A Phase 1 Study in Subjects With Relapsed or Refractory M... | NCT02561962 | Trialant
NCT02561962
Sponsor
Amgen
Status
Completed
Last Update Posted
Feb 1, 2024Actual
Enrollment
42Actual
Phase
Phase 1
Conditions
Multiple Myeloma
Interventions
AMG 224
Countries
United States
Australia
Protocol Section
Identification Module
NCT ID
Results Section
Participant Flow Module
Pre-assignment Details
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Derived Section
Miscellaneous Info Module
Version Holder
NCT02561962
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
20130314
Secondary IDs
Not provided
Brief Title
A Phase 1 Study in Subjects With Relapsed or Refractory Multiple Myeloma
Official Title
A Phase 1 First in Human Study Evaluating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 224 in Subjects With Relapsed or Refractory Multiple Myeloma
Acronym
Not provided
Organization
AmgenINDUSTRY
Status Module
Record Verification Date
May 2023
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Nov 20, 2015Actual
Primary Completion Date
Nov 30, 2018Actual
Completion Date
Apr 21, 2022Actual
First Submitted Date
Sep 25, 2015
First Submission Date that Met QC Criteria
Sep 25, 2015
First Posted Date
Sep 28, 2015Estimated
Results Waived
Not provided
Results First Submitted Date
Jul 29, 2021
Results First Submitted that Met QC Criteria
Sep 9, 2021
Results First Posted Date
Oct 7, 2021Actual
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 18, 2023
Last Update Posted Date
Feb 1, 2024Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
AmgenINDUSTRY
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
This is a first in human phase 1 multicenter open label study in subjects with relapsed or refractory multiple myeloma.
Detailed Description
This is a first in human phase 1 multicenter open label study to evaluate the safety and tolerability of AMG 224 in subjects with relapsed or refractory multiple myeloma. The study will be conducted in 2 parts. Part 1 is the dose-exploration and part 2 is the dose-expansion. Study medication will be administered once every 3 weeks by intravenous (IV) infusion.
Conditions Module
Conditions
Multiple Myeloma
Keywords
Multiple Myeloma
Relapsed Multiple Myeloma
Refractory Multiple Myeloma
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 1
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
42Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Dose Exploration: AMG 224 Dose A
Experimental
Participants were administered AMG 224 Dose A as an intravenous (IV) infusion once every 3 weeks (Q3W) on Day 1 of each cycle, where each cycle is 3 weeks.
Drug: AMG 224
Dose Exploration: AMG 224 Dose B
Experimental
Participants were administered AMG 224 Dose B as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.
Drug: AMG 224
Dose Exploration: AMG 224 Dose C
Experimental
Participants were administered AMG 224 Dose C as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.
Drug: AMG 224
Dose Exploration: AMG 224 Dose D
Experimental
Participants were administered AMG 224 Dose D as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.
Drug: AMG 224
Dose Exploration: AMG 224 Dose E
Experimental
Participants were administered AMG 224 Dose E as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.
Interventions
Name
Type
Description
Arm Group Labels
Other Names
AMG 224
Drug
Administered as an IV infusion.
Dose Expansion: AMG 224 Dose H + no prior CD38 targeting antibody treatment
Number of Participants Who Experienced a Dose-Limiting Toxicity (DLT)
Adverse events, including DLTs, were graded using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. A DLT was considered as any of the below, if judged by the investigator to be possibly related to AMG 224:
Hematological:
Grade 4 neutropenia lasting > 7 days
Grade 3 or 4 neutropenia with fever > 38.5°C
Grade 3 thrombocytopenia with ≥ Grade 2 hemorrhage
Grade 4 thrombocytopenia lasting > 7 days
Grade 3 anemia with symptoms or required intervention
Grade 4 anemia
Lymphopenia is not considered a DLT
Non-hematological:
≥ Grade 3 nausea, vomiting or diarrhea persisting > 3 days despite optimal medical support
Grade 3 fatigue persisting > 7 days
≥ Grade 3 acute kidney injury lasting > 3 days
Elevation of aspartate aminotransferase or alanine aminotransferase >3x to >8x upper limit of normal (ULT) dependent on criteria
Total bilirubin > 3x ULN
Participants meeting the criteria for Hy's Law case were considered to have a DLT.
Day 1 to Day 28
Number of Participants With a Treatment-emergent Adverse Event (TEAE)
An adverse event (AE) is defined as any untoward medical occurrence in a clinical trial participant.
TEAEs were any AE that occurred after receiving at least 1 dose of treatment.
Treatment-related TEAEs were those considered related to study treatment by the investigator.
Any clinically significant changes in ECGs, vital signs, physical examination with a neurologic assessment and clinical laboratory tests were recorded as TEAEs.
Day 1 of Cycle 1 to up to the end of Cycle 4, where each cycle is 3 weeks; up to 12 weeks.
Secondary Outcomes
Measure
Description
Time Frame
Maximum Observed Concentration (Cmax) of AMG 224 Conjugated Antibody, Total Anti-B-cell Maturation Antigen (Anti-BCMA) Antibody, and Total Unconjugated DM1
Cmax of AMG 224 conjugated antibody, total anti-BCMA antibody and total unconjugated DM1 was measured. DM1 is a semi-synthetic derivative of the ansamycin antibiotic, maytansine conjugated to the non-cleavable linker 4-[N-maleimidomethyl] cyclohexane-1-carboxylate conjugated to lysine residues in the antibody (MCC).
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
- Pathologically documented,multiple myeloma relapsed or refractory progressive disease after at least 3 lines of therapy for multiple myeloma.
Prior therapeutic treatment or regimens must include proteasome inhibitors (e.g. bortezomib) and immunomodulatory drugs (e.g. lenalidomide).
Willing and able to undergo bone marrow aspirate per protocol (with or without bone marrow biopsy per institutional guidelines).
Measurable disease per the International Myeloma Working Group (IMWG) response criteria
Hematological function, as follows, without transfusion support:
Absolute neutrophil count ≥ 1.0 X 10^9/L,
Platelet count ≥ 75 X 10^9/L (in patients with < 50% of bone marrow nucleated cells were plasma cells) or ≥ 50 X 10^9/L (in patients with ≥ 50% of bone marrow nucleated cells were plasma cells) without transfusion or growth factor support
Hemoglobin > 8 g/dL (> 80 g/L)
Adequate renal and hepatic function
Left ventricular ejection fraction (LVEF) > 50%
Exclusion Criteria:
Currently receiving treatment in another investigational device or drug study, or less than 28 days since ending treatment on another investigational device or drug study
Autologous stem cell transplant less than 90 days prior to study day 1
Multiple myeloma with IgM subtype
POEMS (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes) syndrome, Plasma cell leukemia, Waldenstrom's macroglobulinemia or Amyloidosis
Glucocorticoid therapy (prednisone > 30 mg/day or equivalent) within 7 days prior to study day
Myocardial infarction within 6 months of study day 1, symptomatic congestive heart failure (New York Heart Association > class II)
A baseline ECG QTcF > 470 msec
Anti-tumor therapy (chemotherapy, antibody therapy, molecular targeted therapy, or investigational agent) within 28 days prior to study day 1
Lee HC, Raje NS, Landgren O, Upreti VV, Wang J, Avilion AA, Hu X, Rasmussen E, Ngarmchamnanrith G, Fujii H, Spencer A. Phase 1 study of the anti-BCMA antibody-drug conjugate AMG 224 in patients with relapsed/refractory multiple myeloma. Leukemia. 2021 Jan;35(1):255-258. doi: 10.1038/s41375-020-0834-9. Epub 2020 Apr 21. No abstract available.
De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request
Types
Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame
Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication (or other new use) have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
Access Criteria
Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors, and if not approved, may be further arbitrated by a Data Sharing Independent Review Panel. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the link below.
Doses of AMG 224 in dose exploration part range from lowest in Dose A (30mg) up to highest in Dose G (250mg). Specific doses are blinded due to the protection of propriety information.
Recruitment Details
A total of 42 participants were enrolled in the study at 4 research centers in Australia and the United States from 20 November 2015 to 21 April 2022. Primary completion date: 30 Nov 2018.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Dose Exploration: AMG 224 Dose A
Participants were administered AMG 224 Dose A as an intravenous (IV) infusion once every 3 weeks (Q3W) on Day 1 of each cycle, where each cycle is 3 weeks.
FG001
Dose Exploration: AMG 224 Dose B
Participants were administered AMG 224 Dose B as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.
FG002
Dose Exploration: AMG 224 Dose C
Participants were administered AMG 224 Dose C as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.
FG003
Dose Exploration: AMG 224 Dose D
Participants were administered AMG 224 Dose D as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.
FG004
Dose Exploration: AMG 224 Dose E
Participants were administered AMG 224 Dose E as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.
FG005
Dose Exploration: AMG 224 Dose F
Participants were administered AMG 224 Dose F as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.
FG006
Dose Exploration: AMG 224 Dose G
Participants were administered AMG 224 Dose G as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.
Participants who had prior treatment with CD38-targeting antibody were administered AMG 224 Dose H (the maximum tolerated dose [MTD] identified based on the dose exploration phase) as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.
FG008
Dose Expansion: AMG 224 Dose H + no Prior CD38 Targeting Antibody Treatment
Participants who had no prior treatment with CD38-targeting antibody were administered AMG 224 Dose H (the MTD identified based on the dose exploration phase) as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
FG0003 subjects
FG0013 subjects
FG0023 subjects
FG0033 subjects
FG0046 subjects
FG0056 subjects
FG0065 subjects
FG00711 subjects
FG0082 subjects
Received Treatment
FG0003 subjects
FG0013 subjects
FG0023 subjects
FG0033 subjects
FG004
COMPLETED
FG0002 subjects
FG0013 subjects
FG0023 subjects
FG0033 subjects
FG004
NOT COMPLETED
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Withdrawal by Subject
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG003
Baseline Characteristics Module
Baseline Analysis Population Description
Safety analysis set: all participants that are enrolled and received at least 1 dose of AMG 224.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Dose Exploration: AMG 224 Dose A
Participants were administered AMG 224 Dose A as an intravenous (IV) infusion once every 3 weeks (Q3W) on Day 1 of each cycle, where each cycle is 3 weeks.
BG001
Dose Exploration: AMG 224 Dose B
Denominators
Units
Counts
Participants
BG000
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Outcome Measures Module
Outcome Measures
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 Who Experienced a Dose-Limiting Toxicity (DLT)
Adverse events, including DLTs, were graded using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. A DLT was considered as any of the below, if judged by the investigator to be possibly related to AMG 224:
Hematological:
Grade 4 neutropenia lasting > 7 days
Grade 3 or 4 neutropenia with fever > 38.5°C
Grade 3 thrombocytopenia with ≥ Grade 2 hemorrhage
Grade 4 thrombocytopenia lasting > 7 days
Grade 3 anemia with symptoms or required intervention
Grade 4 anemia
Lymphopenia is not considered a DLT
Non-hematological:
≥ Grade 3 nausea, vomiting or diarrhea persisting > 3 days despite optimal medical support
Grade 3 fatigue persisting > 7 days
≥ Grade 3 acute kidney injury lasting > 3 days
Elevation of aspartate aminotransferase or alanine aminotransferase >3x to >8x upper limit of normal (ULT) dependent on criteria
Total bilirubin > 3x ULN
Participants meeting the criteria for Hy's Law case were considered to have a DLT.
DLT analysis set: all participants who are DLT evaluable. A participant was not DLT-evaluable if the participant discontinued treatment for any reason other than a DLT prior to completing the first 28 days of AMG 224 treatment or did not receive 2 doses of AMG 224 during the 28-day DLT window.
Posted
Count of Participants
Participants
Day 1 to Day 28
Adverse Events Module
Frequency Threshold
5
Time Frame
All-cause mortality was collected from enrollment to the end of study visit, up to approximately 6 years. Treatment-emergent adverse events were collected from the first administration of AMG 224 up to 37 days after the last dose of investigational product (median treatment duration was 9 weeks).
Description
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
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
Dose Exploration: AMG 224 Dose A
Participants were administered AMG 224 Dose A as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.
Participants who had prior treatment with CD38-targeting antibody were administered AMG 224 Dose H (the maximum tolerated dose [MTD] based on the dose exploration phase) as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.
Drug: AMG 224
Dose Expansion: AMG 224 Dose H + no prior CD38 targeting antibody treatment
Experimental
Participants who had no prior treatment with CD38-targeting antibody were administered AMG 224 Dose H (the MTD based on the dose exploration phase) as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.
Drug: AMG 224
Dose Exploration: AMG 224 Dose A
Dose Exploration: AMG 224 Dose B
Dose Exploration: AMG 224 Dose C
Dose Exploration: AMG 224 Dose D
Dose Exploration: AMG 224 Dose E
Dose Exploration: AMG 224 Dose F
Dose Exploration: AMG 224 Dose G
AMG 224 and anti-BCMA antibody: pre-dose, 0.5 hours, end of infusion (EOI), 4 hours, 24 hours, 96 hours, 168 hours, and 336 hours post-dose (Cycles 1 + 2); DM1: pre-dose, 0.5 hours, EOI, 4 hours, 24 hours, and 96 hours post-dose (Cycles 1 + 2)
Minimum Observed Concentration (Cmin) of AMG 224 Conjugated Antibody, Total Anti-BCMA Antibody, and Total Unconjugated DM1
Cmin of AMG 224 conjugated antibody, total anti-BCMA antibody and total unconjugated DM1 was measured.
Area Under the Concentration-time Curve (AUC) of AMG 224 Conjugated Antibody, Total Anti-BCMA Antibody, and Total Unconjugated DM1
AUC from time zero to 3 weeks (AUC(3 weeks)) was determined for AMG 224 conjugated antibody and total anti-BCMA antibody, and AUC from time zero to 96 hours (AUC(0-96hr)) was determined for DM1.
Best Overall Response (BOR) According to International Myeloma Working Group Uniform Response Criteria (IMWG-URC)
BOR was the best observed post baseline disease response per IMWG-URC: Complete response (CR): Negative immunofixation on serum and urine, soft tissue plasmacytomas disappearance, < 5% plasma cells in bone marrow (BM). Stringent CR (sCR): CR and normal serum free light chain ratio and no clonal cells in BM. Very Good Partial Response (VGPR): Serum and urine M-protein detectable by immunofixation or ≥ 90% reduction in serum M-protein (urine M-protein level < 100 mg/24-h). PR: ≥ 50% reduction of serum M-protein and 24-h urinary M-protein by ≥ 90% or to < 200 mg/24-h. Minor Response (MR): 25-49% reduction of serum M-protein and 50-89% in 24-h urinary M-protein, exceeding 200 mg/24-h. Stable Disease (SD): Not meeting criteria for CR, VGPR, PR or Progressive Disease (PD). PD: ≥ 25% increase in serum or urine M-component, development of new or increased size of existing bone lesions or soft tissue plasmacytomas, hypercalcemia attributed to the plasma cell proliferative disorder.
Day 1 of Cycle 1 to up to the end of study visit; up to approximately 6 years
Time To Progression (TTP) According to IMWG-URC
TTP was the time from the first administration of AMG 224 to the first objective assessment of disease progression as per IMWG-URC or deaths or if applicable date of censoring. The median TTP was estimated using the Kaplan-Meier method
Day 1 of Cycle 1 to up to the end of study visit; up to approximately 6 years
Duration of Response (DOR) According to IMWG-URC
DOR was defined as the time between the date of the first observation indicating an objective response as PR (or better) through to the subsequent date of disease progression as classified by the IMWG-URC for Multiple Myeloma or death or where applicable date of censoring. The median DOR was estimated using the Kaplan-Meier method.
Day 1 of Cycle 1 to up to the end of study visit; up to approximately 6 years
Number of Participants With Conversion to Minimal Residual Disease (MRD)-Negativity
MRD negative was defined as a tumor load of less than 1 clonal cell in 10^5 normal cells (as determined by flow cytometry).
Day 1 of Cycle 1 to up to the end of study visit; up to approximately 6 years
Number of Participants With Anti-AMG 224 Antibodies
The number of participants who tested positive for pre-existing binding antibodies prior to exposure to AMG 224 and who tested positive for anti-AMG 224 binding antibodies after dosing with AMG 224 are presented. Participants with transient post-baseline results were binding antibody positive post-baseline with a negative or no result at baseline and a negative result at the participant's last timepoint tested.
Day 1 of Cycle 1 to up to the end of study visit; up to approximately 6 years
Boston
Massachusetts
02114
United States
Research Site
New York
New York
10065
United States
Research Site
Houston
Texas
77030
United States
Research Site
Prahran
Victoria
3181
Australia
6 subjects
FG0056 subjects
FG0065 subjects
FG0079 subjects
FG0082 subjects
4 subjects
FG0053 subjects
FG0063 subjects
FG0077 subjects
FG0082 subjects
2 subjects
FG0053 subjects
FG0062 subjects
FG0074 subjects
FG0080 subjects
0 subjects
FG0041 subjects
FG0051 subjects
FG0062 subjects
FG0071 subjects
FG0080 subjects
Decision by sponsor
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0041 subjects
FG0051 subjects
FG0060 subjects
FG0073 subjects
FG0080 subjects
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0051 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
Participants were administered AMG 224 Dose B as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.
BG002
Dose Exploration: AMG 224 Dose C
Participants were administered AMG 224 Dose C as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.
BG003
Dose Exploration: AMG 224 Dose D
Participants were administered AMG 224 Dose D as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.
BG004
Dose Exploration: AMG 224 Dose E
Participants were administered AMG 224 Dose E as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.
BG005
Dose Exploration: AMG 224 Dose F
Participants were administered AMG 224 Dose F as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.
BG006
Dose Exploration: AMG 224 Dose G
Participants were administered AMG 224 Dose G as an intravenous (IV) infusion once every 3 weeks (Q3W) on Day 1 of each cycle, where each cycle is 3 weeks.
Participants who had prior treatment with CD38-targeting antibody were administered AMG 224 Dose H (the maximum tolerated dose [MTD] identified based on the dose exploration phase) as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.
BG008
Dose Expansion: AMG 224 Dose H + no Prior CD38 Targeting Antibody Treatment
Participants who had no prior treatment with CD38-targeting antibody were administered AMG 224 Dose H (the MTD identified based on the dose exploration phase) as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.
BG009
Total
Total of all reporting groups
3
BG0013
BG0023
BG0033
BG0046
BG0056
BG0065
BG0079
BG0082
BG00940
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00063.3± 7.0
BG00163.7± 3.8
BG00264.3± 11.2
BG00370.7± 4.0
BG00460.5± 7.1
BG00565.0± 5.7
BG00658.2± 6.0
BG00771.3± 8.7
BG00853.0± 9.9
BG00964.5± 8.4
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0001
BG0012
BG0021
BG0031
BG0043
BG0054
BG0064
BG0074
BG0081
BG00921
Male
BG0002
BG0011
BG0022
BG0032
BG004
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0000
BG0010
BG0020
BG0030
BG0042
BG0052
BG0062
BG0071
BG0081
BG0098
Not Hispanic or Latino
BG0003
BG0013
BG0023
BG0033
BG004
Unknown or Not Reported
BG0000
BG0010
BG0020
BG0030
BG004
Race/Ethnicity, Customized
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Asian
BG0000
BG0010
BG0021
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
BG0091
Black (or African American)
BG0000
BG0010
BG0020
BG0030
BG004
White
BG0000
BG0011
BG0022
BG0033
BG004
Other
BG0003
BG0012
BG0020
BG0030
BG004
ID
Title
Description
OG000
Dose Exploration: AMG 224 Dose A
Participants were administered AMG 224 Dose A as an intravenous (IV) infusion once every 3 weeks (Q3W) on Day 1 of each cycle, where each cycle is 3 weeks.
OG001
Dose Exploration: AMG 224 Dose B
Participants were administered AMG 224 Dose B as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.
OG002
Dose Exploration: AMG 224 Dose C
Participants were administered AMG 224 Dose C as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.
OG003
Dose Exploration: AMG 224 Dose D
Participants were administered AMG 224 Dose D as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.
OG004
Dose Exploration: AMG 224 Dose E
Participants were administered AMG 224 Dose E as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.
OG005
Dose Exploration: AMG 224 Dose F
Participants were administered AMG 224 Dose F as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.
OG006
Dose Exploration: AMG 224 Dose G
Participants were administered AMG 224 Dose G as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.
Participants who had prior treatment with CD38-targeting antibody were administered AMG 224 Dose H (the maximum tolerated dose [MTD] identified based on the dose exploration phase) as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.
OG008
Dose Expansion: AMG 224 Dose H + no Prior CD38 Targeting Antibody Treatment
Participants who had no prior treatment with CD38-targeting antibody were administered AMG 224 Dose H (the MTD identified based on the dose exploration phase) as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.
Units
Counts
Participants
OG0003
OG0013
OG0023
OG0033
OG0043
OG0056
OG0064
OG0078
OG0081
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0051
OG0063
OG0070
OG0080
Primary
Number of Participants With a Treatment-emergent Adverse Event (TEAE)
An adverse event (AE) is defined as any untoward medical occurrence in a clinical trial participant.
TEAEs were any AE that occurred after receiving at least 1 dose of treatment.
Treatment-related TEAEs were those considered related to study treatment by the investigator.
Any clinically significant changes in ECGs, vital signs, physical examination with a neurologic assessment and clinical laboratory tests were recorded as TEAEs.
Safety analysis set: all participants that are enrolled and received at least 1 dose of AMG 224.
Posted
Count of Participants
Participants
Day 1 of Cycle 1 to up to the end of Cycle 4, where each cycle is 3 weeks; up to 12 weeks.
ID
Title
Description
OG000
Dose Exploration: AMG 224 Dose A
Participants were administered AMG 224 Dose A as an intravenous (IV) infusion once every 3 weeks (Q3W) on Day 1 of each cycle, where each cycle is 3 weeks.
OG001
Dose Exploration: AMG 224 Dose B
Participants were administered AMG 224 Dose B as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.
OG002
Dose Exploration: AMG 224 Dose C
Participants were administered AMG 224 Dose C as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.
OG003
Dose Exploration: AMG 224 Dose D
Participants were administered AMG 224 Dose D as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.
OG004
Dose Exploration: AMG 224 Dose E
Participants were administered AMG 224 Dose E as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.
OG005
Dose Exploration: AMG 224 Dose F
Participants were administered AMG 224 Dose F as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.
OG006
Dose Exploration: AMG 224 Dose G
Participants were administered AMG 224 Dose G as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.
Participants who had prior treatment with CD38-targeting antibody were administered AMG 224 Dose H (the maximum tolerated dose [MTD] identified based on the dose exploration phase) as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.
OG008
Dose Expansion: AMG 224 Dose H + no Prior CD38 Targeting Antibody Treatment
Participants who had no prior treatment with CD38-targeting antibody were administered AMG 224 Dose H (the MTD identified based on the dose exploration phase) as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.
Units
Counts
Participants
OG0003
OG0013
OG0023
OG003
Title
Denominators
Categories
TEAE
Title
Measurements
OG0003
OG0013
OG0023
OG003
Secondary
Maximum Observed Concentration (Cmax) of AMG 224 Conjugated Antibody, Total Anti-B-cell Maturation Antigen (Anti-BCMA) Antibody, and Total Unconjugated DM1
Cmax of AMG 224 conjugated antibody, total anti-BCMA antibody and total unconjugated DM1 was measured. DM1 is a semi-synthetic derivative of the ansamycin antibiotic, maytansine conjugated to the non-cleavable linker 4-[N-maleimidomethyl] cyclohexane-1-carboxylate conjugated to lysine residues in the antibody (MCC).
The pharmacokinetic (PK) parameter analysis set included participants who received at least 1 dose of AMG 224 and for whom PK parameters could be adequately estimated.
Posted
Mean
Full Range
µg/mL
AMG 224 and anti-BCMA antibody: pre-dose, 0.5 hours, end of infusion (EOI), 4 hours, 24 hours, 96 hours, 168 hours, and 336 hours post-dose (Cycles 1 + 2); DM1: pre-dose, 0.5 hours, EOI, 4 hours, 24 hours, and 96 hours post-dose (Cycles 1 + 2)
ID
Title
Description
OG000
Dose Exploration: AMG 224 Dose A
Participants were administered AMG 224 Dose A as an intravenous (IV) infusion once every 3 weeks (Q3W) on Day 1 of each cycle, where each cycle is 3 weeks.
OG001
Dose Exploration: AMG 224 Dose B
Participants were administered AMG 224 Dose B as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.
OG002
Dose Exploration: AMG 224 Dose C
Participants were administered AMG 224 Dose C as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.
OG003
Dose Exploration: AMG 224 Dose D
Participants were administered AMG 224 Dose D as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.
OG004
Dose Exploration: AMG 224 Dose E
Participants were administered AMG 224 Dose E as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.
OG005
Dose Exploration: AMG 224 Dose F
Participants were administered AMG 224 Dose F as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.
OG006
Dose Exploration: AMG 224 Dose G
Participants were administered AMG 224 Dose G as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.
OG007
Dose Expansion: AMG 224 3 mg/kg
All participants in Dose Expansion who had prior treatment or no prior treatment with a CD38-targeting antibody were administered the MTD of AMG 224 identified in the dose escalation as 3 mg/kg. AMG 224 was administered as an intravenous (IV) infusion once every 3 weeks (Q3W) on Day 1 of each cycle, where each cycle is 3 weeks.
Units
Counts
Participants
OG0003
OG0013
OG0023
OG003
Title
Denominators
Categories
AMG 224 Conjugated Antibody after Cycle 1
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG0023
ParticipantsOG003
Secondary
Minimum Observed Concentration (Cmin) of AMG 224 Conjugated Antibody, Total Anti-BCMA Antibody, and Total Unconjugated DM1
Cmin of AMG 224 conjugated antibody, total anti-BCMA antibody and total unconjugated DM1 was measured.
The PK parameter analysis set included participants who received at least 1 dose of AMG 224 and for whom PK parameters could be adequately estimated.
Participants were administered AMG 224 Dose A as an intravenous (IV) infusion once every 3 weeks (Q3W) on Day 1 of each cycle, where each cycle is 3 weeks.
OG001
Dose Exploration: AMG 224 Dose B
Participants were administered AMG 224 Dose B as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.
OG002
Dose Exploration: AMG 224 Dose C
Participants were administered AMG 224 Dose C as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.
OG003
Dose Exploration: AMG 224 Dose D
Participants were administered AMG 224 Dose D as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.
OG004
Dose Exploration: AMG 224 Dose E
Participants were administered AMG 224 Dose E as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.
OG005
Dose Exploration: AMG 224 Dose F
Participants were administered AMG 224 Dose F as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.
OG006
Dose Exploration: AMG 224 Dose G
Participants were administered AMG 224 Dose G as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.
OG007
Dose Expansion: AMG 224 3 mg/kg
All participants in Dose Expansion who had prior treatment or no prior treatment with a CD38-targeting antibody were administered the MTD of AMG 224 identified in the dose escalation as 3 mg/kg. AMG 224 was administered as an intravenous (IV) infusion once every 3 weeks (Q3W) on Day 1 of each cycle, where each cycle is 3 weeks.
Units
Counts
Participants
OG0003
OG0013
OG0023
OG003
Title
Denominators
Categories
AMG 224 Conjugated Antibody after Cycle 1
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG0023
ParticipantsOG003
Secondary
Area Under the Concentration-time Curve (AUC) of AMG 224 Conjugated Antibody, Total Anti-BCMA Antibody, and Total Unconjugated DM1
AUC from time zero to 3 weeks (AUC(3 weeks)) was determined for AMG 224 conjugated antibody and total anti-BCMA antibody, and AUC from time zero to 96 hours (AUC(0-96hr)) was determined for DM1.
The PK parameter analysis set included participants who received at least 1 dose of AMG 224 and for whom PK parameters could be adequately estimated. All participants included in the overall number of participants analyzed contributed data to this endpoint.
Participants were administered AMG 224 Dose A as an intravenous (IV) infusion once every 3 weeks (Q3W) on Day 1 of each cycle, where each cycle is 3 weeks.
OG001
Dose Exploration: AMG 224 Dose B
Participants were administered AMG 224 Dose B as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.
OG002
Dose Exploration: AMG 224 Dose C
Participants were administered AMG 224 Dose C as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.
OG003
Dose Exploration: AMG 224 Dose D
Participants were administered AMG 224 Dose D as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.
OG004
Dose Exploration: AMG 224 Dose E
Participants were administered AMG 224 Dose E as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.
OG005
Dose Exploration: AMG 224 Dose F
Participants were administered AMG 224 Dose F as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.
OG006
Dose Exploration: AMG 224 Dose G
Participants were administered AMG 224 Dose G as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.
OG007
Dose Expansion: AMG 224 3 mg/kg
All participants in Dose Expansion who had prior treatment or no prior treatment with a CD38-targeting antibody were administered the MTD of AMG 224 identified in the dose escalation as 3 mg/kg. AMG 224 was administered as an intravenous (IV) infusion once every 3 weeks (Q3W) on Day 1 of each cycle, where each cycle is 3 weeks.
Units
Counts
Participants
OG0003
OG0013
OG0023
OG003
Title
Denominators
Categories
AUC(3weeks): AMG 224 Conjugated Antibody after Cycle 1
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG0023
ParticipantsOG003
Secondary
Clearance (CL) of AMG 224 Conjugated Antibody, Total Anti-BCMA Antibody, and Total Unconjugated DM1
CL of AMG 224 conjugated antibody, total anti-BCMA antibody and total unconjugated DM1 was determined.
The PK parameter analysis set included participants who received at least 1 dose of AMG 224 and for whom PK parameters could be adequately estimated.
Participants were administered AMG 224 Dose A as an intravenous (IV) infusion once every 3 weeks (Q3W) on Day 1 of each cycle, where each cycle is 3 weeks.
OG001
Dose Exploration: AMG 224 Dose B
Participants were administered AMG 224 Dose B as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.
OG002
Dose Exploration: AMG 224 Dose C
Participants were administered AMG 224 Dose C as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.
OG003
Dose Exploration: AMG 224 Dose D
Participants were administered AMG 224 Dose D as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.
OG004
Dose Exploration: AMG 224 Dose E
Participants were administered AMG 224 Dose E as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.
OG005
Dose Exploration: AMG 224 Dose F
Participants were administered AMG 224 Dose F as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.
OG006
Dose Exploration: AMG 224 Dose G
Participants were administered AMG 224 Dose G as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.
OG007
Dose Expansion: AMG 224 3 mg/kg
All participants in Dose Expansion who had prior treatment or no prior treatment with a CD38-targeting antibody were administered the MTD of AMG 224 identified in the dose escalation as 3 mg/kg. AMG 224 was administered as an intravenous (IV) infusion once every 3 weeks (Q3W) on Day 1 of each cycle, where each cycle is 3 weeks.
Units
Counts
Participants
OG0003
OG0013
OG0023
OG003
Title
Denominators
Categories
AMG 224 Conjugated Antibody after Cycle 1
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG0023
ParticipantsOG003
Secondary
Terminal Half-life (t1/2,z) of AMG 224 Conjugated Antibody, Total Anti-BCMA Antibody, and Total Unconjugated DM1
The t1/2,z of AMG 224 conjugated antibody, total anti-BCMA antibody and total unconjugated DM1 was measured.
The PK parameter analysis set included participants who received at least 1 dose of AMG 224 and for whom PK parameters could be adequately estimated. All participants included in the overall number of participants analyzed contributed data to this endpoint.
Participants were administered AMG 224 Dose A as an intravenous (IV) infusion once every 3 weeks (Q3W) on Day 1 of each cycle, where each cycle is 3 weeks.
OG001
Dose Exploration: AMG 224 Dose B
Participants were administered AMG 224 Dose B as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.
OG002
Dose Exploration: AMG 224 Dose C
Participants were administered AMG 224 Dose C as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.
OG003
Dose Exploration: AMG 224 Dose D
Participants were administered AMG 224 Dose D as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.
OG004
Dose Exploration: AMG 224 Dose E
Participants were administered AMG 224 Dose E as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.
OG005
Dose Exploration: AMG 224 Dose F
Participants were administered AMG 224 Dose F as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.
OG006
Dose Exploration: AMG 224 Dose G
Participants were administered AMG 224 Dose G as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.
OG007
Dose Expansion: AMG 224 3 mg/kg
All participants in Dose Expansion who had prior treatment or no prior treatment with a CD38-targeting antibody were administered the MTD of AMG 224 identified in the dose escalation as 3 mg/kg. AMG 224 was administered as an intravenous (IV) infusion once every 3 weeks (Q3W) on Day 1 of each cycle, where each cycle is 3 weeks.
Units
Counts
Participants
OG0003
OG0013
OG0021
OG003
Title
Denominators
Categories
AMG 224 Conjugated Antibody after Cycle 1
ParticipantsOG0002
ParticipantsOG0013
ParticipantsOG0021
ParticipantsOG003
Secondary
Best Overall Response (BOR) According to International Myeloma Working Group Uniform Response Criteria (IMWG-URC)
BOR was the best observed post baseline disease response per IMWG-URC: Complete response (CR): Negative immunofixation on serum and urine, soft tissue plasmacytomas disappearance, < 5% plasma cells in bone marrow (BM). Stringent CR (sCR): CR and normal serum free light chain ratio and no clonal cells in BM. Very Good Partial Response (VGPR): Serum and urine M-protein detectable by immunofixation or ≥ 90% reduction in serum M-protein (urine M-protein level < 100 mg/24-h). PR: ≥ 50% reduction of serum M-protein and 24-h urinary M-protein by ≥ 90% or to < 200 mg/24-h. Minor Response (MR): 25-49% reduction of serum M-protein and 50-89% in 24-h urinary M-protein, exceeding 200 mg/24-h. Stable Disease (SD): Not meeting criteria for CR, VGPR, PR or Progressive Disease (PD). PD: ≥ 25% increase in serum or urine M-component, development of new or increased size of existing bone lesions or soft tissue plasmacytomas, hypercalcemia attributed to the plasma cell proliferative disorder.
Safety analysis set included all participants who received at least 1 dose of AMG 224.
Posted
Count of Participants
Participants
Day 1 of Cycle 1 to up to the end of study visit; up to approximately 6 years
ID
Title
Description
OG000
Dose Exploration: AMG 224 Dose A
Participants were administered AMG 224 Dose A as an intravenous (IV) infusion once every 3 weeks (Q3W) on Day 1 of each cycle, where each cycle is 3 weeks.
OG001
Dose Exploration: AMG 224 Dose B
Participants were administered AMG 224 Dose B as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.
OG002
Dose Exploration: AMG 224 Dose C
Participants were administered AMG 224 Dose C as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.
OG003
Dose Exploration: AMG 224 Dose D
Participants were administered AMG 224 Dose D as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.
OG004
Dose Exploration: AMG 224 Dose E
Participants were administered AMG 224 Dose E as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.
OG005
Dose Exploration: AMG 224 Dose F
Participants were administered AMG 224 Dose F as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.
OG006
Dose Exploration: AMG 224 Dose G
Participants were administered AMG 224 Dose G as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.
Participants who had prior treatment with CD38-targeting antibody were administered AMG 224 Dose H (the maximum tolerated dose [MTD] identified based on the dose exploration phase) as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.
OG008
Dose Expansion: AMG 224 Dose H + no Prior CD38 Targeting Antibody Treatment
Participants who had no prior treatment with CD38-targeting antibody were administered AMG 224 Dose H (the MTD identified based on the dose exploration phase) as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.
Units
Counts
Participants
OG0003
OG0013
OG0023
OG003
Title
Denominators
Categories
sCR
Title
Measurements
OG0000
OG0010
OG0020
OG003
Secondary
Time To Progression (TTP) According to IMWG-URC
TTP was the time from the first administration of AMG 224 to the first objective assessment of disease progression as per IMWG-URC or deaths or if applicable date of censoring. The median TTP was estimated using the Kaplan-Meier method
The safety analysis set included all participants who received at least 1 dose of AMG 224.
Posted
Median
80% Confidence Interval
months
Day 1 of Cycle 1 to up to the end of study visit; up to approximately 6 years
ID
Title
Description
OG000
Dose Exploration: AMG 224 Dose A
Participants were administered AMG 224 Dose A as an intravenous (IV) infusion once every 3 weeks (Q3W) on Day 1 of each cycle, where each cycle is 3 weeks.
OG001
Dose Exploration: AMG 224 Dose B
Participants were administered AMG 224 Dose B as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.
OG002
Dose Exploration: AMG 224 Dose C
Participants were administered AMG 224 Dose C as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.
OG003
Dose Exploration: AMG 224 Dose D
Participants were administered AMG 224 Dose D as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.
OG004
Dose Exploration: AMG 224 Dose E
Participants were administered AMG 224 Dose E as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.
OG005
Dose Exploration: AMG 224 Dose F
Participants were administered AMG 224 Dose F as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.
OG006
Dose Exploration: AMG 224 Dose G
Participants were administered AMG 224 Dose G as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.
Participants who had prior treatment with CD38-targeting antibody were administered AMG 224 Dose H (the maximum tolerated dose [MTD] identified based on the dose exploration phase) as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.
OG008
Dose Expansion: AMG 224 Dose H + no Prior CD38 Targeting Antibody Treatment
Participants who had no prior treatment with CD38-targeting antibody were administered AMG 224 Dose H (the MTD identified based on the dose exploration phase) as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.
Units
Counts
Participants
OG0003
OG0013
OG0023
OG003
Title
Denominators
Categories
Title
Measurements
OG00074.9(3.5 to NA)Too few events to estimate the upper 80% confidence interval (CI)
OG0011.6(0.7 to NA)Too few events to estimate the upper 80% CI
OG002
Secondary
Duration of Response (DOR) According to IMWG-URC
DOR was defined as the time between the date of the first observation indicating an objective response as PR (or better) through to the subsequent date of disease progression as classified by the IMWG-URC for Multiple Myeloma or death or where applicable date of censoring. The median DOR was estimated using the Kaplan-Meier method.
The safety analysis set included all participants who received at least 1 dose of AMG 224.
Posted
Median
80% Confidence Interval
months
Day 1 of Cycle 1 to up to the end of study visit; up to approximately 6 years
ID
Title
Description
OG000
Dose Exploration: AMG 224 Dose A
Participants were administered AMG 224 Dose A as an intravenous (IV) infusion once every 3 weeks (Q3W) on Day 1 of each cycle, where each cycle is 3 weeks.
OG001
Dose Exploration: AMG 224 Dose B
Participants were administered AMG 224 Dose B as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.
OG002
Dose Exploration: AMG 224 Dose C
Participants were administered AMG 224 Dose C as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.
OG003
Dose Exploration: AMG 224 Dose D
Participants were administered AMG 224 Dose D as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.
OG004
Dose Exploration: AMG 224 Dose E
Participants were administered AMG 224 Dose E as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.
OG005
Dose Exploration: AMG 224 Dose F
Participants were administered AMG 224 Dose F as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.
OG006
Dose Exploration: AMG 224 Dose G
Participants were administered AMG 224 Dose G as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.
Participants who had prior treatment with CD38-targeting antibody were administered AMG 224 Dose H (the maximum tolerated dose [MTD] identified based on the dose exploration phase) as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.
OG008
Dose Expansion: AMG 224 Dose H + no Prior CD38 Targeting Antibody Treatment
Participants who had no prior treatment with CD38-targeting antibody were administered AMG 224 Dose H (the MTD identified based on the dose exploration phase) as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.
Units
Counts
Participants
OG0003
OG0013
OG0023
OG003
Title
Denominators
Categories
Title
Measurements
OG00063.1(NA to NA)Too few events to estimate the 80% CIs
OG001NA(NA to NA)No events therefore median and 80% CIs could not be estimated
OG002NA
Secondary
Number of Participants With Conversion to Minimal Residual Disease (MRD)-Negativity
MRD negative was defined as a tumor load of less than 1 clonal cell in 10^5 normal cells (as determined by flow cytometry).
Safety analysis set: all participants that are enrolled and received at least 1 dose of AMG 224.
Posted
Count of Participants
Participants
Day 1 of Cycle 1 to up to the end of study visit; up to approximately 6 years
ID
Title
Description
OG000
Dose Exploration: AMG 224 Dose A
Participants were administered AMG 224 Dose A as an intravenous (IV) infusion once every 3 weeks (Q3W) on Day 1 of each cycle, where each cycle is 3 weeks.
OG001
Dose Exploration: AMG 224 Dose B
Participants were administered AMG 224 Dose B as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.
OG002
Dose Exploration: AMG 224 Dose C
Participants were administered AMG 224 Dose C as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.
OG003
Dose Exploration: AMG 224 Dose D
Participants were administered AMG 224 Dose D as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.
OG004
Dose Exploration: AMG 224 Dose E
Participants were administered AMG 224 Dose E as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.
OG005
Dose Exploration: AMG 224 Dose F
Participants were administered AMG 224 Dose F as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.
OG006
Dose Exploration: AMG 224 Dose G
Participants were administered AMG 224 Dose G as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.
Participants who had prior treatment with CD38-targeting antibody were administered AMG 224 Dose H (the maximum tolerated dose [MTD] identified based on the dose exploration phase) as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.
OG008
Dose Expansion: AMG 224 Dose H + no Prior CD38 Targeting Antibody Treatment
Participants who had no prior treatment with CD38-targeting antibody were administered AMG 224 Dose H (the MTD identified based on the dose exploration phase) as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.
Units
Counts
Participants
OG0003
OG0013
OG0023
OG003
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG003
Secondary
Number of Participants With Anti-AMG 224 Antibodies
The number of participants who tested positive for pre-existing binding antibodies prior to exposure to AMG 224 and who tested positive for anti-AMG 224 binding antibodies after dosing with AMG 224 are presented. Participants with transient post-baseline results were binding antibody positive post-baseline with a negative or no result at baseline and a negative result at the participant's last timepoint tested.
The safety analysis set included all participants who received at least 1 dose of AMG 224.
Posted
Number
participants
Day 1 of Cycle 1 to up to the end of study visit; up to approximately 6 years
ID
Title
Description
OG000
Dose Exploration: AMG 224 Dose A
Participants were administered AMG 224 Dose A as an intravenous (IV) infusion once every 3 weeks (Q3W) on Day 1 of each cycle, where each cycle is 3 weeks.
OG001
Dose Exploration: AMG 224 Dose B
Participants were administered AMG 224 Dose B as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.
OG002
Dose Exploration: AMG 224 Dose C
Participants were administered AMG 224 Dose C as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.
OG003
Dose Exploration: AMG 224 Dose D
Participants were administered AMG 224 Dose D as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.
OG004
Dose Exploration: AMG 224 Dose E
Participants were administered AMG 224 Dose E as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.
OG005
Dose Exploration: AMG 224 Dose F
Participants were administered AMG 224 Dose F as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.
OG006
Dose Exploration: AMG 224 Dose G
Participants were administered AMG 224 Dose G as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.
Participants who had prior treatment with CD38-targeting antibody were administered AMG 224 Dose H (the maximum tolerated dose [MTD] identified based on the dose exploration phase) as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.
OG008
Dose Expansion: AMG 224 Dose H + no Prior CD38 Targeting Antibody Treatment
Participants who had no prior treatment with CD38-targeting antibody were administered AMG 224 Dose H (the MTD identified based on the dose exploration phase) as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.
Units
Counts
Participants
OG0003
OG0013
OG0023
OG003
Title
Denominators
Categories
Binding antibody positive at anytime
Title
Measurements
OG0000
OG0010
OG0020
OG003
0
3
0
3
3
3
EG001
Dose Exploration: AMG 224 Dose B
Participants were administered AMG 224 Dose B as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.
0
3
1
3
3
3
EG002
Dose Exploration: AMG 224 Dose C
Participants were administered AMG 224 Dose C as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.
0
3
0
3
3
3
EG003
Dose Exploration: AMG 224 Dose D
Participants were administered AMG 224 Dose D as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks
0
3
2
3
3
3
EG004
Dose Exploration: AMG 224 Dose E
Participants were administered AMG 224 Dose E as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.
0
6
2
6
5
6
EG005
Dose Exploration: AMG 224 Dose F
Participants were administered AMG 224 Dose F as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.
0
6
2
6
6
6
EG006
Dose Exploration: AMG 224 Dose G
Participants were administered AMG 224 Dose G as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks
Participants who had prior treatment with CD38-targeting antibody were administered AMG 224 Dose H (the maximum tolerated dose [MTD] identified based on the dose exploration phase) as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.
0
11
6
9
7
9
EG008
Dose Expansion: AMG 224 Dose H + no Prior CD38 Targeting Antibody Treatment
Participants who had no prior treatment with CD38-targeting antibody were administered AMG 224 Dose H (the MTD identified based on the dose exploration phase) as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.
0
2
0
2
2
2
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0031 affected3 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0060 affected5 at risk
EG0071 affected9 at risk
EG0080 affected2 at risk
Febrile neutropenia
Blood and lymphatic system disorders
MedDRA 25.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0060 affected5 at risk
EG0071 affected9 at risk
EG0080 affected2 at risk
Neutropenia
Blood and lymphatic system disorders
MedDRA 25.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected6 at risk
EG0051 affected6 at risk
EG0060 affected5 at risk
EG0070 affected9 at risk
EG0080 affected2 at risk
Plasma cell disorder
Blood and lymphatic system disorders
MedDRA 25.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0061 affected5 at risk
EG0070 affected9 at risk
EG0080 affected2 at risk
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA 25.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected6 at risk
EG0051 affected6 at risk
EG0060 affected5 at risk
EG0071 affected9 at risk
EG0080 affected2 at risk
Atrial flutter
Cardiac disorders
MedDRA 25.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0060 affected5 at risk
EG0071 affected9 at risk
EG0080 affected2 at risk
Nausea
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0041 affected6 at risk
EG0050 affected6 at risk
EG0060 affected5 at risk
EG0070 affected9 at risk
EG0080 affected2 at risk
Pyrexia
General disorders
MedDRA 25.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0031 affected3 at risk
EG0041 affected6 at risk
EG0051 affected6 at risk
EG0060 affected5 at risk
EG0070 affected9 at risk
EG0080 affected2 at risk
Cholecystitis acute
Hepatobiliary disorders
MedDRA 25.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0060 affected5 at risk
EG0071 affected9 at risk
EG0080 affected2 at risk
Acute sinusitis
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0061 affected5 at risk
EG0070 affected9 at risk
EG0080 affected2 at risk
Influenza
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0041 affected6 at risk
EG0050 affected6 at risk
EG0060 affected5 at risk
EG0070 affected9 at risk
EG0080 affected2 at risk
Lower respiratory tract infection
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0031 affected3 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0060 affected5 at risk
EG0070 affected9 at risk
EG0080 affected2 at risk
Parainfluenzae virus infection
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected6 at risk
EG0051 affected6 at risk
EG0060 affected5 at risk
EG0070 affected9 at risk
EG0080 affected2 at risk
Pneumonia
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0060 affected5 at risk
EG0071 affected9 at risk
EG0080 affected2 at risk
Pneumonia pneumococcal
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0060 affected5 at risk
EG0071 affected9 at risk
EG0080 affected2 at risk
Clavicle fracture
Injury, poisoning and procedural complications
MedDRA 25.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0060 affected5 at risk
EG0071 affected9 at risk
EG0080 affected2 at risk
Fall
Injury, poisoning and procedural complications
MedDRA 25.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0060 affected5 at risk
EG0071 affected9 at risk
EG0080 affected2 at risk
Femur fracture
Injury, poisoning and procedural complications
MedDRA 25.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0060 affected5 at risk
EG0071 affected9 at risk
EG0080 affected2 at risk
Infusion related reaction
Injury, poisoning and procedural complications
MedDRA 25.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0031 affected3 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0060 affected5 at risk
EG0070 affected9 at risk
EG0080 affected2 at risk
Platelet count decreased
Investigations
MedDRA 25.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0041 affected6 at risk
EG0050 affected6 at risk
EG0061 affected5 at risk
EG0070 affected9 at risk
EG0080 affected2 at risk
Dehydration
Metabolism and nutrition disorders
MedDRA 25.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0031 affected3 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0060 affected5 at risk
EG0070 affected9 at risk
EG0080 affected2 at risk
Failure to thrive
Metabolism and nutrition disorders
MedDRA 25.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0060 affected5 at risk
EG0071 affected9 at risk
EG0080 affected2 at risk
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 25.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0060 affected5 at risk
EG0071 affected9 at risk
EG0080 affected2 at risk
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 25.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0041 affected6 at risk
EG0050 affected6 at risk
EG0060 affected5 at risk
EG0071 affected9 at risk
EG0080 affected2 at risk
Pathological fracture
Musculoskeletal and connective tissue disorders
MedDRA 25.0
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0060 affected5 at risk
EG0071 affected9 at risk
EG0080 affected2 at risk
Plasmacytoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 25.0
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0060 affected5 at risk
EG0070 affected9 at risk
EG0080 affected2 at risk
Facial paralysis
Nervous system disorders
MedDRA 25.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0060 affected5 at risk
EG0071 affected9 at risk
EG0080 affected2 at risk
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0031 affected3 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0060 affected5 at risk
EG0070 affected9 at risk
EG0080 affected2 at risk
Left ventricular failure
Cardiac disorders
MedDRA 25.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0031 affected3 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0060 affected5 at risk
EG0070 affected9 at risk
EG0080 affected2 at risk
Septic shock
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0060 affected5 at risk
EG0071 affected9 at risk
EG0080 affected2 at risk
Urinary tract infection
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0031 affected3 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0060 affected5 at risk
EG0070 affected9 at risk
EG0080 affected2 at risk
Urinary tract infection bacterial
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0031 affected3 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0060 affected5 at risk
EG0070 affected9 at risk
EG0080 affected2 at risk
Post procedural haemorrhage
Injury, poisoning and procedural complications
MedDRA 25.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0060 affected5 at risk
EG0071 affected9 at risk
EG0080 affected2 at risk
Hypervolaemia
Metabolism and nutrition disorders
MedDRA 25.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0031 affected3 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0060 affected5 at risk
EG0070 affected9 at risk
EG0080 affected2 at risk
Basal cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 25.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0031 affected3 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0060 affected5 at risk
EG0070 affected9 at risk
EG0080 affected2 at risk
Haematuria
Renal and urinary disorders
MedDRA 25.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0060 affected5 at risk
EG0071 affected9 at risk
EG0080 affected2 at risk
Hydronephrosis
Renal and urinary disorders
MedDRA 25.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0060 affected5 at risk
EG0071 affected9 at risk
EG0080 affected2 at risk
Haemoptysis
Respiratory, thoracic and mediastinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0060 affected5 at risk
EG0071 affected9 at risk
EG0080 affected2 at risk
Skin haemorrhage
Skin and subcutaneous tissue disorders
MedDRA 25.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0060 affected5 at risk
EG0071 affected9 at risk
EG0080 affected2 at risk
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0031 affected3 at risk
EG0043 affected6 at risk
EG0055 affected6 at risk
EG0063 affected5 at risk
EG0072 affected9 at risk
EG0080 affected2 at risk
Leukopenia
Blood and lymphatic system disorders
MedDRA 25.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected6 at risk
EG0051 affected6 at risk
EG0061 affected5 at risk
EG0071 affected9 at risk
EG0080 affected2 at risk
Neutropenia
Blood and lymphatic system disorders
MedDRA 25.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected6 at risk
EG0051 affected6 at risk
EG0061 affected5 at risk
EG0072 affected9 at risk
EG0081 affected2 at risk
Splenic lesion
Blood and lymphatic system disorders
MedDRA 25.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0061 affected5 at risk
EG0070 affected9 at risk
EG0080 affected2 at risk
Splenomegaly
Blood and lymphatic system disorders
MedDRA 25.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0061 affected5 at risk
EG0070 affected9 at risk
EG0080 affected2 at risk
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA 25.0
Systematic Assessment
EG0002 affected3 at risk
EG0013 affected3 at risk
EG0022 affected3 at risk
EG0032 affected3 at risk
EG0041 affected6 at risk
EG0055 affected6 at risk
EG0063 affected5 at risk
EG0076 affected9 at risk
EG0081 affected2 at risk
Thrombocytosis
Blood and lymphatic system disorders
MedDRA 25.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected6 at risk
EG0051 affected6 at risk
EG0060 affected5 at risk
EG0070 affected9 at risk
EG0080 affected2 at risk
Palpitations
Cardiac disorders
MedDRA 25.0
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected6 at risk
EG0051 affected6 at risk
EG0060 affected5 at risk
EG0070 affected9 at risk
EG0080 affected2 at risk
Tachycardia
Cardiac disorders
MedDRA 25.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0041 affected6 at risk
EG0050 affected6 at risk
EG0060 affected5 at risk
EG0070 affected9 at risk
EG0080 affected2 at risk
Tinnitus
Ear and labyrinth disorders
MedDRA 25.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected6 at risk
EG0051 affected6 at risk
EG0060 affected5 at risk
EG0070 affected9 at risk
EG0080 affected2 at risk
Vertigo positional
Ear and labyrinth disorders
MedDRA 25.0
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0060 affected5 at risk
EG0070 affected9 at risk
EG0080 affected2 at risk
Conjunctival haemorrhage
Eye disorders
MedDRA 25.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG0030 affected3 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0060 affected5 at risk
EG0070 affected9 at risk
EG0080 affected2 at risk
Diplopia
Eye disorders
MedDRA 25.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected6 at risk
EG0051 affected6 at risk
EG0060 affected5 at risk
EG0070 affected9 at risk
EG0080 affected2 at risk
Dry eye
Eye disorders
MedDRA 25.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0031 affected3 at risk
EG0040 affected6 at risk
EG0051 affected6 at risk
EG0060 affected5 at risk
EG0071 affected9 at risk
EG0081 affected2 at risk
Eye irritation
Eye disorders
MedDRA 25.0
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0060 affected5 at risk
EG0070 affected9 at risk
EG0080 affected2 at risk
Eye pruritus
Eye disorders
MedDRA 25.0
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0060 affected5 at risk
EG0070 affected9 at risk
EG0080 affected2 at risk
Lacrimation increased
Eye disorders
MedDRA 25.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0031 affected3 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0060 affected5 at risk
EG0072 affected9 at risk
EG0081 affected2 at risk
Ocular hyperaemia
Eye disorders
MedDRA 25.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0060 affected5 at risk
EG0071 affected9 at risk
EG0080 affected2 at risk
Vision blurred
Eye disorders
MedDRA 25.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected6 at risk
EG0051 affected6 at risk
EG0060 affected5 at risk
EG0071 affected9 at risk
EG0080 affected2 at risk
Visual acuity reduced
Eye disorders
MedDRA 25.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG0030 affected3 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0060 affected5 at risk
EG0070 affected9 at risk
EG0080 affected2 at risk
Visual impairment
Eye disorders
MedDRA 25.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0041 affected6 at risk
EG0050 affected6 at risk
EG0060 affected5 at risk
EG0070 affected9 at risk
EG0080 affected2 at risk
Vitreous haemorrhage
Eye disorders
MedDRA 25.0
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0060 affected5 at risk
EG0070 affected9 at risk
EG0080 affected2 at risk
Abdominal discomfort
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0061 affected5 at risk
EG0070 affected9 at risk
EG0080 affected2 at risk
Abdominal distension
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0061 affected5 at risk
EG0070 affected9 at risk
EG0080 affected2 at risk
Abdominal pain
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0061 affected5 at risk
EG0070 affected9 at risk
EG0080 affected2 at risk
Abdominal pain upper
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0031 affected3 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0061 affected5 at risk
EG0071 affected9 at risk
EG0080 affected2 at risk
Constipation
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0032 affected3 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0060 affected5 at risk
EG0072 affected9 at risk
EG0081 affected2 at risk
Diarrhoea
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0002 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0043 affected6 at risk
EG0051 affected6 at risk
EG0060 affected5 at risk
EG0074 affected9 at risk
EG0080 affected2 at risk
Dry mouth
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0060 affected5 at risk
EG0070 affected9 at risk
EG0080 affected2 at risk
Dysphagia
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected6 at risk
EG0051 affected6 at risk
EG0060 affected5 at risk
EG0070 affected9 at risk
EG0080 affected2 at risk
Flatulence
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0061 affected5 at risk
EG0070 affected9 at risk
EG0080 affected2 at risk
Gingival bleeding
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected6 at risk
EG0051 affected6 at risk
EG0060 affected5 at risk
EG0070 affected9 at risk
EG0080 affected2 at risk
Nausea
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0002 affected3 at risk
EG0012 affected3 at risk
EG0020 affected3 at risk
EG0031 affected3 at risk
EG0041 affected6 at risk
EG0054 affected6 at risk
EG0062 affected5 at risk
EG0073 affected9 at risk
EG0081 affected2 at risk
Oral disorder
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected6 at risk
EG0051 affected6 at risk
EG0060 affected5 at risk
EG0070 affected9 at risk
EG0080 affected2 at risk
Stomatitis
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0060 affected5 at risk
EG0071 affected9 at risk
EG0081 affected2 at risk
Toothache
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0061 affected5 at risk
EG0070 affected9 at risk
EG0080 affected2 at risk
Vomiting
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG0030 affected3 at risk
EG0040 affected6 at risk
EG0052 affected6 at risk
EG0060 affected5 at risk
EG0072 affected9 at risk
EG0080 affected2 at risk
Asthenia
General disorders
MedDRA 25.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected6 at risk
EG0051 affected6 at risk
EG0060 affected5 at risk
EG0070 affected9 at risk
EG0080 affected2 at risk
Chest pain
General disorders
MedDRA 25.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0031 affected3 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0060 affected5 at risk
EG0071 affected9 at risk
EG0080 affected2 at risk
Chills
General disorders
MedDRA 25.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG0030 affected3 at risk
EG0041 affected6 at risk
EG0051 affected6 at risk
EG0060 affected5 at risk
EG0070 affected9 at risk
EG0080 affected2 at risk
Fatigue
General disorders
MedDRA 25.0
Systematic Assessment
EG0002 affected3 at risk
EG0011 affected3 at risk
EG0020 affected3 at risk
EG0033 affected3 at risk
EG0043 affected6 at risk
EG0054 affected6 at risk
EG0060 affected5 at risk
EG0076 affected9 at risk
EG0080 affected2 at risk
Infusion site bruising
General disorders
MedDRA 25.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG0030 affected3 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0060 affected5 at risk
EG0070 affected9 at risk
EG0080 affected2 at risk
Malaise
General disorders
MedDRA 25.0
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0060 affected5 at risk
EG0070 affected9 at risk
EG0080 affected2 at risk
Mucosal inflammation
General disorders
MedDRA 25.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0031 affected3 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0060 affected5 at risk
EG0070 affected9 at risk
EG0080 affected2 at risk
Oedema
General disorders
MedDRA 25.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0031 affected3 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0060 affected5 at risk
EG0070 affected9 at risk
EG0080 affected2 at risk
Oedema peripheral
General disorders
MedDRA 25.0
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0031 affected3 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0060 affected5 at risk
EG0071 affected9 at risk
EG0080 affected2 at risk
Pain
General disorders
MedDRA 25.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0031 affected3 at risk
EG0040 affected6 at risk
EG0051 affected6 at risk
EG0061 affected5 at risk
EG0071 affected9 at risk
EG0081 affected2 at risk
Pyrexia
General disorders
MedDRA 25.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0031 affected3 at risk
EG0042 affected6 at risk
EG0052 affected6 at risk
EG0061 affected5 at risk
EG0072 affected9 at risk
EG0081 affected2 at risk
Cholecystitis acute
Hepatobiliary disorders
MedDRA 25.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0060 affected5 at risk
EG0071 affected9 at risk
EG0080 affected2 at risk
Beta haemolytic streptococcal infection
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0031 affected3 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0060 affected5 at risk
EG0070 affected9 at risk
EG0080 affected2 at risk
Cellulitis
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0031 affected3 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0060 affected5 at risk
EG0071 affected9 at risk
EG0080 affected2 at risk
Ear infection
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected6 at risk
EG0051 affected6 at risk
EG0060 affected5 at risk
EG0070 affected9 at risk
EG0080 affected2 at risk
Folliculitis
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0060 affected5 at risk
EG0070 affected9 at risk
EG0080 affected2 at risk
Gastroenteritis
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0041 affected6 at risk
EG0050 affected6 at risk
EG0060 affected5 at risk
EG0070 affected9 at risk
EG0080 affected2 at risk
Gastrointestinal candidiasis
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected6 at risk
EG0051 affected6 at risk
EG0060 affected5 at risk
EG0070 affected9 at risk
EG0080 affected2 at risk
Herpes ophthalmic
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0031 affected3 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0060 affected5 at risk
EG0070 affected9 at risk
EG0080 affected2 at risk
Hordeolum
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0061 affected5 at risk
EG0070 affected9 at risk
EG0080 affected2 at risk
Influenza
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0060 affected5 at risk
EG0070 affected9 at risk
EG0081 affected2 at risk
Lower respiratory tract infection
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0060 affected5 at risk
EG0070 affected9 at risk
EG0080 affected2 at risk
Nasopharyngitis
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0060 affected5 at risk
EG0072 affected9 at risk
EG0080 affected2 at risk
Oral candidiasis
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0060 affected5 at risk
EG0070 affected9 at risk
EG0081 affected2 at risk
Otitis externa
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0060 affected5 at risk
EG0070 affected9 at risk
EG0080 affected2 at risk
Respiratory tract infection
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0060 affected5 at risk
EG0070 affected9 at risk
EG0080 affected2 at risk
Respiratory tract infection viral
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0060 affected5 at risk
EG0070 affected9 at risk
EG0080 affected2 at risk
Rhinitis
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected6 at risk
EG0051 affected6 at risk
EG0060 affected5 at risk
EG0070 affected9 at risk
EG0080 affected2 at risk
Upper respiratory tract infection
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0002 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0031 affected3 at risk
EG0041 affected6 at risk
EG0051 affected6 at risk
EG0061 affected5 at risk
EG0071 affected9 at risk
EG0081 affected2 at risk
Urinary tract infection
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0031 affected3 at risk
EG0041 affected6 at risk
EG0051 affected6 at risk
EG0060 affected5 at risk
EG0071 affected9 at risk
EG0080 affected2 at risk
Urinary tract infection staphylococcal
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0060 affected5 at risk
EG0071 affected9 at risk
EG0080 affected2 at risk
Viral upper respiratory tract infection
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0002 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0060 affected5 at risk
EG0070 affected9 at risk
EG0080 affected2 at risk
Contusion
Injury, poisoning and procedural complications
MedDRA 25.0
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0031 affected3 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0060 affected5 at risk
EG0071 affected9 at risk
EG0081 affected2 at risk
Foot fracture
Injury, poisoning and procedural complications
MedDRA 25.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG0030 affected3 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0060 affected5 at risk
EG0070 affected9 at risk
EG0080 affected2 at risk
Skin abrasion
Injury, poisoning and procedural complications
MedDRA 25.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0041 affected6 at risk
EG0050 affected6 at risk
EG0060 affected5 at risk
EG0071 affected9 at risk
EG0080 affected2 at risk
Skin laceration
Injury, poisoning and procedural complications
MedDRA 25.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0060 affected5 at risk
EG0071 affected9 at risk
EG0080 affected2 at risk
Skin wound
Injury, poisoning and procedural complications
MedDRA 25.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0060 affected5 at risk
EG0071 affected9 at risk
EG0080 affected2 at risk
Stress fracture
Injury, poisoning and procedural complications
MedDRA 25.0
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0060 affected5 at risk
EG0070 affected9 at risk
EG0080 affected2 at risk
Wound
Injury, poisoning and procedural complications
MedDRA 25.0
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0020 affected3 at risk
EG0031 affected3 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0060 affected5 at risk
EG0070 affected9 at risk
EG0080 affected2 at risk
Activated partial thromboplastin time prolonged
Investigations
MedDRA 25.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0061 affected5 at risk
EG0070 affected9 at risk
EG0080 affected2 at risk
Alanine aminotransferase increased
Investigations
MedDRA 25.0
Systematic Assessment
EG0001 affected3 at risk
EG0012 affected3 at risk
EG0021 affected3 at risk
EG0031 affected3 at risk
EG0041 affected6 at risk
EG0053 affected6 at risk
EG0062 affected5 at risk
EG0073 affected9 at risk
EG0081 affected2 at risk
Aspartate aminotransferase increased
Investigations
MedDRA 25.0
Systematic Assessment
EG0001 affected3 at risk
EG0012 affected3 at risk
EG0021 affected3 at risk
EG0031 affected3 at risk
EG0041 affected6 at risk
EG0054 affected6 at risk
EG0062 affected5 at risk
EG0074 affected9 at risk
EG0081 affected2 at risk
Blood alkaline phosphatase increased
Investigations
MedDRA 25.0
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0020 affected3 at risk
EG0031 affected3 at risk
EG0040 affected6 at risk
EG0051 affected6 at risk
EG0063 affected5 at risk
EG0073 affected9 at risk
EG0081 affected2 at risk
Blood creatine increased
Investigations
MedDRA 25.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0060 affected5 at risk
EG0071 affected9 at risk
EG0080 affected2 at risk
Blood creatinine decreased
Investigations
MedDRA 25.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected6 at risk
EG0051 affected6 at risk
EG0060 affected5 at risk
EG0071 affected9 at risk
EG0080 affected2 at risk
Blood creatinine increased
Investigations
MedDRA 25.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0031 affected3 at risk
EG0042 affected6 at risk
EG0051 affected6 at risk
EG0061 affected5 at risk
EG0072 affected9 at risk
EG0081 affected2 at risk
Blood lactate dehydrogenase increased
Investigations
MedDRA 25.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0060 affected5 at risk
EG0071 affected9 at risk
EG0080 affected2 at risk
Blood potassium decreased
Investigations
MedDRA 25.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0031 affected3 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0060 affected5 at risk
EG0071 affected9 at risk
EG0080 affected2 at risk
Blood urea increased
Investigations
MedDRA 25.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0031 affected3 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0060 affected5 at risk
EG0072 affected9 at risk
EG0080 affected2 at risk
Calcium ionised increased
Investigations
MedDRA 25.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0060 affected5 at risk
EG0071 affected9 at risk
EG0080 affected2 at risk
Coagulation time prolonged
Investigations
MedDRA 25.0
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0060 affected5 at risk
EG0070 affected9 at risk
EG0080 affected2 at risk
Gamma-glutamyltransferase increased
Investigations
MedDRA 25.0
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0061 affected5 at risk
EG0070 affected9 at risk
EG0080 affected2 at risk
Lymphocyte count decreased
Investigations
MedDRA 25.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0031 affected3 at risk
EG0041 affected6 at risk
EG0050 affected6 at risk
EG0060 affected5 at risk
EG0070 affected9 at risk
EG0080 affected2 at risk
Platelet count decreased
Investigations
MedDRA 25.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG0030 affected3 at risk
EG0041 affected6 at risk
EG0050 affected6 at risk
EG0061 affected5 at risk
EG0071 affected9 at risk
EG0080 affected2 at risk
Weight decreased
Investigations
MedDRA 25.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0041 affected6 at risk
EG0050 affected6 at risk
EG0060 affected5 at risk
EG0072 affected9 at risk
EG0080 affected2 at risk
White blood cell count decreased
Investigations
MedDRA 25.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected6 at risk
EG0052 affected6 at risk
EG0061 affected5 at risk
EG0071 affected9 at risk
EG0081 affected2 at risk
Decreased appetite
Metabolism and nutrition disorders
MedDRA 25.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected6 at risk
EG0051 affected6 at risk
EG0060 affected5 at risk
EG0073 affected9 at risk
EG0080 affected2 at risk
Hyperalbuminaemia
Metabolism and nutrition disorders
MedDRA 25.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected6 at risk
EG0051 affected6 at risk
EG0060 affected5 at risk
EG0070 affected9 at risk
EG0080 affected2 at risk
Hypercalcaemia
Metabolism and nutrition disorders
MedDRA 25.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0031 affected3 at risk
EG0041 affected6 at risk
EG0051 affected6 at risk
EG0061 affected5 at risk
EG0074 affected9 at risk
EG0080 affected2 at risk
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 25.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0031 affected3 at risk
EG0041 affected6 at risk
EG0053 affected6 at risk
EG0061 affected5 at risk
EG0072 affected9 at risk
EG0081 affected2 at risk
Hypermagnesaemia
Metabolism and nutrition disorders
MedDRA 25.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0031 affected3 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0060 affected5 at risk
EG0070 affected9 at risk
EG0080 affected2 at risk
Hypernatraemia
Metabolism and nutrition disorders
MedDRA 25.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0031 affected3 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0060 affected5 at risk
EG0071 affected9 at risk
EG0080 affected2 at risk
Hyperuricaemia
Metabolism and nutrition disorders
MedDRA 25.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0031 affected3 at risk
EG0041 affected6 at risk
EG0051 affected6 at risk
EG0061 affected5 at risk
EG0070 affected9 at risk
EG0080 affected2 at risk
Hypoalbuminaemia
Metabolism and nutrition disorders
MedDRA 25.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0031 affected3 at risk
EG0040 affected6 at risk
EG0051 affected6 at risk
EG0061 affected5 at risk
EG0071 affected9 at risk
EG0080 affected2 at risk
Hypoglycaemia
Metabolism and nutrition disorders
MedDRA 25.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected6 at risk
EG0051 affected6 at risk
EG0060 affected5 at risk
EG0070 affected9 at risk
EG0080 affected2 at risk
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA 25.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0031 affected3 at risk
EG0041 affected6 at risk
EG0052 affected6 at risk
EG0062 affected5 at risk
EG0072 affected9 at risk
EG0080 affected2 at risk
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 25.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0060 affected5 at risk
EG0071 affected9 at risk
EG0080 affected2 at risk
Iron deficiency
Metabolism and nutrition disorders
MedDRA 25.0
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0060 affected5 at risk
EG0070 affected9 at risk
EG0080 affected2 at risk
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 25.0
Systematic Assessment
EG0002 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0042 affected6 at risk
EG0052 affected6 at risk
EG0060 affected5 at risk
EG0075 affected9 at risk
EG0081 affected2 at risk
Arthritis
Musculoskeletal and connective tissue disorders
MedDRA 25.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected6 at risk
EG0051 affected6 at risk
EG0060 affected5 at risk
EG0070 affected9 at risk
EG0080 affected2 at risk
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 25.0
Systematic Assessment
EG0002 affected3 at risk
EG0011 affected3 at risk
EG0021 affected3 at risk
EG0031 affected3 at risk
EG0041 affected6 at risk
EG0050 affected6 at risk
EG0060 affected5 at risk
EG0072 affected9 at risk
EG0081 affected2 at risk
Bone pain
Musculoskeletal and connective tissue disorders
MedDRA 25.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0060 affected5 at risk
EG0071 affected9 at risk
EG0081 affected2 at risk
Groin pain
Musculoskeletal and connective tissue disorders
MedDRA 25.0
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0060 affected5 at risk
EG0070 affected9 at risk
EG0080 affected2 at risk
Joint swelling
Musculoskeletal and connective tissue disorders
MedDRA 25.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0041 affected6 at risk
EG0050 affected6 at risk
EG0060 affected5 at risk
EG0071 affected9 at risk
EG0080 affected2 at risk
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA 25.0
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0060 affected5 at risk
EG0070 affected9 at risk
EG0080 affected2 at risk
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA 25.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected6 at risk
EG0051 affected6 at risk
EG0060 affected5 at risk
EG0071 affected9 at risk
EG0081 affected2 at risk
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA 25.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0041 affected6 at risk
EG0050 affected6 at risk
EG0060 affected5 at risk
EG0071 affected9 at risk
EG0081 affected2 at risk
Musculoskeletal discomfort
Musculoskeletal and connective tissue disorders
MedDRA 25.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected6 at risk
EG0051 affected6 at risk
EG0060 affected5 at risk
EG0070 affected9 at risk
EG0080 affected2 at risk
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA 25.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0060 affected5 at risk
EG0070 affected9 at risk
EG0081 affected2 at risk
Musculoskeletal stiffness
Musculoskeletal and connective tissue disorders
MedDRA 25.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0041 affected6 at risk
EG0050 affected6 at risk
EG0060 affected5 at risk
EG0071 affected9 at risk
EG0080 affected2 at risk
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 25.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0041 affected6 at risk
EG0051 affected6 at risk
EG0060 affected5 at risk
EG0074 affected9 at risk
EG0081 affected2 at risk
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 25.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0061 affected5 at risk
EG0070 affected9 at risk
EG0080 affected2 at risk
Tendonitis
Musculoskeletal and connective tissue disorders
MedDRA 25.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0060 affected5 at risk
EG0070 affected9 at risk
EG0081 affected2 at risk
Plasmacytoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 25.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected6 at risk
EG0051 affected6 at risk
EG0060 affected5 at risk
EG0071 affected9 at risk
EG0080 affected2 at risk
Dizziness
Nervous system disorders
MedDRA 25.0
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0020 affected3 at risk
EG0032 affected3 at risk
EG0040 affected6 at risk
EG0052 affected6 at risk
EG0060 affected5 at risk
EG0072 affected9 at risk
EG0081 affected2 at risk
Headache
Nervous system disorders
MedDRA 25.0
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG0030 affected3 at risk
EG0041 affected6 at risk
EG0050 affected6 at risk
EG0061 affected5 at risk
EG0071 affected9 at risk
EG0082 affected2 at risk
Hypoaesthesia
Nervous system disorders
MedDRA 25.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0041 affected6 at risk
EG0050 affected6 at risk
EG0061 affected5 at risk
EG0070 affected9 at risk
EG0080 affected2 at risk
Memory impairment
Nervous system disorders
MedDRA 25.0
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0060 affected5 at risk
EG0071 affected9 at risk
EG0081 affected2 at risk
Neuropathy peripheral
Nervous system disorders
MedDRA 25.0
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0021 affected3 at risk
EG0031 affected3 at risk
EG0041 affected6 at risk
EG0050 affected6 at risk
EG0060 affected5 at risk
EG0071 affected9 at risk
EG0080 affected2 at risk
Paraesthesia
Nervous system disorders
MedDRA 25.0
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0060 affected5 at risk
EG0071 affected9 at risk
EG0080 affected2 at risk
Peripheral sensory neuropathy
Nervous system disorders
MedDRA 25.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected6 at risk
EG0051 affected6 at risk
EG0060 affected5 at risk
EG0071 affected9 at risk
EG0080 affected2 at risk
Tremor
Nervous system disorders
MedDRA 25.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected6 at risk
EG0051 affected6 at risk
EG0060 affected5 at risk
EG0070 affected9 at risk
EG0080 affected2 at risk
Agitation
Psychiatric disorders
MedDRA 25.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0061 affected5 at risk
EG0070 affected9 at risk
EG0080 affected2 at risk
Depression
Psychiatric disorders
MedDRA 25.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0060 affected5 at risk
EG0072 affected9 at risk
EG0080 affected2 at risk
Insomnia
Psychiatric disorders
MedDRA 25.0
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected6 at risk
EG0051 affected6 at risk
EG0060 affected5 at risk
EG0071 affected9 at risk
EG0081 affected2 at risk
Restlessness
Psychiatric disorders
MedDRA 25.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0060 affected5 at risk
EG0070 affected9 at risk
EG0081 affected2 at risk
Sleep disorder
Psychiatric disorders
MedDRA 25.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0041 affected6 at risk
EG0051 affected6 at risk
EG0060 affected5 at risk
EG0070 affected9 at risk
EG0080 affected2 at risk
Stress
Psychiatric disorders
MedDRA 25.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0041 affected6 at risk
EG0050 affected6 at risk
EG0060 affected5 at risk
EG0070 affected9 at risk
EG0080 affected2 at risk
Chromaturia
Renal and urinary disorders
MedDRA 25.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0061 affected5 at risk
EG0070 affected9 at risk
EG0080 affected2 at risk
Haematuria
Renal and urinary disorders
MedDRA 25.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0031 affected3 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0060 affected5 at risk
EG0071 affected9 at risk
EG0080 affected2 at risk
Urinary incontinence
Renal and urinary disorders
MedDRA 25.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0041 affected6 at risk
EG0050 affected6 at risk
EG0060 affected5 at risk
EG0070 affected9 at risk
EG0080 affected2 at risk
Urinary retention
Renal and urinary disorders
MedDRA 25.0
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0060 affected5 at risk
EG0070 affected9 at risk
EG0080 affected2 at risk
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 25.0
Systematic Assessment
EG0001 affected3 at risk
EG0011 affected3 at risk
EG0020 affected3 at risk
EG0031 affected3 at risk
EG0041 affected6 at risk
EG0051 affected6 at risk
EG0060 affected5 at risk
EG0072 affected9 at risk
EG0081 affected2 at risk
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 25.0
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0031 affected3 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0060 affected5 at risk
EG0073 affected9 at risk
EG0082 affected2 at risk
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0031 affected3 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0061 affected5 at risk
EG0071 affected9 at risk
EG0081 affected2 at risk
Hiccups
Respiratory, thoracic and mediastinal disorders
MedDRA 25.0
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0060 affected5 at risk
EG0070 affected9 at risk
EG0080 affected2 at risk
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0031 affected3 at risk
EG0040 affected6 at risk
EG0051 affected6 at risk
EG0061 affected5 at risk
EG0071 affected9 at risk
EG0080 affected2 at risk
Nasal dryness
Respiratory, thoracic and mediastinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0031 affected3 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0060 affected5 at risk
EG0070 affected9 at risk
EG0080 affected2 at risk
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0041 affected6 at risk
EG0050 affected6 at risk
EG0060 affected5 at risk
EG0070 affected9 at risk
EG0081 affected2 at risk
Paranasal sinus discomfort
Respiratory, thoracic and mediastinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0060 affected5 at risk
EG0070 affected9 at risk
EG0081 affected2 at risk
Productive cough
Respiratory, thoracic and mediastinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0041 affected6 at risk
EG0050 affected6 at risk
EG0060 affected5 at risk
EG0070 affected9 at risk
EG0080 affected2 at risk
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA 25.0
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected6 at risk
EG0051 affected6 at risk
EG0060 affected5 at risk
EG0071 affected9 at risk
EG0081 affected2 at risk
Alopecia
Skin and subcutaneous tissue disorders
MedDRA 25.0
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0061 affected5 at risk
EG0070 affected9 at risk
EG0080 affected2 at risk
Erythema
Skin and subcutaneous tissue disorders
MedDRA 25.0
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0060 affected5 at risk
EG0070 affected9 at risk
EG0080 affected2 at risk
Hyperhidrosis
Skin and subcutaneous tissue disorders
MedDRA 25.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0041 affected6 at risk
EG0050 affected6 at risk
EG0060 affected5 at risk
EG0070 affected9 at risk
EG0080 affected2 at risk
Night sweats
Skin and subcutaneous tissue disorders
MedDRA 25.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0041 affected6 at risk
EG0050 affected6 at risk
EG0060 affected5 at risk
EG0070 affected9 at risk
EG0080 affected2 at risk
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 25.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected6 at risk
EG0051 affected6 at risk
EG0060 affected5 at risk
EG0071 affected9 at risk
EG0080 affected2 at risk
Rash
Skin and subcutaneous tissue disorders
MedDRA 25.0
Systematic Assessment
EG0002 affected3 at risk
EG0011 affected3 at risk
EG0020 affected3 at risk
EG0031 affected3 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0060 affected5 at risk
EG0070 affected9 at risk
EG0081 affected2 at risk
Rash maculo-papular
Skin and subcutaneous tissue disorders
MedDRA 25.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0031 affected3 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0061 affected5 at risk
EG0070 affected9 at risk
EG0080 affected2 at risk
Rosacea
Skin and subcutaneous tissue disorders
MedDRA 25.0
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0060 affected5 at risk
EG0070 affected9 at risk
EG0080 affected2 at risk
Skin hyperpigmentation
Skin and subcutaneous tissue disorders
MedDRA 25.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0061 affected5 at risk
EG0070 affected9 at risk
EG0080 affected2 at risk
Skin induration
Skin and subcutaneous tissue disorders
MedDRA 25.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0060 affected5 at risk
EG0071 affected9 at risk
EG0080 affected2 at risk
Skin lesion
Skin and subcutaneous tissue disorders
MedDRA 25.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0031 affected3 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0060 affected5 at risk
EG0070 affected9 at risk
EG0081 affected2 at risk
Cholecystectomy
Surgical and medical procedures
MedDRA 25.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0060 affected5 at risk
EG0071 affected9 at risk
EG0080 affected2 at risk
Skin neoplasm excision
Surgical and medical procedures
MedDRA 25.0
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0060 affected5 at risk
EG0070 affected9 at risk
EG0080 affected2 at risk
Flushing
Vascular disorders
MedDRA 25.0
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0041 affected6 at risk
EG0050 affected6 at risk
EG0060 affected5 at risk
EG0070 affected9 at risk
EG0080 affected2 at risk
Hot flush
Vascular disorders
MedDRA 25.0
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0031 affected3 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0060 affected5 at risk
EG0070 affected9 at risk
EG0080 affected2 at risk
Hypertension
Vascular disorders
MedDRA 25.0
Systematic Assessment
EG0002 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected6 at risk
EG0051 affected6 at risk
EG0061 affected5 at risk
EG0070 affected9 at risk
EG0080 affected2 at risk
Hypotension
Vascular disorders
MedDRA 25.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0041 affected6 at risk
EG0050 affected6 at risk
EG0061 affected5 at risk
EG0070 affected9 at risk
EG0080 affected2 at risk
Phimosis
Congenital, familial and genetic disorders
MedDRA 25.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0031 affected3 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0060 affected5 at risk
EG0070 affected9 at risk
EG0080 affected2 at risk
Ear haemorrhage
Ear and labyrinth disorders
MedDRA 25.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0060 affected5 at risk
EG0071 affected9 at risk
EG0080 affected2 at risk
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0060 affected5 at risk
EG0070 affected9 at risk
EG0080 affected2 at risk
Haemorrhoidal haemorrhage
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0031 affected3 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0060 affected5 at risk
EG0070 affected9 at risk
EG0080 affected2 at risk
Mouth haemorrhage
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0060 affected5 at risk
EG0070 affected9 at risk
EG0081 affected2 at risk
Proctalgia
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0031 affected3 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0060 affected5 at risk
EG0070 affected9 at risk
EG0080 affected2 at risk
Rectal haemorrhage
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0031 affected3 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0060 affected5 at risk
EG0070 affected9 at risk
EG0080 affected2 at risk
Influenza like illness
General disorders
MedDRA 25.0
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0060 affected5 at risk
EG0070 affected9 at risk
EG0080 affected2 at risk
Hepatic steatosis
Hepatobiliary disorders
MedDRA 25.0
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0060 affected5 at risk
EG0070 affected9 at risk
EG0080 affected2 at risk
Metapneumovirus infection
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0060 affected5 at risk
EG0070 affected9 at risk
EG0080 affected2 at risk
Sinusitis
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0060 affected5 at risk
EG0071 affected9 at risk
EG0080 affected2 at risk
Skin infection
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0031 affected3 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0060 affected5 at risk
EG0070 affected9 at risk
EG0080 affected2 at risk
Blood bilirubin increased
Investigations
MedDRA 25.0
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0060 affected5 at risk
EG0070 affected9 at risk
EG0080 affected2 at risk
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 25.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0031 affected3 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0060 affected5 at risk
EG0070 affected9 at risk
EG0080 affected2 at risk
Joint range of motion decreased
Musculoskeletal and connective tissue disorders
MedDRA 25.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0060 affected5 at risk
EG0071 affected9 at risk
EG0080 affected2 at risk
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA 25.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0031 affected3 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0060 affected5 at risk
EG0070 affected9 at risk
EG0080 affected2 at risk
Acrochordon
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 25.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0031 affected3 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0060 affected5 at risk
EG0070 affected9 at risk
EG0080 affected2 at risk
Seborrhoeic keratosis
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 25.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0031 affected3 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0060 affected5 at risk
EG0070 affected9 at risk
EG0080 affected2 at risk
Skin papilloma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 25.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0031 affected3 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0060 affected5 at risk
EG0070 affected9 at risk
EG0080 affected2 at risk
Dizziness postural
Nervous system disorders
MedDRA 25.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0061 affected5 at risk
EG0070 affected9 at risk
EG0080 affected2 at risk
Taste disorder
Nervous system disorders
MedDRA 25.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0060 affected5 at risk
EG0071 affected9 at risk
EG0080 affected2 at risk
Product after taste
Product Issues
MedDRA 25.0
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0060 affected5 at risk
EG0070 affected9 at risk
EG0080 affected2 at risk
Confusional state
Psychiatric disorders
MedDRA 25.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0060 affected5 at risk
EG0071 affected9 at risk
EG0080 affected2 at risk
Dysphonia
Respiratory, thoracic and mediastinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0060 affected5 at risk
EG0071 affected9 at risk
EG0080 affected2 at risk
Upper-airway cough syndrome
Respiratory, thoracic and mediastinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0060 affected5 at risk
EG0071 affected9 at risk
EG0080 affected2 at risk
Actinic keratosis
Skin and subcutaneous tissue disorders
MedDRA 25.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0031 affected3 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0060 affected5 at risk
EG0070 affected9 at risk
EG0080 affected2 at risk
Spider naevus
Skin and subcutaneous tissue disorders
MedDRA 25.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0060 affected5 at risk
EG0070 affected9 at risk
EG0081 affected2 at risk
Sinus operation
Surgical and medical procedures
MedDRA 25.0
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected3 at risk
EG0020 affected3 at risk
EG0030 affected3 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0060 affected5 at risk
EG0070 affected9 at risk
EG0081 affected2 at risk
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
D014652
Vascular Diseases
D002318
Cardiovascular Diseases
D010265
Paraproteinemias
D001796
Blood Protein Disorders
D006402
Hematologic Diseases
D006425
Hemic and Lymphatic Diseases
D006474
Hemorrhagic Disorders
D008232
Lymphoproliferative Disorders
D007160
Immunoproliferative Disorders
D007154
Immune System Diseases
3
BG0052
BG0061
BG0075
BG0081
BG00919
4
BG0054
BG0063
BG0078
BG0081
BG00932
0
BG0050
BG0060
BG0070
BG0080
BG0090
1
BG0052
BG0061
BG0072
BG0080
BG0096
4
BG0053
BG0063
BG0077
BG0082
BG00925
1
BG0051
BG0061
BG0070
BG0080
BG0098
3
OG0046
OG0056
OG0065
OG0079
OG0082
3
OG0046
OG0056
OG0065
OG0079
OG0082
Treatment-related TEAE
Title
Measurements
OG0003
OG0013
OG0023
OG0033
OG0045
OG0055
OG0065
OG0077
OG0081
3
OG0045
OG0056
OG0065
OG00710
3
ParticipantsOG0045
ParticipantsOG0055
ParticipantsOG0065
ParticipantsOG00710
Title
Measurements
OG00011.4(5.99 to 14.3)
OG00122.0(16.4 to 28.9)
OG00225.3(20.0 to 31.2)
OG00332.9(19.8 to 42.9)
OG00437.5(6.32 to 67.7)
OG00554.2(45.1 to 74.4)
OG00661.9(47.1 to 75.5)
OG00755.8(39.9 to 80.9)
AMG 224 Conjugated Antibody after Cycle 2
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG0023
ParticipantsOG0033
ParticipantsOG0043
ParticipantsOG0055
ParticipantsOG0062
ParticipantsOG0078
Title
Measurements
OG00011.5(8.26 to 15.4)
OG00129.3(20.6 to 44.6)
OG00231.0(26.4 to 39.0)
OG003
Total Anti-BCMA Antibody after Cycle 1
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG0023
ParticipantsOG0033
ParticipantsOG0045
ParticipantsOG0055
ParticipantsOG0065
ParticipantsOG00710
Title
Measurements
OG00011.9(7.09 to 14.5)
OG00123.9(20.4 to 30.5)
OG00225.3(21.4 to 29.8)
OG003
Total Anti-BCMA Antibody after Cycle 2
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG0023
ParticipantsOG0033
ParticipantsOG0045
ParticipantsOG0055
ParticipantsOG0062
ParticipantsOG0078
Title
Measurements
OG00011.9(9.84 to 13.5)
OG00134.6(22.5 to 51.8)
OG00233.2(28.9 to 40.5)
OG003
DM1 after Cycle 1
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG0023
ParticipantsOG0033
ParticipantsOG0045
ParticipantsOG0056
ParticipantsOG0065
ParticipantsOG00710
Title
Measurements
OG0000.00(0.00 to 0.00)
OG0010.00(0.00 to 0.00)
OG0020.000312(0.00 to 0.000501)
OG003
DM1 after Cycle 2
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG0023
ParticipantsOG0033
ParticipantsOG0043
ParticipantsOG0055
ParticipantsOG0062
ParticipantsOG0078
Title
Measurements
OG0000.00(0.00 to 0.00)
OG0010.000119(0.00 to 0.000356)
OG0020.000414(0.000297 to 0.000590)
OG003
3
OG0045
OG0056
OG0065
OG00710
3
ParticipantsOG0045
ParticipantsOG0055
ParticipantsOG0062
ParticipantsOG0078
Title
Measurements
OG0001.45(0.970 to 1.71)
OG0012.81(2.11 to 4.05)
OG0024.54(3.70 to 5.46)
OG0034.40(1.69 to 8.80)
OG0043.51(2.11 to 6.32)
OG00510.5(5.75 to 18.2)
OG0069.29(3.87 to 14.7)
OG00710.6(3.65 to 16.6)
AMG 224 Conjugated Antibody after Cycle 2
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG0023
ParticipantsOG0033
ParticipantsOG0043
ParticipantsOG0055
ParticipantsOG0062
ParticipantsOG0078
Title
Measurements
OG0001.51(0.811 to 1.93)
OG0013.06(2.44 to 4.05)
OG0026.71(5.97 to 7.99)
OG003
Total Anti-BCMA Antibody after Cycle 1
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG0023
ParticipantsOG0033
ParticipantsOG0043
ParticipantsOG0055
ParticipantsOG0062
ParticipantsOG0078
Title
Measurements
OG0001.70(1.05 to 2.07)
OG0013.91(2.56 to 5.83)
OG0026.69(5.52 to 8.27)
OG003
Total Anti-BCMA Antibody after Cycle 2
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG0023
ParticipantsOG0033
ParticipantsOG0043
ParticipantsOG0055
ParticipantsOG0062
ParticipantsOG0078
Title
Measurements
OG0002.25(1.25 to 2.78)
OG0014.62(3.78 to 5.83)
OG00211.9(10.2 to 14.7)
OG003
DM1 after Cycle 1
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG0023
ParticipantsOG0033
ParticipantsOG0044
ParticipantsOG0056
ParticipantsOG0065
ParticipantsOG00710
Title
Measurements
OG0000.00(0.00 to 0.00)
OG0010.00(0.00 to 0.00)
OG0020.00(0.00 to 0.00)
OG003
DM1 after Cycle 2
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG0023
ParticipantsOG0033
ParticipantsOG0042
ParticipantsOG0055
ParticipantsOG0062
ParticipantsOG0078
Title
Measurements
OG0000.00(0.00 to 0.00)
OG0010.00(0.00 to 0.00)
OG0020.00(0.00 to 0.00)
OG003
3
OG0045
OG0056
OG0064
OG0078
3
ParticipantsOG0045
ParticipantsOG0055
ParticipantsOG0062
ParticipantsOG0078
Title
Measurements
OG0001850(1240 to 2560)
OG0013450(2870 to 4240)
OG0024520(3910 to 4950)
OG0035260(2750 to 7570)
OG0043710(1590 to 4970)
OG00510400(9040 to 14300)
OG00610500(7060 to 14000)
OG0079690(5620 to 14000)
AUC(3weeks): AMG 224 Conjugated Antibody after Cycle 2
ParticipantsOG0003
ParticipantsOG0012
ParticipantsOG0023
ParticipantsOG0033
ParticipantsOG0043
ParticipantsOG0053
ParticipantsOG0061
ParticipantsOG0077
Title
Measurements
OG0002330(1340 to 2900)
OG0013650(3460 to 3840)
OG0026360(5820 to 7250)
OG003
AUC(3weeks): Total Anti-BCMA Antibody after Cycle 1
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG0023
ParticipantsOG0033
ParticipantsOG0043
ParticipantsOG0055
ParticipantsOG0062
ParticipantsOG0078
Title
Measurements
OG0001990(1300 to 2690)
OG0013850(3300 to 4450)
OG0025120(4540 to 5910)
OG003
AUC(3weeks): Total Anti-BCMA Antibody after Cycle 2
ParticipantsOG0003
ParticipantsOG0012
ParticipantsOG0023
ParticipantsOG0033
ParticipantsOG0043
ParticipantsOG0053
ParticipantsOG0061
ParticipantsOG0077
Title
Measurements
OG0002530(1460 to 3310)
OG0014370(4180 to 4560)
OG0028140(7140 to 10100)
OG003
AUC(0-96hr): DM1 after Cycle 1
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
ParticipantsOG0041
ParticipantsOG0055
ParticipantsOG0063
ParticipantsOG0074
Title
Measurements
OG0040.0729(0.0729 to 0.0729)
OG0050.0487(0.0328 to 0.0597)
OG0060.0579(0.0421 to 0.0668)
OG007
AUC(0-96hr): DM1 after Cycle 2
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
ParticipantsOG0041
ParticipantsOG0055
ParticipantsOG0061
ParticipantsOG0077
Title
Measurements
OG0040.0561(0.0561 to 0.0561)
OG0050.0654(0.0484 to 0.0770)
OG0060.0684(0.0684 to 0.0684)
OG007
3
OG0045
OG0056
OG0065
OG00710
3
ParticipantsOG0045
ParticipantsOG0055
ParticipantsOG0065
ParticipantsOG00710
Title
Measurements
OG00017.7(11.7 to 24.2)
OG00117.9(14.2 to 20.9)
OG00220.1(18.2 to 23.0)
OG00327.2(15.8 to 43.7)
OG00447.0(28.2 to 100)
OG00518.8(13.3 to 21.0)
OG00626.0(17.9 to 35.4)
OG00726.6(15.1 to 42.7)
AMG 224 Conjugated Antibody after Cycle 2
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG0023
ParticipantsOG0033
ParticipantsOG0043
ParticipantsOG0055
ParticipantsOG0062
ParticipantsOG0077
Title
Measurements
OG00014.5(10.3 to 22.3)
OG00115.9(14.8 to 17.3)
OG00214.3(12.4 to 15.5)
OG003
Total Anti-BCMA Antibody after Cycle 1
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG0023
ParticipantsOG0033
ParticipantsOG0045
ParticipantsOG0055
ParticipantsOG0065
ParticipantsOG0079
Title
Measurements
OG00016.5(11.1 to 23.2)
OG00115.8(13.5 to 18.2)
OG00217.8(15.2 to 19.8)
OG003
Total Anti-BCMA Antibody after Cycle 2
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG0023
ParticipantsOG0033
ParticipantsOG0043
ParticipantsOG0055
ParticipantsOG0062
ParticipantsOG0078
Title
Measurements
OG00013.4(9.07 to 20.5)
OG00113.4(12.9 to 14.3)
OG00211.4(8.92 to 12.6)
OG003
DM1 after Cycle 1
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0022
ParticipantsOG0033
ParticipantsOG0045
ParticipantsOG0056
ParticipantsOG0065
ParticipantsOG00710
Title
Measurements
OG00220800000(20400000 to 21300000)
OG00353300000(6310000 to 131000000)
OG0049310000(2190000 to 24300000)
OG005
DM1 after Cycle 2
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG0023
ParticipantsOG0033
ParticipantsOG0042
ParticipantsOG0055
ParticipantsOG0062
ParticipantsOG0077
Title
Measurements
OG00118700000(18700000 to 18700000)
OG00269800000(13500000 to 173000000)
OG00311300000(5860000 to 21700000)
OG004
2
OG0045
OG0051
OG0062
OG0076
2
ParticipantsOG0043
ParticipantsOG0051
ParticipantsOG0062
ParticipantsOG0073
Title
Measurements
OG000217(217 to 218)
OG001218(191 to 284)
OG002278(278 to 278)
OG003196(174 to 219)
OG004139(135 to 160)
OG005189(189 to 189)
OG006195(192 to 198)
OG007199(158 to 217)
AMG 224 Conjugated Antibody after Cycle 2
ParticipantsOG0003
ParticipantsOG0012
ParticipantsOG0020
ParticipantsOG0032
ParticipantsOG0043
ParticipantsOG0051
ParticipantsOG0061
ParticipantsOG0073
Title
Measurements
OG000201(194 to 215)
OG001221(193 to 249)
OG003189(159 to 220)
OG004
Total Anti-BCMA Antibody after Cycle 1
ParticipantsOG0002
ParticipantsOG0011
ParticipantsOG0020
ParticipantsOG0032
ParticipantsOG0044
ParticipantsOG0051
ParticipantsOG0061
ParticipantsOG0072
Title
Measurements
OG000234(231 to 238)
OG001198(198 to 198)
OG003242(197 to 287)
OG004
Total Anti-BCMA Antibody after Cycle 2
ParticipantsOG0003
ParticipantsOG0011
ParticipantsOG0020
ParticipantsOG0032
ParticipantsOG0041
ParticipantsOG0050
ParticipantsOG0061
ParticipantsOG0074
Title
Measurements
OG000269(250 to 277)
OG001255(255 to 255)
OG003230(211 to 249)
OG004
DM1 after Cycle 1
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
ParticipantsOG0041
ParticipantsOG0051
ParticipantsOG0060
ParticipantsOG0071
Title
Measurements
OG00450.2(50.2 to 50.2)
OG00552.1(52.1 to 52.1)
OG00748.8(48.8 to 48.8)
DM1 after Cycle 2
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
3
OG0046
OG0056
OG0065
OG0079
OG0082
1
OG0040
OG0051
OG0060
OG0070
OG0080
CR
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0071
OG0080
VGPR
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0081
PR
Title
Measurements
OG0001
OG0010
OG0020
OG0030
OG0042
OG0050
OG0061
OG0071
OG0080
MR
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0071
OG0080
SD
Title
Measurements
OG0002
OG0011
OG0021
OG0032
OG0041
OG0052
OG0061
OG0072
OG0080
Progressive disease
Title
Measurements
OG0000
OG0012
OG0022
OG0030
OG0040
OG0050
OG0060
OG0072
OG0080
Unevaluable
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0043
OG0053
OG0063
OG0072
OG0081
3
OG0046
OG0056
OG0065
OG0079
OG0082
1.4
(0.8 to NA)
Too few events to estimate the upper 80% CI
OG0033.7(2.1 to NA)Too few events to estimate the upper 80% CI
OG00414.0(11.6 to NA)Too few events to estimate the upper 80% CI
OG0052.3(1.4 to 6.0)
OG0062.8(0.7 to NA)Too few events to estimate the upper 80% CI
OG0077.2(0.7 to 12.3)
OG0084.4(0.3 to NA)Too few events to estimate the upper 80% CI
3
OG0046
OG0056
OG0065
OG0079
OG0082
(NA to NA)
No events therefore median and 80% CIs could not be estimated
OG00360.8(NA to NA)Too few events to estimate the 80% CIs
OG0049.1(8.1 to NA)Too few events to estimate the upper 80% CI
OG00519.2(NA to NA)Too few events to estimate the 80% CIs
OG0064.1(NA to NA)Too few events to estimate the 80% CIs
OG00718.7(6.7 to NA)Too few events to estimate the upper 80% CI
OG0087.7(NA to NA)Too few events to estimate the 80% CIs
3
OG0046
OG0056
OG0065
OG0079
OG0082
0
OG0040
OG0050
OG0060
OG0070
OG0080
3
OG0046
OG0056
OG0065
OG0079
OG0082
0
OG0040
OG0052
OG0061
OG0071
OG0081
Binding antibody positive at/before baseline
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0051
OG0060
OG0070
OG0081
Binding antibody positive post-baseline with a negative/no result at baseline
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0051
OG0061
OG0071
OG0080
Binding antibody positive post-baseline with a negative/no result at baseline: Transient