A Study of AGEN2034 in Advanced Tumors and Cervical Cancer | NCT03104699 | Trialant
NCT03104699
Sponsor
Agenus Inc.
Status
Completed
Last Update Posted
Jul 30, 2025Actual
Enrollment
211Actual
Phase
Phase 1Phase 2
Conditions
Advanced Cancer
Cervical Cancer
Interventions
AGEN2034
Countries
United States
Australia
Belgium
Brazil
Chile
Estonia
France
Poland
Spain
Protocol Section
Identification Module
NCT ID
NCT03104699
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
C-700-01
Secondary IDs
Not provided
Brief Title
A Study of AGEN2034 in Advanced Tumors and Cervical Cancer
Official Title
A Phase 1/2, Open-Label, Multiple Ascending Dose Trial to Investigate the Safety, Tolerability, Pharmacokinetics, Biological, and Clinical Activity of AGEN2034 in Subjects With Metastatic or Locally Advanced Solid Tumors, With Expansion to Second Line Cervical Cancer
Acronym
Not provided
Organization
Agenus Inc.INDUSTRY
Status Module
Record Verification Date
Jul 2025
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Apr 11, 2017Actual
Primary Completion Date
Jun 15, 2022Actual
Completion Date
Jun 15, 2022Actual
First Submitted Date
Mar 27, 2017
First Submission Date that Met QC Criteria
Apr 6, 2017
First Posted Date
Apr 7, 2017Actual
Results Waived
Not provided
Results First Submitted Date
May 29, 2025
Results First Submitted that Met QC Criteria
Jul 25, 2025
Results First Posted Date
Jul 30, 2025Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Jun 1, 2023
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Jul 30, 2025Actual
Last Update Submitted Date
Jul 25, 2025
Last Update Posted Date
Jul 30, 2025Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Agenus Inc.INDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
This is a 2-part trial: a Phase 1, open-label, dose-escalation study in participants with metastatic or locally advanced solid tumors, with a consecutive Phase 2 expansion to evaluate efficacy in participants with recurrent, unresectable, or metastatic (advanced) cervical cancer that has progressed after a platinum-based treatment regimen.
Detailed Description
Phase 1: Dose Escalation
Phase 1 will consist of a standard 3+3 dose escalation with the following escalating dose levels and schedules:
Part A1: 1, 3, and 10 milligrams/kilogram (mg/kg) administered every 2 weeks
Part A2: 6 and 10 mg/kg every 3 weeks
Each participant will stay on the dose level and schedule assigned at trial entry. Participants will receive AGEN2034 for a maximum of 2 years or until confirmed progression, unacceptable toxicity, or any criterion for stopping the study drug or withdrawal from the trial occurs.
A Safety Monitoring Committee (SMC) will assess safety; decide on dose-escalation and opening of backfill enrollment; define the recommended Phase 2 dose (RP2D); and determine opening of the Phase 2 cohorts.
In Part A1, the first participant of each cohort will be observed for 16 days (that is, ≥48 hours after second dose) for occurrence of dose-limiting toxicity (DLT) before the second participant is administered trial medication. Thereafter, within each cohort, consecutively enrolled participants may initiate treatment ≥48 hours after the prior enrolled participant-initiated treatment. Dose escalation will continue until the maximum tolerated dose (MTD) is reached or the maximum planned dose level (10.0 mg/kg) is shown to be safe. The MTD is defined as the dose below which ≥2 DLTs are observed.
Once Part A1 is completed, enrollment to Part A2 will begin. If <2 DLTs are observed in Part A1 at the maximum planned dose of 10 mg/kg every 2 weeks, open enrollment to Part A2 will begin with enrollment of 10 participants at 6 mg/kg every 3 weeks, followed by open enrollment of 10 participants at 10 mg/kg every 3 weeks. If ≥2 DLTs are observed in Part A1, at the maximum planned dose in Part A1, the standard 3+3 dose escalation will resume with Part A2 where consecutively enrolled participants in dose escalation may initiate treatment ≥48 hours after the prior enrolled participant-initiated treatment.
For cohorts in dose escalation, concurrent with the 3+3 dose escalation schema, additional participants will be backfilled to lower dose levels to ensure that each cohort enrolls a total of 10 participants. Participants enrolled to backfill cohorts may be enrolled simultaneously, without sequential dosing (that is, not required to wait 48 hours between 2 participants). These additional participants at each dose level will have the purpose of generating additional safety, pharmacokinetics, and receptor occupancy data, and will not undergo formal DLT observation.
Phase 2: Dose Expansion
To further characterize safety and efficacy, participants with recurrent, unresectable, or metastatic cervical cancer will be enrolled in Phase 2 and receive the RP2D of AGEN2034 (3 mg/kg every 2 weeks) for a maximum of 2 years or until confirmed progression, unacceptable toxicity, or any criterion for stopping the study drug or withdrawal from the trial occurs.
An SMC will assess safety, and an Independent Data Monitoring Committee will evaluate safety and efficacy.
Conditions Module
Conditions
Advanced Cancer
Cervical Cancer
Keywords
Antibodies
Immunologic effects
Physiological Effects of Drugs
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 1Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
211Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Monotherapy
Experimental
Dose of 3 mg/kg intravenous (IV) every 2 weeks for up to 24 months.
Drug: AGEN2034
Interventions
Name
Type
Description
Arm Group Labels
Other Names
AGEN2034
Drug
Anti-programmed cell death protein-1 (PD-1) Monoclonal Antibody
Monotherapy
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Phase 1: Number of Participants Experiencing Dose-limiting Toxicities (DLTs) for Balstilimab
A DLT was defined as any treatment-related toxicity that was National Cancer Institute Common Terminology Criteria for Adverse Event Grade ≥3, confirmed by the safety monitoring committee to be relevant for the study drug treatment, and that occurred during the first 3 weeks of balstilimab treatment in the dose escalation portion of the study (DLT evaluation period).
21 days
Phase 1: Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
An adverse event (AE) was any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product, which did not necessarily have a causal relationship with the treatment. TEAEs were AEs with onset dates during the on-treatment period, or the worsening of an event during the on-treatment period. A summary of all Serious Adverse Events and Other Adverse Events (nonserious), regardless of causality, is located in the 'Reported Adverse Events' Section.
Up to 3 years
Phase 2: Objective Response Rate (ORR) as Determined by an Independent Endpoint Review Committee (IERC)
ORR was defined as percentage of participants with a best overall response (BOR) of complete response (CR) or partial response (PR), as determined by an IERC per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1). BOR was defined as the best response recorded from the start of the study treatment until the end of treatment. CR was defined as disappearance of all target lesions, and PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Up to 3 years
Secondary Outcomes
Measure
Description
Time Frame
Phase 1: Receptor Occupancy of Circulating T Cells
The percentage of PD-1 receptor occupancy on circulating T cells was measured as an indication of target engagement. An increase in percent occupancy indicates a potential increase in drug effectiveness.
4 hours after the first dose (Cycle 1 Day 1) and immediately prior to the second dose (Cycle 2 Day 1) (2-3 weeks/cycle)
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Voluntarily agree to participate by giving written informed consent. Participation in pharmacogenomics testing is optional.
Be ≥18 years of age.
Diagnosis and prior systemic treatment:
Phase 1: Have a histologically or cytologically confirmed diagnosis of a metastatic or locally advanced solid tumor for which no standard therapy is available or standard therapy has failed.
Phase 2: I. Have (1) a histologically or cytologically confirmed diagnosis of squamous-cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the cervix, and (2) metastatic, locally advanced, and/or unresectable disease at the time of enrollment. Histologic confirmation of the original primary tumor is required via pathology report. Note: The following cervical tumors are not eligible: minimal deviation/adenoma malignum, gastric type adenocarcinoma, clear cell carcinoma, and mesonephric carcinoma. II. Has cervical cancer and has relapsed after a platinum-based treatment (first line) regimen for advanced (recurrent, unresectable, or metastatic) disease; Note: Participants who have received >1 prior systemic treatment regimen for their advanced or metastatic disease will be eligible in the following cases: Participant receiving chemotherapy concurrently with primary radiation (for example, weekly cisplatin) or participant receiving adjuvant chemotherapy following completion of radiation therapy (for example, paclitaxel and carboplatin for ≤4 cycles) and progressed within 6 months after treatment completion.
Measurable disease - based on investigator assessment
Phase 1: Have objective evidence of disease; the presence of measurable disease is not required.
Phase 2: Have measurable disease on imaging based on Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1). Note: Participants must have at least one "target lesion" to be used to assess response, as defined by RECIST 1.1. Tumors within a previously irradiated field will be designated as "non-target" lesions unless progression is documented or a biopsy is obtained to confirm persistence at least 90 days following completion of radiation therapy. Note: Measurable disease by RECIST 1.1 must be confirmed by independent central radiologic review prior to first dose. Participants without centrally confirmed measurable disease at baseline will not be eligible for this trial.
Have a life expectancy of at least 3 months and an Eastern Cooperative Oncology Group performance status of 0 or 1.
Have adequate organ function as indicated by the following laboratory values:
Adequate hematological function defined by absolute neutrophil count ≥1.5 x 10^9/liter (L), platelet count ≥100 x 10^9/L, and stable hemoglobin ≥8 grams/deciliter (without transfusions within 1 week before first dose).
Adequate hepatic function based by a total bilirubin level ≤ the institutional upper limit of normal (IULN), aspartate aminotransferase level ≤2.5 x IULN, alanine aminotransferase level ≤2.5 x IULN, and alkaline phosphatase ≤2.5 x IULN.
Adequate renal function defined as creatinine ≤1.5 x IULN or calculated creatinine clearance ≥50 milliliters/minute for participants with creatinine levels >1.5 x IULN (if no local guideline is available, creatinine clearance should be calculated using the Cockcroft-Gault Method).
Adequate coagulation defined by international normalized ratio or prothrombin time ≤1.5 x IULN (unless the participant is receiving anticoagulant therapy); and activated partial thromboplastin time ≤1.5 x IULN (unless the participant is receiving anticoagulant therapy)
Other than the cancer for which the participant is enrolled, have no history of prior malignancy, with the exception of basal cell carcinoma of the skin, superficial bladder cancer, squamous-cell carcinoma of the skin, or has undergone potentially curative therapy with no evidence of that disease recurrence for 5 years since initiation of that therapy.
In Phase 2, participants must provide a sufficient and adequate formalin-fixed paraffin-embedded tumor tissue sample preferably from the most recent biopsy of a tumor lesion, collected either at the time of or after the diagnosis of advanced or metastatic disease has been made and from a site not previously irradiated. If no tumor tissue is available, a fresh biopsy will be required.
Note: Tissue from needle or excisional biopsy or from resection is required.
Female participants must have a negative serum pregnancy test at screening (within 72 hours before first dose of study drug) if of childbearing potential or be of non-childbearing potential. Non-childbearing potential is defined as (by other than medical reasons):
≥45 years of age and has not menstruated for greater than 1 year,
Amenorrheic for <2 years without a hysterectomy and oophorectomy and a follicle-stimulating hormone value in the postmenopausal range upon pretrial (screening) evaluation,
Whose status is post hysterectomy, oophorectomy or tubal ligation.
If of childbearing potential, female participants must be willing to use 2 highly effective methods (defined in the informed consent form [ICF]) throughout the study, starting with the screening visit through 120 days after the last dose of study treatment.
Note: Abstinence is acceptable if this is the established and preferred contraception for the participant.
Male participants with a female partner(s) of childbearing potential must agree to use 2 highly effective methods (defined in the ICF) throughout the trial starting with the screening visit through 120 days after the last dose of study treatment is received. Males with pregnant partners must agree to use a condom; no additional method of contraception is required for the pregnant partner.
Note: Abstinence is acceptable if this is the established and preferred contraception for the participant.
Is willing and able to comply with the requirements of the protocol.
Exclusion Criteria:
Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigation device within 4 weeks before the first dose of treatment.
Has an inadequate washout period prior to first dose of study drug defined as:
Received systemic cytotoxic chemotherapy or biological therapy within 3 weeks before first dose,
Received radiation therapy within 3 weeks before first dose, or
Had major surgery within 4 weeks before first dose.
Has received prior therapy with:
Any antibody/drug targeting T-cell co-regulatory proteins (immune checkpoints) such as anti-PD-1, anti-programmed cell death ligand 1, or anti-cytotoxic T-lymphocyte antigen 4 (CTLA-4) antibodies
For Phase 2: >1 systemic treatment regimen for the advanced (recurrent, unresectable, or metastatic) cervical cancer for which the participant is considered for the study Note: In Phase 1, prior treatment with a CTLA-4 antibody is permissible for participants with metastatic melanoma.
Has persisting toxicity related to prior therapy of National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03 (NCI CTCAE) Grade >1 severity.
Note: Sensory neuropathy or alopecia of Grade ≤2 is acceptable.
Is expected to require any other form of systemic or localized antineoplastic therapy while on trial (including maintenance therapy with another agent, radiation therapy, and/or surgical resection).
Has known severe hypersensitivity reactions to fully human monoclonal antibodies (NCI CTCAE Grade ≥3), any history of anaphylaxis, or uncontrolled asthma.
Is receiving systemic corticosteroid ≤7 days prior to the first dose of trial treatment or receiving any other form of systemic immunosuppressive medication (corticosteroid use on study for management of immune-related adverse events, and/or a premedication for IV contrast allergies/reactions is allowed). Participants who are receiving daily corticosteroid replacement therapy are an exception to this rule. Examples of permitted therapy are daily prednisone at doses of 5 to 7.5 mg or equivalent hydrocortisone dose, and steroid therapy administered by topical, intraocular, intranasal, and/or inhalation routes.
Has a central nervous system tumor, metastasis(es), and/or carcinomatous meningitis identified either on the baseline brain imaging obtained during the screening period or identified prior to consent. Note: Participants with history of brain metastases that have been treated may participate provided they show evidence of stable supra-tentorial lesions at screening (based on 2 sets of brain images, performed ≥4 weeks apart, and obtained after the brain metastases treatment). In addition, any neurologic symptoms that developed either as a result of the brain metastases or their treatment must have resolved or be minimal and be expected as sequelae from treated lesions. For individuals who received steroids as part of brain metastases treatment, steroids must be discontinued ≥7 days prior to first dose of study drug.
Has active or history of autoimmune disease that has required systemic treatment within 2 years of the start of trial treatment (that is, with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (that is, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment. Note: Participants with type 1 diabetes, vitiligo, psoriasis, hypo-, or hyperthyroid disease not requiring immunosuppressive treatment are eligible.
Has had an allogeneic tissue/solid organ transplant.
Has or had interstitial lung disease or has had a history of pneumonitis that has required oral or IV corticosteroids.
Has an active infection requiring intravenous systemic therapy.
Has known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies).
Has known active Hepatitis B, Hepatitis C or tuberculosis. Active Hepatitis B is defined as a known positive Hepatitis B surface antigen result. Active Hepatitis C is defined by a known positive Hepatitis C antibody result and known quantitative Hepatitis C virus ribonucleic acid results greater than the lower limits of detection of the assay.
Has clinically significant (that is, active) cardiovascular disease: cerebral vascular accident/stroke or myocardial infarction within 6 months before enrollment, unstable angina, congestive heart failure (New York Heart Association class ≥II), or serious uncontrolled cardiac arrhythmia requiring medication.
Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the participant's participation for the full duration of the trial, or is not in the best interest of the participant to participate, in the opinion of the treating Investigator.
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
Is, at the time of signing informed consent, a regular user (including "recreational use") of any illicit drugs or had a recent history (within the last year) of substance abuse (including alcohol).
Is legally incapacitated or has limited legal capacity.
Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit through 120 days after the last dose of study treatment.
Accepts Healthy Volunteers
No
Sex
Female
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
Medical Director
Agenus Inc.
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
HonorHealth Research Institute
Scottsdale
Arizona
85258
United States
City of Hope
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
Plan to Share IPD
No
Description
Not provided
Types
Not provided
Time Frame
Not provided
Access Criteria
Not provided
URL
Not provided
Results Section
Participant Flow Module
Pre-assignment Details
Not provided
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Phase 1: Balstilimab Dose 1
Participants received 1 milligram/kilogram (mg/kg) every 2 weeks (Q2W) balstilimab for up to 24 months.
FG001
Phase 1: Balstilimab Dose 2
Participants received 3 mg/kg Q2W balstilimab for up to 24 months.
Periods
Title
Milestones
Reasons Not Completed
Phase 1: Dose Escalation
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
Sep 27, 2019
May 29, 2025
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Georgia
Lithuania
Moldova
Romania
Ukraine
Submission Tracking
Estimated Results First Submitted Date
Not provided
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
N/A
Intervention Model
Single Group 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
Anti-PD-1
Phase 1: Maximum Observed Concentration (Cmax) of Balstilimab
Blood samples were collected for serum balstilimab concentration determinations. Results are reported as micrograms/milliliter (ug/mL).
Day 1 (Pre-dose up to 24 hours post dose) of Cycle 1 and Cycle 2 (2-3 weeks/cycle) (up to 3 weeks)
Phase 1: Area Under the Drug Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUC0-last) of Balstilimab
Blood samples were collected for serum balstilimab concentration determinations. Results are reported as hours*micrograms/milliliter (h*µg/mL).
Day 1 (Pre-dose up to 24 hours post dose) of Cycle 1 and Cycle 2 (2-3 weeks/cycle) (up to 3 weeks)
Phase 1: Number of Participants With Serum Anti-drug Antibodies (ADAs) for Balstilimab
Blood samples were collected for serum balstilimab ADA determination.
Up to 2.5 years
Phase 2: Number of Participants Experiencing TEAEs
An AE was any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product, which did not necessarily have a causal relationship with the treatment. TEAEs were AEs with onset dates during the on-treatment period, or the worsening of an event during the on-treatment period. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.
Up to 3 years
Phase 2: Cmax of Balstilimab
Blood samples were collected for serum balstilimab concentration determinations. Results are reported in μg/mL.
Day 1 (Pre-dose up to 24 hours post dose) of Cycle 1 and Cycle 2 (2 weeks/cycle) (up to 2 weeks)
Phase 2: AUC0-last of Balstilimab
Blood samples were collected for serum balstilimab concentration determinations. Results are reported in day*μg/mL.
Day 1 (Pre-dose up to 24 hours post dose) of Cycle 1 and Cycle 2 (2 weeks/cycle) (up to 2 weeks)
Phase 2: Number of Participants With Serum ADAs for Balstilimab
Blood samples were collected for serum balstilimab ADA determination.
Up to 2.5 years
Phase 2: ORR as Determined by the Investigator
ORR was defined as percentage of participants with a BOR of CR or PR, as determined by the investigator per RECIST 1.1. BOR was defined as the best response recorded from the start of the study treatment until the end of treatment. CR was defined as disappearance of all target lesions, and PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Up to 3 years
Phase 2: Duration of Response (DOR)
DOR was defined as time from first observation of response to first observation of documented progressive disease (PD) (or death within 12 weeks after last tumor assessment), per RECIST 1.1 and as determined by an IERC and the investigator. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this included the baseline sum if that is the smallest on study). Participants without an event at analysis cutoff date were censored on date of last tumor assessment.
Up to 3 years
Phase 2: Disease Control Rate (DCR) as Determined by an IERC
DCR was defined as the percentage of participants with CR, PR, or stable disease (SD) for at least 12 weeks. CR was defined as disappearance of all target lesions, PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this included the baseline sum if that is the smallest on study).
Up to 3 years
Phase 2: Tumor Control Rate (TCR) as Determined by an IERC
TCR was defined as percentage of participants who had a BOR of either SD or a confirmed objective response (CR or PR). CR was defined as disappearance of all target lesions, PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this included the baseline sum if that is the smallest on study).
Up to 3 years
Phase 2: Time to Response (TTR) as Determined by an IERC
TTR was defined as the time from the first dose date to first observation of confirmed response.
Up to 3 years
Phase 2: Progression-free Survival (PFS)
PFS was defined as time from first treatment administration to first observation of documented PD (or death within 12 weeks after last tumor assessment), per RECIST 1.1, as determined by an IERC and investigator. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this included the baseline sum if that is the smallest on study). Participants without an event at analysis cutoff date were censored on date of last tumor assessment.
Up to 3 years
Phase 2: Overall Survival (OS)
OS was defined as time from start of treatment to death. For participants who were still alive at the time of data cutoff for trial analysis or who were lost to follow-up, survival was censored at the last recorded date that the participant was known to have been alive as of the cutoff date for analysis.
Up to 3 years
Duarte
California
91010
United States
University of Southern California - Keck School of Medicine
Los Angeles
California
90033
United States
Sylvester Comprehensive Cancer Center
Miami
Florida
33136
United States
Florida Cancer Specialists & Research Institute
Sarasota
Florida
34232
United States
Augusta Oncology
Augusta
Georgia
30912
United States
Robert H. Lurie Comprehensive Cancer Center of Northwestern University
Chicago
Illinois
60611
United States
Dana Farber Cancer Institute
Boston
Massachusetts
02215
United States
The Ohio State University Comprehensive Cancer Center
Columbus
Ohio
43210
United States
The University of Oklahoma Health Sciences Center
Oklahoma City
Oklahoma
73104
United States
The University of Texas MD Anderson Cancer Center
Houston
Texas
77030
United States
Swedish Medical Center-Cherry Hill Campus
Seattle
Washington
98104
United States
Pindara Private Hospital
Benowa
Queensland
4217
Australia
Calvary North Adelaide Hospital
North Adelaide
South Australia
5006
Australia
Cliniques Universitaires Saint-Luc
Brussels
1200
Belgium
IMIP
Recife
Pernambuco
50070-550
Brazil
Instituto Nacional de Câncer
Rio de Janeiro
Rio de Janeiro
20220-410
Brazil
Hospital de Caridade de Ijuí
Ijuí
Rio Grande do Sul
98700-000
Brazil
Hospital Mãe de Deus
Porto Alegre
Rio Grande do Sul
90110-270
Brazil
Instituto do Cancer do Estado de São Paulo
São Paulo
São Paulo
01246-000
Brazil
Hospital Amaral Carvalho
São Paulo
São Paulo
03162-065
Brazil
Fundação Faculdade Regional de Medicina de São José do Rio Preto
São José do Rio Preto
15090-000
Brazil
Centro Oncológico del Norte
Antofagasta
AN
1240000
Chile
Centro De Investigación Del Cancer James Lind
Temuco
AR
4800827
Chile
Fundación Arturo López Pérez
Santiago
RM
7500918
Chile
Bradford Hill
Santiago
RM
8420323
Chile
East-Tallinn Central Hospital
Tallinn
1131
Estonia
North Estonia Medical Centre Foundation
Tallinn
13419
Estonia
Institut Bergonié
Bordeaux
33076
France
Centre Léon Bérard
Lyon
69008
France
L'Institut Paoli - Calmettes
Marseille
13273
France
CHU Hôpital de la Timone
Marseille
13385
France
Centre Antoine-Lacassagne
Nice
6189
France
Hôpital Cochin
Paris
75014
France
Groupe Hospitalier Diaconesses Croix Saint-Simon - Hopital de la Croix Saint-Simon
Paris
75020
France
Clinique Armoricaine de Radiologie
Plérin
22190
France
Institute de Cancerologie de l'Ouest (ICO) - René Gauducheau
Saint-Herblain
44805
France
Institut Claudius Regaud
Toulouse
31100
France
Gustave Roussy
Villejuif
94800
France
Szpital Swietego Rafala w Krakowie
Krakow
Lesser Poland Voivodeship
30-693
Poland
Szpitale Pomorskie Sp. z o.o.
Gdynia
Pomeranian Voivodeship
81-519
Poland
Vall d'Hebron Institut d'Oncologia
Barcelona
8035
Spain
Hospital Clínic de Barcelona
Barcelona
8036
Spain
Clínica Universidad de Navarra
Madrid
28027
Spain
FG002
Phase 1: Balstilimab Dose 3
Participants received 6 mg/kg every 3 weeks (Q3W) balstilimab for up to 24 months.
FG003
Phase 1: Balstilimab Dose 4
Participants received 10 mg/kg Q2W balstilimab for up to 24 months.
FG004
Phase 1: Balstilimab Dose 5
Participants received 10 mg/kg Q3W balstilimab for up to 24 months.
FG005
Phase 2: Balstilimab Recommended Phase 2 Dose
Participants received 3 mg/kg Q2W balstilimab for a maximum of 24 months or until progression, unacceptable toxicity, stopping the study drug, or withdrawal from the study.
FG00010 subjects
FG00110 subjects
FG00210 subjects
FG00310 subjects
FG00410 subjects
FG0050 subjects
Received at Least 1 Dose of Study Drug
Safety Analysis Set
FG00010 subjects
FG00110 subjects
FG00210 subjects
FG00310 subjects
FG00410 subjects
FG0050 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0022 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
NOT COMPLETED
FG00010 subjects
FG00110 subjects
FG0028 subjects
FG00310 subjects
FG00410 subjects
FG0050 subjects
Type
Comment
Reasons
Withdrawal by Subject
FG0002 subjects
FG0012 subjects
FG0024 subjects
FG0038 subjects
FG0044 subjects
FG0050 subjects
Physician Decision
FG0000 subjects
FG0010 subjects
FG0022 subjects
FG0031 subjects
FG004
Death
FG0006 subjects
FG0013 subjects
FG0020 subjects
FG0031 subjects
FG004
Completed Follow Up
FG0002 subjects
FG0012 subjects
FG0021 subjects
FG0030 subjects
FG004
Lost to Follow-up
FG0000 subjects
FG0011 subjects
FG0021 subjects
FG0030 subjects
FG004
Progressive Disease
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Disease Progression
FG0000 subjects
FG0012 subjects
FG0020 subjects
FG0030 subjects
FG004
Protocol Violation
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Phase 2: Dose Expansion
Type
Comment
Milestone Data
STARTED
FG0000 subjectsPhase 1 participants did not continue into Phase 2.
FG0010 subjectsPhase 1 participants did not continue into Phase 2.
FG0020 subjectsPhase 1 participants did not continue into Phase 2.
FG0030 subjectsPhase 1 participants did not continue into Phase 2.
FG0040 subjectsPhase 1 participants did not continue into Phase 2.
FG005161 subjectsPhase 2 participants enrolled separately from Phase 1.
Received at Least 1 Dose of Study Drug
Safety Analysis Set
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
COMPLETED
Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section.
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Safety Analysis Set: all participants who received at least 1 dose of balstilimab.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Phase 1: Balstilimab Dose 1
Participants received 1 mg/kg Q2W balstilimab for up to 24 months.
BG001
Phase 1: Balstilimab Dose 2
Participants received 3 mg/kg Q2W balstilimab for up to 24 months.
BG002
Phase 1: Balstilimab Dose 3
Participants received 6 mg/kg Q3W balstilimab for up to 24 months.
BG003
Phase 1: Balstilimab Dose 4
Participants received 10 mg/kg Q2W balstilimab for up to 24 months.
BG004
Phase 1: Balstilimab Dose 5
Participants received 10 mg/kg Q3W balstilimab for up to 24 months.
BG005
Phase 2: Balstilimab Recommended Phase 2 Dose
Participants received 3 mg/kg Q2W balstilimab for a maximum of 24 months or until progression, unacceptable toxicity, stopping the study drug, or withdrawal from the study.
BG006
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00010
BG00110
BG00210
BG00310
BG00410
BG005161
BG006211
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Customized
Count of Participants
Participants
Title
Denominators
Categories
Adults (18-64 years)
Title
Measurements
BG0007
BG0019
BG0026
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0008
BG0018
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0001
BG0010
BG002
Race/Ethnicity, Customized
Count of Participants
Participants
Title
Denominators
Categories
Asian
Title
Measurements
BG0000
BG0013
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
Phase 1: Number of Participants Experiencing Dose-limiting Toxicities (DLTs) for Balstilimab
A DLT was defined as any treatment-related toxicity that was National Cancer Institute Common Terminology Criteria for Adverse Event Grade ≥3, confirmed by the safety monitoring committee to be relevant for the study drug treatment, and that occurred during the first 3 weeks of balstilimab treatment in the dose escalation portion of the study (DLT evaluation period).
DLT Analysis Set: all participants who were enrolled for DLT evaluation (excluding participants enrolled to backfill cohorts) and either received all balstilimab administrations or stopped treatment due to a DLT during the DLT evaluation period. Here, 'Overall Number of Participants Analyzed' signifies those participants who were evaluable for this outcome measure.
Posted
Count of Participants
Participants
21 days
ID
Title
Description
OG000
Phase 1: Balstilimab Dose 1
Participants received 1 mg/kg Q2W balstilimab for up to 24 months.
OG001
Phase 1: Balstilimab Dose 2
Participants received 3 mg/kg Q2W balstilimab for up to 24 months.
OG002
Phase 1: Balstilimab Dose 3
Participants received 6 mg/kg Q3W balstilimab for up to 24 months.
OG003
Phase 1: Balstilimab Dose 4
Participants received 10 mg/kg Q2W balstilimab for up to 24 months.
OG004
Phase 1: Balstilimab Dose 5
Participants received 10 mg/kg Q3W balstilimab for up to 24 months.
Units
Counts
Participants
OG0003
OG0016
OG0023
OG003
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG003
Primary
Phase 1: Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
An adverse event (AE) was any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product, which did not necessarily have a causal relationship with the treatment. TEAEs were AEs with onset dates during the on-treatment period, or the worsening of an event during the on-treatment period. A summary of all Serious Adverse Events and Other Adverse Events (nonserious), regardless of causality, is located in the 'Reported Adverse Events' Section.
Safety Analysis Set: all participants who received at least 1 dose of balstilimab.
Posted
Count of Participants
Participants
Up to 3 years
ID
Title
Description
OG000
Phase 1: Balstilimab Dose 1
Participants received 1 mg/kg Q2W balstilimab for up to 24 months.
OG001
Phase 1: Balstilimab Dose 2
Participants received 3 mg/kg Q2W balstilimab for up to 24 months.
OG002
Phase 1: Balstilimab Dose 3
Participants received 6 mg/kg Q3W balstilimab for up to 24 months.
OG003
Primary
Phase 2: Objective Response Rate (ORR) as Determined by an Independent Endpoint Review Committee (IERC)
ORR was defined as percentage of participants with a best overall response (BOR) of complete response (CR) or partial response (PR), as determined by an IERC per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1). BOR was defined as the best response recorded from the start of the study treatment until the end of treatment. CR was defined as disappearance of all target lesions, and PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Intent-to-Treat Efficacy Analysis Set: all participants who received ≥1 dose of balstilimab with measurable disease at baseline (per IERC).
Posted
Number
95% Confidence Interval
percentage of participants
Up to 3 years
ID
Title
Description
OG000
Phase 2: Balstilimab Recommended Phase 2 Dose
Participants received 3 mg/kg Q2W balstilimab for a maximum of 24 months or until progression, unacceptable toxicity, stopping the study drug, or withdrawal from the study.
Units
Counts
Participants
OG000
Secondary
Phase 1: Receptor Occupancy of Circulating T Cells
The percentage of PD-1 receptor occupancy on circulating T cells was measured as an indication of target engagement. An increase in percent occupancy indicates a potential increase in drug effectiveness.
Receptor Occupancy Analysis Set: all participants who completed ≥1 balstilimab infusion, with adequate measurements of PD-1 receptor occupancy on circulating T cells. Here, 'Number Analyzed' signifies those participants who were evaluable for this outcome measure at the specified time points.
Posted
Mean
Standard Deviation
percent occupancy
4 hours after the first dose (Cycle 1 Day 1) and immediately prior to the second dose (Cycle 2 Day 1) (2-3 weeks/cycle)
ID
Title
Description
OG000
Phase 1: Balstilimab Dose 1
Participants received 1 mg/kg Q2W balstilimab for up to 24 months.
OG001
Phase 1: Balstilimab Dose 2
Participants received 3 mg/kg Q2W balstilimab for up to 24 months.
OG002
Phase 1: Balstilimab Dose 3
Participants received 6 mg/kg Q3W balstilimab for up to 24 months.
OG003
Secondary
Phase 1: Maximum Observed Concentration (Cmax) of Balstilimab
Blood samples were collected for serum balstilimab concentration determinations. Results are reported as micrograms/milliliter (ug/mL).
Pharmacokinetic Analysis Set: all participants who completed ≥1 balstilimab infusion of study drug and who had sufficient evaluable drug concentration measurements prior to and after treatment. Here, 'Number Analyzed' signifies those participants who were evaluable for this outcome measure at the specified time points.
Posted
Geometric Mean
Geometric Coefficient of Variation
ug/mL
Day 1 (Pre-dose up to 24 hours post dose) of Cycle 1 and Cycle 2 (2-3 weeks/cycle) (up to 3 weeks)
ID
Title
Description
OG000
Phase 1: Balstilimab Dose 1
Participants received 1 mg/kg Q2W balstilimab for up to 24 months.
OG001
Phase 1: Balstilimab Dose 2
Participants received 3 mg/kg Q2W balstilimab for up to 24 months.
OG002
Phase 1: Balstilimab Dose 3
Participants received 6 mg/kg Q3W balstilimab for up to 24 months.
OG003
Phase 1: Balstilimab Dose 4
Secondary
Phase 1: Area Under the Drug Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUC0-last) of Balstilimab
Blood samples were collected for serum balstilimab concentration determinations. Results are reported as hours*micrograms/milliliter (h*µg/mL).
Pharmacokinetic Analysis Set: all participants who completed ≥1 balstilimab infusion and who had sufficient evaluable drug concentration measurements prior to and after treatment. Here, 'Number Analyzed' signifies those participants who were evaluable for this outcome measure at the specified time points.
Posted
Geometric Mean
Geometric Coefficient of Variation
h*µg/mL
Day 1 (Pre-dose up to 24 hours post dose) of Cycle 1 and Cycle 2 (2-3 weeks/cycle) (up to 3 weeks)
ID
Title
Description
OG000
Phase 1: Balstilimab Dose 1
Participants received 1 mg/kg Q2W balstilimab for up to 24 months.
OG001
Phase 1: Balstilimab Dose 2
Participants received 3 mg/kg Q2W balstilimab for up to 24 months.
OG002
Phase 1: Balstilimab Dose 3
Participants received 6 mg/kg Q3W balstilimab for up to 24 months.
OG003
Secondary
Phase 1: Number of Participants With Serum Anti-drug Antibodies (ADAs) for Balstilimab
Blood samples were collected for serum balstilimab ADA determination.
Safety Analysis Set: all participants who received at least 1 dose of balstilimab.
Posted
Count of Participants
Participants
Up to 2.5 years
ID
Title
Description
OG000
Phase 1: Balstilimab Dose 1
Participants received 1 mg/kg Q2W balstilimab for up to 24 months.
OG001
Phase 1: Balstilimab Dose 2
Participants received 3 mg/kg Q2W balstilimab for up to 24 months.
OG002
Phase 1: Balstilimab Dose 3
Participants received 6 mg/kg Q3W balstilimab for up to 24 months.
OG003
Phase 1: Balstilimab Dose 4
Participants received 10 mg/kg Q2W balstilimab for up to 24 months.
OG004
Phase 1: Balstilimab Dose 5
Secondary
Phase 2: Number of Participants Experiencing TEAEs
An AE was any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product, which did not necessarily have a causal relationship with the treatment. TEAEs were AEs with onset dates during the on-treatment period, or the worsening of an event during the on-treatment period. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.
Safety Analysis Set: all participants who received at least 1 dose of balstilimab.
Posted
Count of Participants
Participants
Up to 3 years
ID
Title
Description
OG000
Phase 2: Balstilimab Recommended Phase 2 Dose
Participants received 3 mg/kg Q2W balstilimab for a maximum of 24 months or until progression, unacceptable toxicity, stopping the study drug, or withdrawal from the study.
Units
Counts
Participants
OG000
Secondary
Phase 2: Cmax of Balstilimab
Blood samples were collected for serum balstilimab concentration determinations. Results are reported in μg/mL.
Pharmacokinetic Analysis Set: all participants who completed ≥1 balstilimab infusion and who had sufficient evaluable drug concentration measurements prior to and after treatment. Here, 'Number Analyzed' signifies those participants who were evaluable for this outcome measure at the specified time points.
Posted
Geometric Mean
Geometric Coefficient of Variation
μg/mL
Day 1 (Pre-dose up to 24 hours post dose) of Cycle 1 and Cycle 2 (2 weeks/cycle) (up to 2 weeks)
ID
Title
Description
OG000
Phase 2: Balstilimab Recommended Phase 2 Dose
Participants received 3 mg/kg Q2W balstilimab for a maximum of 24 months or until progression, unacceptable toxicity, stopping the study drug, or withdrawal from the study.
Units
Counts
Participants
OG000
Secondary
Phase 2: AUC0-last of Balstilimab
Blood samples were collected for serum balstilimab concentration determinations. Results are reported in day*μg/mL.
Pharmacokinetic Analysis Set: all participants who completed ≥1 balstilimab infusion and who had sufficient evaluable drug concentration measurements prior to and after treatment. Here, 'Number Analyzed' signifies those participants who were evaluable for this outcome measure at the specified time points.
Posted
Geometric Mean
Geometric Coefficient of Variation
day*μg/mL
Day 1 (Pre-dose up to 24 hours post dose) of Cycle 1 and Cycle 2 (2 weeks/cycle) (up to 2 weeks)
ID
Title
Description
OG000
Phase 2: Balstilimab Recommended Phase 2 Dose
Participants received 3 mg/kg Q2W balstilimab for a maximum of 24 months or until progression, unacceptable toxicity, stopping the study drug, or withdrawal from the study.
Units
Counts
Participants
OG000
Secondary
Phase 2: Number of Participants With Serum ADAs for Balstilimab
Blood samples were collected for serum balstilimab ADA determination.
Safety Analysis Set: all participants who received at least 1 dose of balstilimab.
Posted
Count of Participants
Participants
Up to 2.5 years
ID
Title
Description
OG000
Phase 2: Balstilimab Recommended Phase 2 Dose
Participants received 3 mg/kg Q2W balstilimab for a maximum of 24 months or until progression, unacceptable toxicity, stopping the study drug, or withdrawal from the study.
Units
Counts
Participants
OG000
Secondary
Phase 2: ORR as Determined by the Investigator
ORR was defined as percentage of participants with a BOR of CR or PR, as determined by the investigator per RECIST 1.1. BOR was defined as the best response recorded from the start of the study treatment until the end of treatment. CR was defined as disappearance of all target lesions, and PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Intent-to-Treat Efficacy Analysis Set: all participants who received ≥1 dose of balstilimab with measurable disease at baseline.
Posted
Number
95% Confidence Interval
percentage of participants
Up to 3 years
ID
Title
Description
OG000
Phase 2: Balstilimab Recommended Phase 2 Dose
Participants received 3 mg/kg Q2W balstilimab for a maximum of 24 months or until progression, unacceptable toxicity, stopping the study drug, or withdrawal from the study.
Units
Counts
Participants
OG000
Secondary
Phase 2: Duration of Response (DOR)
DOR was defined as time from first observation of response to first observation of documented progressive disease (PD) (or death within 12 weeks after last tumor assessment), per RECIST 1.1 and as determined by an IERC and the investigator. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this included the baseline sum if that is the smallest on study). Participants without an event at analysis cutoff date were censored on date of last tumor assessment.
Intent-to-Treat Efficacy Analysis Set: all participants who received ≥1 dose of balstilimab with measurable disease at baseline (per IERC). Here, 'Overall Number of Participants Analyzed' and 'Number Analyzed' signify those participants who were evaluable for this outcome measure.
Posted
Median
95% Confidence Interval
months
Up to 3 years
ID
Title
Description
OG000
Phase 2: Balstilimab Recommended Phase 2 Dose
Participants received 3 mg/kg Q2W balstilimab for a maximum of 24 months or until progression, unacceptable toxicity, stopping the study drug, or withdrawal from the study.
Units
Counts
Participants
Secondary
Phase 2: Disease Control Rate (DCR) as Determined by an IERC
DCR was defined as the percentage of participants with CR, PR, or stable disease (SD) for at least 12 weeks. CR was defined as disappearance of all target lesions, PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this included the baseline sum if that is the smallest on study).
Intent-to-Treat Efficacy Analysis Set: all participants who received ≥1 dose of balstilimab with measurable disease at baseline (per IERC).
Posted
Number
95% Confidence Interval
percentage of participants
Up to 3 years
ID
Title
Description
OG000
Phase 2: Balstilimab Recommended Phase 2 Dose
Participants received 3 mg/kg Q2W balstilimab for a maximum of 24 months or until progression, unacceptable toxicity, stopping the study drug, or withdrawal from the study.
Units
Counts
Participants
Secondary
Phase 2: Tumor Control Rate (TCR) as Determined by an IERC
TCR was defined as percentage of participants who had a BOR of either SD or a confirmed objective response (CR or PR). CR was defined as disappearance of all target lesions, PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this included the baseline sum if that is the smallest on study).
Intent-to-Treat Efficacy Analysis Set: all participants who received ≥1 dose of balstilimab with measurable disease at baseline (per IERC).
Posted
Number
95% Confidence Interval
percentage of participants
Up to 3 years
ID
Title
Description
OG000
Phase 2: Balstilimab Recommended Phase 2 Dose
Participants received 3 mg/kg Q2W balstilimab for a maximum of 24 months or until progression, unacceptable toxicity, stopping the study drug, or withdrawal from the study.
Units
Counts
Participants
Secondary
Phase 2: Time to Response (TTR) as Determined by an IERC
TTR was defined as the time from the first dose date to first observation of confirmed response.
Intent-to-Treat Efficacy Analysis Set: all participants who received ≥1 dose of balstilimab with measurable disease at baseline (per IERC). Here, 'Overall Number of Participants Analyzed' signifies those participants who were evaluable for this outcome measure.
Posted
Median
95% Confidence Interval
days
Up to 3 years
ID
Title
Description
OG000
Phase 2: Balstilimab Recommended Phase 2 Dose
Participants received 3 mg/kg Q2W balstilimab for a maximum of 24 months or until progression, unacceptable toxicity, stopping the study drug, or withdrawal from the study.
Units
Counts
Participants
OG000
Secondary
Phase 2: Progression-free Survival (PFS)
PFS was defined as time from first treatment administration to first observation of documented PD (or death within 12 weeks after last tumor assessment), per RECIST 1.1, as determined by an IERC and investigator. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this included the baseline sum if that is the smallest on study). Participants without an event at analysis cutoff date were censored on date of last tumor assessment.
Intent-to-Treat Efficacy Analysis Set: all participants who received ≥1 dose of balstilimab with measurable disease at baseline (per IERC). Here, 'Overall Number of Participants Analyzed' and 'Number Analyzed' signify those participants who were evaluable for this outcome measure.
Posted
Median
95% Confidence Interval
months
Up to 3 years
ID
Title
Description
OG000
Phase 2: Balstilimab Recommended Phase 2 Dose
Participants received 3 mg/kg Q2W balstilimab for a maximum of 24 months or until progression, unacceptable toxicity, stopping the study drug, or withdrawal from the study.
Units
Counts
Participants
OG000
Secondary
Phase 2: Overall Survival (OS)
OS was defined as time from start of treatment to death. For participants who were still alive at the time of data cutoff for trial analysis or who were lost to follow-up, survival was censored at the last recorded date that the participant was known to have been alive as of the cutoff date for analysis.
Intent-to-Treat Efficacy Analysis Set: all participants who received ≥1 dose of balstilimab with measurable disease at baseline (per IERC). Here, 'Overall Number of Participants Analyzed' and 'Number Analyzed' signify those participants who were evaluable for this outcome measure.
Posted
Median
95% Confidence Interval
months
Up to 3 years
ID
Title
Description
OG000
Phase 2: Balstilimab Recommended Phase 2 Dose
Participants received 3 mg/kg Q2W balstilimab for a maximum of 24 months or until progression, unacceptable toxicity, stopping the study drug, or withdrawal from the study.
Units
Counts
Participants
OG000
Time Frame
From Day 1 to the end of study (3 years)
Description
All reported safety data based upon the Safety Analysis Set: all participants who received at least 1 dose of balstilimab.
All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section. Only deaths notified as leading to study discontinuation during Phase 2 are reported in the Participant Flow section.
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
Phase 1: Balstilimab Dose 1
Participants received 1 mg/kg Q2W balstilimab for up to 24 months.
6
10
5
10
10
10
EG001
Phase 1: Balstilimab Dose 2
Participants received 3 mg/kg Q2W balstilimab for up to 24 months.
3
10
3
10
10
10
EG002
Phase 1: Balstilimab Dose 3
Participants received 6 mg/kg Q3W balstilimab for up to 24 months.
0
10
5
10
10
10
EG003
Phase 1: Balstilimab Dose 4
Participants received 10 mg/kg Q2W balstilimab for up to 24 months.
1
10
3
10
10
10
EG004
Phase 1: Balstilimab Dose 5
Participants received 10 mg/kg Q3W balstilimab for up to 24 months.
1
10
2
10
10
10
EG005
Phase 2: Balstilimab Recommended Phase 2 Dose
Participants received 3 mg/kg Q2W balstilimab for a maximum of 24 months or until progression, unacceptable toxicity, stopping the study drug, or withdrawal from the study.
108
161
90
161
158
161
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Cancer pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.1
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG0030 affected10 at risk
EG004
Metastases to spine
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.1
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Tumour associated fever
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.1
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Tumour pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.1
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Tumour haemorrhage
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.1
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Malignant ascites
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.1
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Metastases to meninges
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.1
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Breast cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.1
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Malignant pleural effusion
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.1
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Hypertensive crisis
Vascular disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0021 affected10 at risk
EG003
Pelvic venous thrombosis
Vascular disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Shock haemorrhagic
Vascular disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Superior vena cava syndrome
Vascular disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Venous thrombosis
Vascular disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
General physical health deterioration
General disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Pyrexia
General disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Fatigue
General disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Oedema
General disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Oedema peripheral
General disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Pelvic pain
Reproductive system and breast disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Vaginal haemorrhage
Reproductive system and breast disorders
MedDRA 22.1
Systematic Assessment
This is a sex-specific adverse event. Only female participants were at risk.
EG0000 affected8 at risk
EG0010 affected8 at risk
EG0020 affected9 at risk
EG003
Cervix haemorrhage uterine
Reproductive system and breast disorders
MedDRA 22.1
Systematic Assessment
This is a sex-specific adverse event. Only female participants were at risk.
EG0000 affected8 at risk
EG0010 affected8 at risk
EG0020 affected9 at risk
EG003
Pneumonitis
Respiratory, thoracic and mediastinal disorders
MedDRA 22.1
Systematic Assessment
EG0001 affected10 at risk
EG0011 affected10 at risk
EG0020 affected10 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Acute respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Obstructive airways disorder
Respiratory, thoracic and mediastinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Confusional state
Psychiatric disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected10 at risk
EG0011 affected10 at risk
EG0020 affected10 at risk
EG003
Blood creatinine increased
Investigations
MedDRA 22.1
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
General physical condition abnormal
Investigations
MedDRA 22.1
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Aortic injury
Injury, poisoning and procedural complications
MedDRA 22.1
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Cystitis radiation
Injury, poisoning and procedural complications
MedDRA 22.1
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Femur fracture
Injury, poisoning and procedural complications
MedDRA 22.1
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Lumbar vertebral fracture
Injury, poisoning and procedural complications
MedDRA 22.1
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Cardiopulmonary failure
Cardiac disorders
MedDRA 22.1
Systematic Assessment
EG0001 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Acute coronary syndrome
Cardiac disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Ischaemic stroke
Nervous system disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0021 affected10 at risk
EG003
Syncope
Nervous system disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Brain oedema
Nervous system disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Headache
Nervous system disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Hemiparesis
Nervous system disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Seizure
Nervous system disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Anaemia
Blood and lymphatic system disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Immune thrombocytopenic purpura
Blood and lymphatic system disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Colitis
Gastrointestinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0021 affected10 at risk
EG003
Colonic fistula
Gastrointestinal disorders
MedDRA 22.1
Systematic Assessment
EG0001 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 22.1
Systematic Assessment
EG0001 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0021 affected10 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0021 affected10 at risk
EG003
Small intestinal obstruction
Gastrointestinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0021 affected10 at risk
EG003
Upper GI haemorrhage
Gastrointestinal disorders
MedDRA 22.1
Systematic Assessment
EG0001 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0021 affected10 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Immune-mediated enterocolitis
Gastrointestinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Intestinal obstruction
Gastrointestinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Large intestinal obstruction
Gastrointestinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Gastrointestinal obstruction
Gastrointestinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Ascites
Gastrointestinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Intestinal ischaemia
Gastrointestinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Intra-abdominal haemorrhage
Gastrointestinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Large intestine perforation
Gastrointestinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Mechanical ileus
Gastrointestinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Bile duct obstruction
Hepatobiliary disorders
MedDRA 22.1
Systematic Assessment
EG0001 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Hepatitis
Hepatobiliary disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected10 at risk
EG0011 affected10 at risk
EG0020 affected10 at risk
EG003
Biliary dilatation
Hepatobiliary disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Psoriasis
Skin and subcutaneous tissue disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Renal failure
Renal and urinary disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Immune-mediated nephritis
Renal and urinary disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Postrenal failure
Renal and urinary disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Pyelocaliectasis
Renal and urinary disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Hydronephrosis
Renal and urinary disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Oliguria
Renal and urinary disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Prerenal failure
Renal and urinary disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Proteinuria
Renal and urinary disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Ureteric obstruction
Renal and urinary disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Urogenital fistula
Renal and urinary disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Adrenal insufficiency
Endocrine disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Hypercalcaemia of malignancy
Endocrine disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0000 affected10 at risk
EG0011 affected10 at risk
EG0020 affected10 at risk
EG003
Bacteraemia
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Impetigo
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0000 affected10 at risk
EG0011 affected10 at risk
EG0020 affected10 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0000 affected10 at risk
EG0011 affected10 at risk
EG0020 affected10 at risk
EG003
Corona virus infection
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Device related infection
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Urosepsis
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Arboviral infection
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Clostridium difficile colitis
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Escherichia pyelonephritis
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Escherichia urinary tract infection
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Fungal infection
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Herpes zoster
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Intervertebral discitis
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Klebsiella bacteraemia
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Pyelonephritis
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Pyelonephritis acute
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Septic shock
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Diabetic ketoacidosis
Metabolism and nutrition disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Nausea
Gastrointestinal disorders
MedDRA 22.1
Systematic Assessment
EG0006 affected10 at risk
EG0013 affected10 at risk
EG0024 affected10 at risk
EG0035 affected10 at risk
EG0043 affected10 at risk
EG00547 affected161 at risk
Constipation
Gastrointestinal disorders
MedDRA 22.1
Systematic Assessment
EG0004 affected10 at risk
EG0012 affected10 at risk
EG0022 affected10 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 22.1
Systematic Assessment
EG0003 affected10 at risk
EG0014 affected10 at risk
EG0022 affected10 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 22.1
Systematic Assessment
EG0003 affected10 at risk
EG0013 affected10 at risk
EG0022 affected10 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 22.1
Systematic Assessment
EG0001 affected10 at risk
EG0012 affected10 at risk
EG0022 affected10 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 22.1
Systematic Assessment
EG0001 affected10 at risk
EG0011 affected10 at risk
EG0021 affected10 at risk
EG003
Asthenia
General disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected10 at risk
EG0011 affected10 at risk
EG0021 affected10 at risk
EG003
Fatigue
General disorders
MedDRA 22.1
Systematic Assessment
EG0007 affected10 at risk
EG0014 affected10 at risk
EG0023 affected10 at risk
EG003
Pyrexia
General disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0023 affected10 at risk
EG003
Oedema peripheral
General disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected10 at risk
EG0011 affected10 at risk
EG0021 affected10 at risk
EG003
Anaemia
Blood and lymphatic system disorders
MedDRA 22.1
Systematic Assessment
EG0007 affected10 at risk
EG0014 affected10 at risk
EG0023 affected10 at risk
EG003
Lymphopenia
Blood and lymphatic system disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 22.1
Systematic Assessment
EG0003 affected10 at risk
EG0011 affected10 at risk
EG0023 affected10 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 22.1
Systematic Assessment
EG0001 affected10 at risk
EG0012 affected10 at risk
EG0021 affected10 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 22.1
Systematic Assessment
EG0001 affected10 at risk
EG0011 affected10 at risk
EG0021 affected10 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 22.1
Systematic Assessment
EG0001 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA 22.1
Systematic Assessment
EG0001 affected10 at risk
EG0010 affected10 at risk
EG0021 affected10 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0002 affected10 at risk
EG0013 affected10 at risk
EG0020 affected10 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 22.1
Systematic Assessment
EG0003 affected10 at risk
EG0015 affected10 at risk
EG0023 affected10 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0022 affected10 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected10 at risk
EG0011 affected10 at risk
EG0020 affected10 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 22.1
Systematic Assessment
EG0001 affected10 at risk
EG0010 affected10 at risk
EG0021 affected10 at risk
EG003
Blood creatinine increased
Investigations
MedDRA 22.1
Systematic Assessment
EG0001 affected10 at risk
EG0012 affected10 at risk
EG0021 affected10 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 22.1
Systematic Assessment
EG0000 affected10 at risk
EG0011 affected10 at risk
EG0020 affected10 at risk
EG003
Blood alkaline phosphatase increased
Investigations
MedDRA 22.1
Systematic Assessment
EG0001 affected10 at risk
EG0011 affected10 at risk
EG0022 affected10 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 22.1
Systematic Assessment
EG0000 affected10 at risk
EG0011 affected10 at risk
EG0021 affected10 at risk
EG003
Weight decreased
Investigations
MedDRA 22.1
Systematic Assessment
EG0002 affected10 at risk
EG0011 affected10 at risk
EG0020 affected10 at risk
EG003
Gamma-glutamyltransferase increased
Investigations
MedDRA 22.1
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0022 affected10 at risk
EG003
Lipase increased
Investigations
MedDRA 22.1
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 22.1
Systematic Assessment
EG0002 affected10 at risk
EG0011 affected10 at risk
EG0021 affected10 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 22.1
Systematic Assessment
EG0004 affected10 at risk
EG0013 affected10 at risk
EG0021 affected10 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 22.1
Systematic Assessment
EG0001 affected10 at risk
EG0012 affected10 at risk
EG0021 affected10 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected10 at risk
EG0012 affected10 at risk
EG0021 affected10 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Headache
Nervous system disorders
MedDRA 22.1
Systematic Assessment
EG0001 affected10 at risk
EG0011 affected10 at risk
EG0021 affected10 at risk
EG003
Dysuria
Renal and urinary disorders
MedDRA 22.1
Systematic Assessment
EG0001 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Proteinuria
Renal and urinary disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA 22.1
Systematic Assessment
EG0001 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Pelvic pain
Reproductive system and breast disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Vaginal haemorrhage
Reproductive system and breast disorders
MedDRA 22.1
Systematic Assessment
This is a sex-specific adverse event. Only female participants were at risk.
EG0001 affected8 at risk
EG0010 affected8 at risk
EG0020 affected9 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA 22.1
Systematic Assessment
EG0001 affected10 at risk
EG0012 affected10 at risk
EG0021 affected10 at risk
EG003
Hyperthyroidism
Endocrine disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0021 affected10 at risk
EG003
Immune-mediated hypothyroidism
Endocrine disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Hypertension
Vascular disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA 22.1
Systematic Assessment
EG0001 affected10 at risk
EG0011 affected10 at risk
EG0020 affected10 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected10 at risk
EG0011 affected10 at risk
EG0020 affected10 at risk
EG003
Ascites
Gastrointestinal disorders
MedDRA 22.1
Systematic Assessment
EG0001 affected10 at risk
EG0011 affected10 at risk
EG0022 affected10 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA 22.1
Systematic Assessment
EG0001 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Abdominal pain lower
Gastrointestinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected10 at risk
EG0011 affected10 at risk
EG0020 affected10 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Toothache
Gastrointestinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected10 at risk
EG0011 affected10 at risk
EG0020 affected10 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Rectal haemorrhage
Gastrointestinal disorders
MedDRA 22.1
Systematic Assessment
EG0001 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Colitis
Gastrointestinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0021 affected10 at risk
EG003
Anal incontinence
Gastrointestinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Anorectal discomfort
Gastrointestinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0021 affected10 at risk
EG003
Intestinal haemorrhage
Gastrointestinal disorders
MedDRA 22.1
Systematic Assessment
EG0001 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Lip erythema
Gastrointestinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected10 at risk
EG0011 affected10 at risk
EG0020 affected10 at risk
EG003
Periodontal disease
Gastrointestinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected10 at risk
EG0011 affected10 at risk
EG0020 affected10 at risk
EG003
Pain
General disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0021 affected10 at risk
EG003
Mucosal inflammation
General disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0021 affected10 at risk
EG003
Chills
General disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected10 at risk
EG0011 affected10 at risk
EG0020 affected10 at risk
EG003
Oedema
General disorders
MedDRA 22.1
Systematic Assessment
EG0001 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Malaise
General disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected10 at risk
EG0011 affected10 at risk
EG0020 affected10 at risk
EG003
Catheter site pain
General disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected10 at risk
EG0011 affected10 at risk
EG0020 affected10 at risk
EG003
Gait disturbance
General disorders
MedDRA 22.1
Systematic Assessment
EG0001 affected10 at risk
EG0010 affected10 at risk
EG0021 affected10 at risk
EG003
Early satiety
General disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Leukocytosis
Blood and lymphatic system disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0021 affected10 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0021 affected10 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected10 at risk
EG0011 affected10 at risk
EG0021 affected10 at risk
EG003
Hypoalbuminaemia
Metabolism and nutrition disorders
MedDRA 22.1
Systematic Assessment
EG0001 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Hypocalcaemia
Metabolism and nutrition disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Hypophosphataemia
Metabolism and nutrition disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Hypernatraemia
Metabolism and nutrition disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Hypoglycaemia
Metabolism and nutrition disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0021 affected10 at risk
EG003
Flank pain
Musculoskeletal and connective tissue disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0021 affected10 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA 22.1
Systematic Assessment
EG0002 affected10 at risk
EG0010 affected10 at risk
EG0021 affected10 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA 22.1
Systematic Assessment
EG0002 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Osteopenia
Musculoskeletal and connective tissue disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0022 affected10 at risk
EG003
Foot deformity
Musculoskeletal and connective tissue disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0021 affected10 at risk
EG003
Myositis
Musculoskeletal and connective tissue disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0000 affected10 at risk
EG0011 affected10 at risk
EG0021 affected10 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0000 affected10 at risk
EG0011 affected10 at risk
EG0021 affected10 at risk
EG003
Cystitis
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0001 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Influenza
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0021 affected10 at risk
EG003
Sinusitis
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Candida infection
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0000 affected10 at risk
EG0011 affected10 at risk
EG0020 affected10 at risk
EG003
Folliculitis
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0021 affected10 at risk
EG003
Fungal infection
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0001 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Tooth infection
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Acarodermatitis
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0021 affected10 at risk
EG003
Bacterial disease carrier
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0021 affected10 at risk
EG003
Impetigo
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0000 affected10 at risk
EG0011 affected10 at risk
EG0020 affected10 at risk
EG003
Laryngitis
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Lymphocyte count decreased
Investigations
MedDRA 22.1
Systematic Assessment
EG0000 affected10 at risk
EG0011 affected10 at risk
EG0020 affected10 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA 22.1
Systematic Assessment
EG0000 affected10 at risk
EG0011 affected10 at risk
EG0020 affected10 at risk
EG003
Blood creatine phosphokinase increased
Investigations
MedDRA 22.1
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
International normalised ratio increased
Investigations
MedDRA 22.1
Systematic Assessment
EG0001 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected10 at risk
EG0011 affected10 at risk
EG0020 affected10 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected10 at risk
EG0011 affected10 at risk
EG0020 affected10 at risk
EG003
Dysphonia
Respiratory, thoracic and mediastinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected10 at risk
EG0011 affected10 at risk
EG0020 affected10 at risk
EG003
Rhinitis allergic
Respiratory, thoracic and mediastinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected10 at risk
EG0012 affected10 at risk
EG0020 affected10 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected10 at risk
EG0011 affected10 at risk
EG0020 affected10 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Dyspnoea exertional
Respiratory, thoracic and mediastinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected10 at risk
EG0011 affected10 at risk
EG0020 affected10 at risk
EG003
Pneumonitis
Respiratory, thoracic and mediastinal disorders
MedDRA 22.1
Systematic Assessment
EG0001 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Productive cough
Respiratory, thoracic and mediastinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Chronic obstructive pulmonary disease
Respiratory, thoracic and mediastinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Haemoptysis
Respiratory, thoracic and mediastinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected10 at risk
EG0011 affected10 at risk
EG0020 affected10 at risk
EG003
Wheezing
Respiratory, thoracic and mediastinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Hiccups
Respiratory, thoracic and mediastinal disorders
MedDRA 22.1
Systematic Assessment
EG0001 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected10 at risk
EG0011 affected10 at risk
EG0020 affected10 at risk
EG003
Nasal polyps
Respiratory, thoracic and mediastinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected10 at risk
EG0011 affected10 at risk
EG0020 affected10 at risk
EG003
Sinus congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected10 at risk
EG0011 affected10 at risk
EG0020 affected10 at risk
EG003
Sneezing
Respiratory, thoracic and mediastinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0021 affected10 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
MedDRA 22.1
Systematic Assessment
EG0003 affected10 at risk
EG0011 affected10 at risk
EG0020 affected10 at risk
EG003
Night sweats
Skin and subcutaneous tissue disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Dermatitis contact
Skin and subcutaneous tissue disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected10 at risk
EG0011 affected10 at risk
EG0020 affected10 at risk
EG003
Onycholysis
Skin and subcutaneous tissue disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0021 affected10 at risk
EG003
Rash macular
Skin and subcutaneous tissue disorders
MedDRA 22.1
Systematic Assessment
EG0001 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Eczema nummular
Skin and subcutaneous tissue disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Photosensitivity reaction
Skin and subcutaneous tissue disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0021 affected10 at risk
EG003
Skin discolouration
Skin and subcutaneous tissue disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Skin exfoliation
Skin and subcutaneous tissue disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected10 at risk
EG0011 affected10 at risk
EG0020 affected10 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 22.1
Systematic Assessment
EG0001 affected10 at risk
EG0012 affected10 at risk
EG0022 affected10 at risk
EG003
Dysgeusia
Nervous system disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected10 at risk
EG0011 affected10 at risk
EG0020 affected10 at risk
EG003
Syncope
Nervous system disorders
MedDRA 22.1
Systematic Assessment
EG0001 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Sinus headache
Nervous system disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Pollakiuria
Renal and urinary disorders
MedDRA 22.1
Systematic Assessment
EG0001 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected10 at risk
EG0011 affected10 at risk
EG0020 affected10 at risk
EG003
Urinary incontinence
Renal and urinary disorders
MedDRA 22.1
Systematic Assessment
EG0001 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Hydronephrosis
Renal and urinary disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected10 at risk
EG0011 affected10 at risk
EG0020 affected10 at risk
EG003
Nephritis
Renal and urinary disorders
MedDRA 22.1
Systematic Assessment
EG0001 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Urinary retention
Renal and urinary disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0021 affected10 at risk
EG003
Urinary tract pain
Renal and urinary disorders
MedDRA 22.1
Systematic Assessment
EG0001 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Erectile dysfunction
Reproductive system and breast disorders
MedDRA 22.1
Systematic Assessment
This is a sex-specific adverse event. Only male participants were at risk.
EG0000 affected2 at risk
EG0011 affected2 at risk
EG0020 affected1 at risk
EG003
Vaginal odour
Reproductive system and breast disorders
MedDRA 22.1
Systematic Assessment
This is a sex-specific adverse event. Only female participants were at risk.
EG0000 affected8 at risk
EG0010 affected8 at risk
EG0020 affected9 at risk
EG003
Depression
Psychiatric disorders
MedDRA 22.1
Systematic Assessment
EG0002 affected10 at risk
EG0010 affected10 at risk
EG0021 affected10 at risk
EG003
Confusional state
Psychiatric disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected10 at risk
EG0012 affected10 at risk
EG0020 affected10 at risk
EG003
Irritability
Psychiatric disorders
MedDRA 22.1
Systematic Assessment
EG0001 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Mental status changes
Psychiatric disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0021 affected10 at risk
EG003
Hot flush
Vascular disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0021 affected10 at risk
EG003
Flushing
Vascular disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0022 affected10 at risk
EG003
Hypotension
Vascular disorders
MedDRA 22.1
Systematic Assessment
EG0001 affected10 at risk
EG0011 affected10 at risk
EG0020 affected10 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRA 22.1
Systematic Assessment
EG0001 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Embolism
Vascular disorders
MedDRA 22.1
Systematic Assessment
EG0001 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Thrombophlebitis superficial
Vascular disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected10 at risk
EG0011 affected10 at risk
EG0020 affected10 at risk
EG003
Adrenal insufficiency
Endocrine disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected10 at risk
EG0011 affected10 at risk
EG0020 affected10 at risk
EG003
Tachycardia
Cardiac disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Bradycardia
Cardiac disorders
MedDRA 22.1
Systematic Assessment
EG0001 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Sinus bradycardia
Cardiac disorders
MedDRA 22.1
Systematic Assessment
EG0001 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Vision blurred
Eye disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0021 affected10 at risk
EG003
Dry eye
Eye disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Vitreous floaters
Eye disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0021 affected10 at risk
EG003
Infusion related reaction
Injury, poisoning and procedural complications
MedDRA 22.1
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Arthropod bite
Injury, poisoning and procedural complications
MedDRA 22.1
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0021 affected10 at risk
EG003
Radiation skin injury
Injury, poisoning and procedural complications
MedDRA 22.1
Systematic Assessment
EG0001 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Spinal column injury
Injury, poisoning and procedural complications
MedDRA 22.1
Systematic Assessment
EG0001 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Stoma site irritation
Injury, poisoning and procedural complications
MedDRA 22.1
Systematic Assessment
EG0000 affected10 at risk
EG0011 affected10 at risk
EG0020 affected10 at risk
EG003
Cholecystitis
Hepatobiliary disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Cancer pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.1
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Tumour pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.1
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected10 at risk
EG003
Tumour thrombosis
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Female Urogenital Diseases and Pregnancy Complications
D000091642
Urogenital Diseases
D000091662
Genital Diseases
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
C000720935
balstilimab
C000711728
spartalizumab
Ancestor Terms
Not provided
Browse Leaves
Not provided
Browse Branches
Not provided
0 subjects
FG0050 subjects
1 subjects
FG0050 subjects
2 subjects
FG0050 subjects
0 subjects
FG0050 subjects
1 subjects
FG0050 subjects
0 subjects
FG0050 subjects
2 subjects
FG0050 subjects
FG0040 subjects
FG005161 subjects
0 subjects
FG0040 subjects
FG00528 subjects
0 subjects
FG005133 subjects
0 subjects
FG0040 subjects
FG0056 subjects
Death
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG005107 subjects
Participant Left to Participate in Another Trial
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0051 subjects
Administrative Study Closure
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG00513 subjects
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0055 subjects
Progressive Disease
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0051 subjects
7
BG0046
BG005119
BG006154
From 65-84 years
Title
Measurements
BG0003
BG0011
BG0024
BG0033
BG0044
BG00542
BG00657
9
BG0039
BG0048
BG005161
BG006203
Male
BG0002
BG0012
BG0021
BG0031
BG0042
BG0050
BG0068
2
BG0031
BG0041
BG00538
BG00643
Not Hispanic or Latino
BG0009
BG00110
BG0028
BG0039
BG0049
BG00539
BG00684
Unknown or Not Reported
BG0000
BG0010
BG0020
BG0030
BG0040
BG00584
BG00684
1
BG0031
BG0041
BG0051
BG0067
Black or African American
Title
Measurements
BG0002
BG0011
BG0020
BG0030
BG0040
BG0052
BG0065
White
Title
Measurements
BG0008
BG0016
BG0029
BG0039
BG0049
BG00572
BG006113
Not Reported (France)
Title
Measurements
BG0000
BG0010
BG0020
BG0030
BG0040
BG00581
BG00681
Romanian
Title
Measurements
BG0000
BG0010
BG0020
BG0030
BG0040
BG0051
BG0061
Mixed
Title
Measurements
BG0000
BG0010
BG0020
BG0030
BG0040
BG0053
BG0063
Brown
Title
Measurements
BG0000
BG0010
BG0020
BG0030
BG0040
BG0051
BG0061
3
OG0043
0
OG0040
Phase 1: Balstilimab Dose 4
Participants received 10 mg/kg Q2W balstilimab for up to 24 months.
OG004
Phase 1: Balstilimab Dose 5
Participants received 10 mg/kg Q3W balstilimab for up to 24 months.
Units
Counts
Participants
OG00010
OG00110
OG00210
OG00310
OG00410
Title
Denominators
Categories
Title
Measurements
OG00010
OG00110
OG00210
OG00310
OG00410
160
Title
Denominators
Categories
Title
Measurements
OG00015.6(10.8 to 22.0)
Phase 1: Balstilimab Dose 4
Participants received 10 mg/kg Q2W balstilimab for up to 24 months.
OG004
Phase 1: Balstilimab Dose 5
Participants received 10 mg/kg Q3W balstilimab for up to 24 months.
Units
Counts
Participants
OG00010
OG0015
OG0020
OG0033
OG0040
Title
Denominators
Categories
Cycle 1 Day 1
ParticipantsOG00010
ParticipantsOG0015
ParticipantsOG0020
ParticipantsOG0033
ParticipantsOG0040
Title
Measurements
OG00073.2± 11.95
OG00169.4± 5.52
OG00376.6± 2.95
Cycle 2 Day 1
ParticipantsOG00010
ParticipantsOG0013
ParticipantsOG0020
ParticipantsOG0033
Participants received 10 mg/kg Q2W balstilimab for up to 24 months.
OG004
Phase 1: Balstilimab Dose 5
Participants received 10 mg/kg Q3W balstilimab for up to 24 months.
Units
Counts
Participants
OG00010
OG0019
OG00210
OG00310
OG00410
Title
Denominators
Categories
Cycle 1 Day 1
ParticipantsOG00010
ParticipantsOG0019
ParticipantsOG00210
ParticipantsOG0039
ParticipantsOG00410
Title
Measurements
OG00018.1± 34.3
OG00171.9± 19.5
OG002153± 23.7
OG003
Cycle 2 Day 1
ParticipantsOG00010
ParticipantsOG0019
ParticipantsOG0028
ParticipantsOG00310
Phase 1: Balstilimab Dose 4
Participants received 10 mg/kg Q2W balstilimab for up to 24 months.
OG004
Phase 1: Balstilimab Dose 5
Participants received 10 mg/kg Q3W balstilimab for up to 24 months.
Units
Counts
Participants
OG00010
OG0019
OG00210
OG00310
OG00410
Title
Denominators
Categories
Cycle 1 Day 1
ParticipantsOG00010
ParticipantsOG0019
ParticipantsOG00210
ParticipantsOG0039
ParticipantsOG00410
Title
Measurements
OG0001265± 47.4
OG0016470± 34.6
OG00212632± 51.5
OG003
Cycle 2 Day 1
ParticipantsOG00010
ParticipantsOG0019
ParticipantsOG0028
ParticipantsOG00310
Participants received 10 mg/kg Q3W balstilimab for up to 24 months.
Units
Counts
Participants
OG00010
OG00110
OG00210
OG00310
OG00410
Title
Denominators
Categories
Title
Measurements
OG0003
OG0010
OG0020
OG0030
OG0040
161
Title
Denominators
Categories
Title
Measurements
OG000161
124
Title
Denominators
Categories
Cycle 1 Day 1
ParticipantsOG000124
Title
Measurements
OG00055.4± 42.8
Cycle 2 Day 1
ParticipantsOG00028
Title
Measurements
OG00056.6± 23.9
124
Title
Denominators
Categories
Cycle 1 Day 1
ParticipantsOG000124
Title
Measurements
OG000174± 46.3
Cycle 2 Day 1
ParticipantsOG00028
Title
Measurements
OG000184± 59.7
161
Title
Denominators
Categories
Title
Measurements
OG0007
160
Title
Denominators
Categories
Title
Measurements
OG00014.4(9.8 to 20.6)
OG000
25
Title
Denominators
Categories
IERC
ParticipantsOG00025
Title
Measurements
OG000NA(7.3 to NA)The upper bound of the 95% confidence interval of the median could not be estimated as the median was not reached at the data cut-off.
Investigator
ParticipantsOG00023
Title
Measurements
OG000NA(8.9 to NA)The upper bound of the 95% confidence interval of the median could not be estimated as the median was not reached at the data cut-off.