A Dose-finding Study of CC-90009 in Subjects With Relapse... | NCT02848001 | Trialant
NCT02848001
Sponsor
Celgene
Status
Terminated
Last Update Posted
Jun 12, 2025Actual
Enrollment
101Actual
Phase
Phase 1
Conditions
Leukemia, Myeloid, Acute
Myelodysplastic Syndromes
Interventions
CC-90009
Countries
United States
Canada
France
Norway
Spain
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT02848001
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
CC-90009-AML-001
Secondary IDs
ID
Type
Description
Link
2017-001535-39
EudraCT Number
Brief Title
A Dose-finding Study of CC-90009 in Subjects With Relapsed or Refractory Acute Myeloid Leukemia or Relapsed or Refractory Higher-risk Myelodysplastic Syndromes
Official Title
A Phase 1, Open-label, Dose Finding Study of CC-90009, a Novel Cereblon E3 Ligase Modulating Drug, in Subjects With Relapsed or Refractory Acute Myeloid Leukemia or Relapsed or Refractory Higher-Risk Myelodysplastic Syndromes
Acronym
Not provided
Organization
CelgeneINDUSTRY
Status Module
Record Verification Date
May 2025
Overall Recruitment Status or Expanded Access Status
Terminated
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Trial terminated because of lack of efficacy in the short term acute phase.
Expanded Access Info
No
Start Date
Nov 14, 2016Actual
Primary Completion Date
Apr 11, 2023Actual
Completion Date
Apr 11, 2024Actual
First Submitted Date
Jun 22, 2016
First Submission Date that Met QC Criteria
Jul 25, 2016
First Posted Date
Jul 28, 2016Estimated
Results Waived
Not provided
Results First Submitted Date
Apr 11, 2025
Results First Submitted that Met QC Criteria
May 27, 2025
Results First Posted Date
Jun 12, 2025Actual
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
May 27, 2025
Last Update Posted Date
Jun 12, 2025Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
CelgeneINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
CC-90009-AML-001 is a phase 1, open-label, dose escalation and expansion, study in subjects with relapsed or refractory acute myeloid leukemia and relapsed or refractory higher-risk myelodysplastic syndrome.
Detailed Description
Study CC-90009-AML-001 is an open-label, Phase 1, dose escalation and expansion, first-in-human clinical study of CC-90009 in subjects with relapsed or refractory acute myeloid leukemia (AML) and relapsed or refractory higher-risk myelodysplastic syndrome.
The dose escalation part (Part A) of the study will evaluate the safety and tolerability of escalating doses of CC-90009 in relapsed and refractory AML. The expansion part, (Part B), will further evaluate the safety and efficacy of CC-90009 administered at or below the maximum tolerated dose (MTD) in selected expansion cohorts of one or more dosing regimens in order to determine the recommended Phase 2 dose (RP2D) for subjects with relapsed or refractory AML and relapsed or refractory higher-risk myelodysplastic syndrome.
Conditions Module
Conditions
Leukemia, Myeloid, Acute
Myelodysplastic Syndromes
Keywords
CC-90009
Hematologic Cancers
Leukemia
Acute Myeloid Leukemia
Myelodysplastic Syndrome
AML
MDS
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 1
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
101Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
CC-90009 - Part A
Experimental
Will be administered intravenously per dosing schedule in a 28-day cycle.
Drug: CC-90009
CC-90009 - Part B - AML and MDS patients
Experimental
Relapsed or refractory AML and MDS subjects. IP will be administered intravenously per dosing schedule determined in Part A
Drug: CC-90009
Interventions
Name
Type
Description
Arm Group Labels
Other Names
CC-90009
Drug
CC-90009
CC-90009 - Part A
CC-90009 - Part B - AML and MDS patients
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Number of Participants With Dose Limiting Toxicity (DLTs)
A participant evaluable for DLT is defined as one that: Has received at least 80% of the total planned Cycle 1 dose (eg, ≥ 4 CC-90009 doses for the Days 1-5 schedule to be completed on or before Day 10, ≥ 6 CC-90009 doses for the Days 1- 7 schedule to be completed on or before Day 10, ≥8 doses by Day 14 for the Days 1-10 schedule, or ≥ 5 doses by Day 14 for the D1-3/D8-10 schedule) of CC-90009 during Cycle 1 without experiencing a DLT, Or; Experienced a DLT after receiving at least one dose (or fraction thereof) of CC-90009 in part A.
From first dose to at least 28 days and up to 42 days post first dose (Up to 42 days)
Secondary Outcomes
Measure
Description
Time Frame
Non-Tolerated Dose (NTD) of CC-90009
The NTD is defined as a dose level at which 2 or more of up to 6 evaluable participants in any dose cohort experience a DLT in Cycle 1 during dose escalation (Part A)
From first dose to at least 28 days and up to 42 days post first dose (Up to 42 days)
Maximum Tolerated Dose (MTD) of CC-90009
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Men and women ≥ 18 years of age, at the time of signing the ICD (Informed Consent Document).
Subject must understand and voluntarily sign an ICD prior to any study-related assessments/procedures being conducted.
Relapsed or refractory AML (Acute Myeloid Leukemia) (Parts A and B) or relapsed or refractory (R/R) higher-risk MDS (Myelodysplastic Syndrome) (HR-MDS) (Part B only) as defined by World Health Organization criteria who are not suitable for other established therapies.
In Part A, R/R AML
In Part B, R/R AML including
Relapsed after allogeneic HSCT or
In second or later relapse or
Refractory to initial induction or re-induction treatment or
Refractory or relapse after HMA treatment (HMA failure defined as primary progression or lack of clinical benefit after a minimum of 6 cycles or unable to tolerate HMA due to toxicity) or
Refractory within 1 year of initial treatment (excluding those with favorable risk based on cytogenetics)
In Part B, R/R HR-MDS (Revised International Prognostic Scoring System score (IPSS-R) > 3.5 points, IPSS-R calculated during screening period):
IPSS-R intermediate risk (in combination with more than 10% bone marrow blasts or poor or very poor IPSS-R cytogenetic risk) or
IPSS-R high or
IPSS-R very high risk
Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 to 2.
At least 4 weeks (from first dose) has elapsed from donor lymphocyte infusion (DLI) without conditioning.
Subjects must have the following screening laboratory values:
Corrected serum Ca or free (ionized) serum Ca within normal limits (WNL).
o Corrected Ca (mg/dL) = Total Ca (mg/dL) - 0.8 (albumin [g/dL] - 4)
Total White Blood Cell count (WBC) < 25 x 10^9/L prior to first infusion. Prior or concurrent treatment with hydroxyurea to achieve this level is allowed.
Potassium and magnesium within normal limits or correctable with supplements.
Aspartate aminotransferase/serum glutamic oxaloacetic transaminase (AST/SGOT) or alanine aminotransferase/serum glutamate pyruvic transaminase (ALT/SGPT) ≤ 2.5 x Upper Limit of Normal (ULN).
Uric acid ≤ 7.5 mg/dL (446 μmol/L). Prior and/or concurrent treatment with hypouricemic agents (eg, allopurinol, rasburicase) are allowed.
Selected electrolytes within normal limits or correctable with supplements.
Serum bilirubin ≤ 1.5 x ULN (upper limit of normal).
Estimated serum creatinine clearance of ≥ 60 mL/min using the Cockcroft-Gault equation. Measured creatinine clearance from a 24-hour urine collection is acceptable if clinically indicated.
International normalized ratio (INR) < 1.5 x ULN and Partial thromboplastin time (PTT) < 1.5 x ULN.
Exclusion Criteria:
Subjects with acute promyelocytic leukemia (APL)
Subjects with clinical symptoms suggesting active central nervous system (CNS) leukemia or known CNS leukemia. Evaluation of cerebrospinal fluid is only required if there is clinical suspicion of CNS involvement by leukemia during screening.
Patients with prior autologous hematopoietic stem cell transplant who, in the investigator's judgment, have not fully recovered from the effects of the last transplant (e.g., transplant related side effects).
Prior allogeneic hematopoietic stem cell transplant (HSCT) with either standard or reduced intensity conditioning ≤ 6 months prior to starting CC-90009.
Subjects on systemic immunosuppressive therapy post HSCT at the time of screening, or with clinically significant graft-versus-host disease (GVHD).
Prior systemic cancer-directed treatments or investigational modalities ≤ 5 half lives or 4 weeks prior to starting CC-90009, whichever is shorter. Hydroxyurea is allowed to control peripheral leukemia blasts.
Leukapheresis ≤ 2 weeks prior to starting CC-90009.
Surka C, Jin L, Mbong N, Lu CC, Jang IS, Rychak E, Mendy D, Clayton T, Tindall E, Hsu C, Fontanillo C, Tran E, Contreras A, Ng SWK, Matyskiela M, Wang K, Chamberlain P, Cathers B, Carmichael J, Hansen J, Wang JCY, Minden MD, Fan J, Pierce DW, Pourdehnad M, Rolfe M, Lopez-Girona A, Dick JE, Lu G. CC-90009, a novel cereblon E3 ligase modulator, targets acute myeloid leukemia blasts and leukemia stem cells. Blood. 2021 Feb 4;137(5):661-677. doi: 10.1182/blood.2020008676.
The MTD is defined as the last dose level(s) below the NTD with 0 or 1 out of 6 evaluable participants experiencing a DLT in Cycle 1 during dose escalation (part A).
From first dose to at least 28 days and up to 42 days post first dose (Up to 42 days)
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
An AE is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a participant during the course of a study using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Treatment-emergent adverse events (TEAEs) are defined as any AEs that begin on or after the start of study drug through 28 days after the last dose of study drug or serious AEs that are suspected of being related to study drug.
From first dose until 28 days post last dose (Up to 25 months)
Change From Baseline by Laboratory Test - Chemistry Parameters 1
Change from baseline for chemistry laboratory parameters. Baseline = last value before start of treatment
From baseline until 28 days post last dose (Up to 25 months)
Change From Baseline by Laboratory Test - Chemistry Parameters 2
Change from baseline for chemistry laboratory parameters. Baseline = last value before start of treatment
From baseline until 28 days post last dose (Up to 25 months)
Change From Baseline by Laboratory Test - Chemistry Parameters 3
Change from baseline for chemistry laboratory parameters. Baseline = last value before start of treatment
From baseline until 28 days post last dose (Up to 25 months)
Change From Baseline for Vital Signs by Test - Parameters 1
Change from Baseline for Vital Signs Parameters. Baseline = last value before start of treatment.
From baseline until 28 days post last dose (Up to 25 months)
Change From Baseline for Vital Signs by Test - Parameters 2
Change from Baseline for Vital Signs Parameters. Baseline = last value before start of treatment.
From baseline until 28 days post last dose (Up to 25 months)
Change From Baseline for Vital Signs by Test - Parameters 3
Change from Baseline for Vital Signs Parameters. Baseline = last value before start of treatment.
From baseline until 28 days post last dose (Up to 25 months)
Change From Baseline for Vital Signs by Test - Parameters 4
Change from Baseline for Vital Signs Parameters. Baseline = last value before start of treatment.
From baseline until 28 days post last dose (Up to 25 months)
Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 1
Change from Baseline for Electrocardiogram (ECG) Parameters. Baseline = last value before start of treatment.
From baseline until 28 days post last dose (Up to 25 months)
Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 2
Change from Baseline for Electrocardiogram (ECG) Parameters. Baseline = last value before start of treatment.
From baseline until 28 days post last dose (Up to 25 months)
Eastern Cooperative Oncology Group (ECOG) Performance Status
Number of participants with post-baseline grade increase or decrease from baseline. Grade 0=; Grade 1=; Grade 2=; Grade 3=; Grade 4=; Grade 5=; . Baseline = last value before start of treatment.
From baseline until 28 days post last dose (Up to 25 months)
Left Ventricular Ejection Fraction (LVEF) Percent Change From Baseline
Left Ventricular Ejection Fraction (LVEF) percent change from baseline. Baseline = last value before start of treatment.
Minimum Post Baseline Value=lowest value of the measured parameter is recorded after the baseline measurement.
Maximum Post Baseline Value=highest value of the measured parameter is recorded after the baseline measurement.
From baseline until 28 days post last dose (Up to 25 months)
Objective Response Rate (ORR)
Objectve response is defined as the percent of participants whose best overall response is any type of Morphologic Complete Remission [CR] (CR, Morphologic Complete Remission with Incomplete Blood Count Recovery (CRi), Morphologic Complete Remission with Partial Hematologic Recovery (CRh), Cytogenetic Complete Remission (CRc) and Molecular Complete Remission (CRm)) or Morphologic Leukemia - Free State or partial remission. CR=neutrophils ≥ 1,000μL, platelets ≥100,000μL, blasts <5%; CRi=residual neutropenia < 1,000/μL, thrombocytopenia < 100,000/μL. CRh=neutrophils ≥ 500μL, platelets ≥500,000μL, blasts <5%; CRc=neutrophils ≥ 1,000μL, platelets ≥100,000μL, blasts <5%; cytogenetics normal; CRm=neutrophils ≥ 1,000μL, platelets ≥100,000μL, blasts <5%, negative EMD; PR=neutrophils ≥ 1,000μL, platelets ≥100,000μL, blasts decrease in ≥ 50 resulting in 5 to 25%.
Up to approximately 25 months after the last dose
Overall Survival (OS)
OS is defined as the time from the date of the first dose to the date of death from any cause.
Up to approximately 25 months after the last dose
Relapse-free Survival (RFS)
RFS is defined only for participants who achieved CR or CRi (for AML) / CR or PR (for MDS) and is measured as the interval from the date of first CR or CRi (for AML) / CR or PR (for MDS) to the date of relapse or death from any cause, whichever occurs first. CR=neutrophils ≥ 1,000μL, platelets ≥100,000μL, blasts <5%; CRi=residual neutropenia < 1,000 μL, thrombocytopenia < 100,000/μL. PR=neutrophils ≥ 1,000μL, platelets ≥100,000μL, blasts decrease in ≥ 50 resulting in 5 to 25%.
Up to approximately 25 months after the last dose
Progression-free Survival (PFS)
PFS is defined as the time from the date of the first dose to the date of first relapse after CR/CRi (for AML)/relapse after CR/PR(for MDS), or PD, or death resulting from any cause, whichever occurs first. CR=neutrophils ≥ 1,000μL, platelets ≥100,000μL, blasts <5%; CRi=residual neutropenia < 1,000 μL, thrombocytopenia < 100,000/μL. PR=neutrophils ≥ 1,000μL, platelets ≥100,000μL, blasts decrease in ≥ 50 resulting in 5 to 25%. PD=At least 50% decrement from maximum remission/response levels in granulocytes or platelets; Reduction in Hgb concentration by ≥ 2 g/dL; Transfusion dependence. Based on Kaplan-Meier Estimates.
Up to approximately 25 months after the last dose
Event-free Survival (EFS)
EFS is defined as the interval from the date of the first dose to an event including disease progression (PD), treatment failure, relapse, or death from any cause, whichever occurs first. PD=At least 50% decrement from maximum remission/response levels in granulocytes or platelets; Reduction in Hgb concentration by ≥ 2 g/dL; Transfusion dependence. Based on Kaplan-Meier Estimates.
Up to approximately 25 months after the last dose
Duration of Remission/Response (DOR)
DOR is defined as the time from first remission/response observed to the date of relapse, death or PD. PD=At least 50% decrement from maximum remission/response levels in granulocytes or platelets; Reduction in Hgb concentration by ≥ 2 g/dL; Transfusion dependence. Based on Kaplan-Meier Estimates.
Up to approximately 25 months after the last dose
Time to Remission/Response (TTR)
TTR is defined as the time between the date of first dose and the earliest date any remission/response (any complete remissions or partial remissions or better) is observed. CR=neutrophils ≥ 1,000μL, platelets ≥100,000μL, blasts <5%; CRi=residual neutropenia < 1,000 μL, thrombocytopenia < 100,000/μL. CRh=neutrophils ≥ 500μL, platelets ≥500,000μL, blasts <5%; CRc=neutrophils ≥ 1,000μL, platelets ≥100,000μL, blasts <5%; cytogenetics normal; CRm=neutrophils ≥ 1,000μL, platelets ≥100,000μL, blasts <5%, negative EMD; PR=neutrophils ≥ 1,000μL, platelets ≥100,000μL, blasts decrease in ≥ 50 resulting in 5 to 25%. Based on Kaplan-Meier Estimates.
Up to approximately 25 months after the last dose
Complete Remission Rate (CRR)
The complete remission rate (CRR) is defined as the percent of participants whose best overall response is any type of Morphologic Complete Remission [CR] (CR, Morphologic Complete Remission with Incomplete Blood Count Recovery (CRi), Morphologic Complete Remission with Partial Hematologic Recovery (CRh), Cytogenetic Complete Remission (CRc) and Molecular Complete Remission (CRm)). CR=neutrophils ≥ 1,000μL, platelets ≥100,000μL, blasts <5%; CRi=residual neutropenia < 1,000/μL, thrombocytopenia < 100,000/μL. CRh=neutrophils ≥ 500μL, platelets ≥500,000μL, blasts <5%; CRc=neutrophils ≥ 1,000μL, platelets ≥100,000μL, blasts <5%; cytogenetics normal; CRm=neutrophils ≥ 1,000μL, platelets ≥100,000μL, blasts <5%, negative EMD.
Up to approximately 88 months
Time to Acute Myeloid Leukemia (AML) Transformation
Time to acute AML transformation in part B Myelodysplastic Syndromes (MDS) participants only. Based on Kaplan-Meier Estimates.
Up to approximately 88 months
Maximum Observed Plasma Concentration (Cmax)
Maximum observed plasma concentration, obtained directly from the observed concentration versus time data
Cycle 1 Day 1(C1D1), C1D5, C1D7, C1D8, C1D10,
Time to Peak Plasma Concentration (Tmax)
Time to peak plasma concentration, obtained directly from the observed concentration versus time data.
Cycle 1 Day 1(C1D1), C1D5, C1D7, C1D8, C1D10. 1 cycle = 28 days
Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours Post-dose (AUC 0 - 24)
Area under the plasma concentration-time curve from Time 0 to 24 hours post-dose.
Cycle 1 Day 1(C1D1), C1D5, C1D7, C1D8, C1D10. 1 cycle = 28 days
Terminal Phase Elimination Half-life (T1/2)
Terminal phase elimination half-life calculated as [(ln 2)/λz], where λz is the apparent terminal rate constant. t1/2 will only be calculated when a reliable estimate for λz can be obtained.
Cycle 1 Day 1(C1D1) and C1D5. 1 cycle = 28 days
Total Body Clearance (CL)
Total plasma clearance after IV administration, calculated as [Dose/ AUC(INF)] following single administration, and [Dose/ AUC(0-24)] at steady state.
Cycle 1 Day 1(C1D1), C1D5, C1D7, C1D8, C1D10. 1 cycle = 28 days
Volume of Distribution (Vz)
Volume of distribution calculated at first dose only. Calculated as [Vz = Dose/ AUC(INF) * λz for Day 1].
Part A - CC-90009 QD 3.6 mg + Dexamethasone 10 mg IV (Days 1 - 5 of 28)
FG007
Part A - 4.5 mg
Part A - CC-90009 daily (QD) 4.5 mg (Days 1 - 5 of 28)
FG008
Part A - 3.6 mg (Days 1 - 7 of 28)
Part A - CC-90009 QD 3.6 mg (Days 1 - 7 of 28)
FG009
Part A - 3.0 mg (Days 1- 10 of 28)
Part A - CC-90009 QD 3.0 mg (Days 1- 10 of 28)
FG010
Part A - 3.0 mg (Day 1 - 3 & Day 8 - 10 of 28)
Part A - CC-90009 daily (QD) 3.0 mg (Day 1 - 3 & Day 8 - 10 of 28)
FG011
Part A - 3.6 mg (Day 1 - 3 & Day 8 - 10 of 28)
Part A - CC-90009 daily (QD) 3.6 mg (Day 1 - 3 & Day 8 - 10 of 28)
FG012
Part B - AML 3.6 mg + DEX
Part B - 3.6 mg + DEX (Days 1 - 5 of 28)
FG013
Part B - MDS 3.6 mg + DEX
Part B - MDS CC-90009 3.6 mg + Dexamethasone (Days 1 - 5 of 28)
FG014
Part B - AML 2.4 mg
Part B - AML CC-90009 2.4 mg (Days 1 - 7 of 28)
FG015
Part B - AML 3.0 mg
Part B - 3.0 mg (Days 1 - 7 of 28)
FG016
Part B - MDS 3.0 mg
Part B - MDS 3.0 mg (Days 1 - 7 of 28)
FG0002 subjects
FG0012 subjects
FG0022 subjects
FG0037 subjects
FG00415 subjects
FG0053 subjects
FG0068 subjects
FG0077 subjects
FG0087 subjects
FG0099 subjects
FG0103 subjects
FG0117 subjects
FG0128 subjects
FG0132 subjects
FG0149 subjects
FG0159 subjects
FG0161 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0141 subjects
FG0150 subjects
FG0160 subjects
NOT COMPLETED
FG0002 subjects
FG0012 subjects
FG0022 subjects
FG0037 subjects
FG00415 subjects
FG0053 subjects
FG0068 subjects
FG0077 subjects
FG0087 subjects
FG0099 subjects
FG0103 subjects
FG0117 subjects
FG0128 subjects
FG0132 subjects
FG0148 subjects
FG0159 subjects
FG0161 subjects
Type
Comment
Reasons
other reasons
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG0044 subjects
FG0051 subjects
FG0060 subjects
FG0072 subjects
FG0082 subjects
FG0093 subjects
FG0100 subjects
FG0111 subjects
FG0121 subjects
FG0130 subjects
FG0140 subjects
FG0152 subjects
FG0161 subjects
Lack of Efficacy
FG0000 subjects
FG0011 subjects
FG0021 subjects
FG0032 subjects
FG004
Progressive Disease
FG0002 subjects
FG0011 subjects
FG0020 subjects
FG0034 subjects
FG004
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Death
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG004
Physician Decision
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Part A - 0.3 mg
Part A - CC-90009 QD 0.3 mg (Days 1 - 5 of 28)
BG001
Part A - 0.6 mg
Part A - CC-90009 QD 0.6 mg (Days 1 - 5 of 28)
BG002
Part A - 1.2 mg
Part A - CC-90009 QD 1.2 mg (Days 1 - 5 of 28)
BG003
Part A - 2.4 mg
Part A - 2.4 mg (Days 1 - 5 of 28)
BG004
Part A - 3.0 mg
Part A - CC-90009 QD 3.0 mg (Days 1 - 5 of 28)
BG005
Part A - 3.6 mg
Part A - CC-90009 QD 3.6 mg (Days 1 - 5 of 28)
BG006
Part A - 3.6 mg + DEX
Part A - CC-90009 QD 3.6 mg + Dexamethasone 10 mg IV (Days 1 - 5 of 28)
BG007
Part A - 4.5 mg
Part A - CC-90009 daily (QD) 4.5 mg (Days 1 - 5 of 28)
BG008
Part A - 3.6 mg (Days 1 - 7 of 28)
Part A - CC-90009 QD 3.6 mg (Days 1 - 7 of 28)
BG009
Part A - 3.0 mg (Days 1- 10 of 28)
Part A - CC-90009 QD 3.0 mg (Days 1- 10 of 28)
BG010
Part A - 3.0 mg (Day 1 - 3 & Day 8 - 10 of 28)
Part A - CC-90009 daily (QD) 3.0 mg (Day 1 - 3 & Day 8 - 10 of 28)
BG011
Part A - 3.6 mg (Day 1 - 3 & Day 8 - 10 of 28)
Part A - CC-90009 daily (QD) 3.6 mg (Day 1 - 3 & Day 8 - 10 of 28)
BG012
Part B - AML 3.6 mg + DEX
Part B - 3.6 mg + DEX (Days 1 - 5 of 28)
BG013
Part B - MDS 3.6 mg + DEX
Part B - MDS CC-90009 3.6 mg + Dexamethasone (Days 1 - 5 of 28)
BG014
Part B - AML 2.4 mg
Part B - AML CC-90009 2.4 mg (Days 1 - 7 of 28)
BG015
Part B - AML 3.0 mg
Part B - 3.0 mg (Days 1 - 7 of 28)
BG016
Part B - MDS 3.0 mg
Part B - MDS 3.0 mg (Days 1 - 7 of 28)
BG017
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0002
BG0012
BG0022
BG0037
BG00415
BG0053
BG0068
BG0077
BG0087
BG0099
BG0103
BG0117
BG0128
BG0132
BG0149
BG0159
BG0161
BG017101
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
Years
Title
Denominators
Categories
Title
Measurements
BG00064.0± 8.49
BG00170.0± 11.31
BG00260.0± 8.49
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0001
BG0012
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0001
BG0010
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Number of Participants With Dose Limiting Toxicity (DLTs)
A participant evaluable for DLT is defined as one that: Has received at least 80% of the total planned Cycle 1 dose (eg, ≥ 4 CC-90009 doses for the Days 1-5 schedule to be completed on or before Day 10, ≥ 6 CC-90009 doses for the Days 1- 7 schedule to be completed on or before Day 10, ≥8 doses by Day 14 for the Days 1-10 schedule, or ≥ 5 doses by Day 14 for the D1-3/D8-10 schedule) of CC-90009 during Cycle 1 without experiencing a DLT, Or; Experienced a DLT after receiving at least one dose (or fraction thereof) of CC-90009 in part A.
All treated participants in dose escalation (Part A)
Posted
Count of Participants
Participants
From first dose to at least 28 days and up to 42 days post first dose (Up to 42 days)
ID
Title
Description
OG000
Part A - 0.3 mg
Part A - CC-90009 QD 0.3 mg (Days 1 - 5 of 28)
OG001
Part A - 0.6 mg
Part A - CC-90009 QD 0.6 mg (Days 1 - 5 of 28)
OG002
Part A - 1.2 mg
Part A - CC-90009 QD 1.2 mg (Days 1 - 5 of 28)
OG003
Part A - 2.4 mg
Part A - 2.4 mg (Days 1 - 5 of 28)
OG004
Part A - 3.0 mg
Part A - CC-90009 QD 3.0 mg (Days 1 - 5 of 28)
OG005
Part A - 3.6 mg
Part A - CC-90009 QD 3.6 mg (Days 1 - 5 of 28)
OG006
Part A - 3.6 mg + DEX
Part A - CC-90009 QD 3.6 mg + Dexamethasone 10 mg IV (Days 1 - 5 of 28)
OG007
Part A - 4.5 mg
Part A - CC-90009 daily (QD) 4.5 mg (Days 1 - 5 of 28)
OG008
Part A - 3.6 mg (Days 1 - 7 of 28)
Part A - CC-90009 QD 3.6 mg (Days 1 - 7 of 28)
OG009
Part A - 3.0 mg (Days 1- 10 of 28)
Part A - CC-90009 QD 3.0 mg (Days 1- 10 of 28)
OG010
Part A - 3.0 mg (Day 1 - 3 & Day 8 - 10 of 28)
Part A - CC-90009 daily (QD) 3.0 mg (Day 1 - 3 & Day 8 - 10 of 28)
OG011
Part A - 3.6 mg (Day 1 - 3 & Day 8 - 10 of 28)
Part A - CC-90009 daily (QD) 3.6 mg (Day 1 - 3 & Day 8 - 10 of 28)
Units
Counts
Participants
OG0002
OG0012
OG0022
OG003
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG003
Secondary
Non-Tolerated Dose (NTD) of CC-90009
The NTD is defined as a dose level at which 2 or more of up to 6 evaluable participants in any dose cohort experience a DLT in Cycle 1 during dose escalation (Part A)
All treated participants in dose escalation (Part A)
Posted
Number
mg
From first dose to at least 28 days and up to 42 days post first dose (Up to 42 days)
ID
Title
Description
OG000
Dose Escalation (Part A)
Dose Escalation (Part A) of CC-90009
Units
Counts
Participants
OG00072
Secondary
Maximum Tolerated Dose (MTD) of CC-90009
The MTD is defined as the last dose level(s) below the NTD with 0 or 1 out of 6 evaluable participants experiencing a DLT in Cycle 1 during dose escalation (part A).
All treated participants in dose escalation (Part A)
Posted
Number
mg
From first dose to at least 28 days and up to 42 days post first dose (Up to 42 days)
ID
Title
Description
OG000
Dose Escalation (Part A)
Dose Escalation (Part A) of CC-90009
Units
Counts
Participants
OG00072
Secondary
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
An AE is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a participant during the course of a study using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Treatment-emergent adverse events (TEAEs) are defined as any AEs that begin on or after the start of study drug through 28 days after the last dose of study drug or serious AEs that are suspected of being related to study drug.
All treated participants
Posted
Count of Participants
Participants
From first dose until 28 days post last dose (Up to 25 months)
ID
Title
Description
OG000
Part A - 0.3 mg
Part A - CC-90009 QD 0.3 mg (Days 1 - 5 of 28)
OG001
Part A - 0.6 mg
Part A - CC-90009 QD 0.6 mg (Days 1 - 5 of 28)
OG002
Part A - 1.2 mg
Part A - CC-90009 QD 1.2 mg (Days 1 - 5 of 28)
OG003
Part A - 2.4 mg
Secondary
Change From Baseline by Laboratory Test - Chemistry Parameters 1
Change from baseline for chemistry laboratory parameters. Baseline = last value before start of treatment
All treated participants with baseline and post baseline measurements
Posted
Mean
Standard Deviation
g/L
From baseline until 28 days post last dose (Up to 25 months)
ID
Title
Description
OG000
Part A - 0.3 mg
Part A - CC-90009 QD 0.3 mg (Days 1 - 5 of 28)
OG001
Part A - 0.6 mg
Part A - CC-90009 QD 0.6 mg (Days 1 - 5 of 28)
OG002
Part A - 1.2 mg
Part A - CC-90009 QD 1.2 mg (Days 1 - 5 of 28)
OG003
Part A - 2.4 mg
Part A - 2.4 mg (Days 1 - 5 of 28)
OG004
Part A - 3.0 mg
Part A - CC-90009 QD 3.0 mg (Days 1 - 5 of 28)
Secondary
Change From Baseline by Laboratory Test - Chemistry Parameters 2
Change from baseline for chemistry laboratory parameters. Baseline = last value before start of treatment
All treated participants with baseline and post baseline measurements
Posted
Mean
Standard Deviation
U/L
From baseline until 28 days post last dose (Up to 25 months)
ID
Title
Description
OG000
Part A - 0.3 mg
Part A - CC-90009 QD 0.3 mg (Days 1 - 5 of 28)
OG001
Part A - 0.6 mg
Part A - CC-90009 QD 0.6 mg (Days 1 - 5 of 28)
OG002
Part A - 1.2 mg
Part A - CC-90009 QD 1.2 mg (Days 1 - 5 of 28)
OG003
Part A - 2.4 mg
Part A - 2.4 mg (Days 1 - 5 of 28)
OG004
Part A - 3.0 mg
Part A - CC-90009 QD 3.0 mg (Days 1 - 5 of 28)
Secondary
Change From Baseline by Laboratory Test - Chemistry Parameters 3
Change from baseline for chemistry laboratory parameters. Baseline = last value before start of treatment
All treated participants with baseline and post baseline measurements
Posted
Mean
Standard Deviation
mmol/L
From baseline until 28 days post last dose (Up to 25 months)
ID
Title
Description
OG000
Part A - 0.3 mg
Part A - CC-90009 QD 0.3 mg (Days 1 - 5 of 28)
OG001
Part A - 0.6 mg
Part A - CC-90009 QD 0.6 mg (Days 1 - 5 of 28)
OG002
Part A - 1.2 mg
Part A - CC-90009 QD 1.2 mg (Days 1 - 5 of 28)
OG003
Part A - 2.4 mg
Part A - 2.4 mg (Days 1 - 5 of 28)
OG004
Part A - 3.0 mg
Part A - CC-90009 QD 3.0 mg (Days 1 - 5 of 28)
Secondary
Change From Baseline for Vital Signs by Test - Parameters 1
Change from Baseline for Vital Signs Parameters. Baseline = last value before start of treatment.
All treated participants with baseline and post baseline measurements
Posted
Mean
Standard Deviation
mmHg
From baseline until 28 days post last dose (Up to 25 months)
ID
Title
Description
OG000
Part A - 0.3 mg
Part A - CC-90009 QD 0.3 mg (Days 1 - 5 of 28)
OG001
Part A - 0.6 mg
Part A - CC-90009 QD 0.6 mg (Days 1 - 5 of 28)
OG002
Part A - 1.2 mg
Part A - CC-90009 QD 1.2 mg (Days 1 - 5 of 28)
OG003
Part A - 2.4 mg
Part A - 2.4 mg (Days 1 - 5 of 28)
OG004
Part A - 3.0 mg
Part A - CC-90009 QD 3.0 mg (Days 1 - 5 of 28)
Secondary
Change From Baseline for Vital Signs by Test - Parameters 2
Change from Baseline for Vital Signs Parameters. Baseline = last value before start of treatment.
All treated participants with baseline and post baseline measurements
Posted
Mean
Standard Deviation
beats/min
From baseline until 28 days post last dose (Up to 25 months)
ID
Title
Description
OG000
Part A - 0.3 mg
Part A - CC-90009 QD 0.3 mg (Days 1 - 5 of 28)
OG001
Part A - 0.6 mg
Part A - CC-90009 QD 0.6 mg (Days 1 - 5 of 28)
OG002
Part A - 1.2 mg
Part A - CC-90009 QD 1.2 mg (Days 1 - 5 of 28)
OG003
Part A - 2.4 mg
Part A - 2.4 mg (Days 1 - 5 of 28)
OG004
Part A - 3.0 mg
Part A - CC-90009 QD 3.0 mg (Days 1 - 5 of 28)
Secondary
Change From Baseline for Vital Signs by Test - Parameters 3
Change from Baseline for Vital Signs Parameters. Baseline = last value before start of treatment.
All treated participants with baseline and post baseline measurements
Posted
Mean
Standard Deviation
Celsius
From baseline until 28 days post last dose (Up to 25 months)
ID
Title
Description
OG000
Part A - 0.3 mg
Part A - CC-90009 QD 0.3 mg (Days 1 - 5 of 28)
OG001
Part A - 0.6 mg
Part A - CC-90009 QD 0.6 mg (Days 1 - 5 of 28)
OG002
Part A - 1.2 mg
Part A - CC-90009 QD 1.2 mg (Days 1 - 5 of 28)
OG003
Part A - 2.4 mg
Part A - 2.4 mg (Days 1 - 5 of 28)
OG004
Part A - 3.0 mg
Part A - CC-90009 QD 3.0 mg (Days 1 - 5 of 28)
Secondary
Change From Baseline for Vital Signs by Test - Parameters 4
Change from Baseline for Vital Signs Parameters. Baseline = last value before start of treatment.
All treated participants with baseline and post baseline measurements
Posted
Mean
Standard Deviation
Kg
From baseline until 28 days post last dose (Up to 25 months)
ID
Title
Description
OG000
Part A - 0.3 mg
Part A - CC-90009 QD 0.3 mg (Days 1 - 5 of 28)
OG001
Part A - 0.6 mg
Part A - CC-90009 QD 0.6 mg (Days 1 - 5 of 28)
OG002
Part A - 1.2 mg
Part A - CC-90009 QD 1.2 mg (Days 1 - 5 of 28)
OG003
Part A - 2.4 mg
Part A - 2.4 mg (Days 1 - 5 of 28)
OG004
Part A - 3.0 mg
Part A - CC-90009 QD 3.0 mg (Days 1 - 5 of 28)
Secondary
Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 1
Change from Baseline for Electrocardiogram (ECG) Parameters. Baseline = last value before start of treatment.
All treated participants with baseline and post baseline measurements
Posted
Mean
Standard Deviation
beats/min
From baseline until 28 days post last dose (Up to 25 months)
ID
Title
Description
OG000
Part A - 0.3 mg
Part A - CC-90009 QD 0.3 mg (Days 1 - 5 of 28)
OG001
Part A - 0.6 mg
Part A - CC-90009 QD 0.6 mg (Days 1 - 5 of 28)
OG002
Part A - 1.2 mg
Part A - CC-90009 QD 1.2 mg (Days 1 - 5 of 28)
OG003
Part A - 2.4 mg
Part A - 2.4 mg (Days 1 - 5 of 28)
OG004
Part A - 3.0 mg
Part A - CC-90009 QD 3.0 mg (Days 1 - 5 of 28)
Secondary
Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 2
Change from Baseline for Electrocardiogram (ECG) Parameters. Baseline = last value before start of treatment.
All treated participants with baseline and post baseline measurements
Posted
Mean
Standard Deviation
msec
From baseline until 28 days post last dose (Up to 25 months)
ID
Title
Description
OG000
Part A - 0.3 mg
Part A - CC-90009 QD 0.3 mg (Days 1 - 5 of 28)
OG001
Part A - 0.6 mg
Part A - CC-90009 QD 0.6 mg (Days 1 - 5 of 28)
OG002
Part A - 1.2 mg
Part A - CC-90009 QD 1.2 mg (Days 1 - 5 of 28)
OG003
Part A - 2.4 mg
Part A - 2.4 mg (Days 1 - 5 of 28)
OG004
Part A - 3.0 mg
Part A - CC-90009 QD 3.0 mg (Days 1 - 5 of 28)
Secondary
Eastern Cooperative Oncology Group (ECOG) Performance Status
Number of participants with post-baseline grade increase or decrease from baseline. Grade 0=; Grade 1=; Grade 2=; Grade 3=; Grade 4=; Grade 5=; . Baseline = last value before start of treatment.
All treated participants with baseline and post baseline measurements
Posted
Count of Participants
Participants
From baseline until 28 days post last dose (Up to 25 months)
ID
Title
Description
OG000
Part A - 0.3 mg
Part A - CC-90009 QD 0.3 mg (Days 1 - 5 of 28)
OG001
Part A - 0.6 mg
Part A - CC-90009 QD 0.6 mg (Days 1 - 5 of 28)
OG002
Part A - 1.2 mg
Part A - CC-90009 QD 1.2 mg (Days 1 - 5 of 28)
OG003
Part A - 2.4 mg
Part A - 2.4 mg (Days 1 - 5 of 28)
OG004
Part A - 3.0 mg
Secondary
Left Ventricular Ejection Fraction (LVEF) Percent Change From Baseline
Left Ventricular Ejection Fraction (LVEF) percent change from baseline. Baseline = last value before start of treatment.
Minimum Post Baseline Value=lowest value of the measured parameter is recorded after the baseline measurement.
Maximum Post Baseline Value=highest value of the measured parameter is recorded after the baseline measurement.
All treated participants with baseline and post baseline measurements
Posted
Mean
Standard Deviation
Percent change
From baseline until 28 days post last dose (Up to 25 months)
ID
Title
Description
OG000
Part A - 0.3 mg
Part A - CC-90009 QD 0.3 mg (Days 1 - 5 of 28)
OG001
Part A - 0.6 mg
Part A - CC-90009 QD 0.6 mg (Days 1 - 5 of 28)
OG002
Part A - 1.2 mg
Part A - CC-90009 QD 1.2 mg (Days 1 - 5 of 28)
OG003
Part A - 2.4 mg
Part A - 2.4 mg (Days 1 - 5 of 28)
Secondary
Objective Response Rate (ORR)
Objectve response is defined as the percent of participants whose best overall response is any type of Morphologic Complete Remission [CR] (CR, Morphologic Complete Remission with Incomplete Blood Count Recovery (CRi), Morphologic Complete Remission with Partial Hematologic Recovery (CRh), Cytogenetic Complete Remission (CRc) and Molecular Complete Remission (CRm)) or Morphologic Leukemia - Free State or partial remission. CR=neutrophils ≥ 1,000μL, platelets ≥100,000μL, blasts <5%; CRi=residual neutropenia < 1,000/μL, thrombocytopenia < 100,000/μL. CRh=neutrophils ≥ 500μL, platelets ≥500,000μL, blasts <5%; CRc=neutrophils ≥ 1,000μL, platelets ≥100,000μL, blasts <5%; cytogenetics normal; CRm=neutrophils ≥ 1,000μL, platelets ≥100,000μL, blasts <5%, negative EMD; PR=neutrophils ≥ 1,000μL, platelets ≥100,000μL, blasts decrease in ≥ 50 resulting in 5 to 25%.
All treated participants
Posted
Number
95% Confidence Interval
Percent of participants
Up to approximately 25 months after the last dose
ID
Title
Description
OG000
Part A - 0.3 mg
Part A - CC-90009 QD 0.3 mg (Days 1 - 5 of 28)
OG001
Part A - 0.6 mg
Part A - CC-90009 QD 0.6 mg (Days 1 - 5 of 28)
OG002
Part A - 1.2 mg
Secondary
Overall Survival (OS)
OS is defined as the time from the date of the first dose to the date of death from any cause.
All treated participants
Posted
Median
95% Confidence Interval
Months
Up to approximately 25 months after the last dose
ID
Title
Description
OG000
Part A - 0.3 mg
Part A - CC-90009 QD 0.3 mg (Days 1 - 5 of 28)
OG001
Part A - 0.6 mg
Part A - CC-90009 QD 0.6 mg (Days 1 - 5 of 28)
OG002
Part A - 1.2 mg
Part A - CC-90009 QD 1.2 mg (Days 1 - 5 of 28)
OG003
Part A - 2.4 mg
Part A - 2.4 mg (Days 1 - 5 of 28)
OG004
Part A - 3.0 mg
Part A - CC-90009 QD 3.0 mg (Days 1 - 5 of 28)
Secondary
Relapse-free Survival (RFS)
RFS is defined only for participants who achieved CR or CRi (for AML) / CR or PR (for MDS) and is measured as the interval from the date of first CR or CRi (for AML) / CR or PR (for MDS) to the date of relapse or death from any cause, whichever occurs first. CR=neutrophils ≥ 1,000μL, platelets ≥100,000μL, blasts <5%; CRi=residual neutropenia < 1,000 μL, thrombocytopenia < 100,000/μL. PR=neutrophils ≥ 1,000μL, platelets ≥100,000μL, blasts decrease in ≥ 50 resulting in 5 to 25%.
All treated participants
Posted
Median
95% Confidence Interval
Months
Up to approximately 25 months after the last dose
ID
Title
Description
OG000
Part A - 0.3 mg
Part A - CC-90009 QD 0.3 mg (Days 1 - 5 of 28)
OG001
Part A - 0.6 mg
Part A - CC-90009 QD 0.6 mg (Days 1 - 5 of 28)
OG002
Part A - 1.2 mg
Part A - CC-90009 QD 1.2 mg (Days 1 - 5 of 28)
OG003
Part A - 2.4 mg
Part A - 2.4 mg (Days 1 - 5 of 28)
Secondary
Progression-free Survival (PFS)
PFS is defined as the time from the date of the first dose to the date of first relapse after CR/CRi (for AML)/relapse after CR/PR(for MDS), or PD, or death resulting from any cause, whichever occurs first. CR=neutrophils ≥ 1,000μL, platelets ≥100,000μL, blasts <5%; CRi=residual neutropenia < 1,000 μL, thrombocytopenia < 100,000/μL. PR=neutrophils ≥ 1,000μL, platelets ≥100,000μL, blasts decrease in ≥ 50 resulting in 5 to 25%. PD=At least 50% decrement from maximum remission/response levels in granulocytes or platelets; Reduction in Hgb concentration by ≥ 2 g/dL; Transfusion dependence. Based on Kaplan-Meier Estimates.
All treated participants
Posted
Median
95% Confidence Interval
Months
Up to approximately 25 months after the last dose
ID
Title
Description
OG000
Part A - 0.3 mg
Part A - CC-90009 QD 0.3 mg (Days 1 - 5 of 28)
OG001
Part A - 0.6 mg
Part A - CC-90009 QD 0.6 mg (Days 1 - 5 of 28)
OG002
Part A - 1.2 mg
Part A - CC-90009 QD 1.2 mg (Days 1 - 5 of 28)
OG003
Part A - 2.4 mg
Secondary
Event-free Survival (EFS)
EFS is defined as the interval from the date of the first dose to an event including disease progression (PD), treatment failure, relapse, or death from any cause, whichever occurs first. PD=At least 50% decrement from maximum remission/response levels in granulocytes or platelets; Reduction in Hgb concentration by ≥ 2 g/dL; Transfusion dependence. Based on Kaplan-Meier Estimates.
All treated participants
Posted
Median
95% Confidence Interval
Months
Up to approximately 25 months after the last dose
ID
Title
Description
OG000
Part A - 0.3 mg
Part A - CC-90009 QD 0.3 mg (Days 1 - 5 of 28)
OG001
Part A - 0.6 mg
Part A - CC-90009 QD 0.6 mg (Days 1 - 5 of 28)
OG002
Part A - 1.2 mg
Part A - CC-90009 QD 1.2 mg (Days 1 - 5 of 28)
OG003
Part A - 2.4 mg
Part A - 2.4 mg (Days 1 - 5 of 28)
OG004
Secondary
Duration of Remission/Response (DOR)
DOR is defined as the time from first remission/response observed to the date of relapse, death or PD. PD=At least 50% decrement from maximum remission/response levels in granulocytes or platelets; Reduction in Hgb concentration by ≥ 2 g/dL; Transfusion dependence. Based on Kaplan-Meier Estimates.
All treated participants with response
Posted
Median
95% Confidence Interval
Months
Up to approximately 25 months after the last dose
ID
Title
Description
OG000
Part A - 0.3 mg
Part A - CC-90009 QD 0.3 mg (Days 1 - 5 of 28)
OG001
Part A - 0.6 mg
Part A - CC-90009 QD 0.6 mg (Days 1 - 5 of 28)
OG002
Part A - 1.2 mg
Part A - CC-90009 QD 1.2 mg (Days 1 - 5 of 28)
OG003
Part A - 2.4 mg
Part A - 2.4 mg (Days 1 - 5 of 28)
OG004
Part A - 3.0 mg
Secondary
Time to Remission/Response (TTR)
TTR is defined as the time between the date of first dose and the earliest date any remission/response (any complete remissions or partial remissions or better) is observed. CR=neutrophils ≥ 1,000μL, platelets ≥100,000μL, blasts <5%; CRi=residual neutropenia < 1,000 μL, thrombocytopenia < 100,000/μL. CRh=neutrophils ≥ 500μL, platelets ≥500,000μL, blasts <5%; CRc=neutrophils ≥ 1,000μL, platelets ≥100,000μL, blasts <5%; cytogenetics normal; CRm=neutrophils ≥ 1,000μL, platelets ≥100,000μL, blasts <5%, negative EMD; PR=neutrophils ≥ 1,000μL, platelets ≥100,000μL, blasts decrease in ≥ 50 resulting in 5 to 25%. Based on Kaplan-Meier Estimates.
All treated participants with available TTR results
Posted
Median
Full Range
Months
Up to approximately 25 months after the last dose
ID
Title
Description
OG000
Part A - 0.3 mg
Part A - CC-90009 QD 0.3 mg (Days 1 - 5 of 28)
OG001
Part A - 0.6 mg
Part A - CC-90009 QD 0.6 mg (Days 1 - 5 of 28)
OG002
Part A - 1.2 mg
Part A - CC-90009 QD 1.2 mg (Days 1 - 5 of 28)
OG003
Secondary
Complete Remission Rate (CRR)
The complete remission rate (CRR) is defined as the percent of participants whose best overall response is any type of Morphologic Complete Remission [CR] (CR, Morphologic Complete Remission with Incomplete Blood Count Recovery (CRi), Morphologic Complete Remission with Partial Hematologic Recovery (CRh), Cytogenetic Complete Remission (CRc) and Molecular Complete Remission (CRm)). CR=neutrophils ≥ 1,000μL, platelets ≥100,000μL, blasts <5%; CRi=residual neutropenia < 1,000/μL, thrombocytopenia < 100,000/μL. CRh=neutrophils ≥ 500μL, platelets ≥500,000μL, blasts <5%; CRc=neutrophils ≥ 1,000μL, platelets ≥100,000μL, blasts <5%; cytogenetics normal; CRm=neutrophils ≥ 1,000μL, platelets ≥100,000μL, blasts <5%, negative EMD.
All treated participants with available CRR results
Posted
Number
95% Confidence Interval
Percent of participants
Up to approximately 88 months
ID
Title
Description
OG000
Part A - 0.3 mg
Part A - CC-90009 QD 0.3 mg (Days 1 - 5 of 28)
OG001
Part A - 0.6 mg
Part A - CC-90009 QD 0.6 mg (Days 1 - 5 of 28)
OG002
Part A - 1.2 mg
Part A - CC-90009 QD 1.2 mg (Days 1 - 5 of 28)
Secondary
Time to Acute Myeloid Leukemia (AML) Transformation
Time to acute AML transformation in part B Myelodysplastic Syndromes (MDS) participants only. Based on Kaplan-Meier Estimates.
All treated participants in part B - MDS only as pre-specified
Posted
Median
Full Range
Months
Up to approximately 88 months
ID
Title
Description
OG000
Part B - MDS 3.6 mg + DEX
Part B - MDS 3.6 mg + DEX (Days 1 - 5 of 28)
OG001
Part B - MDS 3.0 mg
Part B - MDS 3.0 mg (Days 1 - 7 of 28)
Units
Counts
Participants
OG000
Secondary
Maximum Observed Plasma Concentration (Cmax)
Maximum observed plasma concentration, obtained directly from the observed concentration versus time data
All treated participants with pharmacokinetic measurements
Posted
Geometric Mean
Geometric Coefficient of Variation
ng/mL
Cycle 1 Day 1(C1D1), C1D5, C1D7, C1D8, C1D10,
ID
Title
Description
OG000
Part A - 0.3 mg
Part A - CC-90009 QD 0.3 mg (Days 1 - 5 of 28)
OG001
Part A - 0.6 mg
Part A - CC-90009 QD 0.6 mg (Days 1 - 5 of 28)
OG002
Part A - 1.2 mg
Part A - CC-90009 QD 1.2 mg (Days 1 - 5 of 28)
OG003
Part A - 2.4 mg
Part A - 2.4 mg (Days 1 - 5 of 28)
OG004
Part A - 3.0 mg
Part A - CC-90009 QD 3.0 mg (Days 1 - 5 of 28)
Secondary
Time to Peak Plasma Concentration (Tmax)
Time to peak plasma concentration, obtained directly from the observed concentration versus time data.
All treated participants with pharmacokinetic measurements
Posted
Median
Full Range
hour
Cycle 1 Day 1(C1D1), C1D5, C1D7, C1D8, C1D10. 1 cycle = 28 days
ID
Title
Description
OG000
Part A - 0.3 mg
Part A - CC-90009 QD 0.3 mg (Days 1 - 5 of 28)
OG001
Part A - 0.6 mg
Part A - CC-90009 QD 0.6 mg (Days 1 - 5 of 28)
OG002
Part A - 1.2 mg
Part A - CC-90009 QD 1.2 mg (Days 1 - 5 of 28)
OG003
Part A - 2.4 mg
Part A - 2.4 mg (Days 1 - 5 of 28)
OG004
Part A - 3.0 mg
Part A - CC-90009 QD 3.0 mg (Days 1 - 5 of 28)
Secondary
Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours Post-dose (AUC 0 - 24)
Area under the plasma concentration-time curve from Time 0 to 24 hours post-dose.
All treated participants with pharmacokinetic measurements
Posted
Geometric Mean
Geometric Coefficient of Variation
h*ng/mL
Cycle 1 Day 1(C1D1), C1D5, C1D7, C1D8, C1D10. 1 cycle = 28 days
ID
Title
Description
OG000
Part A - 0.3 mg
Part A - CC-90009 QD 0.3 mg (Days 1 - 5 of 28)
OG001
Part A - 0.6 mg
Part A - CC-90009 QD 0.6 mg (Days 1 - 5 of 28)
OG002
Part A - 1.2 mg
Part A - CC-90009 QD 1.2 mg (Days 1 - 5 of 28)
OG003
Part A - 2.4 mg
Part A - 2.4 mg (Days 1 - 5 of 28)
OG004
Part A - 3.0 mg
Secondary
Terminal Phase Elimination Half-life (T1/2)
Terminal phase elimination half-life calculated as [(ln 2)/λz], where λz is the apparent terminal rate constant. t1/2 will only be calculated when a reliable estimate for λz can be obtained.
All treated participants with pharmacokinetic measurements
Posted
Median
Full Range
hour
Cycle 1 Day 1(C1D1) and C1D5. 1 cycle = 28 days
ID
Title
Description
OG000
Part A - 0.3 mg
Part A - CC-90009 QD 0.3 mg (Days 1 - 5 of 28)
OG001
Part A - 0.6 mg
Part A - CC-90009 QD 0.6 mg (Days 1 - 5 of 28)
OG002
Part A - 1.2 mg
Part A - CC-90009 QD 1.2 mg (Days 1 - 5 of 28)
OG003
Part A - 2.4 mg
Part A - 2.4 mg (Days 1 - 5 of 28)
OG004
Part A - 3.0 mg
Secondary
Total Body Clearance (CL)
Total plasma clearance after IV administration, calculated as [Dose/ AUC(INF)] following single administration, and [Dose/ AUC(0-24)] at steady state.
All treated participants with pharmacokinetic measurements
Posted
Geometric Mean
Geometric Coefficient of Variation
L/h
Cycle 1 Day 1(C1D1), C1D5, C1D7, C1D8, C1D10. 1 cycle = 28 days
ID
Title
Description
OG000
Part A - 0.3 mg
Part A - CC-90009 QD 0.3 mg (Days 1 - 5 of 28)
OG001
Part A - 0.6 mg
Part A - CC-90009 QD 0.6 mg (Days 1 - 5 of 28)
OG002
Part A - 1.2 mg
Part A - CC-90009 QD 1.2 mg (Days 1 - 5 of 28)
OG003
Part A - 2.4 mg
Part A - 2.4 mg (Days 1 - 5 of 28)
OG004
Part A - 3.0 mg
Secondary
Volume of Distribution (Vz)
Volume of distribution calculated at first dose only. Calculated as [Vz = Dose/ AUC(INF) * λz for Day 1].
All treated participants with pharmacokinetic measurements
Posted
Geometric Mean
Geometric Coefficient of Variation
L
Cycle 1 Day 1(C1D1) and C1D5. 1 cycle = 28 days
ID
Title
Description
OG000
Part A - 0.3 mg
Part A - CC-90009 QD 0.3 mg (Days 1 - 5 of 28)
OG001
Part A - 0.6 mg
Part A - CC-90009 QD 0.6 mg (Days 1 - 5 of 28)
OG002
Part A - 1.2 mg
Part A - CC-90009 QD 1.2 mg (Days 1 - 5 of 28)
OG003
Part A - 2.4 mg
Part A - 2.4 mg (Days 1 - 5 of 28)
OG004
Part A - 3.0 mg
Part A - CC-90009 QD 3.0 mg (Days 1 - 5 of 28)
Secondary
Renal Clearance (CLr)
Renal clearance of CC-90009 (CLr)
All treated participants with pharmacokinetic measurements
Posted
Geometric Mean
Geometric Coefficient of Variation
L/h
Cycle 1 Day 1(C1D1). 1 cycle = 28 days
ID
Title
Description
OG000
Part A - 0.3 mg
Part A - CC-90009 QD 0.3 mg (Days 1 - 5 of 28)
OG001
Part A - 0.6 mg
Part A - CC-90009 QD 0.6 mg (Days 1 - 5 of 28)
OG002
Part A - 1.2 mg
Part A - CC-90009 QD 1.2 mg (Days 1 - 5 of 28)
OG003
Part A - 2.4 mg
Part A - 2.4 mg (Days 1 - 5 of 28)
OG004
Part A - 3.0 mg
Part A - CC-90009 QD 3.0 mg (Days 1 - 5 of 28)
Time Frame
Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Description
Not provided
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
Part A - 0.3 mg (Days 1 - 5 of 28)
Part A - CC-90009 QD 0.3 mg (Days 1 - 5 of 28)
2
2
0
2
2
2
EG001
Part A - 0.6 mg (Days 1 - 5 of 28)
Part A - CC-90009 QD 0.6 mg (Days 1 - 5 of 28)
2
2
0
2
2
2
EG002
Part A - 1.2 mg (Days 1 - 5 of 28)
Part A - CC-90009 QD 1.2 mg (Days 1 - 5 of 28)
2
2
1
2
2
2
EG003
Part A - 2.4 mg (Days 1 - 5 of 28)
Part A - CC-90009 2.4 mg (Days 1 - 5 of 28)
7
7
6
7
7
7
EG004
Part A - 3.0 mg (Days 1 - 5 of 28)
Part A - CC-90009 QD 3.0 mg (Days 1 - 5 of 28)
14
15
15
15
15
15
EG005
Part A - 3.6 mg (Days 1 - 5 of 28)
Part A - CC-90009 QD 3.6 mg (Days 1 - 5 of 28)
2
3
3
3
3
3
EG006
Part A - 3.6 mg + DEX (Days 1 - 5 of 28)
Part A - CC-90009 QD 3.6 mg + Dexamethasone 10 mg IV (Days 1 - 5 of 28)
8
8
7
8
8
8
EG007
Part A - 4.5 mg (Days 1 - 5 of 28)
Part A - CC-90009 daily (QD) 4.5 mg (Days 1 - 5 of 28)
6
7
7
7
7
7
EG008
Part A - 3.6 mg (Days 1 - 7 of 28)
Part A - CC-90009 QD 3.6 mg (Days 1 - 7 of 28)
7
7
7
7
7
7
EG009
Part A - 3.0 mg (Days 1- 10 of 28)
Part A - CC-90009 QD 3.0 mg (Days 1- 10 of 28)
7
9
6
9
9
9
EG010
Part A - 3.0 mg (Day 1 - 3 & Day 8 - 10 of 28)
Part A - CC-90009 daily (QD) 3.0 mg (Day 1 - 3 & Day 8 - 10 of 28)
2
3
3
3
3
3
EG011
Part A - 3.6 mg (Day 1 - 3 & Day 8 - 10 of 28)
Part A - CC-90009 daily (QD) 3.6 mg (Day 1 - 3 & Day 8 - 10 of 28)
7
7
6
7
7
7
EG012
Part B - 3.6 mg + DEX (Days 1 - 5 of 28)
Part B - MDS CC-90009 3.6 mg + Dexamethasone (Days 1 - 5 of 28)
8
8
8
8
8
8
EG013
Part B - MDS 3.6 mg + DEX (Days 1 - 5 of 28)
Part B - MDS CC-90009 3.6 mg + Dexamethasone (Days 1 - 5 of 28)
2
2
1
2
2
2
EG014
Part B - 2.4 mg (Days 1 - 7 of 28)
Part B - MDS CC-90009 24 mg (Days 1 - 7 of 28)
9
9
9
9
8
9
EG015
Part B - 3.0 mg (Days 1 - 7 of 28)
Part B - CC-90009 3.0 mg (Days 1 - 7 of 28)
9
9
8
9
9
9
EG016
Part B - MDS 3.0 mg (Days 1 - 7 of 28)
Part B - MDS CC-90009 3.0 mg (Days 1 - 7 of 28)
0
1
0
1
1
1
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Febrile neutropenia
Blood and lymphatic system disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG0030 affected7 at risk
EG0044 affected15 at risk
EG0050 affected3 at risk
EG0065 affected8 at risk
EG0072 affected7 at risk
EG0081 affected7 at risk
EG0090 affected9 at risk
EG0101 affected3 at risk
EG0112 affected7 at risk
EG0121 affected8 at risk
EG0131 affected2 at risk
EG0141 affected9 at risk
EG0150 affected9 at risk
EG0160 affected1 at risk
Hyperleukocytosis
Blood and lymphatic system disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Leukocytosis
Blood and lymphatic system disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Splenic infarction
Blood and lymphatic system disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Arrhythmia
Cardiac disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Atrial fibrillation
Cardiac disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Cardiac arrest
Cardiac disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Pericarditis
Cardiac disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Pulseless electrical activity
Cardiac disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Abdominal pain
Gastrointestinal disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Colitis
Gastrointestinal disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Diarrhoea
Gastrointestinal disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Gastrointestinal haemorrhage
Gastrointestinal disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Nausea
Gastrointestinal disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Neutropenic colitis
Gastrointestinal disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Rectal haemorrhage
Gastrointestinal disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Stomatitis
Gastrointestinal disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Upper gastrointestinal haemorrhage
Gastrointestinal disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Volvulus
Gastrointestinal disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Fatigue
General disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
General physical health deterioration
General disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Multiple organ dysfunction syndrome
General disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Pyrexia
General disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Systemic inflammatory response syndrome
General disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Hyperbilirubinaemia
Hepatobiliary disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Anal infection
Infections and infestations
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Bacteraemia
Infections and infestations
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Bacterial sepsis
Infections and infestations
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Catheter site infection
Infections and infestations
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Cellulitis
Infections and infestations
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Citrobacter infection
Infections and infestations
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Clostridium difficile colitis
Infections and infestations
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Clostridium difficile infection
Infections and infestations
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Device related bacteraemia
Infections and infestations
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Device related infection
Infections and infestations
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0021 affected2 at risk
EG003
Device related sepsis
Infections and infestations
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Enterobacter infection
Infections and infestations
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Enterococcal bacteraemia
Infections and infestations
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Escherichia bacteraemia
Infections and infestations
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Escherichia sepsis
Infections and infestations
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Eye infection
Infections and infestations
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Klebsiella bacteraemia
Infections and infestations
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Klebsiella sepsis
Infections and infestations
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Oral infection
Infections and infestations
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Pneumonia
Infections and infestations
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0021 affected2 at risk
EG003
Pneumonia fungal
Infections and infestations
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Pneumonia pseudomonal
Infections and infestations
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Pneumonia viral
Infections and infestations
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Pseudomonal bacteraemia
Infections and infestations
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Sepsis
Infections and infestations
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0021 affected2 at risk
EG003
Sepsis syndrome
Infections and infestations
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Septic shock
Infections and infestations
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Sinusitis
Infections and infestations
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Staphylococcal bacteraemia
Infections and infestations
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Stenotrophomonas infection
Infections and infestations
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Stenotrophomonas sepsis
Infections and infestations
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Urinary tract infection
Infections and infestations
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Facial bones fracture
Injury, poisoning and procedural complications
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Blood bilirubin increased
Investigations
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Blood creatinine increased
Investigations
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
C-reactive protein increased
Investigations
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
SARS-CoV-2 test positive
Investigations
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Dehydration
Metabolism and nutrition disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Hyperglycaemic hyperosmolar nonketotic syndrome
Metabolism and nutrition disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Hypocalcaemia
Metabolism and nutrition disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Bone pain
Musculoskeletal and connective tissue disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Acute myeloid leukaemia
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Chloroma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Diabetic hyperosmolar coma
Nervous system disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Haemorrhage intracranial
Nervous system disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Peripheral sensory neuropathy
Nervous system disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Presyncope
Nervous system disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Syncope
Nervous system disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Acute kidney injury
Renal and urinary disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Haematuria
Renal and urinary disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Acute pulmonary oedema
Respiratory, thoracic and mediastinal disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Pulmonary mass
Respiratory, thoracic and mediastinal disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Respiratory failure
Respiratory, thoracic and mediastinal disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Hypertension
Vascular disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Hypotension
Vascular disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Orthostatic hypotension
Vascular disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0021 affected2 at risk
EG0030 affected7 at risk
EG0040 affected15 at risk
EG0050 affected3 at risk
EG0060 affected8 at risk
EG0073 affected7 at risk
EG0080 affected7 at risk
EG0092 affected9 at risk
EG0100 affected3 at risk
EG0110 affected7 at risk
EG0121 affected8 at risk
EG0130 affected2 at risk
EG0143 affected9 at risk
EG0153 affected9 at risk
EG0161 affected1 at risk
Bone marrow failure
Blood and lymphatic system disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Coagulopathy
Blood and lymphatic system disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Cytopenia
Blood and lymphatic system disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Disseminated intravascular coagulation
Blood and lymphatic system disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Febrile neutropenia
Blood and lymphatic system disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Leukocytosis
Blood and lymphatic system disorders
26.0
Systematic Assessment
EG0001 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Leukopenia
Blood and lymphatic system disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Splenic infarction
Blood and lymphatic system disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Angina pectoris
Cardiac disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Arrhythmia
Cardiac disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Atrial fibrillation
Cardiac disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Atrioventricular block second degree
Cardiac disorders
26.0
Systematic Assessment
EG0001 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Bradycardia
Cardiac disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Dilated cardiomyopathy
Cardiac disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Pericardial effusion
Cardiac disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Sinus bradycardia
Cardiac disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Sinus tachycardia
Cardiac disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Tachycardia
Cardiac disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0021 affected2 at risk
EG003
Ventricular extrasystoles
Cardiac disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Ear haemorrhage
Ear and labyrinth disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Hypoacusis
Ear and labyrinth disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Tinnitus
Ear and labyrinth disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Vertigo
Ear and labyrinth disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Vertigo positional
Ear and labyrinth disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Adrenal insufficiency
Endocrine disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Hyperparathyroidism
Endocrine disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Hypoparathyroidism
Endocrine disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Eye pain
Eye disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Periorbital oedema
Eye disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Scleritis
Eye disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Vision blurred
Eye disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Visual impairment
Eye disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Abdominal discomfort
Gastrointestinal disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Abdominal distension
Gastrointestinal disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Abdominal pain
Gastrointestinal disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Abdominal pain lower
Gastrointestinal disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Anal incontinence
Gastrointestinal disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Ascites
Gastrointestinal disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Colitis
Gastrointestinal disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Constipation
Gastrointestinal disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Diarrhoea
Gastrointestinal disorders
26.0
Systematic Assessment
EG0001 affected2 at risk
EG0010 affected2 at risk
EG0021 affected2 at risk
EG003
Dry mouth
Gastrointestinal disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Dyspepsia
Gastrointestinal disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Enterocolitis
Gastrointestinal disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Faecaloma
Gastrointestinal disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Faeces discoloured
Gastrointestinal disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Flatulence
Gastrointestinal disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Gastritis
Gastrointestinal disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Gastrointestinal necrosis
Gastrointestinal disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Gingival hypertrophy
Gastrointestinal disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Haemorrhoidal haemorrhage
Gastrointestinal disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Haemorrhoids
Gastrointestinal disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Nausea
Gastrointestinal disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0022 affected2 at risk
EG003
Neutropenic colitis
Gastrointestinal disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Odynophagia
Gastrointestinal disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Oral disorder
Gastrointestinal disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Oral pain
Gastrointestinal disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Proctalgia
Gastrointestinal disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Proctitis
Gastrointestinal disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Rectal haemorrhage
Gastrointestinal disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Salivary hypersecretion
Gastrointestinal disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0011 affected2 at risk
EG0020 affected2 at risk
EG003
Small intestinal obstruction
Gastrointestinal disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Stomatitis
Gastrointestinal disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Tongue haemorrhage
Gastrointestinal disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Vomiting
Gastrointestinal disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0021 affected2 at risk
EG003
Asthenia
General disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Axillary pain
General disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0011 affected2 at risk
EG0020 affected2 at risk
EG003
Catheter site erythema
General disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Catheter site inflammation
General disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Catheter site pain
General disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Chest discomfort
General disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Chest pain
General disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Chills
General disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Cyst
General disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Facial pain
General disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Fatigue
General disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0011 affected2 at risk
EG0020 affected2 at risk
EG003
Feeling cold
General disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Gait disturbance
General disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
General physical health deterioration
General disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Hyperthermia
General disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Hypothermia
General disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Illness
General disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Infusion site extravasation
General disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Injection site pain
General disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Localised oedema
General disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Mucosal haemorrhage
General disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Mucosal inflammation
General disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Multiple organ dysfunction syndrome
General disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Non-cardiac chest pain
General disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Oedema
General disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0021 affected2 at risk
EG003
Oedema peripheral
General disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0011 affected2 at risk
EG0020 affected2 at risk
EG003
Pain
General disorders
26.0
Systematic Assessment
EG0001 affected2 at risk
EG0010 affected2 at risk
EG0021 affected2 at risk
EG003
Pyrexia
General disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0011 affected2 at risk
EG0021 affected2 at risk
EG003
Gallbladder oedema
Hepatobiliary disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Hepatotoxicity
Hepatobiliary disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Hyperbilirubinaemia
Hepatobiliary disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Hypertransaminasaemia
Hepatobiliary disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Jaundice
Hepatobiliary disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Cytokine release syndrome
Immune system disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Cytokine storm
Immune system disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Graft versus host disease in skin
Immune system disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Hypersensitivity
Immune system disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Acinetobacter bacteraemia
Infections and infestations
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Anal abscess
Infections and infestations
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Bacteraemia
Infections and infestations
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
COVID-19
Infections and infestations
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Candida infection
Infections and infestations
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Catheter site infection
Infections and infestations
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Cellulitis
Infections and infestations
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0021 affected2 at risk
EG003
Clostridium difficile colitis
Infections and infestations
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Clostridium difficile infection
Infections and infestations
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Conjunctivitis
Infections and infestations
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Diverticulitis
Infections and infestations
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Enterococcal bacteraemia
Infections and infestations
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Enterocolitis infectious
Infections and infestations
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Folliculitis
Infections and infestations
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Herpes simplex
Infections and infestations
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Infected cyst
Infections and infestations
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Lip infection
Infections and infestations
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Lower respiratory tract infection
Infections and infestations
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Metapneumovirus infection
Infections and infestations
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Mucosal infection
Infections and infestations
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Neutropenic sepsis
Infections and infestations
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Oral candidiasis
Infections and infestations
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Oral herpes
Infections and infestations
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Oropharyngeal candidiasis
Infections and infestations
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Pneumonia
Infections and infestations
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0021 affected2 at risk
EG003
Postoperative wound infection
Infections and infestations
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Respiratory tract infection
Infections and infestations
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Salmonellosis
Infections and infestations
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Sialoadenitis
Infections and infestations
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Sinusitis
Infections and infestations
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Staphylococcal infection
Infections and infestations
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Subcutaneous abscess
Infections and infestations
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Tooth infection
Infections and infestations
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0011 affected2 at risk
EG0020 affected2 at risk
EG003
Urinary tract infection
Infections and infestations
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Vascular device infection
Infections and infestations
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Corneal abrasion
Injury, poisoning and procedural complications
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Facial bones fracture
Injury, poisoning and procedural complications
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Fall
Injury, poisoning and procedural complications
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Head injury
Injury, poisoning and procedural complications
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Infusion related reaction
Injury, poisoning and procedural complications
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0011 affected2 at risk
EG0020 affected2 at risk
EG003
Limb injury
Injury, poisoning and procedural complications
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Muscle rupture
Injury, poisoning and procedural complications
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Procedural pain
Injury, poisoning and procedural complications
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Skin abrasion
Injury, poisoning and procedural complications
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Skin laceration
Injury, poisoning and procedural complications
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Spinal compression fracture
Injury, poisoning and procedural complications
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Activated partial thromboplastin time prolonged
Investigations
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Alanine aminotransferase increased
Investigations
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Aspartate aminotransferase increased
Investigations
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Bilirubin conjugated increased
Investigations
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Blood alkaline phosphatase increased
Investigations
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Blood bicarbonate decreased
Investigations
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Blood bilirubin increased
Investigations
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Blood bilirubin unconjugated increased
Investigations
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Blood creatinine increased
Investigations
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Blood fibrinogen decreased
Investigations
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Blood glucose increased
Investigations
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Blood lactate dehydrogenase increased
Investigations
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Blood lactic acid increased
Investigations
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Blood parathyroid hormone decreased
Investigations
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Blood phosphorus increased
Investigations
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Blood urea increased
Investigations
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Blood uric acid decreased
Investigations
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Brain natriuretic peptide increased
Investigations
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
C-reactive protein increased
Investigations
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Calcium ionised decreased
Investigations
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Cardiac murmur
Investigations
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Chest X-ray abnormal
Investigations
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Clostridium test positive
Investigations
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Coagulation time prolonged
Investigations
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Ejection fraction decreased
Investigations
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Electrocardiogram QRS complex abnormal
Investigations
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Electrocardiogram QT prolonged
Investigations
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Electrocardiogram QT shortened
Investigations
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Electrocardiogram ST segment abnormal
Investigations
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Electrocardiogram T wave inversion
Investigations
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Gamma-glutamyltransferase increased
Investigations
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Haemoglobin decreased
Investigations
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
International normalised ratio increased
Investigations
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Lipase increased
Investigations
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Lymphocyte count decreased
Investigations
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Lymphocyte count increased
Investigations
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Neutrophil count decreased
Investigations
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Neutrophil count increased
Investigations
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Occult blood positive
Investigations
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Platelet count decreased
Investigations
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Protein total decreased
Investigations
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Staphylococcus test positive
Investigations
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Transaminases increased
Investigations
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Troponin I increased
Investigations
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Troponin increased
Investigations
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Vitamin D decreased
Investigations
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Weight decreased
Investigations
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Weight increased
Investigations
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
White blood cell count decreased
Investigations
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
White blood cell count increased
Investigations
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0011 affected2 at risk
EG0020 affected2 at risk
EG003
Acidosis
Metabolism and nutrition disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Cachexia
Metabolism and nutrition disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
26.0
Systematic Assessment
EG0001 affected2 at risk
EG0011 affected2 at risk
EG0020 affected2 at risk
EG003
Dehydration
Metabolism and nutrition disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Folate deficiency
Metabolism and nutrition disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Hyperferritinaemia
Metabolism and nutrition disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Hypermagnesaemia
Metabolism and nutrition disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Hypernatraemia
Metabolism and nutrition disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Hyperphosphataemia
Metabolism and nutrition disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Hyperuricaemia
Metabolism and nutrition disorders
26.0
Systematic Assessment
EG0001 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Hypervolaemia
Metabolism and nutrition disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Hypoalbuminaemia
Metabolism and nutrition disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Hypocalcaemia
Metabolism and nutrition disorders
26.0
Systematic Assessment
EG0001 affected2 at risk
EG0010 affected2 at risk
EG0021 affected2 at risk
EG003
Hypoglycaemia
Metabolism and nutrition disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
26.0
Systematic Assessment
EG0001 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Hypophagia
Metabolism and nutrition disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Hypophosphataemia
Metabolism and nutrition disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Hypoproteinaemia
Metabolism and nutrition disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Hypovolaemia
Metabolism and nutrition disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Lactic acidosis
Metabolism and nutrition disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Metabolic acidosis
Metabolism and nutrition disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0021 affected2 at risk
EG003
Metabolic alkalosis
Metabolism and nutrition disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Refeeding syndrome
Metabolism and nutrition disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Tumour lysis syndrome
Metabolism and nutrition disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Type 2 diabetes mellitus
Metabolism and nutrition disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Vitamin K deficiency
Metabolism and nutrition disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0021 affected2 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Bone lesion
Musculoskeletal and connective tissue disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Bone pain
Musculoskeletal and connective tissue disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Cervical spinal stenosis
Musculoskeletal and connective tissue disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Flank pain
Musculoskeletal and connective tissue disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Groin pain
Musculoskeletal and connective tissue disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0011 affected2 at risk
EG0020 affected2 at risk
EG003
Musculoskeletal stiffness
Musculoskeletal and connective tissue disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Myositis
Musculoskeletal and connective tissue disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
26.0
Systematic Assessment
EG0001 affected2 at risk
EG0011 affected2 at risk
EG0020 affected2 at risk
EG003
Sarcopenia
Musculoskeletal and connective tissue disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Soft tissue swelling
Musculoskeletal and connective tissue disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Acute myeloid leukaemia
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Leukaemia cutis
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Dizziness
Nervous system disorders
26.0
Systematic Assessment
EG0001 affected2 at risk
EG0010 affected2 at risk
EG0021 affected2 at risk
EG003
Dysgeusia
Nervous system disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Headache
Nervous system disorders
26.0
Systematic Assessment
EG0001 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Hemiparesis
Nervous system disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Lethargy
Nervous system disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Memory impairment
Nervous system disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Nerve compression
Nervous system disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Neuropathy peripheral
Nervous system disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Optic neuritis
Nervous system disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Paraesthesia
Nervous system disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Peripheral sensory neuropathy
Nervous system disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Presyncope
Nervous system disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0021 affected2 at risk
EG003
Sinus headache
Nervous system disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Syncope
Nervous system disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Taste disorder
Nervous system disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Tremor
Nervous system disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Device leakage
Product Issues
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Agitation
Psychiatric disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Anxiety
Psychiatric disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0011 affected2 at risk
EG0021 affected2 at risk
EG003
Confusional state
Psychiatric disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Delirium
Psychiatric disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Delusion
Psychiatric disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Depression
Psychiatric disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Hallucination
Psychiatric disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Insomnia
Psychiatric disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Mental status changes
Psychiatric disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Restlessness
Psychiatric disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Acute kidney injury
Renal and urinary disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Chronic kidney disease
Renal and urinary disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0021 affected2 at risk
EG003
Dysuria
Renal and urinary disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Haematuria
Renal and urinary disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Pollakiuria
Renal and urinary disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Polyuria
Renal and urinary disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Proteinuria
Renal and urinary disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Renal failure
Renal and urinary disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Renal impairment
Renal and urinary disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Urinary incontinence
Renal and urinary disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Urinary retention
Renal and urinary disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Benign prostatic hyperplasia
Reproductive system and breast disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Acute respiratory distress syndrome
Respiratory, thoracic and mediastinal disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Acute respiratory failure
Respiratory, thoracic and mediastinal disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Bronchospasm
Respiratory, thoracic and mediastinal disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0021 affected2 at risk
EG003
Dysphonia
Respiratory, thoracic and mediastinal disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0011 affected2 at risk
EG0020 affected2 at risk
EG003
Haemoptysis
Respiratory, thoracic and mediastinal disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0011 affected2 at risk
EG0020 affected2 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
26.0
Systematic Assessment
EG0001 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Pneumonitis
Respiratory, thoracic and mediastinal disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Pulmonary oedema
Respiratory, thoracic and mediastinal disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Respiratory failure
Respiratory, thoracic and mediastinal disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Sinus pain
Respiratory, thoracic and mediastinal disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Tachypnoea
Respiratory, thoracic and mediastinal disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Wheezing
Respiratory, thoracic and mediastinal disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Acne
Skin and subcutaneous tissue disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Blood blister
Skin and subcutaneous tissue disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Dermatitis
Skin and subcutaneous tissue disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0021 affected2 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Ecchymosis
Skin and subcutaneous tissue disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0021 affected2 at risk
EG003
Erythema nodosum
Skin and subcutaneous tissue disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Hyperhidrosis
Skin and subcutaneous tissue disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Madarosis
Skin and subcutaneous tissue disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Pain of skin
Skin and subcutaneous tissue disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0011 affected2 at risk
EG0020 affected2 at risk
EG003
Palmar-plantar erythrodysaesthesia syndrome
Skin and subcutaneous tissue disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Petechiae
Skin and subcutaneous tissue disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0011 affected2 at risk
EG0020 affected2 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Rash papular
Skin and subcutaneous tissue disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Skin exfoliation
Skin and subcutaneous tissue disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Skin haemorrhage
Skin and subcutaneous tissue disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Skin lesion
Skin and subcutaneous tissue disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Skin ulcer
Skin and subcutaneous tissue disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Stasis dermatitis
Skin and subcutaneous tissue disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Urticaria
Skin and subcutaneous tissue disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Deep vein thrombosis
Vascular disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Embolism
Vascular disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Flushing
Vascular disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Haematoma
Vascular disorders
26.0
Systematic Assessment
EG0001 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Hot flush
Vascular disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Hypertension
Vascular disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Hypotension
Vascular disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Hypovolaemic shock
Vascular disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Lymphoedema
Vascular disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Orthostatic hypotension
Vascular disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Pallor
Vascular disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Thrombophlebitis
Vascular disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Thrombosis
Vascular disorders
26.0
Systematic Assessment
EG0000 affected2 at risk
EG0010 affected2 at risk
EG0020 affected2 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.