Enapotamab Vedotin (HuMax-AXL-ADC) Safety Study in Patien... | NCT02988817 | Trialant
NCT02988817
Sponsor
Genmab
Status
Completed
Last Update Posted
Aug 1, 2023Actual
Enrollment
306Actual
Phase
Phase 1Phase 2
Conditions
Ovarian Cancer
Cervical Cancer
Endometrial Cancer
Non Small Cell Lung Cancer (NSCLC)
Thyroid Cancer
Melanoma
Sarcoma
Solid Tumors
Interventions
Enapotamab vedotin (HuMax-AXL-ADC)
Countries
United States
Belgium
Denmark
Netherlands
Spain
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT02988817
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
GCT1021-01
Secondary IDs
ID
Type
Description
Link
2016-002243-42
EudraCT Number
211258
Other Identifier
IRAS ID; UK Research Summaries Database
Brief Title
Enapotamab Vedotin (HuMax-AXL-ADC) Safety Study in Patients With Solid Tumors
Official Title
First-in-human, Open-label, Dose-escalation Trial With Expansion Cohorts to Evaluate Safety of Axl-specific Antibody-drug Conjugate (Enapotamab Vedotin, HuMax®-AXL-ADC) in Patients With Solid Tumors
Acronym
Not provided
Organization
GenmabINDUSTRY
Status Module
Record Verification Date
Jul 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 23, 2016Actual
Primary Completion Date
Nov 12, 2021Actual
Completion Date
Nov 12, 2021Actual
First Submitted Date
Dec 1, 2016
First Submission Date that Met QC Criteria
Dec 8, 2016
First Posted Date
Dec 9, 2016Estimated
Results Waived
Not provided
Results First Submitted Date
Nov 7, 2022
Results First Submitted that Met QC Criteria
Dec 12, 2022
Results First Posted Date
Jan 5, 2023Actual
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
Jul 31, 2023
Last Update Posted Date
Aug 1, 2023Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
GenmabINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
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
The purpose of the trial is to determine the maximum tolerated dose and to establish the safety profile of HuMax-AXL-ADC in a mixed population of patients with specified solid tumors
Detailed Description
The trial consists of two parts; a dose escalation part (phase I, first in-human (FIH)) and an expansion part (phase IIa).
The dose escalation part has 2 dosing schedules: 1 dose every 3 weeks (1Q3W) dose regimen, and 3 doses every 4 weeks (3Q4W) dosing regimen.
The Expansion part of the trial will further explore the recommended phase 2 dose and dosing regimens of HuMax-AXL-ADC as determined in dose escalation part.
Conditions Module
Conditions
Ovarian Cancer
Cervical Cancer
Endometrial Cancer
Non Small Cell Lung Cancer (NSCLC)
Thyroid Cancer
Melanoma
Sarcoma
Solid Tumors
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 1Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
306Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Enapotamab vedotin (HuMax-AXL-ADC)
Experimental
Participants in all cohorts of the trial (both in escalation and expansion phase) will be administered enapotamab vedotin (HuMax-AXL-ADC) intravenously (IV).
Biological: Enapotamab vedotin (HuMax-AXL-ADC)
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Enapotamab vedotin (HuMax-AXL-ADC)
Biological
Enapotamab vedotin (HuMax-AXL-ADC) will be administered intravenously.
Enapotamab vedotin (HuMax-AXL-ADC)
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Number of Participants With Dose-limiting Toxicities (DLTs) for Dose-escalation Part
The DLTs were defined as Grade (G) 4 neutropenia or G4 thrombocytopenia for a minimal duration of 7 days, G3 and G4 febrile neutropenia, >=G3 hemorrhage associated with >=G3 thrombocytopenia, G4 anemia; Stevens Johnson syndrome, toxic epidermal necrolysis, >=G3 cutaneous vasculitis; G3 neuropathy (not improved to G1 within 3 weeks following pausing of dosing) and G4 neuropathy; G3 infusion-related reactions (IRR) that did not resolve to G1 or baseline within 24 hours; G4 IRR or G4 anaphylaxis events; >= G3 diarrhoea and/or vomiting persisting >48 hours or G3 nausea lasting 7 days (both despite optimal medical management); or any >=G3 related non-hematological AEs, which occurred during the Cycle 1 and regarded as medically important as assessed by the Data Monitoring Committee (excluding Grade 3 fatigue or non-hematological laboratory abnormalities as specified in protocol).
From Day 1 to Day 21 of first cycle for 1Q3W dosing regimen and from Day 1 to Day 28 of first cycle for 3Q4W dosing regimen
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE is defined as an AE that meets one of the following criteria: requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, is a congenital anomaly/birth defect, is medically important, results in death, or is life-threatening. In this trial, a TEAE was defined as an AE occurring or worsening between the first dose of enapotamab vedotin and 30 days after the last dose received.
Day 1 through Day 1130 (maximum observed duration)
Number of Participants With Treatment-emergent Infusion-related AEs and TEAEs Related to Enapotamab Vedotin
Number of participants with treatment-emergent infusion-related AEs and TEAEs related to enapotamab vedotin is reported.
Day 1 through Day 1130 (maximum observed duration)
Secondary Outcomes
Measure
Description
Time Frame
Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC0-inf) of Conjugated Enapotamab Vedotin for 1Q3W Dose-escalation Part
The AUC0-inf of conjugated enapotamab vedotin for 1Q3W dose-escalation part is reported. Sample scheduling of the 3Q4W dosing regimen did not allow calculation of the specific outcome measure.
Predose, end of infusion (EOI), and 2 and 5 hours after EOI on Day 1 of Cycles 1 and 3
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
For the dose escalation part: Patients with selected, relapsed or refractory solid tumors who have failed available standard therapy or who are not candidates for standard therapy. For the expansion part: Patients with advanced and/or metastatic solid tumors who are not candidates for standard therapy
Patients must have measurable disease according to Response Evaluation Criteria In Solid Tumors (RECIST).
For the expansion patients must provide a tumor tissue sample from archival tissue or fresh biopsy at enrolment
Age ≥ 18 years.
Acceptable renal function
Acceptable liver function
Acceptable hematological status
Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Life expectancy of at least three months.
Patients, both females and males, of childbearing/reproductive potential must agree to use adequate contraception while included in the trial and for six months after the last infusion of HuMax-AXL-ADC
Patients must provide a signed informed consent form before any trial relates activities are carried out.
Exclusion Criteria:
Acute deep vein thrombosis or clinically relevant pulmonary embolism, not stable for at least 4 weeks prior to first IMP administration.
Have clinically significant cardiac disease
Known congestive heart failure and/ or a known decreased cardiac ejection fraction of < 45%. A baseline QT interval as corrected by Fridericia's formula (QTcF) > 480 msec, a complete left bundle branch block (defined as a QRS interval ≥ 120 msec in left bundle branch block form) or an incomplete left bundle branch block.
Uncontrolled hypertension
Have received granulocyte colony stimulating factor (G-CSF) or granulocyte/macrophage colony stimulating factor support 3 weeks prior to first IMP administration.
Have received a cumulative dose of corticosteroid > 150 mg prednisone (or equivalent doses of corticosteroids) within two weeks before the first Investigational Medicinal Product (IMP) administration.
History of ≥ grade 3 allergic reactions to monoclonal antibody therapy as well as known or suspected allergy or intolerance to any agent given in the course of this trial.
Major surgery within four weeks before first IMP administration.
Any history of intracerebral arteriovenous malformation, cerebral aneurysm, brain metastases or stroke.
Any anticancer therapy including; small molecules, immunotherapy, chemotherapy monoclonal antibodies or any other experimental drug within five half-lives but maximum four weeks before first infusion. Accepted exceptions are bisphosphonates, denosumab and gonadotropin-releasing hormone agonist or antagonist.
Prior therapy with a conjugated or unconjugated auristatin derivative/vinca-binding site targeting payload.
Radiotherapy within 14 days prior to first IMP administration.
Known past or current malignancy other than inclusion diagnosis, except for:
Cervical carcinoma of Stage 1B or less.
Non-invasive basal cell or squamous cell skin carcinoma.
Non-invasive, superficial bladder cancer.
Prostate cancer with a current prostate specific antigen (PSA) level < 0.1 ng/mL.
Breast cancer in BRCA1 or BRCA2 positive ovarian cancer patients.
Any curable cancer with a complete response (CR) of > 2 years duration.
Melanoma patients with an lactate dehydrogenase (LDH) ≥ 3 x upper limit normal (ULN).
Ongoing significant, uncontrolled medical condition including:
o Serious, non-healing wound, skin ulcer (of any grade), or bone fracture.
Grade 2 or higher peripheral neuropathy.
Clinically significant active viral, bacterial or fungal infection
Known human immunodeficiency virus seropositivity.
Known positive serology for hepatitis B (unless due to vaccination or passive immunization due to immunoglobulin therapy)
Known positive serology for hepatitis C (unless due to immunoglobulin therapy)
Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the trial or evaluation of the trial result
History of organ allograft (except for corneal transplant) or autologous or allogeneic bone marrow transplant, or stem cell rescue within 3 months prior to the first dose of IMP
Body weight < 40 kg
Women who are pregnant or breast feeding.
Pulmonary hemorrhage or hemoptysis > 2.5 ml blood within 6 weeks unless cause has been addressed and is medically resolved.
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.3 mg/kg 1Q3W until the end of treatment.
Number of Participants With >= Grade 3 TEAEs as Assessed by National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 4.03
Number of participants with TEAEs of >= Grade 3 as assessed by NCI-CTCAE v4.03 is reported. The NCI-CTCAE is a descriptive terminology is used for AE reporting. The NCI-CTCAE v4.03 displays Grades 1 through 5 with unique clinical descriptions of severity for each AE, based on this general guideline: Grade 1 as mild AE, Grade 2 as moderate AE, Grade 3 as severe AE, Grade 4 as life-threatening or disabling AE, and Grade 5 as death. If a participant reported multiple severity grades for an AE, only the maximum grade was used.
Day 1 through Day 1130 (maximum observed duration)
Number of Participants With Grade 3 or 4 Laboratory Results
Number of participants with laboratory measurements graded as Grade 3 or 4 by NCI-CTCAE v 4.03 is reported.
Day 1 through Day 1130 (maximum observed duration)
Area Under the Plasma Concentration-time Curve From Time 0 to Last Measurable Concentration (AUC0-last) of Conjugated Enapotamab Vedotin for 1Q3W Dose-escalation Part
The AUC0-last of conjugated enapotamab vedotin for 1Q3W dose-escalation part is reported. Sample scheduling of the 3Q4W dosing regimen did not allow calculation of the specific outcome measure.
Predose, EOI, and 2 and 5 hours after EOI on Day 1 of Cycles 1 and 3
Maximum Observed Plasma Concentration (Cmax) of Conjugated Enapotamab Vedotin for Dose-escalation Part
The Cmax of conjugated enapotamab vedotin for dose-escalation part is reported.
For 1Q3W dosing regimen: Predose, EOI, and 2 and 5 hours after EOI on Day 1 of Cycles 1 and 3; For 3Q4W dosing regimen: Predose and EOI on Days 1 and 8 of Cycles 1 and 3; and predose, EOI, and 2 and 5 hours after EOI on Day 15 of Cycles 1 and 3
Total Clearance (CL) of Conjugated Enapotamab Vedotin in Dose-escalation Part
The total CL of conjugated enapotamab vedotin in dose-escalation part is reported.
For 1Q3W dosing regimen: Predose, EOI, and 2 and 5 hours after EOI on Day 1 of Cycles 1 and 3; For 3Q4W dosing regimen: EOI, and 2 and 5 hours after EOI on Day 15 of Cycles 1 and 3
Time of Maximum Plasma Concentration (Tmax) of Conjugated Enapotamab Vedotin for Dose-escalation Part
The Tmax of conjugated enapotamab vedotin for dose-escalation part is reported.
For 1Q3W dosing regimen: Predose, EOI, and 2 and 5 hours after EOI on Day 1 of Cycles 1 and 3; For 3Q4W dosing regimen: Predose, EOI, and 2 and 5 hours after EOI on Day 15 of Cycles 1 and 3
Half-life Lambda-z (t1/2) of Conjugated Enapotamab Vedotin for Dose-escalation Part
The t1/2 of conjugated enapotamab vedotin for dose-escalation part is reported.
For 1Q3W dosing regimen: Predose, EOI, and 2 and 5 hours after EOI on Day 1 of Cycles 1 and 3; For 3Q4W dosing regimen: Predose, EOI, and 2 and 5 hours after EOI on Day 15 of Cycles 1 and 3
Volume of Distribution at Steady State (Vss) of Conjugated Enapotamab Vedotin for Dose-escalation Part
The Vss of conjugated enapotamab vedotin for dose-escalation part is reported.
For 1Q3W dosing regimen: Predose, EOI, and 2 and 5 hours after EOI on Day 1 of Cycles 1 and 3; For 3Q4W dosing regimen: Predose, EOI, and 2 and 5 hours after EOI on Day 15 of Cycles 1 and 3
AUC0-inf of Free Toxin Monomethyl Auristatin E (MMAE) for 1Q3W Dose-escalation Part
The AUC0-inf of MMAE for 1Q3W dose-escalation part is reported. Sample scheduling of the 3Q4W dosing regimen did not allow calculation of the specific outcome measure.
Predose, EOI, and 2 and 5 hours after EOI on Day 1 of Cycles 1 and 3
AUC0-last of MMAE for 1Q3W Dose-escalation Part
The AUC0-last of MMAE for 1Q3W dose-escalation part is reported. Sample scheduling of the 3Q4W dosing regimen did not allow calculation of the specific outcome measure.
Predose, EOI, and 2 and 5 hours after EOI on Day 1 of Cycles 1 and 3
Cmax of MMAE for Dose-escalation Part
The Cmax of MMAE for dose-escalation part is reported.
For 1Q3W dosing regimen: Predose, EOI, and 2 and 5 hours after EOI on Day 1 of Cycles 1 and 3; For 3Q4W dosing regimen: Predose and EOI on Days 1 and 8 of Cycles 1 and 3; and predose, EOI, and 2 and 5 hours after EOI on Day 15 of Cycles 1 and 3
Total CL of MMAE in Dose-escalation Part
The total CL of MMAE in dose-escalation part is reported.
For 1Q3W dosing regimen: Predose, EOI, and 2 and 5 hours after EOI on Day 1 of Cycles 1 and 3; For 3Q4W dosing regimen: EOI, and 2 and 5 hours after EOI on Day 15 of Cycles 1 and 3
Tmax of MMAE for Dose-escalation Part
The Tmax of MMAE for dose-escalation part is reported.
For 1Q3W dosing regimen: Predose, EOI, and 2 and 5 hours after EOI on Day 1 of Cycles 1 and 3; For 3Q4W dosing regimen: Predose, EOI, and 2 and 5 hours after EOI on Day 15 of Cycles 1 and 3
t1/2 of MMAE for Dose-escalation Part
The t1/2 of MMAE for dose-escalation part is reported.
For 1Q3W dosing regimen: Predose, EOI, and 2 and 5 hours after EOI on Day 1 of Cycles 1 and 3; For 3Q4W dosing regimen: Predose, EOI, and 2 and 5 hours after EOI on Day 15 of Cycles 1 and 3
Number of Participants With Antidrug Antibodies (ADAs) Confirmed Positive to Enapotamab Vedotin
The ADA assessment was performed according to a tiered approach. First samples were screened for an ADA response; positively screened samples were analyzed in a confirmation method. Subsequently confirmed positive samples were analyzed for titre and the presence of neutralizing antibodies. Number of participants with ADA confirmed positive to enapotamab vedotin is reported.
Day 1 through Day 1130 (Dose-escalation part: Predose of Day 1 of Cycles 1 to 12, end of treatment [EOT], and 30 days after last study drug; Expansion part: Predose on Day 1 of Cycles 1 to 5, then every fourth cycle until PD)
Number of Participants With Objective Response (OR) Based on Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) As Assessed by Investigator
Radiological evaluation based on RECIST v1.1 was performed by the investigator using computed tomography (CT) scans/ magnetic resonance imaging (MRI) scans/ positron emission tomography (PET) scans. The OR was defined as confirmed CR or confirmed PR per RECIST v1.1. The changes in tumor measurements that were confirmed by repeat assessments performed no less than 4 weeks after initial response are called confirmed responses. The CR was defined as disappearance of all target and non-target lesions and all pathological lymph nodes must have decreased to < 10 mm in short axis. The PR was defined as at least a 30% decrease in the sum of the longest diameters (LD) of target lesions taking as reference the baseline sum of LD.
Day 1 through 44.5 months (maximum observed duration)
Number of Participants With Best Cancer Antigen 125 (CA-125) Response
The best CA-125 response was evaluated in participants with ovarian cancer. A CA-125 partial response was defined as at least a 50% reduction in CA-125 levels in blood from a pretreatment sample. Participants who had a CA-125 partial response and had CA-125 level falls to within the reference range (0-35 units/mL) were classified as CA-125 complete responders. The response was confirmed and maintained for at least 28 days. The best overall response (CA-125 partial response and CA-125 complete response) is reported.
From Screening (within 2 weeks before starting of the study treatment) through Day 1130 (maximum observed duration)
Duration of Response (DoR) Based on RECIST v1.1 as Assessed by Investigator for Expansion Part
The DoR was defined as the number of months from the first documentation of objective tumor response (CR or PR) to the date of first progressive disease (PD) or death. The OR was defined as confirmed CR or confirmed PR per RECIST v1.1. The changes in tumor measurements that were confirmed by repeat assessments performed no less than 4 weeks after initial response are called confirmed responses. The CR was defined as disappearance of all target and non-target lesions and all pathological lymph nodes must have decreased to < 10 mm in short axis. The PR was defined as at least a 30% decrease in the sum of the longest diameters (LD) of target lesions taking as reference the baseline sum of LD. The PD was defined as at least 20% increase in the sum of LD of target lesions taking as reference the smallest sum of the LD recorded since the treatment started or the appearance of one or more new target and non-target lesions and/or unequivocal progression of existing non-target lesions.
Day 1 through 44.5 months (maximum observed duration)
Progression Free Survival (PFS) as Assessed by Investigator
The PFS was defined as the number of months from the date of first study drug administration to first PD or death. The PD was defined as at least 20% increase in the sum of longest diameters of target lesions taking as reference the smallest sum of the longest diameters recorded since the treatment started or the appearance of one or more new lesions. The PFS was estimated using Kaplan-Meier method.
Day 1 through 44.5 months (maximum observed duration)
Overall Survival (OS)
Overall survival was defined as the number of months from date of first study drug administration to death. The OS was estimated using Kaplan-Meier method.
Day 1 through 44.5 months (maximum observed duration)
Change in AXL Expression (Total Tumor H-score) From Baseline to EOT Visit for Expansion Part
Change in AXL expression (total humor H-score in membrane or cytoplasm) from Baseline to EOT visit for the expansion part is reported. The H-score captures both the intensity and proportion of AXL positive tumor cells and was defined by the formula: H-score = (1 × % 1+ tumor cells) + (2 × % 2+ tumor cells) + (3 × % 3+ tumor cells); where '1+' indicates weak staining intensity, '2+' indicates medium staining intensity, and '3+' indicates strong staining intensity. The H-score values ranges from 0 to 300. Lower H-scores represent lower AXL expression in the tumor sample, while higher scores represent stronger AXL expression in the tumor samples.
Baseline (Study Days -21 to 1) and EOT visit (Day 1100)
Aurora
Colorado
80045
United States
Yale University, Smilow Cancer Center at Yale New Haven Hospital
New Haven
Connecticut
06520
United States
Mayo Clinic Jacksonville
Jacksonville
Florida
32224
United States
Moffitt Cancer Center
Tampa
Florida
33612
United States
Emory University School of Medicine, Winship Cancer Institute
Atlanta
Georgia
30322
United States
University of Iowa
Iowa City
Iowa
52242
United States
Dana-Farber Cancer Institute
Boston
Massachusetts
02115
United States
University of Michigan Comprehensive Cancer Center
Ann Arbor
Michigan
48109
United States
Mayo Clinic Rochester
Rochester
Minnesota
55905
United States
Washington University
St Louis
Missouri
63110
United States
Roswell Park Comprehensive Cancer Center
Buffalo
New York
14263
United States
Laura and Isaac Perlmutter Cancer Center at NYU Langone
New York
New York
10016
United States
Herbert Irving Comprehensive Cancer Center
New York
New York
10034
United States
Duke Cancer Institute
Durham
North Carolina
27710
United States
Fox Chase Cancer Center
Philadelphia
Pennsylvania
19111
United States
Mary Crowley Cancer Research Center
Dallas
Texas
75230
United States
University of Texas MD Anderson Cancer Center
Houston
Texas
77030
United States
University of Utah Huntsman Cancer Institute
Salt Lake City
Utah
84112
United States
University of Wisconsin Carbone Cancer Center
Madison
Wisconsin
53792
United States
Universitair Ziekenhuizen Leuven
Leuven
Flemish Brabant
3000
Belgium
Institut Roi Albert II - Cliniques Universitaires Saint Luc
Brussels
1200
Belgium
Universitair Ziekenhuis Brussel - Oncologisch Centrum
Jette
1090
Belgium
Medische oncologie, Oncologisch Centrum - AZ Groeninge
Kortrijk
8500
Belgium
U.Z. Leuven Gasthuisberg, Department of General Medical Oncology
Leuven
3000
Belgium
CHU de Liège, Medical Oncology et. Domaine Universitaire du Sart Tilman
Liège
4000
Belgium
Rigshospitalet, Copenhagen University Hospital
Copenhagen
DK-2100
Denmark
The Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital
Amsterdam
1066
Netherlands
Leiden University Medical Centre
Leiden
2333
Netherlands
Erasmus MC, Medical Oncology
Rotterdam
3015
Netherlands
UMC Utrecht Cancer Center
Utrecht
3584
Netherlands
Hospital Unversitario Vall D'hebron
Barcelona
08035
Spain
Oncologia Mèdica/ Medical Oncology Department Institut Catalá d'Oncologia (ICO)
Barcelona
08909
Spain
University Hospital of Girona
Girona
17007
Spain
Hospital Universitario 12 Octubre Servicio de Oncologia Medica
Madrid
28041
Spain
Hospital Virgen de la Victoria
Málaga
29016
Spain
University Hospital Lozano Blesa, Aragón Health Research Institute (IIS Aragón)
Zaragoza
50009
Spain
University College London Hospitals
London
NW1 2PG
United Kingdom
The Christie NHS Foundation Trust Clinical Trials Unit
Manchester
M20 4BX
United Kingdom
Sir Bobby Robson Clinical Trials Unit at the Northern Centre for Cancer Care, Freeman Hospital
Newcastle
NE7 7DN
United Kingdom
The Royal Marsden Hospital
Sutton
SM2 5PT
United Kingdom
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.6 mg/kg 1Q3W until the end of treatment.
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.0 mg/kg 1Q3W until the end of treatment..
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.5 mg/kg 1Q3W until the end of treatment..
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 2.0 mg/kg 1Q3W until the end of treatment.
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 2.4 mg/kg 1Q3W until the end of treatment.
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.6 mg/kg 3Q4W until the end of treatment.
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.8 mg/kg 3Q4W until the end of treatment.
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.0 mg/kg 3Q4W until the end of treatment.
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.2 mg/kg 3Q4W until the end of treatment.
FG011
Expansion Part Cohort 1: Enapotamab Vedotin 2.2 mg/kg 1Q3W
Participants with advanced and/or metastatic NSCLC with classical sensitizing epidermal growth factor receptor (EGFR) mutations and/or EGFR mutations targeted by third-generation tyrosine kinase inhibitors, received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
FG012
Expansion Part Cohort 3: Enapotamab Vedotin 2.2 mg/kg 1Q3W
Participants with advanced and/or metastatic melanoma with BRAF V600 mutation received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
FG013
Expansion Part Cohort 4: Enapotamab Vedotin 2.2 mg/kg 1Q3W
Participants with advanced and/or metastatic melanoma with BRAF V600 wild type received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
FG014
Expansion Part Cohort 5: Enapotamab Vedotin 2.2 mg/kg 1Q3W
Participants with advanced and/or metastatic sarcoma received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
FG015
Expansion Part Cohort 6: Enapotamab Vedotin 1.0 mg/kg 3Q4W
Participants with advanced and/or metastatic solid tumors (excluding NSCLC, melanoma, sarcoma, and ovarian cancer unless having a known AXL gene amplification) received IV infusion of enapotamab vedotin 1.0 mg/kg 3Q4W until the end of treatment.
FG016
Expansion Part Cohort 7: Enapotamab Vedotin 2.2 mg/kg 1Q3W
Participants with advanced and/or metastatic platinum-resistant ovarian cancer received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
FG017
Expansion Part Cohort 2: Enapotamab Vedotin 2.2 mg/kg 1Q3W
Participants with advanced and/or metastatic NSCLC without activating EGFR mutations or anaplastic lymphoma kinase (ALK) rearrangements received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
FG018
Expansion Part Cohort 2: Enapotamab Vedotin 1.8 mg/kg 1Q3W
Participants with advanced and/or metastatic NSCLC without activating EGFR mutations or ALK rearrangements received IV infusion of enapotamab vedotin 1.8 mg/kg 1Q3W until the end of treatment.
FG019
Expansion Part Cohort 8: Enapotamab Vedotin 1.0 mg/kg 3Q4W
Participants with advanced and/or metastatic NSCLC without activating EGFR mutations or ALK rearrangements received IV infusion of enapotamab vedotin 1.0 mg/kg 3Q4W until the end of treatment.
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FG01821 subjects
FG01926 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
FG0170 subjects
FG0180 subjects
FG0190 subjects
NOT COMPLETED
FG0001 subjects
FG0011 subjects
FG0023 subjects
FG0033 subjects
FG00410 subjects
FG00511 subjects
FG0063 subjects
FG0073 subjects
FG0083 subjects
FG0096 subjects
FG0103 subjects
FG01122 subjects
FG01216 subjects
FG01325 subjects
FG01425 subjects
FG01544 subjects
FG01625 subjects
FG01755 subjects
FG01821 subjects
FG01926 subjects
Type
Comment
Reasons
Withdrawal by Subject
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG0043 subjects
FG0051 subjects
FG0062 subjects
FG0071 subjects
FG0081 subjects
FG0091 subjects
FG0101 subjects
FG01112 subjects
FG0126 subjects
FG0136 subjects
FG0144 subjects
FG0155 subjects
FG0164 subjects
FG01711 subjects
FG0184 subjects
FG0192 subjects
Death
FG0000 subjects
FG0011 subjects
FG0023 subjects
FG0031 subjects
FG004
Other
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG004
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Sponsor decision
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Physician Decision
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
The full analysis set included all participants who received at least 1 dose of enapotamab vedotin. Participants were analyzed according to the assigned treatment/dose (planned dose level and schedule).
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.3 mg/kg 1Q3W until the end of treatment.
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.6 mg/kg 1Q3W until the end of treatment.
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.0 mg/kg 1Q3W until the end of treatment.
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.5 mg/kg 1Q3W until the end of treatment.
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 2.0 mg/kg 1Q3W until the end of treatment.
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 2.4 mg/kg 1Q3W until the end of treatment.
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.6 mg/kg 3Q4W until the end of treatment.
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.8 mg/kg 3Q4W until the end of treatment.
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.0 mg/kg 3Q4W until the end of treatment.
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.2 mg/kg 3Q4W until the end of treatment.
BG011
Expansion Part Cohort 1: Enapotamab Vedotin 2.2 mg/kg 1Q3W
Participants with advanced and/or classical metastatic NSCLC with classical sensitizing EGFR mutations and/or EGFR mutations targeted by third-generation tyrosine kinase inhibitors) received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
BG012
Expansion Part Cohort 3: Enapotamab Vedotin 2.2 mg/kg 1Q3W
Participants with advanced and/or metastatic melanoma with BRAF V600 mutation received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
BG013
Expansion Part Cohort 4: Enapotamab Vedotin 2.2 mg/kg 1Q3W
Participants with advanced and/or metastatic melanoma with BRAF V600 wild type received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
BG014
Expansion Part Cohort 5: Enapotamab Vedotin 2.2 mg/kg 1Q3W
Participants with advanced and/or metastatic sarcoma received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
BG015
Expansion Part Cohort 6: Enapotamab Vedotin 1.0 mg/kg 3Q4W
Participants with advanced and/or metastatic solid tumors (excluding NSCLC, melanoma, sarcoma, and ovarian cancer unless having a known AXL gene amplification) received IV infusion of enapotamab vedotin 1.0 mg/kg 3Q4W until the end of treatment.
BG016
Expansion Part Cohort 7: Enapotamab Vedotin 2.2 mg/kg 1Q3W
Participants with advanced and/or metastatic platinum-resistant ovarian cancer received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
BG017
Expansion Part Cohort 2: Enapotamab Vedotin 2.2 mg/kg 1Q3W
Participants with advanced and/or metastatic NSCLC without activating EGFR mutations or ALK rearrangements received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
BG018
Expansion Part Cohort 2: Enapotamab Vedotin 1.8 mg/kg 1Q3W
Participants with advanced and/or metastatic NSCLC without activating EGFR mutations or ALK rearrangements received IV infusion of enapotamab vedotin 1.8 mg/kg 1Q3W until the end of treatment.
BG019
Expansion Part Cohort 8: Enapotamab Vedotin 1.0 mg/kg 3Q4W
Participants with advanced and/or metastatic NSCLC without activating EGFR mutations or ALK rearrangements received IV infusion of enapotamab vedotin 1.0 mg/kg 3Q4W until the end of treatment.
BG020
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0001
BG0011
BG0023
BG0033
BG00410
BG00511
BG0063
BG0073
BG0083
BG0096
BG0103
BG01122
BG01216
BG01325
BG01425
BG01544
BG01625
BG01755
BG01821
BG01926
BG020306
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Customized
Count of Participants
Participants
Title
Denominators
Categories
>=18 to <65 years
Title
Measurements
BG0001
BG0010
BG0022
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0001
BG0011
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0000
BG0010
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Number of Participants With Dose-limiting Toxicities (DLTs) for Dose-escalation Part
The DLTs were defined as Grade (G) 4 neutropenia or G4 thrombocytopenia for a minimal duration of 7 days, G3 and G4 febrile neutropenia, >=G3 hemorrhage associated with >=G3 thrombocytopenia, G4 anemia; Stevens Johnson syndrome, toxic epidermal necrolysis, >=G3 cutaneous vasculitis; G3 neuropathy (not improved to G1 within 3 weeks following pausing of dosing) and G4 neuropathy; G3 infusion-related reactions (IRR) that did not resolve to G1 or baseline within 24 hours; G4 IRR or G4 anaphylaxis events; >= G3 diarrhoea and/or vomiting persisting >48 hours or G3 nausea lasting 7 days (both despite optimal medical management); or any >=G3 related non-hematological AEs, which occurred during the Cycle 1 and regarded as medically important as assessed by the Data Monitoring Committee (excluding Grade 3 fatigue or non-hematological laboratory abnormalities as specified in protocol).
Dose-determining set included all participants from the Safety Set (participants who received at least 1 dose of enapotamab vedotin, had at least one valid post-baseline safety assessment, and were classified according to first dose received) who either met the minimum exposure criterion and completed the DLT observation period, or who experienced a DLT during Cycle 1.
Posted
Count of Participants
Participants
From Day 1 to Day 21 of first cycle for 1Q3W dosing regimen and from Day 1 to Day 28 of first cycle for 3Q4W dosing regimen
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.3 mg/kg 1Q3W until the end of treatment.
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.6 mg/kg 1Q3W until the end of treatment.
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.0 mg/kg 1Q3W until the end of treatment.
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.5 mg/kg 1Q3W until the end of treatment.
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 2.0 mg/kg 1Q3W until the end of treatment.
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
Units
Counts
Participants
OG0001
OG0011
OG0023
OG003
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG003
Primary
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE is defined as an AE that meets one of the following criteria: requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, is a congenital anomaly/birth defect, is medically important, results in death, or is life-threatening. In this trial, a TEAE was defined as an AE occurring or worsening between the first dose of enapotamab vedotin and 30 days after the last dose received.
The safety set included all participants who received at least 1 dose of enapotamab vedotin and had at least one valid post-baseline safety assessment. Participants were classified according to first dose received.
Posted
Count of Participants
Participants
Day 1 through Day 1130 (maximum observed duration)
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.3 mg/kg 1Q3W until the end of treatment.
Number of Participants With Treatment-emergent Infusion-related AEs and TEAEs Related to Enapotamab Vedotin
Number of participants with treatment-emergent infusion-related AEs and TEAEs related to enapotamab vedotin is reported.
The safety set included all participants who received at least 1 dose of enapotamab vedotin and had at least one valid post-baseline safety assessment. Participants were classified according to first dose received.
Posted
Count of Participants
Participants
Day 1 through Day 1130 (maximum observed duration)
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.3 mg/kg 1Q3W until the end of treatment.
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.6 mg/kg 1Q3W until the end of treatment.
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.0 mg/kg 1Q3W until the end of treatment.
Primary
Number of Participants With >= Grade 3 TEAEs as Assessed by National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 4.03
Number of participants with TEAEs of >= Grade 3 as assessed by NCI-CTCAE v4.03 is reported. The NCI-CTCAE is a descriptive terminology is used for AE reporting. The NCI-CTCAE v4.03 displays Grades 1 through 5 with unique clinical descriptions of severity for each AE, based on this general guideline: Grade 1 as mild AE, Grade 2 as moderate AE, Grade 3 as severe AE, Grade 4 as life-threatening or disabling AE, and Grade 5 as death. If a participant reported multiple severity grades for an AE, only the maximum grade was used.
The safety set included all participants who received at least 1 dose of enapotamab vedotin and had at least one valid post-baseline safety assessment. Participants were classified according to first dose received.
Posted
Count of Participants
Participants
Day 1 through Day 1130 (maximum observed duration)
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.3 mg/kg 1Q3W until the end of treatment.
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.6 mg/kg 1Q3W until the end of treatment.
Secondary
Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC0-inf) of Conjugated Enapotamab Vedotin for 1Q3W Dose-escalation Part
The AUC0-inf of conjugated enapotamab vedotin for 1Q3W dose-escalation part is reported. Sample scheduling of the 3Q4W dosing regimen did not allow calculation of the specific outcome measure.
Pharmacokinetic (PK) analysis set included all participants who were exposed to at least 1 dose of enapotamab vedotin and who had at least 1 postdose PK measurement. 'Number analyzed' denotes the number of participants evaluated for the specified time point.
Posted
Geometric Mean
Geometric Coefficient of Variation
day*ug/mL
Predose, end of infusion (EOI), and 2 and 5 hours after EOI on Day 1 of Cycles 1 and 3
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.3 mg/kg 1Q3W until the end of treatment.
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.6 mg/kg 1Q3W until the end of treatment.
Area Under the Plasma Concentration-time Curve From Time 0 to Last Measurable Concentration (AUC0-last) of Conjugated Enapotamab Vedotin for 1Q3W Dose-escalation Part
The AUC0-last of conjugated enapotamab vedotin for 1Q3W dose-escalation part is reported. Sample scheduling of the 3Q4W dosing regimen did not allow calculation of the specific outcome measure.
The PK analysis set included all participants who were exposed to at least 1 dose of enapotamab vedotin and who had at least 1 postdose PK measurement. 'Number analyzed' denotes the number of participants evaluated for the specified time point.
Posted
Geometric Mean
Geometric Coefficient of Variation
day*ug/mL
Predose, EOI, and 2 and 5 hours after EOI on Day 1 of Cycles 1 and 3
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.3 mg/kg 1Q3W until the end of treatment.
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.6 mg/kg 1Q3W until the end of treatment.
Maximum Observed Plasma Concentration (Cmax) of Conjugated Enapotamab Vedotin for Dose-escalation Part
The Cmax of conjugated enapotamab vedotin for dose-escalation part is reported.
The PK analysis set included all participants who were exposed to at least 1 dose of enapotamab vedotin and who had at least 1 postdose PK measurement. 'Number analyzed' denotes the number of participants evaluated for the specified time point.
Posted
Geometric Mean
Geometric Coefficient of Variation
ug/mL
For 1Q3W dosing regimen: Predose, EOI, and 2 and 5 hours after EOI on Day 1 of Cycles 1 and 3; For 3Q4W dosing regimen: Predose and EOI on Days 1 and 8 of Cycles 1 and 3; and predose, EOI, and 2 and 5 hours after EOI on Day 15 of Cycles 1 and 3
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.3 mg/kg 1Q3W until the end of treatment.
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.6 mg/kg 1Q3W until the end of treatment.
Total Clearance (CL) of Conjugated Enapotamab Vedotin in Dose-escalation Part
The total CL of conjugated enapotamab vedotin in dose-escalation part is reported.
The PK analysis set included all participants who were exposed to at least 1 dose of enapotamab vedotin and who had at least 1 postdose PK measurement. 'Number analyzed' denotes the number of participants evaluated for the specified time point.
Posted
Geometric Mean
Geometric Coefficient of Variation
L/day
For 1Q3W dosing regimen: Predose, EOI, and 2 and 5 hours after EOI on Day 1 of Cycles 1 and 3; For 3Q4W dosing regimen: EOI, and 2 and 5 hours after EOI on Day 15 of Cycles 1 and 3
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.3 mg/kg 1Q3W until the end of treatment.
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.6 mg/kg 1Q3W until the end of treatment.
Time of Maximum Plasma Concentration (Tmax) of Conjugated Enapotamab Vedotin for Dose-escalation Part
The Tmax of conjugated enapotamab vedotin for dose-escalation part is reported.
The PK analysis set included all participants who were exposed to at least 1 dose of enapotamab vedotin and who had at least 1 postdose PK measurement. 'Number analyzed' denotes the number of participants evaluated for the specified time point.
Posted
Median
Full Range
Day
For 1Q3W dosing regimen: Predose, EOI, and 2 and 5 hours after EOI on Day 1 of Cycles 1 and 3; For 3Q4W dosing regimen: Predose, EOI, and 2 and 5 hours after EOI on Day 15 of Cycles 1 and 3
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.3 mg/kg 1Q3W until the end of treatment.
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.6 mg/kg 1Q3W until the end of treatment.
Half-life Lambda-z (t1/2) of Conjugated Enapotamab Vedotin for Dose-escalation Part
The t1/2 of conjugated enapotamab vedotin for dose-escalation part is reported.
The PK analysis set included all participants who were exposed to at least 1 dose of enapotamab vedotin and who had at least 1 postdose PK measurement. 'Number analyzed' denotes the number of participants evaluated for the specified time point.
Posted
Median
Full Range
Day
For 1Q3W dosing regimen: Predose, EOI, and 2 and 5 hours after EOI on Day 1 of Cycles 1 and 3; For 3Q4W dosing regimen: Predose, EOI, and 2 and 5 hours after EOI on Day 15 of Cycles 1 and 3
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.3 mg/kg 1Q3W until the end of treatment.
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.6 mg/kg 1Q3W until the end of treatment.
Volume of Distribution at Steady State (Vss) of Conjugated Enapotamab Vedotin for Dose-escalation Part
The Vss of conjugated enapotamab vedotin for dose-escalation part is reported.
The PK analysis set included all participants who were exposed to at least 1 dose of enapotamab vedotin and who had at least 1 postdose PK measurement. 'Number analyzed' denotes the number of participants evaluated for the specified time point.
Posted
Geometric Mean
Geometric Coefficient of Variation
L/day
For 1Q3W dosing regimen: Predose, EOI, and 2 and 5 hours after EOI on Day 1 of Cycles 1 and 3; For 3Q4W dosing regimen: Predose, EOI, and 2 and 5 hours after EOI on Day 15 of Cycles 1 and 3
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.3 mg/kg 1Q3W until the end of treatment.
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.6 mg/kg 1Q3W until the end of treatment.
AUC0-inf of Free Toxin Monomethyl Auristatin E (MMAE) for 1Q3W Dose-escalation Part
The AUC0-inf of MMAE for 1Q3W dose-escalation part is reported. Sample scheduling of the 3Q4W dosing regimen did not allow calculation of the specific outcome measure.
The PK analysis set included all participants who were exposed to at least 1 dose of enapotamab vedotin and who had at least 1 postdose PK measurement. 'Number analyzed' denotes the number of participants evaluated for the specified time point.
Posted
Geometric Mean
Geometric Coefficient of Variation
day*pg/mL
Predose, EOI, and 2 and 5 hours after EOI on Day 1 of Cycles 1 and 3
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.3 mg/kg 1Q3W until the end of treatment.
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.6 mg/kg 1Q3W until the end of treatment.
The AUC0-last of MMAE for 1Q3W dose-escalation part is reported. Sample scheduling of the 3Q4W dosing regimen did not allow calculation of the specific outcome measure.
The PK analysis set included all participants who were exposed to at least 1 dose of enapotamab vedotin and who had at least 1 postdose PK measurement. 'Number analyzed' denotes the number of participants evaluated for the specified time point.
Posted
Geometric Mean
Geometric Coefficient of Variation
day*pg/mL
Predose, EOI, and 2 and 5 hours after EOI on Day 1 of Cycles 1 and 3
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.3 mg/kg 1Q3W until the end of treatment.
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.6 mg/kg 1Q3W until the end of treatment.
The Cmax of MMAE for dose-escalation part is reported.
The PK analysis set included all participants who were exposed to at least 1 dose of enapotamab vedotin and who had at least 1 postdose PK measurement. 'Number analyzed' denotes the number of participants evaluated for the specified time point.
Posted
Geometric Mean
Geometric Coefficient of Variation
pg/mL
For 1Q3W dosing regimen: Predose, EOI, and 2 and 5 hours after EOI on Day 1 of Cycles 1 and 3; For 3Q4W dosing regimen: Predose and EOI on Days 1 and 8 of Cycles 1 and 3; and predose, EOI, and 2 and 5 hours after EOI on Day 15 of Cycles 1 and 3
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.3 mg/kg 1Q3W until the end of treatment.
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.6 mg/kg 1Q3W until the end of treatment.
The total CL of MMAE in dose-escalation part is reported.
The PK analysis set included all participants who were exposed to at least 1 dose of enapotamab vedotin and who had at least 1 postdose PK measurement. 'Number analyzed' denotes the number of participants evaluated for the specified time point.
Posted
Geometric Mean
Geometric Coefficient of Variation
L/day
For 1Q3W dosing regimen: Predose, EOI, and 2 and 5 hours after EOI on Day 1 of Cycles 1 and 3; For 3Q4W dosing regimen: EOI, and 2 and 5 hours after EOI on Day 15 of Cycles 1 and 3
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.3 mg/kg 1Q3W until the end of treatment.
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.6 mg/kg 1Q3W until the end of treatment.
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.0 mg/kg 1Q3W until the end of treatment.
Secondary
Tmax of MMAE for Dose-escalation Part
The Tmax of MMAE for dose-escalation part is reported.
The PK analysis set included all participants who were exposed to at least 1 dose of enapotamab vedotin and who had at least 1 postdose PK measurement. 'Number analyzed' denotes the number of participants evaluated for the specified time point.
Posted
Median
Full Range
Day
For 1Q3W dosing regimen: Predose, EOI, and 2 and 5 hours after EOI on Day 1 of Cycles 1 and 3; For 3Q4W dosing regimen: Predose, EOI, and 2 and 5 hours after EOI on Day 15 of Cycles 1 and 3
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.3 mg/kg 1Q3W until the end of treatment.
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.6 mg/kg 1Q3W until the end of treatment.
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.0 mg/kg 1Q3W until the end of treatment.
Secondary
t1/2 of MMAE for Dose-escalation Part
The t1/2 of MMAE for dose-escalation part is reported.
The PK analysis set included all participants who were exposed to at least 1 dose of enapotamab vedotin and who had at least 1 postdose PK measurement. 'Number analyzed' denotes the number of participants evaluated for the specified time point.
Posted
Median
Full Range
Day
For 1Q3W dosing regimen: Predose, EOI, and 2 and 5 hours after EOI on Day 1 of Cycles 1 and 3; For 3Q4W dosing regimen: Predose, EOI, and 2 and 5 hours after EOI on Day 15 of Cycles 1 and 3
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.3 mg/kg 1Q3W until the end of treatment.
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.6 mg/kg 1Q3W until the end of treatment.
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.0 mg/kg 1Q3W until the end of treatment.
Secondary
Number of Participants With Antidrug Antibodies (ADAs) Confirmed Positive to Enapotamab Vedotin
The ADA assessment was performed according to a tiered approach. First samples were screened for an ADA response; positively screened samples were analyzed in a confirmation method. Subsequently confirmed positive samples were analyzed for titre and the presence of neutralizing antibodies. Number of participants with ADA confirmed positive to enapotamab vedotin is reported.
The safety set included all participants who received at least 1 dose of enapotamab vedotin and had at least one valid post-baseline safety assessment. Participants were classified according to first dose received.
Posted
Count of Participants
Participants
Day 1 through Day 1130 (Dose-escalation part: Predose of Day 1 of Cycles 1 to 12, end of treatment [EOT], and 30 days after last study drug; Expansion part: Predose on Day 1 of Cycles 1 to 5, then every fourth cycle until PD)
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.3 mg/kg 1Q3W until the end of treatment.
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.6 mg/kg 1Q3W until the end of treatment.
Secondary
Number of Participants With Objective Response (OR) Based on Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) As Assessed by Investigator
Radiological evaluation based on RECIST v1.1 was performed by the investigator using computed tomography (CT) scans/ magnetic resonance imaging (MRI) scans/ positron emission tomography (PET) scans. The OR was defined as confirmed CR or confirmed PR per RECIST v1.1. The changes in tumor measurements that were confirmed by repeat assessments performed no less than 4 weeks after initial response are called confirmed responses. The CR was defined as disappearance of all target and non-target lesions and all pathological lymph nodes must have decreased to < 10 mm in short axis. The PR was defined as at least a 30% decrease in the sum of the longest diameters (LD) of target lesions taking as reference the baseline sum of LD.
The full analysis set included all participants who received at least 1 dose of enapotamab vedotin. Participants were classified according to first dose received.
Posted
Count of Participants
Participants
Day 1 through 44.5 months (maximum observed duration)
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.3 mg/kg 1Q3W until the end of treatment.
Number of Participants With Best Cancer Antigen 125 (CA-125) Response
The best CA-125 response was evaluated in participants with ovarian cancer. A CA-125 partial response was defined as at least a 50% reduction in CA-125 levels in blood from a pretreatment sample. Participants who had a CA-125 partial response and had CA-125 level falls to within the reference range (0-35 units/mL) were classified as CA-125 complete responders. The response was confirmed and maintained for at least 28 days. The best overall response (CA-125 partial response and CA-125 complete response) is reported.
Participants from the full analysis set with ovarian cancer who had an initial CA-125 level of at least twice the upper limit of the reference range within 2 weeks before starting the study treatment were evaluated for this outcome measure.
Posted
Count of Participants
Participants
From Screening (within 2 weeks before starting of the study treatment) through Day 1130 (maximum observed duration)
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.3 mg/kg 1Q3W until the end of treatment.
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.6 mg/kg 1Q3W until the end of treatment.
Secondary
Duration of Response (DoR) Based on RECIST v1.1 as Assessed by Investigator for Expansion Part
The DoR was defined as the number of months from the first documentation of objective tumor response (CR or PR) to the date of first progressive disease (PD) or death. The OR was defined as confirmed CR or confirmed PR per RECIST v1.1. The changes in tumor measurements that were confirmed by repeat assessments performed no less than 4 weeks after initial response are called confirmed responses. The CR was defined as disappearance of all target and non-target lesions and all pathological lymph nodes must have decreased to < 10 mm in short axis. The PR was defined as at least a 30% decrease in the sum of the longest diameters (LD) of target lesions taking as reference the baseline sum of LD. The PD was defined as at least 20% increase in the sum of LD of target lesions taking as reference the smallest sum of the LD recorded since the treatment started or the appearance of one or more new target and non-target lesions and/or unequivocal progression of existing non-target lesions.
The full analysis set included all participants who received at least 1 dose of enapotamab vedotin. Participants were classified according to first dose received. Participants who achieved confirmed OR by the investigator assessment were evaluated for this outcome measure.
Posted
Median
95% Confidence Interval
Months
Day 1 through 44.5 months (maximum observed duration)
ID
Title
Description
OG000
Expansion Part Cohort 1: Enapotamab Vedotin 2.2 mg/kg 1Q3W
Participants with advanced and/or metastatic NSCLC with classical sensitizing EGFR mutations and/or EGFR mutations targeted by third-generation tyrosine kinase inhibitors) received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
Secondary
Progression Free Survival (PFS) as Assessed by Investigator
The PFS was defined as the number of months from the date of first study drug administration to first PD or death. The PD was defined as at least 20% increase in the sum of longest diameters of target lesions taking as reference the smallest sum of the longest diameters recorded since the treatment started or the appearance of one or more new lesions. The PFS was estimated using Kaplan-Meier method.
The full analysis set included all participants who received at least 1 dose of enapotamab vedotin. Participants were classified according to first dose received.
Posted
Median
95% Confidence Interval
Months
Day 1 through 44.5 months (maximum observed duration)
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.3 mg/kg 1Q3W until the end of treatment.
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.6 mg/kg 1Q3W until the end of treatment.
Overall survival was defined as the number of months from date of first study drug administration to death. The OS was estimated using Kaplan-Meier method.
The full analysis set included all participants who received at least 1 dose of enapotamab vedotin. Participants were classified according to first dose received.
Posted
Median
95% Confidence Interval
Months
Day 1 through 44.5 months (maximum observed duration)
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.3 mg/kg 1Q3W until the end of treatment.
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.6 mg/kg 1Q3W until the end of treatment.
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.0 mg/kg 1Q3W until the end of treatment.
Secondary
Change in AXL Expression (Total Tumor H-score) From Baseline to EOT Visit for Expansion Part
Change in AXL expression (total humor H-score in membrane or cytoplasm) from Baseline to EOT visit for the expansion part is reported. The H-score captures both the intensity and proportion of AXL positive tumor cells and was defined by the formula: H-score = (1 × % 1+ tumor cells) + (2 × % 2+ tumor cells) + (3 × % 3+ tumor cells); where '1+' indicates weak staining intensity, '2+' indicates medium staining intensity, and '3+' indicates strong staining intensity. The H-score values ranges from 0 to 300. Lower H-scores represent lower AXL expression in the tumor sample, while higher scores represent stronger AXL expression in the tumor samples.
The full analysis set included all participants who received at least 1 dose of enapotamab vedotin. Participants were classified according to first dose received in the expansion part. Participants who had tumor H-scores in membrane or cytoplasm assessed at Baseline and at the end of treatment visit were evaluated for this outcome measure.
Posted
Mean
Standard Deviation
Score on a scale
Baseline (Study Days -21 to 1) and EOT visit (Day 1100)
ID
Title
Description
OG000
Expansion Part Cohort 1: Enapotamab Vedotin 2.2 mg/kg 1Q3W
Participants with advanced and/or metastatic NSCLC with classical sensitizing EGFR mutations and/or EGFR mutations targeted by third-generation tyrosine kinase inhibitors) received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
OG001
Expansion Part Cohort 3: Enapotamab Vedotin 2.2 mg/kg 1Q3W
Primary
Number of Participants With Grade 3 or 4 Laboratory Results
Number of participants with laboratory measurements graded as Grade 3 or 4 by NCI-CTCAE v 4.03 is reported.
The safety set included all participants who received at least 1 dose of enapotamab vedotin and had at least one valid post-baseline safety assessment. Participants were classified according to first dose received.
Posted
Count of Participants
Participants
Day 1 through Day 1130 (maximum observed duration)
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.3 mg/kg 1Q3W until the end of treatment.
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.6 mg/kg 1Q3W until the end of treatment.
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.0 mg/kg 1Q3W until the end of treatment.
Time Frame
For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
Description
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.3 mg/kg 1Q3W until the end of treatment.
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.6 mg/kg 1Q3W until the end of treatment.
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.0 mg/kg 1Q3W until the end of treatment.
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.5 mg/kg 1Q3W until the end of treatment.
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 2.0 mg/kg 1Q3W until the end of treatment.
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 2.4 mg/kg 1Q3W until the end of treatment.
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.6 mg/kg 3Q4W until the end of treatment.
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.8 mg/kg 3Q4W until the end of treatment.
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.0 mg/kg 3Q4W until the end of treatment.
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.2 mg/kg 3Q4W until the end of treatment.
1
3
3
3
3
3
EG011
Expansion Part Cohort 1: Enapotamab Vedotin 2.2 mg/kg 1Q3W
Participants with advanced and/or metastatic NSCLC with classical sensitizing classical EGFR mutations and/or EGFR mutations targeted by third-generation tyrosine kinase inhibitors) received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
8
22
15
22
22
22
EG012
Expansion Part Cohort 3: Enapotamab Vedotin 2.2 mg/kg 1Q3W
Participants with advanced and/or metastatic melanoma with BRAF V600 mutation received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
9
16
5
16
16
16
EG013
Expansion Part Cohort 4: Enapotamab Vedotin 2.2 mg/kg 1Q3W
Participants with advanced and/or metastatic melanoma with BRAF V600 wild type received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
17
25
16
25
24
25
EG014
Expansion Part Cohort 5: Enapotamab Vedotin 2.2 mg/kg 1Q3W
Participants with advanced and/or metastatic sarcoma received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
18
25
10
25
25
25
EG015
Expansion Part Cohort 6: Enapotamab Vedotin 1.0 mg/kg 3Q4W
Participants with advanced and/or metastatic solid tumors (excluding NSCLC, melanoma, sarcoma, and ovarian cancer unless having a known AXL gene amplification) received IV infusion of enapotamab vedotin 1.0 mg/kg 3Q4W until the end of treatment.
30
44
16
44
44
44
EG016
Expansion Part Cohort 7: Enapotamab Vedotin 2.2 mg/kg 1Q3W
Participants with advanced and/or metastatic platinum-resistant ovarian cancer received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
17
25
12
25
25
25
EG017
Expansion Part Cohort 2: Enapotamab Vedotin 2.2 mg/kg 1Q3W
Participants with advanced and/or metastatic NSCLC without activating EGFR mutations or ALK rearrangements received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
38
56
33
56
56
56
EG018
Expansion Part Cohort 2: Enapotamab Vedotin 1.8 mg/kg 1Q3W
Participants with advanced and/or metastatic NSCLC without activating EGFR mutations or ALK rearrangements received IV infusion of enapotamab vedotin 1.8 mg/kg 1Q3W until the end of treatment.
14
22
7
20
20
20
EG019
Expansion Part Cohort 8: Enapotamab Vedotin 1.0 mg/kg 3Q4W
Participants with advanced and/or metastatic NSCLC without activating EGFR mutations or ALK rearrangements received IV infusion of enapotamab vedotin 1.0 mg/kg 3Q4W until the end of treatment.
16
26
14
26
23
26
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected10 at risk
EG0051 events1 affected11 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0091 events1 affected6 at risk
EG0101 events1 affected3 at risk
EG0110 events0 affected22 at risk
EG0120 events0 affected16 at risk
EG0130 events0 affected25 at risk
EG0140 events0 affected25 at risk
EG0150 events0 affected44 at risk
EG0160 events0 affected25 at risk
EG0171 events1 affected56 at risk
EG0180 events0 affected20 at risk
EG0190 events0 affected26 at risk
Febrile Neutropenia
Blood and lymphatic system disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Atrial Fibrillation
Cardiac disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Cardiac Tamponade
Cardiac disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Supraventricular Tachycardia
Cardiac disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Adrenal Insufficiency
Endocrine disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Inappropriate Antidiuretic Hormone Secretion
Endocrine disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Abdominal Pain
Gastrointestinal disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Abdominal Pain Upper
Gastrointestinal disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Colitis
Gastrointestinal disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Ileus
Gastrointestinal disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Intestinal Obstruction
Gastrointestinal disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Pancreatitis
Gastrointestinal disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Small Intestinal Obstruction
Gastrointestinal disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Chest Pain
General disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Death
General disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Fatigue
General disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
General Physical Health Deterioration
General disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Influenza Like Illness
General disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Multiple Organ Dysfunction Syndrome
General disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Oedema
General disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Pyrexia
General disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Biliary Obstruction
Hepatobiliary disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Drug-Induced Liver Injury
Hepatobiliary disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Hyperbilirubinaemia
Hepatobiliary disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Portal Vein Thrombosis
Hepatobiliary disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Non-Cardiac Chest Pain
General disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Bacteraemia
Infections and infestations
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Bronchitis
Infections and infestations
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Cellulitis
Infections and infestations
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Cholangitis Infective
Infections and infestations
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Infection
Infections and infestations
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Lower Respiratory Tract Infection
Infections and infestations
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Neutropenic Sepsis
Infections and infestations
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Pneumocystis Jirovecii Infection
Infections and infestations
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Pneumonia
Infections and infestations
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Sepsis
Infections and infestations
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Septic Shock
Infections and infestations
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Staphylococcal Bacteraemia
Infections and infestations
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Urinary Tract Infection
Infections and infestations
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Femoral Neck Fracture
Injury, poisoning and procedural complications
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Hip Fracture
Injury, poisoning and procedural complications
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Blood Creatine Phosphokinase Increased
Investigations
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Blood Creatinine Increased
Investigations
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Lipase Increased
Investigations
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Lymphocyte Count Decreased
Investigations
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Neutrophil Count Decreased
Investigations
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
White Blood Cell Count Decreased
Investigations
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Hypocalcaemia
Metabolism and nutrition disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Hypophosphataemia
Metabolism and nutrition disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Bone Pain
Musculoskeletal and connective tissue disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Flank Pain
Musculoskeletal and connective tissue disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Lymphangiosis Carcinomatosa
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Malignant Neoplasm Progression
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Metastases to Central Nervous System
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Metastases to Peritoneum
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Neoplasm Progression
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Pericardial Effusion Malignant
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Acute Motor-Sensory Axonal Neuropathy
Nervous system disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Cerebrovascular Accident
Nervous system disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Encephalopathy
Nervous system disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Headache
Nervous system disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Loss Of Consciousness
Nervous system disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Monoplegia
Nervous system disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Neuralgia
Nervous system disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Partial Seizures
Nervous system disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Peripheral Motor Neuropathy
Nervous system disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Peripheral Sensorimotor Neuropathy
Nervous system disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Seizure
Nervous system disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Somnolence
Nervous system disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Transient Ischaemic Attack
Nervous system disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Device Occlusion
Product Issues
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Confusional State
Psychiatric disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Delirium
Psychiatric disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Mental Status Changes
Psychiatric disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Psychotic Disorder
Psychiatric disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Acute Respiratory Failure
Respiratory, thoracic and mediastinal disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Dysphonia
Respiratory, thoracic and mediastinal disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Haemoptysis
Respiratory, thoracic and mediastinal disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Pneumonia Aspiration
Respiratory, thoracic and mediastinal disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Pneumonitis
Respiratory, thoracic and mediastinal disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Pneumothorax
Respiratory, thoracic and mediastinal disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Pulmonary Embolism
Respiratory, thoracic and mediastinal disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Tracheal Obstruction Extrinsic
Respiratory, thoracic and mediastinal disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Deep Vein Thrombosis
Vascular disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Embolism
Vascular disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Hypertension
Vascular disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Hypotension
Vascular disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Peripheral Embolism
Vascular disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected3 at risk
EG0032 events1 affected3 at risk
EG0048 events4 affected10 at risk
EG0051 events1 affected11 at risk
EG0062 events1 affected3 at risk
EG0071 events1 affected3 at risk
EG0080 events0 affected3 at risk
EG00910 events3 affected6 at risk
EG0100 events0 affected3 at risk
EG0116 events4 affected22 at risk
EG0122 events2 affected16 at risk
EG0136 events3 affected25 at risk
EG0146 events4 affected25 at risk
EG0158 events6 affected44 at risk
EG0163 events3 affected25 at risk
EG01714 events11 affected56 at risk
EG0183 events3 affected20 at risk
EG0195 events4 affected26 at risk
Anaemia Macrocytic
Blood and lymphatic system disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Anaemia of chronic disease
Blood and lymphatic system disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Coagulopathy
Blood and lymphatic system disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Febrile Neutropenia
Blood and lymphatic system disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Iron Deficiency Anaemia
Blood and lymphatic system disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0011 events1 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Leukocytosis
Blood and lymphatic system disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Leukopenia
Blood and lymphatic system disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Lymphadenopathy
Blood and lymphatic system disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Lymphopenia
Blood and lymphatic system disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0011 events1 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0022 events1 affected3 at risk
EG003
Normocytic Anaemia
Blood and lymphatic system disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected3 at risk
EG003
Atrial Fibrillation
Cardiac disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Palpitations
Cardiac disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Pericardial Effusion
Cardiac disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Sinus Tachycardia
Cardiac disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Supraventricular Tachycardia
Cardiac disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Tachycardia
Cardiac disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Ventricular Extrasystoles
Cardiac disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Tinnitus
Ear and labyrinth disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Adrenal Insufficiency
Endocrine disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Hyperthyroidism
Endocrine disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Hypothyroidism
Endocrine disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Blepharitis
Eye disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Borderline Glaucoma
Eye disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Cataract
Eye disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Conjunctival Haemorrhage
Eye disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Diplopia
Eye disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Dry Eye
Eye disorders
MedDRA (v24.0)
Systematic Assessment
EG0001 events1 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Eye Irritation
Eye disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Eye Pain
Eye disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Lacrimation Increased
Eye disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Ocular Hyperaemia
Eye disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Photophobia
Eye disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Photopsia
Eye disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Trichomegaly
Eye disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Vision Blurred
Eye disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Visual Impairment
Eye disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Vitreous Floaters
Eye disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Abdominal Discomfort
Gastrointestinal disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Abdominal Distension
Gastrointestinal disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Abdominal Pain
Gastrointestinal disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Abdominal Pain Lower
Gastrointestinal disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Abdominal Pain Upper
Gastrointestinal disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Ascites
Gastrointestinal disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Cheilitis
Gastrointestinal disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Colitis
Gastrointestinal disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected3 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Dry Mouth
Gastrointestinal disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Duodenogastric Reflux
Gastrointestinal disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Epigastric Discomfort
Gastrointestinal disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Eructation
Gastrointestinal disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Flatulence
Gastrointestinal disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Gastric Disorder
Gastrointestinal disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected3 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Gastrointestinal Pain
Gastrointestinal disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Gastrooesophageal Reflux Disease
Gastrointestinal disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Gingival Discomfort
Gastrointestinal disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Gingival Pain
Gastrointestinal disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Haematochezia
Gastrointestinal disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Haemorrhoids
Gastrointestinal disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Hiatus Hernia
Gastrointestinal disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Hyperaesthesia Teeth
Gastrointestinal disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Impaired Gastric Emptying
Gastrointestinal disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Intestinal Obstruction
Gastrointestinal disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA (v24.0)
Systematic Assessment
EG0001 events1 affected1 at risk
EG0011 events1 affected1 at risk
EG0021 events1 affected3 at risk
EG003
Neutropenic Colitis
Gastrointestinal disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Pancreatitis
Gastrointestinal disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Proctalgia
Gastrointestinal disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Retching
Gastrointestinal disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Salivary Duct Inflammation
Gastrointestinal disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Toothache
Gastrointestinal disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0011 events1 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Application Site Reaction
General disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Asthenia
General disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Axillary Pain
General disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Chest Discomfort
General disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Chest Pain
General disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Chills
General disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Condition Aggravated
General disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Face Oedema
General disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Fatigue
General disorders
MedDRA (v24.0)
Systematic Assessment
EG0001 events1 affected1 at risk
EG0011 events1 affected1 at risk
EG0023 events2 affected3 at risk
EG003
Feeling Abnormal
General disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Gait Disturbance
General disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Hernia Pain
General disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Inflammation
General disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Influenza Like Illness
General disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Infusion Site Reaction
General disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Localised Oedema
General disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Malaise
General disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Medical Device Discomfort
General disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Mucosal Inflammation
General disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Nodule
General disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Non-cardiac Chest Pain
General disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Oedema
General disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Oedema Peripheral
General disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Pain
General disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Peripheral Swelling
General disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Physical Deconditioning
General disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Pyrexia
General disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected3 at risk
EG003
Soft Tissue Inflammation
General disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Temperature Intolerance
General disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Tenderness
General disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Vaccination Site Reaction
General disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Xerosis
General disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Biliary Colic
Hepatobiliary disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Cholangitis
Hepatobiliary disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Hepatic Failure
Hepatobiliary disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Hepatic Steatosis
Hepatobiliary disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Hepatitis
Hepatobiliary disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Jaundice
Hepatobiliary disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Bacteriuria
Infections and infestations
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Bronchiolitis
Immune system disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Bronchitis
Infections and infestations
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0011 events1 affected1 at risk
EG0020 events0 affected3 at risk
EG003
COVID-19
Infections and infestations
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Candida Infection
Infections and infestations
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Cellulitis
Infections and infestations
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected3 at risk
EG003
Citrobacter Infection
Infections and infestations
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Conjunctivitis
Infections and infestations
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Cystitis
Infections and infestations
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected3 at risk
EG003
Cystitis Escherichia
Infections and infestations
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Epididymitis
Infections and infestations
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Escherichia Urinary Tract Infection
Infections and infestations
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Eye Infection
Infections and infestations
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Fungal Infection
Infections and infestations
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Fungal Oesophagitis
Infections and infestations
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Gastroenteritis Viral
Infections and infestations
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Herpes Simplex
Infections and infestations
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Herpes Zoster
Infections and infestations
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Infection
Infections and infestations
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Influenza
Infections and infestations
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Lower Respiratory Tract Infection
Infections and infestations
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Lung Abscess
Infections and infestations
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Oral Candidiasis
Infections and infestations
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Parainfluenzae Virus Infection
Infections and infestations
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Paronychia
Infections and infestations
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Pneumonia
Infections and infestations
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Pyuria
Infections and infestations
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Rash Pustular
Infections and infestations
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Rhinitis
Infections and infestations
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Sinusitis
Infections and infestations
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Skin Infection
Infections and infestations
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Tooth Infection
Infections and infestations
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Upper Respiratory Tract Infection
Infections and infestations
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected3 at risk
EG003
Urinary Tract Candidiasis
Infections and infestations
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Urinary Tract Infection
Infections and infestations
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Vaginal Infection
Infections and infestations
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Viral Infection
Infections and infestations
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Clavicle Fracture
Injury, poisoning and procedural complications
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Compression Fracture
Injury, poisoning and procedural complications
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Infusion Related Reaction
Injury, poisoning and procedural complications
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Injury
Injury, poisoning and procedural complications
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Ligament Sprain
Injury, poisoning and procedural complications
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Lip Injury
Injury, poisoning and procedural complications
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Lumbar Vertebral Fracture
Injury, poisoning and procedural complications
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Overdose
Injury, poisoning and procedural complications
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Post Procedural Discomfort
Injury, poisoning and procedural complications
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Post Procedural Swelling
Injury, poisoning and procedural complications
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Procedural Pain
Injury, poisoning and procedural complications
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Radiation Necrosis
Injury, poisoning and procedural complications
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Tendon Rupture
Injury, poisoning and procedural complications
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Thermal Burn
Injury, poisoning and procedural complications
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Wound
Injury, poisoning and procedural complications
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Wrist Fracture
Injury, poisoning and procedural complications
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Activated Partial Thromboplastin Time Prolonged
Investigations
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Alanine Aminotransferase Increased
Investigations
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0011 events1 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Amylase Increased
Investigations
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Aspartate Aminotransferase Increased
Investigations
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0011 events1 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Blood Albumin Decreased
Investigations
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Blood Alkaline Phosphatase Increased
Investigations
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0011 events1 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Blood Bilirubin Increased
Investigations
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Blood Cholesterol Increased
Investigations
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Blood Creatine Phosphokinase Increased
Investigations
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Blood Creatinine Increased
Investigations
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0011 events1 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Blood Iron Decreased
Investigations
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Blood Lactate Dehydrogenase Increased
Investigations
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Blood Magnesium Decreased
Investigations
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Blood Phosphorus Decreased
Investigations
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Blood Potassium Increased
Investigations
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Blood Sodium Decreased
Investigations
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Blood Thyroid Stimulating Hormone Increased
Investigations
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Blood Triglycerides Increased
Investigations
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Blood Urea Increased
Investigations
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Brain Natriuretic Peptide Increased
Investigations
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Breath Sounds Abnormal
Investigations
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
C-reactive Protein Increased
Investigations
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Electrocardiogram QT Prolonged
Investigations
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Gamma-glutamyltransferase Increased
Investigations
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Glomerular Filtration Rate Decreased
Investigations
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
International Normalised Ratio Increased
Investigations
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Lipase Increased
Investigations
MedDRA (v24.0)
Systematic Assessment
EG0001 events1 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Lymphocyte Count Decreased
Investigations
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Neutrophil Count Decreased
Investigations
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Platelet Count Decreased
Investigations
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
SARS-CoV-2 Test Positive
Investigations
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Staphylococcus Test Positive
Investigations
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Troponin T Increased
Investigations
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Troponin Increased
Investigations
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Vitamin B12 Decreased
Investigations
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Weight Decreased
Investigations
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Weight Increased
Investigations
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
White Blood Cell Count Decreased
Investigations
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
White Blood Cells Urine Positive
Investigations
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Decreased Appetite
Metabolism and nutrition disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0011 events1 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Fluid Overload
Metabolism and nutrition disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Hypercholesterolaemia
Metabolism and nutrition disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected3 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Hypermagnesaemia
Investigations
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Hypernatraemia
Metabolism and nutrition disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Hypertriglyceridaemia
Metabolism and nutrition disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Hyperuricaemia
Investigations
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Hypoalbuminaemia
Metabolism and nutrition disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Hypocalcaemia
Investigations
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Hypoglycaemia
Metabolism and nutrition disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0012 events1 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Hypophagia
Metabolism and nutrition disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Hypophosphataemia
Metabolism and nutrition disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Iron Deficiency
Metabolism and nutrition disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Malnutrition
Metabolism and nutrition disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Polydipsia
Metabolism and nutrition disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Type 2 Diabetes Mellitus
Metabolism and nutrition disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Vitamin D Deficiency
Metabolism and nutrition disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA (v24.0)
Systematic Assessment
EG0001 events1 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Arthritis
Musculoskeletal and connective tissue disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Back Pain
Musculoskeletal and connective tissue disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0022 events2 affected3 at risk
EG003
Bone Pain
Musculoskeletal and connective tissue disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Bursitis
Musculoskeletal and connective tissue disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Fistula
Musculoskeletal and connective tissue disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Flank Pain
Musculoskeletal and connective tissue disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Groin Pain
Musculoskeletal and connective tissue disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Joint Range of Motion Decreased
Musculoskeletal and connective tissue disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Limb Discomfort
Musculoskeletal and connective tissue disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Mobility Decreased
Musculoskeletal and connective tissue disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Muscle Spasms
Musculoskeletal and connective tissue disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0014 events1 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Muscle Tightness
Metabolism and nutrition disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Muscular Weakness
Musculoskeletal and connective tissue disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Musculoskeletal Chest Pain
Musculoskeletal and connective tissue disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Musculoskeletal Discomfort
Musculoskeletal and connective tissue disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Musculoskeletal Stiffness
Musculoskeletal and connective tissue disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA (v24.0)
Systematic Assessment
EG0001 events1 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected3 at risk
EG003
Neck Pain
Musculoskeletal and connective tissue disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected3 at risk
EG003
Pain in Extremity
Musculoskeletal and connective tissue disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Polyarthritis
Musculoskeletal and connective tissue disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Spinal Pain
Musculoskeletal and connective tissue disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Cancer Pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Amputation Stump Pain
Nervous system disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Autonomic Nervous System Imbalance
Nervous system disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Autonomic Neuropathy
Nervous system disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Balance Disorder
Nervous system disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Carpal Tunnel Syndrome
Nervous system disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Cognitive Disorder
Nervous system disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Depressed Level of Consciousness
Nervous system disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Disturbance in Attention
Nervous system disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Dizziness
Nervous system disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected3 at risk
EG003
Dysaesthesia
Nervous system disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Dysgeusia
Nervous system disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Headache
Nervous system disorders
MedDRA (v24.0)
Systematic Assessment
EG0001 events1 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Hyperaesthesia
Nervous system disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Hypoaesthesia
Nervous system disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Lethargy
Nervous system disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Metabolic Encephalopathy
Nervous system disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Migraine
Nervous system disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Mononeuropathy
Nervous system disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Monoplegia
Nervous system disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Neuralgia
Nervous system disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected3 at risk
EG003
Neuropathy Peripheral
Nervous system disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Neurotoxicity
Nervous system disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Paresis
Nervous system disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Parosmia
Nervous system disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Peripheral Motor Neuropathy
Nervous system disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Peripheral Sensorimotor Neuropathy
Nervous system disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Peripheral Sensory Neuropathy
Nervous system disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0011 events1 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Peroneal Nerve Palsy
Nervous system disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Polyneuropathy
Nervous system disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Presyncope
Nervous system disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Pyramidal Tract Syndrome
Nervous system disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Restless Legs Syndrome
Nervous system disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Seizure
Nervous system disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Spinal Cord Compression
Nervous system disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected3 at risk
EG003
Syncope
Nervous system disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Taste Disorder
Nervous system disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Tremor
Nervous system disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Agitation
Psychiatric disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Confusional State
Psychiatric disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Delirium
Psychiatric disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Depressed Mood
Psychiatric disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Depression
Psychiatric disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Hallucination
Psychiatric disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Hallucination, Olfactory
Psychiatric disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Hallucination, Visual
Psychiatric disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Irritability
Psychiatric disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Mental Status Changes
Psychiatric disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Restlessness
Psychiatric disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Acute Kidney Injury
Renal and urinary disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Bladder Discomfort
Renal and urinary disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Calculus Bladder
Renal and urinary disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Dysuria
Renal and urinary disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Hydronephrosis
Renal and urinary disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Hypertonic Bladder
Renal and urinary disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Nocturia
Renal and urinary disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Pollakiuria
Renal and urinary disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Polyuria
Renal and urinary disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Proteinuria
Renal and urinary disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Urge Incontinence
Renal and urinary disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Urinary Incontinence
Renal and urinary disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Urinary Retention
Renal and urinary disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Benign Prostatic Hyperplasia
Reproductive system and breast disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Breast Pain
Reproductive system and breast disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Dysmenorrhoea
Reproductive system and breast disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Perineal Pain
Reproductive system and breast disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Vaginal Discharge
Reproductive system and breast disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Vaginal Haemorrhage
Reproductive system and breast disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected3 at risk
EG003
Vulvovaginal Dryness
Reproductive system and breast disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Vulvovaginal Pain
Reproductive system and breast disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Adductor Vocal Cord Weakness
Reproductive system and breast disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Aspiration
Respiratory, thoracic and mediastinal disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0011 events1 affected1 at risk
EG0021 events1 affected3 at risk
EG003
Dysaesthesia Pharynx
Respiratory, thoracic and mediastinal disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Dysphonia
Respiratory, thoracic and mediastinal disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Dyspnoea Exertional
Respiratory, thoracic and mediastinal disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0011 events1 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Haemoptysis
Respiratory, thoracic and mediastinal disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Hypoventilation
Respiratory, thoracic and mediastinal disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Nasal Congestion
Respiratory, thoracic and mediastinal disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Nasal Discomfort
Respiratory, thoracic and mediastinal disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Oropharyngeal Pain
Respiratory, thoracic and mediastinal disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Paranasal Sinus Discomfort
Respiratory, thoracic and mediastinal disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Pleural Effusion
Respiratory, thoracic and mediastinal disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Pleuritic Pain
Respiratory, thoracic and mediastinal disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Pneumonia Aspiration
Respiratory, thoracic and mediastinal disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Pneumonitis
Respiratory, thoracic and mediastinal disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Productive Cough
Respiratory, thoracic and mediastinal disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Pulmonary Embolism
Respiratory, thoracic and mediastinal disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Pulmonary Haemorrhage
Respiratory, thoracic and mediastinal disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Rhinitis Allergic
Respiratory, thoracic and mediastinal disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Sinus Congestion
Respiratory, thoracic and mediastinal disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Sinus Disorder
Respiratory, thoracic and mediastinal disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Sinus Pain
Respiratory, thoracic and mediastinal disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Upper-airway Cough Syndrome
Respiratory, thoracic and mediastinal disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Vasomotor Rhinitis
Respiratory, thoracic and mediastinal disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Wheezing
Respiratory, thoracic and mediastinal disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Blister
Skin and subcutaneous tissue disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Dermatitis Allergic
Skin and subcutaneous tissue disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Dermatitis Bullous
Skin and subcutaneous tissue disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Dermatitis Contact
Skin and subcutaneous tissue disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Dry Skin
Skin and subcutaneous tissue disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Ecchymosis
Skin and subcutaneous tissue disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Eczema
Skin and subcutaneous tissue disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Erythema Multiforme
Skin and subcutaneous tissue disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Hair Texture Abnormal
Skin and subcutaneous tissue disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Hyperhidrosis
Skin and subcutaneous tissue disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Lichenoid Keratosis
Skin and subcutaneous tissue disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Nail Discolouration
Skin and subcutaneous tissue disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Nail Disorder
Skin and subcutaneous tissue disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Nail Dystrophy
Skin and subcutaneous tissue disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Night Sweats
Skin and subcutaneous tissue disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Onychoclasis
Skin and subcutaneous tissue disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Psoriasis
Skin and subcutaneous tissue disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected3 at risk
EG003
Rash Erythematous
Skin and subcutaneous tissue disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Rash Macular
Skin and subcutaneous tissue disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Rash Maculo-papular
Skin and subcutaneous tissue disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Rash Pruritic
Skin and subcutaneous tissue disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Skin Disorder
Skin and subcutaneous tissue disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Skin Hyperpigmentation
Skin and subcutaneous tissue disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Skin Irritation
Skin and subcutaneous tissue disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Skin Lesion
Skin and subcutaneous tissue disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Skin Mass
Skin and subcutaneous tissue disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Skin Reaction
Skin and subcutaneous tissue disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Deep Vein Thrombosis
Vascular disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Flushing
Vascular disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Hot Flush
Vascular disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Hypertension
Vascular disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Hypotension
Vascular disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Jugular Vein Thrombosis
Vascular disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Orthostatic Hypotension
Vascular disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Thrombophlebitis
Vascular disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 affected3 at risk
EG003
Thrombophlebitis Superficial
Vascular disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Thrombosis
Vascular disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
Vascular Compression
Vascular disorders
MedDRA (v24.0)
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected3 at risk
EG003
No participants with castration-resistant prostate cancer were enrolled, hence no prostate-specific antigen (PSA) data were available and pre-specified outcome measure related to PSA data are not reported.
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is at least 12 months but less than 18 months from the end of study (database lock). The sponsor cannot require changes to the communication and cannot extend the embargo.
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 2.4 mg/kg 1Q3W until the end of treatment.
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.6 mg/kg 3Q4W until the end of treatment.
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.8 mg/kg 3Q4W until the end of treatment.
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.0 mg/kg 3Q4W until the end of treatment.
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.2 mg/kg 3Q4W until the end of treatment.
3
OG00410
OG00510
OG0063
OG0073
OG0083
OG0096
OG0102
0
OG0041
OG0052
OG0061
OG0070
OG0080
OG0090
OG0102
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.6 mg/kg 1Q3W until the end of treatment.
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.0 mg/kg 1Q3W until the end of treatment.
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.5 mg/kg 1Q3W until the end of treatment.
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 2.0 mg/kg 1Q3W until the end of treatment.
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 2.4 mg/kg 1Q3W until the end of treatment.
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.6 mg/kg 3Q4W until the end of treatment.
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.8 mg/kg 3Q4W until the end of treatment.
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.0 mg/kg 3Q4W until the end of treatment.
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.2 mg/kg 3Q4W until the end of treatment.
OG011
Expansion Part Cohort 1: Enapotamab Vedotin 2.2 mg/kg 1Q3W
Participants with advanced and/or metastatic NSCLC with classical sensitizing EGFR mutations and/or EGFR mutations targeted by third-generation tyrosine kinase inhibitors) received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
OG012
Expansion Part Cohort 3: Enapotamab Vedotin 2.2 mg/kg 1Q3W
Participants with advanced and/or metastatic melanoma with BRAF V600 mutation received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
OG013
Expansion Part Cohort 4: Enapotamab Vedotin 2.2 mg/kg 1Q3W
Participants with advanced and/or metastatic melanoma with BRAF V600 wild type received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
OG014
Expansion Part Cohort 5: Enapotamab Vedotin 2.2 mg/kg 1Q3W
Participants with advanced and/or metastatic sarcoma received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
OG015
Expansion Part Cohort 6: Enapotamab Vedotin 1.0 mg/kg 3Q4W
Participants with advanced and/or metastatic solid tumors (excluding NSCLC, melanoma, sarcoma, and ovarian cancer unless having a known AXL gene amplification) received IV infusion of enapotamab vedotin 1.0 mg/kg 3Q4W until the end of treatment.
OG016
Expansion Part Cohort 7: Enapotamab Vedotin 2.2 mg/kg 1Q3W
Participants with advanced and/or metastatic platinum-resistant ovarian cancer received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
OG017
Expansion Part Cohort 2: Enapotamab Vedotin 2.2 mg/kg 1Q3W
Participants with advanced and/or metastatic NSCLC without activating EGFR mutations or ALK rearrangements received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
OG018
Expansion Part Cohort 2: Enapotamab Vedotin 1.8 mg/kg 1Q3W
Participants with advanced and/or metastatic NSCLC without activating EGFR mutations or ALK rearrangements received IV infusion of enapotamab vedotin 1.8 mg/kg 1Q3W until the end of treatment.
OG019
Expansion Part Cohort 8: Enapotamab Vedotin 1.0 mg/kg 3Q4W
Participants with advanced and/or metastatic NSCLC without activating EGFR mutations or ALK rearrangements received IV infusion of enapotamab vedotin 1.0 mg/kg 3Q4W until the end of treatment.
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.5 mg/kg 1Q3W until the end of treatment.
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 2.0 mg/kg 1Q3W until the end of treatment.
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 2.4 mg/kg 1Q3W until the end of treatment.
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.6 mg/kg 3Q4W until the end of treatment.
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.8 mg/kg 3Q4W until the end of treatment.
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.0 mg/kg 3Q4W until the end of treatment.
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.2 mg/kg 3Q4W until the end of treatment.
OG011
Expansion Part Cohort 1: Enapotamab Vedotin 2.2 mg/kg 1Q3W
Participants with advanced and/or metastatic NSCLC with classical sensitizing EGFR mutations and/or EGFR mutations targeted by third-generation tyrosine kinase inhibitors) received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
OG012
Expansion Part Cohort 3: Enapotamab Vedotin 2.2 mg/kg 1Q3W
Participants with advanced and/or metastatic melanoma with BRAF V600 mutation received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
OG013
Expansion Part Cohort 4: Enapotamab Vedotin 2.2 mg/kg 1Q3W
Participants with advanced and/or metastatic melanoma with BRAF V600 wild type received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
OG014
Expansion Part Cohort 5: Enapotamab Vedotin 2.2 mg/kg 1Q3W
Participants with advanced and/or metastatic sarcoma received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
OG015
Expansion Part Cohort 6: Enapotamab Vedotin 1.0 mg/kg 3Q4W
Participants with advanced and/or metastatic solid tumors (excluding NSCLC, melanoma, sarcoma, and ovarian cancer unless having a known AXL gene amplification) received IV infusion of enapotamab vedotin 1.0 mg/kg 3Q4W until the end of treatment.
OG016
Expansion Part Cohort 7: Enapotamab Vedotin 2.2 mg/kg 1Q3W
Participants with advanced and/or metastatic platinum-resistant ovarian cancer received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
OG017
Expansion Part Cohort 2: Enapotamab Vedotin 2.2 mg/kg 1Q3W
Participants with advanced and/or metastatic NSCLC without activating EGFR mutations or ALK rearrangements received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
OG018
Expansion Part Cohort 2: Enapotamab Vedotin 1.8 mg/kg 1Q3W
Participants with advanced and/or metastatic NSCLC without activating EGFR mutations or ALK rearrangements received IV infusion of enapotamab vedotin 1.8 mg/kg 1Q3W until the end of treatment.
OG019
Expansion Part Cohort 8: Enapotamab Vedotin 1.0 mg/kg 3Q4W
Participants with advanced and/or metastatic NSCLC without activating EGFR mutations or ALK rearrangements received IV infusion of enapotamab vedotin 1.0 mg/kg 3Q4W until the end of treatment.
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.0 mg/kg 1Q3W until the end of treatment.
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.5 mg/kg 1Q3W until the end of treatment.
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 2.0 mg/kg 1Q3W until the end of treatment.
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 2.4 mg/kg 1Q3W until the end of treatment.
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.6 mg/kg 3Q4W until the end of treatment.
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.8 mg/kg 3Q4W until the end of treatment.
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.0 mg/kg 3Q4W until the end of treatment.
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.2 mg/kg 3Q4W until the end of treatment.
OG011
Expansion Part Cohort 1: Enapotamab Vedotin 2.2 mg/kg 1Q3W
Participants with advanced and/or metastatic NSCLC with classical sensitizing EGFR mutations and/or EGFR mutations targeted by third-generation tyrosine kinase inhibitors) received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
OG012
Expansion Part Cohort 3: Enapotamab Vedotin 2.2 mg/kg 1Q3W
Participants with advanced and/or metastatic melanoma with BRAF V600 mutation received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
OG013
Expansion Part Cohort 4: Enapotamab Vedotin 2.2 mg/kg 1Q3W
Participants with advanced and/or metastatic melanoma with BRAF V600 wild type received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
OG014
Expansion Part Cohort 5: Enapotamab Vedotin 2.2 mg/kg 1Q3W
Participants with advanced and/or metastatic sarcoma received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
OG015
Expansion Part Cohort 6: Enapotamab Vedotin 1.0 mg/kg 3Q4W
Participants with advanced and/or metastatic solid tumors (excluding NSCLC, melanoma, sarcoma, and ovarian cancer unless having a known AXL gene amplification) received IV infusion of enapotamab vedotin 1.0 mg/kg 3Q4W until the end of treatment.
OG016
Expansion Part Cohort 7: Enapotamab Vedotin 2.2 mg/kg 1Q3W
Participants with advanced and/or metastatic platinum-resistant ovarian cancer received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
OG017
Expansion Part Cohort 2: Enapotamab Vedotin 2.2 mg/kg 1Q3W
Participants with advanced and/or metastatic NSCLC without activating EGFR mutations or ALK rearrangements received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
OG018
Expansion Part Cohort 2: Enapotamab Vedotin 1.8 mg/kg 1Q3W
Participants with advanced and/or metastatic NSCLC without activating EGFR mutations or ALK rearrangements received IV infusion of enapotamab vedotin 1.8 mg/kg 1Q3W until the end of treatment.
OG019
Expansion Part Cohort 8: Enapotamab Vedotin 1.0 mg/kg 3Q4W
Participants with advanced and/or metastatic NSCLC without activating EGFR mutations or ALK rearrangements received IV infusion of enapotamab vedotin 1.0 mg/kg 3Q4W until the end of treatment.
Units
Counts
Participants
OG0001
OG0011
OG0023
OG0033
OG00410
OG00511
OG0063
OG0073
OG0083
OG0096
OG0103
OG01122
OG01216
OG01325
OG01425
OG01544
OG01625
OG01756
OG01820
OG01926
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG0032
OG0047
OG0059
OG0063
OG0071
OG0080
OG0093
OG0103
OG01115
OG0126
OG01318
OG01416
OG01521
OG01615
OG01740
OG01814
OG01913
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.0 mg/kg 1Q3W until the end of treatment.
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.5 mg/kg 1Q3W until the end of treatment.
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 2.0 mg/kg 1Q3W until the end of treatment.
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 2.4 mg/kg 1Q3W until the end of treatment.
Units
Counts
Participants
OG0001
OG0011
OG0023
OG0033
OG00410
OG00511
OG0063
Title
Denominators
Categories
Cycle 1 Day 1
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0023
ParticipantsOG0033
ParticipantsOG00410
ParticipantsOG00510
ParticipantsOG0063
Title
Measurements
OG0006.143± NAGeometric coefficient of variation was not derived as only one participant was evaluated for this arm.
OG00113.233± NAGeometric coefficient of variation was not derived as only one participant was evaluated for this arm.
OG00218.353± 8.6
OG003
Cycle 3 Day 1
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0021
ParticipantsOG0031
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.0 mg/kg 1Q3W until the end of treatment.
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.5 mg/kg 1Q3W until the end of treatment.
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 2.0 mg/kg 1Q3W until the end of treatment.
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 2.4 mg/kg 1Q3W until the end of treatment.
Units
Counts
Participants
OG0001
OG0011
OG0023
OG0033
OG00410
OG00511
OG0063
Title
Denominators
Categories
Cycle 1 Day 1
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0023
ParticipantsOG0033
ParticipantsOG00410
ParticipantsOG00510
ParticipantsOG0063
Title
Measurements
OG0005.509± NAGeometric coefficient of variation was not derived as only one participant was evaluated for this arm.
OG00110.369± NAGeometric coefficient of variation was not derived as only one participant was evaluated for this arm.
OG00216.004± 18.5
OG003
Cycle 3 Day 1
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0021
ParticipantsOG0031
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.0 mg/kg 1Q3W until the end of treatment.
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.5 mg/kg 1Q3W until the end of treatment.
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 2.0 mg/kg 1Q3W until the end of treatment.
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 2.4 mg/kg 1Q3W until the end of treatment.
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.6 mg/kg 3Q4W until the end of treatment.
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.8 mg/kg 3Q4W until the end of treatment.
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.0 mg/kg 3Q4W until the end of treatment.
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.2 mg/kg 3Q4W until the end of treatment.
Units
Counts
Participants
OG0001
OG0011
OG0023
OG0033
OG00410
OG00511
OG0063
OG0073
OG0083
OG0096
OG0103
Title
Denominators
Categories
Cycle 1 Day 1
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0023
ParticipantsOG0033
ParticipantsOG00410
ParticipantsOG00510
ParticipantsOG0063
ParticipantsOG0073
ParticipantsOG0082
ParticipantsOG0096
ParticipantsOG0103
Title
Measurements
OG0007.250± NAGeometric coefficient of variation was not derived as only one participant was evaluated for this arm.
OG00112.600± NAGeometric coefficient of variation was not derived as only one participant was evaluated for this arm.
OG00216.615± 16.7
OG003
Cycle 1 Day 8
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Cycle 1 Day 15
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Cycle 3 Day 1
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0021
ParticipantsOG0031
Cycle 3 Day 8
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Cycle 3 Day 15
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.0 mg/kg 1Q3W until the end of treatment.
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.5 mg/kg 1Q3W until the end of treatment.
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 2.0 mg/kg 1Q3W until the end of treatment.
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 2.4 mg/kg 1Q3W until the end of treatment.
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.6 mg/kg 3Q4W until the end of treatment.
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.8 mg/kg 3Q4W until the end of treatment.
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.0 mg/kg 3Q4W until the end of treatment.
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.2 mg/kg 3Q4W until the end of treatment.
Units
Counts
Participants
OG0001
OG0011
OG0023
OG0033
OG00410
OG00511
OG0063
OG0073
OG0083
OG0096
OG0103
Title
Denominators
Categories
Cycle 1 Day 1
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0023
ParticipantsOG0033
ParticipantsOG00410
ParticipantsOG00510
ParticipantsOG0063
ParticipantsOG0070
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG0100
Title
Measurements
OG0004.053± NAGeometric coefficient of variation was not derived as only one participant was evaluated for this arm.
OG0013.446± NAGeometric coefficient of variation was not derived as only one participant was evaluated for this arm.
OG0023.538± 21.8
OG003
Cycle 1 Day 15
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Cycle 3 day 1
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0021
ParticipantsOG0031
Cycle 3 Day 15
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.0 mg/kg 1Q3W until the end of treatment.
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.5 mg/kg 1Q3W until the end of treatment.
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 2.0 mg/kg 1Q3W until the end of treatment.
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 2.4 mg/kg 1Q3W until the end of treatment.
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.6 mg/kg 3Q4W until the end of treatment.
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.8 mg/kg 3Q4W until the end of treatment.
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.0 mg/kg 3Q4W until the end of treatment.
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.2 mg/kg 3Q4W until the end of treatment.
Units
Counts
Participants
OG0001
OG0011
OG0023
OG0033
OG00410
OG00511
OG0063
OG0073
OG0083
OG0096
OG0103
Title
Denominators
Categories
Cycle 1 Day 1
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0023
ParticipantsOG0033
ParticipantsOG00410
ParticipantsOG00510
ParticipantsOG0063
ParticipantsOG0070
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG0100
Title
Measurements
OG0000.06(0.06 to 0.06)
OG0010.03(0.03 to 0.03)
OG0020.036(0.03 to 0.04)
OG003
Cycle 1 Day 15
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Cycle 3 Day 1
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0021
ParticipantsOG0031
Cycle 3 Day 15
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.0 mg/kg 1Q3W until the end of treatment.
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.5 mg/kg 1Q3W until the end of treatment.
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 2.0 mg/kg 1Q3W until the end of treatment.
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 2.4 mg/kg 1Q3W until the end of treatment.
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.6 mg/kg 3Q4W until the end of treatment.
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.8 mg/kg 3Q4W until the end of treatment.
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.0 mg/kg 3Q4W until the end of treatment.
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.2 mg/kg 3Q4W until the end of treatment.
Units
Counts
Participants
OG0001
OG0011
OG0023
OG0033
OG00410
OG00511
OG0063
OG0073
OG0083
OG0096
OG0103
Title
Denominators
Categories
Cycle 1 Day 1
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0023
ParticipantsOG0033
ParticipantsOG00410
ParticipantsOG00510
ParticipantsOG0063
ParticipantsOG0070
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG0100
Title
Measurements
OG0000.87(0.87 to 0.87)
OG0011.49(1.49 to 1.49)
OG0021.362(1.02 to 1.39)
OG003
Cycle 1 Day 15
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Cycle 3 Day 1
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0021
ParticipantsOG0031
Cycle 3 Day 15
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.0 mg/kg 1Q3W until the end of treatment.
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.5 mg/kg 1Q3W until the end of treatment.
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 2.0 mg/kg 1Q3W until the end of treatment.
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 2.4 mg/kg 1Q3W until the end of treatment.
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.6 mg/kg 3Q4W until the end of treatment.
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.8 mg/kg 3Q4W until the end of treatment.
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.0 mg/kg 3Q4W until the end of treatment.
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.2 mg/kg 3Q4W until the end of treatment.
Units
Counts
Participants
OG0001
OG0011
OG0023
OG0033
OG00410
OG00511
OG0063
OG0073
OG0083
OG0096
OG0103
Title
Denominators
Categories
Cycle 1 Day 1
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0023
ParticipantsOG0033
ParticipantsOG00410
ParticipantsOG00510
ParticipantsOG0063
ParticipantsOG0070
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG0100
Title
Measurements
OG0004.909± NAGeometric coefficient of variation was not derived as only one participant was evaluated for this arm.
OG0016.544± NAGeometric coefficient of variation was not derived as only one participant was evaluated for this arm.
OG0025.873± 9.8
OG003
Cycle 1 Day 15
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Cycle 3 Day 1
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0021
ParticipantsOG0031
Cycle 3 Day 15
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.0 mg/kg 1Q3W until the end of treatment.
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.5 mg/kg 1Q3W until the end of treatment.
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 2.0 mg/kg 1Q3W until the end of treatment.
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 2.4 mg/kg 1Q3W until the end of treatment.
Units
Counts
Participants
OG0001
OG0011
OG0023
OG0033
OG00410
OG00511
OG0063
Title
Denominators
Categories
Cycle 1 Day 1
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0023
ParticipantsOG0033
ParticipantsOG00410
ParticipantsOG00510
ParticipantsOG0062
Title
Measurements
OG0003832.48± NAGeometric coefficient of variation was not derived as only one participant was evaluated for this arm.
OG0016144.11± NAGeometric coefficient of variation was not derived as only one participant was evaluated for this arm.
OG00213673.7± 110.4
OG003
Cycle 3 Day 1
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0021
ParticipantsOG0031
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.0 mg/kg 1Q3W until the end of treatment.
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.5 mg/kg 1Q3W until the end of treatment.
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 2.0 mg/kg 1Q3W until the end of treatment.
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 2.4 mg/kg 1Q3W until the end of treatment.
Units
Counts
Participants
OG0001
OG0011
OG0023
OG0033
OG00410
OG00511
OG0063
Title
Denominators
Categories
Cycle 1 Day 1
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0023
ParticipantsOG0033
ParticipantsOG00410
ParticipantsOG00510
ParticipantsOG0063
Title
Measurements
OG0003364.64± NAGeometric coefficient of variation was not derived as only one participant was evaluated for this arm.
OG0015980.86± NAGeometric coefficient of variation was not derived as only one participant was evaluated for this arm.
OG00213194.4± 110.4
OG003
Cycle3 Day 1
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0021
ParticipantsOG0031
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.0 mg/kg 1Q3W until the end of treatment.
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.5 mg/kg 1Q3W until the end of treatment.
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 2.0 mg/kg 1Q3W until the end of treatment.
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 2.4 mg/kg 1Q3W until the end of treatment.
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.6 mg/kg 3Q4W until the end of treatment.
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.8 mg/kg 3Q4W until the end of treatment.
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.0 mg/kg 3Q4W until the end of treatment.
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.2 mg/kg 3Q4W until the end of treatment.
Units
Counts
Participants
OG0001
OG0011
OG0023
OG0033
OG00410
OG00511
OG0063
OG0073
OG0083
OG0096
OG0103
Title
Denominators
Categories
Cycle 1 Day 1
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0023
ParticipantsOG0033
ParticipantsOG00410
ParticipantsOG00510
ParticipantsOG0063
ParticipantsOG0073
ParticipantsOG0083
ParticipantsOG0096
ParticipantsOG0103
Title
Measurements
OG000700.000± NAGeometric coefficient of variation was not derived as only one participant was evaluated for this arm.
OG001947.000± NAGeometric coefficient of variation was not derived as only one participant was evaluated for this arm.
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.5 mg/kg 1Q3W until the end of treatment.
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 2.0 mg/kg 1Q3W until the end of treatment.
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 2.4 mg/kg 1Q3W until the end of treatment.
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.6 mg/kg 3Q4W until the end of treatment.
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.8 mg/kg 3Q4W until the end of treatment.
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.0 mg/kg 3Q4W until the end of treatment.
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.2 mg/kg 3Q4W until the end of treatment.
Units
Counts
Participants
OG0001
OG0011
OG0023
OG0033
OG00410
OG00511
OG0063
OG0073
OG0083
OG0096
OG0103
Title
Denominators
Categories
Cycle 1 Day 1
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0023
ParticipantsOG0033
ParticipantsOG00410
ParticipantsOG00510
ParticipantsOG0062
ParticipantsOG0070
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG0100
Title
Measurements
OG0006497.09± NAGeometric coefficient of variation was not derived as only one participant was evaluated for this arm.
OG0017421.74± NAGeometric coefficient of variation was not derived as only one participant was evaluated for this arm.
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.5 mg/kg 1Q3W until the end of treatment.
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 2.0 mg/kg 1Q3W until the end of treatment.
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 2.4 mg/kg 1Q3W until the end of treatment.
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.6 mg/kg 3Q4W until the end of treatment.
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.8 mg/kg 3Q4W until the end of treatment.
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.0 mg/kg 3Q4W until the end of treatment.
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.2 mg/kg 3Q4W until the end of treatment.
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.5 mg/kg 1Q3W until the end of treatment.
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 2.0 mg/kg 1Q3W until the end of treatment.
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 2.4 mg/kg 1Q3W until the end of treatment.
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.6 mg/kg 3Q4W until the end of treatment.
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.8 mg/kg 3Q4W until the end of treatment.
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.0 mg/kg 3Q4W until the end of treatment.
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.2 mg/kg 3Q4W until the end of treatment.
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.0 mg/kg 1Q3W until the end of treatment.
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.5 mg/kg 1Q3W until the end of treatment.
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 2.0 mg/kg 1Q3W until the end of treatment.
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 2.4 mg/kg 1Q3W until the end of treatment.
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.6 mg/kg 3Q4W until the end of treatment.
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.8 mg/kg 3Q4W until the end of treatment.
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.0 mg/kg 3Q4W until the end of treatment.
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.2 mg/kg 3Q4W until the end of treatment.
OG011
Expansion Part Cohort 1: Enapotamab Vedotin 2.2 mg/kg 1Q3W
Participants with advanced and/or metastatic NSCLC with classical sensitizing EGFR mutations and/or EGFR mutations targeted by third-generation tyrosine kinase inhibitors) received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
OG012
Expansion Part Cohort 3: Enapotamab Vedotin 2.2 mg/kg 1Q3W
Participants with advanced and/or metastatic melanoma with BRAF V600 mutation received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
OG013
Expansion Part Cohort 4: Enapotamab Vedotin 2.2 mg/kg 1Q3W
Participants with advanced and/or metastatic melanoma with BRAF V600 wild type received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
OG014
Expansion Part Cohort 5: Enapotamab Vedotin 2.2 mg/kg 1Q3W
Participants with advanced and/or metastatic sarcoma received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
OG015
Expansion Part Cohort 6: Enapotamab Vedotin 1.0 mg/kg 3Q4W
Participants with advanced and/or metastatic solid tumors (excluding NSCLC, melanoma, sarcoma, and ovarian cancer unless having a known AXL gene amplification) received IV infusion of enapotamab vedotin 1.0 mg/kg 3Q4W until the end of treatment.
OG016
Expansion Part Cohort 7: Enapotamab Vedotin 2.2 mg/kg 1Q3W
Participants with advanced and/or metastatic platinum-resistant ovarian cancer received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
OG017
Expansion Part Cohort 2: Enapotamab Vedotin 2.2 mg/kg 1Q3W
Participants with advanced and/or metastatic NSCLC without activating EGFR mutations or ALK rearrangements received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
OG018
Expansion Part Cohort 2: Enapotamab Vedotin 1.8 mg/kg 1Q3W
Participants with advanced and/or metastatic NSCLC without activating EGFR mutations or ALK rearrangements received IV infusion of enapotamab vedotin 1.8 mg/kg 1Q3W until the end of treatment.
OG019
Expansion Part Cohort 8: Enapotamab Vedotin 1.0 mg/kg 3Q4W
Participants with advanced and/or metastatic NSCLC without activating EGFR mutations or ALK rearrangements received IV infusion of enapotamab vedotin 1.0 mg/kg 3Q4W until the end of treatment.
Units
Counts
Participants
OG0001
OG0011
OG0023
OG0033
OG00410
OG00511
OG0063
OG0073
OG0083
OG0096
OG0103
OG01122
OG01216
OG01325
OG01425
OG01544
OG01625
OG01756
OG01820
OG01926
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0021
OG0031
OG0045
OG0051
OG0061
OG0070
OG0080
OG0092
OG0100
OG0110
OG0124
OG0131
OG0143
OG0150
OG0167
OG0175
OG0180
OG0190
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.6 mg/kg 1Q3W until the end of treatment.
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.0 mg/kg 1Q3W until the end of treatment.
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.5 mg/kg 1Q3W until the end of treatment.
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 2.0 mg/kg 1Q3W until the end of treatment.
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 2.4 mg/kg 1Q3W until the end of treatment.
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.6 mg/kg 3Q4W until the end of treatment.
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.8 mg/kg 3Q4W until the end of treatment.
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.0 mg/kg 3Q4W until the end of treatment.
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.2 mg/kg 3Q4W until the end of treatment.
OG011
Expansion Part Cohort 1: Enapotamab Vedotin 2.2 mg/kg 1Q3W
Participants with advanced and/or metastatic NSCLC with classical sensitizing EGFR mutations and/or EGFR mutations targeted by third-generation tyrosine kinase inhibitors) received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
OG012
Expansion Part Cohort 3: Enapotamab Vedotin 2.2 mg/kg 1Q3W
Participants with advanced and/or metastatic melanoma with BRAF V600 mutation received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
OG013
Expansion Part Cohort 4: Enapotamab Vedotin 2.2 mg/kg 1Q3W
Participants with advanced and/or metastatic melanoma with BRAF V600 wild type received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
OG014
Expansion Part Cohort 5: Enapotamab Vedotin 2.2 mg/kg 1Q3W
Participants with advanced and/or metastatic sarcoma received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
OG015
Expansion Part Cohort 6: Enapotamab Vedotin 1.0 mg/kg 3Q4W
Participants with advanced and/or metastatic solid tumors (excluding NSCLC, melanoma, sarcoma, and ovarian cancer unless having a known AXL gene amplification) received IV infusion of enapotamab vedotin 1.0 mg/kg 3Q4W until the end of treatment.
OG016
Expansion Part Cohort 7: Enapotamab Vedotin 2.2 mg/kg 1Q3W
Participants with advanced and/or metastatic platinum-resistant ovarian cancer received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
OG017
Expansion Part Cohort 2: Enapotamab Vedotin 2.2 mg/kg 1Q3W
Participants with advanced and/or metastatic NSCLC without activating EGFR mutations or ALK rearrangements received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
OG018
Expansion Part Cohort 2: Enapotamab Vedotin 1.8 mg/kg 1Q3W
Participants with advanced and/or metastatic NSCLC without activating EGFR mutations or ALK rearrangements received IV infusion of enapotamab vedotin 1.8 mg/kg 1Q3W until the end of treatment.
OG019
Expansion Part Cohort 8: Enapotamab Vedotin 1.0 mg/kg 3Q4W
Participants with advanced and/or metastatic NSCLC without activating EGFR mutations or ALK rearrangements received IV infusion of enapotamab vedotin 1.0 mg/kg 3Q4W until the end of treatment.
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.0 mg/kg 1Q3W until the end of treatment.
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.5 mg/kg 1Q3W until the end of treatment.
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 2.0 mg/kg 1Q3W until the end of treatment.
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 2.4 mg/kg 1Q3W until the end of treatment.
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.6 mg/kg 3Q4W until the end of treatment.
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.8 mg/kg 3Q4W until the end of treatment.
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.0 mg/kg 3Q4W until the end of treatment.
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.2 mg/kg 3Q4W until the end of treatment.
OG011
Expansion Part Cohort 1: Enapotamab Vedotin 2.2 mg/kg 1Q3W
Participants with advanced and/or metastatic NSCLC with classical sensitizing EGFR mutations and/or EGFR mutations targeted by third-generation tyrosine kinase inhibitors) received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
OG012
Expansion Part Cohort 3: Enapotamab Vedotin 2.2 mg/kg 1Q3W
Participants with advanced and/or metastatic melanoma with BRAF V600 mutation received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
OG013
Expansion Part Cohort 4: Enapotamab Vedotin 2.2 mg/kg 1Q3W
Participants with advanced and/or metastatic melanoma with BRAF V600 wild type received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
OG014
Expansion Part Cohort 5: Enapotamab Vedotin 2.2 mg/kg 1Q3W
Participants with advanced and/or metastatic sarcoma received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
OG015
Expansion Part Cohort 6: Enapotamab Vedotin 1.0 mg/kg 3Q4W
Participants with advanced and/or metastatic solid tumors (excluding NSCLC, melanoma, sarcoma, and ovarian cancer unless having a known AXL gene amplification) received IV infusion of enapotamab vedotin 1.0 mg/kg 3Q4W until the end of treatment.
OG016
Expansion Part Cohort 7: Enapotamab Vedotin 2.2 mg/kg 1Q3W
Participants with advanced and/or metastatic platinum-resistant ovarian cancer received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
OG017
Expansion Part Cohort 2: Enapotamab Vedotin 2.2 mg/kg 1Q3W
Participants with advanced and/or metastatic NSCLC without activating EGFR mutations or ALK rearrangements received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
OG018
Expansion Part Cohort 2: Enapotamab Vedotin 1.8 mg/kg 1Q3W
Participants with advanced and/or metastatic NSCLC without activating EGFR mutations or ALK rearrangements received IV infusion of enapotamab vedotin 1.8 mg/kg 1Q3W until the end of treatment.
OG019
Expansion Part Cohort 8: Enapotamab Vedotin 1.0 mg/kg 3Q4W
Participants with advanced and/or metastatic NSCLC without activating EGFR mutations or ALK rearrangements received IV infusion of enapotamab vedotin 1.0 mg/kg 3Q4W until the end of treatment.
Units
Counts
Participants
OG0000
OG0011
OG0020
OG0031
OG0043
OG0053
OG0061
OG0071
OG0080
OG0092
OG0102
OG0110
OG0120
OG0130
OG0140
OG0150
OG01619
OG0170
OG0180
OG0190
Title
Denominators
Categories
CA-125 partial response
Title
Measurements
OG0010
OG0030
OG0040
OG0050
OG0061
OG0070
OG0090
OG0100
OG0162
CA-125 complete response
Title
Measurements
OG0010
OG0030
OG0040
OG005
OG001
Expansion Part Cohort 3: Enapotamab Vedotin 2.2 mg/kg 1Q3W
Participants with advanced and/or metastatic melanoma with BRAF V600 mutation received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
OG002
Expansion Part Cohort 4: Enapotamab Vedotin 2.2 mg/kg 1Q3W
Participants with advanced and/or metastatic melanoma with BRAF V600 wild type received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
OG003
Expansion Part Cohort 5: Enapotamab Vedotin 2.2 mg/kg 1Q3W
Participants with advanced and/or metastatic sarcoma received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
OG004
Expansion Part Cohort 6: Enapotamab Vedotin 1.0 mg/kg 3Q4W
Participants with advanced and/or metastatic solid tumors (excluding NSCLC, melanoma, sarcoma, and ovarian cancer unless having a known AXL gene amplification) received IV infusion of enapotamab vedotin 1.0 mg/kg 3Q4W until the end of treatment.
OG005
Expansion Part Cohort 7: Enapotamab Vedotin 2.2 mg/kg 1Q3W
Participants with advanced and/or metastatic platinum-resistant ovarian cancer received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
OG006
Expansion Part Cohort 2: Enapotamab Vedotin 2.2 mg/kg 1Q3W
Participants with advanced and/or metastatic NSCLC without activating EGFR mutations or ALK rearrangements received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
OG007
Expansion Part Cohort 2: Enapotamab Vedotin 1.8 mg/kg 1Q3W
Participants with advanced and/or metastatic NSCLC without activating EGFR mutations or ALK rearrangements received IV infusion of enapotamab vedotin 1.8 mg/kg 1Q3W until the end of treatment.
OG008
Expansion Part Cohort 8: Enapotamab Vedotin 1.0 mg/kg 3Q4W
Participants with advanced and/or metastatic NSCLC without activating EGFR mutations or ALK rearrangements received IV infusion of enapotamab vedotin 1.0 mg/kg 3Q4W until the end of treatment.
Units
Counts
Participants
OG0000
OG0011
OG0022
OG0030
OG0042
OG0051
OG0061
OG0071
OG0081
Title
Denominators
Categories
Title
Measurements
OG0014.2(NA to NA)95% confidence interval was not reached due to an insufficient events being observed.
OG0024.1(2.4 to NA)Upper limit of 95% confidence interval was not reached due to an insufficient events being observed.
OG0044.9(2.6 to NA)Upper limit of 95% confidence interval was not reached due to an insufficient events being observed.
OG0053.0(NA to NA)95% confidence interval was not reached due to an insufficient events being observed.
OG006NA(3.0 to NA)Median and upper limit of 95% confidence interval was not reached due to an insufficient events being observed.
OG0073.0(NA to NA)95% confidence interval was not reached due to an insufficient events being observed.
OG0084.9(NA to NA)95% confidence interval was not reached due to an insufficient events being observed.
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.0 mg/kg 1Q3W until the end of treatment.
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.5 mg/kg 1Q3W until the end of treatment.
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 2.0 mg/kg 1Q3W until the end of treatment.
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 2.4 mg/kg 1Q3W until the end of treatment.
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.6 mg/kg 3Q4W until the end of treatment.
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.8 mg/kg 3Q4W until the end of treatment.
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.0 mg/kg 3Q4W until the end of treatment.
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.2 mg/kg 3Q4W until the end of treatment.
OG011
Expansion Part Cohort 1: Enapotamab Vedotin 2.2 mg/kg 1Q3W
Participants with advanced and/or metastatic NSCLC with classical sensitizing EGFR mutations and/or EGFR mutations targeted by third-generation tyrosine kinase inhibitors) received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
OG012
Expansion Part Cohort 3: Enapotamab Vedotin 2.2 mg/kg 1Q3W
Participants with advanced and/or metastatic melanoma with BRAF V600 mutation received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
OG013
Expansion Part Cohort 4: Enapotamab Vedotin 2.2 mg/kg 1Q3W
Participants with advanced and/or metastatic melanoma with BRAF V600 wild type received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
OG014
Expansion Part Cohort 5: Enapotamab Vedotin 2.2 mg/kg 1Q3W
Participants with advanced and/or metastatic sarcoma received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
OG015
Expansion Part Cohort 6: Enapotamab Vedotin 1.0 mg/kg 3Q4W
Participants with advanced and/or metastatic solid tumors (excluding NSCLC, melanoma, sarcoma, and ovarian cancer unless having a known AXL gene amplification) received IV infusion of enapotamab vedotin 1.0 mg/kg 3Q4W until the end of treatment.
OG016
Expansion Part Cohort 7: Enapotamab Vedotin 2.2 mg/kg 1Q3W
Participants with advanced and/or metastatic NSCLC without activating EGFR mutations or ALK rearrangements received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
OG017
Expansion Part Cohort 2: Enapotamab Vedotin 2.2 mg/kg 1Q3W
Participants with advanced and/or metastatic NSCLC without activating EGFR mutations or ALK rearrangements received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
OG018
Expansion Part Cohort 2: Enapotamab Vedotin 1.8 mg/kg 1Q3W
Participants with advanced and/or metastatic NSCLC without activating EGFR mutations or ALK rearrangements received IV infusion of enapotamab vedotin 1.8 mg/kg 1Q3W until the end of treatment.
OG019
Expansion Part Cohort 8: Enapotamab Vedotin 1.0 mg/kg 3Q4W
Participants with advanced and/or metastatic NSCLC without activating EGFR mutations or ALK rearrangements received IV infusion of enapotamab vedotin 1.0 mg/kg 3Q4W until the end of treatment.
Units
Counts
Participants
OG0001
OG0011
OG0023
OG0033
OG00410
OG00511
OG0063
OG0073
OG0083
OG0096
OG0103
OG01122
OG01216
OG01325
OG01425
OG01544
OG01625
OG01755
OG01821
OG01926
Title
Denominators
Categories
Title
Measurements
OG0006.7(NA to NA)95% confidence interval was not reached due to an insufficient events being observed.
OG0013.5(NA to NA)95% confidence interval was not reached due to an insufficient events being observed.
OG0021.3(1.2 to NA)Upper limit of 95% confidence interval was not reached due to an insufficient events being observed.
OG0035.3(1.1 to NA)Upper limit of 95% confidence interval was not reached due to an insufficient events being observed.
OG0042.8(1.4 to NA)Upper limit of 95% confidence interval was not reached due to an insufficient events being observed.
OG0052.6(0.7 to NA)Upper limit of 95% confidence interval was not reached due to an insufficient events being observed.
OG006NA(NA to NA)Median and 95% confidence interval were not reached due to an insufficient events being observed.
OG0071.6(NA to NA)95% confidence interval was not reached due to an insufficient events being observed.
OG0081.6(1.3 to NA)Upper limit of 95% confidence interval was not reached due to an insufficient events being observed.
OG0094.3(1.0 to NA)Upper limit of 95% confidence interval was not reached due to an insufficient events being observed.
OG0100.8(0.4 to NA)Upper limit of 95% confidence interval was not reached due to an insufficient events being observed.
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.5 mg/kg 1Q3W until the end of treatment.
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 2.0 mg/kg 1Q3W until the end of treatment.
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 2.4 mg/kg 1Q3W until the end of treatment.
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.6 mg/kg 3Q4W until the end of treatment.
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.8 mg/kg 3Q4W until the end of treatment.
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.0 mg/kg 3Q4W until the end of treatment.
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.2 mg/kg 3Q4W until the end of treatment.
OG011
Expansion Part Cohort 1: Enapotamab Vedotin 2.2 mg/kg 1Q3W
Participants with advanced and/or metastatic NSCLC with classical sensitizing EGFR mutations and/or EGFR mutations targeted by third-generation tyrosine kinase inhibitors) received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
OG012
Expansion Part Cohort 3: Enapotamab Vedotin 2.2 mg/kg 1Q3W
Participants with advanced and/or metastatic melanoma with BRAF V600 mutation received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
OG013
Expansion Part Cohort 4: Enapotamab Vedotin 2.2 mg/kg 1Q3W
Participants with advanced and/or metastatic melanoma with BRAF V600 wild type received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
OG014
Expansion Part Cohort 5: Enapotamab Vedotin 2.2 mg/kg 1Q3W
Participants with advanced and/or metastatic sarcoma received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.st.
OG015
Expansion Part Cohort 6: Enapotamab Vedotin 1.0 mg/kg 3Q4W
Participants with advanced and/or metastatic solid tumors (excluding NSCLC, melanoma, sarcoma, and ovarian cancer unless having a known AXL gene amplification) received IV infusion of enapotamab vedotin 1.0 mg/kg 3Q4W until the end of treatment.
OG016
Expansion Part Cohort 7: Enapotamab Vedotin 2.2 mg/kg 1Q3W
Participants with advanced and/or metastatic platinum-resistant ovarian cancer received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
OG017
Expansion Part Cohort 2: Enapotamab Vedotin 2.2 mg/kg 1Q3W
Participants with advanced and/or metastatic NSCLC without activating EGFR mutations or ALK rearrangements received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
OG018
Expansion Part Cohort 2: Enapotamab Vedotin 1.8 mg/kg 1Q3W
Participants with advanced and/or metastatic NSCLC without activating EGFR mutations or ALK rearrangements received IV infusion of enapotamab vedotin 1.8 mg/kg 1Q3W until the end of treatment.
OG019
Expansion Part Cohort 8: Enapotamab Vedotin 1.0 mg/kg 3Q4W
Participants with advanced and/or metastatic NSCLC without activating EGFR mutations or ALK rearrangements received IV infusion of enapotamab vedotin 1.0 mg/kg 3Q4W until the end of treatment.
Units
Counts
Participants
OG0001
OG0011
OG0023
OG0033
OG00410
OG00511
OG0063
OG0073
OG0083
OG0096
OG0103
OG01122
OG01216
OG01325
OG01425
OG01544
OG01625
OG01755
OG01821
OG01926
Title
Denominators
Categories
Title
Measurements
OG000NA(NA to NA)Median and 95% confidence interval were not reached due to an insufficient events being observed.
OG0014.3(NA to NA)95% confidence interval was not reached due to an insufficient events being observed.
OG0026.4(6.3 to NA)Upper limit of 95% confidence interval was not reached due to an insufficient events being observed.
OG003NA(6.7 to NA)Median and upper limit of 95% confidence interval were not reached due to an insufficient events being observed.
OG00414.5(3.1 to NA)Upper limit of 95% confidence interval was not reached due to an insufficient events being observed.
OG0057.6(2.2 to 12.1)
OG00644.5(NA to NA)95% confidence interval was not reached due to an insufficient events being observed.
OG0076.7(6.7 to NA)Upper limit of 95% confidence interval was not reached due to an insufficient events being observed.
OG00814.3(NA to NA)95% confidence interval was not reached due to an insufficient events being observed.
OG0097.7(4.3 to NA)Upper limit of 95% confidence interval was not reached due to an insufficient events being observed.
OG01021.7(0.4 to NA)Upper limit of 95% confidence interval was not reached due to an insufficient events being observed.
OG01116.5(4.1 to 25.9)
OG0128.6(3.6 to 19.1)
OG0139.2(4.0 to 14.9)
OG01417.1(5.7 to 24.3)
OG0157.0(5.2 to 11.6)
OG0168.4(6.5 to 12.4)
OG01711.3(8.0 to 15.5)
OG0188.7(5.8 to 14.1)
OG0198.0(4.1 to 12.9)
Participants with advanced and/or metastatic melanoma with BRAF V600 mutation received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
OG002
Expansion Part Cohort 4: Enapotamab Vedotin 2.2 mg/kg 1Q3W
Participants with advanced and/or metastatic melanoma with BRAF V600 wild type received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
OG003
Expansion Part Cohort 5: Enapotamab Vedotin 2.2 mg/kg 1Q3W
Participants with advanced and/or metastatic sarcoma received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
OG004
Expansion Part Cohort 6: Enapotamab Vedotin 1.0 mg/kg 3Q4W
Participants with advanced and/or metastatic solid tumors (excluding NSCLC, melanoma, sarcoma, and ovarian cancer unless having a known AXL gene amplification) received IV infusion of enapotamab vedotin 1.0 mg/kg 3Q4W until the end of treatment.
OG005
Expansion Part Cohort 7: Enapotamab Vedotin 2.2 mg/kg 1Q3W
Participants with advanced and/or metastatic platinum-resistant ovarian cancer received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
OG006
Expansion Part Cohort 2: Enapotamab Vedotin 2.2 mg/kg 1Q3W
Participants with advanced and/or metastatic NSCLC without activating EGFR mutations or ALK rearrangements received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
OG007
Expansion Part Cohort 2: Enapotamab Vedotin 1.8 mg/kg 1Q3W
Participants with advanced and/or metastatic NSCLC without activating EGFR mutations or ALK rearrangements received IV infusion of enapotamab vedotin 1.8 mg/kg 1Q3W until the end of treatment.
OG008
Expansion Part Cohort 8: Enapotamab Vedotin 1.0 mg/kg 3Q4W
Participants with advanced and/or metastatic NSCLC without activating EGFR mutations or ALK rearrangements received IV infusion of enapotamab vedotin 1.0 mg/kg 3Q4W until the end of treatment.
Units
Counts
Participants
OG0001
OG0011
OG0020
OG0031
OG0040
OG0051
OG0061
OG0070
OG0080
Title
Denominators
Categories
Title
Measurements
OG000-8.0± NAStandard deviation was not derived as only one participant was evaluated.
OG001-1.0± NAStandard deviation was not derived as only one participant was evaluated.
OG003-30.0± NAStandard deviation was not derived as only one participant was evaluated.
OG00535.0± NAStandard deviation was not derived as only one participant was evaluated.
OG006-14.0± NAStandard deviation was not derived as only one participant was evaluated.
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.5 mg/kg 1Q3W until the end of treatment.
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 2.0 mg/kg 1Q3W until the end of treatment.
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 2.4 mg/kg 1Q3W until the end of treatment.
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.6 mg/kg 3Q4W until the end of treatment.
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.8 mg/kg 3Q4W until the end of treatment.
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.0 mg/kg 3Q4W until the end of treatment.
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.2 mg/kg 3Q4W until the end of treatment.
OG011
Expansion Part Cohort 1: Enapotamab Vedotin 2.2 mg/kg 1Q3W
Participants with advanced and/or metastatic NSCLC with classical sensitizing EGFR mutations and/or EGFR mutations targeted by third-generation tyrosine kinase inhibitors) received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
OG012
Expansion Part Cohort 3: Enapotamab Vedotin 2.2 mg/kg 1Q3W
Participants with advanced and/or metastatic melanoma with BRAF V600 mutation received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
OG013
Expansion Part Cohort 4: Enapotamab Vedotin 2.2 mg/kg 1Q3W
Participants with advanced and/or metastatic melanoma with BRAF V600 wild type received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
OG014
Expansion Part Cohort 5: Enapotamab Vedotin 2.2 mg/kg 1Q3W
Participants with advanced and/or metastatic sarcoma received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
OG015
Expansion Part Cohort 6: Enapotamab Vedotin 1.0 mg/kg 3Q4W
Participants with advanced and/or metastatic solid tumors (excluding NSCLC, melanoma, sarcoma, and ovarian cancer unless having a known AXL gene amplification) received IV infusion of enapotamab vedotin 1.0 mg/kg 3Q4W until the end of treatment.
OG016
Expansion Part Cohort 7: Enapotamab Vedotin 2.2 mg/kg 1Q3W
Participants with advanced and/or metastatic platinum-resistant ovarian cancer received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
OG017
Expansion Part Cohort 2: Enapotamab Vedotin 2.2 mg/kg 1Q3W
Participants with advanced and/or metastatic NSCLC without activating EGFR mutations or ALK rearrangements received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
OG018
Expansion Part Cohort 2: Enapotamab Vedotin 1.8 mg/kg 1Q3W
Participants with advanced and/or metastatic NSCLC without activating EGFR mutations or ALK rearrangements received IV infusion of enapotamab vedotin 1.8 mg/kg 1Q3W until the end of treatment.
OG019
Expansion Part Cohort 8: Enapotamab Vedotin 1.0 mg/kg 3Q4W
Participants with advanced and/or metastatic NSCLC without activating EGFR mutations or ALK rearrangements received IV infusion of enapotamab vedotin 1.0 mg/kg 3Q4W until the end of treatment.
Units
Counts
Participants
OG0001
OG0011
OG0023
OG0033
OG00410
OG00511
OG0063
OG0073
OG0083
OG0096
OG0103
OG01122
OG01216
OG01325
OG01425
OG01544
OG01625
OG01756
OG01820
OG01926
Title
Denominators
Categories
Activated partial thromboplastin time
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0051
OG0061
OG0070
OG0080
OG0090
OG0100
OG0110
OG0120
OG0130
OG0140
OG0151
OG0160
OG0172
OG0180
OG0190
Alanine aminotransferase
Title
Measurements
OG0000
OG0011
OG0020
OG003
Amylase
Title
Measurements
OG0000
OG0010
OG0020
OG003
Aspartate aminotransferase
Title
Measurements
OG0000
OG0011
OG0020
OG003
Calcium
Title
Measurements
OG0000
OG0010
OG0020
OG003
Gamma-glutamyl transferase
Title
Measurements
OG0000
OG0011
OG0020
OG003
Leukocytes
Title
Measurements
OG0000
OG0010
OG0020
OG003
Lipase
Title
Measurements
OG0000
OG0010
OG0020
OG003
Lymphocytes
Title
Measurements
OG0001
OG0010
OG0020
OG003
Magnesium
Title
Measurements
OG0000
OG0010
OG0020
OG003
Neutrophils
Title
Measurements
OG0000
OG0010
OG0020
OG003
Potassium
Title
Measurements
OG0000
OG0010
OG0020
OG003
Prothrombin Intl. Normalized Ratio
Title
Measurements
OG0000
OG0010
OG0021
OG003
Sodium
Title
Measurements
OG0000
OG0010
OG0020
OG003
Triglycerides
Title
Measurements
OG0000
OG0010
OG0020
OG003
Alkaline Phosphatase
Title
Measurements
OG0000
OG0010
OG0020
OG003
Hemoglobin
Title
Measurements
OG0000
OG0010
OG0020
OG003
Albumin
Title
Measurements
OG0000
OG0010
OG0020
OG003
Bilirubin
Title
Measurements
OG0000
OG0010
OG0020
OG003
Cholesterol
Title
Measurements
OG0000
OG0010
OG0020
OG003
0 events
0 affected
3 at risk
EG0040 events0 affected10 at risk
EG0050 events0 affected11 at risk
EG0061 events1 affected3 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected6 at risk
EG0101 events1 affected3 at risk
EG0110 events0 affected22 at risk
EG0120 events0 affected16 at risk
EG0130 events0 affected25 at risk
EG0141 events1 affected25 at risk
EG0151 events1 affected44 at risk
EG0161 events1 affected25 at risk
EG0171 events1 affected56 at risk
EG0180 events0 affected20 at risk
EG0190 events0 affected26 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected10 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected6 at risk
EG0100 events0 affected3 at risk
EG0110 events0 affected22 at risk
EG0120 events0 affected16 at risk
EG0132 events2 affected25 at risk
EG0140 events0 affected25 at risk
EG0150 events0 affected44 at risk
EG0160 events0 affected25 at risk
EG0171 events1 affected56 at risk
EG0180 events0 affected20 at risk
EG0190 events0 affected26 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected10 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected6 at risk
EG0100 events0 affected3 at risk
EG0110 events0 affected22 at risk
EG0120 events0 affected16 at risk
EG0130 events0 affected25 at risk
EG0140 events0 affected25 at risk
EG0150 events0 affected44 at risk
EG0160 events0 affected25 at risk
EG0171 events1 affected56 at risk
EG0180 events0 affected20 at risk
EG0190 events0 affected26 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected10 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected6 at risk
EG0100 events0 affected3 at risk
EG0110 events0 affected22 at risk
EG0120 events0 affected16 at risk
EG0130 events0 affected25 at risk
EG0140 events0 affected25 at risk
EG0150 events0 affected44 at risk
EG0160 events0 affected25 at risk
EG0170 events0 affected56 at risk
EG0180 events0 affected20 at risk
EG0191 events1 affected26 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected10 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected6 at risk
EG0100 events0 affected3 at risk
EG0110 events0 affected22 at risk
EG0120 events0 affected16 at risk
EG0130 events0 affected25 at risk
EG0140 events0 affected25 at risk
EG0151 events1 affected44 at risk
EG0160 events0 affected25 at risk
EG0171 events1 affected56 at risk
EG0180 events0 affected20 at risk
EG0190 events0 affected26 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected10 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected6 at risk
EG0100 events0 affected3 at risk
EG0110 events0 affected22 at risk
EG0120 events0 affected16 at risk
EG0130 events0 affected25 at risk
EG0140 events0 affected25 at risk
EG0152 events1 affected44 at risk
EG0160 events0 affected25 at risk
EG0170 events0 affected56 at risk
EG0180 events0 affected20 at risk
EG0190 events0 affected26 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected10 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected6 at risk
EG0100 events0 affected3 at risk
EG0110 events0 affected22 at risk
EG0120 events0 affected16 at risk
EG0131 events1 affected25 at risk
EG0141 events1 affected25 at risk
EG0150 events0 affected44 at risk
EG0160 events0 affected25 at risk
EG0170 events0 affected56 at risk
EG0180 events0 affected20 at risk
EG0190 events0 affected26 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected10 at risk
EG0051 events1 affected11 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected6 at risk
EG0100 events0 affected3 at risk
EG0110 events0 affected22 at risk
EG0120 events0 affected16 at risk
EG0131 events1 affected25 at risk
EG0140 events0 affected25 at risk
EG0150 events0 affected44 at risk
EG0160 events0 affected25 at risk
EG0172 events2 affected56 at risk
EG0180 events0 affected20 at risk
EG0190 events0 affected26 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected10 at risk
EG0051 events1 affected11 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected6 at risk
EG0100 events0 affected3 at risk
EG0110 events0 affected22 at risk
EG0120 events0 affected16 at risk
EG0130 events0 affected25 at risk
EG0140 events0 affected25 at risk
EG0150 events0 affected44 at risk
EG0160 events0 affected25 at risk
EG0170 events0 affected56 at risk
EG0180 events0 affected20 at risk
EG0190 events0 affected26 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected10 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected6 at risk
EG0100 events0 affected3 at risk
EG0110 events0 affected22 at risk
EG0120 events0 affected16 at risk
EG0130 events0 affected25 at risk
EG0140 events0 affected25 at risk
EG0150 events0 affected44 at risk
EG0160 events0 affected25 at risk
EG0173 events3 affected56 at risk
EG0180 events0 affected20 at risk
EG0190 events0 affected26 at risk
0 events
0 affected
3 at risk
EG0044 events4 affected10 at risk
EG0051 events1 affected11 at risk
EG0062 events2 affected3 at risk
EG0071 events1 affected3 at risk
EG0080 events0 affected3 at risk
EG0091 events1 affected6 at risk
EG0100 events0 affected3 at risk
EG0117 events7 affected22 at risk
EG0124 events4 affected16 at risk
EG0134 events4 affected25 at risk
EG0143 events3 affected25 at risk
EG0152 events2 affected44 at risk
EG0160 events0 affected25 at risk
EG0174 events3 affected56 at risk
EG0181 events1 affected20 at risk
EG0191 events1 affected26 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected10 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0092 events1 affected6 at risk
EG0101 events1 affected3 at risk
EG0110 events0 affected22 at risk
EG0120 events0 affected16 at risk
EG0130 events0 affected25 at risk
EG0140 events0 affected25 at risk
EG0150 events0 affected44 at risk
EG0160 events0 affected25 at risk
EG0171 events1 affected56 at risk
EG0181 events1 affected20 at risk
EG0190 events0 affected26 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected10 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected6 at risk
EG0100 events0 affected3 at risk
EG0110 events0 affected22 at risk
EG0120 events0 affected16 at risk
EG0130 events0 affected25 at risk
EG0140 events0 affected25 at risk
EG0151 events1 affected44 at risk
EG0160 events0 affected25 at risk
EG0170 events0 affected56 at risk
EG0180 events0 affected20 at risk
EG0190 events0 affected26 at risk
1 events
1 affected
3 at risk
EG0040 events0 affected10 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected6 at risk
EG0100 events0 affected3 at risk
EG0111 events1 affected22 at risk
EG0120 events0 affected16 at risk
EG0130 events0 affected25 at risk
EG0140 events0 affected25 at risk
EG0150 events0 affected44 at risk
EG0160 events0 affected25 at risk
EG0171 events1 affected56 at risk
EG0180 events0 affected20 at risk
EG0190 events0 affected26 at risk
1 events
1 affected
3 at risk
EG0040 events0 affected10 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected6 at risk
EG0100 events0 affected3 at risk
EG0110 events0 affected22 at risk
EG0120 events0 affected16 at risk
EG0130 events0 affected25 at risk
EG0140 events0 affected25 at risk
EG0151 events1 affected44 at risk
EG0161 events1 affected25 at risk
EG0171 events1 affected56 at risk
EG0180 events0 affected20 at risk
EG0190 events0 affected26 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected10 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected6 at risk
EG0100 events0 affected3 at risk
EG0111 events1 affected22 at risk
EG0120 events0 affected16 at risk
EG0130 events0 affected25 at risk
EG0140 events0 affected25 at risk
EG0150 events0 affected44 at risk
EG0160 events0 affected25 at risk
EG0176 events4 affected56 at risk
EG0181 events1 affected20 at risk
EG0190 events0 affected26 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected10 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected6 at risk
EG0100 events0 affected3 at risk
EG0110 events0 affected22 at risk
EG0120 events0 affected16 at risk
EG0130 events0 affected25 at risk
EG0140 events0 affected25 at risk
EG0150 events0 affected44 at risk
EG0160 events0 affected25 at risk
EG0170 events0 affected56 at risk
EG0180 events0 affected20 at risk
EG0191 events1 affected26 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected10 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected6 at risk
EG0100 events0 affected3 at risk
EG0110 events0 affected22 at risk
EG0120 events0 affected16 at risk
EG0130 events0 affected25 at risk
EG0140 events0 affected25 at risk
EG0151 events1 affected44 at risk
EG0162 events2 affected25 at risk
EG0170 events0 affected56 at risk
EG0180 events0 affected20 at risk
EG0191 events1 affected26 at risk
0 events
0 affected
3 at risk
EG0041 events1 affected10 at risk
EG0051 events1 affected11 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected6 at risk
EG0100 events0 affected3 at risk
EG0112 events2 affected22 at risk
EG0120 events0 affected16 at risk
EG0130 events0 affected25 at risk
EG0140 events0 affected25 at risk
EG0150 events0 affected44 at risk
EG0161 events1 affected25 at risk
EG0173 events3 affected56 at risk
EG0180 events0 affected20 at risk
EG0190 events0 affected26 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected10 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected6 at risk
EG0100 events0 affected3 at risk
EG0110 events0 affected22 at risk
EG0120 events0 affected16 at risk
EG0130 events0 affected25 at risk
EG0140 events0 affected25 at risk
EG0150 events0 affected44 at risk
EG0160 events0 affected25 at risk
EG0171 events1 affected56 at risk
EG0180 events0 affected20 at risk
EG0191 events1 affected26 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected10 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected6 at risk
EG0100 events0 affected3 at risk
EG0110 events0 affected22 at risk
EG0120 events0 affected16 at risk
EG0130 events0 affected25 at risk
EG0140 events0 affected25 at risk
EG0150 events0 affected44 at risk
EG0160 events0 affected25 at risk
EG0170 events0 affected56 at risk
EG0180 events0 affected20 at risk
EG0191 events1 affected26 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected10 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0091 events1 affected6 at risk
EG0101 events1 affected3 at risk
EG0110 events0 affected22 at risk
EG0120 events0 affected16 at risk
EG0131 events1 affected25 at risk
EG0140 events0 affected25 at risk
EG0150 events0 affected44 at risk
EG0160 events0 affected25 at risk
EG0172 events2 affected56 at risk
EG0180 events0 affected20 at risk
EG0191 events1 affected26 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected10 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected6 at risk
EG0100 events0 affected3 at risk
EG0110 events0 affected22 at risk
EG0120 events0 affected16 at risk
EG0130 events0 affected25 at risk
EG0140 events0 affected25 at risk
EG0150 events0 affected44 at risk
EG0163 events3 affected25 at risk
EG0171 events1 affected56 at risk
EG0180 events0 affected20 at risk
EG0190 events0 affected26 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected10 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected6 at risk
EG0100 events0 affected3 at risk
EG0110 events0 affected22 at risk
EG0120 events0 affected16 at risk
EG0130 events0 affected25 at risk
EG0140 events0 affected25 at risk
EG0150 events0 affected44 at risk
EG0160 events0 affected25 at risk
EG0170 events0 affected56 at risk
EG0181 events1 affected20 at risk
EG0190 events0 affected26 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected10 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected6 at risk
EG0100 events0 affected3 at risk
EG0110 events0 affected22 at risk
EG0120 events0 affected16 at risk
EG0130 events0 affected25 at risk
EG0141 events1 affected25 at risk
EG0150 events0 affected44 at risk
EG0160 events0 affected25 at risk
EG0170 events0 affected56 at risk
EG0180 events0 affected20 at risk
EG0190 events0 affected26 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected10 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected6 at risk
EG0100 events0 affected3 at risk
EG0110 events0 affected22 at risk
EG0120 events0 affected16 at risk
EG0130 events0 affected25 at risk
EG0140 events0 affected25 at risk
EG0150 events0 affected44 at risk
EG0160 events0 affected25 at risk
EG0170 events0 affected56 at risk
EG0180 events0 affected20 at risk
EG0190 events0 affected26 at risk
0 events
0 affected
3 at risk
EG0041 events1 affected10 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected6 at risk
EG0100 events0 affected3 at risk
EG0110 events0 affected22 at risk
EG0120 events0 affected16 at risk
EG0130 events0 affected25 at risk
EG0142 events2 affected25 at risk
EG0151 events1 affected44 at risk
EG0160 events0 affected25 at risk
EG0170 events0 affected56 at risk
EG0180 events0 affected20 at risk
EG0191 events1 affected26 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected10 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected6 at risk
EG0100 events0 affected3 at risk
EG0110 events0 affected22 at risk
EG0120 events0 affected16 at risk
EG0130 events0 affected25 at risk
EG0140 events0 affected25 at risk
EG0151 events1 affected44 at risk
EG0161 events1 affected25 at risk
EG0170 events0 affected56 at risk
EG0180 events0 affected20 at risk
EG0190 events0 affected26 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected10 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected6 at risk
EG0100 events0 affected3 at risk
EG0110 events0 affected22 at risk
EG0120 events0 affected16 at risk
EG0130 events0 affected25 at risk
EG0140 events0 affected25 at risk
EG0150 events0 affected44 at risk
EG0160 events0 affected25 at risk
EG0170 events0 affected56 at risk
EG0180 events0 affected20 at risk
EG0191 events1 affected26 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected10 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected6 at risk
EG0101 events1 affected3 at risk
EG0110 events0 affected22 at risk
EG0120 events0 affected16 at risk
EG0130 events0 affected25 at risk
EG0140 events0 affected25 at risk
EG0150 events0 affected44 at risk
EG0160 events0 affected25 at risk
EG0171 events1 affected56 at risk
EG0180 events0 affected20 at risk
EG0190 events0 affected26 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected10 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected6 at risk
EG0100 events0 affected3 at risk
EG0110 events0 affected22 at risk
EG0120 events0 affected16 at risk
EG0130 events0 affected25 at risk
EG0140 events0 affected25 at risk
EG0150 events0 affected44 at risk
EG0160 events0 affected25 at risk
EG0171 events1 affected56 at risk
EG0180 events0 affected20 at risk
EG0190 events0 affected26 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected10 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected6 at risk
EG0100 events0 affected3 at risk
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EG0190 events0 affected26 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected10 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected6 at risk
EG0100 events0 affected3 at risk
EG0111 events1 affected22 at risk
EG0120 events0 affected16 at risk
EG0130 events0 affected25 at risk
EG0140 events0 affected25 at risk
EG0151 events1 affected44 at risk
EG0160 events0 affected25 at risk
EG0171 events1 affected56 at risk
EG0183 events2 affected20 at risk
EG0192 events2 affected26 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected10 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected6 at risk
EG0100 events0 affected3 at risk
EG0110 events0 affected22 at risk
EG0120 events0 affected16 at risk
EG0130 events0 affected25 at risk
EG0140 events0 affected25 at risk
EG0150 events0 affected44 at risk
EG0160 events0 affected25 at risk
EG0171 events1 affected56 at risk
EG0180 events0 affected20 at risk
EG0190 events0 affected26 at risk
1 events
1 affected
3 at risk
EG0041 events1 affected10 at risk
EG0051 events1 affected11 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected6 at risk
EG0100 events0 affected3 at risk
EG0112 events2 affected22 at risk
EG0124 events3 affected16 at risk
EG0134 events4 affected25 at risk
EG0142 events1 affected25 at risk
EG0157 events6 affected44 at risk
EG0164 events3 affected25 at risk
EG0177 events6 affected56 at risk
EG0181 events1 affected20 at risk
EG0193 events3 affected26 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected10 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected6 at risk
EG0100 events0 affected3 at risk
EG0110 events0 affected22 at risk
EG0120 events0 affected16 at risk
EG0130 events0 affected25 at risk
EG0141 events1 affected25 at risk
EG0150 events0 affected44 at risk
EG0160 events0 affected25 at risk
EG0170 events0 affected56 at risk
EG0180 events0 affected20 at risk
EG0190 events0 affected26 at risk
0 events
0 affected
3 at risk
EG0041 events1 affected10 at risk
EG0051 events1 affected11 at risk
EG0060 events0 affected3 at risk
EG0071 events1 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected6 at risk
EG0100 events0 affected3 at risk
EG0110 events0 affected22 at risk
EG0121 events1 affected16 at risk
EG0130 events0 affected25 at risk
EG0143 events2 affected25 at risk
EG0155 events5 affected44 at risk
EG0162 events2 affected25 at risk
EG0177 events6 affected56 at risk
EG0184 events3 affected20 at risk
EG0195 events3 affected26 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected10 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected6 at risk
EG0100 events0 affected3 at risk
EG0111 events1 affected22 at risk
EG0122 events1 affected16 at risk
EG0130 events0 affected25 at risk
EG0140 events0 affected25 at risk
EG0150 events0 affected44 at risk
EG0160 events0 affected25 at risk
EG0170 events0 affected56 at risk
EG0180 events0 affected20 at risk
EG0190 events0 affected26 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected10 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected6 at risk
EG0100 events0 affected3 at risk
EG0110 events0 affected22 at risk
EG0120 events0 affected16 at risk
EG0130 events0 affected25 at risk
EG0140 events0 affected25 at risk
EG0151 events1 affected44 at risk
EG0160 events0 affected25 at risk
EG0170 events0 affected56 at risk
EG0180 events0 affected20 at risk
EG0190 events0 affected26 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected10 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected6 at risk
EG0100 events0 affected3 at risk
EG0110 events0 affected22 at risk
EG0121 events1 affected16 at risk
EG0131 events1 affected25 at risk
EG0140 events0 affected25 at risk
EG0150 events0 affected44 at risk
EG0160 events0 affected25 at risk
EG0170 events0 affected56 at risk
EG0180 events0 affected20 at risk
EG0190 affected26 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected10 at risk
EG0051 events1 affected11 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected6 at risk
EG0100 events0 affected3 at risk
EG0110 events0 affected22 at risk
EG0120 events0 affected16 at risk
EG0130 events0 affected25 at risk
EG0142 events2 affected25 at risk
EG0150 events0 affected44 at risk
EG0160 events0 affected25 at risk
EG0171 events1 affected56 at risk
EG0180 events0 affected20 at risk
EG0190 events0 affected26 at risk
0 events
0 affected
3 at risk
EG0041 events1 affected10 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected6 at risk
EG0100 events0 affected3 at risk
EG0110 events0 affected22 at risk
EG0120 events0 affected16 at risk
EG0130 events0 affected25 at risk
EG0140 events0 affected25 at risk
EG0150 events0 affected44 at risk
EG0160 events0 affected25 at risk
EG0170 events0 affected56 at risk
EG0180 events0 affected20 at risk
EG0190 events0 affected26 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected10 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected6 at risk
EG0100 events0 affected3 at risk
EG0110 events0 affected22 at risk
EG0120 events0 affected16 at risk
EG0131 events1 affected25 at risk
EG0140 events0 affected25 at risk
EG0150 events0 affected44 at risk
EG0160 events0 affected25 at risk
EG0170 events0 affected56 at risk
EG0180 events0 affected20 at risk
EG0190 events0 affected26 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected10 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected3 at risk
EG0070 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected6 at risk
EG0100 events0 affected3 at risk
EG0110 events0 affected22 at risk
EG0120 events0 affected16 at risk
EG0130 events0 affected25 at risk
EG0140 events0 affected25 at risk
EG0150 events0 affected44 at risk
EG0160 events0 affected25 at risk
EG0170 events0 affected56 at risk
EG0181 events1 affected20 at risk
EG0190 events0 affected26 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected10 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected6 at risk
EG0100 events0 affected3 at risk
EG0110 events0 affected22 at risk
EG0120 events0 affected16 at risk
EG0130 events0 affected25 at risk
EG0140 events0 affected25 at risk
EG0150 events0 affected44 at risk
EG0160 events0 affected25 at risk
EG0170 events0 affected56 at risk
EG0180 events0 affected20 at risk
EG0191 events1 affected26 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected10 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected6 at risk
EG0100 events0 affected3 at risk
EG0110 events0 affected22 at risk
EG0121 events1 affected16 at risk
EG0130 events0 affected25 at risk
EG0140 events0 affected25 at risk
EG0150 events0 affected44 at risk
EG0160 events0 affected25 at risk
EG0170 events0 affected56 at risk
EG0180 events0 affected20 at risk
EG0190 events0 affected26 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected10 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected6 at risk
EG0100 events0 affected3 at risk
EG0110 events0 affected22 at risk
EG0120 events0 affected16 at risk
EG0130 events0 affected25 at risk
EG0140 events0 affected25 at risk
EG0151 events1 affected44 at risk
EG0160 events0 affected25 at risk
EG0170 events0 affected56 at risk
EG0180 events0 affected20 at risk
EG0190 events0 affected26 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected10 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected6 at risk
EG0101 events1 affected3 at risk
EG0110 events0 affected22 at risk
EG0120 events0 affected16 at risk
EG0130 affected25 at risk
EG0141 events1 affected25 at risk
EG0150 events0 affected44 at risk
EG0160 events0 affected25 at risk
EG0170 events0 affected56 at risk
EG0180 events0 affected20 at risk
EG0190 events0 affected26 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected10 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected6 at risk
EG0100 events0 affected3 at risk
EG0110 events0 affected22 at risk
EG0120 events0 affected16 at risk
EG0130 events0 affected25 at risk
EG0140 events0 affected25 at risk
EG0151 events1 affected44 at risk
EG0160 events0 affected25 at risk
EG0170 events0 affected56 at risk
EG0180 events0 affected20 at risk
EG0190 events0 affected26 at risk
2 events
1 affected
3 at risk
EG0040 events0 affected10 at risk
EG0051 events1 affected11 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected6 at risk
EG0100 events0 affected3 at risk
EG0110 events0 affected22 at risk
EG0120 events0 affected16 at risk
EG0131 events1 affected25 at risk
EG0141 events1 affected25 at risk
EG0152 events2 affected44 at risk
EG0160 events0 affected25 at risk
EG0170 events0 affected56 at risk
EG0180 events0 affected20 at risk
EG0190 events0 affected26 at risk
1 events
1 affected
3 at risk
EG0041 events1 affected10 at risk
EG0051 events1 affected11 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected3 at risk
EG0081 events1 affected3 at risk
EG0091 events1 affected6 at risk
EG0100 events0 affected3 at risk
EG0113 events3 affected22 at risk
EG0124 events4 affected16 at risk
EG0131 events1 affected25 at risk
EG0149 events3 affected25 at risk
EG0150 events0 affected44 at risk
EG0164 events4 affected25 at risk
EG0173 events3 affected56 at risk
EG0180 events0 affected20 at risk
EG0191 events1 affected26 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected10 at risk
EG0051 events1 affected11 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected6 at risk
EG0100 events0 affected3 at risk
EG0110 events0 affected22 at risk
EG0120 events0 affected16 at risk
EG0132 events2 affected25 at risk
EG0143 events3 affected25 at risk
EG0151 events1 affected44 at risk
EG0160 events0 affected25 at risk
EG0177 events7 affected56 at risk
EG0180 events0 affected20 at risk
EG0191 events1 affected26 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected10 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected6 at risk
EG0100 events0 affected3 at risk
EG0110 events0 affected22 at risk
EG0121 events1 affected16 at risk
EG0130 events0 affected25 at risk
EG0140 events0 affected25 at risk
EG0150 events0 affected44 at risk
EG0160 events0 affected25 at risk
EG0170 events0 affected56 at risk
EG0180 events0 affected20 at risk
EG0190 events0 affected26 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected10 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected6 at risk
EG0100 events0 affected3 at risk
EG0110 events0 affected22 at risk
EG0121 events1 affected16 at risk
EG0131 events1 affected25 at risk
EG0140 events0 affected25 at risk
EG0151 events1 affected44 at risk
EG0160 events0 affected25 at risk
EG0171 events1 affected56 at risk
EG0180 events0 affected20 at risk
EG0192 events2 affected26 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected10 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected6 at risk
EG0100 events0 affected3 at risk
EG0110 events0 affected22 at risk
EG0120 events0 affected16 at risk
EG0130 events0 affected25 at risk
EG0140 events0 affected25 at risk
EG0150 events0 affected44 at risk
EG0161 events1 affected25 at risk
EG0170 events0 affected56 at risk
EG0180 events0 affected20 at risk
EG0190 events0 affected26 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected10 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected6 at risk
EG0100 events0 affected3 at risk
EG0111 events1 affected22 at risk
EG0120 events0 affected16 at risk
EG0130 events0 affected25 at risk
EG0140 events0 affected25 at risk
EG0150 events0 affected44 at risk
EG0160 events0 affected25 at risk
EG0170 events0 affected56 at risk
EG0180 events0 affected20 at risk
EG0190 events0 affected26 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected10 at risk
EG0051 events1 affected11 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected6 at risk
EG0100 events0 affected3 at risk
EG0110 events0 affected22 at risk
EG0120 events0 affected16 at risk
EG0130 events0 affected25 at risk
EG0140 events0 affected25 at risk
EG0150 events0 affected44 at risk
EG0160 events0 affected25 at risk
EG0170 events0 affected56 at risk
EG0180 events0 affected20 at risk
EG0190 events0 affected26 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected10 at risk
EG0050 events0 affected11 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected6 at risk
EG0100 events0 affected3 at risk
EG0110 events0 affected22 at risk
EG0120 events0 affected16 at risk
EG0130 events0 affected25 at risk
EG0140 events0 affected25 at risk
EG0150 events0 affected44 at risk
EG0160 events0 affected25 at risk
EG0170 events0 affected56 at risk
EG0181 events1 affected20 at risk
EG0190 events0 affected26 at risk
2
OG0047
OG0056
OG0062
OG0071
OG0080
OG0092
OG0103
OG01115
OG0125
OG01316
OG01410
OG01516
OG01612
OG01733
OG0187
OG01914
3
OG00410
OG00510
OG0063
OG0073
OG0083
OG0096
OG0103
OG01121
OG01215
OG01324
OG01424
OG01538
OG01623
OG01752
OG01816
OG01920
40.921
± 27.7
OG00464.140± 13.2
OG00567.998± 32.2
OG00676.264± 31.7
Participants
OG004
8
ParticipantsOG0054
ParticipantsOG0060
Title
Measurements
OG0005.780± NAGeometric coefficient of variation was not derived as only one participant was evaluated for this arm.
OG00110.892± NAGeometric coefficient of variation was not derived as only one participant was evaluated for this arm.
OG00218.664± NAGeometric coefficient of variation was not derived as only one participant was evaluated for this arm.
OG00339.589± NAGeometric coefficient of variation was not derived as only one participant was evaluated for this arm.
OG00456.842± 23.8
OG00561.161± 10.7
36.526
± 29.7
OG00458.410± 11.6
OG00562.563± 29.7
OG00671.196± 32.5
Participants
OG004
8
ParticipantsOG0054
ParticipantsOG0060
Title
Measurements
OG0005.306± NAGeometric coefficient of variation was not derived as only one participant was evaluated for this arm.
OG0019.157± NAGeometric coefficient of variation was not derived as only one participant was evaluated for this arm.
OG00215.047± NAGeometric coefficient of variation was not derived as only one participant was evaluated for this arm.
OG00336.333± NAGeometric coefficient of variation was not derived as only one participant was evaluated for this arm.
OG00451.541± 21.4
OG00557.759± 11.9
33.005
± 9.4
OG00439.647± 11.4
OG00543.377± 25.6
OG00648.548± 33.0
OG00710.127± 40.2
OG00814.307± 31.6
OG00918.040± 12.0
OG01017.928± 22.0
Participants
OG004
0
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0073
ParticipantsOG0083
ParticipantsOG0096
ParticipantsOG0103
Title
Measurements
OG00714.201± 11.9
OG00816.765± 36.3
OG00918.698± 8.1
OG01018.958± 19.5
Participants
OG004
0
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0073
ParticipantsOG0083
ParticipantsOG0096
ParticipantsOG0101
Title
Measurements
OG00713.172± 8.0
OG00816.166± 37.2
OG00916.991± 7.8
OG01018.500± NAGeometric coefficient of variation was not derived as only one participant was evaluated for this arm.
Participants
OG004
8
ParticipantsOG0054
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0081
ParticipantsOG0091
ParticipantsOG0100
Title
Measurements
OG0006.870± NAGeometric coefficient of variation was not derived as only one participant was evaluated for this arm.
OG00111.000± NAGeometric coefficient of variation was not derived as only one participant was evaluated for this arm.
OG00216.200± NAGeometric coefficient of variation was not derived as only one participant was evaluated for this arm.
OG00332.400± NAGeometric coefficient of variation was not derived as only one participant was evaluated for this arm.
OG00435.890± 17.9
OG00538.928± 9.0
OG00822.400± NAGeometric coefficient of variation was not derived as only one participant was evaluated for this arm.
OG00921.800± NAGeometric coefficient of variation was not derived as only one participant was evaluated for this arm.
Participants
OG004
0
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0081
ParticipantsOG0090
ParticipantsOG0100
Title
Measurements
OG00821.200± NAGeometric coefficient of variation was not derived as only one participant was evaluated for this arm.
Participants
OG004
0
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0081
ParticipantsOG0091
ParticipantsOG0100
Title
Measurements
OG00824.100± NAGeometric coefficient of variation was not derived as only one participant was evaluated for this arm.
OG00922.800± NAGeometric coefficient of variation was not derived as only one participant was evaluated for this arm.
2.307
± 28.3
OG0042.202± 22.2
OG0052.205± 25.4
OG0061.783± 24.3
Participants
OG004
0
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0073
ParticipantsOG0083
ParticipantsOG0096
ParticipantsOG0101
Title
Measurements
OG0073.679± 9.4
OG0083.084± 93.8
OG0093.402± 31.3
OG0102.629± NAGeometric coefficient of variation was not derived as only one participant was evaluated for this arm.
Participants
OG004
8
ParticipantsOG0054
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG0100
Title
Measurements
OG0004.360± NAGeometric coefficient of variation was not derived as only one participant was evaluated for this arm.
OG0014.187± NAGeometric coefficient of variation was not derived as only one participant was evaluated for this arm.
OG0023.000± NAGeometric coefficient of variation was not derived as only one participant was evaluated for this arm.
OG0032.160± NAGeometric coefficient of variation was not derived as only one participant was evaluated for this arm.
OG0042.285± 27.1
OG0052.539± 14.7
Participants
OG004
0
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0081
ParticipantsOG0091
ParticipantsOG0100
Title
Measurements
OG0082.281± NAGeometric coefficient of variation was not derived as only one participant was evaluated for this arm.
OG0093.412± NAGeometric coefficient of variation was not derived as only one participant was evaluated for this arm.
0.033
(0.03 to 0.04)
OG0040.032(0.02 to 0.09)
OG0050.032(0.02 to 0.04)
OG0060.03(0.02 to 0.03)
Participants
OG004
0
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0073
ParticipantsOG0083
ParticipantsOG0096
ParticipantsOG0101
Title
Measurements
OG00714.010(13.96 to 14.88)
OG00814.058(13.98 to 14.08)
OG00914.083(14.00 to 14.19)
OG01013.98(13.98 to 13.98)
Participants
OG004
8
ParticipantsOG0054
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG0100
Title
Measurements
OG0000.04(0.04 to 0.04)
OG0010.03(0.03 to 0.03)
OG0020.04(0.04 to 0.04)
OG0030.030(0.03 to 0.03)
OG0040.036(0.02 to 0.05)
OG0050.042(0.03 to 0.11)
Participants
OG004
0
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0081
ParticipantsOG0091
ParticipantsOG0100
Title
Measurements
OG00814.02(14.02 to 14.02)
OG00913.98(13.98 to 13.98)
1.384
(1.19 to 1.65)
OG0042.004(1.67 to 2.53)
OG0051.810(1.53 to 2.74)
OG0062.153(1.99 to 2.60)
Participants
OG004
0
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0073
ParticipantsOG0083
ParticipantsOG0096
ParticipantsOG0101
Title
Measurements
OG0071.097(0.66 to 1.56)
OG0081.398(0.91 to 1.81)
OG0091.423(0.77 to 1.96)
OG0102.05(2.05 to 2.05)
Participants
OG004
8
ParticipantsOG0054
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG0100
Title
Measurements
OG0000.78(0.78 to 0.78)
OG0011.07(1.07 to 1.07)
OG0021.130(1.13 to 1.13)
OG0031.68(1.68 to 1.68)
OG0042.117(1.55 to 2.90)
OG0052.035(1.38 to 2.74)
Participants
OG004
0
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0081
ParticipantsOG0091
ParticipantsOG0100
Title
Measurements
OG0081.51(1.51 to 1.51)
OG0091.44(1.44 to 1.44)
4.208
± 12.5
OG0046.028± 18.4
OG0055.489± 24.2
OG0065.038± 27.3
Participants
OG004
0
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0073
ParticipantsOG0083
ParticipantsOG0096
ParticipantsOG0101
Title
Measurements
OG00757.736± 10.0
OG00848.001± 91.1
OG00953.436± 28.0
OG01042.708± NAGeometric coefficient of variation was not derived as only one participant was evaluated for this arm.
Participants
OG004
8
ParticipantsOG0054
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG0100
Title
Measurements
OG0004.755± NAGeometric coefficient of variation was not derived as only one participant was evaluated for this arm.
OG0016.288± NAGeometric coefficient of variation was not derived as only one participant was evaluated for this arm.
OG0024.870± NAGeometric coefficient of variation was not derived as only one participant was evaluated for this arm.
OG0034.534± NAGeometric coefficient of variation was not derived as only one participant was evaluated for this arm.
OG0046.072± 24.2
OG0056.656± 22.0
Participants
OG004
0
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0081
ParticipantsOG0091
ParticipantsOG0100
Title
Measurements
OG00836.476± NAGeometric coefficient of variation was not derived as only one participant was evaluated for this arm.
OG00953.085± NAGeometric coefficient of variation was not derived as only one participant was evaluated for this arm.
26549.1
± 82.9
OG00433494.5± 47.1
OG00550459.6± 117.0
OG00648626.4± 95.5
Participants
OG004
8
ParticipantsOG0054
ParticipantsOG0061
Title
Measurements
OG0003248.46± NAGeometric coefficient of variation was not derived as only one participant was evaluated for this arm.
OG0017452.05± NAGeometric coefficient of variation was not derived as only one participant was evaluated for this arm.
OG0024338.20± NAGeometric coefficient of variation was not derived as only one participant was evaluated for this arm.
OG00347093.9± NAGeometric coefficient of variation was not derived as only one participant was evaluated for this arm.
OG00430512.0± 47.8
OG00534188.6± 46.6
OG00616754.5± NAGeometric coefficient of variation was not derived as only one participant was evaluated for this arm.
25549.3
± 80.8
OG00431854.7± 46.4
OG00534659.4± 81.2
OG00638963.5± 65.4
Participants
OG004
8
ParticipantsOG0054
ParticipantsOG0061
Title
Measurements
OG0002642.23± NAGeometric coefficient of variation was not derived as only one participant was evaluated for this arm.
OG0017263.16± NAGeometric coefficient of variation was not derived as only one participant was evaluated for this arm.
OG0024156.66± NAGeometric coefficient of variation was not derived as only one participant was evaluated for this arm.
OG00344553.3± NAGeometric coefficient of variation was not derived as only one participant was evaluated for this arm.
OG00428890.0± 47.4
OG00531429.9± 43.2
OG00616354.3± NAGeometric coefficient of variation was not derived as only one participant was evaluated for this arm.
4036.47
± 81.8
OG0044265.60± 46.1
OG0055154.58± 61.9
OG0065617.89± 34.7
OG007161.140± 75.0
OG008175.315± 159.4
OG009303.977± 45.3
OG010244.623± 48.9
Participants
OG004
0
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0073
ParticipantsOG0083
ParticipantsOG0096
ParticipantsOG0103
Title
Measurements
OG007738.227± 28.2
OG008766.467± 91.4
OG0091982.67± 58.1
OG0101553.93± 86.2
Participants
OG004
0
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0073
ParticipantsOG0083
ParticipantsOG0096
ParticipantsOG0101
Title
Measurements
OG0071715.54± 42.8
OG0082525.75± 54.7
OG0094379.50± 58.2
OG0103720.00± NAGeometric coefficient of variation was not derived as only one participant was evaluated for this arm.
Participants
OG004
8
ParticipantsOG0054
ParticipantsOG0061
ParticipantsOG0070
ParticipantsOG0081
ParticipantsOG0091
ParticipantsOG0100
Title
Measurements
OG000631.000± NAGeometric coefficient of variation was not derived as only one participant was evaluated for this arm.
OG0011200.000± NAGeometric coefficient of variation was not derived as only one participant was evaluated for this arm.
OG002628.000± NAGeometric coefficient of variation was not derived as only one participant was evaluated for this arm.
OG0036500.00± NAGeometric coefficient of variation was not derived as only one participant was evaluated for this arm.
OG0043964.40± 49.4
OG0054127.31± 39.3
OG0062180.00± NAGeometric coefficient of variation was not derived as only one participant was evaluated for this arm.
OG008442.000± NAGeometric coefficient of variation was not derived as only one participant was evaluated for this arm.
OG009558.000± NAGeometric coefficient of variation was not derived as only one participant was evaluated for this arm.
Participants
OG004
0
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0081
ParticipantsOG0090
ParticipantsOG0100
Title
Measurements
OG0081060.00± NAGeometric coefficient of variation was not derived as only one participant was evaluated for this arm.
Participants
OG004
0
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0081
ParticipantsOG0091
ParticipantsOG0100
Title
Measurements
OG0082960.00± NAGeometric coefficient of variation was not derived as only one participant was evaluated for this arm.
OG0095190.00± NAGeometric coefficient of variation was not derived as only one participant was evaluated for this arm.
3555.78
± 90.6
OG0044216.71± 42.0
OG0052971.09± 107.2
OG0062813.05± 35.9
Participants
OG004
0
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0073
ParticipantsOG0083
ParticipantsOG0096
ParticipantsOG0100
Title
Measurements
OG0074819.44± 25.8
OG0084666.23± 35.5
OG0092847.55± 46.7
Participants
OG004
8
ParticipantsOG0054
ParticipantsOG0061
ParticipantsOG0070
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG0100
Title
Measurements
OG0007757.51± NAGeometric coefficient of variation was not derived as only one participant was evaluated for this arm.
OG0016119.12± NAGeometric coefficient of variation was not derived as only one participant was evaluated for this arm.
OG00212908.6± NAGeometric coefficient of variation was not derived as only one participant was evaluated for this arm.
OG0031815.52± NAGeometric coefficient of variation was not derived as only one participant was evaluated for this arm.
OG0044256.44± 50.1
OG0054542.22± 42.8
OG0065849.18± NAGeometric coefficient of variation was not derived as only one participant was evaluated for this arm.
Participants
OG004
0
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0081
ParticipantsOG0091
ParticipantsOG0100
Title
Measurements
OG0083899.39± NAGeometric coefficient of variation was not derived as only one participant was evaluated for this arm.
OG0092507.90± NAGeometric coefficient of variation was not derived as only one participant was evaluated for this arm.