Study of Sacituzumab Govitecan in Participants With Metas... | NCT03964727 | Trialant
NCT03964727
Sponsor
Gilead Sciences
Status
Active, not recruiting
Last Update Posted
Apr 28, 2026Actual
Enrollment
227Actual
Phase
Phase 2
Conditions
Metastatic Solid Tumor
Interventions
Sacituzumab Govitecan-hziy
Countries
United States
Australia
Belgium
Canada
France
Hong Kong
Spain
Taiwan
Protocol Section
Identification Module
NCT ID
NCT03964727
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
IMMU-132-11
Secondary IDs
ID
Type
Description
Link
2019-000579-18
EudraCT Number
2024-513611-28
Other Identifier
European Medicines Agency
Brief Title
Study of Sacituzumab Govitecan in Participants With Metastatic Solid Tumors
Official Title
A Phase 2 Open-Label Study of Sacituzumab Govitecan (IMMU-132) in Subjects With Metastatic Solid Tumors
Acronym
TROPiCS-03
Organization
Gilead SciencesINDUSTRY
Status Module
Record Verification Date
Apr 2026
Overall Recruitment Status or Expanded Access Status
Active, not recruiting
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Oct 15, 2019Actual
Primary Completion Date
Jan 15, 2025Actual
Completion Date
Dec 2026Estimated
First Submitted Date
Apr 29, 2019
First Submission Date that Met QC Criteria
May 24, 2019
First Posted Date
May 28, 2019Actual
Results Waived
Not provided
Results First Submitted Date
Jan 14, 2026
Results First Submitted that Met QC Criteria
Jan 14, 2026
Results First Posted Date
Jan 30, 2026Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Apr 9, 2026
Last Update Posted Date
Apr 28, 2026Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Gilead SciencesINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The goal of this clinical study is to learn more about the study drug, sacituzumab govitecan-hziy, in participants with metastatic (cancer that has spread) solid tumors.
Based on protocol amendment 1, participants with non-small cell lung cancer (NSCLC) subtypes such as adenocarcinoma and SCC with high trophoblast cell-surface antigen 2 (Trop-2) expression will receive sacituzumab govitecan-hziy (SG) 10 mg/kg of body weight, administered as a slow intravenous (IV) infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria will be met.
Drug: Sacituzumab Govitecan-hziy
Cohort 1 Group 2: NSCLC (Adenocarcinoma)
Experimental
Based on protocol amendment 2 or 3, participants with NSCLC subtype of adenocarcinoma with or without high Trop-2 expression will receive SG 10 mg/kg of body weight, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria will be met.
Drug: Sacituzumab Govitecan-hziy
Cohort 1 Group 3: NSCLC (SCC)
Experimental
Based on protocol amendment 2 or 3, participants with NSCLC subtype of SCC with or without high Trop-2 expression will receive SG 10 mg/kg of body weight, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria will be met.
Drug: Sacituzumab Govitecan-hziy
Cohort 2: Head And Neck Squamous Cell Carcinoma (HNSCC)
Objective Response Rate (ORR) According to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 by Investigator's Assessment
ORR was defined as the percentage of participants who had the best overall response of either complete response (CR) or partial response (PR). Responses are based on the investigator-assessed tumor response using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) criteria for each histologic cohort. CR: Disappearance of all target and non-target lesions; and normalization of tumor marker levels initially above upper limits of normal; PR: >30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. The ORR rate was calculated with a two-sided exact 95% CI using the Clopper-Pearson method. Percentages are rounded off.
Cohort 1: Up to 5.3 years; Cohort 2: Up to 3.4 years; Cohort 3: Up to 3.3 years; Cohort 4: Up to 2.5 years
Secondary Outcomes
Measure
Description
Time Frame
ORR According to RECIST 1.1 by Blinded Independent Central Review (BICR) Assessment
ORR was defined as the percentage of participants who had the best overall response of either CR or PR. Responses are based on BICR assessment using RECIST 1.1 criteria for each histologic cohort. CR: Disappearance of all target and non-target lesions; and normalization of tumor marker levels initially above upper limits of normal; PR: >30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. The ORR rate was calculated with a two-sided exact 95% CI using the Clopper-Pearson method.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Key Inclusion Criteria:
Individuals with the following histologically documented metastatic (M1, Stage IV) or locally advanced solid tumors
NSCLC [adenocarcinoma or squamous cell carcinoma (SCC)] that has progressed after prior platinum-based chemotherapy and programmed death-(ligand) 1 (PD-(L)1) directed therapy
HNSCC that has progressed after prior platinum-based chemotherapy and anti-PD-(L)1 directed therapy No more than 3 prior lines of systemic treatment is allowed
Endometrial carcinoma that has progressed after prior platinum-based chemotherapy and anti-PD-(L)1 directed therapy No more than 3 prior lines of systemic treatment is allowed.
Extensive stage SCLC that has progressed after prior platinum-based chemotherapy and PD-(L)1 directed therapy. No more than one prior line of systemic treatment is allowed (re-challenge with the same initial regimen is not allowed)
Eastern Cooperative Oncology Group (ECOG) Performance status score of 0 or 1
Adequate hematologic counts without transfusional or growth factor support within 2 weeks of study drug initiation
Adequate hepatic and renal function [Creatinine Clearance (CrCl) ≥30mL/min]
Individual must have at least a 3-month life expectancy
Have measurable disease by Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) as per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria
Key Exclusion Criteria:
Have had a prior anti-cancer biologic agent within 4 weeks prior to study Day 1 or have had prior chemotherapy, targeted small molecule therapy, radiation therapy within 2 weeks prior to Study Day 1
Have not recovered (i.e., ≤ Grade 1) from adverse events due to a previously administered agent
Have previously received topoisomerase I inhibitors
Have an active second malignancy
Have known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Individuals with previously treated brain metastases may participate provided they have stable CNS disease for at least 4 weeks prior to the first dose of study drug and all neurologic symptoms have returned to baseline, have no evidence of new or enlarging brain metastases and are taking ≤20 mg/day of prednisone or its equivalent. All individuals with carcinomatous meningitis are excluded regardless of clinical stability
Additional cohort specific exclusion criteria
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Gilead Study Director
Gilead Sciences
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Alaska Oncology & Hematology, LLC
Anchorage
Alaska
99508
United States
USOR - Arizona Oncology - Glendale - Saguaro Cancer Center
396 participants were screened. Data submitted represent primary analysis performed on data collected by the Primary Completion Date. Complete data will be submitted within 1 year of the study completion date.
Recruitment Details
Participants were enrolled at study sites in the United States, France, Australia, Hong Kong, Spain, Taiwan, Canada, and Belgium.
Based on protocol amendment 1, participants with non-small cell lung cancer (NSCLC) subtypes such as adenocarcinoma and SCC with high trophoblast cell-surface antigen 2 (Trop-2) expression received sacituzumab govitecan-hziy (SG) 10 mg/kg of body weight, administered as a slow intravenous (IV) infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria was met (up to 22.1 months).
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
Dec 17, 2024
Dec 2, 2025
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Non-Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
Experimental
Participants with HNSCC will receive SG 10 mg/kg of body weight, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria will be met.
Drug: Sacituzumab Govitecan-hziy
Cohort 3: Endometrial Cancer (EC)
Experimental
Participants with EC will receive SG 10 mg/kg of body weight, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria will be met.
Drug: Sacituzumab Govitecan-hziy
Cohort 4: Extensive-Stage Small Cell Lung Cancer (ES-SCLC)
Experimental
Participants with ES-SCLC will receive SG 10 mg/kg of body weight, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria will be met.
Drug: Sacituzumab Govitecan-hziy
Cohort 1 Group 3: NSCLC (SCC)
Cohort 2: Head And Neck Squamous Cell Carcinoma (HNSCC)
Cohort 3: Endometrial Cancer (EC)
Cohort 4: Extensive-Stage Small Cell Lung Cancer (ES-SCLC)
IMMU-132
GS-0132
Cohort 1: Up to 5.3 years; Cohort 2: Up to 3.4 years; Cohort 3: Up to 3.3 years; Cohort 4: Up to 2.5 years
Duration of Response (DOR) According to RECIST 1.1 by BICR Assessment
DOR was the date of the first evaluation showing documented response, either PR or CR, to date of the first progression of disease (PD) or death from any cause,whichever comes first. Response are according to RECIST 1.1 by BICR for each histological cohort. CR: Disappearance of all target and non-target lesions; and normalization of tumor marker levels initially above upper limits of normal;PR: >30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. Disease progression was defined as an increase of >20% in the sum of diameters of target lesions, taking as reference the smallest sum on study(this includes the baseline sum if that is the smallest on study). In addition, the sum must also demonstrate an absolute increase of more than 5 mm or the appearance of ≥ 1 new non-target lesions and/or unequivocal progression of existing non-target lesions. DOR was estimated using Kaplan-Meier estimate. The 95% CI was computed by Brookmeyer-Crowley method.
Cohort 1: Up to 5.3 years; Cohort 2: Up to 3.4 years; Cohort 3: Up to 3.3 years; Cohort 4: Up to 2.5 years
Clinical Benefit Rate (CBR) According to RECIST 1.1 by BICR Assessment
CBR was percentage of participants with best overall response of CR, PR,or durable stable disease (SD) (SD ≥ 6 months after first dose). Responses are according to RECIST 1.1 by BICR.CR: Disappearance of all target and non-target lesions;& normalization of tumor marker levels initially above upper limits of normal;PR:>30% decrease in sum of LD of target lesions, taking as reference the baseline sum LD. SD:Neither sufficient shrinkage for PR nor sufficient increase for PD, taking reference of smallest sum LD since treatment started or ≥ 1 non-target lesions with maintenance of tumor marker level above normal limits.PD: Increase of >20% in sum of diameters of target lesions, taking reference of smallest sum(this includes baseline sum if smallest on study), the sum must also demonstrate an absolute increase of more than 5 mm or of ≥ 1 new non-target lesions and/or unequivocal progression of existing non-target lesions. Two-sided CI was based on Clopper-Pearson method.
Cohort 1: Up to 5.3 years; Cohort 2: Up to 3.4 years; Cohort 3: Up to 3.3 years; Cohort 4: Up to 2.5 years
Progression-free Survival (PFS) According to RECIST 1.1 by BICR Assessment
PFS was defined as the time from the first dose until objective tumor progression or death from any cause, whichever comes first. Responses are according to RECIST 1.1 by BICR. Disease progression was defined as an increase of >20% in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition, the sum must also demonstrate an absolute increase of more than 5 mm or the appearance ≥ 1 new non-target lesions and/or unequivocal progression of existing non-target lesions. PFS was estimated using Kaplan-Meier estimate. The 95% CI for median was computed by Brookmeyer-Crowley method.
Cohort 1: Up to 5.3 years; Cohort 2: Up to 3.4 years; Cohort 3: Up to 3.3 years; Cohort 4: Up to 2.5 years
DOR According to RECIST 1.1 by Investigator's Assessment
DOR was the date of the first evaluation showing documented response, either PR or CR, to date of the first PD or death from any cause, whichever comes first. Responses are based on investigator-assessed tumor response by RECIST 1.1 criteria for each histological cohort.CR:Disappearance of all target and non-target lesions;and normalization of tumor marker levels initially above upper limits of normal;PR:>30% decrease in the sum of the LD of target lesions,taking as reference the baseline sum LD. Disease progression was defined as increase of >20% in sum of diameters of target lesions, taking as reference the smallest sum on study(this includes the baseline sum if that is the smallest on study).In addition, the sum must also demonstrate an absolute increase of more than 5 mm or the appearance of ≥ 1 new non-target lesions and/or unequivocal progression of existing non-target lesions. DOR was estimated using Kaplan-Meier estimate. The 95% CI was computed by Brookmeyer-Crowley method.
Cohort 1: Up to 5.3 years; Cohort 2: Up to 3.4 years; Cohort 3: Up to 3.3 years; Cohort 4: Up to 2.5 years
CBR According to RECIST 1.1 by Investigator's Assessment
CBR was the percentage of participants with the best overall response of CR, PR,or durable SD (SD ≥ 6 months after first dose) by investigator-assessed tumor response using RECIST 1.1 criteria.CR:Disappearance of all target and non-target lesions;& normalization of tumor marker levels initially above upper limits of normal;PR:>30% decrease in sum of LD of target lesions,taking as reference the baseline sum LD. SD:Neither sufficient shrinkage for PR nor sufficient increase for PD,taking reference of smallest sum LD since treatment started or ≥ 1 non-target lesions with maintenance of tumor marker level above normal limits.PD: Increase of >20% in sum of diameters of target lesions,taking reference of smallest sum(this includes baseline sum if smallest on study),the sum must also demonstrate an absolute increase of more than 5 mm or of ≥ 1 new non-target lesions and/or unequivocal progression of existing non-target lesions.Two-sided CI was based on Clopper-Pearson method.
Cohort 1: Up to 5.3 years; Cohort 2: Up to 3.4 years; Cohort 3: Up to 3.3 years; Cohort 4: Up to 2.5 years
PFS According to RECIST 1.1 by Investigator's Assessment
PFS was defined as the time from the first dose until objective tumor progression or death from any cause, whichever comes first. Responses are based on the investigator-assessed tumor response using RECIST 1.1 criteria. Disease progression was defined as an increase of >20% in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition, the sum must also demonstrate an absolute increase of more than 5 mm or the appearance ≥ 1 new non-target lesions and/or unequivocal progression of existing non-target lesions. PFS was estimated using Kaplan-Meier estimate. The 95% CI for median was computed by Brookmeyer-Crowley method.
Cohort 1: Up to 5.3 years; Cohort 2: Up to 3.4 years; Cohort 3: Up to 3.3 years; Cohort 4: Up to 2.5 years
Overall Survival (OS)
OS was defined as the interval from the first dose date of drug to death from any cause. OS was estimated using Kaplan-Meier estimate. The 95% CI for median was computed by Brookmeyer-Crowley method.
Cohort 1: Up to 5.3 years; Cohort 2: Up to 3.4 years; Cohort 3: Up to 3.3 years; Cohort 4: Up to 2.5 years
Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs)
A TEAE was defined as any AE with an onset date on or after the study drug start date and no later than 30 days after last dose of study drug or the day before initiation of subsequent therapy, whichever comes first.
Up to 7.2 years
Percentage of Participants Experiencing Clinically Significant Laboratory Abnormalities
A treatment-emergent laboratory abnormality was defined as any value that increased at least 1 toxicity grade from baseline during the treatment-emergent period.
Up to 7.2 years
Pharmacokinetic (PK) Parameter: Cmax of Total SN-38
Cmax was defined as the maximum observed concentration of total SN-38 (the active metabolite of sacituzumab Govitecan-hziy). Cycle length=21 days.
Cohort 1: Post dose: Day 1 of Cycles 1,2,3,7,11,17,23,29,35,41,47; Cohort 2: Post dose: Day 1 of Cycles 1,2,3,7,11,17; Cohort 3: Post dose: Day 1 of Cycles 1,2,3,7,11,17,23,29,35,41,47,53; Cohort 4: Post dose: Day 1 of Cycles 1,2,3,7,11,17,23,29
PK Parameter: Cmax of Free SN-38
Cmax was defined as the maximum observed concentration of free SN-38 (the active metabolite of sacituzumab Govitecan-hziy). Cycle length=21 days.
Cohort 1: Post dose: Day 1 of Cycles 1,2,3,7,11,17,23,29,35,41,47; Cohort 2: Post dose: Day 1 of Cycles 1,2,3,7,11,17; Cohort 3: Post dose: Day 1 of Cycles 1,2,3,7,11,17,23,29,35,41,47,53; Cohort 4: Post dose: Day 1 of Cycles 1,2,3,7,11,17,23,29
PK Parameter: Cmax of Total Antibody
Cmax was defined as the maximum observed concentration of total antibody of SG [hRS7 immunoglobulin (IgG) and hRS7-SN-38]. Cycle length=21 days.
Cohort 1: Post dose: Day 1 of Cycles 1,2,3,7,11,17,23,29,35,41,47; Cohort 2: Post dose: Day 1 of Cycles 1,2,3,7,11,17; Cohort 3: Post dose: Day 1 of Cycles 1,2,3,7,11,17,23,29,35,41,47,53; Cohort 4: Post dose: Day 1 of Cycles 1,2,3,7,11,17,23,29
PK Parameter: Ctrough of Total SN-38
Ctrough was defined as concentration at the end of the dosing interval of total SN-38 (the active metabolite of sacituzumab Govitecan-hziy).
Cycle length=21 days; C=Cohort; D=Day; EOT=End of Treatment; PD=predose; SFU=Safety Follow-up (up to 30 days after EOT date)
University of Colorado Hospital - Anschutz Cancer Pavilion
Aurora
Colorado
80045
United States
Smilow Cancer Hospital at Yale
New Haven
Connecticut
06520
United States
SIU School of Medicine, Simmons Cancer Institute at SIU
Springfield
Illinois
62702
United States
PathGroup Labs, LLC
Fort Wayne
Indiana
46804
United States
Parkview Research Center
Fort Wayne
Indiana
46845
United States
University of Kentucky Medical Center
Lexington
Kentucky
40536
United States
Christus Highland Cancer Treatment Center
Shreveport
Louisiana
71105
United States
University of Michigan Rogel Cancer Center
Ann Arbor
Michigan
48109
United States
Karmanos Cancer Institute
Detroit
Michigan
48201
United States
North Mississippi Medical Center - Hematology and Oncology - Tupelo
Tupelo
Mississippi
38801
United States
Washington University School of Medicine - Siteman Cancer Center
St Louis
Missouri
63110
United States
David C. Pratt Center
St Louis
Missouri
63141
United States
Comprehensive Cancer of Nevada
Las Vegas
Nevada
89052
United States
New York Oncology Hematology - Albany Medical Center
Albany
New York
12208
United States
Memorial Sloan Kettering Cancer Center
New York
New York
10065
United States
Weill Cornell Medicine - Upper East Side
New York
New York
10065
United States
Montefiore Medical Center
The Bronx
New York
10467
United States
University Hospitals Cleveland Medical Center
Cleveland
Ohio
44106
United States
Willamette Valley Cancer Institute and Research Center - Eugene
Eugene
Oregon
97401
United States
Tennessee Oncology, PLLC
Nashville
Tennessee
37203
United States
The University of Texas MD Anderson Cancer Center
Houston
Texas
77030
United States
Texas Oncology - Tyler
Tyler
Texas
75702
United States
Blue Ridge Cancer Care - Wytheville
Blacksburg
Virginia
24060
United States
Virginia Cancer Specialists, PC
Fairfax
Virginia
22031
United States
Providence Regional Cancer Partnership
Everett
Washington
98201
United States
Southern Highlands Cancer Center
Bowral
New South Wales
2576
Australia
Macquarie University
North Ryde
New South Wales
2109
Australia
Calvary Mater Newcastle Hospital
Waratah
New South Wales
2298
Australia
Blacktown Hospital
Westmead
New South Wales
2145
Australia
Pindara Private Hospital
Benowa
Queensland
4217
Australia
Mater Cancer Centre, Mater Misericordiae Limited
South Brisbane
Queensland
4101
Australia
Lyell McEwin Hospital
Elizabeth Vale
South Australia
5112
Australia
Monash Medical Centre, Monash Health
Clayton
Victoria
3168
Australia
The Andrew Love Cancer Centre, Geelong Hospital
Geelong
Victoria
3220
Australia
Cliniques Universitaires UCL Saint-Luc
Brussels
1200
Belgium
Grand Hopital de Charleroi asbl (GHdC)
Charleroi
6000
Belgium
Cross Cancer Institute
Edmonton
T6G 1Z2
Canada
London Health Sciences Centre- Victoria Hospital
London
N6A 5W9
Canada
Jewish General Hospital
Montreal
H3T 1E2
Canada
The Ottawa Hospital
Ottawa
K1H 8L6
Canada
Institut Bergonie
Bordeaux
33000
France
Centre George Francois Leclerc
Dijon
21000
France
Institut Claudius Régaud - IUCT Oncopole
Toulouse
31059
France
Institut Gustave Roussy
Villejuif
94805
France
Hong Kong Integrated Oncology Centre
Central
Hong Kong
Hong Kong Sanatorium & Hospital
Happy Valley
Hong Kong
Queen Mary Hospital
Hong Kong
Hong Kong
Hong Kong United Oncology Center
Kowloon
Hong Kong
Department of Clinical Oncology, The Chinese University of Hong Kong, Prince of Wales Hospital
Shatin
Hong Kong
Hospital de la Santa Creu i Sant Pau
Barcelona
08041
Spain
Institut Català d'Oncologia
Barcelona
08908
Spain
Hospital Universitari Vall d'Hebron
Barcelona
8035
Spain
Hospital Universitario 12 de Octubre
Madrid
28041
Spain
Hospital Clínico Universitario de Valencia
Valencia
46010
Spain
Changhua Christian Hospital
Changhua
Taiwan
Taipei TzuChi Hospital
New Taipei City
Taiwan
Chi Mei Medical Center
Tainan
Taiwan
National Cheng Kung University Hospital
Tainan
Taiwan
Chang Gung Medical Foundation, Linkou Chang Gung Memorial Hospital
Taoyuan City
33305
Taiwan
Background
Michel L, Jimeno A, Sukari A, Beck JT, Chiu J, Ahern E, Hilton J, Even C, Zanetta S, Mekan S, Patel J, Wu T, Dumbrava EE. Sacituzumab Govitecan in Patients with Relapsed/Refractory Advanced Head and Neck Squamous Cell Carcinoma: Results from the Phase II TROPiCS-03 Basket Study. Clin Cancer Res. 2025 Mar 3;31(5):832-838. doi: 10.1158/1078-0432.CCR-24-2523.
Dowlati A, Chiang AC, Cervantes A, Babu S, Hamilton E, Wong SF, Tazbirkova A, Sullivan IG, van Marcke C, Italiano A, Patel J, Mekan S, Wu T, Waqar SN. Phase 2 Open-Label Study of Sacituzumab Govitecan as Second-Line Therapy in Patients With Extensive-Stage SCLC: Results From TROPiCS-03. J Thorac Oncol. 2025 Jun;20(6):799-808. doi: 10.1016/j.jtho.2024.12.028. Epub 2025 Jan 2.
FG001
Cohort 1 Group 2: NSCLC (Adenocarcinoma)
Based on protocol amendment 2 or 3, participants with NSCLC subtype of adenocarcinoma with or without high Trop-2 expression received SG 10 mg/kg of body weight, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria was met (up to 38.7 months).
FG002
Cohort 1 Group 3: NSCLC (SCC)
Based on protocol amendment 2 or 3, participants with NSCLC subtype of SCC with or without high Trop-2 expression received SG 10 mg/kg of body weight, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria was met (up to 20.7 months).
FG003
Cohort 2: Head And Neck Squamous Cell Carcinoma (HNSCC)
Participants with HNSCC received SG 10 mg/kg of body weight, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria was met (up to 12.3 months).
FG004
Cohort 3: Endometrial Cancer (EC)
Participants with EC received SG 10 mg/kg of body weight, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria was met (up to 40.0 months).
FG005
Cohort 4: Extensive-Stage Small Cell Lung Cancer (ES-SCLC)
Participants with ES-SCLC received SG 10 mg/kg of body weight, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria was met (up to 29.3 months).
FG00031 subjects
FG00134 subjects
FG00231 subjects
FG00343 subjects
FG00441 subjects
FG00543 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
NOT COMPLETED
FG00031 subjects
FG00134 subjects
FG00231 subjects
FG00343 subjects
FG00441 subjects
FG00543 subjects
Type
Comment
Reasons
Death
FG00014 subjects
FG00123 subjects
FG00225 subjects
FG00331 subjects
FG00428 subjects
FG00532 subjects
Still on study
FG0000 subjects
FG0016 subjects
FG0022 subjects
FG0034 subjects
FG004
Reason not specified
FG00016 subjects
FG0013 subjects
FG0021 subjects
FG0030 subjects
FG004
Withdrawal by Subject
FG0001 subjects
FG0012 subjects
FG0023 subjects
FG0037 subjects
FG004
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG004
The Safety Analysis Set included all participants who received at least 1 dose of SG.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Cohort 1 Group 1: NSCLC [Adenocarcinoma + SCC]
Based on protocol amendment 1, participants with NSCLC subtypes such as adenocarcinoma and SCC with high Trop-2 expression received SG 10 mg/kg, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria was met (up to 22.1 months).
BG001
Cohort 1 Group 2: NSCLC (Adenocarcinoma)
Based on protocol amendment 2 or 3, participants with NSCLC subtype of adenocarcinoma with or without high Trop-2 expression received SG 10 mg/kg, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria was met (up to 38.7 months).
BG002
Cohort 1 Group 3: NSCLC (SCC)
Based on protocol amendment 2 or 3, participants with NSCLC subtype of SCC with or without high Trop-2 expression received SG 10 mg/kg, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria was met (up to 20.7 months).
BG003
Cohort 2: HNSCC
Participants with HNSCC received SG 10 mg/kg, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria was met (up to 12.3 months).
BG004
Cohort 3: EC
Participants with EC received SG 10 mg/kg, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria was met (up to 40.0 months).
BG005
Cohort 4: ES-SCLC
Participants with ES-SCLC received SG 10 mg/kg, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria was met (up to 29.3 months).
BG006
Total~(N=223)
Denominators
Units
Counts
Participants
BG00031
BG00134
BG00231
BG00343
BG00441
BG00543
BG006223
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Categorical
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
<=18 years
BG0000
BG0010
BG0020
BG003
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00065± 8.7
BG00164± 10.5
BG002
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00015
BG00119
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0000
BG0012
BG002
Race/Ethnicity, Customized
Count of Participants
Participants
Title
Denominators
Categories
Race
Title
Measurements
White
BG00023
BG00126
BG002
Region of Enrollment
Count of Participants
Participants
Title
Denominators
Categories
United States
Title
Measurements
BG00031
BG00132
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
Objective Response Rate (ORR) According to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 by Investigator's Assessment
ORR was defined as the percentage of participants who had the best overall response of either complete response (CR) or partial response (PR). Responses are based on the investigator-assessed tumor response using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) criteria for each histologic cohort. CR: Disappearance of all target and non-target lesions; and normalization of tumor marker levels initially above upper limits of normal; PR: >30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. The ORR rate was calculated with a two-sided exact 95% CI using the Clopper-Pearson method. Percentages are rounded off.
The Full Analysis Set included all participants who received at least 1 dose of SG.
Posted
Number
95% Confidence Interval
percentage of participants
Cohort 1: Up to 5.3 years; Cohort 2: Up to 3.4 years; Cohort 3: Up to 3.3 years; Cohort 4: Up to 2.5 years
ID
Title
Description
OG000
Cohort 1 Group 1: NSCLC [Adenocarcinoma + SCC]
Based on protocol amendment 1, participants with NSCLC subtypes such as adenocarcinoma and SCC with high Trop-2 expression received SG 10 mg/kg, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria was met (up to 22.1 months).
OG001
Cohort 1 Group 2: NSCLC (Adenocarcinoma)
Based on protocol amendment 2 or 3, participants with NSCLC subtype of adenocarcinoma with or without high Trop-2 expression received SG 10 mg/kg, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria was met (up to 38.7 months).
OG002
Cohort 1 Group 3: NSCLC (SCC)
Based on protocol amendment 2 or 3, participants with NSCLC subtype of SCC with or without high Trop-2 expression received SG 10 mg/kg, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria was met (up to 20.7 months).
OG003
Cohort 2: HNSCC
Participants with HNSCC received SG 10 mg/kg, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria was met (up to 12.3 months).
OG004
Cohort 3: EC
Participants with EC received SG 10 mg/kg, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria was met (up to 40.0 months).
OG005
Cohort 4: ES-SCLC
Participants with ES-SCLC received SG 10 mg/kg, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria was met (up to 29.3 months).
Units
Counts
Participants
OG00031
OG00134
OG00231
OG003
Title
Denominators
Categories
Title
Measurements
OG00012.9(3.6 to 29.8)
OG0015.9(0.7 to 19.7)
OG0026.5(0.8 to 21.4)
OG003
Secondary
ORR According to RECIST 1.1 by Blinded Independent Central Review (BICR) Assessment
ORR was defined as the percentage of participants who had the best overall response of either CR or PR. Responses are based on BICR assessment using RECIST 1.1 criteria for each histologic cohort. CR: Disappearance of all target and non-target lesions; and normalization of tumor marker levels initially above upper limits of normal; PR: >30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. The ORR rate was calculated with a two-sided exact 95% CI using the Clopper-Pearson method.
Participants in the Full Analysis Set were analyzed.
Posted
Number
95% Confidence Interval
percentage of participants
Cohort 1: Up to 5.3 years; Cohort 2: Up to 3.4 years; Cohort 3: Up to 3.3 years; Cohort 4: Up to 2.5 years
ID
Title
Description
OG000
Cohort 1 Group 1: NSCLC [Adenocarcinoma + SCC]
Based on protocol amendment 1, participants with NSCLC subtypes such as adenocarcinoma and SCC with high Trop-2 expression received SG 10 mg/kg, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria was met (up to 22.1 months).
OG001
Cohort 1 Group 2: NSCLC (Adenocarcinoma)
Based on protocol amendment 2 or 3, participants with NSCLC subtype of adenocarcinoma with or without high Trop-2 expression received SG 10 mg/kg, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria was met (up to 38.7 months).
Secondary
Duration of Response (DOR) According to RECIST 1.1 by BICR Assessment
DOR was the date of the first evaluation showing documented response, either PR or CR, to date of the first progression of disease (PD) or death from any cause,whichever comes first. Response are according to RECIST 1.1 by BICR for each histological cohort. CR: Disappearance of all target and non-target lesions; and normalization of tumor marker levels initially above upper limits of normal;PR: >30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. Disease progression was defined as an increase of >20% in the sum of diameters of target lesions, taking as reference the smallest sum on study(this includes the baseline sum if that is the smallest on study). In addition, the sum must also demonstrate an absolute increase of more than 5 mm or the appearance of ≥ 1 new non-target lesions and/or unequivocal progression of existing non-target lesions. DOR was estimated using Kaplan-Meier estimate. The 95% CI was computed by Brookmeyer-Crowley method.
Participants in the Full Analysis Set who achieved confirmed CR or PR/with objective response were analyzed.
Posted
Median
95% Confidence Interval
months
Cohort 1: Up to 5.3 years; Cohort 2: Up to 3.4 years; Cohort 3: Up to 3.3 years; Cohort 4: Up to 2.5 years
ID
Title
Description
OG000
Cohort 1 Group 1: NSCLC [Adenocarcinoma + SCC]
Based on protocol amendment 1, participants with NSCLC subtypes such as adenocarcinoma and SCC with high Trop-2 expression received SG 10 mg/kg, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria was met (up to 22.1 months).
Secondary
Clinical Benefit Rate (CBR) According to RECIST 1.1 by BICR Assessment
CBR was percentage of participants with best overall response of CR, PR,or durable stable disease (SD) (SD ≥ 6 months after first dose). Responses are according to RECIST 1.1 by BICR.CR: Disappearance of all target and non-target lesions;& normalization of tumor marker levels initially above upper limits of normal;PR:>30% decrease in sum of LD of target lesions, taking as reference the baseline sum LD. SD:Neither sufficient shrinkage for PR nor sufficient increase for PD, taking reference of smallest sum LD since treatment started or ≥ 1 non-target lesions with maintenance of tumor marker level above normal limits.PD: Increase of >20% in sum of diameters of target lesions, taking reference of smallest sum(this includes baseline sum if smallest on study), the sum must also demonstrate an absolute increase of more than 5 mm or of ≥ 1 new non-target lesions and/or unequivocal progression of existing non-target lesions. Two-sided CI was based on Clopper-Pearson method.
Participants in the Full Analysis Set were analyzed.
Posted
Number
95% Confidence Interval
percentage of participants
Cohort 1: Up to 5.3 years; Cohort 2: Up to 3.4 years; Cohort 3: Up to 3.3 years; Cohort 4: Up to 2.5 years
ID
Title
Description
OG000
Cohort 1 Group 1: NSCLC [Adenocarcinoma + SCC]
Based on protocol amendment 1, participants with NSCLC subtypes such as adenocarcinoma and SCC with high Trop-2 expression received SG 10 mg/kg, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria was met (up to 22.1 months).
Secondary
Progression-free Survival (PFS) According to RECIST 1.1 by BICR Assessment
PFS was defined as the time from the first dose until objective tumor progression or death from any cause, whichever comes first. Responses are according to RECIST 1.1 by BICR. Disease progression was defined as an increase of >20% in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition, the sum must also demonstrate an absolute increase of more than 5 mm or the appearance ≥ 1 new non-target lesions and/or unequivocal progression of existing non-target lesions. PFS was estimated using Kaplan-Meier estimate. The 95% CI for median was computed by Brookmeyer-Crowley method.
Participants in the Full Analysis Set were analyzed.
Posted
Median
95% Confidence Interval
months
Cohort 1: Up to 5.3 years; Cohort 2: Up to 3.4 years; Cohort 3: Up to 3.3 years; Cohort 4: Up to 2.5 years
ID
Title
Description
OG000
Cohort 1 Group 1: NSCLC [Adenocarcinoma + SCC]
Based on protocol amendment 1, participants with NSCLC subtypes such as adenocarcinoma and SCC with high Trop-2 expression received SG 10 mg/kg, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria was met (up to 22.1 months).
OG001
Cohort 1 Group 2: NSCLC (Adenocarcinoma)
Secondary
DOR According to RECIST 1.1 by Investigator's Assessment
DOR was the date of the first evaluation showing documented response, either PR or CR, to date of the first PD or death from any cause, whichever comes first. Responses are based on investigator-assessed tumor response by RECIST 1.1 criteria for each histological cohort.CR:Disappearance of all target and non-target lesions;and normalization of tumor marker levels initially above upper limits of normal;PR:>30% decrease in the sum of the LD of target lesions,taking as reference the baseline sum LD. Disease progression was defined as increase of >20% in sum of diameters of target lesions, taking as reference the smallest sum on study(this includes the baseline sum if that is the smallest on study).In addition, the sum must also demonstrate an absolute increase of more than 5 mm or the appearance of ≥ 1 new non-target lesions and/or unequivocal progression of existing non-target lesions. DOR was estimated using Kaplan-Meier estimate. The 95% CI was computed by Brookmeyer-Crowley method.
Participants in the Full Analysis Set who achieved confirmed CR or PR/with objective response were analyzed.
Posted
Median
95% Confidence Interval
months
Cohort 1: Up to 5.3 years; Cohort 2: Up to 3.4 years; Cohort 3: Up to 3.3 years; Cohort 4: Up to 2.5 years
ID
Title
Description
OG000
Cohort 1 Group 1: NSCLC [Adenocarcinoma + SCC]
Based on protocol amendment 1, participants with NSCLC subtypes such as adenocarcinoma and SCC with high Trop-2 expression received SG 10 mg/kg, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria was met (up to 22.1 months).
Secondary
CBR According to RECIST 1.1 by Investigator's Assessment
CBR was the percentage of participants with the best overall response of CR, PR,or durable SD (SD ≥ 6 months after first dose) by investigator-assessed tumor response using RECIST 1.1 criteria.CR:Disappearance of all target and non-target lesions;& normalization of tumor marker levels initially above upper limits of normal;PR:>30% decrease in sum of LD of target lesions,taking as reference the baseline sum LD. SD:Neither sufficient shrinkage for PR nor sufficient increase for PD,taking reference of smallest sum LD since treatment started or ≥ 1 non-target lesions with maintenance of tumor marker level above normal limits.PD: Increase of >20% in sum of diameters of target lesions,taking reference of smallest sum(this includes baseline sum if smallest on study),the sum must also demonstrate an absolute increase of more than 5 mm or of ≥ 1 new non-target lesions and/or unequivocal progression of existing non-target lesions.Two-sided CI was based on Clopper-Pearson method.
Participants in the Full Analysis Set were analyzed.
Posted
Number
95% Confidence Interval
percentage of participants
Cohort 1: Up to 5.3 years; Cohort 2: Up to 3.4 years; Cohort 3: Up to 3.3 years; Cohort 4: Up to 2.5 years
ID
Title
Description
OG000
Cohort 1 Group 1: NSCLC [Adenocarcinoma + SCC]
Based on protocol amendment 1, participants with NSCLC subtypes such as adenocarcinoma and SCC with high Trop-2 expression received SG 10 mg/kg, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria was met (up to 22.1 months).
Secondary
PFS According to RECIST 1.1 by Investigator's Assessment
PFS was defined as the time from the first dose until objective tumor progression or death from any cause, whichever comes first. Responses are based on the investigator-assessed tumor response using RECIST 1.1 criteria. Disease progression was defined as an increase of >20% in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition, the sum must also demonstrate an absolute increase of more than 5 mm or the appearance ≥ 1 new non-target lesions and/or unequivocal progression of existing non-target lesions. PFS was estimated using Kaplan-Meier estimate. The 95% CI for median was computed by Brookmeyer-Crowley method.
Participants in the Full Analysis Set were analyzed.
Posted
Median
95% Confidence Interval
months
Cohort 1: Up to 5.3 years; Cohort 2: Up to 3.4 years; Cohort 3: Up to 3.3 years; Cohort 4: Up to 2.5 years
ID
Title
Description
OG000
Cohort 1 Group 1: NSCLC [Adenocarcinoma + SCC]
Based on protocol amendment 1, participants with NSCLC subtypes such as adenocarcinoma and SCC with high Trop-2 expression received SG 10 mg/kg, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria was met (up to 22.1 months).
OG001
Cohort 1 Group 2: NSCLC (Adenocarcinoma)
Secondary
Overall Survival (OS)
OS was defined as the interval from the first dose date of drug to death from any cause. OS was estimated using Kaplan-Meier estimate. The 95% CI for median was computed by Brookmeyer-Crowley method.
Participants in the Full Analysis Set were analyzed.
Posted
Median
95% Confidence Interval
months
Cohort 1: Up to 5.3 years; Cohort 2: Up to 3.4 years; Cohort 3: Up to 3.3 years; Cohort 4: Up to 2.5 years
ID
Title
Description
OG000
Cohort 1 Group 1: NSCLC [Adenocarcinoma + SCC]
Based on protocol amendment 1, participants with NSCLC subtypes such as adenocarcinoma and SCC with high Trop-2 expression received SG 10 mg/kg, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria was met (up to 22.1 months).
OG001
Cohort 1 Group 2: NSCLC (Adenocarcinoma)
Based on protocol amendment 2 or 3, participants with NSCLC subtype of adenocarcinoma with or without high Trop-2 expression received SG 10 mg/kg, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria was met (up to 38.7 months).
OG002
Secondary
Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs)
A TEAE was defined as any AE with an onset date on or after the study drug start date and no later than 30 days after last dose of study drug or the day before initiation of subsequent therapy, whichever comes first.
Not Posted
Dec 2027
Up to 7.2 years
Participants
Secondary
Percentage of Participants Experiencing Clinically Significant Laboratory Abnormalities
A treatment-emergent laboratory abnormality was defined as any value that increased at least 1 toxicity grade from baseline during the treatment-emergent period.
Not Posted
Dec 2027
Up to 7.2 years
Participants
Secondary
Pharmacokinetic (PK) Parameter: Cmax of Total SN-38
Cmax was defined as the maximum observed concentration of total SN-38 (the active metabolite of sacituzumab Govitecan-hziy). Cycle length=21 days.
The PK Analysis Set included all enrolled participants who received at least 1 dose of SG per protocol & had at least 1 evaluable posttreatment serum concentration of Total SN-38. Participants with available data were analyzed.As all participants were dosed with same dose of SG, the PK analysis for 3 NSCLC cohorts[Cohort 1 Group 1:NSCLC [Adenocarcinoma + SCC],Cohort 1 Group 2:NSCLC(Adenocarcinoma), and Cohort 1 Group 3:NSCLC(SCC)] were combined. The combined PK data was summarized & reported.
Posted
Mean
Standard Deviation
nanograms per milliliter (ng/mL)
Cohort 1: Post dose: Day 1 of Cycles 1,2,3,7,11,17,23,29,35,41,47; Cohort 2: Post dose: Day 1 of Cycles 1,2,3,7,11,17; Cohort 3: Post dose: Day 1 of Cycles 1,2,3,7,11,17,23,29,35,41,47,53; Cohort 4: Post dose: Day 1 of Cycles 1,2,3,7,11,17,23,29
ID
Title
Description
OG000
Cohort 1: NSCLC
Participants with NSCLC subtypes such as adenocarcinoma and SCC with high Trop-2 expression (based on protocol amendment 1) and with or without high Trop-2 expression (based on protocol amendment 2 or 3) received SG 10 mg/kg, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria was met (up to 38.7 months).
OG001
Cohort 2: HNSCC
Secondary
PK Parameter: Cmax of Free SN-38
Cmax was defined as the maximum observed concentration of free SN-38 (the active metabolite of sacituzumab Govitecan-hziy). Cycle length=21 days.
The PK Analysis Set included all enrolled participants who received at least 1 dose of SG per protocol & had at least 1 evaluable posttreatment serum concentration of Free SN-38. Participants with available data were analyzed. As all participants were dosed with same dose of SG, the PK analysis for the 3 NSCLC cohorts[Cohort 1 Group 1:NSCLC [Adenocarcinoma + SCC],Cohort 1 Group 2:NSCLC(Adenocarcinoma), and Cohort 1 Group 3:NSCLC(SCC)] were combined.The combined PK data was summarized & reported.
Posted
Mean
Standard Deviation
ng/mL
Cohort 1: Post dose: Day 1 of Cycles 1,2,3,7,11,17,23,29,35,41,47; Cohort 2: Post dose: Day 1 of Cycles 1,2,3,7,11,17; Cohort 3: Post dose: Day 1 of Cycles 1,2,3,7,11,17,23,29,35,41,47,53; Cohort 4: Post dose: Day 1 of Cycles 1,2,3,7,11,17,23,29
ID
Title
Description
OG000
Cohort 1: NSCLC
Participants with NSCLC subtypes such as adenocarcinoma and SCC with high Trop-2 expression (based on protocol amendment 1) and with or without high Trop-2 expression (based on protocol amendment 2 or 3) received SG 10 mg/kg, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria was met (up to 38.7 months).
OG001
Cohort 2: HNSCC
Secondary
PK Parameter: Cmax of Total Antibody
Cmax was defined as the maximum observed concentration of total antibody of SG [hRS7 immunoglobulin (IgG) and hRS7-SN-38]. Cycle length=21 days.
The PK Analysis Set included all enrolled participants who received at least 1 dose of SG per protocol & had at least 1 evaluable posttreatment serum concentration of Total Antibody. Participants with available data were analyzed. As all participants were dosed with same dose of SG, the PK analysis for 3 NSCLC cohorts[Cohort 1 Group 1:NSCLC [Adenocarcinoma + SCC],Cohort 1 Group 2:NSCLC(Adenocarcinoma), & Cohort 1 Group 3:NSCLC(SCC)] were combined. The combined PK data was summarized & reported.
Posted
Mean
Standard Deviation
ng/mL
Cohort 1: Post dose: Day 1 of Cycles 1,2,3,7,11,17,23,29,35,41,47; Cohort 2: Post dose: Day 1 of Cycles 1,2,3,7,11,17; Cohort 3: Post dose: Day 1 of Cycles 1,2,3,7,11,17,23,29,35,41,47,53; Cohort 4: Post dose: Day 1 of Cycles 1,2,3,7,11,17,23,29
ID
Title
Description
OG000
Cohort 1: NSCLC
Participants with NSCLC subtypes such as adenocarcinoma and SCC with high Trop-2 expression (based on protocol amendment 1) and with or without high Trop-2 expression (based on protocol amendment 2 or 3) received SG 10 mg/kg, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria was met (up to 38.7 months).
OG001
Cohort 2: HNSCC
Secondary
PK Parameter: Ctrough of Total SN-38
Ctrough was defined as concentration at the end of the dosing interval of total SN-38 (the active metabolite of sacituzumab Govitecan-hziy).
Cycle length=21 days; C=Cohort; D=Day; EOT=End of Treatment; PD=predose; SFU=Safety Follow-up (up to 30 days after EOT date)
The PK Analysis Set included all enrolled participants who received at least 1 dose of SG per protocol & had at least 1 evaluable posttreatment serum concentration of Total SN-38. Participants with available data were analyzed. As all participants were dosed with same dose of SG, the PK analysis for 3 NSCLC cohorts [Cohort 1 Group 1:NSCLC [Adenocarcinoma + SCC],Cohort 1 Group 2:NSCLC(Adenocarcinoma), and Cohort 1 Group 3:NSCLC(SCC)] were combined. The combined PK data was summarized & reported.
Participants with NSCLC subtypes such as adenocarcinoma and SCC with high Trop-2 expression (based on protocol amendment 1) and with or without high Trop-2 expression (based on protocol amendment 2 or 3) received SG 10 mg/kg, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria was met (up to 38.7 months).
OG001
Secondary
PK Parameter: Ctrough of Free SN-38
Ctrough was defined as concentration at the end of the dosing interval of free SN-38 (the active metabolite of sacituzumab Govitecan-hziy).
Cycle length=21 days; C=Cohort; D=Day; EOT=End of Treatment; PD=predose; SFU=Safety Follow-up (up to 30 days after EOT date)
The PK Analysis Set included all enrolled participants who received at least 1 dose of SG per protocol and had at least 1 evaluable posttreatment serum concentration of Free SN-38. Participants with available data were analyzed. As all participants were dosed with same dose of SG, the PK analysis for 3 NSCLC cohorts [Cohort 1 Group 1:NSCLC [Adenocarcinoma + SCC],Cohort 1 Group 2:NSCLC(Adenocarcinoma), and Cohort 1 Group 3:NSCLC(SCC)] were combined. The combined PK data was summarized & reported.
Participants with NSCLC subtypes such as adenocarcinoma and SCC with high Trop-2 expression (based on protocol amendment 1) and with or without high Trop-2 expression (based on protocol amendment 2 or 3) received SG 10 mg/kg, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria was met (up to 38.7 months).
OG001
Secondary
PK Parameter: Ctrough of Total Antibody
Ctrough was defined as concentration at the end of the dosing interval of total antibody of SG [hRS7 immunoglobulin (IgG) and hRS7-SN-38].
Cycle length=21 days; C=Cohort; D=Day; EOT=End of Treatment; PD=predose; SFU=Safety Follow-up (up to 30 days after EOT date)
The PK Analysis Set included all enrolled participants who received at least 1 dose of SG per protocol & had at least 1 evaluable posttreatment serum concentration of Total Antibody. Participants with available data were analyzed. As all participants were dosed with same dose of SG,the PK analysis for 3 NSCLC cohorts[Cohort 1 Group 1:NSCLC [Adenocarcinoma + SCC],Cohort 1 Group 2:NSCLC(Adenocarcinoma), and Cohort 1 Group 3:NSCLC(SCC)] were combined. The combined PK data was summarized & reported.
Participants with NSCLC subtypes such as adenocarcinoma and SCC with high Trop-2 expression (based on protocol amendment 1) and with or without high Trop-2 expression (based on protocol amendment 2 or 3) received SG 10 mg/kg , administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria was met (up to 38.7 months).
Secondary
Percentage of Participants With Positive Anti-SG Antibodies
Cycle length=21 days; C=Cohort; D=Day; EOT=End of Treatment; PD=predose; SFU=Safety Follow-up (up to 30 days after EOT date)
The Immunogenicity Analysis Set included all enrolled participants who received at least 1 dose of SG and had at least 1 evaluable posttreatment anti-SG antibody test result.
Based on protocol amendment 1, participants with NSCLC subtypes such as adenocarcinoma and SCC with high Trop-2 expression received SG 10 mg/kg, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria was met (up to 22.1 months).
OG001
Cohort 1 Group 2: NSCLC (Adenocarcinoma)
Based on protocol amendment 2 or 3, participants with NSCLC subtype of adenocarcinoma with or without high Trop-2 expression received SG 10 mg/kg, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria was met (up to 38.7 months).
Time Frame
All-Cause Mortality and Adverse Events: Up to 5.3 years
Description
All-Cause Mortality: The All Enrolled Analysis Set included all participants who were assigned enrollment dates.; Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of SG.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Cohort 1 Group 1: NSCLC [Adenocarcinoma + SCC]
Based on protocol amendment 1, participants with NSCLC subtypes such as adenocarcinoma and SCC with high Trop-2 expression received SG 10 mg/kg, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria was met (up to 22.1 months).
26
31
15
31
30
31
EG001
Cohort 1 Group 2: NSCLC (Adenocarcinoma)
Based on protocol amendment 2 or 3, participants with NSCLC subtype of adenocarcinoma with or without high Trop-2 expression received SG 10 mg/kg, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria was met (up to 38.7 months).
27
34
11
34
34
34
EG002
Cohort 1 Group 3: NSCLC (SCC)
Based on protocol amendment 2 or 3, participants with NSCLC subtype of SCC with or without high Trop-2 expression received SG 10 mg/kg, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria was met (up to 20.7 months).
28
31
13
31
30
31
EG003
Cohort 2: HNSCC
Participants with HNSCC received SG 10 mg/kg, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria was met (up to 12.3 months).
35
43
13
43
43
43
EG004
Cohort 3: EC
Participants with EC received SG 10 mg/kg, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria was met (up to 40.0 months).
30
41
19
41
40
41
EG005
Cohort 4: ES-SCLC
Participants with ES-SCLC received SG 10 mg/kg, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria was met (up to 29.3 months).
32
43
22
43
43
43
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anemia
Blood and lymphatic system disorders
MedDRA 27.1
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected34 at risk
EG0020 affected31 at risk
EG0030 affected43 at risk
EG0041 affected41 at risk
EG0051 affected43 at risk
Disseminated intravascular coagulation
Blood and lymphatic system disorders
MedDRA 27.1
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected34 at risk
EG0020 affected31 at risk
EG003
Febrile neutropenia
Blood and lymphatic system disorders
MedDRA 27.1
Systematic Assessment
EG0001 affected31 at risk
EG0011 affected34 at risk
EG0022 affected31 at risk
EG003
Leukopenia
Blood and lymphatic system disorders
MedDRA 27.1
Systematic Assessment
EG0002 affected31 at risk
EG0011 affected34 at risk
EG0020 affected31 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA 27.1
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected34 at risk
EG0020 affected31 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA 27.1
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected34 at risk
EG0020 affected31 at risk
EG003
Acute left ventricular failure
Cardiac disorders
MedDRA 27.1
Systematic Assessment
EG0001 affected31 at risk
EG0010 affected34 at risk
EG0020 affected31 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA 27.1
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected34 at risk
EG0021 affected31 at risk
EG003
Myopericarditis
Cardiac disorders
MedDRA 27.1
Systematic Assessment
EG0001 affected31 at risk
EG0010 affected34 at risk
EG0020 affected31 at risk
EG003
Sinus tachycardia
Cardiac disorders
MedDRA 27.1
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected34 at risk
EG0020 affected31 at risk
EG003
Tachycardia
Cardiac disorders
MedDRA 27.1
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected34 at risk
EG0021 affected31 at risk
EG003
Hypoacusis
Ear and labyrinth disorders
MedDRA 27.1
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected34 at risk
EG0020 affected31 at risk
EG003
Optic nerve disorder
Eye disorders
MedDRA 27.1
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected34 at risk
EG0020 affected31 at risk
EG003
Abdominal hernia
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected34 at risk
EG0020 affected31 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0001 affected31 at risk
EG0011 affected34 at risk
EG0020 affected31 at risk
EG003
Anal haemorrhage
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected34 at risk
EG0020 affected31 at risk
EG003
Colitis
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 affected31 at risk
EG0011 affected34 at risk
EG0020 affected31 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected34 at risk
EG0021 affected31 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0001 affected31 at risk
EG0011 affected34 at risk
EG0022 affected31 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 affected31 at risk
EG0011 affected34 at risk
EG0021 affected31 at risk
EG003
Enterocolitis
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 affected31 at risk
EG0011 affected34 at risk
EG0020 affected31 at risk
EG003
Gastric haemorrhage
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 affected31 at risk
EG0011 affected34 at risk
EG0020 affected31 at risk
EG003
Gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected34 at risk
EG0020 affected31 at risk
EG003
Gastrointestinal toxicity
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected34 at risk
EG0020 affected31 at risk
EG003
Intestinal obstruction
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected34 at risk
EG0020 affected31 at risk
EG003
Large intestinal obstruction
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0001 affected31 at risk
EG0010 affected34 at risk
EG0020 affected31 at risk
EG003
Lower gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected34 at risk
EG0020 affected31 at risk
EG003
Melaena
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected34 at risk
EG0020 affected31 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 affected31 at risk
EG0011 affected34 at risk
EG0021 affected31 at risk
EG003
Neutropenic colitis
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0002 affected31 at risk
EG0010 affected34 at risk
EG0020 affected31 at risk
EG003
Oesophageal stenosis
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected34 at risk
EG0021 affected31 at risk
EG003
Oral pain
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected34 at risk
EG0020 affected31 at risk
EG003
Rectal haemorrhage
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected34 at risk
EG0020 affected31 at risk
EG003
Small intestinal obstruction
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected34 at risk
EG0020 affected31 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected34 at risk
EG0020 affected31 at risk
EG003
Upper gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 affected31 at risk
EG0011 affected34 at risk
EG0021 affected31 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected34 at risk
EG0020 affected31 at risk
EG003
Death
General disorders
MedDRA 27.1
Systematic Assessment
EG0002 affected31 at risk
EG0010 affected34 at risk
EG0020 affected31 at risk
EG003
Fatigue
General disorders
MedDRA 27.1
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected34 at risk
EG0020 affected31 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA 27.1
Systematic Assessment
EG0000 affected31 at risk
EG0011 affected34 at risk
EG0020 affected31 at risk
EG003
Pyrexia
General disorders
MedDRA 27.1
Systematic Assessment
EG0000 affected31 at risk
EG0011 affected34 at risk
EG0021 affected31 at risk
EG003
Cholecystitis acute
Hepatobiliary disorders
MedDRA 27.1
Systematic Assessment
EG0001 affected31 at risk
EG0010 affected34 at risk
EG0020 affected31 at risk
EG003
Appendicitis perforated
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected34 at risk
EG0020 affected31 at risk
EG003
Arthritis bacterial
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 affected31 at risk
EG0011 affected34 at risk
EG0020 affected31 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected34 at risk
EG0020 affected31 at risk
EG003
Clostridium colitis
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0001 affected31 at risk
EG0010 affected34 at risk
EG0020 affected31 at risk
EG003
Clostridium difficile colitis
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0001 affected31 at risk
EG0010 affected34 at risk
EG0020 affected31 at risk
EG003
Covid-19
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 affected31 at risk
EG0011 affected34 at risk
EG0021 affected31 at risk
EG003
Diarrhoea infectious
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected34 at risk
EG0020 affected31 at risk
EG003
Empyema
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected34 at risk
EG0020 affected31 at risk
EG003
Endocarditis
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected34 at risk
EG0021 affected31 at risk
EG003
Enterocolitis infectious
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0001 affected31 at risk
EG0011 affected34 at risk
EG0020 affected31 at risk
EG003
Gastroenteritis Escherichia coli
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected34 at risk
EG0020 affected31 at risk
EG003
Herpes simplex reactivation
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected34 at risk
EG0020 affected31 at risk
EG003
Herpes zoster
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected34 at risk
EG0021 affected31 at risk
EG003
Lower respiratory tract infection
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected34 at risk
EG0020 affected31 at risk
EG003
Lower respiratory tract infection viral
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected34 at risk
EG0020 affected31 at risk
EG003
Neutropenic sepsis
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected34 at risk
EG0020 affected31 at risk
EG003
Osteomyelitis
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected34 at risk
EG0020 affected31 at risk
EG003
Parainfluenzae virus infection
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected34 at risk
EG0020 affected31 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0001 affected31 at risk
EG0010 affected34 at risk
EG0024 affected31 at risk
EG003
Pneumonia aspiration
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0001 affected31 at risk
EG0010 affected34 at risk
EG0020 affected31 at risk
EG003
Pneumonia bacterial
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected34 at risk
EG0022 affected31 at risk
EG003
Pneumonia pneumococcal
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 affected31 at risk
EG0011 affected34 at risk
EG0020 affected31 at risk
EG003
Pyelonephritis
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected34 at risk
EG0020 affected31 at risk
EG003
Respiratory syncytial virus infection
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 affected31 at risk
EG0012 affected34 at risk
EG0020 affected31 at risk
EG003
Sepsis
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0001 affected31 at risk
EG0010 affected34 at risk
EG0022 affected31 at risk
EG003
Septic encephalopathy
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0001 affected31 at risk
EG0010 affected34 at risk
EG0020 affected31 at risk
EG003
Septic shock
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected34 at risk
EG0020 affected31 at risk
EG003
Skin infection
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected34 at risk
EG0020 affected31 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected34 at risk
EG0020 affected31 at risk
EG003
Urosepsis
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected34 at risk
EG0020 affected31 at risk
EG003
Compression fracture
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected34 at risk
EG0020 affected31 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected34 at risk
EG0020 affected31 at risk
EG003
Rib fracture
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected34 at risk
EG0020 affected31 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 27.1
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected34 at risk
EG0020 affected31 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 27.1
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected34 at risk
EG0020 affected31 at risk
EG003
Blood alkaline phosphatase increased
Investigations
MedDRA 27.1
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected34 at risk
EG0020 affected31 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA 27.1
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected34 at risk
EG0020 affected31 at risk
EG003
Blood creatinine increased
Investigations
MedDRA 27.1
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected34 at risk
EG0020 affected31 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 27.1
Systematic Assessment
EG0001 affected31 at risk
EG0010 affected34 at risk
EG0020 affected31 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 27.1
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected34 at risk
EG0020 affected31 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 27.1
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected34 at risk
EG0020 affected31 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 27.1
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected34 at risk
EG0022 affected31 at risk
EG003
Cancer pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 27.1
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected34 at risk
EG0020 affected31 at risk
EG003
Tumour haemorrhage
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 27.1
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected34 at risk
EG0020 affected31 at risk
EG003
Tumour pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 27.1
Systematic Assessment
EG0001 affected31 at risk
EG0010 affected34 at risk
EG0020 affected31 at risk
EG003
Haemorrhage intracranial
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG0001 affected31 at risk
EG0010 affected34 at risk
EG0020 affected31 at risk
EG003
Neuropathy peripheral
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected34 at risk
EG0020 affected31 at risk
EG003
Spinal cord compression
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected34 at risk
EG0020 affected31 at risk
EG003
Syncope
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected34 at risk
EG0020 affected31 at risk
EG003
Device dislocation
Product Issues
MedDRA 27.1
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected34 at risk
EG0020 affected31 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA 27.1
Systematic Assessment
EG0001 affected31 at risk
EG0010 affected34 at risk
EG0020 affected31 at risk
EG003
Hydronephrosis
Renal and urinary disorders
MedDRA 27.1
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected34 at risk
EG0020 affected31 at risk
EG003
Urinary retention
Renal and urinary disorders
MedDRA 27.1
Systematic Assessment
EG0000 affected31 at risk
EG0011 affected34 at risk
EG0020 affected31 at risk
EG003
Urinary tract obstruction
Renal and urinary disorders
MedDRA 27.1
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected34 at risk
EG0020 affected31 at risk
EG003
Acute respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA 27.1
Systematic Assessment
EG0001 affected31 at risk
EG0010 affected34 at risk
EG0020 affected31 at risk
EG003
Aspiration
Respiratory, thoracic and mediastinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected34 at risk
EG0021 affected31 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 27.1
Systematic Assessment
EG0001 affected31 at risk
EG0012 affected34 at risk
EG0023 affected31 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 affected31 at risk
EG0011 affected34 at risk
EG0020 affected31 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA 27.1
Systematic Assessment
EG0001 affected31 at risk
EG0010 affected34 at risk
EG0020 affected31 at risk
EG003
Pneumothorax
Respiratory, thoracic and mediastinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected34 at risk
EG0021 affected31 at risk
EG003
Pneumothorax spontaneous
Respiratory, thoracic and mediastinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 affected31 at risk
EG0011 affected34 at risk
EG0020 affected31 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected34 at risk
EG0020 affected31 at risk
EG003
Respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 affected31 at risk
EG0011 affected34 at risk
EG0020 affected31 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRA 27.1
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected34 at risk
EG0021 affected31 at risk
EG003
Embolism
Vascular disorders
MedDRA 27.1
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected34 at risk
EG0020 affected31 at risk
EG003
Hypotension
Vascular disorders
MedDRA 27.1
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected34 at risk
EG0021 affected31 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anemia
Blood and lymphatic system disorders
MedDRA 27.1
Systematic Assessment
EG0009 affected31 at risk
EG00112 affected34 at risk
EG0026 affected31 at risk
EG00313 affected43 at risk
EG00419 affected41 at risk
EG00513 affected43 at risk
Leukocytosis
Blood and lymphatic system disorders
MedDRA 27.1
Systematic Assessment
EG0001 affected31 at risk
EG0014 affected34 at risk
EG0021 affected31 at risk
EG003
Leukopenia
Blood and lymphatic system disorders
MedDRA 27.1
Systematic Assessment
EG0006 affected31 at risk
EG0018 affected34 at risk
EG0025 affected31 at risk
EG003
Lymphopenia
Blood and lymphatic system disorders
MedDRA 27.1
Systematic Assessment
EG0001 affected31 at risk
EG0014 affected34 at risk
EG0022 affected31 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA 27.1
Systematic Assessment
EG00016 affected31 at risk
EG00116 affected34 at risk
EG00215 affected31 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA 27.1
Systematic Assessment
EG0000 affected31 at risk
EG0014 affected34 at risk
EG0020 affected31 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA 27.1
Systematic Assessment
EG0002 affected31 at risk
EG0011 affected34 at risk
EG0022 affected31 at risk
EG003
Tachycardia
Cardiac disorders
MedDRA 27.1
Systematic Assessment
EG0002 affected31 at risk
EG0014 affected34 at risk
EG0023 affected31 at risk
EG003
Dry eye
Eye disorders
MedDRA 27.1
Systematic Assessment
EG0000 affected31 at risk
EG0013 affected34 at risk
EG0020 affected31 at risk
EG003
Vision blurred
Eye disorders
MedDRA 27.1
Systematic Assessment
EG0002 affected31 at risk
EG0011 affected34 at risk
EG0020 affected31 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0001 affected31 at risk
EG0010 affected34 at risk
EG0022 affected31 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0002 affected31 at risk
EG0017 affected34 at risk
EG0025 affected31 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0001 affected31 at risk
EG0011 affected34 at risk
EG0022 affected31 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG00011 affected31 at risk
EG00113 affected34 at risk
EG00211 affected31 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG00021 affected31 at risk
EG00117 affected34 at risk
EG00215 affected31 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0002 affected31 at risk
EG0014 affected34 at risk
EG0021 affected31 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0002 affected31 at risk
EG0013 affected34 at risk
EG0022 affected31 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0001 affected31 at risk
EG0013 affected34 at risk
EG0021 affected31 at risk
EG003
Haemorrhoidal haemorrhage
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected34 at risk
EG0022 affected31 at risk
EG003
Haemorrhoids
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected34 at risk
EG0023 affected31 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG00012 affected31 at risk
EG00120 affected34 at risk
EG00212 affected31 at risk
EG003
Oral pain
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0001 affected31 at risk
EG0010 affected34 at risk
EG0020 affected31 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0005 affected31 at risk
EG0016 affected34 at risk
EG0021 affected31 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0007 affected31 at risk
EG0017 affected34 at risk
EG0027 affected31 at risk
EG003
Chest pain
General disorders
MedDRA 27.1
Systematic Assessment
EG0002 affected31 at risk
EG0011 affected34 at risk
EG0021 affected31 at risk
EG003
Chills
General disorders
MedDRA 27.1
Systematic Assessment
EG0001 affected31 at risk
EG0013 affected34 at risk
EG0021 affected31 at risk
EG003
Fatigue
General disorders
MedDRA 27.1
Systematic Assessment
EG00015 affected31 at risk
EG00120 affected34 at risk
EG00218 affected31 at risk
EG003
Mucosal inflammation
General disorders
MedDRA 27.1
Systematic Assessment
EG0000 affected31 at risk
EG0012 affected34 at risk
EG0020 affected31 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA 27.1
Systematic Assessment
EG0002 affected31 at risk
EG0010 affected34 at risk
EG0024 affected31 at risk
EG003
Oedema
General disorders
MedDRA 27.1
Systematic Assessment
EG0000 affected31 at risk
EG0012 affected34 at risk
EG0020 affected31 at risk
EG003
Oedema peripheral
General disorders
MedDRA 27.1
Systematic Assessment
EG0003 affected31 at risk
EG0016 affected34 at risk
EG0024 affected31 at risk
EG003
Peripheral swelling
General disorders
MedDRA 27.1
Systematic Assessment
EG0000 affected31 at risk
EG0012 affected34 at risk
EG0020 affected31 at risk
EG003
Pyrexia
General disorders
MedDRA 27.1
Systematic Assessment
EG0002 affected31 at risk
EG0013 affected34 at risk
EG0025 affected31 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0002 affected31 at risk
EG0012 affected34 at risk
EG0020 affected31 at risk
EG003
Covid-19
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 affected31 at risk
EG0014 affected34 at risk
EG0022 affected31 at risk
EG003
Herpes zoster
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0001 affected31 at risk
EG0012 affected34 at risk
EG0021 affected31 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0002 affected31 at risk
EG0012 affected34 at risk
EG0027 affected31 at risk
EG003
Sinusitis
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 affected31 at risk
EG0013 affected34 at risk
EG0020 affected31 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 affected31 at risk
EG0013 affected34 at risk
EG0021 affected31 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 affected31 at risk
EG0012 affected34 at risk
EG0022 affected31 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0001 affected31 at risk
EG0010 affected34 at risk
EG0022 affected31 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0001 affected31 at risk
EG0012 affected34 at risk
EG0021 affected31 at risk
EG003
Infusion related reaction
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0000 affected31 at risk
EG0012 affected34 at risk
EG0020 affected31 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 27.1
Systematic Assessment
EG0000 affected31 at risk
EG0011 affected34 at risk
EG0022 affected31 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 27.1
Systematic Assessment
EG0000 affected31 at risk
EG0011 affected34 at risk
EG0020 affected31 at risk
EG003
Blood alkaline phosphatase increased
Investigations
MedDRA 27.1
Systematic Assessment
EG0002 affected31 at risk
EG0013 affected34 at risk
EG0020 affected31 at risk
EG003
Blood creatinine increased
Investigations
MedDRA 27.1
Systematic Assessment
EG0002 affected31 at risk
EG0012 affected34 at risk
EG0024 affected31 at risk
EG003
Blood potassium decreased
Investigations
MedDRA 27.1
Systematic Assessment
EG0002 affected31 at risk
EG0010 affected34 at risk
EG0020 affected31 at risk
EG003
Weight decreased
Investigations
MedDRA 27.1
Systematic Assessment
EG0003 affected31 at risk
EG0012 affected34 at risk
EG0022 affected31 at risk
EG003
Weight increased
Investigations
MedDRA 27.1
Systematic Assessment
EG0002 affected31 at risk
EG0010 affected34 at risk
EG0020 affected31 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 27.1
Systematic Assessment
EG0008 affected31 at risk
EG00110 affected34 at risk
EG00211 affected31 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 27.1
Systematic Assessment
EG0004 affected31 at risk
EG0017 affected34 at risk
EG0026 affected31 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 27.1
Systematic Assessment
EG0000 affected31 at risk
EG0012 affected34 at risk
EG0021 affected31 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA 27.1
Systematic Assessment
EG0001 affected31 at risk
EG0012 affected34 at risk
EG0020 affected31 at risk
EG003
Hypoalbuminaemia
Metabolism and nutrition disorders
MedDRA 27.1
Systematic Assessment
EG0001 affected31 at risk
EG0010 affected34 at risk
EG0020 affected31 at risk
EG003
Hypocalcaemia
Metabolism and nutrition disorders
MedDRA 27.1
Systematic Assessment
EG0002 affected31 at risk
EG0012 affected34 at risk
EG0020 affected31 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 27.1
Systematic Assessment
EG0005 affected31 at risk
EG0015 affected34 at risk
EG0025 affected31 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA 27.1
Systematic Assessment
EG0006 affected31 at risk
EG0013 affected34 at risk
EG0025 affected31 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 27.1
Systematic Assessment
EG0002 affected31 at risk
EG0013 affected34 at risk
EG0023 affected31 at risk
EG003
Hypophosphataemia
Metabolism and nutrition disorders
MedDRA 27.1
Systematic Assessment
EG0002 affected31 at risk
EG0013 affected34 at risk
EG0024 affected31 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 27.1
Systematic Assessment
EG0005 affected31 at risk
EG0014 affected34 at risk
EG0021 affected31 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 27.1
Systematic Assessment
EG0004 affected31 at risk
EG0013 affected34 at risk
EG0027 affected31 at risk
EG003
Bone pain
Musculoskeletal and connective tissue disorders
MedDRA 27.1
Systematic Assessment
EG0001 affected31 at risk
EG0012 affected34 at risk
EG0022 affected31 at risk
EG003
Groin pain
Musculoskeletal and connective tissue disorders
MedDRA 27.1
Systematic Assessment
EG0002 affected31 at risk
EG0010 affected34 at risk
EG0020 affected31 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA 27.1
Systematic Assessment
EG0001 affected31 at risk
EG0011 affected34 at risk
EG0022 affected31 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA 27.1
Systematic Assessment
EG0002 affected31 at risk
EG0011 affected34 at risk
EG0022 affected31 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA 27.1
Systematic Assessment
EG0002 affected31 at risk
EG0011 affected34 at risk
EG0021 affected31 at risk
EG003
Musculoskeletal stiffness
Musculoskeletal and connective tissue disorders
MedDRA 27.1
Systematic Assessment
EG0002 affected31 at risk
EG0011 affected34 at risk
EG0020 affected31 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 27.1
Systematic Assessment
EG0002 affected31 at risk
EG0011 affected34 at risk
EG0022 affected31 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA 27.1
Systematic Assessment
EG0002 affected31 at risk
EG0010 affected34 at risk
EG0021 affected31 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 27.1
Systematic Assessment
EG0002 affected31 at risk
EG0014 affected34 at risk
EG0021 affected31 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG0003 affected31 at risk
EG0015 affected34 at risk
EG0025 affected31 at risk
EG003
Dysgeusia
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG0001 affected31 at risk
EG0013 affected34 at risk
EG0021 affected31 at risk
EG003
Headache
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG0008 affected31 at risk
EG0018 affected34 at risk
EG0025 affected31 at risk
EG003
Neuropathy peripheral
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG0001 affected31 at risk
EG0011 affected34 at risk
EG0020 affected31 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG0001 affected31 at risk
EG0010 affected34 at risk
EG0021 affected31 at risk
EG003
Peripheral sensory neuropathy
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG0004 affected31 at risk
EG0011 affected34 at risk
EG0021 affected31 at risk
EG003
Taste disorder
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG0002 affected31 at risk
EG0010 affected34 at risk
EG0020 affected31 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA 27.1
Systematic Assessment
EG0002 affected31 at risk
EG0012 affected34 at risk
EG0021 affected31 at risk
EG003
Confusional state
Psychiatric disorders
MedDRA 27.1
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected34 at risk
EG0022 affected31 at risk
EG003
Depression
Psychiatric disorders
MedDRA 27.1
Systematic Assessment
EG0002 affected31 at risk
EG0013 affected34 at risk
EG0020 affected31 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA 27.1
Systematic Assessment
EG0003 affected31 at risk
EG0012 affected34 at risk
EG0023 affected31 at risk
EG003
Vaginal haemorrhage
Reproductive system and breast disorders
MedDRA 27.1
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected34 at risk
EG0020 affected31 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 27.1
Systematic Assessment
EG0004 affected31 at risk
EG0017 affected34 at risk
EG0025 affected31 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 27.1
Systematic Assessment
EG0008 affected31 at risk
EG0013 affected34 at risk
EG0029 affected31 at risk
EG003
Dyspnoea exertional
Respiratory, thoracic and mediastinal disorders
MedDRA 27.1
Systematic Assessment
EG0001 affected31 at risk
EG0012 affected34 at risk
EG0021 affected31 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA 27.1
Systematic Assessment
EG0002 affected31 at risk
EG0013 affected34 at risk
EG0020 affected31 at risk
EG003
Haemoptysis
Respiratory, thoracic and mediastinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 affected31 at risk
EG0013 affected34 at risk
EG0021 affected31 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDRA 27.1
Systematic Assessment
EG0002 affected31 at risk
EG0011 affected34 at risk
EG0022 affected31 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 27.1
Systematic Assessment
EG0001 affected31 at risk
EG0012 affected34 at risk
EG0023 affected31 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA 27.1
Systematic Assessment
EG0002 affected31 at risk
EG0012 affected34 at risk
EG0021 affected31 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA 27.1
Systematic Assessment
EG0002 affected31 at risk
EG0011 affected34 at risk
EG0021 affected31 at risk
EG003
Productive cough
Respiratory, thoracic and mediastinal disorders
MedDRA 27.1
Systematic Assessment
EG0002 affected31 at risk
EG0011 affected34 at risk
EG0022 affected31 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA 27.1
Systematic Assessment
EG0002 affected31 at risk
EG0012 affected34 at risk
EG0020 affected31 at risk
EG003
Upper-airway cough syndrome
Respiratory, thoracic and mediastinal disorders
MedDRA 27.1
Systematic Assessment
EG0002 affected31 at risk
EG0011 affected34 at risk
EG0020 affected31 at risk
EG003
Wheezing
Respiratory, thoracic and mediastinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 affected31 at risk
EG0013 affected34 at risk
EG0021 affected31 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
MedDRA 27.1
Systematic Assessment
EG00014 affected31 at risk
EG00122 affected34 at risk
EG00213 affected31 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
MedDRA 27.1
Systematic Assessment
EG0003 affected31 at risk
EG0012 affected34 at risk
EG0021 affected31 at risk
EG003
Hyperhidrosis
Skin and subcutaneous tissue disorders
MedDRA 27.1
Systematic Assessment
EG0000 affected31 at risk
EG0013 affected34 at risk
EG0022 affected31 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 27.1
Systematic Assessment
EG0002 affected31 at risk
EG0014 affected34 at risk
EG0022 affected31 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 27.1
Systematic Assessment
EG0004 affected31 at risk
EG0014 affected34 at risk
EG0023 affected31 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
MedDRA 27.1
Systematic Assessment
EG0002 affected31 at risk
EG0012 affected34 at risk
EG0021 affected31 at risk
EG003
Flushing
Vascular disorders
MedDRA 27.1
Systematic Assessment
EG0002 affected31 at risk
EG0010 affected34 at risk
EG0020 affected31 at risk
EG003
Hot flush
Vascular disorders
MedDRA 27.1
Systematic Assessment
EG0002 affected31 at risk
EG0010 affected34 at risk
EG0021 affected31 at risk
EG003
Hypertension
Vascular disorders
MedDRA 27.1
Systematic Assessment
EG0001 affected31 at risk
EG0011 affected34 at risk
EG0023 affected31 at risk
EG003
Hypotension
Vascular disorders
MedDRA 27.1
Systematic Assessment
EG0006 affected31 at risk
EG0014 affected34 at risk
EG0025 affected31 at risk
EG003
Lymphocele
Vascular disorders
MedDRA 27.1
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected34 at risk
EG0022 affected31 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met:
The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or
The study has been completed at all study sites for at least 2 years
Based on protocol amendment 2 or 3, participants with NSCLC subtype of SCC with or without high Trop-2 expression received SG 10 mg/kg, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria was met (up to 20.7 months).
OG003
Cohort 2: HNSCC
Participants with HNSCC received SG 10 mg/kg, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria was met (up to 12.3 months).
OG004
Cohort 3: EC
Participants with EC received SG 10 mg/kg, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria was met (up to 40.0 months).
OG005
Cohort 4: ES-SCLC
Participants with ES-SCLC received SG 10 mg/kg, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria was met (up to 29.3 months).
Units
Counts
Participants
OG00031
OG00134
OG00231
OG00343
OG00441
OG00543
Title
Denominators
Categories
Title
Measurements
OG0003.2(0.1 to 16.7)
OG0018.8(1.9 to 23.7)
OG00216.1(5.5 to 33.7)
OG00318.6(8.4 to 33.4)
OG00424.4(12.4 to 40.3)
OG00544.2(29.1 to 60.1)
OG001
Cohort 1 Group 2: NSCLC (Adenocarcinoma)
Based on protocol amendment 2 or 3, participants with NSCLC subtype of adenocarcinoma with or without high Trop-2 expression received SG 10 mg/kg, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria was met (up to 38.7 months).
OG002
Cohort 1 Group 3: NSCLC (SCC)
Based on protocol amendment 2 or 3, participants with NSCLC subtype of SCC with or without high Trop-2 expression received SG 10 mg/kg, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria was met (up to 20.7 months).
OG003
Cohort 2: HNSCC
Participants with HNSCC received SG 10 mg/kg, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria was met (up to 12.3 months).
OG004
Cohort 3: EC
Participants with EC received SG 10 mg/kg, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria was met (up to 40.0 months).
OG005
Cohort 4: ES-SCLC
Participants with ES-SCLC received SG 10 mg/kg, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria was met (up to 29.3 months).
Units
Counts
Participants
OG0001
OG0013
OG0025
OG0038
OG00410
OG00519
Title
Denominators
Categories
Title
Measurements
OG0002.86(NA to NA)Upper and lower limit of confidence interval (CI) were not estimable due to low number of participants with events.
OG00122.08(10.55 to NA)Upper limit of CI was not estimable due to low number of participants with events.
OG0024.70(2.10 to NA)Upper limit of CI was not estimable due to low number of participants with events.
OG0038.67(2.83 to NA)Upper limit of CI was not estimable due to low number of participants with events.
OG00416.00(2.76 to NA)Upper limit of CI was not estimable due to low number of participants with events.
OG0056.01(2.92 to 10.22)
OG001
Cohort 1 Group 2: NSCLC (Adenocarcinoma)
Based on protocol amendment 2 or 3, participants with NSCLC subtype of adenocarcinoma with or without high Trop-2 expression received SG 10 mg/kg, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria was met (up to 38.7 months).
OG002
Cohort 1 Group 3: NSCLC (SCC)
Based on protocol amendment 2 or 3, participants with NSCLC subtype of SCC with or without high Trop-2 expression received SG 10 mg/kg, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria was met (up to 20.7 months).
OG003
Cohort 2: HNSCC
Participants with HNSCC received SG 10 mg/kg, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria was met (up to 12.3 months).
OG004
Cohort 3: EC
Participants with EC received SG 10 mg/kg, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria was met (up to 40.0 months).
OG005
Cohort 4: ES-SCLC
Participants with ES-SCLC received SG 10 mg/kg, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria was met (up to 29.3 months).
Units
Counts
Participants
OG00031
OG00134
OG00231
OG00343
OG00441
OG00543
Title
Denominators
Categories
Title
Measurements
OG00029.0(14.2 to 48.0)
OG00123.5(10.7 to 41.2)
OG00219.4(7.5 to 37.5)
OG00327.9(15.3 to 43.7)
OG00439.0(24.2 to 55.5)
OG00546.5(31.2 to 62.3)
Based on protocol amendment 2 or 3, participants with NSCLC subtype of adenocarcinoma with or without high Trop-2 expression received SG 10 mg/kg, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria was met (up to 38.7 months).
OG002
Cohort 1 Group 3: NSCLC (SCC)
Based on protocol amendment 2 or 3, participants with NSCLC subtype of SCC with or without high Trop-2 expression received SG 10 mg/kg, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria was met (up to 20.7 months).
OG003
Cohort 2: HNSCC
Participants with HNSCC received SG 10 mg/kg, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria was met (up to 12.3 months).
OG004
Cohort 3: EC
Participants with EC received SG 10 mg/kg, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria was met (up to 40.0 months).
OG005
Cohort 4: ES-SCLC
Participants with ES-SCLC received SG 10 mg/kg, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria was met (up to 29.3 months).
Units
Counts
Participants
OG00031
OG00134
OG00231
OG00343
OG00441
OG00543
Title
Denominators
Categories
Title
Measurements
OG0004.11(2.50 to 7.52)
OG0014.24(2.27 to 7.59)
OG0022.73(1.41 to 5.49)
OG0033.25(1.74 to 6.47)
OG0045.55(2.79 to 9.59)
OG0054.40(3.19 to 6.67)
OG001
Cohort 1 Group 2: NSCLC (Adenocarcinoma)
Based on protocol amendment 2 or 3, participants with NSCLC subtype of adenocarcinoma with or without high Trop-2 expression received SG 10 mg/kg, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria was met (up to 38.7 months).
OG002
Cohort 1 Group 3: NSCLC (SCC)
Based on protocol amendment 2 or 3, participants with NSCLC subtype of SCC with or without high Trop-2 expression received SG 10 mg/kg, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria was met (up to 20.7 months).
OG003
Cohort 2: HNSCC
Participants with HNSCC received SG 10 mg/kg, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria was met (up to 12.3 months).
OG004
Cohort 3: EC
Participants with EC received SG 10 mg/kg, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria was met (up to 40.0 months).
OG005
Cohort 4: ES-SCLC
Participants with ES-SCLC received SG 10 mg/kg, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria was met (up to 29.3 months).
Units
Counts
Participants
OG0004
OG0012
OG0022
OG0037
OG00411
OG00519
Title
Denominators
Categories
Title
Measurements
OG0008.56(6.41 to NA)Upper limit of CI was not estimable due to low number of participants with events.
OG00121.09(11.10 to NA)Upper limit of CI was not estimable due to low number of participants with events.
OG0027.87(6.05 to NA)Upper limit of CI was not estimable due to low number of participants with events.
OG0034.21(2.60 to 8.67)
OG0049.92(2.79 to NA)Upper limit of CI was not estimable due to low number of participants with events.
OG0056.31(3.52 to 10.22)
OG001
Cohort 1 Group 2: NSCLC (Adenocarcinoma)
Based on protocol amendment 2 or 3, participants with NSCLC subtype of adenocarcinoma with or without high Trop-2 expression received SG 10 mg/kg, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria was met (up to 38.7 months).
OG002
Cohort 1 Group 3: NSCLC (SCC)
Based on protocol amendment 2 or 3, participants with NSCLC subtype of SCC with or without high Trop-2 expression received SG 10 mg/kg, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria was met (up to 20.7 months).
OG003
Cohort 2: HNSCC
Participants with HNSCC received SG 10 mg/kg, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria was met (up to 12.3 months).
OG004
Cohort 3: EC
Participants with EC received SG 10 mg/kg, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria was met (up to 40.0 months).
OG005
Cohort 4: ES-SCLC
Participants with ES-SCLC received SG 10 mg/kg, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria was met (up to 29.3 months).
Units
Counts
Participants
OG00031
OG00134
OG00231
OG00343
OG00441
OG00543
Title
Denominators
Categories
Title
Measurements
OG00032.3(16.7 to 51.4)
OG00120.6(8.7 to 37.9)
OG00216.1(5.5 to 33.7)
OG00330.2(17.2 to 46.1)
OG00441.5(26.3 to 57.9)
OG00548.8(33.3 to 64.5)
Based on protocol amendment 2 or 3, participants with NSCLC subtype of adenocarcinoma with or without high Trop-2 expression received SG 10 mg/kg, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria was met (up to 38.7 months).
OG002
Cohort 1 Group 3: NSCLC (SCC)
Based on protocol amendment 2 or 3, participants with NSCLC subtype of SCC with or without high Trop-2 expression received SG 10 mg/kg, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria was met (up to 20.7 months).
OG003
Cohort 2: HNSCC
Participants with HNSCC received SG 10 mg/kg, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria was met (up to 12.3 months).
OG004
Cohort 3: EC
Participants with EC received SG 10 mg/kg, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria was met (up to 40.0 months).
OG005
Cohort 4: ES-SCLC
Participants with ES-SCLC received SG 10 mg/kg, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria was met (up to 29.3 months).
Units
Counts
Participants
OG00031
OG00134
OG00231
OG00343
OG00441
OG00543
Title
Denominators
Categories
Title
Measurements
OG0002.79(1.48 to 7.82)
OG0013.78(1.41 to 5.65)
OG0022.56(1.41 to 5.49)
OG0034.14(1.71 to 5.78)
OG0044.96(2.76 to 9.82)
OG0054.40(3.81 to 6.11)
Cohort 1 Group 3: NSCLC (SCC)
Based on protocol amendment 2 or 3, participants with NSCLC subtype of SCC with or without high Trop-2 expression received SG 10 mg/kg, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria was met (up to 20.7 months).
OG003
Cohort 2: HNSCC
Participants with HNSCC received SG 10 mg/kg, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria was met (up to 12.3 months).
OG004
Cohort 3: EC
Participants with EC received SG 10 mg/kg, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria was met (up to 40.0 months).
OG005
Cohort 4: ES-SCLC
Participants with ES-SCLC received SG 10 mg/kg, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria was met (up to 29.3 months).
Units
Counts
Participants
OG00031
OG00134
OG00231
OG00343
OG00441
OG00543
Title
Denominators
Categories
Title
Measurements
OG00014.26(4.34 to 23.72)
OG00111.02(4.24 to 20.47)
OG0027.29(5.16 to 10.22)
OG0038.97(7.52 to 12.22)
OG00414.95(5.88 to 21.42)
OG00511.73(6.57 to 14.72)
Participants with HNSCC received SG 10 mg/kg, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria was met (up to 12.3 months).
OG002
Cohort 3: EC
Participants with EC received SG 10 mg/kg, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria was met (up to 40 months).
OG003
Cohort 4: ES-SCLC
Participants with ES-SCLC received SG 10 mg/kg, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria was met (up to 29.3 months).
Units
Counts
Participants
OG00058
OG00139
OG00239
OG00338
Title
Denominators
Categories
Cycle 1 Day 1
ParticipantsOG00058
ParticipantsOG00139
ParticipantsOG00239
ParticipantsOG00338
Title
Measurements
OG0004790± 1170
OG0014410± 734
OG0024920± 1060
OG003
Cycle 2 Day 1
ParticipantsOG00046
ParticipantsOG00136
ParticipantsOG00231
ParticipantsOG00333
Cycle 3 Day 1
ParticipantsOG00034
ParticipantsOG00125
ParticipantsOG00227
ParticipantsOG00333
Cycle 7 Day 1
ParticipantsOG00019
ParticipantsOG00113
ParticipantsOG00220
ParticipantsOG00318
Cycle 11 Day 1
ParticipantsOG00013
ParticipantsOG0013
ParticipantsOG00215
ParticipantsOG00310
Cycle 17 Day 1
ParticipantsOG0007
ParticipantsOG0014
ParticipantsOG0029
ParticipantsOG0034
Cycle 23 Day 1
ParticipantsOG0005
ParticipantsOG0010
ParticipantsOG0025
ParticipantsOG0032
Cycle 29 Day 1
ParticipantsOG0004
ParticipantsOG0010
ParticipantsOG0024
ParticipantsOG0032
Cycle 35 Day 1
ParticipantsOG0004
ParticipantsOG0010
ParticipantsOG0024
ParticipantsOG0030
Cycle 41 Day 1
ParticipantsOG0002
ParticipantsOG0010
ParticipantsOG0021
ParticipantsOG0030
Cycle 47 Day 1
ParticipantsOG0002
ParticipantsOG0010
ParticipantsOG0021
ParticipantsOG0030
Cycle 53 Day 1
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0021
ParticipantsOG0030
Participants with HNSCC received SG 10 mg/kg, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria was met (up to 12.3 months).
OG002
Cohort 3: EC
Participants with EC received SG 10 mg/kg, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria was met (up to 40 months).
OG003
Cohort 4: ES-SCLC
Participants with ES-SCLC received SG 10 mg/kg, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria was met (up to 29.3 months).
Units
Counts
Participants
OG00058
OG00139
OG00239
OG00337
Title
Denominators
Categories
Cycle 1 Day 1
ParticipantsOG00058
ParticipantsOG00139
ParticipantsOG00239
ParticipantsOG00337
Title
Measurements
OG00065.4± 23.5
OG001200± 386
OG00294.5± 143
OG003
Cycle 2 Day 1
ParticipantsOG00046
ParticipantsOG00135
ParticipantsOG00231
ParticipantsOG00333
Cycle 3 Day 1
ParticipantsOG00033
ParticipantsOG00125
ParticipantsOG00227
ParticipantsOG00332
Cycle 7 Day 1
ParticipantsOG00019
ParticipantsOG00113
ParticipantsOG00220
ParticipantsOG00318
Cycle 11 Day 1
ParticipantsOG00013
ParticipantsOG0013
ParticipantsOG00215
ParticipantsOG00310
Cycle 17 Day 1
ParticipantsOG0007
ParticipantsOG0014
ParticipantsOG0029
ParticipantsOG0034
Cycle 23 Day 1
ParticipantsOG0005
ParticipantsOG0010
ParticipantsOG0025
ParticipantsOG0032
Cycle 29 Day 1
ParticipantsOG0004
ParticipantsOG0010
ParticipantsOG0024
ParticipantsOG0032
Cycle 35 Day 1
ParticipantsOG0004
ParticipantsOG0010
ParticipantsOG0024
ParticipantsOG0030
Cycle 41 Day 1
ParticipantsOG0002
ParticipantsOG0010
ParticipantsOG0021
ParticipantsOG0030
Cycle 47 Day 1
ParticipantsOG0002
ParticipantsOG0010
ParticipantsOG0021
ParticipantsOG0030
Cycle 53 Day 1
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0021
ParticipantsOG0030
Participants with HNSCC received SG 10 mg/kg, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria was met (up to 12.3 months).
OG002
Cohort 3: EC
Participants with EC received SG 10 mg/kg, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria was met (up to 40 months).
OG003
Cohort 4: ES-SCLC
Participants with ES-SCLC received SG 10 mg/kg, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria was met (up to 29.3 months).
Units
Counts
Participants
OG00057
OG00138
OG00238
OG00338
Title
Denominators
Categories
Cycle 1 Day 1
ParticipantsOG00057
ParticipantsOG00138
ParticipantsOG00238
ParticipantsOG00338
Title
Measurements
OG000232000± 79200
OG001209000± 54700
OG002249000± 77700
OG003
Cycle 2 Day 1
ParticipantsOG00046
ParticipantsOG00135
ParticipantsOG00231
ParticipantsOG00332
Cycle 3 Day 1
ParticipantsOG00034
ParticipantsOG00125
ParticipantsOG00228
ParticipantsOG00332
Cycle 7 Day 1
ParticipantsOG00019
ParticipantsOG00113
ParticipantsOG00220
ParticipantsOG00318
Cycle 11 Day 1
ParticipantsOG00012
ParticipantsOG0013
ParticipantsOG00215
ParticipantsOG00310
Cycle 17 Day 1
ParticipantsOG0007
ParticipantsOG0014
ParticipantsOG0029
ParticipantsOG0034
Cycle 23 Day 1
ParticipantsOG0005
ParticipantsOG0010
ParticipantsOG0025
ParticipantsOG0032
Cycle 29 Day 1
ParticipantsOG0003
ParticipantsOG0010
ParticipantsOG0023
ParticipantsOG0031
Cycle 35 Day 1
ParticipantsOG0004
ParticipantsOG0010
ParticipantsOG0024
ParticipantsOG0030
Cycle 41 Day 1
ParticipantsOG0002
ParticipantsOG0010
ParticipantsOG0021
ParticipantsOG0030
Cycle 47 Day 1
ParticipantsOG0002
ParticipantsOG0010
ParticipantsOG0021
ParticipantsOG0030
Cycle 53 Day 1
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0021
ParticipantsOG0030
Cohort 2: HNSCC
Participants with HNSCC received SG 10 mg/kg, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria was met (up to 12.3 months).
OG002
Cohort 3: EC
Participants with EC received SG 10 mg/kg, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria was met (up to 40 months).
OG003
Cohort 4: ES-SCLC
Participants with ES-SCLC received SG 10 mg/kg, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria was met (up to 29.3 months).
Units
Counts
Participants
OG00085
OG00141
OG00239
OG00337
Title
Denominators
Categories
Cycle 1 Day 1
ParticipantsOG00085
ParticipantsOG00141
ParticipantsOG00239
ParticipantsOG00337
Title
Measurements
OG000NA± NAMean and standard deviation were not calculable as the values were below the limit of quantitation.
OG001NA± NAMean and standard deviation were not calculable as the values were below the limit of quantitation.
OG002NA± NAMean and standard deviation were not calculable as the values were below the limit of quantitation.
OG003
Cycle 2 Day 1
ParticipantsOG00012
ParticipantsOG00111
ParticipantsOG00214
ParticipantsOG0038
Cycle 3 Day 1
ParticipantsOG00030
ParticipantsOG00117
ParticipantsOG00219
ParticipantsOG00313
Cycle 7 Day 1
ParticipantsOG00016
ParticipantsOG0016
ParticipantsOG00213
ParticipantsOG0039
Cycle 11 Day 1
ParticipantsOG00014
ParticipantsOG0012
ParticipantsOG00211
ParticipantsOG0036
Cycle 17 Day 1
ParticipantsOG00012
ParticipantsOG0013
ParticipantsOG0028
ParticipantsOG0033
Cycle 23 Day 1
ParticipantsOG0006
ParticipantsOG0010
ParticipantsOG0021
ParticipantsOG0032
Cycle 29 Day 1
ParticipantsOG0004
ParticipantsOG0010
ParticipantsOG0023
ParticipantsOG0031
Cycle 35 Day 1
ParticipantsOG0004
ParticipantsOG0010
ParticipantsOG0022
ParticipantsOG0030
Cycle 41 Day 1
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0021
ParticipantsOG0030
Cycle 47 Day 1
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0021
ParticipantsOG0030
Cycle 53 Day 1
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0021
ParticipantsOG0030
EOT
ParticipantsOG00016
ParticipantsOG00110
ParticipantsOG00212
ParticipantsOG00311
SFU
ParticipantsOG0001
ParticipantsOG0019
ParticipantsOG0021
ParticipantsOG00312
Cohort 2: HNSCC
Participants with HNSCC received SG 10 mg/kg, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria was met (up to 12.3 months).
OG002
Cohort 3: EC
Participants with EC received SG 10 mg/kg, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria was met (up to 40 months).
OG003
Cohort 4: ES-SCLC
Participants with ES-SCLC received SG 10 mg/kg, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria was met (up to 29.3 months).
Units
Counts
Participants
OG00085
OG00141
OG00239
OG00337
Title
Denominators
Categories
Cycle 1 Day 1
ParticipantsOG00085
ParticipantsOG00141
ParticipantsOG00239
ParticipantsOG00337
Title
Measurements
OG000NA± NAMean and standard deviation were not calculable as the values were below the limit of quantitation.
OG001NA± NAMean and standard deviation were not calculable as the values were below the limit of quantitation.
OG002NA± NAMean and standard deviation were not calculable as the values were below the limit of quantitation.
OG003
Cycle 2 Day 1
ParticipantsOG0002
ParticipantsOG0013
ParticipantsOG0026
ParticipantsOG0031
Cycle 3 Day 1
ParticipantsOG0004
ParticipantsOG0011
ParticipantsOG0024
ParticipantsOG0031
Cycle 7 Day 1
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0021
ParticipantsOG00317
Cycle 11 Day 1
ParticipantsOG0001
ParticipantsOG0013
ParticipantsOG0021
ParticipantsOG00310
Cycle 17 Day 1
ParticipantsOG0003
ParticipantsOG0014
ParticipantsOG0021
ParticipantsOG0034
Cycle 23 Day 1
ParticipantsOG0002
ParticipantsOG0010
ParticipantsOG0025
ParticipantsOG0032
Cycle 29 Day 1
ParticipantsOG0006
ParticipantsOG0010
ParticipantsOG0021
ParticipantsOG0031
Cycle 35 Day 1
ParticipantsOG0004
ParticipantsOG0010
ParticipantsOG0021
ParticipantsOG0030
Cycle 41 Day 1
ParticipantsOG0002
ParticipantsOG0010
ParticipantsOG0021
ParticipantsOG0030
Cycle 47 Day 1
ParticipantsOG0002
ParticipantsOG0010
ParticipantsOG0021
ParticipantsOG0030
Cycle 53 Day 1
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0021
ParticipantsOG0030
EOT
ParticipantsOG0002
ParticipantsOG00129
ParticipantsOG0021
ParticipantsOG0031
SFU
ParticipantsOG0008
ParticipantsOG0019
ParticipantsOG0026
ParticipantsOG00312
OG001
Cohort 2: HNSCC
Participants with HNSCC received SG 10 mg/kg, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria was met (up to 12.3 months).
OG002
Cohort 3: EC
Participants with EC received SG 10 mg/kg, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria was met (up to 40 months).
OG003
Cohort 4: ES-SCLC
Participants with ES-SCLC received SG 10 mg/kg, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria was met (up to 29.3 months).
Units
Counts
Participants
OG00078
OG00141
OG00235
OG00336
Title
Denominators
Categories
Cycle 1 Day 1
ParticipantsOG00078
ParticipantsOG00141
ParticipantsOG00235
ParticipantsOG00336
Title
Measurements
OG000NA± NAMean and standard deviation were not calculable as the values were below the limit of quantitation.
OG001NA± NAMean and standard deviation were not calculable as the values were below the limit of quantitation.
OG002NA± NAMean and standard deviation were not calculable as the values were below the limit of quantitation.
OG003
Cycle 2 Day 1
ParticipantsOG00048
ParticipantsOG00135
ParticipantsOG00230
ParticipantsOG00332
Cycle 3 Day 1
ParticipantsOG00048
ParticipantsOG00125
ParticipantsOG00231
ParticipantsOG00332
Cycle 7 Day 1
ParticipantsOG00028
ParticipantsOG00114
ParticipantsOG00228
ParticipantsOG00317
Cycle 11 Day 1
ParticipantsOG00021
ParticipantsOG0013
ParticipantsOG00215
ParticipantsOG00310
Cycle 17 Day 1
ParticipantsOG00012
ParticipantsOG0014
ParticipantsOG0029
ParticipantsOG0033
Cycle 23 Day 1
ParticipantsOG00010
ParticipantsOG0010
ParticipantsOG0025
ParticipantsOG0032
Cycle 29 Day 1
ParticipantsOG0005
ParticipantsOG0010
ParticipantsOG0024
ParticipantsOG0031
Cycle 35 Day 1
ParticipantsOG0004
ParticipantsOG0010
ParticipantsOG0023
ParticipantsOG0030
Cycle 41 Day 1
ParticipantsOG0002
ParticipantsOG0010
ParticipantsOG0021
ParticipantsOG0030
Cycle 47 Day 1
ParticipantsOG0002
ParticipantsOG0010
ParticipantsOG0021
ParticipantsOG0030
Cycle 53 Day 1
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0021
ParticipantsOG0030
EOT
ParticipantsOG00044
ParticipantsOG00125
ParticipantsOG00224
ParticipantsOG00320
SFU
ParticipantsOG0007
ParticipantsOG0018
ParticipantsOG0026
ParticipantsOG00310
OG002
Cohort 1 Group 3: NSCLC (SCC)
Based on protocol amendment 2 or 3, participants with NSCLC subtype of SCC with or without high Trop-2 expression received SG 10 mg/kg, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria was met (up to 20.7 months).
OG003
Cohort 2: HNSCC
Participants with HNSCC received SG 10 mg/kg, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria was met (up to 12.3 months).
OG004
Cohort 3: EC
Participants with EC received SG 10 mg/kg, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria was met (up to 40.0 months).
OG005
Cohort 4: ES-SCLC
Participants with ES-SCLC received SG 10 mg/kg, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, unacceptable toxicity, study withdrawal, death, or another treatment discontinuation criteria was met (up to 29.3 months).
Units
Counts
Participants
OG00030
OG00133
OG00229
OG00343
OG00441
OG00543
Title
Denominators
Categories
Title
Measurements
OG0000
OG0013.0
OG0023.4
OG0034.7
OG0042.4
OG0054.7
0 affected
43 at risk
EG0041 affected41 at risk
EG0050 affected43 at risk
1 affected
43 at risk
EG0047 affected41 at risk
EG0053 affected43 at risk
0 affected
43 at risk
EG0040 affected41 at risk
EG0050 affected43 at risk
1 affected
43 at risk
EG0042 affected41 at risk
EG0051 affected43 at risk
0 affected
43 at risk
EG0041 affected41 at risk
EG0051 affected43 at risk
0 affected
43 at risk
EG0040 affected41 at risk
EG0050 affected43 at risk
0 affected
43 at risk
EG0040 affected41 at risk
EG0050 affected43 at risk
0 affected
43 at risk
EG0040 affected41 at risk
EG0050 affected43 at risk
0 affected
43 at risk
EG0041 affected41 at risk
EG0050 affected43 at risk
0 affected
43 at risk
EG0040 affected41 at risk
EG0050 affected43 at risk
0 affected
43 at risk
EG0040 affected41 at risk
EG0051 affected43 at risk
0 affected
43 at risk
EG0040 affected41 at risk
EG0051 affected43 at risk
0 affected
43 at risk
EG0040 affected41 at risk
EG0051 affected43 at risk
0 affected
43 at risk
EG0040 affected41 at risk
EG0050 affected43 at risk
0 affected
43 at risk
EG0040 affected41 at risk
EG0051 affected43 at risk
2 affected
43 at risk
EG0041 affected41 at risk
EG0051 affected43 at risk
0 affected
43 at risk
EG0040 affected41 at risk
EG0050 affected43 at risk
0 affected
43 at risk
EG0045 affected41 at risk
EG0050 affected43 at risk
1 affected
43 at risk
EG0040 affected41 at risk
EG0051 affected43 at risk
0 affected
43 at risk
EG0041 affected41 at risk
EG0050 affected43 at risk
0 affected
43 at risk
EG0040 affected41 at risk
EG0050 affected43 at risk
0 affected
43 at risk
EG0040 affected41 at risk
EG0051 affected43 at risk
0 affected
43 at risk
EG0041 affected41 at risk
EG0050 affected43 at risk
0 affected
43 at risk
EG0041 affected41 at risk
EG0050 affected43 at risk
0 affected
43 at risk
EG0040 affected41 at risk
EG0050 affected43 at risk
0 affected
43 at risk
EG0040 affected41 at risk
EG0051 affected43 at risk
0 affected
43 at risk
EG0041 affected41 at risk
EG0050 affected43 at risk
0 affected
43 at risk
EG0040 affected41 at risk
EG0050 affected43 at risk
0 affected
43 at risk
EG0040 affected41 at risk
EG0050 affected43 at risk
0 affected
43 at risk
EG0040 affected41 at risk
EG0050 affected43 at risk
1 affected
43 at risk
EG0040 affected41 at risk
EG0050 affected43 at risk
0 affected
43 at risk
EG0040 affected41 at risk
EG0051 affected43 at risk
0 affected
43 at risk
EG0041 affected41 at risk
EG0050 affected43 at risk
0 affected
43 at risk
EG0040 affected41 at risk
EG0051 affected43 at risk
0 affected
43 at risk
EG0040 affected41 at risk
EG0050 affected43 at risk
0 affected
43 at risk
EG0041 affected41 at risk
EG0050 affected43 at risk
1 affected
43 at risk
EG0042 affected41 at risk
EG0050 affected43 at risk
0 affected
43 at risk
EG0041 affected41 at risk
EG0050 affected43 at risk
0 affected
43 at risk
EG0040 affected41 at risk
EG0052 affected43 at risk
2 affected
43 at risk
EG0040 affected41 at risk
EG0051 affected43 at risk
0 affected
43 at risk
EG0040 affected41 at risk
EG0050 affected43 at risk
0 affected
43 at risk
EG0040 affected41 at risk
EG0051 affected43 at risk
0 affected
43 at risk
EG0040 affected41 at risk
EG0050 affected43 at risk
1 affected
43 at risk
EG0040 affected41 at risk
EG0050 affected43 at risk
0 affected
43 at risk
EG0040 affected41 at risk
EG0050 affected43 at risk
0 affected
43 at risk
EG0041 affected41 at risk
EG0050 affected43 at risk
0 affected
43 at risk
EG0040 affected41 at risk
EG0051 affected43 at risk
0 affected
43 at risk
EG0040 affected41 at risk
EG0051 affected43 at risk
1 affected
43 at risk
EG0040 affected41 at risk
EG0050 affected43 at risk
0 affected
43 at risk
EG0040 affected41 at risk
EG0050 affected43 at risk
0 affected
43 at risk
EG0040 affected41 at risk
EG0050 affected43 at risk
0 affected
43 at risk
EG0041 affected41 at risk
EG0050 affected43 at risk
0 affected
43 at risk
EG0041 affected41 at risk
EG0050 affected43 at risk
0 affected
43 at risk
EG0040 affected41 at risk
EG0050 affected43 at risk
0 affected
43 at risk
EG0041 affected41 at risk
EG0051 affected43 at risk
0 affected
43 at risk
EG0040 affected41 at risk
EG0051 affected43 at risk
0 affected
43 at risk
EG0040 affected41 at risk
EG0052 affected43 at risk
0 affected
43 at risk
EG0041 affected41 at risk
EG0050 affected43 at risk
1 affected
43 at risk
EG0040 affected41 at risk
EG0050 affected43 at risk
1 affected
43 at risk
EG0042 affected41 at risk
EG0052 affected43 at risk
2 affected
43 at risk
EG0040 affected41 at risk
EG0050 affected43 at risk
0 affected
43 at risk
EG0040 affected41 at risk
EG0050 affected43 at risk
0 affected
43 at risk
EG0040 affected41 at risk
EG0050 affected43 at risk
0 affected
43 at risk
EG0041 affected41 at risk
EG0050 affected43 at risk
1 affected
43 at risk
EG0040 affected41 at risk
EG0050 affected43 at risk
1 affected
43 at risk
EG0041 affected41 at risk
EG0052 affected43 at risk
0 affected
43 at risk
EG0040 affected41 at risk
EG0050 affected43 at risk
1 affected
43 at risk
EG0041 affected41 at risk
EG0050 affected43 at risk
1 affected
43 at risk
EG0040 affected41 at risk
EG0050 affected43 at risk
1 affected
43 at risk
EG0041 affected41 at risk
EG0050 affected43 at risk
0 affected
43 at risk
EG0042 affected41 at risk
EG0050 affected43 at risk
0 affected
43 at risk
EG0041 affected41 at risk
EG0050 affected43 at risk
0 affected
43 at risk
EG0041 affected41 at risk
EG0050 affected43 at risk
0 affected
43 at risk
EG0040 affected41 at risk
EG0051 affected43 at risk
0 affected
43 at risk
EG0041 affected41 at risk
EG0050 affected43 at risk
0 affected
43 at risk
EG0041 affected41 at risk
EG0050 affected43 at risk
0 affected
43 at risk
EG0041 affected41 at risk
EG0050 affected43 at risk
0 affected
43 at risk
EG0041 affected41 at risk
EG0050 affected43 at risk
0 affected
43 at risk
EG0041 affected41 at risk
EG0050 affected43 at risk
0 affected
43 at risk
EG0041 affected41 at risk
EG0050 affected43 at risk
0 affected
43 at risk
EG0043 affected41 at risk
EG0050 affected43 at risk
0 affected
43 at risk
EG0040 affected41 at risk
EG0051 affected43 at risk
0 affected
43 at risk
EG0040 affected41 at risk
EG0050 affected43 at risk
0 affected
43 at risk
EG0040 affected41 at risk
EG0051 affected43 at risk
1 affected
43 at risk
EG0040 affected41 at risk
EG0050 affected43 at risk
0 affected
43 at risk
EG0040 affected41 at risk
EG0050 affected43 at risk
0 affected
43 at risk
EG0040 affected41 at risk
EG0051 affected43 at risk
0 affected
43 at risk
EG0040 affected41 at risk
EG0051 affected43 at risk
0 affected
43 at risk
EG0040 affected41 at risk
EG0051 affected43 at risk
0 affected
43 at risk
EG0041 affected41 at risk
EG0050 affected43 at risk
1 affected
43 at risk
EG0040 affected41 at risk
EG0050 affected43 at risk
0 affected
43 at risk
EG0043 affected41 at risk
EG0050 affected43 at risk
0 affected
43 at risk
EG0041 affected41 at risk
EG0050 affected43 at risk
0 affected
43 at risk
EG0040 affected41 at risk
EG0050 affected43 at risk
0 affected
43 at risk
EG0041 affected41 at risk
EG0050 affected43 at risk
0 affected
43 at risk
EG0040 affected41 at risk
EG0050 affected43 at risk
1 affected
43 at risk
EG0040 affected41 at risk
EG0050 affected43 at risk
0 affected
43 at risk
EG0040 affected41 at risk
EG0051 affected43 at risk
1 affected
43 at risk
EG0040 affected41 at risk
EG0050 affected43 at risk
1 affected
43 at risk
EG0040 affected41 at risk
EG0050 affected43 at risk
0 affected
43 at risk
EG0040 affected41 at risk
EG0050 affected43 at risk
0 affected
43 at risk
EG0040 affected41 at risk
EG0050 affected43 at risk
1 affected
43 at risk
EG0040 affected41 at risk
EG0050 affected43 at risk
1 affected
43 at risk
EG0040 affected41 at risk
EG0050 affected43 at risk
0 affected
43 at risk
EG0040 affected41 at risk
EG0050 affected43 at risk
0 affected
43 at risk
EG0042 affected41 at risk
EG0050 affected43 at risk
0 affected
43 at risk
EG0040 affected41 at risk
EG0051 affected43 at risk
1 affected
43 at risk
EG0040 affected41 at risk
EG0051 affected43 at risk
8 affected
43 at risk
EG0046 affected41 at risk
EG0053 affected43 at risk
4 affected
43 at risk
EG0042 affected41 at risk
EG0050 affected43 at risk
19 affected
43 at risk
EG00424 affected41 at risk
EG00524 affected43 at risk
2 affected
43 at risk
EG0043 affected41 at risk
EG0053 affected43 at risk
0 affected
43 at risk
EG0040 affected41 at risk
EG0052 affected43 at risk
0 affected
43 at risk
EG0040 affected41 at risk
EG0050 affected43 at risk
0 affected
43 at risk
EG0042 affected41 at risk
EG0050 affected43 at risk
0 affected
43 at risk
EG0041 affected41 at risk
EG0050 affected43 at risk
0 affected
43 at risk
EG0042 affected41 at risk
EG0051 affected43 at risk
3 affected
43 at risk
EG0043 affected41 at risk
EG0058 affected43 at risk
0 affected
43 at risk
EG0042 affected41 at risk
EG0053 affected43 at risk
6 affected
43 at risk
EG00415 affected41 at risk
EG00518 affected43 at risk
20 affected
43 at risk
EG00422 affected41 at risk
EG00533 affected43 at risk
1 affected
43 at risk
EG0041 affected41 at risk
EG0051 affected43 at risk
2 affected
43 at risk
EG0040 affected41 at risk
EG0052 affected43 at risk
4 affected
43 at risk
EG0042 affected41 at risk
EG0051 affected43 at risk
0 affected
43 at risk
EG0040 affected41 at risk
EG0050 affected43 at risk
0 affected
43 at risk
EG0041 affected41 at risk
EG0051 affected43 at risk
20 affected
43 at risk
EG00423 affected41 at risk
EG00517 affected43 at risk
3 affected
43 at risk
EG0040 affected41 at risk
EG0051 affected43 at risk
3 affected
43 at risk
EG0045 affected41 at risk
EG0057 affected43 at risk
15 affected
43 at risk
EG00410 affected41 at risk
EG0058 affected43 at risk
0 affected
43 at risk
EG0041 affected41 at risk
EG0050 affected43 at risk
0 affected
43 at risk
EG0041 affected41 at risk
EG0051 affected43 at risk
19 affected
43 at risk
EG00424 affected41 at risk
EG00527 affected43 at risk
2 affected
43 at risk
EG0041 affected41 at risk
EG0051 affected43 at risk
0 affected
43 at risk
EG0040 affected41 at risk
EG0051 affected43 at risk
0 affected
43 at risk
EG0042 affected41 at risk
EG0050 affected43 at risk
0 affected
43 at risk
EG0046 affected41 at risk
EG0055 affected43 at risk
1 affected
43 at risk
EG0040 affected41 at risk
EG0050 affected43 at risk
3 affected
43 at risk
EG0045 affected41 at risk
EG0052 affected43 at risk
1 affected
43 at risk
EG0041 affected41 at risk
EG0052 affected43 at risk
5 affected
43 at risk
EG0048 affected41 at risk
EG0055 affected43 at risk
0 affected
43 at risk
EG0042 affected41 at risk
EG0051 affected43 at risk
4 affected
43 at risk
EG0041 affected41 at risk
EG0052 affected43 at risk
2 affected
43 at risk
EG0042 affected41 at risk
EG0053 affected43 at risk
2 affected
43 at risk
EG0044 affected41 at risk
EG0053 affected43 at risk
1 affected
43 at risk
EG0047 affected41 at risk
EG0054 affected43 at risk
0 affected
43 at risk
EG0042 affected41 at risk
EG0051 affected43 at risk
1 affected
43 at risk
EG0045 affected41 at risk
EG0054 affected43 at risk
0 affected
43 at risk
EG0041 affected41 at risk
EG0050 affected43 at risk
1 affected
43 at risk
EG0043 affected41 at risk
EG0053 affected43 at risk
1 affected
43 at risk
EG0043 affected41 at risk
EG0051 affected43 at risk
0 affected
43 at risk
EG0041 affected41 at risk
EG0052 affected43 at risk
2 affected
43 at risk
EG0042 affected41 at risk
EG0054 affected43 at risk
0 affected
43 at risk
EG0040 affected41 at risk
EG0050 affected43 at risk
5 affected
43 at risk
EG0044 affected41 at risk
EG0054 affected43 at risk
1 affected
43 at risk
EG0040 affected41 at risk
EG0050 affected43 at risk
11 affected
43 at risk
EG0043 affected41 at risk
EG00510 affected43 at risk
1 affected
43 at risk
EG0042 affected41 at risk
EG0051 affected43 at risk
0 affected
43 at risk
EG0040 affected41 at risk
EG0052 affected43 at risk
3 affected
43 at risk
EG0042 affected41 at risk
EG0052 affected43 at risk
1 affected
43 at risk
EG0041 affected41 at risk
EG0054 affected43 at risk
0 affected
43 at risk
EG0042 affected41 at risk
EG0051 affected43 at risk
6 affected
43 at risk
EG0047 affected41 at risk
EG0056 affected43 at risk
7 affected
43 at risk
EG00411 affected41 at risk
EG0057 affected43 at risk
7 affected
43 at risk
EG0044 affected41 at risk
EG0054 affected43 at risk
5 affected
43 at risk
EG0042 affected41 at risk
EG0051 affected43 at risk
2 affected
43 at risk
EG0041 affected41 at risk
EG0054 affected43 at risk
1 affected
43 at risk
EG0047 affected41 at risk
EG0054 affected43 at risk
2 affected
43 at risk
EG0040 affected41 at risk
EG0050 affected43 at risk
0 affected
43 at risk
EG0040 affected41 at risk
EG0050 affected43 at risk
0 affected
43 at risk
EG0044 affected41 at risk
EG0052 affected43 at risk
2 affected
43 at risk
EG0043 affected41 at risk
EG0052 affected43 at risk
0 affected
43 at risk
EG0040 affected41 at risk
EG0050 affected43 at risk
0 affected
43 at risk
EG0040 affected41 at risk
EG0050 affected43 at risk
1 affected
43 at risk
EG0040 affected41 at risk
EG0051 affected43 at risk
0 affected
43 at risk
EG0041 affected41 at risk
EG0050 affected43 at risk
0 affected
43 at risk
EG0040 affected41 at risk
EG0054 affected43 at risk
3 affected
43 at risk
EG0043 affected41 at risk
EG0056 affected43 at risk
1 affected
43 at risk
EG0044 affected41 at risk
EG0056 affected43 at risk
3 affected
43 at risk
EG0045 affected41 at risk
EG0051 affected43 at risk
0 affected
43 at risk
EG0041 affected41 at risk
EG0055 affected43 at risk
1 affected
43 at risk
EG0042 affected41 at risk
EG0053 affected43 at risk
1 affected
43 at risk
EG0042 affected41 at risk
EG0053 affected43 at risk
0 affected
43 at risk
EG0040 affected41 at risk
EG0051 affected43 at risk
0 affected
43 at risk
EG0040 affected41 at risk
EG0052 affected43 at risk
0 affected
43 at risk
EG0040 affected41 at risk
EG0051 affected43 at risk
1 affected
43 at risk
EG0041 affected41 at risk
EG0052 affected43 at risk
1 affected
43 at risk
EG0042 affected41 at risk
EG0053 affected43 at risk
0 affected
43 at risk
EG0043 affected41 at risk
EG0050 affected43 at risk
4 affected
43 at risk
EG0046 affected41 at risk
EG0055 affected43 at risk
11 affected
43 at risk
EG0042 affected41 at risk
EG0053 affected43 at risk
0 affected
43 at risk
EG0041 affected41 at risk
EG0051 affected43 at risk
2 affected
43 at risk
EG0043 affected41 at risk
EG0052 affected43 at risk
0 affected
43 at risk
EG0041 affected41 at risk
EG0051 affected43 at risk
2 affected
43 at risk
EG0041 affected41 at risk
EG0051 affected43 at risk
0 affected
43 at risk
EG0041 affected41 at risk
EG0050 affected43 at risk
2 affected
43 at risk
EG0041 affected41 at risk
EG0050 affected43 at risk
1 affected
43 at risk
EG0041 affected41 at risk
EG0050 affected43 at risk
6 affected
43 at risk
EG0040 affected41 at risk
EG0051 affected43 at risk
0 affected
43 at risk
EG0041 affected41 at risk
EG0051 affected43 at risk
0 affected
43 at risk
EG0040 affected41 at risk
EG0051 affected43 at risk
2 affected
43 at risk
EG0040 affected41 at risk
EG0050 affected43 at risk
16 affected
43 at risk
EG00417 affected41 at risk
EG00513 affected43 at risk
2 affected
43 at risk
EG0041 affected41 at risk
EG0053 affected43 at risk
0 affected
43 at risk
EG0040 affected41 at risk
EG0052 affected43 at risk
6 affected
43 at risk
EG0046 affected41 at risk
EG0053 affected43 at risk
5 affected
43 at risk
EG0048 affected41 at risk
EG0058 affected43 at risk
1 affected
43 at risk
EG0042 affected41 at risk
EG0051 affected43 at risk
0 affected
43 at risk
EG0040 affected41 at risk
EG0051 affected43 at risk
0 affected
43 at risk
EG0041 affected41 at risk
EG0050 affected43 at risk
1 affected
43 at risk
EG0041 affected41 at risk
EG0052 affected43 at risk
4 affected
43 at risk
EG0041 affected41 at risk
EG0055 affected43 at risk
0 affected
43 at risk
EG0040 affected41 at risk
EG0050 affected43 at risk
4670
± 738
Title
Measurements
OG0004420± 1010
OG0014210± 807
OG0024640± 1840
OG0034330± 760
Title
Measurements
OG0004280± 1420
OG0013930± 1080
OG0024440± 1130
OG0034150± 1040
Title
Measurements
OG0004220± 949
OG0013750± 1090
OG0024430± 915
OG0034210± 1160
Title
Measurements
OG0004210± 1200
OG0014720± 1210
OG0024390± 1030
OG0034250± 1390
Title
Measurements
OG0004620± 849
OG0014700± 647
OG0024970± 922
OG0035510± 783
Title
Measurements
OG0005140± 1090
OG0024880± 1050
OG0035420± 912
Title
Measurements
OG0004580± 679
OG0024720± 499
OG0035520± 424
Title
Measurements
OG0004360± 1100
OG0024110± 898
Title
Measurements
OG0005230± 1150
OG0025450± NASince only 1 participant was analyzed, standard deviation cannot be calculated.
Title
Measurements
OG0004260± 1610
OG0024580± NASince only 1 participant was analyzed, standard deviation cannot be calculated.
Title
Measurements
OG0025210± NASince only 1 participant was analyzed, standard deviation cannot be calculated.
78.5
± 60.6
Title
Measurements
OG00067.0± 40.2
OG00194.9± 160
OG00270.2± 69.1
OG00387.1± 65.8
Title
Measurements
OG000107± 277
OG00146.8± 17.2
OG00262.5± 41.1
OG00374.4± 75.9
Title
Measurements
OG00064.6± 26.1
OG00170.7± 50.1
OG00263.8± 57.2
OG00378.7± 63.3
Title
Measurements
OG00054.6± 11.1
OG00157.1± 29.8
OG00259.3± 54.0
OG00351.6± 25.2
Title
Measurements
OG00056.6± 11.0
OG00152.1± 18.1
OG00273.3± 37.6
OG00374.6± 35.2
Title
Measurements
OG00072.8± 35.9
OG00257.3± 21.2
OG00353.0± 17.3
Title
Measurements
OG00067.0± 23.0
OG002158± 140
OG003170± 138
Title
Measurements
OG00069.4± 51.1
OG00290.4± 81.3
Title
Measurements
OG00076.1± 32.3
OG002158± NASince only 1 participant was analyzed, standard deviation cannot be calculated.
Title
Measurements
OG00041.9± 8.77
OG002369± NASince only 1 participant was analyzed, standard deviation cannot be calculated.
Title
Measurements
OG002239± NASince only 1 participant was analyzed, standard deviation cannot be calculated.
222000
± 49400
Title
Measurements
OG000245000± 79700
OG001234000± 98700
OG002258000± 114000
OG003231000± 73000
Title
Measurements
OG000260000± 108000
OG001234000± 80600
OG002294000± 114000
OG003240000± 82100
Title
Measurements
OG000272000± 139000
OG001245000± 108000
OG002305000± 116000
OG003260000± 107000
Title
Measurements
OG000287000± 120000
OG001330000± 114000
OG002339000± 123000
OG003315000± 132000
Title
Measurements
OG000313000± 95800
OG001369000± 179000
OG002338000± 127000
OG003380000± 128000
Title
Measurements
OG000356000± 145000
OG002313000± 104000
OG003473000± 45300
Title
Measurements
OG000227000± 218000
OG002360000± 108000
OG003506000± NASince only 1 participant was analyzed, standard deviation cannot be calculated.
Title
Measurements
OG000304000± 63700
OG002286000± 137000
Title
Measurements
OG000282000± 66500
OG002434000± NASince only 1 participant was analyzed, standard deviation cannot be calculated.
Title
Measurements
OG000257000± 47400
OG002283000± NASince only 1 participant was analyzed, standard deviation cannot be calculated.
Title
Measurements
OG002281000± NASince only 1 participant was analyzed, standard deviation cannot be calculated.
NA
± NA
Mean and standard deviation were not calculable as the values were below the limit of quantitation.
Title
Measurements
OG000NA± NAMean and standard deviation were not calculable as the values were below the limit of quantitation.
OG001NA± NAMean and standard deviation were not calculable as the values were below the limit of quantitation.
OG002NA± NAMean and standard deviation were not calculable as the values were below the limit of quantitation.
OG003NA± NAMean and standard deviation were not calculable as the values were below the limit of quantitation.
Title
Measurements
OG000NA± NAMean and standard deviation were not calculable as the values were below the limit of quantitation.
OG001NA± NAMean and standard deviation were not calculable as the values were below the limit of quantitation.
OG002NA± NAMean and standard deviation were not calculable as the values were below the limit of quantitation.
OG003NA± NAMean and standard deviation were not calculable as the values were below the limit of quantitation.
Title
Measurements
OG000NA± NAMean and standard deviation were not calculable as the values were below the limit of quantitation.
OG001NA± NAMean and standard deviation were not calculable as the values were below the limit of quantitation.
OG002NA± NAMean and standard deviation were not calculable as the values were below the limit of quantitation.
OG003NA± NAMean and standard deviation were not calculable as the values were below the limit of quantitation.
Title
Measurements
OG000NA± NAMean and standard deviation were not calculable as the values were below the limit of quantitation.
OG001NA± NAMean and standard deviation were not calculable as the values were below the limit of quantitation.
OG002NA± NAMean and standard deviation were not calculable as the values were below the limit of quantitation.
OG003NA± NAMean and standard deviation were not calculable as the values were below the limit of quantitation.
Title
Measurements
OG00010.1± 4.05
OG0019.78± 2.66
OG00210.8± 5.27
OG0039.69± 3.46
Title
Measurements
OG000NA± NAMean and standard deviation were not calculable as the values were below the limit of quantitation.
OG002NA± NAMean and standard deviation were not calculable as the values were below the limit of quantitation.
OG00310.1± 2.99
Title
Measurements
OG000NA± NAMean and standard deviation were not calculable as the values were below the limit of quantitation.
OG00221.0± 24.4
OG0036.68± NASince only 1 participant was analyzed, standard deviation cannot be calculated.
Title
Measurements
OG0007.00± 1.78
OG002NA± NAMean and standard deviation were not calculable as the values were below the limit of quantitation.
Title
Measurements
OG000NA± NAMean and standard deviation were not calculable as the values were below the limit of quantitation.
OG0026.61± NASince only 1 participant was analyzed, standard deviation cannot be calculated.
Title
Measurements
OG000NA± NAMean and standard deviation were not calculable as the values were below the limit of quantitation.
OG0026.12± NASince only 1 participant was analyzed, standard deviation cannot be calculated.
Title
Measurements
OG0027.55± NASince only 1 participant was analyzed, standard deviation cannot be calculated.
Title
Measurements
OG000NA± NAMean and standard deviation were not calculable as the values were below the limit of quantitation.
OG001NA± NAMean and standard deviation were not calculable as the values were below the limit of quantitation.
OG002NA± NAMean and standard deviation were not calculable as the values were below the limit of quantitation.
OG003NA± NAMean and standard deviation were not calculable as the values were below the limit of quantitation.
Title
Measurements
OG000NA± NAMean and standard deviation were not calculable as the values were below the limit of quantitation.
OG001NA± NAMean and standard deviation were not calculable as the values were below the limit of quantitation.
OG002NA± NAMean and standard deviation were not calculable as the values were below the limit of quantitation.
OG003NA± NAMean and standard deviation were not calculable as the values were below the limit of quantitation.
NA
± NA
Mean and standard deviation were not calculable as the values were below the limit of quantitation.
Title
Measurements
OG000NA± NAMean and standard deviation were not calculable as the values were below the limit of quantitation.
OG001NA± NAMean and standard deviation were not calculable as the values were below the limit of quantitation.
OG002NA± NAMean and standard deviation were not calculable as the values were below the limit of quantitation.
OG003NA± NAMean and standard deviation were not calculable as the values were below the limit of quantitation.
Title
Measurements
OG000NA± NAMean and standard deviation were not calculable as the values were below the limit of quantitation.
OG001NA± NAMean and standard deviation were not calculable as the values were below the limit of quantitation.
OG002NA± NAMean and standard deviation were not calculable as the values were below the limit of quantitation.
OG003NA± NAMean and standard deviation were not calculable as the values were below the limit of quantitation.
Title
Measurements
OG000NA± NAMean and standard deviation were not calculable as the values were below the limit of quantitation.
OG001NA± NAMean and standard deviation were not calculable as the values were below the limit of quantitation.
OG002NA± NAMean and standard deviation were not calculable as the values were below the limit of quantitation.
OG003NA± NAMean and standard deviation were not calculable as the values were below the limit of quantitation.
Title
Measurements
OG000NA± NAMean and standard deviation were not calculable as the values were below the limit of quantitation.
OG001NA± NAMean and standard deviation were not calculable as the values were below the limit of quantitation.
OG002NA± NAMean and standard deviation were not calculable as the values were below the limit of quantitation.
OG003NA± NAMean and standard deviation were not calculable as the values were below the limit of quantitation.
Title
Measurements
OG000NA± NAMean and standard deviation were not calculable as the values were below the limit of quantitation.
OG001NA± NAMean and standard deviation were not calculable as the values were below the limit of quantitation.
OG002NA± NAMean and standard deviation were not calculable as the values were below the limit of quantitation.
OG003NA± NAMean and standard deviation were not calculable as the values were below the limit of quantitation.
Title
Measurements
OG000NA± NAMean and standard deviation were not calculable as the values were below the limit of quantitation.
OG002NA± NAMean and standard deviation were not calculable as the values were below the limit of quantitation.
OG003NA± NAMean and standard deviation were not calculable as the values were below the limit of quantitation.
Title
Measurements
OG000NA± NAMean and standard deviation were not calculable as the values were below the limit of quantitation.
OG002NA± NAMean and standard deviation were not calculable as the values were below the limit of quantitation.
OG003NA± NAMean and standard deviation were not calculable as the values were below the limit of quantitation.
Title
Measurements
OG000NA± NAMean and standard deviation were not calculable as the values were below the limit of quantitation.
OG002NA± NAMean and standard deviation were not calculable as the values were below the limit of quantitation.
Title
Measurements
OG000NA± NAMean and standard deviation were not calculable as the values were below the limit of quantitation.
OG002NA± NAMean and standard deviation were not calculable as the values were below the limit of quantitation.
Title
Measurements
OG000NA± NAMean and standard deviation were not calculable as the values were below the limit of quantitation.
OG002NA± NAMean and standard deviation were not calculable as the values were below the limit of quantitation.
Title
Measurements
OG002NA± NAMean and standard deviation were not calculable as the values were below the limit of quantitation.
Title
Measurements
OG000NA± NAMean and standard deviation were not calculable as the values were below the limit of quantitation.
OG001NA± NAMean and standard deviation were not calculable as the values were below the limit of quantitation.
OG002NA± NAMean and standard deviation were not calculable as the values were below the limit of quantitation.
OG003NA± NAMean and standard deviation were not calculable as the values were below the limit of quantitation.
Title
Measurements
OG000NA± NAMean and standard deviation were not calculable as the values were below the limit of quantitation.
OG001NA± NAMean and standard deviation were not calculable as the values were below the limit of quantitation.
OG002NA± NAMean and standard deviation were not calculable as the values were below the limit of quantitation.
OG003NA± NAMean and standard deviation were not calculable as the values were below the limit of quantitation.
NA
± NA
Mean and standard deviation were not calculable as the values were below the limit of quantitation.
Title
Measurements
OG00035200± 24900
OG00152600± 44300
OG00246200± 36100
OG00336000± 26500
Title
Measurements
OG00079500± 58200
OG00169000± 40700
OG00273500± 49100
OG00359500± 49600
Title
Measurements
OG00089600± 80400
OG00170200± 51600
OG002107000± 60800
OG00365200± 44800
Title
Measurements
OG00097500± 77400
OG001169000± 67700
OG00286900± 46800
OG00381600± 44300
Title
Measurements
OG000126000± 61500
OG001124000± 57700
OG002104000± 58800
OG003107000± 20400
Title
Measurements
OG00080700± 56000
OG00258200± 41700
OG00397300± 13800
Title
Measurements
OG00083400± 42200
OG00271100± 4190082800
OG00386100± NASince only 1 participant was analyzed, standard deviation cannot be calculated.
Title
Measurements
OG00094800± 17900
OG00282800± 105000
Title
Measurements
OG00039200± 51600
OG0022660± NASince only 1 participant was analyzed, standard deviation cannot be calculated.
Title
Measurements
OG00042100± 56200
OG0022670± NASince only 1 participant was analyzed, standard deviation cannot be calculated.
Title
Measurements
OG00277200± NASince only 1 participant was analyzed, standard deviation cannot be calculated.