented a favorable outcome with a best quality of life for participant.
Analysis was performed on AT population. Here, "Overall Number of Participants Analyzed" = participants evaluable for this outcome measure and 'number analyzed' = number of participants with available data for each category.
Posted
Mean
Standard Deviation
score on a scale
Baseline, Day 1 of Cycles 2, 3, 4, 5, 6, 7, 8, 9, 10 and End of Treatment (EOT: anytime up to 77 weeks for Stage 1a arms and 53 weeks for stage 1b arm)
ID
Title
Description
OG000
Phase 2 Stage 1a: Isatuximab 3mg/kg Q2W
Participants with multiple Myeloma received Isatuximab 3 mg/kg, as IV infusion on Day 1 and Day 15 of each 28-day cycle until unacceptable AE, disease progression, poor compliance to the study protocol, study termination or lost to follow up (maximum exposure: 77 weeks).
Secondary
Phase 2 Stage 1: Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Multiple Myeloma Specific Module With 20 Items (EORTC QLQ-MY20) Scores: Disease Symptom Subscale Score
EORTC QLQ-MY20 is a validated questionnaire to assess the overall quality of life in participants with MM. It has 4 subscales: body image, future perspective), and 2 symptoms scales (disease symptoms and side-effects of treatment). Disease symptoms subscale used 4-point scale ranged from 1= 'Not at All' to 4= 'Very Much'. Scores were averaged, and transformed to 0 -100 scale, where higher scores = more symptoms and lower health-related quality of life (HRQL) and lower score = less symptoms and more HRQL.
Analysis was performed on AT population. Here, "Overall Number of Participants Analyzed" = participants evaluable for this outcome measure and 'number analyzed' = number of participants with available data for each category.
Posted
Mean
Standard Deviation
score on a scale
Baseline, Day 1 of Cycles 2, 3, 4, 5, 6, 7, 8, 9, 10 and EOT (anytime up to 77 weeks for Stage 1a arms and 53 weeks for stage 1b arm)
ID
Title
Description
OG000
Phase 2 Stage 1a: Isatuximab 3mg/kg Q2W
Participants with multiple Myeloma received Isatuximab 3 mg/kg, as IV infusion on Day 1 and Day 15 of each 28-day cycle until unacceptable AE, disease progression, poor compliance to the study protocol, study termination or lost to follow up (maximum exposure: 77 weeks).
OG001
Phase 2 Stage 1a: Isatuximab 10mg/kg Q2W
Secondary
Phase 2 Stage 1: Change From Baseline in Euro Quality of Life 5 Dimension (EQ-5D) Generic Health Status - Visual Analogue Scale Scores
EQ-5D was a standardized HRQL questionnaire consisting of EQ-5D descriptive system and Visual Analogue Scale (VAS). EQ-5D VAS was used to record a participant's rating for his/her current health-related quality of life state and captured on a vertical VAS (0-100), where 0 = worst imaginable health state and 100 = best imaginable health state.
Analysis was performed on AT population. Here, "Overall Number of Participants Analyzed" = participants evaluable for this outcome measure and 'number analyzed' = number of participants with available data for each category.
Posted
Mean
Standard Deviation
score on a scale
Baseline, Day 1 of Cycles 4, 7, 10, 13, 16, 19, and EOT (anytime up to 77 weeks for Stage 1a arms and 53 weeks for stage 1b arm)
ID
Title
Description
OG000
Phase 2 Stage 1a: Isatuximab 3mg/kg Q2W
Participants with multiple Myeloma received Isatuximab 3 mg/kg, as IV infusion on Day 1 and Day 15 of each 28-day cycle until unacceptable AE, disease progression, poor compliance to the study protocol, study termination or lost to follow up (maximum exposure: 77 weeks).
OG001
Phase 2 Stage 1a: Isatuximab 10mg/kg Q2W
Participants with multiple Myeloma received Isatuximab 10 mg/kg, as IV infusion on Day 1 and Day 15 of each 28-day cycle until unacceptable AE, disease progression, poor compliance to the study protocol, study termination or lost to follow up (maximum exposure: 77 weeks).
Secondary
Pharmacokinetic Assessment: Phase 2 Stage 2: Area Under the Plasma Concentration Versus Time Curve of Isatuximab Over 1 Week Interval
Analysis was performed on PK population which included participants who gave informed consent, received at least one dose (even if incomplete) of isatuximab, had an assessable PK parameter.
Posted
Geometric Mean
Geometric Coefficient of Variation
mcg*hour/mL
Pre-dose, at the end of infusion, 1 hour and 168 hours post dose on Day 1 of Cycle 1
ID
Title
Description
OG000
Phase 2 Stage 2: Isatuximab Alone
Participants with relapsed or relapsed/refractory multiple myeloma (RRMM), received Isatuximab 20 mg/kg, as IV infusion on Day 1, 8, 15 and Day 22 of Cycle 1 (28 days) and then on Day 1 and 15 of each subsequent 28-day cycles until unacceptable AE, disease progression, poor compliance to the study protocol, study termination, lost to follow up or investigator's decision (maximum exposure: 97 weeks).
OG001
Phase 2 Stage 2: Isatuximab + Dexamethasone
Participants with relapsed or RRMM, received Isatuximab 20 mg/kg, as IV infusion on Day 1, 8, 15 and Day 22 of Cycle 1 (28 days) and then on Day 1 and 15 of each subsequent 28-day cycles along with dexamethasone: tablet or as IV infusion (40 mg/day for less than [<] 75 years of age; 20 mg/day for greater than or equal to [>=] 75 years of age) on Days 1, 8, 15 and 22 of each 28 days cycle until unacceptable AE, disease progression, poor compliance to the study protocol, study termination, lost to follow up or investigator's decision (maximum exposure: 97 weeks).
Secondary
Pharmacokinetic Assessment: Phase 2 Stage 2: Area Under the Plasma Concentration Versus Time Curve of Isatuximab Over 2 Weeks Interval
Analysis was performed on PK population.
Posted
Geometric Mean
Geometric Coefficient of Variation
mcg*hour/mL
Cycle 1, Day 1: pre-dose, at the end of infusion, 168 and 336 hours post-infusion
ID
Title
Description
OG000
Phase 2 Stage 2: Isatuximab Alone
Participants with relapsed or relapsed/refractory multiple myeloma (RRMM), received Isatuximab 20 mg/kg, as IV infusion on Day 1, 8, 15 and Day 22 of Cycle 1 (28 days) and then on Day 1 and 15 of each subsequent 28-day cycles until unacceptable AE, disease progression, poor compliance to the study protocol, study termination, lost to follow up or investigator's decision (maximum exposure: 97 weeks).
OG001
Phase 2 Stage 2: Isatuximab + Dexamethasone
Participants with relapsed or RRMM, received Isatuximab 20 mg/kg, as IV infusion on Day 1, 8, 15 and Day 22 of Cycle 1 (28 days) and then on Day 1 and 15 of each subsequent 28-day cycles along with dexamethasone: tablet or as IV infusion (40 mg/day for less than [<] 75 years of age; 20 mg/day for greater than or equal to [>=] 75 years of age) on Days 1, 8, 15 and 22 of each 28 days cycle until unacceptable AE, disease progression, poor compliance to the study protocol, study termination, lost to follow up or investigator's decision (maximum exposure: 97 weeks).
Secondary
Pharmacokinetic Assessment: Phase 2 Stage 2: Area Under the Plasma Concentration Versus Time Curve of Isatuximab Over 4 Weeks Interval
Analysis was performed on PK population.
Posted
Geometric Mean
Geometric Coefficient of Variation
mcg*hour/mL
Cycle 1, Day 1: pre-dose, at the end of infusion, 168, 336, and 672 hours post-infusion
ID
Title
Description
OG000
Phase 2 Stage 2: Isatuximab Alone
Participants with relapsed or relapsed/refractory multiple myeloma (RRMM), received Isatuximab 20 mg/kg, as IV infusion on Day 1, 8, 15 and Day 22 of Cycle 1 (28 days) and then on Day 1 and 15 of each subsequent 28-day cycles until unacceptable AE, disease progression, poor compliance to the study protocol, study termination, lost to follow up or investigator's decision (maximum exposure: 97 weeks).
OG001
Phase 2 Stage 2: Isatuximab + Dexamethasone
Participants with relapsed or RRMM, received Isatuximab 20 mg/kg, as IV infusion on Day 1, 8, 15 and Day 22 of Cycle 1 (28 days) and then on Day 1 and 15 of each subsequent 28-day cycles along with dexamethasone: tablet or as IV infusion (40 mg/day for less than [<] 75 years of age; 20 mg/day for greater than or equal to [>=] 75 years of age) on Days 1, 8, 15 and 22 of each 28 days cycle until unacceptable AE, disease progression, poor compliance to the study protocol, study termination, lost to follow up or investigator's decision (maximum exposure: 97 weeks).
Secondary
Pharmacokinetic Assessment: Phase 2 Stage 2: Plasma Concentration of Isatuximab Before Treatment Administration (Ctrough)
Analysis was performed on PK population.
Posted
Geometric Mean
Geometric Coefficient of Variation
mcg/mL
At Days 7, 14 and 28
ID
Title
Description
OG000
Phase 2 Stage 2: Isatuximab Alone
Participants with relapsed or relapsed/refractory multiple myeloma (RRMM), received Isatuximab 20 mg/kg, as IV infusion on Day 1, 8, 15 and Day 22 of Cycle 1 (28 days) and then on Day 1 and 15 of each subsequent 28-day cycles until unacceptable AE, disease progression, poor compliance to the study protocol, study termination, lost to follow up or investigator's decision (maximum exposure: 97 weeks).
OG001
Phase 2 Stage 2: Isatuximab + Dexamethasone
Participants with relapsed or RRMM, received Isatuximab 20 mg/kg, as IV infusion on Day 1, 8, 15 and Day 22 of Cycle 1 (28 days) and then on Day 1 and 15 of each subsequent 28-day cycles along with dexamethasone: tablet or as IV infusion (40 mg/day for less than [<] 75 years of age; 20 mg/day for greater than or equal to [>=] 75 years of age) on Days 1, 8, 15 and 22 of each 28 days cycle until unacceptable AE, disease progression, poor compliance to the study protocol, study termination, lost to follow up or investigator's decision (maximum exposure: 97 weeks).
Secondary
Pharmacokinetic Assessment: Phase 2 Stage 2: Accumulation Ratio of Isatuximab Based on Ctrough
Ctrough is the plasma concentration observed before treatment administration. For 1st category, the accumulation ratio was calculated by dividing Ctrough value of Cycle 2 Day 1 by Cycle 1 Day 8 and for second category, accumulation ratio was calculated by dividing Ctrough value of Cycle 4 Day 1 by Cycle 1 Day 8.
Analysis was performed on PK population. Here, 'number of participants analyzed' = participants evaluable for this outcome measure.
Posted
Mean
Standard Deviation
ratio
Cycle 2, Day 1; Cycle 1, Day 8; Cycle 4, Day 1
ID
Title
Description
OG000
Phase 2 Stage 2: Isatuximab Alone
Participants with relapsed or relapsed/refractory multiple myeloma (RRMM), received Isatuximab 20 mg/kg, as IV infusion on Day 1, 8, 15 and Day 22 of Cycle 1 (28 days) and then on Day 1 and 15 of each subsequent 28-day cycles until unacceptable AE, disease progression, poor compliance to the study protocol, study termination, lost to follow up or investigator's decision (maximum exposure: 97 weeks).
OG001
Phase 2 Stage 2: Isatuximab + Dexamethasone
Participants with relapsed or RRMM, received Isatuximab 20 mg/kg, as IV infusion on Day 1, 8, 15 and Day 22 of Cycle 1 (28 days) and then on Day 1 and 15 of each subsequent 28-day cycles along with dexamethasone: tablet or as IV infusion (40 mg/day for less than [<] 75 years of age; 20 mg/day for greater than or equal to [>=] 75 years of age) on Days 1, 8, 15 and 22 of each 28 days cycle until unacceptable AE, disease progression, poor compliance to the study protocol, study termination, lost to follow up or investigator's decision (maximum exposure: 97 weeks).
Secondary
Immunogenicity Assessment: Phase 2 Stage 2: Number of Participants With Anti-drug Antibodies to Isatuximab
ADA response was categorized as: treatment induced and treatment boosted response. Treatment-induced ADA was defined as ADA that developed at any time during the ADA on-study observation period (defined as the time from the first isatuximab administration until end of Phase 2 Stage 2) in participants without preexisting ADA (defined as: ADA that were present in samples drawn before treatment), including participants without pre-treatment (before treatment) samples. Treatment boosted ADA was defined as pre-existing ADA that increased at least 2 titer steps between pre-treatment (before treatment) and post-treatment.
Analysis was performed on ADA evaluable population which included all treated participants with at least one ADA assessment with a reportable result during the ADA on-study observation period.
Posted
Count of Participants
Participants
Up to 97 weeks
ID
Title
Description
OG000
Phase 2 Stage 2: Isatuximab Alone
Participants with relapsed or relapsed/refractory multiple myeloma (RRMM), received Isatuximab 20 mg/kg, as IV infusion on Day 1, 8, 15 and Day 22 of Cycle 1 (28 days) and then on Day 1 and 15 of each subsequent 28-day cycles until unacceptable AE, disease progression, poor compliance to the study protocol, study termination, lost to follow up or investigator's decision (maximum exposure: 97 weeks).
OG001
Phase 2 Stage 2: Isatuximab + Dexamethasone
Time Frame
All AEs were collected from signing of the informed consent form up to 30 days from last administration of study treatment (maximum exposure up to 120 weeks for Phase 1, 414 weeks for Phase 2 Stage 1a, 92 weeks for Phase 2 Stage 1b, and 301 weeks for Phase 2 Stage 2) regardless of seriousness or relationship to investigational product. All-cause mortality (Deaths) was collected for the entire study duration, 683 weeks
Description
Reported AEs were TEAEs which was defined as an AE that developed or worsened during the 'on treatment period' (time from the first dose of any study treatment up to 30 days after the last administration of the study treatment). Analysis was performed on AT population. For Phase 1, MedDRA 19.1 version was used and for Phase 2 Stage 1 and Phase 2 Stage 2, MedDRA 26.0 version was used.
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
Phase 1: Isatuximab <=1 mg/kg Q2W
Participants with CD38+ HM, received Isatuximab at any one of the dose <=1 mg/kg (i.e. either 0.0001 mg/kg or 0.001mg/kg or 0.01mg/kg or 0.03mg/kg, or 0.1mg/kg or 0.3 mg/kg or 1 mg/kg as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal by participant, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
5
16
3
16
16
16
EG001
Phase 1: Isatuximab 3mg/kg Q2W
Participants with CD38+HM, received Isatuximab 3 mg/kg, as IV infusion on Day 1 of each14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
1
6
3
6
6
6
EG002
Phase 1: Isatuximab 5mg/kg Q2W
Participants with CD38+ HM, received Isatuximab 5 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
0
3
1
3
3
3
EG003
Phase1:Isatuximab (CD38+HM and Standard Risk Multiple Myeloma)
Participants with CD38+ HM along with participants with standard risk multiple myeloma were included this in arm and, received Isatuximab 10 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
0
26
10
26
26
26
EG004
Phase 1: Isatuximab (CD38 + HM and High Risk Multiple Myeloma)
Participants with CD38+ HM along with participants with high risk multiple myeloma were included this in arm and, received Isatuximab 10 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
2
18
10
18
18
18
EG005
Phase 1: Isatuximab 10mg/kg QW
Participants with CD38+ HM, received Isatuximab 10 mg/kg, as IV infusion QW, i.e. on Day 1 and 8 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
2
6
3
6
6
6
EG006
Phase 1: Isatuximab 20mg/kg Q2W
Participants with CD38+ HM, received Isatuximab 20 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
2
7
3
7
6
7
EG007
Phase 1: Isatuximab 20mg/kg QW
Participants with CD38+ HM, received Isatuximab 20 mg/kg, as IV infusion QW, i.e. on Day 1 and 8 of each 14-day treatment cycle until occurrence of DLT, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
0
7
3
7
6
7
EG008
Phase 2 Stage 1a: Isatuximab 3mg/kg Q2W
Participants with multiple Myeloma received Isatuximab 3 mg/kg, as IV infusion on Day 1 and Day 15 of each 28-day cycle until unacceptable AE, disease progression, poor compliance to the study protocol, study termination or lost to follow up (maximum exposure: 414 weeks).
11
23
13
23
22
23
EG009
Phase 2 Stage 1a: Isatuximab 10mg/kg Q2W
Participants with multiple Myeloma received Isatuximab 10 mg/kg, as IV infusion on Day 1 and Day 15 of each 28-day cycle until unacceptable AE, disease progression, poor compliance to the study protocol, study termination or lost to follow up (maximum exposure: 414 weeks).
13
24
11
24
23
24
EG010
Phase 2 Stage 1a: Isatuximab 10mg/kg Q2W; Then Q4W
Participants with multiple Myeloma received Isatuximab 10 mg/kg, as IV infusion Q2W, i.e. on Day 1, 8, 15 and 22 of Cycle 1 and 2 (each cycle 28 days), then Q2W, i.e. on Day 1 and Day 15 of each 28-days cycle until unacceptable AE, disease progression, poor compliance to the study protocol, study termination or lost to follow up (maximum exposure: 414 weeks).
11
25
10
25
25
25
EG011
Phase 2 Stage 1b: Isatuximab 20 mg/kg QW and Then Q2W
Participants with multiple Myeloma received Isatuximab 20 mg/kg, as IV infusion on Day 1 and Day 15 of Cycle 1 and 2 (each cycle 28 days), then Day 1 of each 28-days cycle until Unacceptable AE, disease progression, poor compliance to the study protocol, study termination or lost to follow up (maximum exposure: 92 weeks).
11
25
9
25
24
25
EG012
Phase 2 Stage 2: Isatuximab Alone
Participants with relapsed or RRMM, received Isatuximab 20 mg/kg, as IV infusion on Day 1, 8, 15 and Day 22 of Cycle 1 (28 days) and then on Day 1 and 15 of each subsequent 28-day cycles until unacceptable AE, disease progression, poor compliance to the study protocol, study termination, lost to follow up or investigator's decision (maximum exposure: 301 weeks).
56
109
52
109
92
109
EG013
Phase 2 Stage 2: Isatuximab + Dexamethasone
Participants with relapsed or RRMM, received Isatuximab 20 mg/kg, as IV infusion on Day 1, 8, 15 and Day 22 of Cycle 1 (28 days) and then on Day 1 and 15 of each subsequent 28-day cycles along with dexamethasone: tablet or as IV infusion tablet or as IV infusion (40 mg/day for <75 years of age; 20 mg/day for >=75 years of age) on Days 1, 8, 15 and 22 of each 28 days cycle until unacceptable AE, disease progression, poor compliance to the study protocol, study termination, lost to follow up or investigator's decision (maximum exposure: 301 weeks).
25
55
27
55
47
55
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG0031 events1 affected26 at risk
EG0041 events1 affected18 at risk
EG0050 events0 affected6 at risk
EG0061 events1 affected7 at risk
EG0070 events0 affected7 at risk
EG0080 events0 affected23 at risk
EG0090 events0 affected24 at risk
EG0100 events0 affected25 at risk
EG0110 events0 affected25 at risk
EG0124 events4 affected109 at risk
EG0130 events0 affected55 at risk
Febrile Neutropenia
Blood and lymphatic system disorders
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Hyperviscosity Syndrome
Blood and lymphatic system disorders
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Acute Coronary Syndrome
Cardiac disorders
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Acute Myocardial Infarction
Cardiac disorders
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Atrial Fibrillation
Cardiac disorders
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Cardiac Failure
Cardiac disorders
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Stress Cardiomyopathy
Cardiac disorders
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Tachycardia
Cardiac disorders
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Hypercalcaemia Of Malignancy
Endocrine disorders
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Cataract
Eye disorders
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Eye Pain
Eye disorders
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Visual Impairment
Eye disorders
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Diverticular Perforation
Gastrointestinal disorders
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Gastrointestinal Amyloidosis
Gastrointestinal disorders
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Gastrointestinal Haemorrhage
Gastrointestinal disorders
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Ileus
Gastrointestinal disorders
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Intussusception
Gastrointestinal disorders
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Mechanical Ileus
Gastrointestinal disorders
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Nausea
Gastrointestinal disorders
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Obstruction Gastric
Gastrointestinal disorders
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Small Intestinal Obstruction
Gastrointestinal disorders
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Asthenia
General disorders
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Chills
General disorders
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Disease Progression
General disorders
MedDra 26.0
Systematic Assessment
EG0001 events1 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Fatigue
General disorders
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Feeling Cold
General disorders
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
General Physical Health Deterioration
General disorders
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Hyperpyrexia
General disorders
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Malaise
General disorders
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Non-Cardiac Chest Pain
General disorders
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Pain
General disorders
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Performance Status Decreased
General disorders
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Physical Deconditioning
General disorders
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Pyrexia
General disorders
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Sudden Death
General disorders
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Cholestasis
Hepatobiliary disorders
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Hyperbilirubinaemia
Hepatobiliary disorders
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Anaphylactic Reaction
Immune system disorders
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Abdominal Sepsis
Infections and infestations
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Acute Sinusitis
Infections and infestations
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Atypical Pneumonia
Infections and infestations
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Bronchiolitis
Infections and infestations
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Bronchitis
Infections and infestations
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Covid-19 Pneumonia
Infections and infestations
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Campylobacter Gastroenteritis
Infections and infestations
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Cellulitis
Infections and infestations
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Device Related Infection
Infections and infestations
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Escherichia Sepsis
Infections and infestations
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Gastroenteritis
Infections and infestations
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Gastroenteritis Rotavirus
Infections and infestations
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Haemophilus Sepsis
Infections and infestations
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Herpes Zoster
Infections and infestations
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Infectious Colitis
Infections and infestations
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Infective Aortitis
Infections and infestations
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Influenza
Infections and infestations
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Intervertebral Discitis
Infections and infestations
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Lower Respiratory Tract Infection
Infections and infestations
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Lower Respiratory Tract Infection Viral
Infections and infestations
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Lung Infection
Infections and infestations
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Meningitis Bacterial
Infections and infestations
MedDra 26.0
Systematic Assessment
EG0001 events1 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Meningococcal Sepsis
Infections and infestations
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Otitis Media
Infections and infestations
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Parainfluenzae Virus Infection
Infections and infestations
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Pneumococcal Bacteraemia
Infections and infestations
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Pneumocystis Jirovecii Pneumonia
Infections and infestations
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Pneumonia
Infections and infestations
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Pneumonia Aspiration
Infections and infestations
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Pneumonia Bacterial
Infections and infestations
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Pneumonia Mycoplasmal
Infections and infestations
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Pneumonia Respiratory Syncytial Viral
Infections and infestations
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Pneumonia Streptococcal
Infections and infestations
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Pneumonia Viral
Infections and infestations
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Pulmonary Sepsis
Infections and infestations
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Pyelonephritis
Infections and infestations
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Respiratory Syncytial Virus Infection
Infections and infestations
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Respiratory Tract Infection
Infections and infestations
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Sepsis
Infections and infestations
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Septic Shock
Infections and infestations
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Sinusitis
Infections and infestations
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Tracheobronchitis
Infections and infestations
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Upper Respiratory Tract Infection
Infections and infestations
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Urinary Tract Infection
Infections and infestations
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Varicella
Infections and infestations
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Varicella Zoster Virus Infection
Infections and infestations
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Infusion Related Reaction
Injury, poisoning and procedural complications
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Joint Injury
Injury, poisoning and procedural complications
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Post Procedural Complication
Injury, poisoning and procedural complications
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Road Traffic Accident
Injury, poisoning and procedural complications
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Traumatic Fracture
Injury, poisoning and procedural complications
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Blood Creatinine Increased
Investigations
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Blood Pressure Increased
Investigations
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Decreased Appetite
Metabolism and nutrition disorders
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Electrolyte Imbalance
Metabolism and nutrition disorders
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
MedDra 26.0
Systematic Assessment
EG0001 events1 affected16 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Hyperuricaemia
Metabolism and nutrition disorders
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Tumour Lysis Syndrome
Metabolism and nutrition disorders
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Back Pain
Musculoskeletal and connective tissue disorders
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Bone Pain
Musculoskeletal and connective tissue disorders
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected3 at risk
EG003
Musculoskeletal Chest Pain
Musculoskeletal and connective tissue disorders
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Musculoskeletal Pain
Musculoskeletal and connective tissue disorders
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Pain In Extremity
Musculoskeletal and connective tissue disorders
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Pathological Fracture
Musculoskeletal and connective tissue disorders
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Spinal Stenosis
Musculoskeletal and connective tissue disorders
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Basal Cell Carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Colon Cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Malignant Melanoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Myelodysplastic Syndrome
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDra 26.0
Systematic Assessment
EG0001 events1 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Plasma Cell Leukaemia
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Prostate Cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Squamous Cell Carcinoma Of The Oral Cavity
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Cerebral Haemorrhage
Nervous system disorders
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Dizziness
Nervous system disorders
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Headache
Nervous system disorders
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Ischaemic Stroke
Nervous system disorders
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Sciatica
Nervous system disorders
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Seizure
Nervous system disorders
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Somnolence
Nervous system disorders
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Spinal Cord Compression
Nervous system disorders
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Syncope
Nervous system disorders
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Device Malfunction
Product Issues
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Device Occlusion
Product Issues
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Acute Kidney Injury
Renal and urinary disorders
MedDra 26.0
Systematic Assessment
EG0001 events1 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Chronic Kidney Disease
Renal and urinary disorders
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Renal Failure
Renal and urinary disorders
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Pelvic Pain
Reproductive system and breast disorders
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Prostatitis
Reproductive system and breast disorders
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Acute Respiratory Failure
Respiratory, thoracic and mediastinal disorders
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Apnoea
Respiratory, thoracic and mediastinal disorders
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Bronchospasm
Respiratory, thoracic and mediastinal disorders
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Dyspnoea At Rest
Respiratory, thoracic and mediastinal disorders
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Dyspnoea Exertional
Respiratory, thoracic and mediastinal disorders
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Haemoptysis
Respiratory, thoracic and mediastinal disorders
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Laryngeal Oedema
Respiratory, thoracic and mediastinal disorders
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Laryngospasm
Respiratory, thoracic and mediastinal disorders
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Pharyngeal Swelling
Respiratory, thoracic and mediastinal disorders
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Pleural Effusion
Respiratory, thoracic and mediastinal disorders
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Pulmonary Embolism
Respiratory, thoracic and mediastinal disorders
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Pulmonary Fibrosis
Respiratory, thoracic and mediastinal disorders
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Respiratory Alkalosis
Respiratory, thoracic and mediastinal disorders
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Respiratory Tract Haemorrhage
Respiratory, thoracic and mediastinal disorders
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Loss Of Personal Independence In Daily Activities
Social circumstances
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Aortic Aneurysm
Vascular disorders
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Extrinsic Iliac Vein Compression
Vascular disorders
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Hypertensive Crisis
Vascular disorders
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Hypotension
Vascular disorders
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDra 26.0
Systematic Assessment
EG0006 events6 affected16 at risk
EG0012 events2 affected6 at risk
EG0020 events0 affected3 at risk
EG00313 events10 affected26 at risk
EG0047 events4 affected18 at risk
EG0052 events1 affected6 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected7 at risk
EG00814 events9 affected23 at risk
EG0093 events3 affected24 at risk
EG01011 events8 affected25 at risk
EG01112 events8 affected25 at risk
EG0124 events4 affected109 at risk
EG0131 events1 affected55 at risk
Neutropenia
Blood and lymphatic system disorders
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDra 26.0
Systematic Assessment
EG0002 events2 affected16 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Angina Pectoris
Cardiac disorders
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Bradycardia
Cardiac disorders
MedDra 26.0
Systematic Assessment
EG0001 events1 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Bundle Branch Block Right
Cardiac disorders
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Palpitations
Cardiac disorders
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Right Ventricular Hypertrophy
Cardiac disorders
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Sinus Tachycardia
Cardiac disorders
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Tachycardia
Cardiac disorders
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Conjunctival Haemorrhage
Eye disorders
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Diplopia
Eye disorders
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected3 at risk
EG003
Dry Eye
Eye disorders
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Lacrimation Increased
Eye disorders
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Scleral Discolouration
Eye disorders
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Vision Blurred
Eye disorders
MedDra 26.0
Systematic Assessment
EG0002 events2 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Visual Impairment
Eye disorders
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Abdominal Discomfort
Gastrointestinal disorders
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Abdominal Distension
Gastrointestinal disorders
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Abdominal Pain
Gastrointestinal disorders
MedDra 26.0
Systematic Assessment
EG0001 events1 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Abdominal Pain Upper
Gastrointestinal disorders
MedDra 26.0
Systematic Assessment
EG0001 events1 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Abdominal Tenderness
Gastrointestinal disorders
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Constipation
Gastrointestinal disorders
MedDra 26.0
Systematic Assessment
EG0001 events1 affected16 at risk
EG0010 events0 affected6 at risk
EG0022 events2 affected3 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDra 26.0
Systematic Assessment
EG0004 events3 affected16 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected3 at risk
EG003
Dry Mouth
Gastrointestinal disorders
MedDra 26.0
Systematic Assessment
EG0001 events1 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Gastrointestinal Pain
Gastrointestinal disorders
MedDra 26.0
Systematic Assessment
EG0001 events1 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Gastrooesophageal Reflux Disease
Gastrointestinal disorders
MedDra 26.0
Systematic Assessment
EG0001 events1 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Glossitis
Gastrointestinal disorders
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Glossodynia
Gastrointestinal disorders
MedDra 26.0
Systematic Assessment
EG0001 events1 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Haemorrhoids
Gastrointestinal disorders
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Mouth Ulceration
Gastrointestinal disorders
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Nausea
Gastrointestinal disorders
MedDra 26.0
Systematic Assessment
EG0006 events4 affected16 at risk
EG0012 events2 affected6 at risk
EG0021 events1 affected3 at risk
EG003
Rectal Haemorrhage
Gastrointestinal disorders
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDra 26.0
Systematic Assessment
EG0001 events1 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Toothache
Gastrointestinal disorders
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDra 26.0
Systematic Assessment
EG0002 events2 affected16 at risk
EG0011 events1 affected6 at risk
EG0021 events1 affected3 at risk
EG003
Asthenia
General disorders
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Chest Discomfort
General disorders
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Chills
General disorders
MedDra 26.0
Systematic Assessment
EG0006 events4 affected16 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Face Oedema
General disorders
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0022 events1 affected3 at risk
EG003
Fatigue
General disorders
MedDra 26.0
Systematic Assessment
EG00010 events8 affected16 at risk
EG0012 events2 affected6 at risk
EG0021 events1 affected3 at risk
EG003
Feeling Hot
General disorders
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Implant Site Pain
General disorders
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Influenza Like Illness
General disorders
MedDra 26.0
Systematic Assessment
EG0001 events1 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Injection Site Pain
General disorders
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Malaise
General disorders
MedDra 26.0
Systematic Assessment
EG0001 events1 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Non-Cardiac Chest Pain
General disorders
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected3 at risk
EG003
Oedema Peripheral
General disorders
MedDra 26.0
Systematic Assessment
EG0002 events2 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Pain
General disorders
MedDra 26.0
Systematic Assessment
EG0001 events1 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Peripheral Swelling
General disorders
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Pyrexia
General disorders
MedDra 26.0
Systematic Assessment
EG0004 events4 affected16 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected3 at risk
EG003
Cytokine Release Syndrome
Immune system disorders
MedDra 26.0
Systematic Assessment
EG0001 events1 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Angular Cheilitis
Infections and infestations
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Bronchitis
Infections and infestations
MedDra 26.0
Systematic Assessment
EG0001 events1 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Gastroenteritis Viral
Infections and infestations
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Gingivitis
Infections and infestations
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Herpes Simplex
Infections and infestations
MedDra 26.0
Systematic Assessment
EG0001 events1 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Hordeolum
Infections and infestations
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Influenza
Infections and infestations
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Lower Respiratory Tract Infection
Infections and infestations
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Oral Candidiasis
Infections and infestations
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Otitis Media
Infections and infestations
MedDra 26.0
Systematic Assessment
EG0001 events1 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Pneumonia
Infections and infestations
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Pyuria
Infections and infestations
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Respiratory Tract Infection
Infections and infestations
MedDra 26.0
Systematic Assessment
EG0001 events1 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Rhinitis
Infections and infestations
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Sinusitis
Infections and infestations
MedDra 26.0
Systematic Assessment
EG0001 events1 affected16 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected3 at risk
EG003
Tooth Abscess
Infections and infestations
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Tooth Infection
Infections and infestations
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Upper Respiratory Tract Infection
Infections and infestations
MedDra 26.0
Systematic Assessment
EG0004 events1 affected16 at risk
EG0011 events1 affected6 at risk
EG0021 events1 affected3 at risk
EG003
Urinary Tract Infection
Infections and infestations
MedDra 26.0
Systematic Assessment
EG0002 events2 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Accidental Overdose
Injury, poisoning and procedural complications
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDra 26.0
Systematic Assessment
EG0003 events2 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Infusion Related Reaction
Injury, poisoning and procedural complications
MedDra 26.0
Systematic Assessment
EG0007 events5 affected16 at risk
EG0014 events3 affected6 at risk
EG0022 events2 affected3 at risk
EG003
Joint Injury
Injury, poisoning and procedural complications
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected3 at risk
EG003
Procedural Pain
Injury, poisoning and procedural complications
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Scapula Fracture
Injury, poisoning and procedural complications
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Sports Injury
Injury, poisoning and procedural complications
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Blood Creatinine Increased
Investigations
MedDra 26.0
Systematic Assessment
EG0002 events2 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Carbon Monoxide Diffusing Capacity Decreased
Investigations
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Electrocardiogram T Wave Abnormal
Investigations
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Lymphocyte Count Decreased
Investigations
MedDra 26.0
Systematic Assessment
EG0002 events2 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Neutrophil Count Decreased
Investigations
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Platelet Count Decreased
Investigations
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Qrs Axis Abnormal
Investigations
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Weight Decreased
Investigations
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Decreased Appetite
Metabolism and nutrition disorders
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected3 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
MedDra 26.0
Systematic Assessment
EG0002 events2 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Hyperuricaemia
Metabolism and nutrition disorders
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Hypocalcaemia
Metabolism and nutrition disorders
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0012 events2 affected6 at risk
EG0023 events1 affected3 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0011 events1 affected6 at risk
EG0021 events1 affected3 at risk
EG003
Hypophosphataemia
Metabolism and nutrition disorders
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Pseudohyponatraemia
Metabolism and nutrition disorders
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Back Pain
Musculoskeletal and connective tissue disorders
MedDra 26.0
Systematic Assessment
EG0001 events1 affected16 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected3 at risk
EG003
Bone Pain
Musculoskeletal and connective tissue disorders
MedDra 26.0
Systematic Assessment
EG0002 events2 affected16 at risk
EG0010 events0 affected6 at risk
EG0022 events2 affected3 at risk
EG003
Bursitis
Musculoskeletal and connective tissue disorders
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Flank Pain
Musculoskeletal and connective tissue disorders
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Groin Pain
Musculoskeletal and connective tissue disorders
MedDra 26.0
Systematic Assessment
EG0001 events1 affected16 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Joint Swelling
Musculoskeletal and connective tissue disorders
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Limb Discomfort
Musculoskeletal and connective tissue disorders
MedDra 26.0
Systematic Assessment
EG0001 events1 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Muscle Fatigue
Musculoskeletal and connective tissue disorders
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Muscle Spasms
Musculoskeletal and connective tissue disorders
MedDra 26.0
Systematic Assessment
EG0001 events1 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Muscular Weakness
Musculoskeletal and connective tissue disorders
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Musculoskeletal Chest Pain
Musculoskeletal and connective tissue disorders
MedDra 26.0
Systematic Assessment
EG0001 events1 affected16 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected3 at risk
EG003
Musculoskeletal Pain
Musculoskeletal and connective tissue disorders
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected3 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDra 26.0
Systematic Assessment
EG0001 events1 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Neck Pain
Musculoskeletal and connective tissue disorders
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Pain In Extremity
Musculoskeletal and connective tissue disorders
MedDra 26.0
Systematic Assessment
EG0002 events2 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Pathological Fracture
Musculoskeletal and connective tissue disorders
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Spinal Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Spinal Pain
Musculoskeletal and connective tissue disorders
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Basal Cell Carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Tumour Pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected3 at risk
EG003
Amnesia
Nervous system disorders
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Balance Disorder
Nervous system disorders
MedDra 26.0
Systematic Assessment
EG0002 events1 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Cognitive Disorder
Nervous system disorders
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Cranial Nerve Paralysis
Nervous system disorders
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Dizziness
Nervous system disorders
MedDra 26.0
Systematic Assessment
EG0001 events1 affected16 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Dysgeusia
Nervous system disorders
MedDra 26.0
Systematic Assessment
EG0002 events2 affected16 at risk
EG0011 events1 affected6 at risk
EG0021 events1 affected3 at risk
EG003
Head Discomfort
Nervous system disorders
MedDra 26.0
Systematic Assessment
EG0001 events1 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Headache
Nervous system disorders
MedDra 26.0
Systematic Assessment
EG0008 events5 affected16 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected3 at risk
EG003
Hypoaesthesia
Nervous system disorders
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Mental Impairment
Nervous system disorders
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Paraesthesia
Nervous system disorders
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Peripheral Sensory Neuropathy
Nervous system disorders
MedDra 26.0
Systematic Assessment
EG0001 events1 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Restless Legs Syndrome
Nervous system disorders
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Toxic Encephalopathy
Nervous system disorders
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Vith Nerve Paralysis
Nervous system disorders
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Abnormal Dreams
Psychiatric disorders
MedDra 26.0
Systematic Assessment
EG0001 events1 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Agitation
Psychiatric disorders
MedDra 26.0
Systematic Assessment
EG0001 events1 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Anxiety
Psychiatric disorders
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Bradyphrenia
Psychiatric disorders
MedDra 26.0
Systematic Assessment
EG0001 events1 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Confusional State
Psychiatric disorders
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Depression
Psychiatric disorders
MedDra 26.0
Systematic Assessment
EG0001 events1 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Insomnia
Psychiatric disorders
MedDra 26.0
Systematic Assessment
EG0001 events1 affected16 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Irritability
Psychiatric disorders
MedDra 26.0
Systematic Assessment
EG0001 events1 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Nightmare
Psychiatric disorders
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Restlessness
Psychiatric disorders
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Acute Kidney Injury
Renal and urinary disorders
MedDra 26.0
Systematic Assessment
EG0001 events1 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Pollakiuria
Renal and urinary disorders
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Urinary Incontinence
Renal and urinary disorders
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Nipple Pain
Reproductive system and breast disorders
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Vulvovaginal Pain
Reproductive system and breast disorders
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Bronchospasm
Respiratory, thoracic and mediastinal disorders
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDra 26.0
Systematic Assessment
EG0005 events3 affected16 at risk
EG0012 events2 affected6 at risk
EG0021 events1 affected3 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDra 26.0
Systematic Assessment
EG0004 events2 affected16 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Dyspnoea Exertional
Respiratory, thoracic and mediastinal disorders
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected3 at risk
EG003
Laryngeal Discomfort
Respiratory, thoracic and mediastinal disorders
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Laryngospasm
Respiratory, thoracic and mediastinal disorders
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Nasal Congestion
Respiratory, thoracic and mediastinal disorders
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected3 at risk
EG003
Oropharyngeal Pain
Respiratory, thoracic and mediastinal disorders
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Productive Cough
Respiratory, thoracic and mediastinal disorders
MedDra 26.0
Systematic Assessment
EG0001 events1 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Rhinitis Allergic
Respiratory, thoracic and mediastinal disorders
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Sinus Congestion
Respiratory, thoracic and mediastinal disorders
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Sneezing
Respiratory, thoracic and mediastinal disorders
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Throat Irritation
Respiratory, thoracic and mediastinal disorders
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Throat Lesion
Respiratory, thoracic and mediastinal disorders
MedDra 26.0
Systematic Assessment
EG0001 events1 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Throat Tightness
Respiratory, thoracic and mediastinal disorders
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Tracheal Stenosis
Respiratory, thoracic and mediastinal disorders
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Upper-Airway Cough Syndrome
Respiratory, thoracic and mediastinal disorders
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Wheezing
Respiratory, thoracic and mediastinal disorders
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Actinic Keratosis
Skin and subcutaneous tissue disorders
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Dermatitis Acneiform
Skin and subcutaneous tissue disorders
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Dermatitis Contact
Skin and subcutaneous tissue disorders
MedDra 26.0
Systematic Assessment
EG0001 events1 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Hair Texture Abnormal
Skin and subcutaneous tissue disorders
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Hyperhidrosis
Skin and subcutaneous tissue disorders
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Onychoclasis
Skin and subcutaneous tissue disorders
MedDra 26.0
Systematic Assessment
EG0001 events1 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Pain Of Skin
Skin and subcutaneous tissue disorders
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Rash Erythematous
Skin and subcutaneous tissue disorders
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Rash Macular
Skin and subcutaneous tissue disorders
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Rash Maculo-Papular
Skin and subcutaneous tissue disorders
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Rash Pruritic
Skin and subcutaneous tissue disorders
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Skin Disorder
Skin and subcutaneous tissue disorders
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Skin Ulcer
Skin and subcutaneous tissue disorders
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Flushing
Vascular disorders
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected3 at risk
EG003
Hot Flush
Vascular disorders
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Hypertension
Vascular disorders
MedDra 26.0
Systematic Assessment
EG0001 events1 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Hypotension
Vascular disorders
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Pallor
Vascular disorders
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Peripheral Coldness
Vascular disorders
MedDra 26.0
Systematic Assessment
EG0000 events0 affected16 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 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
The Sponsor supports publication of clinical trial results but may request that investigators temporarily delay or alter publications in order to protect proprietary information. The Sponsor may also require that the results of multicenter studies be published only in their entirety and not as individual site data.
Participants with CD38+ HM, received Isatuximab 5 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
OG003
Phase1:Isatuximab (CD38+HM and Standard Risk Multiple Myeloma)
Participants with CD38+ HM along with participants with standard risk multiple myeloma were included in this arm and, received Isatuximab 10 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
OG004
Phase 1: Isatuximab (CD38 + HM and High Risk Multiple Myeloma)
Participants with CD38+ HM along with participants with high risk multiple myeloma were included in this arm and, received Isatuximab 10 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
OG005
Phase 1: Isatuximab 10 mg/kg QW
Participants with CD38+ HM, received Isatuximab 10 mg/kg, as IV infusion QW, i.e. on Day 1 and 8 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
OG006
Phase 1: Isatuximab 20mg/kg Q2W
Participants with CD38+ HM, received Isatuximab 20 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks)..
OG007
Phase 1: Isatuximab 20mg/kg QW
Participants with CD38+ HM, received Isatuximab 20 mg/kg, as IV infusion QW, i.e. on Day 1 and 8 of each 14-day treatment cycle until occurrence of DLT, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
Units
Counts
Participants
OG00016
OG0016
OG0023
OG00326
OG00418
OG0056
OG0067
OG0077
Title
Denominators
Categories
Title
Measurements
OG00016
OG0016
OG0023
OG00326
OG00418
OG0056
OG0067
OG0076
OG001
Phase 2 Stage 1a: Isatuximab 10 mg/kg
Participants with multiple Myeloma received Isatuximab 10 mg/kg, as IV infusion on Day 1 and Day 15 of each 28-day cycle until unacceptable AE, disease progression, poor compliance to the study protocol, study termination or lost to follow up (maximum exposure: 77 weeks).
OG002
Phase 2 Stage 1a: Isatuximab 10mg/kg Q2W and Then Q4W
Participants with multiple Myeloma received Isatuximab 10 mg/kg, as IV infusion Q2W, i.e. on Day 1 and Day 15 of Cycle 1 and 2 (each cycle 28 days), then Q4W, i.e. on Day 1 of each 28-days cycle until unacceptable AE, disease progression, poor compliance to the study protocol, study termination or lost to follow up (maximum exposure: 77 weeks).
OG003
Phase 2 Stage 1b: Isatuximab 20mg/kg QW and Then Q2W
Participants with multiple Myeloma received Isatuximab 20 mg/kg, as IV infusion QW, i.e. on Day 1, 8, 15 and 22 of Cycle 1 and 2 (each cycle 28 days), then Q2W, i.e. on Day 1 and Day 15 of each 28-days cycle until unacceptable AE, disease progression, poor compliance to the study protocol, study termination or lost to follow up (maximum exposure: 53 weeks).
Units
Counts
Participants
OG00023
OG00124
OG00225
OG00325
Title
Denominators
Categories
Title
Measurements
OG0004.3
OG00129.2
OG00220.0
OG00324.0
OG001
Phase 2 Stage 2: Isatuximab + Dexamethasone
Participants with relapsed or RRMM, received Isatuximab 20 mg/kg, as IV infusion on Day 1, 8, 15 and Day 22 of Cycle 1 (28 days) and then on Day 1 and 15 of each subsequent 28-day cycles along with dexamethasone: tablet or as IV infusion (40 mg/day for less than [<] 75 years of age; 20 mg/day for greater than or equal to [>=] 75 years of age) on Days 1, 8, 15 and 22 of each 28 days cycle until unacceptable AE, disease progression, poor compliance to the study protocol, study termination, lost to follow up or investigator's decision (maximum exposure: 97 weeks).
Units
Counts
Participants
OG000109
OG00155
Title
Denominators
Categories
Title
Measurements
OG00023.9
OG00143.6
Participants with CD38+ HM, received Isatuximab 1 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal by participant, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
OG002
Phase 1: Isatuximab 3mg/kg Q2W
Participants with CD38+ HM, received Isatuximab 3 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
OG003
Phase 1: Isatuximab 5mg/kg Q2W
Participants with CD38+ HM, received Isatuximab 5 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
OG004
Phase1:Isatuximab (CD38+HM and Standard Risk Multiple Myeloma)
Participants with CD38+ HM along with participants with standard risk multiple myeloma were included in this arm and, received Isatuximab 10 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
OG005
Phase 1: Isatuximab (CD38 + HM and High Risk Multiple Myeloma)
Participants with CD38+ HM along with participants with high risk multiple myeloma were included in this arm and, received Isatuximab 10 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
OG006
Phase 1: Isatuximab 20mg/kg Q2W
Participants with CD38+ HM, received Isatuximab 20 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
OG007
Phase 1: Isatuximab 10mg/kg QW
Participants with CD38+ HM, received Isatuximab 10 mg/kg, as IV infusion QW, i.e. on Day 1 and 8 of each 14-day treatment cycle until occurrence of unaccepted toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
OG008
Phase 1: Isatuximab 20mg/kg QW
Participants with CD38+ HM, received Isatuximab 20 mg/kg, as IV infusion QW, i.e. on Day 1 and 8 of each 14-day treatment cycle until occurrence of DLT, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
Units
Counts
Participants
OG0006
OG0013
OG0024
OG0032
OG00415
OG0055
OG0063
OG0074
OG0086
Title
Denominators
Categories
Cycle 1 Day 1
ParticipantsOG0006
ParticipantsOG0013
ParticipantsOG0024
ParticipantsOG0032
ParticipantsOG00415
ParticipantsOG0055
ParticipantsOG0063
ParticipantsOG0073
ParticipantsOG0086
Title
Measurements
OG0002.08667± 0.65567
OG00113.18333± 5.74464
OG00244.22500± 15.30651
OG003
Cycle 3 Day 1
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
OG002
Phase 1: Isatuximab 3mg/kg Q2W
Participants with CD38+ HM, received Isatuximab 3 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
OG003
Phase 1: Isatuximab 5mg/kg Q2W
Participants with CD38+ HM, received Isatuximab 5 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
OG004
Phase1:Isatuximab (CD38+HM and Standard Risk Multiple Myeloma)
Participants with CD38+ HM along with participants with standard risk multiple myeloma were included in this arm and, received Isatuximab 10 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
OG005
Phase 1: Isatuximab (CD38 + HM and High Risk Multiple Myeloma)
Participants with CD38+ HM along with participants with high risk multiple myeloma were included in this arm and, received Isatuximab 10 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
OG006
Phase 1: Isatuximab 20mg/kg Q2W
Participants with CD38+ HM, received Isatuximab 20 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
OG007
Phase 1: Isatuximab 10mg/kg QW
Participants with CD38+ HM, received Isatuximab 10 mg/kg, as IV infusion QW, i.e. on Day 1 and 8 of each 14-day treatment cycle until occurrence of unaccepted toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
OG008
Phase 1: Isatuximab 20mg/kg QW
Participants with CD38+ HM, received Isatuximab 20 mg/kg, as IV infusion QW, i.e. on Day 1 and 8 of each 14-day treatment cycle until occurrence of DLT, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
Units
Counts
Participants
OG0006
OG0013
OG0024
OG0032
OG00411
OG0055
OG0063
OG0074
OG0086
Title
Denominators
Categories
Cycle 1 Day 1
ParticipantsOG0006
ParticipantsOG0013
ParticipantsOG0024
ParticipantsOG0032
ParticipantsOG00411
ParticipantsOG0055
ParticipantsOG0063
ParticipantsOG0073
ParticipantsOG0086
Title
Measurements
OG0002.00± 31
OG00112.4± 45
OG00253.7± 28
OG003
Cycle 3 Day 1
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
OG002
Phase 1: Isatuximab 3mg/kg Q2W
Participants with CD38+ HM, received Isatuximab 3 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
OG003
Phase 1: Isatuximab 5mg/kg Q2W
Participants with CD38+ HM, received Isatuximab 5 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
OG004
Phase1:Isatuximab (CD38+HM and Standard Risk Multiple Myeloma)
Participants with CD38+ HM along with participants with standard risk multiple myeloma were included in this arm and, received Isatuximab 10 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
OG005
Phase 1: Isatuximab (CD38 + HM and High Risk Multiple Myeloma)
Participants with CD38+ HM along with participants with high risk multiple myeloma were included in this arm and, received Isatuximab 10 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
OG006
Phase 1: Isatuximab 20mg/kg Q2W
Participants with CD38+ HM, received Isatuximab 20 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks)
OG007
Phase 1: Isatuximab 10mg/kg QW
Participants with CD38+ HM, received Isatuximab 10 mg/kg, as IV infusion QW, i.e. on Day 1 and 8 of each 14-day treatment cycle until occurrence of unaccepted toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
OG008
Phase 1: Isatuximab 20mg/kg QW
Participants with CD38+ HM, received Isatuximab 20 mg/kg, as IV infusion QW, i.e. on Day 1 and 8 of each 14-day treatment cycle until occurrence of DLT, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
Units
Counts
Participants
OG0006
OG0013
OG0024
OG0032
OG00411
OG0055
OG0063
OG0074
OG0086
Title
Denominators
Categories
Cycle 1 Day 1
ParticipantsOG0006
ParticipantsOG0013
ParticipantsOG0024
ParticipantsOG0032
ParticipantsOG00411
ParticipantsOG0055
ParticipantsOG0063
ParticipantsOG0073
ParticipantsOG0086
Title
Measurements
OG0002.49(1.42 to 3.43)
OG0014.35(3.13 to 6.33)
OG0026.99(4.58 to 8.00)
OG003
Cycle 3 Day 1
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Participants with CD38+ HM, received Isatuximab 5 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
OG003
Phase1:Isatuximab (CD38+HM and Standard Risk Multiple Myeloma)
Participants with CD38+ HM along with participants with standard risk multiple myeloma were included in this arm and, received Isatuximab 10 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
OG004
Phase 1: Isatuximab (CD38 + HM and High Risk Multiple Myeloma)
Participants with CD38+ HM along with participants with high risk multiple myeloma were included in this arm and, received Isatuximab 10 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
OG005
Phase 1: Isatuximab 10 mg/kg QW
Participants with CD38+ HM, received Isatuximab 10 mg/kg, as IV infusion QW, i.e. on Day 1 and 8 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
OG006
Phase 1: Isatuximab 20mg/kg Q2W
Participants with CD38+ HM, received Isatuximab 20 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
OG007
Phase 1: Isatuximab 20mg/kg QW
Participants with CD38+ HM, received Isatuximab 20 mg/kg, as IV infusion QW, i.e. on Day 1 and 8 of each 14-day treatment cycle until occurrence of DLT, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
Units
Counts
Participants
OG0003
OG0016
OG0023
OG00318
OG00416
OG0056
OG0066
OG0077
Title
Denominators
Categories
Week 1
ParticipantsOG0003
ParticipantsOG0016
ParticipantsOG0023
ParticipantsOG00318
ParticipantsOG00416
ParticipantsOG0056
ParticipantsOG0066
ParticipantsOG0077
Title
Measurements
OG0000.00223± 86
OG0011.44± 85
OG00215.3± 90
OG003
Week 2
ParticipantsOG0003
ParticipantsOG0016
ParticipantsOG0023
ParticipantsOG00318
Week 3
ParticipantsOG0003
ParticipantsOG0016
ParticipantsOG0022
ParticipantsOG00317
OG002
Phase 1: Isatuximab 5mg/kg Q2W
Participants with CD38+ HM, received Isatuximab 5 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
OG003
Phase1:Isatuximab (CD38+HM and Standard Risk Multiple Myeloma)
Participants with CD38+ HM along with participants with standard risk multiple myeloma were included in this arm and, received Isatuximab 10 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
OG004
Phase 1: Isatuximab (CD38 + HM and High Risk Multiple Myeloma)
Participants with CD38+ HM along with participants with high risk multiple myeloma were included in this arm and, received Isatuximab 10 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
OG005
Phase 1: Isatuximab 10mg/kg QW
Participants with CD38+ HM, received Isatuximab 10 mg/kg, as IV infusion QW, i.e. on Day 1 and 8 of each 14-day treatment cycle until occurrence of unaccepted toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
OG006
Phase 1: Isatuximab 20mg/kg Q2W
Participants with CD38+ HM, received Isatuximab 20 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks)
OG007
Phase 1: Isatuximab 20mg/kg QW
Participants with CD38+ HM, received Isatuximab 20 mg/kg, as IV infusion QW, i.e. on Day 1 and 8 of each 14-day treatment cycle until occurrence of DLT, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
Units
Counts
Participants
OG0003
OG0016
OG0023
OG00318
OG00416
OG0056
OG0066
OG0077
Title
Denominators
Categories
Title
Measurements
OG000222± 80
OG0012624± 24
OG0027174± 54
OG00311566± 48
OG00413480± 38
OG00512680± 35
OG00632739± 28
OG00728405± 27
OG002
Phase 1: Isatuximab 5mg/kg Q2W
Participants with CD38+ HM, received Isatuximab 5 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
OG003
Phase1:Isatuximab (CD38+HM and Standard Risk Multiple Myeloma)
Participants with CD38+ HM along with participants with standard risk multiple myeloma were included in this arm and, received Isatuximab 10 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
OG004
Phase 1: Isatuximab (CD38 + HM and High Risk Multiple Myeloma)
Participants with CD38+ HM along with participants with high risk multiple myeloma were included in this arm and, received Isatuximab 10 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
OG005
Phase 1: Isatuximab 10mg/kg QW
Participants with CD38+ HM, received Isatuximab 10 mg/kg, as IV infusion QW, i.e. on Day 1 and 8 of each 14-day treatment cycle until occurrence of unaccepted toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
OG006
Phase 1: Isatuximab 20mg/kg Q2W
Participants with CD38+ HM, received Isatuximab 20 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
OG007
Phase 1: Isatuximab 20mg/kg QW
Participants with CD38+ HM, received Isatuximab 20 mg/kg, as IV infusion QW, i.e. on Day 1 and 8 of each 14-day treatment cycle until occurrence of DLT, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
Units
Counts
Participants
OG0003
OG0016
OG0023
OG00318
OG00416
OG0056
OG0066
OG0077
Title
Denominators
Categories
Title
Measurements
OG000222± 80
OG0013076± 35
OG0029546± 70
OG00314876± 64
OG00418967± 44
OG00530187± 40
OG00648003± 31
OG00771174± 29
OG002
Phase 1: Isatuximab 5mg/kg Q2W
Participants with CD38+ HM, received Isatuximab 5 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
OG003
Phase1:Isatuximab (CD38+HM and Standard Risk Multiple Myeloma)
Participants with CD38+ HM along with participants with standard risk multiple myeloma , received Isatuximab 10 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
OG004
Phase 1: Isatuximab (CD38 + HM and High Risk Multiple Myeloma)
Participants with CD38+ HM along with participants with high risk multiple myeloma, received Isatuximab 10 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
OG005
Phase 1: Isatuximab 10mg/kg QW
Participants with CD38+ HM, received Isatuximab 10 mg/kg, as IV infusion QW, i.e. on Day 1 and 8 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
OG006
Phase 1: Isatuximab 20mg/kg Q2W
Participants with CD38+ HM, received Isatuximab 20 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
OG007
Phase 1: Isatuximab 20mg/kg QW
Participants with CD38+ HM, received Isatuximab 20 mg/kg, as IV infusion QW, i.e. on Day 1 and 8 of each 14-day treatment cycle until occurrence of DLT, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
Units
Counts
Participants
OG00016
OG0016
OG0023
OG00326
OG00418
OG0056
OG0067
OG0077
Title
Denominators
Categories
TNF alpha
ParticipantsOG00016
ParticipantsOG0015
ParticipantsOG0023
ParticipantsOG00323
ParticipantsOG00416
ParticipantsOG0056
ParticipantsOG0066
ParticipantsOG0075
Title
Measurements
OG000163.181± 253.373
OG001179.783± 191.455
OG002352.974± 220.394
OG003
IL-1 Beta
ParticipantsOG00015
ParticipantsOG0014
ParticipantsOG0023
ParticipantsOG00321
IL-6
ParticipantsOG00016
ParticipantsOG0015
ParticipantsOG0023
ParticipantsOG00323
IFN Gamma
ParticipantsOG00015
ParticipantsOG0013
ParticipantsOG0023
ParticipantsOG00323
Participants with CD38+ HM, received Isatuximab 3 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
OG002
Phase 1: Isatuximab 5mg/kg Q2W
Participants with CD38+ HM, received Isatuximab 5 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
OG003
Phase1:Isatuximab (CD38+HM and Standard Risk Multiple Myeloma)
Participants with CD38+ HM along with participants with standard risk multiple myeloma were included in this arm and, received Isatuximab 10 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
OG004
Phase 1: Isatuximab (CD38 + HM and High Risk Multiple Myeloma)
Participants with CD38+ HM along with participants with high risk multiple myeloma, received Isatuximab 10 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
OG005
Phase 1: Isatuximab 10mg/kg QW
Participants with CD38+ HM, received Isatuximab 10 mg/kg, as IV infusion QW, i.e. on Day 1 and 8 of each 14-day treatment cycle until occurrence of unaccepted toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
OG006
Phase 1: Isatuximab 20mg/kg Q2W
Participants with CD38+ HM, received Isatuximab 20 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
OG007
Phase 1: Isatuximab 20mg/kg QW
Participants with CD38+ HM, received Isatuximab 20 mg/kg, as IV infusion QW, i.e. on Day 1 and 8 of each 14-day treatment cycle until occurrence of DLT, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
Units
Counts
Participants
OG00016
OG0016
OG0023
OG00326
OG00418
OG0056
OG0066
OG0077
Title
Denominators
Categories
Treatment-induced ADA
Title
Measurements
OG0002
OG0010
OG0020
OG0031
OG0041
OG0051
OG0061
OG0071
Treatment boosted ADA
Title
Measurements
OG0000
OG0010
OG0020
OG003
OG001
Phase 1: Isatuximab 3mg/kg Q2W
Participants with CD38+ HM, received Isatuximab 3 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
OG002
Phase 1: Isatuximab 5mg/kg Q2W
Participants with CD38+ HM, received Isatuximab 5 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
OG003
Phase1:Isatuximab (CD38+HM and Standard Risk Multiple Myeloma)
Participants with CD38+ HM along with participants with standard risk multiple myeloma were included in this arm and, received Isatuximab 10 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
OG004
Phase 1: Isatuximab (CD38 + HM and High Risk Multiple Myeloma)
Participants with CD38+ HM along with participants with high risk multiple myeloma were included in this arm and, received Isatuximab 10 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
OG005
Phase 1: Isatuximab 10mg/kg QW
Participants with CD38+ HM, received Isatuximab 10 mg/kg, as IV infusion QW, i.e. on Day 1 and 8 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
OG006
Phase 1: Isatuximab 20mg/kg Q2W
Participants with CD38+ HM, received Isatuximab 20 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
OG007
Phase 1: Isatuximab 20mg/kg QW
Participants with CD38+ HM, received Isatuximab 20 mg/kg, as IV infusion QW, i.e. on Day 1 and 8 of each 14-day treatment cycle until occurrence of DLT, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
Units
Counts
Participants
OG0003
OG0015
OG0023
OG00325
OG00418
OG0056
OG0067
OG0077
Title
Denominators
Categories
OR
Title
Measurements
OG00033.3
OG0010
OG00233.3
OG00328.0
OG00416.7
OG00533.3
OG00614.3
OG00728.6
Clinical benefit
Title
Measurements
OG00033.3
OG00120.0
OG00233.3
OG003
OG001
Phase 1: Isatuximab 5mg/kg Q2W
Participants with CD38+ HM, received Isatuximab 5 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
OG002
Phase1:Isatuximab (CD38+HM and Standard Risk Multiple Myeloma)
Participants with CD38+ HM along with participants with standard risk multiple myeloma were included in this arm and, received Isatuximab 10 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
OG003
Phase 1: Isatuximab (CD38 + HM and High Risk Multiple Myeloma)
Participants with CD38+ HM along with participants with high risk multiple myeloma were included in this arm and, received Isatuximab 10 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
OG004
Phase 1: Isatuximab 10mg/kg QW
Participants with CD38+ HM, received Isatuximab 10 mg/kg, as IV infusion QW, i.e. on Day 1 and 8 of each 14-day treatment cycle until occurrence of unaccepted toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
OG005
Phase 1: Isatuximab 20mg/kg Q2W
Participants with CD38+ HM, received Isatuximab 20 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks)
OG006
Phase 1: Isatuximab 20mg/kg QW
Participants with CD38+ HM, received Isatuximab 20 mg/kg, as IV infusion QW, i.e. on Day 1 and 8 of each 14-day treatment cycle until occurrence of DLT, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
Units
Counts
Participants
OG0001
OG0011
OG0027
OG0033
OG0042
OG0051
OG0062
Title
Denominators
Categories
Title
Measurements
OG00020.21
OG0017.16
OG0025.76± 4.62
OG00310.70± 11.25
OG00414.31± 7.50
OG0053.94
OG0068.82± 7.83
OG002
Phase1:Isatuximab (CD38+HM and Standard Risk Multiple Myeloma)
Participants with CD38+ HM along with participants with standard risk multiple myeloma were included in this arm and, received Isatuximab 10 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
OG003
Phase 1: Isatuximab (CD38 + HM and High Risk Multiple Myeloma)
Participants with CD38+ HM along with participants with high risk multiple myeloma were included in this arm and, received Isatuximab 10 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
OG004
Phase 1: Isatuximab 10mg/kg QW
Participants with CD38+ HM, received Isatuximab 10 mg/kg, as IV infusion QW, i.e. on Day 1 and 8 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
OG005
Phase 1: Isatuximab 20mg/kg Q2W
Participants with CD38+ HM, received Isatuximab 20 mg/kg, as IV infusion on Day 1 of each 14-day treatment cycle until occurrence of unacceptable toxicity, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
OG006
Phase 1: Isatuximab 20mg/kg QW
Participants with CD38+ HM, received Isatuximab 20 mg/kg, as IV infusion QW, i.e. on Day 1 and 8 of each 14-day treatment cycle until occurrence of DLT, disease progression, death, consent withdrawal, investigator's decision, and/or availability of study drug (maximum exposure: 120 weeks).
Units
Counts
Participants
OG0001
OG0011
OG0027
OG0033
OG0042
OG0051
OG0062
Title
Denominators
Categories
Title
Measurements
OG0000.95
OG0016.41
OG0022.52± 3.77
OG0031.96± 1.72
OG0041.38± 0.65
OG0051.18
OG0061.46± 0.77
OG00089
Title
Denominators
Categories
Baseline ECOG 1, During Treatment ECOG 0
Title
Measurements
OG00011
Baseline ECOG 2, During Treatment ECOG 0
Title
Measurements
OG0002
Baseline ECOG 2, During Treatment ECOG 1
Title
Measurements
OG00011
Participants
OG00089
Title
Denominators
Categories
Baseline ECOG 0, During Treatment ECOG 1
Title
Measurements
OG0008
Baseline ECOG 2, During Treatment ECOG 1
Title
Measurements
OG0001
Baseline ECOG 0, During Treatment ECOG 2
Title
Measurements
OG0003
Baseline ECOG 1, During Treatment ECOG 2
Title
Measurements
OG00020
Baseline ECOG 0, During Treatment ECOG 3
Title
Measurements
OG0001
Baseline ECOG 1, During Treatment ECOG 3
Title
Measurements
OG0002
Baseline ECOG 2, During Treatment ECOG 3
Title
Measurements
OG0001
OG002
Phase 2 Stage 1a: Isatuximab 10mg/kg Q2W; Then Q4W
Participants with multiple Myeloma received Isatuximab 10 mg/kg, as IV infusion Q2W, i.e. on Day 1 and Day 15 of Cycle 1 and 2 (each cycle 28 days), then every 4 weeks (Q4W), i.e. on Day 1 of each 28-days cycle until unacceptable AE, disease progression, poor compliance to the study protocol, study termination or lost to follow up (maximum exposure: 414 weeks).
OG003
Phase 2 Stage 1b: Isatuximab 20mg/kg QW and Then Q2W
Participants with multiple Myeloma received Isatuximab 20 mg/kg, as IV infusion QW, i.e. on Day 1, 8, 15 and 22 of Cycle 1 and 2 (each cycle 28 days), then Q2W, i.e. on Day 1 and Day 15 of each 28-days cycle until unacceptable AE, disease progression, poor compliance to the study protocol, study termination or lost to follow up (maximum exposure: 92 weeks).
Units
Counts
Participants
OG00023
OG00124
OG00225
OG00325
Title
Denominators
Categories
Title
Measurements
OG00022
OG00124
OG00225
OG00325
Units
Counts
Participants
OG000109
OG00155
Title
Denominators
Categories
Title
Measurements
OG000101
OG00151
OG001
Phase 2 Stage 1a: Isatuximab 10mg/kg Q2W
Participants with multiple Myeloma received Isatuximab 10 mg/kg, as IV infusion on Day 1 and Day 15 of each 28-day cycle until unacceptable AE, disease progression, poor compliance to the study protocol, study termination or lost to follow up (maximum exposure: 77 weeks).
OG002
Phase 2 Stage 1a: Isatuximab 10mg/kg Q2W; Then Q4W
Participants with multiple Myeloma received Isatuximab 10 mg/kg, as IV infusion Q2W, i.e. on Day 1 and Day 15 of Cycle 1 and 2 (each cycle 28 days), then every 4 weeks (Q4W), i.e. on Day 1 of each 28-days cycle until unacceptable AE, disease progression, poor compliance to the study protocol, study termination or lost to follow up (maximum exposure: 77 weeks).
OG003
Phase 2 Stage 1b: Isatuximab 20mg/kg QW and Then Q2W
Participants with multiple Myeloma received Isatuximab 20 mg/kg, as IV infusion QW, i.e. on Day 1, 8, 15 and 22 of Cycle 1 and 2 (each cycle 28 days), then Q2W, i.e. on Day 1 and Day 15 of each 28-days cycle until unacceptable AE, disease progression, poor compliance to the study protocol, study termination or lost to follow up (maximum exposure: 53 weeks).
Units
Counts
Participants
OG0001
OG0017
OG0025
OG0036
Title
Denominators
Categories
Title
Measurements
OG0001.91
OG00111.17± 5.77
OG0027.31± 3.65
OG0038.11± 2.33
OG001
Phase 2 Stage 2: Isatuximab + Dexamethasone
Participants with relapsed or RRMM, received Isatuximab 20 mg/kg, as IV infusion on Day 1, 8, 15 and Day 22 of Cycle 1 (28 days) and then on Day 1 and 15 of each subsequent 28-day cycles along with dexamethasone: tablet or as IV infusion (40 mg/day for less than [<] 75 years of age; 20 mg/day for greater than or equal to [>=] 75 years of age) on Days 1, 8, 15 and 22 of each 28 days cycle until unacceptable AE, disease progression, poor compliance to the study protocol, study termination, lost to follow up or investigator's decision (maximum exposure: 97 weeks).
Units
Counts
Participants
OG00026
OG00124
Title
Denominators
Categories
Title
Measurements
OG0008.6± 5.2
OG00110.9± 4.6
OG001
Phase 2 Stage 1a: Isatuximab 10mg/kg Q2W
Participants with multiple Myeloma received Isatuximab 10 mg/kg, as IV infusion on Day 1 and Day 15 of each 28-day cycle until unacceptable AE, disease progression, poor compliance to the study protocol, study termination or lost to follow up (maximum exposure: 77 weeks).
OG002
Phase 2 Stage 1a: Isatuximab 10mg/kg Q2W; Then Q4W
Participants with multiple Myeloma received Isatuximab 10 mg/kg, as IV infusion Q2W, i.e. on Day 1 and Day 15 of Cycle 1 and 2 (each cycle 28 days), then every 4 weeks (Q4W), i.e. on Day 1 of each 28-days cycle until unacceptable AE, disease progression, poor compliance to the study protocol, study termination or lost to follow up (maximum exposure: 77 weeks).
OG003
Phase 2 Stage 1b: Isatuximab 20mg/kg QW and Then Q2W
Participants with multiple Myeloma received Isatuximab 20 mg/kg, as IV infusion QW, i.e. on Day 1, 8, 15 and 22 of Cycle 1 and 2 (each cycle 28 days), then Q2W, i.e. on Day 1 and Day 15 of each 28-days cycle until unacceptable AE, disease progression, poor compliance to the study protocol, study termination or lost to follow up (maximum exposure: 53 weeks).
Units
Counts
Participants
OG00023
OG00124
OG00225
OG00325
Title
Denominators
Categories
Title
Measurements
OG0004.3
OG00141.7
OG00232.0
OG00336.0
OG001
Phase 2 Stage 2: Isatuximab + Dexamethasone
Participants with relapsed or RRMM, received Isatuximab 20 mg/kg, as IV infusion on Day 1, 8, 15 and Day 22 of Cycle 1 (28 days) and then on Day 1 and 15 of each subsequent 28-day cycles along with dexamethasone: tablet or as IV infusion (40 mg/day for less than [<] 75 years of age; 20 mg/day for greater than or equal to [>=] 75 years of age) on Days 1, 8, 15 and 22 of each 28 days cycle until unacceptable AE, disease progression, poor compliance to the study protocol, study termination, lost to follow up or investigator's decision (maximum exposure: 97 weeks).
Units
Counts
Participants
OG000109
OG00155
Title
Denominators
Categories
Title
Measurements
OG00043.1
OG00154.5
OG001
Phase 2 Stage 1a: Isatuximab 10mg/kg Q2W
Participants with multiple Myeloma received Isatuximab 10 mg/kg, as IV infusion on Day 1 and Day 15 of each 28-day cycle until unacceptable AE, disease progression, poor compliance to the study protocol, study termination or lost to follow up (maximum exposure: 77 weeks).
OG002
Phase 2 Stage 1a: Isatuximab 10mg/kg Q2W; Then Q4W
Participants with multiple Myeloma received Isatuximab 10 mg/kg, as IV infusion Q2W, i.e. on Day 1 and Day 15 of Cycle 1 and 2 (each cycle 28 days), then every 4 weeks (Q4W), i.e. on Day 1 of each 28-days cycle until unacceptable AE, disease progression, poor compliance to the study protocol, study termination or lost to follow up (maximum exposure: 77 weeks).
OG003
Phase 2 Stage 1b: Isatuximab 20mg/kg QW and Then Q2W
Participants with multiple Myeloma received Isatuximab 20 mg/kg, as IV infusion QW, i.e. on Day 1, 8, 15 and 22 of Cycle 1 and 2 (each cycle 28 days), then Q2W, i.e. on Day 1 and Day 15 of each 28-days cycle until unacceptable AE, disease progression, poor compliance to the study protocol, study termination or lost to follow up (maximum exposure: 53 weeks).
Units
Counts
Participants
OG00023
OG00124
OG00225
OG00325
Title
Denominators
Categories
Title
Measurements
OG0002.1(1.02 to 5.49)
OG0019.6(2.23 to NA)Upper limit of confidence interval was not estimable due to less number of participants with event.
OG0024.4(1.84 to 5.82)
OG0033.6(1.91 to 9.20)
Participants with relapsed or RRMM, received Isatuximab 20 mg/kg, as IV infusion on Day 1, 8, 15 and Day 22 of Cycle 1 (28 days) and then on Day 1 and 15 of each subsequent 28-day cycles along with dexamethasone: tablet or as IV infusion (40 mg/day for less than [<] 75 years of age; 20 mg/day for greater than or equal to [>=] 75 years of age) on Days 1, 8, 15 and 22 of each 28 days cycle until unacceptable AE, disease progression, poor compliance to the study protocol, study termination, lost to follow up or investigator's decision (maximum exposure: 97 weeks).
Units
Counts
Participants
OG000109
OG00155
Title
Denominators
Categories
Title
Measurements
OG0004.86(3.877 to 7.688)
OG00110.15(4.862 to 17.347)
OG003
Phase 2 Stage 1b: Isatuximab 20mg/kg QW and Then Q2W
Participants with multiple Myeloma received Isatuximab 20 mg/kg, as IV infusion QW, i.e. on Day 1, 8, 15 and 22 of Cycle 1 and 2 (each cycle 28 days), then Q2W, i.e. on Day 1 and Day 15 of each 28-days cycle until unacceptable AE, disease progression, poor compliance to the study protocol, study termination or lost to follow up (maximum exposure: 53 weeks).
Units
Counts
Participants
OG00023
OG00124
OG00225
OG00325
Title
Denominators
Categories
Title
Measurements
OG00015.277(4.7310 to NA)Upper limit of Confidence Interval (CI) was not estimable, due to less number of participants with event.
OG00118.628(7.7536 to 20.1068)
OG002NA(8.4435 to NA)Median and upper limit of CI was not estimable, due to less number of participants with event.
OG003NA(8.3450 to NA)Median and upper limit of CI was not estimable, due to less number of participants with event.
Units
Counts
Participants
OG000109
OG00155
Title
Denominators
Categories
Title
Measurements
OG00018.92(13.602 to 23.064)
OG00117.25(15.409 to NA)Upper limit of CI was not estimable, due to less number of participants with event.
OG001
Phase 2 Stage 1a: Isatuximab 10mg/kg Q2W
Participants with multiple Myeloma received Isatuximab 10 mg/kg, as IV infusion on Day 1 and Day 15 of each 28-day cycle until unacceptable AE, disease progression, poor compliance to the study protocol, study termination or lost to follow up (maximum exposure: 77 weeks).
OG002
Phase 2 Stage 1a: Isatuximab 10mg/kg Q2W; Then Q4W
Participants with multiple Myeloma received Isatuximab 10 mg/kg, as IV infusion Q2W, i.e. on Day 1 and Day 15 of Cycle 1 and 2 (each cycle 28 days), then every 4 weeks (Q4W), i.e. on Day 1 of each 28-days cycle until unacceptable AE, disease progression, poor compliance to the study protocol, study termination or lost to follow up (maximum exposure: 77 weeks).
OG003
Phase 2 Stage 1b: Isatuximab 20mg/kg QW and Then Q2W
Participants with multiple Myeloma received Isatuximab 20 mg/kg, as IV infusion QW, i.e. on Day 1, 8, 15 and 22 of Cycle 1 and 2 (each cycle 28 days), then Q2W, i.e. on Day 1 and Day 15 of each 28-days cycle until unacceptable AE, disease progression, poor compliance to the study protocol, study termination or lost to follow up (maximum exposure: 53 weeks).
Units
Counts
Participants
OG00022
OG00121
OG00224
OG00322
Title
Denominators
Categories
Cycle 2 day 1
ParticipantsOG00014
ParticipantsOG00115
ParticipantsOG00219
ParticipantsOG00318
Title
Measurements
OG000-8.33± 20.15
OG0012.22± 16.51
OG002-3.95± 20.67
OG003
Cycle 3 day 1
ParticipantsOG0007
ParticipantsOG00111
ParticipantsOG00214
ParticipantsOG00312
Cycle 4 day 1
ParticipantsOG0004
ParticipantsOG00111
ParticipantsOG00211
ParticipantsOG0039
Cycle 5 day 1
ParticipantsOG0004
ParticipantsOG00112
ParticipantsOG0029
ParticipantsOG0035
Cycle 6 day 1
ParticipantsOG0004
ParticipantsOG0019
ParticipantsOG0027
ParticipantsOG0034
Cycle 7 day 1
ParticipantsOG0002
ParticipantsOG0017
ParticipantsOG0024
ParticipantsOG0035
Cycle 8 day 1
ParticipantsOG0002
ParticipantsOG0016
ParticipantsOG0024
ParticipantsOG0034
Cycle 9 day 1
ParticipantsOG0002
ParticipantsOG0015
ParticipantsOG0024
ParticipantsOG0034
Cycle 10 day 1
ParticipantsOG0002
ParticipantsOG0013
ParticipantsOG0024
ParticipantsOG0035
End of treatment
ParticipantsOG0005
ParticipantsOG0015
ParticipantsOG0023
ParticipantsOG0032
Participants with multiple Myeloma received Isatuximab 10 mg/kg, as IV infusion on Day 1 and Day 15 of each 28-day cycle until unacceptable AE, disease progression, poor compliance to the study protocol, study termination or lost to follow up (maximum exposure: 77 weeks).
OG002
Phase 2 Stage 1a: Isatuximab 10mg/kg Q2W; Then Q4W
Participants with multiple Myeloma received Isatuximab 10 mg/kg, as IV infusion Q2W, i.e. on Day 1 and Day 15 of Cycle 1 and 2 (each cycle 28 days), then every 4 weeks (Q4W), i.e. on Day 1 of each 28-days cycle until unacceptable AE, disease progression, poor compliance to the study protocol, study termination or lost to follow up (maximum exposure: 77 weeks).
OG003
Phase 2 Stage 1b: Isatuximab 20mg/kg QW and Then Q2W
Participants with multiple Myeloma received Isatuximab 20 mg/kg, as IV infusion QW, i.e. on Day 1, 8, 15 and 22 of Cycle 1 and 2 (each cycle 28 days), then Q2W, i.e. on Day 1 and Day 15 of each 28-days cycle until unacceptable AE, disease progression, poor compliance to the study protocol, study termination or lost to follow up (maximum exposure: 53 weeks).
Units
Counts
Participants
OG00022
OG00121
OG00223
OG00322
Title
Denominators
Categories
Cycle 2 day 1
ParticipantsOG00014
ParticipantsOG00113
ParticipantsOG00218
ParticipantsOG00317
Title
Measurements
OG0005.56± 18.36
OG001-3.42± 11.24
OG0020.93± 13.91
OG003
Cycle 3 day 1
ParticipantsOG0007
ParticipantsOG00111
ParticipantsOG00213
ParticipantsOG00311
Cycle 4 day 1
ParticipantsOG0004
ParticipantsOG00110
ParticipantsOG00210
ParticipantsOG0039
Cycle 5 day 1
ParticipantsOG0004
ParticipantsOG00111
ParticipantsOG0028
ParticipantsOG0035
Cycle 6 day 1
ParticipantsOG0004
ParticipantsOG0019
ParticipantsOG0027
ParticipantsOG0034
Cycle 7 day 1
ParticipantsOG0002
ParticipantsOG0016
ParticipantsOG0024
ParticipantsOG0035
Cycle 8 day 1
ParticipantsOG0002
ParticipantsOG0016
ParticipantsOG0024
ParticipantsOG0034
Cycle 9 day 1
ParticipantsOG0002
ParticipantsOG0015
ParticipantsOG0024
ParticipantsOG0034
Cycle 10 day 1
ParticipantsOG0002
ParticipantsOG0013
ParticipantsOG0024
ParticipantsOG0035
End of treatment
ParticipantsOG0004
ParticipantsOG0015
ParticipantsOG0023
ParticipantsOG0032
OG002
Phase 2 Stage 1a: Isatuximab 10mg/kg Q2W; Then Q4W
Participants with multiple Myeloma received Isatuximab 10 mg/kg, as IV infusion Q2W, i.e. on Day 1 and Day 15 of Cycle 1 and 2 (each cycle 28 days), then every 4 weeks (Q4W), i.e. on Day 1 of each 28-days cycle until unacceptable AE, disease progression, poor compliance to the study protocol, study termination or lost to follow up (maximum exposure: 77 weeks).
OG003
Phase 2 Stage 1b: Isatuximab 20mg/kg QW and Then Q2W
Participants with multiple Myeloma received Isatuximab 20 mg/kg, as IV infusion QW, i.e. on Day 1, 8, 15 and 22 of Cycle 1 and 2 (each cycle 28 days), then Q2W, i.e. on Day 1 and Day 15 of each 28-days cycle until unacceptable AE, disease progression, poor compliance to the study protocol, study termination or lost to follow up (maximum exposure: 53 weeks).
Units
Counts
Participants
OG00022
OG00121
OG00222
OG00322
Title
Denominators
Categories
Cycle 4 day 1
ParticipantsOG0004
ParticipantsOG0019
ParticipantsOG0029
ParticipantsOG0039
Title
Measurements
OG000-5.75± 18.55
OG0012.00± 16.88
OG002-4.78± 15.71
OG003
Cycle 7 day 1
ParticipantsOG0002
ParticipantsOG0016
ParticipantsOG0023
ParticipantsOG0035
Cycle 10 day 1
ParticipantsOG0002
ParticipantsOG0013
ParticipantsOG0023
ParticipantsOG0035
Cycle 13 day 1
ParticipantsOG0002
ParticipantsOG0013
ParticipantsOG0021
ParticipantsOG0031
Cycle 16 day 1
ParticipantsOG0002
ParticipantsOG0013
ParticipantsOG0020
ParticipantsOG0030
Cycle 19 day 1
ParticipantsOG0000
ParticipantsOG0012
ParticipantsOG0020
ParticipantsOG0030
End of treatment
ParticipantsOG0004
ParticipantsOG0015
ParticipantsOG0023
ParticipantsOG0032
Units
Counts
Participants
OG000102
OG00152
Title
Denominators
Categories
Title
Measurements
OG00037096± 80
OG00135423± 88
Units
Counts
Participants
OG000102
OG00152
Title
Denominators
Categories
Title
Measurements
OG00091271± 78
OG00186761± 77
Units
Counts
Participants
OG000102
OG00152
Title
Denominators
Categories
Title
Measurements
OG000236360± 72
OG001226372± 66
Units
Counts
Participants
OG000102
OG00152
Title
Denominators
Categories
Day 7
Title
Measurements
OG000137± 75
OG001128± 54
Day 14
Title
Measurements
OG000230± 70
OG001214± 57
Day 28
Title
Measurements
OG000360± 63
OG001305± 66
Units
Counts
Participants
OG00095
OG00148
Title
Denominators
Categories
Cycle 2 Day 1/Cycle 1 Day 8
Title
Measurements
OG000521.38338± 4891.63390
OG0013.24370± 1.73860
Cycle 4 Day 1/Cycle 1 Day 8
Title
Measurements
OG0003.58378± 2.77398
OG0013.95950± 3.19310
Participants with relapsed or RRMM, received Isatuximab 20 mg/kg, as IV infusion on Day 1, 8, 15 and Day 22 of Cycle 1 (28 days) and then on Day 1 and 15 of each subsequent 28-day cycles along with dexamethasone: tablet or as IV infusion (40 mg/day for less than [<] 75 years of age; 20 mg/day for greater than or equal to [>=] 75 years of age) on Days 1, 8, 15 and 22 of each 28 days cycle until unacceptable AE, disease progression, poor compliance to the study protocol, study termination, lost to follow up or investigator's decision (maximum exposure: 97 weeks).
Units
Counts
Participants
OG000107
OG00153
Title
Denominators
Categories
Treatment induced ADA
Title
Measurements
OG0001
OG0010
Treatment boosted ADA
Title
Measurements
OG0000
OG0010
0 events
0 affected
26 at risk
EG0042 events1 affected18 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected7 at risk
EG0081 events1 affected23 at risk
EG0090 events0 affected24 at risk
EG0100 events0 affected25 at risk
EG0110 events0 affected25 at risk
EG0120 events0 affected109 at risk
EG0131 events1 affected55 at risk
0 events
0 affected
26 at risk
EG0040 events0 affected18 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected7 at risk
EG0081 events1 affected23 at risk
EG0090 events0 affected24 at risk
EG0101 events1 affected25 at risk
EG0110 events0 affected25 at risk
EG0120 events0 affected109 at risk
EG0130 events0 affected55 at risk
0 events
0 affected
26 at risk
EG0040 events0 affected18 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected7 at risk
EG0081 events1 affected23 at risk
EG0090 events0 affected24 at risk
EG0100 events0 affected25 at risk
EG0110 events0 affected25 at risk
EG0121 events1 affected109 at risk
EG0131 events1 affected55 at risk
1 events
1 affected
26 at risk
EG0040 events0 affected18 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected7 at risk
EG0080 events0 affected23 at risk
EG0090 events0 affected24 at risk
EG0100 events0 affected25 at risk
EG0110 events0 affected25 at risk
EG0120 events0 affected109 at risk
EG0130 events0 affected55 at risk
0 events
0 affected
26 at risk
EG0040 events0 affected18 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected7 at risk
EG0080 events0 affected23 at risk
EG0090 events0 affected24 at risk
EG0100 events0 affected25 at risk
EG0110 events0 affected25 at risk
EG0121 events1 affected109 at risk
EG0130 events0 affected55 at risk
0 events
0 affected
26 at risk
EG0040 events0 affected18 at risk
EG0052 events1 affected6 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected7 at risk
EG0080 events0 affected23 at risk
EG0090 events0 affected24 at risk
EG0100 events0 affected25 at risk
EG0112 events1 affected25 at risk
EG0121 events1 affected109 at risk
EG0130 events0 affected55 at risk
0 events
0 affected
26 at risk
EG0040 events0 affected18 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected7 at risk
EG0080 events0 affected23 at risk
EG0090 events0 affected24 at risk
EG0100 events0 affected25 at risk
EG0110 events0 affected25 at risk
EG0121 events1 affected109 at risk
EG0130 events0 affected55 at risk
0 events
0 affected
26 at risk
EG0040 events0 affected18 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected7 at risk
EG0071 events1 affected7 at risk
EG0080 events0 affected23 at risk
EG0090 events0 affected24 at risk
EG0100 events0 affected25 at risk
EG0110 events0 affected25 at risk
EG0120 events0 affected109 at risk
EG0130 events0 affected55 at risk
0 events
0 affected
26 at risk
EG0040 events0 affected18 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected7 at risk
EG0080 events0 affected23 at risk
EG0090 events0 affected24 at risk
EG0100 events0 affected25 at risk
EG0110 events0 affected25 at risk
EG0121 events1 affected109 at risk
EG0130 events0 affected55 at risk
0 events
0 affected
26 at risk
EG0040 events0 affected18 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected7 at risk
EG0080 events0 affected23 at risk
EG0090 events0 affected24 at risk
EG0100 events0 affected25 at risk
EG0110 events0 affected25 at risk
EG0121 events1 affected109 at risk
EG0130 events0 affected55 at risk
0 events
0 affected
26 at risk
EG0040 events0 affected18 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected7 at risk
EG0080 events0 affected23 at risk
EG0090 events0 affected24 at risk
EG0100 events0 affected25 at risk
EG0110 events0 affected25 at risk
EG0120 events0 affected109 at risk
EG0131 events1 affected55 at risk
0 events
0 affected
26 at risk
EG0040 events0 affected18 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected7 at risk
EG0080 events0 affected23 at risk
EG0090 events0 affected24 at risk
EG0101 events1 affected25 at risk
EG0110 events0 affected25 at risk
EG0120 events0 affected109 at risk
EG0130 events0 affected55 at risk
0 events
0 affected
26 at risk
EG0040 events0 affected18 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected7 at risk
EG0080 events0 affected23 at risk
EG0090 events0 affected24 at risk
EG0101 events1 affected25 at risk
EG0110 events0 affected25 at risk
EG0120 events0 affected109 at risk
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0 affected
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1 events
1 affected
26 at risk
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1 events
1 affected
26 at risk
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1 events
1 affected
26 at risk
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4 events
4 affected
26 at risk
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0 affected
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0 affected
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2 events
2 affected
26 at risk
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9 events
6 affected
26 at risk
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1 events
1 affected
26 at risk
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1 events
1 affected
26 at risk
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1 affected
26 at risk
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13 events
10 affected
26 at risk
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1 affected
26 at risk
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7 events
6 affected
26 at risk
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4 events
4 affected
26 at risk
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1 affected
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26 at risk
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26 at risk
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1 affected
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26 at risk
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7 affected
26 at risk
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EG0090 events0 affected24 at risk
EG0100 events0 affected25 at risk
EG0113 events3 affected25 at risk
EG0122 events2 affected109 at risk
EG0130 events0 affected55 at risk
1 events
1 affected
26 at risk
EG0040 events0 affected18 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected7 at risk
EG0080 events0 affected23 at risk
EG0091 events1 affected24 at risk
EG0100 events0 affected25 at risk
EG0110 events0 affected25 at risk
EG0123 events3 affected109 at risk
EG0131 events1 affected55 at risk
3 events
3 affected
26 at risk
EG0040 events0 affected18 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected7 at risk
EG0071 events1 affected7 at risk
EG0081 events1 affected23 at risk
EG0097 events6 affected24 at risk
EG0102 events2 affected25 at risk
EG0113 events3 affected25 at risk
EG0124 events2 affected109 at risk
EG01319 events14 affected55 at risk
0 events
0 affected
26 at risk
EG0040 events0 affected18 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected7 at risk
EG0080 events0 affected23 at risk
EG0090 events0 affected24 at risk
EG0100 events0 affected25 at risk
EG0110 events0 affected25 at risk
EG0121 events1 affected109 at risk
EG0131 events1 affected55 at risk
0 events
0 affected
26 at risk
EG0040 events0 affected18 at risk
EG0050 events0 affected6 at risk
EG0061 events1 affected7 at risk
EG0070 events0 affected7 at risk
EG0080 events0 affected23 at risk
EG0090 events0 affected24 at risk
EG0100 events0 affected25 at risk
EG0110 events0 affected25 at risk
EG0120 events0 affected109 at risk
EG0130 events0 affected55 at risk
1 events
1 affected
26 at risk
EG0040 events0 affected18 at risk
EG0053 events1 affected6 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected7 at risk
EG0080 events0 affected23 at risk
EG0090 events0 affected24 at risk
EG0100 events0 affected25 at risk
EG0110 events0 affected25 at risk
EG0120 events0 affected109 at risk
EG0131 events1 affected55 at risk
0 events
0 affected
26 at risk
EG0040 events0 affected18 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected7 at risk
EG0082 events1 affected23 at risk
EG0091 events1 affected24 at risk
EG0100 events0 affected25 at risk
EG0112 events2 affected25 at risk
EG0120 events0 affected109 at risk
EG0130 events0 affected55 at risk
0 events
0 affected
26 at risk
EG0040 events0 affected18 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected7 at risk
EG0080 events0 affected23 at risk
EG0090 events0 affected24 at risk
EG0102 events2 affected25 at risk
EG0110 events0 affected25 at risk
EG0120 events0 affected109 at risk
EG0130 events0 affected55 at risk
0 events
0 affected
26 at risk
EG0040 events0 affected18 at risk
EG0051 events1 affected6 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected7 at risk
EG0080 events0 affected23 at risk
EG0090 events0 affected24 at risk
EG0101 events1 affected25 at risk
EG0112 events1 affected25 at risk
EG0120 events0 affected109 at risk
EG0130 events0 affected55 at risk
0 events
0 affected
26 at risk
EG0040 events0 affected18 at risk
EG0050 events0 affected6 at risk
EG0061 events1 affected7 at risk
EG0070 events0 affected7 at risk
EG0080 events0 affected23 at risk
EG0090 events0 affected24 at risk
EG0100 events0 affected25 at risk
EG0110 events0 affected25 at risk
EG0120 events0 affected109 at risk
EG0130 events0 affected55 at risk
0 events
0 affected
26 at risk
EG0040 events0 affected18 at risk
EG0050 events0 affected6 at risk
EG0061 events1 affected7 at risk
EG0070 events0 affected7 at risk
EG0080 events0 affected23 at risk
EG0090 events0 affected24 at risk
EG0100 events0 affected25 at risk
EG0110 events0 affected25 at risk
EG0120 events0 affected109 at risk
EG0130 events0 affected55 at risk
2 events
2 affected
26 at risk
EG0041 events1 affected18 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected7 at risk
EG0080 events0 affected23 at risk
EG0090 events0 affected24 at risk
EG0100 events0 affected25 at risk
EG0111 events1 affected25 at risk
EG0125 events5 affected109 at risk
EG0131 events1 affected55 at risk
6 events
6 affected
26 at risk
EG0043 events2 affected18 at risk
EG0054 events3 affected6 at risk
EG0061 events1 affected7 at risk
EG0072 events2 affected7 at risk
EG0083 events2 affected23 at risk
EG00914 events10 affected24 at risk
EG01010 events7 affected25 at risk
EG01111 events8 affected25 at risk
EG01222 events19 affected109 at risk
EG01316 events12 affected55 at risk
5 events
4 affected
26 at risk
EG0047 events5 affected18 at risk
EG0052 events1 affected6 at risk
EG0063 events3 affected7 at risk
EG0070 events0 affected7 at risk
EG0086 events5 affected23 at risk
EG0096 events5 affected24 at risk
EG0108 events8 affected25 at risk
EG0114 events4 affected25 at risk
EG01219 events17 affected109 at risk
EG0137 events7 affected55 at risk
0 events
0 affected
26 at risk
EG0040 events0 affected18 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected7 at risk
EG0081 events1 affected23 at risk
EG0092 events2 affected24 at risk
EG0103 events3 affected25 at risk
EG0111 events1 affected25 at risk
EG0123 events3 affected109 at risk
EG0130 events0 affected55 at risk
3 events
3 affected
26 at risk
EG0040 events0 affected18 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected7 at risk
EG0080 events0 affected23 at risk
EG0091 events1 affected24 at risk
EG0104 events4 affected25 at risk
EG0113 events3 affected25 at risk
EG0126 events6 affected109 at risk
EG0131 events1 affected55 at risk
1 events
1 affected
26 at risk
EG0040 events0 affected18 at risk
EG0051 events1 affected6 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected7 at risk
EG0080 events0 affected23 at risk
EG0090 events0 affected24 at risk
EG0100 events0 affected25 at risk
EG0110 events0 affected25 at risk
EG0121 events1 affected109 at risk
EG0130 events0 affected55 at risk
0 events
0 affected
26 at risk
EG0040 events0 affected18 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected7 at risk
EG0080 events0 affected23 at risk
EG0090 events0 affected24 at risk
EG0100 events0 affected25 at risk
EG0110 events0 affected25 at risk
EG0120 events0 affected109 at risk
EG0130 events0 affected55 at risk
0 events
0 affected
26 at risk
EG0040 events0 affected18 at risk
EG0050 events0 affected6 at risk
EG0061 events1 affected7 at risk
EG0070 events0 affected7 at risk
EG0080 events0 affected23 at risk
EG0090 events0 affected24 at risk
EG0100 events0 affected25 at risk
EG0110 events0 affected25 at risk
EG0120 events0 affected109 at risk
EG0130 events0 affected55 at risk
0 events
0 affected
26 at risk
EG0041 events1 affected18 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected7 at risk
EG0071 events1 affected7 at risk
EG0080 events0 affected23 at risk
EG0095 events3 affected24 at risk
EG0105 events4 affected25 at risk
EG0113 events3 affected25 at risk
EG01210 events9 affected109 at risk
EG0132 events2 affected55 at risk
0 events
0 affected
26 at risk
EG0041 events1 affected18 at risk
EG0050 events0 affected6 at risk
EG0061 events1 affected7 at risk
EG0070 events0 affected7 at risk
EG0080 events0 affected23 at risk
EG0095 events4 affected24 at risk
EG0105 events4 affected25 at risk
EG0110 events0 affected25 at risk
EG0123 events3 affected109 at risk
EG0134 events4 affected55 at risk
1 events
1 affected
26 at risk
EG0040 events0 affected18 at risk
EG0054 events1 affected6 at risk
EG0060 events0 affected7 at risk
EG0071 events1 affected7 at risk
EG0080 events0 affected23 at risk
EG0093 events3 affected24 at risk
EG0103 events3 affected25 at risk
EG0112 events1 affected25 at risk
EG0125 events5 affected109 at risk
EG0130 events0 affected55 at risk
0 events
0 affected
26 at risk
EG0041 events1 affected18 at risk
EG0051 events1 affected6 at risk
EG0060 events0 affected7 at risk
EG0071 events1 affected7 at risk
EG0081 events1 affected23 at risk
EG0090 events0 affected24 at risk
EG0101 events1 affected25 at risk
EG0110 events0 affected25 at risk
EG0123 events3 affected109 at risk
EG0131 events1 affected55 at risk
0 events
0 affected
26 at risk
EG0043 events3 affected18 at risk
EG0051 events1 affected6 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected7 at risk
EG0081 events1 affected23 at risk
EG0091 events1 affected24 at risk
EG0101 events1 affected25 at risk
EG0111 events1 affected25 at risk
EG0123 events3 affected109 at risk
EG0131 events1 affected55 at risk
0 events
0 affected
26 at risk
EG0042 events2 affected18 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected7 at risk
EG0081 events1 affected23 at risk
EG0092 events2 affected24 at risk
EG0103 events2 affected25 at risk
EG0113 events3 affected25 at risk
EG0121 events1 affected109 at risk
EG0134 events3 affected55 at risk
0 events
0 affected
26 at risk
EG0041 events1 affected18 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected7 at risk
EG0080 events0 affected23 at risk
EG0091 events1 affected24 at risk
EG0102 events2 affected25 at risk
EG0110 events0 affected25 at risk
EG0122 events2 affected109 at risk
EG0131 events1 affected55 at risk
0 events
0 affected
26 at risk
EG0040 events0 affected18 at risk
EG0050 events0 affected6 at risk
EG0061 events1 affected7 at risk
EG0070 events0 affected7 at risk
EG0080 events0 affected23 at risk
EG0092 events1 affected24 at risk
EG0101 events1 affected25 at risk
EG0112 events2 affected25 at risk
EG0125 events5 affected109 at risk
EG0133 events3 affected55 at risk
0 events
0 affected
26 at risk
EG0040 events0 affected18 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected7 at risk
EG0080 events0 affected23 at risk
EG0090 events0 affected24 at risk
EG0100 events0 affected25 at risk
EG0110 events0 affected25 at risk
EG0120 events0 affected109 at risk
EG0130 events0 affected55 at risk
0 events
0 affected
26 at risk
EG0040 events0 affected18 at risk
EG0050 events0 affected6 at risk
EG0061 events1 affected7 at risk
EG0070 events0 affected7 at risk
EG0080 events0 affected23 at risk
EG0091 events1 affected24 at risk
EG0100 events0 affected25 at risk
EG0111 events1 affected25 at risk
EG0121 events1 affected109 at risk
EG0131 events1 affected55 at risk
0 events
0 affected
26 at risk
EG0040 events0 affected18 at risk
EG0051 events1 affected6 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected7 at risk
EG0080 events0 affected23 at risk
EG0090 events0 affected24 at risk
EG0100 events0 affected25 at risk
EG0110 events0 affected25 at risk
EG0120 events0 affected109 at risk
EG0130 events0 affected55 at risk
1 events
1 affected
26 at risk
EG0040 events0 affected18 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected7 at risk
EG0080 events0 affected23 at risk
EG0093 events2 affected24 at risk
EG0101 events1 affected25 at risk
EG0110 events0 affected25 at risk
EG0121 events1 affected109 at risk
EG0130 events0 affected55 at risk
1 events
1 affected
26 at risk
EG0042 events2 affected18 at risk
EG0050 events0 affected6 at risk
EG0061 events1 affected7 at risk
EG0071 events1 affected7 at risk
EG0081 events1 affected23 at risk
EG0090 events0 affected24 at risk
EG0105 events5 affected25 at risk
EG0113 events3 affected25 at risk
EG0120 events0 affected109 at risk
EG0131 events1 affected55 at risk
0 events
0 affected
26 at risk
EG0040 events0 affected18 at risk
EG0051 events1 affected6 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected7 at risk
EG0080 events0 affected23 at risk
EG0090 events0 affected24 at risk
EG0101 events1 affected25 at risk
EG0110 events0 affected25 at risk
EG0121 events1 affected109 at risk
EG0130 events0 affected55 at risk
0 events
0 affected
26 at risk
EG0040 events0 affected18 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected7 at risk
EG0080 events0 affected23 at risk
EG0090 events0 affected24 at risk
EG0100 events0 affected25 at risk
EG0110 events0 affected25 at risk
EG0121 events1 affected109 at risk
EG0130 events0 affected55 at risk
0 events
0 affected
26 at risk
EG0040 events0 affected18 at risk
EG0050 events0 affected6 at risk
EG0062 events2 affected7 at risk
EG0070 events0 affected7 at risk
EG0080 events0 affected23 at risk
EG0090 events0 affected24 at risk
EG0100 events0 affected25 at risk
EG0110 events0 affected25 at risk
EG0120 events0 affected109 at risk
EG0130 events0 affected55 at risk
0 events
0 affected
26 at risk
EG0040 events0 affected18 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected7 at risk
EG0080 events0 affected23 at risk
EG0090 events0 affected24 at risk
EG0101 events1 affected25 at risk
EG0110 events0 affected25 at risk
EG0120 events0 affected109 at risk
EG0130 events0 affected55 at risk
1 events
1 affected
26 at risk
EG0042 events2 affected18 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected7 at risk
EG0080 events0 affected23 at risk
EG0090 events0 affected24 at risk
EG0100 events0 affected25 at risk
EG0110 events0 affected25 at risk
EG0120 events0 affected109 at risk
EG0131 events1 affected55 at risk
0 events
0 affected
26 at risk
EG0040 events0 affected18 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected7 at risk
EG0080 events0 affected23 at risk
EG0090 events0 affected24 at risk
EG0100 events0 affected25 at risk
EG0110 events0 affected25 at risk
EG0120 events0 affected109 at risk
EG0130 events0 affected55 at risk
0 events
0 affected
26 at risk
EG0040 events0 affected18 at risk
EG0051 events1 affected6 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected7 at risk
EG0080 events0 affected23 at risk
EG0091 events1 affected24 at risk
EG0100 events0 affected25 at risk
EG0111 events1 affected25 at risk
EG0121 events1 affected109 at risk
EG0133 events3 affected55 at risk
1 events
1 affected
26 at risk
EG0040 events0 affected18 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected7 at risk
EG0080 events0 affected23 at risk
EG0090 events0 affected24 at risk
EG0100 events0 affected25 at risk
EG0110 events0 affected25 at risk
EG0120 events0 affected109 at risk
EG0130 events0 affected55 at risk
1 events
1 affected
26 at risk
EG0040 events0 affected18 at risk
EG0051 events1 affected6 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected7 at risk
EG0080 events0 affected23 at risk
EG0090 events0 affected24 at risk
EG0100 events0 affected25 at risk
EG0110 events0 affected25 at risk
EG0120 events0 affected109 at risk
EG0130 events0 affected55 at risk
2 events
2 affected
26 at risk
EG0041 events1 affected18 at risk
EG0050 events0 affected6 at risk
EG0062 events1 affected7 at risk
EG0071 events1 affected7 at risk
EG0080 events0 affected23 at risk
EG0090 events0 affected24 at risk
EG0101 events1 affected25 at risk
EG0110 events0 affected25 at risk
EG0124 events3 affected109 at risk
EG0132 events2 affected55 at risk
0 events
0 affected
26 at risk
EG0040 events0 affected18 at risk
EG0051 events1 affected6 at risk
EG0060 events0 affected7 at risk
EG0071 events1 affected7 at risk
EG0081 events1 affected23 at risk
EG0090 events0 affected24 at risk
EG0101 events1 affected25 at risk
EG0110 events0 affected25 at risk
EG0125 events5 affected109 at risk
EG0131 events1 affected55 at risk
0 events
0 affected
26 at risk
EG0040 events0 affected18 at risk
EG0051 events1 affected6 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected7 at risk
EG0080 events0 affected23 at risk
EG0090 events0 affected24 at risk
EG0100 events0 affected25 at risk
EG0110 events0 affected25 at risk
EG0120 events0 affected109 at risk
EG0130 events0 affected55 at risk
0 events
0 affected
26 at risk
EG0040 events0 affected18 at risk
EG0051 events1 affected6 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected7 at risk
EG0080 events0 affected23 at risk
EG0090 events0 affected24 at risk
EG0100 events0 affected25 at risk
EG0110 events0 affected25 at risk
EG0120 events0 affected109 at risk
EG0130 events0 affected55 at risk
2 events
1 affected
26 at risk
EG0040 events0 affected18 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected7 at risk
EG0080 events0 affected23 at risk
EG0090 events0 affected24 at risk
EG0101 events1 affected25 at risk
EG0110 events0 affected25 at risk
EG0120 events0 affected109 at risk
EG0130 events0 affected55 at risk
0 events
0 affected
26 at risk
EG0040 events0 affected18 at risk
EG0051 events1 affected6 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected7 at risk
EG0081 events1 affected23 at risk
EG0090 events0 affected24 at risk
EG0101 events1 affected25 at risk
EG0110 events0 affected25 at risk
EG0120 events0 affected109 at risk
EG0130 events0 affected55 at risk
0 events
0 affected
26 at risk
EG0040 events0 affected18 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected7 at risk
EG0071 events1 affected7 at risk
EG0080 events0 affected23 at risk
EG0090 events0 affected24 at risk
EG0100 events0 affected25 at risk
EG0110 events0 affected25 at risk
EG0120 events0 affected109 at risk
EG0130 events0 affected55 at risk
0 events
0 affected
26 at risk
EG0040 events0 affected18 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected7 at risk
EG0080 events0 affected23 at risk
EG0090 events0 affected24 at risk
EG0100 events0 affected25 at risk
EG0110 events0 affected25 at risk
EG0120 events0 affected109 at risk
EG0130 events0 affected55 at risk
0 events
0 affected
26 at risk
EG0040 events0 affected18 at risk
EG0051 events1 affected6 at risk
EG0060 events0 affected7 at risk
EG00739 events2 affected7 at risk
EG0084 events4 affected23 at risk
EG0091 events1 affected24 at risk
EG0104 events3 affected25 at risk
EG0115 events4 affected25 at risk
EG0125 events5 affected109 at risk
EG0131 events1 affected55 at risk
0 events
0 affected
26 at risk
EG0040 events0 affected18 at risk
EG0051 events1 affected6 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected7 at risk
EG0080 events0 affected23 at risk
EG0090 events0 affected24 at risk
EG0102 events2 affected25 at risk
EG0111 events1 affected25 at risk
EG0123 events3 affected109 at risk
EG0131 events1 affected55 at risk
1 events
1 affected
26 at risk
EG0042 events2 affected18 at risk
EG0052 events1 affected6 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected7 at risk
EG0083 events3 affected23 at risk
EG0098 events2 affected24 at risk
EG0101 events1 affected25 at risk
EG0110 events0 affected25 at risk
EG0121 events1 affected109 at risk
EG0134 events4 affected55 at risk
0 events
0 affected
26 at risk
EG0040 events0 affected18 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected7 at risk
EG0083 events3 affected23 at risk
EG0092 events2 affected24 at risk
EG0101 events1 affected25 at risk
EG0111 events1 affected25 at risk
EG0125 events5 affected109 at risk
EG0131 events1 affected55 at risk
0 events
0 affected
26 at risk
EG0041 events1 affected18 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected7 at risk
EG0081 events1 affected23 at risk
EG0090 events0 affected24 at risk
EG0100 events0 affected25 at risk
EG0110 events0 affected25 at risk
EG0120 events0 affected109 at risk
EG0130 events0 affected55 at risk
0 events
0 affected
26 at risk
EG0041 events1 affected18 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected7 at risk
EG0080 events0 affected23 at risk
EG0090 events0 affected24 at risk
EG0101 events1 affected25 at risk
EG0110 events0 affected25 at risk
EG0120 events0 affected109 at risk
EG0130 events0 affected55 at risk
125.50000
± 53.03301
OG004171.43333± 50.18853
OG005148.80000± 18.48513
OG006400.33333± 52.51984
OG007173.33333± 20.64784
OG008334.33333± 98.28462
Participants
OG004
0
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0074
ParticipantsOG0086
Title
Measurements
OG007299.82500± 220.83898
OG008715.33333± 188.01241
126
± NA
Geometric Coefficient of Variation was not calculated because it was pre-specified not to calculate the value if number of participants was \<=2.