GEN3014 Trial in Relapsed or Refractory Hematologic Malig... | NCT04824794 | Trialant
NCT04824794
Sponsor
Genmab
Status
Terminated
Last Update Posted
May 19, 2026Actual
Enrollment
130Actual
Phase
Phase 1Phase 2
Conditions
Relapsed or Refractory Multiple Myeloma (RRMM)
Diffuse Large B Cell Lymphoma (DLBCL)
Acute Myeloid Leukemia (AML)
Interventions
GEN3014
Daratumumab
Countries
United States
Australia
Bosnia and Herzegovina
Czechia
Denmark
France
Georgia
Greece
Hungary
Malaysia
Moldova
Netherlands
New Zealand
North Macedonia
Philippines
Poland
South Korea
Spain
Sweden
Ukraine
Protocol Section
Identification Module
NCT ID
NCT04824794
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
GCT3014-01
Secondary IDs
ID
Type
Description
Link
2020-003781-40
EudraCT Number
NL75422.056.21
Registry Identifier
The Netherlands CCMO
2023-507086-26-00
EU Trial (CTIS) Number
Brief Title
GEN3014 Trial in Relapsed or Refractory Hematologic Malignancies
Official Title
An Open-Label, Multicenter, Phase 1/2 Trial of GEN3014 (HexaBody®-CD38) in Relapsed or Refractory Multiple Myeloma and Other Hematologic Malignancies
Acronym
Not provided
Organization
GenmabINDUSTRY
Status Module
Record Verification Date
Apr 2026
Overall Recruitment Status or Expanded Access Status
Terminated
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
The sponsor has decided to discontinue further development of GEN3014 after a comprehensive review of the data, market landscape, and strategic priorities.
Expanded Access Info
No
Start Date
Mar 9, 2021Actual
Primary Completion Date
Jun 30, 2025Actual
Completion Date
Jul 31, 2025Actual
First Submitted Date
Mar 9, 2021
First Submission Date that Met QC Criteria
Mar 29, 2021
First Posted Date
Apr 1, 2021Actual
Results Waived
Not provided
Results First Submitted Date
Feb 5, 2026
Results First Submitted that Met QC Criteria
Apr 27, 2026
Results First Posted Date
May 19, 2026Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Apr 27, 2026
Last Update Posted Date
May 19, 2026Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
GenmabINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The drug that will be investigated in the study is an antibody, GEN3014. Since this is the first study of GEN3014 in humans, the main purpose is to evaluate safety. In addition to safety, the study will determine the recommended GEN3014 dose to be tested in a larger group of participants and assess preliminary clinical activity of GEN3014. GEN3014 will be studied in relapsed (disease has returned) or refractory (resistant to treatment) multiple myeloma (also known as RRMM) and other blood cancers. The study consists of 3 parts:
The Dose Escalation will test increasing doses of GEN3014 to identify a safe dose level to be tested in the other two parts.
Expansion Part A will further test the GEN3014 dose determined from the Dose Escalation.
Expansion Part B will compare intravenous (IV) GEN3014 with the subcutaneous (SC) daratumumab in ex-US countries.
Participants will receive either GEN3014 into the vein or daratumumab under the skin; none will be given placebo. The study duration will be different for the individual participants. Overall, the study may be ongoing up to 5 years after the last participant's first treatment.
Detailed Description
This trial will be conducted in 3 parts: Dose Escalation (phase 1), Expansion Parts, A and B (phase 2).
In the dose escalation phase GEN3014 will be evaluated in RRMM and relapsed and refractory acute myeloid leukemia (R/R AML). The participants will receive GEN3014 administered at various dose levels in 28-day cycles. Dose Limiting Toxicities (DLTs) will be assessed during the first treatment cycle and the Maximum Tolerated Dose (MTD) and/or Recommended phase 2 dose (RP2D) will be determined.
In Expansion Part A, GEN3014 will be further evaluated in 4 cohorts: anti-CD38 monoclonal antibody (mAb)-naive RRMM, anti-CD38 mAb-refractory RRMM, relapsed or refractory diffuse large B-cell lymphoma (R/R DLBCL), and R/R AML at the RP2D identified from the Dose Escalation. In Expansion Part B, GEN3014 IV will be compared to daratumumab SC, head-to-head (H2H) to evaluate whether GEN3014 may be more potent in anti-CD38 mAb-naïve RRMM participants.
Conditions Module
Conditions
Relapsed or Refractory Multiple Myeloma (RRMM)
Diffuse Large B Cell Lymphoma (DLBCL)
Acute Myeloid Leukemia (AML)
Keywords
Hexabody®
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
130Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
GEN3014
Experimental
Experimental: GEN3014 Participants in Dose Escalation phase with
RRMM
R/R AML
Participants in Expansion Part A with
RRMM (anti-CD38 mAb-naïve)
RRMM (anti-CD38 mAb-refractory)
R/R DLBCL
R/R AML
Participants in Expansion Part B with
• RRMM (anti-CD38 mAb-naïve)
Biological: GEN3014
Daratumumab
Active Comparator
Participants in Expansion Part B with
- RRMM (anti-CD38 mAb-naïve)
Drug: Daratumumab
Interventions
Name
Type
Description
Arm Group Labels
Other Names
GEN3014
Biological
GEN3014 is administered by IV infusion.
GEN3014
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Dose Escalation: Number of Participants With Dose Limiting Toxicities (DLTs)
DLTs were defined as: All Grade 5 toxicities, Grade 4 thrombocytopenia, neutropenia or anemia and Grade 3/4 febrile neutropenia and hemorrhage associated with thrombocytopenia, all non-hematological toxicities of grade ≥3 (with exceptions per protocol), Grade 4 tumor lysis syndrome (TLS), Grade 4 infusion-related reaction (IRR), and any liver toxicity of elevated alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥3 times or greater above the upper limit of normal (ULN) with serum total bilirubin of ≥2 times the upper limit of normal, without findings of cholestasis and in the absence of alternative etiologies. DLTs were graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0.
28 days during the first cycle (cycle =28 days)
Dose Escalation: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE was any untoward medical occurrence in a participant or clinical trial participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE was defined as an AE that met 1 of the following criteria: fatal or life-threatening, resulted in persistent or significant disability/incapacity, a congenital anomaly/birth defect, was medically significant (jeopardized the participant or may have required medical or surgical intervention to prevent one of the outcomes listed above), required inpatient hospitalization or prolongation of existing hospitalization. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.
Up to approximately 4 years 3 months
Expansion Part A: Objective Response Rate (ORR)
ORR was defined as the percentage of participants with a partial response (PR) or better based on International Myeloma Working Group (IMWG) criteria for RRMM participants and based on Lugano criteria for DLBCL participants. Per IMWG criteria, PR was defined as ≥50% reduction of serum M-protein plus reduction in 24-h urinary M-protein by ≥90% or to <200 mg per 24 h. In addition to these criteria, if present at baseline, a ≥50% reduction in the size (sum of the product of the diameters [SPD]) of soft tissue plasmacytomas was also required. Per Lugano criteria, PR was defined as ≥50% decrease in SPD of up to 6 target measurable nodes and extranodal sites, absent/normal, regressed, but no increase in non-measurable lesions, spleen regressed >50% in length beyond normal (13 centimeters [cm]), and no new lesions.
Secondary Outcomes
Measure
Description
Time Frame
Dose Escalation and Expansion Part A: Maximum (Peak) Plasma Concentration (Cmax) of GEN3014
Venous blood samples were collected for analyzing concentrations of GEN3014. For the RRMM Dose Escalation 0.2/0.6 mg/kg arm, the participant underwent intraparticipant dose escalation in Cycle 1, where the participant received 0.2 mg/kg during the first week and 0.6 mg/kg from second week and beyond. Therefore, pharmacokinetic (PK) parameters were additionally calculated for Cycle 1 Day 8 dosing only in the RRMM Dose Escalation 0.2/0.6 mg/kg arm to account for the change in dosing over Cycle 1 in this arm.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Key Inclusion Criteria
Must have fresh bone marrow samples collected at Screening for RRMM, R/R AML, and R/R DLBCL with suspected bone marrow involvement.
Dose Escalation phase, Expansion Part A (for MM and AML) and Expansion Part B- Eastern Cooperative Oncology Group (ECOG) performance status (PS) score 0, 1, or 2. Expansion Part A (for DLBCL): ECOG PS 0 or 1.
Has acceptable laboratory test results during the Screening period.
A woman of reproductive potential must agree to use adequate contraception during the trial and for 12 months after the last GEN3014 or daratumumab SC administration.
A woman of childbearing potential must have a negative serum beta-human chorionic gonadotropin (β-hCG) at Screening and additionally, for Expansion Part B, within 72 hours of the first dose of study treatment prior to dosing.
A woman must agree not to donate eggs (ova, oocytes) for assisted reproduction during the trial and for 12 months after receiving the last dose of GEN3014 or daratumumab SC.
A man who is sexually active with a woman of childbearing potential and has not had a vasectomy must agree to use a barrier method of birth control and all men must not donate sperm during the trial and for 12 months after receiving the last dose of GEN3014 or daratumumab SC.
Specific for RRMM:
Must have documented multiple myeloma as defined by the criteria below and have evidence of disease progression on the most recent prior treatment regimen based on IMWG criteria:
Prior documentation of monoclonal plasma cells in the bone marrow ≥10% or presence of a biopsy-proven plasmacytoma and,
Measurable disease at baseline as defined by any of the following:
Immunoglobulin (Ig) G, IgA, IgD, or IgM myeloma: Serum M-protein level ≥0.5 g/dL (≥5 g/L) or urine M protein level ≥200 mg/24 hours or,
Note: Participants with RRMM must have exhausted standard therapies, at the investigator's discretion.
For anti-CD38 mAb-naive RRMM Cohort: Participant received at least 3 prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory imide drug (IMiD) in any order, or is double refractory to a PI and an IMiD; or participant received ≥ 2 prior lines of therapy if 1 of those lines included a combination of PI and IMiD. Note: Participants should not have received any anti-CD38 antibody.
Anti-CD38 mAb-naive RRMM participants will be enrolled from ex-US countries.
Dose Escalation phase - For anti-CD38 mAb-treated RRMM Cohort: Participant has received at least 2 prior lines of therapy and must have discontinued daratumumab or isatuximab for at least 4 weeks prior to the first dose of GEN3014. Note: Participants should not have received any other anti-CD38 antibody except daratumumab or isatuximab.
Specific for R/R AML:
Relapsed or refractory AML, both de novo or secondary; must have failed all conventional therapy. Acute promyelocytic leukemia (APL) is excluded from this trial. Note: Relapse is defined by BM blasts ≥5% in participants who have been in CR previously, or reappearance of blasts in the blood, or development of extramedullary AML. Refractory is defined as not being able to achieve a CR after the initial therapy.
Participant with relapsed AML who received at least 2 prior therapies for AML with the exception of hydroxyurea.
Participant with refractory AML who received at least 1 prior line of therapy for AML with the exception of hydroxyurea.
Participant's life expectancy at Screening is judged to be at least 3 months.
Specific for DLBCL:
Expansion phase: Relapsed or refractory DLBCL, both de novo or histologically transformed. Participants with R/R DLBCL must have exhausted standard therapies, at the investigator's discretion.
Expansion phase: Received at least 2 prior lines of systemic therapy, with 1 being a CD20-containing chemoimmunotherapy.
Expansion phase: Have at least 1 measurable site of disease as per Lugano criteria.
Expansion phase: Must have available archival or fresh tumor tissue or both to submit to a central laboratory for CD38 assay.
Key Exclusion Criteria
Prior treatment with any CD38-directed therapies (eg, daratumumab, isatuximab, CD38 chimeric antigen receptor T cell (CAR-T), bispecific antibody (Ab)) in anti-CD38 mAb-naive RRMM Cohort. Note: Prior daratumumab or isatuximab exposure is allowed for anti-CD38 mAb-treated RRMM participants in the Dose Escalation and anti-CD38 mAb-refractory RRMM Cohort in the Expansion Part A.
Treatment with an anti-cancer agent, chemotherapy, radiation therapy, or major surgery within 2 weeks prior to the first dose of study treatment (Dose Escalation and Expansion Part A) or randomization (Expansion Part B).
Treatment with an investigational drug within 4 weeks or 5 half-lives, whichever is shorter, prior to the first dose of study treatment (Dose Escalation and Expansion Part A) or randomization (Expansion Part B).
Cumulative dose of corticosteroids more than the equivalent of ≥140 mg of prednisone within 2-week period before the first dose of study treatment (Dose Escalation and Expansion Part A) or maximum cumulative dose of dexamethasone 160 mg within 28 days of randomization (Expansion Part B).
Has clinically significant cardiac disease.
Toxicities from previous anti-cancer therapies have not resolved to baseline levels or to Grade 1 or less except for alopecia and peripheral neuropathy.
Primary central nervous system (CNS) tumor or known CNS involvement at Screening.
Has known history/positive serology for hepatitis B.
Known medical history or ongoing hepatitis C infection that has not been cured.
Known history of seropositivity of human immunodeficiency virus (HIV) (Dose Escalation and Expansion Part A) or to be positive for HIV with details in the protocol (Expansion Part B).
Currently receiving any other investigational agents.
A woman who is pregnant or breast-feeding, or who is planning to become pregnant while enrolled in this trial or within 12 months after the last dose of study treatment.
A man who plans to father a child while enrolled in this trial or within 12 months after the last dose of study treatment.
Autologous HSCT within 3 months of the first dose of GEN3014.
Specific Exclusion Criteria for R/R AML:
<5% blasts in blood or bone marrow at Screening.
White blood cell (WBC) counts ≥50,000/microliter (μL) in peripheral blood that cannot be controlled by hydroxyurea prior to the first dose of GEN3014.
Prior autologous HSCT.
Allogenic HSCT within 3 months of the first dose of GEN3014.
Active graft-versus-host-disease requiring immunosuppressive treatment. Any immunosuppressive medication (eg, calcineurin inhibitors) must be stopped ≥4 weeks prior to the first dose of GEN3014.
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
This study had 3 parts (Dose Escalation, Expansion Part A & Part B) and was terminated early. Due to enrollment challenges, the acute myeloid leukemia (AML) Dose Escalation and diffuse large B-cell lymphoma (DLBCL) Expansion Part A cohorts were terminated early. The anti-CD38 monoclonal antibody (mAb)-refractory relapsed or refractory multiple myeloma (RRMM) Cohort and relapsed or refractory (R/R) AML Cohort in Expansion Part A were not opened.
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
RRMM Dose Escalation: GEN3014 0.2/0.6 mg/kg
Participants with RRMM received GEN3014 at a dose of 0.2/0.6 milligrams per kilogram (mg/kg) by intravenous (IV) infusion in 28-day treatment cycles. Intraparticipant dose escalation was performed in this arm (i.e., dose was escalated from 0.2-0.6 mg/kg).
FG001
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
0
More Info Module
Limitations and Caveats
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
Jan 15, 2025
Feb 5, 2026
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
Estimated Results First Submitted Date
Not provided
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Sequential Assignment
Intervention Model Description
Dose escalation part is sequential while the expansion Part A cohorts are parallel. Expansion Part B is sequential to Expansion Part A RRMM cohort. In Expansion Part B, participants with RRMM are randomized (1:1) to treatment.
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
HexaBody®-CD38
Daratumumab
Drug
Daratumumab is administered by SC injections.
Daratumumab
DARZALEX FASPRO®
Up to approximately 4 years 3 months
Expansion Part B: ORR
ORR was defined as the percentage of participants with a PR or better based on IMWG criteria. Per IMWG criteria, PR was defined as ≥50% reduction of serum M-protein plus reduction in 24-h urinary M-protein by ≥90% or to <200 mg per 24 h. In addition to these criteria, if present at baseline, a ≥50% reduction in the size (SPD) of soft tissue plasmacytomas was also required.
Up to approximately 4 years 3 months
Dose Escalation: Cycle 1 Day 1, Cycle 1 Day 8 (RRMM Dose Escalation: GEN3014 0.2/0.6 mg/kg only), Cycle 2 Day 1, Expansion Part A: Cycle 1 Day 1, Cycle 2 Day 1 (cycle =28 days)
Dose Escalation, Expansion Part A and Expansion Part B: Pre-dose (Trough) Concentrations (Ctrough) of GEN3014
Venous blood samples were collected for analyzing concentrations of GEN3014. For the RRMM Dose Escalation 0.2/0.6 mg/kg arm, the participant underwent intraparticipant dose escalation in Cycle 1, where the participant received 0.2 mg/kg during the first week and 0.6 mg/kg from second week and beyond. Therefore, PK parameters were additionally calculated for Cycle 1 Day 8 dosing in the RRMM Dose Escalation 0.2/0.6 mg/kg arm to account for the change in dosing over Cycle 1 in this arm.
Dose Escalation: Cycle (C) 1 Day (D) 1, C1D8 (RRMM GEN3014 0.2/0.6 mg/kg, R/R AML Dose Escalation), C2D1, Expansion Part A: C1D1, C2D1 (R/R DLBCL Expansion Part A: C1D8 and C2D8) Expansion Part B: C1D1, C1D8, C2D1, C3D1, C7D1, C8D1 (cycle = 28 days)
Dose Escalation and Expansion Part A: Area Under the Concentration Time Curve From Zero to Last Quantifiable Sample (AUC0-last) of GEN3014
Venous blood samples were collected for analyzing concentrations of GEN3014. For the RRMM Dose Escalation 0.2/0.6 mg/kg arm, the participant underwent intraparticipant dose escalation in Cycle 1, where the participant received 0.2 mg/kg during the first week and 0.6 mg/kg from second week and beyond. Therefore, PK parameters were additionally calculated for Cycle 1 Day 8 dosing only in the RRMM Dose Escalation 0.2/0.6 mg/kg arm to account for the change in dosing over Cycle 1 in this arm.
Dose Escalation: Cycle 1 Day 1, Cycle 1 Day 8 (RRMM Dose Escalation: GEN3014 0.2/0.6 mg/kg only), Cycle 2 Day 1, Expansion Part A: Cycle 1 Day 1, Cycle 2 Day 1 (cycle =28 days)
Dose Escalation and Expansion Part A: Area Under the Concentration Time Curve From Zero to 168 Hours (AUC0-168 h) of GEN3014
Venous blood samples were collected for analyzing concentrations of GEN3014. For the RRMM Dose Escalation 0.2/0.6 mg/kg arm, the participant underwent intraparticipant dose escalation in Cycle 1, where the participant received 0.2 mg/kg during the first week and 0.6 mg/kg from second week and beyond. Therefore, PK parameters were additionally calculated for Cycle 1 Day 8 dosing only in the RRMM Dose Escalation 0.2/0.6 mg/kg arm to account for the change in dosing over Cycle 1 in this arm.
Dose Escalation: Cycle 1 Day 1, Cycle 1 Day 8 (RRMM Dose Escalation: GEN3014 0.2/0.6 mg/kg only), Cycle 2 Day 1, Expansion Part A: Cycle 1 Day 1, Cycle 2 Day 1 (R/R DLBCL Expansion Part A: Cycle 1 Day 1 only) (cycle =28 days)
Dose Escalation and Expansion Part A: Number of Participants With Anti-Drug Antibodies (ADAs) to GEN3014
Venous blood samples were drawn for analysis of ADAs to GEN3014.
Dose Escalation: Baseline up to a max of approx. 34.5 months, Expansion Part A: Baseline up to a max of approx. 16.6 months
Dose Escalation: ORR
ORR was defined as the percentage of participants with a PR or better. The response in RRMM Cohorts was assessed following IMWG criteria 2016. Per IMWG criteria, PR was defined as ≥50% reduction of serum M-protein plus reduction in 24-h urinary M-protein by ≥90% or to <200 mg per 24 h. In addition to these criteria, if present at baseline, a ≥50% reduction in the size (SPD) of soft tissue plasmacytomas was also required.
Up to approximately 4 years 3 months
Dose Escalation and Expansion Part A: Clinical Benefit Rate (CBR)
CBR was defined as the percentage of participants with a best overall response of minimal response (MR), partial response (PR), very good partial response (VGPR), complete response (CR) or stringent complete response (sCR) as determined by the investigator per IMWG response criteria for RRMM participants. MR=≥25% but ≤49% reduction of serum M-protein, reduction of 24-h urine by 50%-89% and if present at baseline, ≥50% reduction in the size (SPD) of soft tissue plasmacytomas. PR=≥50% reduction of serum M-protein, reduction in 24-h urinary M-protein by ≥90% or to <200mg/24h and if present at baseline,≥50% reduction in SPD of soft tissue plasmacytomas. VGPR=Serum+urine M-protein detectable by IFE but not electrophoresis or ≥90% reduction in serum M-protein+urine M-protein level <100mg/24h. CR=Negative IFE on serum/urine + disappearance of soft tissue plasmacytomas and ≤5% plasma cells in bone marrow aspirates. sCR=CR+normal FLC ratio, absence of clonal cells in bone marrow biopsy by IHC.
Up to approximately 4 years 3 months
Dose Escalation, Expansion Part A and Expansion Part B: Duration of Response (DOR)
DOR was defined as time from first response (PR or better) to timing of disease progression or death (due to any cause), whichever came first.
Up to approximately 4 years 3 months
Dose Escalation, Expansion Part A and Expansion Part B: Time-to-response (TTR)
TTR was defined as the time from date of first dose, or date of randomization for participants in the Expansion Part B, to time of first response (PR or better).
Up to approximately 4 years 3 months
Dose Escalation, Expansion Part A and Expansion Part B: Progression-free Survival (PFS)
PFS was defined as the time from the date of first dose, or date of randomization for participants in the Expansion Part B, to the date of progression or death (due to any cause), whichever came first.
Up to approximately 4 years 3 months
Dose Escalation, Expansion Part A and Expansion Part B: Overall Survival (OS)
OS was defined as the time from the date of first dose, or date of randomization for participants in the Expansion Part B, to the date of death due to any cause.
Up to approximately 4 years 3 months
Expansion Part A and Part B: Number of Participants With AEs and SAEs
An AE was any untoward medical occurrence in a participant or clinical trial participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE was defined as an AE that met 1 of the following criteria: fatal or life-threatening, resulted in persistent or significant disability/incapacity, a congenital anomaly/birth defect, was medically significant (jeopardized the participant or may have required medical or surgical intervention to prevent one of the outcomes listed above), required inpatient hospitalization or prolongation of existing hospitalization. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.
Up to approximately 4 years 3 months
Expansion Part B: Percentage of Participants With Very Good Partial Response (VGPR) or Better
Based on Investigator Assessment per IMWG 2016 Criteria, VGPR was defined as serum and urine M-protein detectable by immunofixation (IFE) but not on electrophoresis or ≥90% reduction in serum M-protein plus urine M-protein level <100 mg per 24 h. Data are reported for the percentage of participants with a VGPR or better.
Up to approximately 4 years 3 months
Expansion Part B: Percentage of Participants With Complete Response (CR) or Better
CR was defined as negative IFE on the serum and urine and disappearance of any soft tissue plasmacytomas and ≤5% plasma cells in bone marrow aspirates based on Investigator assessment per IMWG response criteria. Data are reported for the percentage of participants with CR or better.
Up to approximately 4 years 3 months
Expansion Part B: Time to Next Therapy (TTNT)
TTNT for participants in the Expansion Part B was defined as the time from randomization to the start of subsequent anti-cancer therapy. Participants who withdrew consent or were lost to follow up or died due to causes other than disease progression were censored at their last disease assessment.
Up to approximately 4 years 3 months
Expansion Part B: Number of Participants With Anti-GEN3014 Antibodies and Anti-Daratumumab Antibodies
Venous blood samples were drawn for analysis of ADAs to GEN3014 and daratumumab. In the GEN3014 arm, participants were tested for anti-GEN3014-antibodies; in the daratumumab arm, participants were tested for anti-daratumumab-antibodies.
Cycle 1 Day 22 up to a maximum of approximately 23.9 months (cycles = 28 days)
Cleveland
Ohio
44106
United States
Medical college of Wisconsin
Milwaukee
Wisconsin
53226
United States
Northern Health
Epping
Australia
The Alfred Hospital
Melbourne
Australia
Royal Prince Alfred Hospital
Sydney
Australia
University Clinical Center of the Republic of the Srpska
Banja Luka
Bosnia and Herzegovina
Klinika za hematologiju KCUS
Sarajevo
Bosnia and Herzegovina
UKC - University Clinical Center Tuzla
Tuzla
Bosnia and Herzegovina
Fakultni Nemocnice Brno
Brno
Czechia
Vseobecna fakultni nemocnice
New Town
Czechia
Fakultni Nemocnice Hradec Kralove FNHK
Nový Hradec Králové
Czechia
Fakultni Nemocnice Olomouc (FNOL)
Olomouc
Czechia
FNO - Fakultni nemocnice Ostrava
Poruba
Czechia
Aalborg Universitet
Aalborg
Denmark
Vejle Hospital
Vejle
Denmark
CHRU de Lille
Lille
France
CHRU de Nantes
Nantes
France
ARENSIA Exploratory Medicine LLC
Tbilisi
Georgia
Alexandra General Hospital
Athens
Greece
Evangelismos Hospital NKUA
Athens
Greece
University General Hospital of Patras
Rio
Greece
Ahepa University General hospital
Thessaloniki
Greece
Szabolcs-Szatmar-Bereg County Hospitals and University Hospital, Josa Andras University Hospital
Nyíregyháza
Hungary
Hospital Ampang
Ampang
Malaysia
Hospital Sultanah Aminah
Johor Bahru
Malaysia
Hospital Umum Sarawak
Kuching
Malaysia
Beacon Hospital
Petaling Jaya
Malaysia
Institute of Oncology, ARENSIA Exploratory Medicine
Chisinau
Moldova
Maastricht UMC
Maastricht
Netherlands
Erasmus MC
Rotterdam
Netherlands
UMC Utrecht
Utrecht
Netherlands
Christchurch Hospital
Christchurch
New Zealand
Auckland Cancer Trials Centre
Grafton
New Zealand
Palmerston North Hospital
Palmerston North
New Zealand
North Shore Hospital
Takapuna
New Zealand
University Clinic of Hematology
Skopje
North Macedonia
Makati Medical Center
Makati City
Philippines
University Centrum Kliniczne
Gdansk
Poland
Pratia Onkologia Katowice
Katowice
Poland
Pratia MCM
Krakow
Poland
Wroclaw Medical University
Wroclaw
Poland
Chonnam National University Hwasun Hospital
Gwangju
South Korea
Pusan National University Hospital PNUH
Pusan
South Korea
Gachon University Gil Medical Center
Seongnam
South Korea
Samsung Medical Center
Seoul
South Korea
Seoul National University Hospital
Seoul
South Korea
University of Navarra
Pamplona
Spain
University Hospital of Salamanca
Salamanca
Spain
Karolinska Institute
Huddinge
Sweden
Universitetssjukhuset i Lund
Lund
Sweden
Arensia Exploratory Medicine
Kyiv
Ukraine
RRMM Dose Escalation: GEN3014 2 mg/kg
Participants with RRMM received GEN3014 at a dose of 2 mg/kg by IV infusion in 28-day treatment cycles.
FG002
RRMM Dose Escalation: GEN3014 4 mg/kg
Participants with RRMM received GEN3014 at a dose of 4 mg/kg by IV infusion in 28-day treatment cycles.
FG003
RRMM Dose Escalation: GEN3014 8 mg/kg
Participants with RRMM received GEN3014 at a dose of 8 mg/kg by IV infusion in 28-day treatment cycles.
FG004
RRMM Dose Escalation: GEN3014 16 mg/kg
Participants with RRMM received GEN3014 at a dose of 16 mg/kg by IV infusion in 28-day treatment cycles.
FG005
RRMM Dose Escalation: GEN3014 24 mg/kg
Participants with RRMM received GEN3014 at a dose of 24 mg/kg by IV infusion in 28-day treatment cycles.
FG006
R/R AML Dose Escalation: GEN3014 Dose Level 1
Participants with R/R AML received GEN3014 at dose level 1 (low dose) in 28-day treatment cycles.
FG007
RRMM Expansion Part A: GEN3014
Participants with anti-CD38 mAb-naive RRMM received GEN3014 IV infusion at a dose of 16 mg/kg in 28-day cycles during Expansion Part A.
FG008
R/R DLBCL Expansion Part A: GEN3014
Participants with R/R DLBCL received GEN3014 IV infusion at a dose of 16 mg/kg in 28-day cycles during Expansion Part A.
FG009
RRMM Expansion Part B: Daratumumab
Participants with anti-CD38 mAb-naive RRMM received daratumumab at a dose of 1,800 mg by subcutaneous (SC) injection in 28-day treatment cycles.
FG010
RRMM Expansion Part B: GEN3014
Participants with anti-CD38 mAb-naive RRMM received GEN3014 IV infusion at a dose of 16 mg/kg in 28-day treatment cycles.
FG0001 subjects
FG0011 subjects
FG0023 subjects
FG0033 subjects
FG00411 subjects
FG0055 subjects
FG0065 subjects
FG00711 subjects
FG0082 subjects
FG00943 subjects
FG01045 subjects
Received at Least 1 Dose of Study Drug
FG0001 subjects
FG0011 subjects
FG0023 subjects
FG0033 subjects
FG00411 subjects
FG0055 subjects
FG0065 subjects
FG00711 subjects
FG0082 subjects
FG00943 subjects
FG01045 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
NOT COMPLETED
FG0001 subjects
FG0011 subjects
FG0023 subjects
FG0033 subjects
FG00411 subjects
FG0055 subjects
FG0065 subjects
FG00711 subjects
FG0082 subjects
FG00943 subjects
FG01045 subjects
Type
Comment
Reasons
Death
FG0001 subjects
FG0011 subjects
FG0021 subjects
FG0031 subjects
FG0044 subjects
FG0052 subjects
FG0063 subjects
FG0075 subjects
FG0082 subjects
FG0099 subjects
FG0104 subjects
Lost to Follow-Up
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Early Site Closure
FG0000 subjects
FG0010 subjects
FG0022 subjects
FG0032 subjects
FG004
Sponsor Decision
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Started New Line Of Therapy Due To Disease Progression
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
Started New Line Of Treatment
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Full Analysis Set (FAS) included all enrolled participants who received at least 1 dose of trial drug (GEN3014 or daratumumab SC).
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
RRMM Dose Escalation: GEN3014 0.2/0.6 mg/kg
Participants with RRMM received GEN3014 at a dose of 0.2/0.6 mg/kg by IV infusion in 28-day treatment cycles. Intraparticipant dose escalation was performed in this arm (i.e., dose was escalated from 0.2-0.6 mg/kg).
BG001
RRMM Dose Escalation: GEN3014 2 mg/kg
Participants with RRMM received GEN3014 at a dose of 2 mg/kg by IV infusion in 28-day treatment cycles.
BG002
RRMM Dose Escalation: GEN3014 4 mg/kg
Participants with RRMM received GEN3014 at a dose of 4 mg/kg by IV infusion in 28-day treatment cycles.
BG003
RRMM Dose Escalation: GEN3014 8 mg/kg
Participants with RRMM received GEN3014 at a dose of 8 mg/kg by IV infusion in 28-day treatment cycles.
BG004
RRMM Dose Escalation: GEN3014 16 mg/kg
Participants with RRMM received GEN3014 at a dose of 16 mg/kg by IV infusion in 28-day treatment cycles.
BG005
RRMM Dose Escalation: GEN3014 24 mg/kg
Participants with RRMM received GEN3014 at a dose of 24 mg/kg by IV infusion in 28-day treatment cycles.
BG006
R/R AML Dose Escalation: GEN3014 Dose Level 1
Participants with R/R AML received GEN3014 at dose level 1 (low dose) in 28-day treatment cycles.
BG007
RRMM Expansion Part A: GEN3014
Participants with anti-CD38 mAb-naive RRMM received GEN3014 IV infusion at a dose of 16 mg/kg in 28-day cycles during Expansion Part A.
BG008
R/R DLBCL Expansion Part A: GEN3014
Participants with R/R DLBCL received GEN3014 IV infusion at a dose of 16 mg/kg in 28-day cycles during Expansion Part A.
BG009
RRMM Expansion Part B: Daratumumab
Participants with anti-CD38 mAb-naive RRMM received daratumumab at a dose of 1,800 mg by SC injection in 28-day treatment cycles.
BG010
RRMM Expansion Part B: GEN3014
Participants with anti-CD38 mAb-naive RRMM received GEN3014 IV infusion at a dose of 16 mg/kg in 28-day treatment cycles.
BG011
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0001
BG0011
BG0023
BG0033
BG00411
BG0055
BG0065
BG00711
BG0082
BG00943
BG01045
BG011130
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Categorical
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
<=18 years
BG0000
BG0010
BG0020
BG003
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00067
BG00161
BG002
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0000
BG0010
BG002
Race/Ethnicity, Customized
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0000
BG0010
BG002
Race/Ethnicity, Customized
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG002
Region of Enrollment
Count of Participants
Participants
Title
Denominators
Categories
Australia
Title
Measurements
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
Dose Escalation: Number of Participants With Dose Limiting Toxicities (DLTs)
DLTs were defined as: All Grade 5 toxicities, Grade 4 thrombocytopenia, neutropenia or anemia and Grade 3/4 febrile neutropenia and hemorrhage associated with thrombocytopenia, all non-hematological toxicities of grade ≥3 (with exceptions per protocol), Grade 4 tumor lysis syndrome (TLS), Grade 4 infusion-related reaction (IRR), and any liver toxicity of elevated alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥3 times or greater above the upper limit of normal (ULN) with serum total bilirubin of ≥2 times the upper limit of normal, without findings of cholestasis and in the absence of alternative etiologies. DLTs were graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0.
Dose-Determining Analysis Set (DDS) included all FAS participants (all enrolled participants who received at least 1 dose of trial drug [GEN3014 or daratumumab SC]) in the Dose Escalation part who met the minimum exposure criterion and had sufficient safety evaluations or experienced a DLT during the first 28 days of dosing (ie, in Cycle 1).
Posted
Count of Participants
Participants
28 days during the first cycle (cycle =28 days)
ID
Title
Description
OG000
RRMM Dose Escalation: GEN3014 0.2/0.6 mg/kg
Participants with RRMM received GEN3014 at a dose of 0.2/0.6 mg/kg by IV infusion in 28-day treatment cycles. Intraparticipant dose escalation was performed in this arm (i.e., dose was escalated from 0.2-0.6 mg/kg).
OG001
RRMM Dose Escalation: GEN3014 2 mg/kg
Participants with RRMM received GEN3014 at a dose of 2 mg/kg by IV infusion in 28-day treatment cycles.
OG002
RRMM Dose Escalation: GEN3014 4 mg/kg
Participants with RRMM received GEN3014 at a dose of 4 mg/kg by IV infusion in 28-day treatment cycles.
OG003
RRMM Dose Escalation: GEN3014 8 mg/kg
Participants with RRMM received GEN3014 at a dose of 8 mg/kg by IV infusion in 28-day treatment cycles.
OG004
RRMM Dose Escalation: GEN3014 16 mg/kg
Participants with RRMM received GEN3014 at a dose of 16 mg/kg by IV infusion in 28-day treatment cycles.
OG005
RRMM Dose Escalation: GEN3014 24 mg/kg
Participants with RRMM received GEN3014 at a dose of 24 mg/kg by IV infusion in 28-day treatment cycles.
OG006
R/R AML Dose Escalation: GEN3014 Dose Level 1
Participants with R/R AML received GEN3014 at dose level 1 (low dose) in 28-day treatment cycles.
Units
Counts
Participants
OG0001
OG0011
OG0023
OG003
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG003
Primary
Dose Escalation: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE was any untoward medical occurrence in a participant or clinical trial participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE was defined as an AE that met 1 of the following criteria: fatal or life-threatening, resulted in persistent or significant disability/incapacity, a congenital anomaly/birth defect, was medically significant (jeopardized the participant or may have required medical or surgical intervention to prevent one of the outcomes listed above), required inpatient hospitalization or prolongation of existing hospitalization. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.
Safety Analysis Set included all enrolled participants who received at least 1 dose of trial drug (GEN3014 or daratumumab SC). In the RRMM Dose Escalation: GEN3014 0.2/0.6 mg/kg arm, the participant underwent intraparticipant dose escalation in Cycle 1. As pre-specified, safety data were collected and are reported combined for both 0.2 and 0.6 mg/kg dose levels in this arm.
Posted
Count of Participants
Participants
Up to approximately 4 years 3 months
ID
Title
Description
OG000
RRMM Dose Escalation: GEN3014 0.2/0.6 mg/kg
Participants with RRMM received GEN3014 at a dose of 0.2/0.6 mg/kg by IV infusion in 28-day treatment cycles. Intraparticipant dose escalation was performed in this arm (i.e., dose was escalated from 0.2-0.6 mg/kg).
Primary
Expansion Part A: Objective Response Rate (ORR)
ORR was defined as the percentage of participants with a partial response (PR) or better based on International Myeloma Working Group (IMWG) criteria for RRMM participants and based on Lugano criteria for DLBCL participants. Per IMWG criteria, PR was defined as ≥50% reduction of serum M-protein plus reduction in 24-h urinary M-protein by ≥90% or to <200 mg per 24 h. In addition to these criteria, if present at baseline, a ≥50% reduction in the size (sum of the product of the diameters [SPD]) of soft tissue plasmacytomas was also required. Per Lugano criteria, PR was defined as ≥50% decrease in SPD of up to 6 target measurable nodes and extranodal sites, absent/normal, regressed, but no increase in non-measurable lesions, spleen regressed >50% in length beyond normal (13 centimeters [cm]), and no new lesions.
Full Analysis set included all enrolled participants who received at least 1 dose of trial drug (GEN3014 or daratumumab SC).
Posted
Number
95% Confidence Interval
percentage of participants
Up to approximately 4 years 3 months
ID
Title
Description
OG000
RRMM Expansion Part A: GEN3014
Participants with anti-CD38 mAb-naive RRMM received GEN3014 IV infusion at a dose of 16 mg/kg in 28-day cycles during Expansion Part A.
OG001
R/R DLBCL Expansion Part A: GEN3014
Participants with R/R DLBCL received GEN3014 IV infusion at a dose of 16 mg/kg in 28-day cycles during Expansion Part A.
Primary
Expansion Part B: ORR
ORR was defined as the percentage of participants with a PR or better based on IMWG criteria. Per IMWG criteria, PR was defined as ≥50% reduction of serum M-protein plus reduction in 24-h urinary M-protein by ≥90% or to <200 mg per 24 h. In addition to these criteria, if present at baseline, a ≥50% reduction in the size (SPD) of soft tissue plasmacytomas was also required.
Full Analysis set included all enrolled participants who received at least 1 dose of trial drug (GEN3014 or daratumumab SC).
Posted
Number
95% Confidence Interval
percentage of participants
Up to approximately 4 years 3 months
ID
Title
Description
OG000
RRMM Expansion Part B: Daratumumab
Participants with anti-CD38 mAb-naive RRMM received daratumumab at a dose of 1,800 mg by subcutaneous (SC) injection in 28-day treatment cycles.
OG001
RRMM Expansion Part B: GEN3014
Participants with anti-CD38 mAb-naive RRMM received GEN3014 IV infusion at a dose of 16 mg/kg in 28-day treatment cycles.
Units
Counts
Participants
Secondary
Dose Escalation and Expansion Part A: Maximum (Peak) Plasma Concentration (Cmax) of GEN3014
Venous blood samples were collected for analyzing concentrations of GEN3014. For the RRMM Dose Escalation 0.2/0.6 mg/kg arm, the participant underwent intraparticipant dose escalation in Cycle 1, where the participant received 0.2 mg/kg during the first week and 0.6 mg/kg from second week and beyond. Therefore, pharmacokinetic (PK) parameters were additionally calculated for Cycle 1 Day 8 dosing only in the RRMM Dose Escalation 0.2/0.6 mg/kg arm to account for the change in dosing over Cycle 1 in this arm.
PK Analysis Set=all participants exposed to GEN3014 who had 1+ PK sample collected with a valid bioanalytical result. Overall number of participants analyzed = number of participants evaluable for the outcome measure. Number analyzed=participants evaluable at the specified timepoint.
Posted
Geometric Mean
Geometric Coefficient of Variation
micrograms per milliliter (ug/mL)
Dose Escalation: Cycle 1 Day 1, Cycle 1 Day 8 (RRMM Dose Escalation: GEN3014 0.2/0.6 mg/kg only), Cycle 2 Day 1, Expansion Part A: Cycle 1 Day 1, Cycle 2 Day 1 (cycle =28 days)
ID
Title
Description
OG000
RRMM Dose Escalation: GEN3014 0.2/0.6 mg/kg
Participants with RRMM received GEN3014 at a dose of 0.2/0.6 mg/kg by IV infusion in 28-day treatment cycles. Intraparticipant dose escalation was performed in this arm (i.e., dose was escalated from 0.2-0.6 mg/kg).
OG001
RRMM Dose Escalation: GEN3014 2 mg/kg
Secondary
Dose Escalation, Expansion Part A and Expansion Part B: Pre-dose (Trough) Concentrations (Ctrough) of GEN3014
Venous blood samples were collected for analyzing concentrations of GEN3014. For the RRMM Dose Escalation 0.2/0.6 mg/kg arm, the participant underwent intraparticipant dose escalation in Cycle 1, where the participant received 0.2 mg/kg during the first week and 0.6 mg/kg from second week and beyond. Therefore, PK parameters were additionally calculated for Cycle 1 Day 8 dosing in the RRMM Dose Escalation 0.2/0.6 mg/kg arm to account for the change in dosing over Cycle 1 in this arm.
PK Analysis Set=all participants exposed to GEN3014 with 1+ PK sample with a valid bioanalytical result. Overall number of participants analyzed= participants evaluable for the outcome measure. Number analyzed=participants evaluable at specified timepoint.
Posted
Geometric Mean
Geometric Coefficient of Variation
ug/mL
Dose Escalation: Cycle (C) 1 Day (D) 1, C1D8 (RRMM GEN3014 0.2/0.6 mg/kg, R/R AML Dose Escalation), C2D1, Expansion Part A: C1D1, C2D1 (R/R DLBCL Expansion Part A: C1D8 and C2D8) Expansion Part B: C1D1, C1D8, C2D1, C3D1, C7D1, C8D1 (cycle = 28 days)
ID
Title
Description
OG000
RRMM Dose Escalation: GEN3014 0.2/0.6 mg/kg
Participants with RRMM received GEN3014 at a dose of 0.2/0.6 mg/kg by IV infusion in 28-day treatment cycles. Intraparticipant dose escalation was performed in this arm (i.e., dose was escalated from 0.2-0.6 mg/kg).
OG001
RRMM Dose Escalation: GEN3014 2 mg/kg
Secondary
Dose Escalation and Expansion Part A: Area Under the Concentration Time Curve From Zero to Last Quantifiable Sample (AUC0-last) of GEN3014
Venous blood samples were collected for analyzing concentrations of GEN3014. For the RRMM Dose Escalation 0.2/0.6 mg/kg arm, the participant underwent intraparticipant dose escalation in Cycle 1, where the participant received 0.2 mg/kg during the first week and 0.6 mg/kg from second week and beyond. Therefore, PK parameters were additionally calculated for Cycle 1 Day 8 dosing only in the RRMM Dose Escalation 0.2/0.6 mg/kg arm to account for the change in dosing over Cycle 1 in this arm.
PK Analysis Set=all participants exposed to GEN3014 with 1+ PK sample with a valid bioanalytical result. Overall number of participants analyzed=participants evaluable for the outcome measure. Number analyzed= participants evaluable at the specified timepoint.
Posted
Geometric Mean
Geometric Coefficient of Variation
day*ug/mL
Dose Escalation: Cycle 1 Day 1, Cycle 1 Day 8 (RRMM Dose Escalation: GEN3014 0.2/0.6 mg/kg only), Cycle 2 Day 1, Expansion Part A: Cycle 1 Day 1, Cycle 2 Day 1 (cycle =28 days)
ID
Title
Description
OG000
RRMM Dose Escalation: GEN3014 0.2/0.6 mg/kg
Participants with RRMM received GEN3014 at a dose of 0.2/0.6 mg/kg by IV infusion in 28-day treatment cycles. Intraparticipant dose escalation was performed in this arm (i.e., dose was escalated from 0.2-0.6 mg/kg).
OG001
RRMM Dose Escalation: GEN3014 2 mg/kg
Secondary
Dose Escalation and Expansion Part A: Area Under the Concentration Time Curve From Zero to 168 Hours (AUC0-168 h) of GEN3014
Venous blood samples were collected for analyzing concentrations of GEN3014. For the RRMM Dose Escalation 0.2/0.6 mg/kg arm, the participant underwent intraparticipant dose escalation in Cycle 1, where the participant received 0.2 mg/kg during the first week and 0.6 mg/kg from second week and beyond. Therefore, PK parameters were additionally calculated for Cycle 1 Day 8 dosing only in the RRMM Dose Escalation 0.2/0.6 mg/kg arm to account for the change in dosing over Cycle 1 in this arm.
PK Analysis Set=all participants exposed to GEN3014 with 1+ PK sample with a valid bioanalytical result. Overall number of participants analyzed=participants evaluable for the outcome measure. Number analyzed= participants evaluable at specified timepoint.
Posted
Geometric Mean
Geometric Coefficient of Variation
day*ug/mL
Dose Escalation: Cycle 1 Day 1, Cycle 1 Day 8 (RRMM Dose Escalation: GEN3014 0.2/0.6 mg/kg only), Cycle 2 Day 1, Expansion Part A: Cycle 1 Day 1, Cycle 2 Day 1 (R/R DLBCL Expansion Part A: Cycle 1 Day 1 only) (cycle =28 days)
ID
Title
Description
OG000
RRMM Dose Escalation: GEN3014 0.2/0.6 mg/kg
Participants with RRMM received GEN3014 at a dose of 0.2/0.6 mg/kg by IV infusion in 28-day treatment cycles. Intraparticipant dose escalation was performed in this arm (i.e., dose was escalated from 0.2-0.6 mg/kg).
OG001
RRMM Dose Escalation: GEN3014 2 mg/kg
Secondary
Dose Escalation and Expansion Part A: Number of Participants With Anti-Drug Antibodies (ADAs) to GEN3014
Venous blood samples were drawn for analysis of ADAs to GEN3014.
Immunogenicity Analysis Set=all enrolled participants who received at least 1 dose of trial drug, had a baseline and at least 1 evaluable on-treatment ADA sample.
Posted
Count of Participants
Participants
Dose Escalation: Baseline up to a max of approx. 34.5 months, Expansion Part A: Baseline up to a max of approx. 16.6 months
ID
Title
Description
OG000
RRMM Dose Escalation: GEN3014 0.2/0.6 mg/kg
Participants with RRMM received GEN3014 at a dose of 0.2/0.6 mg/kg by IV infusion in 28-day treatment cycles. Intraparticipant dose escalation was performed in this arm (i.e., dose was escalated from 0.2-0.6 mg/kg).
OG001
RRMM Dose Escalation: GEN3014 2 mg/kg
Participants with RRMM received GEN3014 at a dose of 2 mg/kg by IV infusion in 28-day treatment cycles.
OG002
RRMM Dose Escalation: GEN3014 4 mg/kg
Participants with RRMM received GEN3014 at a dose of 4 mg/kg by IV infusion in 28-day treatment cycles.
Secondary
Dose Escalation: ORR
ORR was defined as the percentage of participants with a PR or better. The response in RRMM Cohorts was assessed following IMWG criteria 2016. Per IMWG criteria, PR was defined as ≥50% reduction of serum M-protein plus reduction in 24-h urinary M-protein by ≥90% or to <200 mg per 24 h. In addition to these criteria, if present at baseline, a ≥50% reduction in the size (SPD) of soft tissue plasmacytomas was also required.
Full Analysis set included all enrolled participants who received at least 1 dose of trial drug (GEN3014 or daratumumab SC). Overall number of participants analyzed = participants evaluable for the outcome measure.
Posted
Number
95% Confidence Interval
percentage of participants
Up to approximately 4 years 3 months
ID
Title
Description
OG000
RRMM Dose Escalation: GEN3014 0.2/0.6 mg/kg
Participants with RRMM received GEN3014 at a dose of 0.2/0.6 mg/kg by IV infusion in 28-day treatment cycles. Intraparticipant dose escalation was performed in this arm (i.e., dose was escalated from 0.2-0.6 mg/kg).
OG001
RRMM Dose Escalation: GEN3014 2 mg/kg
Participants with RRMM received GEN3014 at a dose of 2 mg/kg by IV infusion in 28-day treatment cycles.
OG002
RRMM Dose Escalation: GEN3014 4 mg/kg
Secondary
Dose Escalation and Expansion Part A: Clinical Benefit Rate (CBR)
CBR was defined as the percentage of participants with a best overall response of minimal response (MR), partial response (PR), very good partial response (VGPR), complete response (CR) or stringent complete response (sCR) as determined by the investigator per IMWG response criteria for RRMM participants. MR=≥25% but ≤49% reduction of serum M-protein, reduction of 24-h urine by 50%-89% and if present at baseline, ≥50% reduction in the size (SPD) of soft tissue plasmacytomas. PR=≥50% reduction of serum M-protein, reduction in 24-h urinary M-protein by ≥90% or to <200mg/24h and if present at baseline,≥50% reduction in SPD of soft tissue plasmacytomas. VGPR=Serum+urine M-protein detectable by IFE but not electrophoresis or ≥90% reduction in serum M-protein+urine M-protein level <100mg/24h. CR=Negative IFE on serum/urine + disappearance of soft tissue plasmacytomas and ≤5% plasma cells in bone marrow aspirates. sCR=CR+normal FLC ratio, absence of clonal cells in bone marrow biopsy by IHC.
Full Analysis set included all enrolled participants who received at least 1 dose of trial drug (GEN3014 or daratumumab SC). Overall number of participants analyzed = participants evaluable for the outcome measure. As pre-specified, data for CBR was only collected and derived for RRMM participants.
Posted
Number
95% Confidence Interval
percentage of participants
Up to approximately 4 years 3 months
ID
Title
Description
OG000
RRMM Dose Escalation: GEN3014 0.2/0.6 mg/kg
Participants with RRMM received GEN3014 at a dose of 0.2/0.6 mg/kg by IV infusion in 28-day treatment cycles. Intraparticipant dose escalation was performed in this arm (i.e., dose was escalated from 0.2-0.6 mg/kg).
Secondary
Dose Escalation, Expansion Part A and Expansion Part B: Duration of Response (DOR)
DOR was defined as time from first response (PR or better) to timing of disease progression or death (due to any cause), whichever came first.
Full Analysis set=all enrolled participants who received at least 1 dose of trial drug (GEN3014 or daratumumab SC). Overall number of participants analyzed=participants evaluable for the outcome measure with a response.
Posted
Median
95% Confidence Interval
months
Up to approximately 4 years 3 months
ID
Title
Description
OG000
RRMM Dose Escalation: GEN3014 0.2/0.6 mg/kg
Participants with RRMM received GEN3014 at a dose of 0.2/0.6 mg/kg by IV infusion in 28-day treatment cycles. Intraparticipant dose escalation was performed in this arm (i.e., dose was escalated from 0.2-0.6 mg/kg).
OG001
RRMM Dose Escalation: GEN3014 2 mg/kg
Participants with RRMM received GEN3014 at a dose of 2 mg/kg by IV infusion in 28-day treatment cycles.
OG002
RRMM Dose Escalation: GEN3014 4 mg/kg
Participants with RRMM received GEN3014 at a dose of 4 mg/kg by IV infusion in 28-day treatment cycles.
Secondary
Dose Escalation, Expansion Part A and Expansion Part B: Time-to-response (TTR)
TTR was defined as the time from date of first dose, or date of randomization for participants in the Expansion Part B, to time of first response (PR or better).
Full Analysis set=all enrolled participants who received at least 1 dose of trial drug (GEN3014 or daratumumab SC). Overall number of participants analyzed=participants evaluable for the outcome measure with a response.
Posted
Median
Full Range
months
Up to approximately 4 years 3 months
ID
Title
Description
OG000
RRMM Dose Escalation: GEN3014 0.2/0.6 mg/kg
Participants with RRMM received GEN3014 at a dose of 0.2/0.6 mg/kg by IV infusion in 28-day treatment cycles. Intraparticipant dose escalation was performed in this arm (i.e., dose was escalated from 0.2-0.6 mg/kg).
OG001
RRMM Dose Escalation: GEN3014 2 mg/kg
Participants with RRMM received GEN3014 at a dose of 2 mg/kg by IV infusion in 28-day treatment cycles.
OG002
RRMM Dose Escalation: GEN3014 4 mg/kg
Participants with RRMM received GEN3014 at a dose of 4 mg/kg by IV infusion in 28-day treatment cycles.
Secondary
Dose Escalation, Expansion Part A and Expansion Part B: Progression-free Survival (PFS)
PFS was defined as the time from the date of first dose, or date of randomization for participants in the Expansion Part B, to the date of progression or death (due to any cause), whichever came first.
Full Analysis set=all enrolled participants who received at least 1 dose of trial drug (GEN3014 or daratumumab SC). Overall number of participants analyzed=participants evaluable for the outcome measure.
Posted
Median
95% Confidence Interval
months
Up to approximately 4 years 3 months
ID
Title
Description
OG000
RRMM Dose Escalation: GEN3014 0.2/0.6 mg/kg
Participants with RRMM received GEN3014 at a dose of 0.2/0.6 mg/kg by IV infusion in 28-day treatment cycles. Intraparticipant dose escalation was performed in this arm (i.e., dose was escalated from 0.2-0.6 mg/kg).
OG001
RRMM Dose Escalation: GEN3014 2 mg/kg
Participants with RRMM received GEN3014 at a dose of 2 mg/kg by IV infusion in 28-day treatment cycles.
OG002
RRMM Dose Escalation: GEN3014 4 mg/kg
Participants with RRMM received GEN3014 at a dose of 4 mg/kg by IV infusion in 28-day treatment cycles.
Secondary
Dose Escalation, Expansion Part A and Expansion Part B: Overall Survival (OS)
OS was defined as the time from the date of first dose, or date of randomization for participants in the Expansion Part B, to the date of death due to any cause.
Full Analysis set=all enrolled participants who received at least 1 dose of trial drug (GEN3014 or daratumumab SC). Overall number of participants analyzed=participants evaluable for the outcome measure.
Posted
Median
95% Confidence Interval
months
Up to approximately 4 years 3 months
ID
Title
Description
OG000
RRMM Dose Escalation: GEN3014 0.2/0.6 mg/kg
Participants with RRMM received GEN3014 at a dose of 0.2/0.6 mg/kg by IV infusion in 28-day treatment cycles. Intraparticipant dose escalation was performed in this arm (i.e., dose was escalated from 0.2-0.6 mg/kg).
OG001
RRMM Dose Escalation: GEN3014 2 mg/kg
Participants with RRMM received GEN3014 at a dose of 2 mg/kg by IV infusion in 28-day treatment cycles.
OG002
RRMM Dose Escalation: GEN3014 4 mg/kg
Participants with RRMM received GEN3014 at a dose of 4 mg/kg by IV infusion in 28-day treatment cycles.
Secondary
Expansion Part A and Part B: Number of Participants With AEs and SAEs
An AE was any untoward medical occurrence in a participant or clinical trial participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE was defined as an AE that met 1 of the following criteria: fatal or life-threatening, resulted in persistent or significant disability/incapacity, a congenital anomaly/birth defect, was medically significant (jeopardized the participant or may have required medical or surgical intervention to prevent one of the outcomes listed above), required inpatient hospitalization or prolongation of existing hospitalization. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.
Safety Analysis Set included all enrolled participants who received at least 1 dose of trial drug (GEN3014 or daratumumab SC).
Posted
Count of Participants
Participants
Up to approximately 4 years 3 months
ID
Title
Description
OG000
RRMM Expansion Part A: GEN3014
Participants with anti-CD38 mAb-naive RRMM received GEN3014 IV infusion at a dose of 16 mg/kg in 28-day cycles during Expansion Part A.
OG001
R/R DLBCL Expansion Part A: GEN3014
Secondary
Expansion Part B: Percentage of Participants With Very Good Partial Response (VGPR) or Better
Based on Investigator Assessment per IMWG 2016 Criteria, VGPR was defined as serum and urine M-protein detectable by immunofixation (IFE) but not on electrophoresis or ≥90% reduction in serum M-protein plus urine M-protein level <100 mg per 24 h. Data are reported for the percentage of participants with a VGPR or better.
Full Analysis set included all enrolled participants who received at least 1 dose of trial drug (GEN3014 or daratumumab SC). Overall number of participants analyzed = participants evaluable for the outcome measure.
Posted
Number
95% Confidence Interval
percentage of participants
Up to approximately 4 years 3 months
ID
Title
Description
OG000
RRMM Expansion Part B: Daratumumab
Participants with anti-CD38 mAb-naive RRMM received daratumumab at a dose of 1,800 mg by subcutaneous (SC) injection in 28-day treatment cycles.
OG001
RRMM Expansion Part B: GEN3014
Participants with anti-CD38 mAb-naive RRMM received GEN3014 IV infusion at a dose of 16 mg/kg in 28-day treatment cycles.
Units
Counts
Secondary
Expansion Part B: Percentage of Participants With Complete Response (CR) or Better
CR was defined as negative IFE on the serum and urine and disappearance of any soft tissue plasmacytomas and ≤5% plasma cells in bone marrow aspirates based on Investigator assessment per IMWG response criteria. Data are reported for the percentage of participants with CR or better.
Full Analysis set included all enrolled participants who received at least 1 dose of trial drug (GEN3014 or daratumumab SC). Overall number of participants analyzed=participants evaluable for the outcome measure.
Posted
Number
95% Confidence Interval
percentage of participants
Up to approximately 4 years 3 months
ID
Title
Description
OG000
RRMM Expansion Part B: Daratumumab
Participants with anti-CD38 mAb-naive RRMM received daratumumab at a dose of 1,800 mg by subcutaneous (SC) injection in 28-day treatment cycles.
OG001
RRMM Expansion Part B: GEN3014
Participants with anti-CD38 mAb-naive RRMM received GEN3014 IV infusion at a dose of 16 mg/kg in 28-day treatment cycles.
Units
Counts
Participants
Secondary
Expansion Part B: Time to Next Therapy (TTNT)
TTNT for participants in the Expansion Part B was defined as the time from randomization to the start of subsequent anti-cancer therapy. Participants who withdrew consent or were lost to follow up or died due to causes other than disease progression were censored at their last disease assessment.
Full Analysis set included all enrolled participants who received at least 1 dose of trial drug (GEN3014 or daratumumab SC).
Posted
Median
95% Confidence Interval
months
Up to approximately 4 years 3 months
ID
Title
Description
OG000
RRMM Expansion Part B: Daratumumab
Participants with anti-CD38 mAb-naive RRMM received daratumumab at a dose of 1,800 mg by subcutaneous (SC) injection in 28-day treatment cycles.
OG001
RRMM Expansion Part B: GEN3014
Participants with anti-CD38 mAb-naive RRMM received GEN3014 IV infusion at a dose of 16 mg/kg in 28-day treatment cycles.
Units
Counts
Participants
Secondary
Expansion Part B: Number of Participants With Anti-GEN3014 Antibodies and Anti-Daratumumab Antibodies
Venous blood samples were drawn for analysis of ADAs to GEN3014 and daratumumab. In the GEN3014 arm, participants were tested for anti-GEN3014-antibodies; in the daratumumab arm, participants were tested for anti-daratumumab-antibodies.
The Immunogenicity Analysis Set included all enrolled participants who received at least 1 dose of trial drug and had baseline ADA, and at least 1 evaluable on-treatment ADA sample. Overall number of participants analysed = participants evaluable for the OM.
Posted
Count of Participants
Participants
Cycle 1 Day 22 up to a maximum of approximately 23.9 months (cycles = 28 days)
ID
Title
Description
OG000
RRMM Expansion Part B: Daratumumab
Participants with anti-CD38 mAb-naive RRMM received daratumumab at a dose of 1,800 mg by subcutaneous (SC) injection in 28-day treatment cycles.
OG001
RRMM Expansion Part B: GEN3014
Participants with anti-CD38 mAb-naive RRMM received GEN3014 IV infusion at a dose of 16 mg/kg in 28-day treatment cycles.
Units
Counts
Participants
Time Frame
Up to approximately 4 years 3 months
Description
Safety set included all enrolled participants who received at least 1 dose of trial drug (GEN3014 or daratumumab SC). In the RRMM Dose Escalation: GEN3014 0.2/0.6 mg/kg arm, the participant underwent intraparticipant dose escalation in Cycle 1. As pre-specified, safety data were collected and are reported combined for both 0.2 and 0.6 mg/kg dose levels in this arm.
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
RRMM Dose Escalation: GEN3014 0.2/0.6 mg/kg
Participants with RRMM received GEN3014 at a dose of 0.2/0.6 mg/kg by IV infusion in 28-day treatment cycles. Intraparticipant dose escalation was performed in this arm (i.e., dose was escalated from 0.2-0.6 mg/kg).
1
1
1
1
1
1
EG001
RRMM Dose Escalation: GEN3014 2 mg/kg
Participants with RRMM received GEN3014 at a dose of 2 mg/kg by IV infusion in 28-day treatment cycles.
1
1
1
1
1
1
EG002
RRMM Dose Escalation: GEN3014 4 mg/kg
Participants with RRMM received GEN3014 at a dose of 4 mg/kg by IV infusion in 28-day treatment cycles.
1
3
1
3
3
3
EG003
RRMM Dose Escalation: GEN3014 8 mg/kg
Participants with RRMM received GEN3014 at a dose of 8 mg/kg by IV infusion in 28-day treatment cycles.
1
3
2
3
3
3
EG004
RRMM Dose Escalation: GEN3014 16 mg/kg
Participants with RRMM received GEN3014 at a dose of 16 mg/kg by IV infusion in 28-day treatment cycles.
4
11
6
11
11
11
EG005
RRMM Dose Escalation: GEN3014 24 mg/kg
Participants with RRMM received GEN3014 at a dose of 24 mg/kg by IV infusion in 28-day treatment cycles.
2
5
4
5
5
5
EG006
R/R AML Dose Escalation: GEN3014 Dose Level 1
Participants with R/R AML received GEN3014 at dose level 1 (low dose) in 28-day treatment cycles.
3
5
4
5
5
5
EG007
RRMM Expansion Part A: GEN3014
Participants with anti-CD38 mAb-naive RRMM received GEN3014 IV infusion at a dose of 16 mg/kg in 28-day cycles during Expansion Part A.
5
11
6
11
9
11
EG008
R/R DLBCL Expansion Part A: GEN3014
Participants with R/R DLBCL received GEN3014 IV infusion at a dose of 16 mg/kg in 28-day cycles during Expansion Part A.
2
2
1
2
2
2
EG009
RRMM Expansion Part B: Daratumumab
Participants with anti-CD38 mAb-naive RRMM received daratumumab at a dose of 1,800 mg by subcutaneous (SC) injection in 28-day treatment cycles.
9
43
11
43
34
43
EG010
RRMM Expansion Part B: GEN3014
Participants with anti-CD38 mAb-naive RRMM received GEN3014 IV infusion at a dose of 16 mg/kg in 28-day treatment cycles.
4
45
19
45
45
45
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Enterocolitis infectious
Infections and infestations
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected11 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected5 at risk
EG0070 events0 affected11 at risk
EG0080 events0 affected2 at risk
EG0091 events1 affected43 at risk
EG0100 events0 affected45 at risk
Dyspnoea
Respiratory, thoracic and mediastinal disorders
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Hypervolaemia
Metabolism and nutrition disorders
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Sinus bradycardia
Cardiac disorders
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected3 at risk
EG003
Staphylococcal infection
Infections and infestations
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Fibrin D dimer increased
Investigations
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Rhinovirus infection
Infections and infestations
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Death
General disorders and administration site conditions
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Atypical pneumonia
Infections and infestations
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Gastroenteritis
Infections and infestations
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Vomiting
Gastrointestinal disorders
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Diarrhoea
Gastrointestinal disorders
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Urinary tract infection
Infections and infestations
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Neutropenic sepsis
Infections and infestations
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Sepsis
Infections and infestations
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Embolism arterial
Vascular disorders
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Influenza
Infections and infestations
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Gastric haemorrhage
Gastrointestinal disorders
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Chondrocalcinosis
Musculoskeletal and connective tissue disorders
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Appendicitis
Infections and infestations
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Tumour lysis syndrome
Metabolism and nutrition disorders
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Pneumococcal sepsis
Infections and infestations
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Vascular device infection
Infections and infestations
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Streptococcal bacteraemia
Infections and infestations
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Anaemia
Blood and lymphatic system disorders
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Adenoviral upper respiratory infection
Infections and infestations
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Choroidal detachment
Eye disorders
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Administration related reaction
Injury, poisoning and procedural complications
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Lower respiratory tract infection
Infections and infestations
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Pyrexia
General disorders and administration site conditions
27.1
Systematic Assessment
EG0001 events1 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected3 at risk
EG003
Seizure
Nervous system disorders
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Angina unstable
Cardiac disorders
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Parainfluenzae virus infection
Infections and infestations
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
C-reactive protein increased
Investigations
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Upper respiratory tract infection
Infections and infestations
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Asthma
Respiratory, thoracic and mediastinal disorders
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Brain injury
Nervous system disorders
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Pancreatitis acute
Gastrointestinal disorders
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Cardiac arrest
Cardiac disorders
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Pneumonia fungal
Infections and infestations
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Urinary tract infection enterococcal
Infections and infestations
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Ischaemic stroke
Nervous system disorders
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Respiratory tract infection
Infections and infestations
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Tonsillitis
Infections and infestations
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
COVID-19
Infections and infestations
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Pneumonia
Infections and infestations
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0011 events1 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Infective exacerbation of asthma
Infections and infestations
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Infusion related reaction
Injury, poisoning and procedural complications
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0022 events1 affected3 at risk
EG003
Acute myocardial infarction
Cardiac disorders
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Atrial fibrillation
Cardiac disorders
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Respiratory syncytial virus test positive
Investigations
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Procedural pain
Injury, poisoning and procedural complications
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Pneumonia staphylococcal
Infections and infestations
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Febrile neutropenia
Blood and lymphatic system disorders
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Renal impairment
Renal and urinary disorders
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Gastrointestinal infection
Infections and infestations
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected11 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected5 at risk
EG0070 events0 affected11 at risk
EG0081 events1 affected2 at risk
EG0090 events0 affected43 at risk
EG0100 events0 affected45 at risk
Myalgia
Musculoskeletal and connective tissue disorders
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected3 at risk
EG003
Abdominal distension
Gastrointestinal disorders
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Bronchitis
Infections and infestations
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Blood urea increased
Investigations
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Dehydration
Metabolism and nutrition disorders
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Abdominal pain lower
Gastrointestinal disorders
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Vitreous floaters
Eye disorders
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Arthritis
Musculoskeletal and connective tissue disorders
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected3 at risk
EG003
General physical health deterioration
General disorders and administration site conditions
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Thirst
General disorders and administration site conditions
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Maculopathy
Eye disorders
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Alanine aminotransferase increased
Investigations
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected3 at risk
EG003
Tooth fracture
Injury, poisoning and procedural complications
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Acidosis
Metabolism and nutrition disorders
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Hyperuricaemia
Metabolism and nutrition disorders
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Acute kidney injury
Renal and urinary disorders
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Abdominal pain
Gastrointestinal disorders
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Bone pain
Musculoskeletal and connective tissue disorders
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Neutrophil count decreased
Investigations
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Ear infection
Infections and infestations
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Pain
General disorders and administration site conditions
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Sinus bradycardia
Cardiac disorders
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Hypertensive angiopathy
Vascular disorders
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Bacteraemia
Infections and infestations
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Cellulitis
Infections and infestations
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Fibrin D dimer increased
Investigations
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Non-cardiac chest pain
General disorders and administration site conditions
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Respiratory failure
Respiratory, thoracic and mediastinal disorders
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Catheter site haemorrhage
General disorders and administration site conditions
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Vestibular neuronitis
Infections and infestations
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Scapula fracture
Injury, poisoning and procedural complications
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0011 events1 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Haemorrhoids
Gastrointestinal disorders
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Weight decreased
Investigations
27.1
Systematic Assessment
EG0001 events1 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Mouth haemorrhage
Gastrointestinal disorders
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Gastritis erosive
Gastrointestinal disorders
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Vomiting
Gastrointestinal disorders
27.1
Systematic Assessment
EG0001 events1 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Eczema
Skin and subcutaneous tissue disorders
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Hypertransaminasaemia
Hepatobiliary disorders
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Oral candidiasis
Infections and infestations
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected3 at risk
EG003
Aspartate aminotransferase increased
Investigations
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Dry eye
Eye disorders
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Hyperphosphataemia
Metabolism and nutrition disorders
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Diarrhoea
Gastrointestinal disorders
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0022 events1 affected3 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Blood alkaline phosphatase increased
Investigations
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Gastroenteritis Escherichia coli
Infections and infestations
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected3 at risk
EG003
Urinary tract infection
Infections and infestations
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Disseminated intravascular coagulation
Blood and lymphatic system disorders
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Anxiety
Psychiatric disorders
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected3 at risk
EG003
Hypocalcaemia
Metabolism and nutrition disorders
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Renal failure
Renal and urinary disorders
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Device leakage
Product issues
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Syncope
Nervous system disorders
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Facial pain
General disorders and administration site conditions
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Chest pain
General disorders and administration site conditions
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Skin disorder
Skin and subcutaneous tissue disorders
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Conjunctival oedema
Eye disorders
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Throat irritation
Respiratory, thoracic and mediastinal disorders
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Fatigue
General disorders and administration site conditions
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Chillblains
Injury, poisoning and procedural complications
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Joint swelling
Musculoskeletal and connective tissue disorders
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Skin infection
Infections and infestations
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Hypophosphataemia
Metabolism and nutrition disorders
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Sepsis
Infections and infestations
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Tinnitus
Ear and labyrinth disorders
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Fall
Injury, poisoning and procedural complications
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected3 at risk
EG003
Oral pain
Gastrointestinal disorders
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Herpes virus infection
Infections and infestations
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Blood potassium increased
Investigations
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Varicose vein
Vascular disorders
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Hepatic steatosis
Hepatobiliary disorders
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Vertigo
Ear and labyrinth disorders
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Influenza
Infections and infestations
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Respiratory syncytial virus infection
Infections and infestations
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Dental caries
Gastrointestinal disorders
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Coccydynia
Musculoskeletal and connective tissue disorders
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Testicular pain
Reproductive system and breast disorders
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Haematoma
Vascular disorders
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Human metapneumovirus test positive
Investigations
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
27.1
Systematic Assessment
EG0001 events1 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Wheezing
Respiratory, thoracic and mediastinal disorders
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Chondrocalcinosis
Musculoskeletal and connective tissue disorders
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Iron deficiency
Metabolism and nutrition disorders
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected3 at risk
EG003
Candida infection
Infections and infestations
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Skin abrasion
Injury, poisoning and procedural complications
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Nasopharyngitis
Infections and infestations
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0022 events2 affected3 at risk
EG003
Rhinitis
Infections and infestations
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Paranasal sinus inflammation
Respiratory, thoracic and mediastinal disorders
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Blood creatinine increased
Investigations
27.1
Systematic Assessment
EG0001 events1 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Gallbladder obstruction
Hepatobiliary disorders
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Herpes simplex
Infections and infestations
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Rhinitis allergic
Respiratory, thoracic and mediastinal disorders
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Peripheral swelling
General disorders and administration site conditions
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Asthenia
General disorders and administration site conditions
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected3 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG00210 events3 affected3 at risk
EG003
Contusion
Injury, poisoning and procedural complications
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0012 events1 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Paraesthesia
Nervous system disorders
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Tendonitis
Musculoskeletal and connective tissue disorders
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Procalcitonin increased
Investigations
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Onychoclasis
Skin and subcutaneous tissue disorders
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Food poisoning
Gastrointestinal disorders
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Productive cough
Respiratory, thoracic and mediastinal disorders
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Peripheral sensory neuropathy
Nervous system disorders
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Cutaneous vasculitis
Skin and subcutaneous tissue disorders
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected3 at risk
EG003
Stomatitis
Gastrointestinal disorders
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Body temperature increased
Investigations
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected3 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Balance disorder
Nervous system disorders
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Rotavirus infection
Infections and infestations
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Hypotension
Vascular disorders
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Conjunctivitis
Infections and infestations
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Diabetes mellitus
Metabolism and nutrition disorders
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Oedema peripheral
General disorders and administration site conditions
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected3 at risk
EG003
Type 2 diabetes mellitus
Metabolism and nutrition disorders
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Hypothermia
General disorders and administration site conditions
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Hypogammaglobulinaemia
Immune system disorders
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0022 events1 affected3 at risk
EG003
Folliculitis
Infections and infestations
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Enterococcal infection
Infections and infestations
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Sinusitis
Infections and infestations
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Nausea
Gastrointestinal disorders
27.1
Systematic Assessment
EG0001 events1 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected3 at risk
EG003
Flushing
Vascular disorders
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Increased appetite
Metabolism and nutrition disorders
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Escherichia urinary tract infection
Infections and infestations
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Anaemia
Blood and lymphatic system disorders
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0011 events1 affected1 at risk
EG0021 events1 affected3 at risk
EG003
Melaena
Gastrointestinal disorders
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Osteorrhagia
Musculoskeletal and connective tissue disorders
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Administration related reaction
Injury, poisoning and procedural complications
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Lower respiratory tract infection
Infections and infestations
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Cystitis
Infections and infestations
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Pyrexia
General disorders and administration site conditions
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected3 at risk
EG003
Delirium
Psychiatric disorders
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Conjunctival haemorrhage
Eye disorders
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Gastric polyps
Gastrointestinal disorders
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Cataract
Eye disorders
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Haemophilus infection
Infections and infestations
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Subcutaneous abscess
Infections and infestations
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
C-reactive protein increased
Investigations
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected3 at risk
EG003
Hypermetropia
Eye disorders
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Leukocytosis
Blood and lymphatic system disorders
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Infection
Infections and infestations
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Gingival bleeding
Gastrointestinal disorders
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Upper respiratory tract infection
Infections and infestations
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected3 at risk
EG003
Squamous cell carcinoma of skin
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Restlessness
Psychiatric disorders
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0011 events1 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Upper respiratory tract infection bacterial
Infections and infestations
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Injection site reaction
General disorders and administration site conditions
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Chills
General disorders and administration site conditions
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Pharyngitis
Infections and infestations
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Blood folate decreased
Investigations
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Myocardial ischaemia
Cardiac disorders
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Viral upper respiratory tract infection
Infections and infestations
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Hypoacusis
Ear and labyrinth disorders
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Dermatitis allergic
Skin and subcutaneous tissue disorders
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Polyneuropathy
Nervous system disorders
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Skin papilloma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Retinopathy hypertensive
Eye disorders
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Clavicle fracture
Injury, poisoning and procedural complications
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0011 events1 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Influenza like illness
General disorders and administration site conditions
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Constipation
Gastrointestinal disorders
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Photophobia
Eye disorders
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Vitamin B12 deficiency
Metabolism and nutrition disorders
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected3 at risk
EG003
Hypoalbuminaemia
Metabolism and nutrition disorders
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Sciatica
Nervous system disorders
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Benign prostatic hyperplasia
Reproductive system and breast disorders
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Urinary retention
Renal and urinary disorders
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Obesity
Metabolism and nutrition disorders
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Oesophageal candidiasis
Infections and infestations
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Lymphopenia
Blood and lymphatic system disorders
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected3 at risk
EG003
Flank pain
Musculoskeletal and connective tissue disorders
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Angina pectoris
Cardiac disorders
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Gastritis
Gastrointestinal disorders
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Renal cyst
Renal and urinary disorders
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Gamma-glutamyltransferase increased
Investigations
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Myelopathy
Nervous system disorders
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Injection site erythema
General disorders and administration site conditions
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Dyspepsia
Gastrointestinal disorders
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Respiratory tract infection
Infections and infestations
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Retinopathy
Eye disorders
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Streptococcal infection
Infections and infestations
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Pancreatitis chronic
Gastrointestinal disorders
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected3 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Lymphocyte count decreased
Investigations
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected3 at risk
EG003
Lyme disease
Infections and infestations
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected3 at risk
EG003
Dientamoeba infection
Infections and infestations
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Gingival pain
Gastrointestinal disorders
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
COVID-19
Infections and infestations
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Rash pruritic
Skin and subcutaneous tissue disorders
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Pneumonia
Infections and infestations
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0011 events1 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Infusion related reaction
Injury, poisoning and procedural complications
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG00212 events2 affected3 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected3 at risk
EG003
Periorbital oedema
Eye disorders
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Electrocardiogram Q wave abnormal
Investigations
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Dizziness
Nervous system disorders
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Steroid diabetes
Metabolism and nutrition disorders
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Bradycardia
Cardiac disorders
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Atrial fibrillation
Cardiac disorders
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Hypernatraemia
Metabolism and nutrition disorders
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Leukopenia
Blood and lymphatic system disorders
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Atelectasis
Respiratory, thoracic and mediastinal disorders
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Dizziness postural
Nervous system disorders
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Headache
Nervous system disorders
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Hypertension
Vascular disorders
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Hypofibrinogenaemia
Blood and lymphatic system disorders
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
International normalised ratio increased
Investigations
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Lymphadenopathy
Blood and lymphatic system disorders
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Insomnia
Psychiatric disorders
27.1
Systematic Assessment
EG0001 events1 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Troponin I increased
Investigations
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Vaccination complication
Injury, poisoning and procedural complications
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Limb injury
Injury, poisoning and procedural complications
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected3 at risk
EG003
Vision blurred
Eye disorders
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0011 events1 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Febrile neutropenia
Blood and lymphatic system disorders
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Orchitis noninfective
Reproductive system and breast disorders
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Nodal rhythm
Cardiac disorders
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Bronchitis bacterial
Infections and infestations
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Urticaria
Skin and subcutaneous tissue disorders
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Flatulence
Gastrointestinal disorders
27.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
The overall study was terminated early. The AML Dose Escalation cohort and the DLBCL Expansion Part A cohort were terminated early due to enrollment challenges. The anti-CD38 mAb-refractory RRMM cohort and the R/R AML cohort in Expansion Part A were not opened.