An Investigational Immuno-therapy Study to Investigate th... | NCT02488759 | Trialant
NCT02488759
Sponsor
Bristol-Myers Squibb
Status
Completed
Last Update Posted
Nov 13, 2023Actual
Enrollment
578Actual
Phase
Phase 1Phase 2
Conditions
Various Advanced Cancer
Interventions
Nivolumab
Ipilimumab
Relatlimab
Daratumumab
Countries
United States
Belgium
France
Germany
Japan
Mexico
Netherlands
South Korea
Spain
Taiwan
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT02488759
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
CA209-358
Secondary IDs
ID
Type
Description
Link
2015-000230-29
EudraCT Number
Brief Title
An Investigational Immuno-therapy Study to Investigate the Safety and Effectiveness of Nivolumab, and Nivolumab Combination Therapy in Virus-associated Tumors
Official Title
Non-Comparative, Open-Label, Multiple Cohort, Phase 1/2 Study of Nivolumab Monotherapy and Nivolumab Combination Therapy in Subjects With Virus-Positive and Virus-Negative Solid Tumors
Acronym
CheckMate358
Organization
Bristol-Myers SquibbINDUSTRY
Status Module
Record Verification Date
Nov 2023
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Oct 13, 2015Actual
Primary Completion Date
Mar 19, 2021Actual
Completion Date
Oct 24, 2022Actual
First Submitted Date
Jun 30, 2015
First Submission Date that Met QC Criteria
Jun 30, 2015
First Posted Date
Jul 2, 2015Estimated
Results Waived
Not provided
Results First Submitted Date
Mar 17, 2022
Results First Submitted that Met QC Criteria
Mar 17, 2022
Results First Posted Date
Apr 12, 2022Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Nov 8, 2023
Last Update Posted Date
Nov 13, 2023Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Bristol-Myers SquibbINDUSTRY
Collaborators
Name
Class
Ono Pharmaceutical Co., Ltd.
INDUSTRY
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The purpose of this study to investigate the safety and effectiveness of nivolumab, and nivolumab combination therapy, to treat patients who have virus-associated tumors. Certain viruses have been known to play a role in tumor formation and growth. This study will investigate the effects of the study drugs, in patients who have the following types of tumors:
Anal canal cancer-No longer enrolling this tumor type
Cervical cancer
Epstein Barr Virus (EBV) positive gastric cancer-No longer enrolling this tumor type
Merkel Cell Cancer
Penile cancer-No longer enrolling this tumor type
Vaginal and vulvar cancer-No longer enrolling this tumor type
Nasopharyngeal Cancer - No longer enrolling this tumor type
Head and Neck Cancer - No longer enrolling this tumor type
Detailed Description
Not provided
Conditions Module
Conditions
Various Advanced Cancer
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 1Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
578Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Neoadjuvant Cohort
Experimental
Nivolumab intravenous infusion as specified
**Not participating: Japan, Korea, and Taiwan
Drug: Nivolumab
Metastatic Monotherapy Cohort
Experimental
Nivolumab intravenous infusion as specified
Drug: Nivolumab
Nivolumab plus Ipilimumab Cohort
Experimental
Nivolumab intravenous infusion as specified with Ipilimumab intravenous infusion as specified
**Not participating: Belgium, France and Germany
Cohort expansion participating countries: Spain, US, UK, Netherlands, Japan and Mexico
**Not participating in cohort expansion: France, Germany, Korea and Taiwan
Drug: Nivolumab
Drug: Ipilimumab
Nivolumab plus Relatlimab Cohort
Experimental
Nivolumab intravenous infusion as specified with Relatlimab intravenous infusion as specified
** Not Participating: Belgium, Germany, France, Japan, Korea, Taiwan, UK, and Netherlands
Enrollment is closed for this cohort
Drug: Nivolumab
Drug: Relatlimab
Nivolumab plus Daratumumab Cohort
Experimental
Nivolumab intravenous infusion as specified with Daratumumab intravenous infusion as specified
**Not Participating: Belgium, Germany, France, Japan, Korea, Taiwan, UK, and Netherlands
Enrollment is closed for this cohort
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Nivolumab
Drug
Metastatic Monotherapy Cohort
Neoadjuvant Cohort
Nivolumab plus Daratumumab Cohort
Nivolumab plus Ipilimumab Cohort
Nivolumab plus Relatlimab Cohort
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Neoadjuvant: Number of Participants With Drug-Related Select Adverse Events (AEs)
Number of participants with any grade of drug-related select adverse events (AEs) including endocrine, gastrointestinal, hepatic, pulmonary, renal, skin, and hypersensitivity AEs in Neoadjuvant cohort
From first dose to 30 days post last dose (Up to 2 months)
Neoadjuvant: Number of Participants With Drug-Related Serious Adverse Events (SAEs)
Number of participants with any grade of drug-related serious adverse events (SAEs) in Neoadjuvant cohort
From first dose to 30 days post last dose (Up to 2 months)
Neoadjuvant: Rate of Surgery Delay
Rate of surgery delay is defined as the percentage of participants in the neoadjuvant cohort with surgery delayed > 4 weeks from the planned surgery date or planned start date for chemoradiation due to a drug-related adverse event.
Participants with the following diseases will be assessed:
HPV positive squamous cell carcinoma of the Head and Neck (SCCHN);
Objective response rate (ORR) is defined as the percentage of participants with a best overall response (BOR) of confirmed complete response (CR) or partial response (PR) using RECIST 1.1 criteria. An ORR in excess of 10% will be considered of clinical interest, and an ORR of 25% or greater will be considered of strong clinical interest.
Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm.
Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Participants with the following diseases will be assessed:
EBV positive related gastric cancer;
HPV positive SCCHN;
Other anogenital HPV associated cancers;
GYN (Cervical, Vaginal, Vulvar) carcinoma;
Merkel cell carcinoma (MCC);
Nasopharyngeal carcinoma (NPC)
Secondary Outcomes
Measure
Description
Time Frame
Metastatic: Investigator-Assessed Duration of Response (DoR)
Duration of response (DoR) is defined as the time from first confirmed response (complete response or partial response) to the date of the initial objectively documented tumor progression as determined per investigator assessment using RECIST 1.1 criteria or death due to any cause, whichever occurs first. Participants with the following diseases will be assessed:
EBV positive related gastric cancer;
HPV positive SCCHN;
Other anogenital HPV associated cancers;
GYN (Cervical, Vaginal, Vulvar) carcinoma;
Merkel cell carcinoma (MCC);
Nasopharyngeal carcinoma (NPC) NOTE: "Cervical, Randomized" and "Cervical, Pooled" are not mutually exclusive categories.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Histopathologic confirmation of the following tumor types (please refer to protocol for full details pertaining to eligible tumor types):
Merkel Cell Carcinoma
Gastric or Gastro-Esophageal junction carcinoma (No longer enrolling this tumor type)
Nasopharyngeal Carcinoma
Squamous cell carcinoma (SCC) of the cervix, vagina, or vulva
Squamous cell carcinoma of the Head and Neck
Squamous cell carcinoma of the anal canal and penis
Recurrent/metastatic SCC of the cervix not amenable to curative treatment with surgery and/or radiation therapy who are unsuitable for platinum-based therapy may enroll in the cervical cancer Combination B expansion cohort
Measurable disease by CT or MRI
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Patient willing to comply to provide tumor tissue (archival or fresh biopsy specimen)
Men and women of age 18 or older
Exclusion Criteria:
Active brain metastases or leptomeningeal metastases
Patients with active, known or suspected autoimmune disease
Patients with a condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications
Bhatia S, Topalian SL, Sharfman W, Meyer T, Steven N, Lao CD, Farinas-Madrid L, Devriese LA, Moore K, Ferris RL, Honma Y, Elias I, Srirangam A, Garnett-Benson C, Lee M, Nghiem P. Nivolumab With or Without Ipilimumab in Patients With Recurrent or Metastatic Merkel Cell Carcinoma: A Nonrandomized, Open-Label, International, Multicenter Phase I/II Study. J Clin Oncol. 2025 Mar 20;43(9):1137-1147. doi: 10.1200/JCO-24-02138. Epub 2025 Jan 31.
Nivolumab IV over 30 minutes at 240 mg every 2 weeks for a maximum of 24 months or until disease progression, unacceptable toxicity, or withdrawal of consent, whichever comes first
FG001
Metastatic Combo A
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Started = treated
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
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
May 7, 2019
Mar 17, 2022
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Argentina
Romania
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
No data available
No data is available for this block.
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
Drug: Nivolumab
Drug: Daratumumab
Ipilimumab
Drug
Nivolumab plus Ipilimumab Cohort
Relatlimab
Drug
Nivolumab plus Relatlimab Cohort
BMS-986016
Anti-LAG 3
Daratumumab
Drug
Nivolumab plus Daratumumab Cohort
Darzalex
From the date of first dose to the date of the initial objectively documented tumor progression or the date of the last tumor assessment prior to subsequent therapy (Up to 65 months)
From first confirmed response (complete response or partial response) to the date of the initial objectively documented tumor progression or death due to any cause, whichever occurs first (Up to 83 months)
Metastatic: Overall Survival (OS)
Overall survival (OS) is defined as the time from first dosing date to the date of death. A participant who has not died will be censored at last known date alive. Participants with the following diseases will be assessed:
EBV positive related gastric cancer;
HPV positive SCCHN;
Other anogenital HPV associated cancers;
GYN (Cervical, Vaginal, Vulvar) carcinoma;
Merkel cell carcinoma (MCC);
Nasopharyngeal carcinoma (NPC) Note: "Cervical, Randomized" and "Cervical, Pooled" are not mutually exclusive categories
From the first dosing date to the date of death (Up to 83 months)
Investigator-assessed progression free survival (PFS) is defined as the time from first dosing date to the date of the first documented tumor progression, as determined by investigators (per RECIST 1.1), or death due to any cause, whichever occurs first. Participants with the following diseases will be assessed:
EBV positive related gastric cancer;
HPV positive SCCHN;
Other anogenital HPV associated cancers;
GYN (Cervical, Vaginal, Vulvar) carcinoma;
Merkel cell carcinoma (MCC);
Nasopharyngeal carcinoma (NPC) Note: "Cervical, Randomized" and "Cervical, Pooled" are not mutually exclusive categories
From the first dosing date to the date of the first documented tumor progression or death due to any cause, whichever occurs first (Up to 83 months)
Oaknin A, Moore K, Meyer T, Lopez-Picazo Gonzalez J, Devriese LA, Amin A, Lao CD, Boni V, Sharfman WH, Park JC, Tahara M, Topalian SL, Magallanes M, Molina Alavez A, Khan TA, Copigneaux C, Lee M, Garnett-Benson C, Wang X, Naumann RW. Nivolumab with or without ipilimumab in patients with recurrent or metastatic cervical cancer (CheckMate 358): a phase 1-2, open-label, multicohort trial. Lancet Oncol. 2024 May;25(5):588-602. doi: 10.1016/S1470-2045(24)00088-3. Epub 2024 Apr 9.
Pulliam T, Jani S, Jing L, Ryu H, Jojic A, Shasha C, Zhang J, Kulikauskas R, Church C, Garnett-Benson C, Gooley T, Chapuis A, Paulson K, Smith KN, Pardoll DM, Newell EW, Koelle DM, Topalian SL, Nghiem P. Circulating cancer-specific CD8 T cell frequency is associated with response to PD-1 blockade in Merkel cell carcinoma. Cell Rep Med. 2024 Feb 20;5(2):101412. doi: 10.1016/j.xcrm.2024.101412. Epub 2024 Feb 10.
Ferris RL, Spanos WC, Leidner R, Goncalves A, Martens UM, Kyi C, Sharfman W, Chung CH, Devriese LA, Gauthier H, Chiosea SI, Vujanovic L, Taube JM, Stein JE, Li J, Li B, Chen T, Barrows A, Topalian SL. Neoadjuvant nivolumab for patients with resectable HPV-positive and HPV-negative squamous cell carcinomas of the head and neck in the CheckMate 358 trial. J Immunother Cancer. 2021 Jun;9(6):e002568. doi: 10.1136/jitc-2021-002568.
Appelbaum J, Wells D, Hiatt JB, Steinbach G, Stewart FM, Thomas H, Nghiem P, Kapur RP, Thompson JA, Bhatia S. Fatal enteric plexus neuropathy after one dose of ipilimumab plus nivolumab: a case report. J Immunother Cancer. 2018 Aug 31;6(1):82. doi: 10.1186/s40425-018-0396-9.
Nivolumab 3 mg/kg IV over 30 minutes every 2 weeks + Ipilimumab 1 mg/kg IV over 30 minutes every 6 weeks for a maximum of 24 months or until disease progression, unacceptable toxicity, or withdrawal of consent, whichever comes first
FG002
Metastatic Combo B
Nivolumab 1 mg/kg IV over 30 minutes + Ipilimumab 3 mg/kg IV over 30 minutes every 3 weeks for 4 doses followed by Nivolumab 240 mg IV over 30 minutes every 2 weeks for a maximum of 24 months or until disease progression, unacceptable toxicity, or withdrawal of consent, whichever comes first
FG003
Metastatic Combo C
Nivolumab 240 mg IV over 30 minutes + BMS-986016 (Relatlimab) 80 mg IV over 60 minutes administered every 2 weeks for a maximum of 24 months, or until disease progression, unacceptable toxicity, or withdrawal of consent, whichever comes first
FG004
Metastatic Combo D
Daratumumab 16 mg/kg IV weekly for the first 8 weeks. Starting at Week 3, Nivolumab 240 mg IV over 30 minutes every 2 weeks. Daratumumab 16 mg/kg every 2 weeks from Weeks 9-24. Starting at Week 25, Nivolumab 480 mg IV flat dose over 30 minutes every 4 weeks; daratumumab 16 mg/kg every 4 weeks for a maximum of 24 months or until progression, unacceptable toxicity, or withdrawal of consent, whichever comes first
FG005
Neoadjuvant
Nivolumab administered intravenously (IV) over 30 minutes at 240 mg for 2 doses, on Day 1 and Day 15
FG000113 subjects
FG001195 subjects
FG002133 subjects
FG0038 subjects
FG0046 subjects
FG005123 subjects
COMPLETED
Completed = completed the treatment period
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG005116 subjects
NOT COMPLETED
FG000113 subjects
FG001195 subjects
FG002133 subjects
FG0038 subjects
FG0046 subjects
FG0057 subjects
Type
Comment
Reasons
Disease progression
FG00073 subjects
FG001111 subjects
FG00262 subjects
FG0037 subjects
FG0044 subjects
FG0052 subjects
Study drug toxicity
FG00011 subjects
FG00133 subjects
FG00231 subjects
FG0030 subjects
FG004
Adverse event unrelated to study drug
FG0009 subjects
FG00111 subjects
FG0027 subjects
FG0030 subjects
FG004
Participant request to discontinue study treatment
FG0006 subjects
FG0018 subjects
FG0024 subjects
FG0030 subjects
Withdrawal by Subject
FG0004 subjects
FG0010 subjects
FG0023 subjects
FG0030 subjects
FG004
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0022 subjects
FG0030 subjects
FG004
Maximum clinical benefit
FG0003 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
Other reasons
FG0007 subjects
FG00132 subjects
FG00223 subjects
FG0031 subjects
FG004
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Metastatic Monotherapy
Nivolumab IV over 30 minutes at 240 mg every 2 weeks for a maximum of 24 months or until disease progression, unacceptable toxicity, or withdrawal of consent, whichever comes first
BG001
Metastatic Combo A
Nivolumab 3 mg/kg IV over 30 minutes every 2 weeks + Ipilimumab 1 mg/kg IV over 30 minutes every 6 weeks for a maximum of 24 months or until disease progression, unacceptable toxicity, or withdrawal of consent, whichever comes first
BG002
Metastatic Combo B
Nivolumab 1 mg/kg IV over 30 minutes + Ipilimumab 3 mg/kg IV over 30 minutes every 3 weeks for 4 doses followed by Nivolumab 240 mg IV over 30 minutes every 2 weeks for a maximum of 24 months or until disease progression, unacceptable toxicity, or withdrawal of consent, whichever comes first
BG003
Metastatic Combo C
Nivolumab 240 mg IV over 30 minutes + BMS-986016 (Relatlimab) 80 mg IV over 60 minutes administered every 2 weeks for a maximum of 24 months, or until disease progression, unacceptable toxicity, or withdrawal of consent, whichever comes first
BG004
Metastatic Combo D
Daratumumab 16 mg/kg IV weekly for the first 8 weeks. Starting at Week 3, Nivolumab 240 mg IV over 30 minutes every 2 weeks. Daratumumab 16 mg/kg every 2 weeks from Weeks 9-24. Starting at Week 25, Nivolumab 480 mg IV flat dose over 30 minutes every 4 weeks; daratumumab 16 mg/kg every 4 weeks for a maximum of 24 months or until progression, unacceptable toxicity, or withdrawal of consent, whichever comes first
BG005
Neoadjuvant
Nivolumab administered intravenously (IV) over 30 minutes at 240 mg for 2 doses, on Day 1 and Day 15
BG006
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG000113
BG001195
BG002133
BG0038
BG0046
BG005123
BG006578
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
Years
Title
Denominators
Categories
Title
Measurements
BG00057.4± 13.5
BG00157.5± 13.2
BG00248.2± 12.3
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00039
BG00185
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0002
BG0010
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Neoadjuvant: Number of Participants With Drug-Related Select Adverse Events (AEs)
Number of participants with any grade of drug-related select adverse events (AEs) including endocrine, gastrointestinal, hepatic, pulmonary, renal, skin, and hypersensitivity AEs in Neoadjuvant cohort
All treated participants in the neoadjuvant cohort
Posted
Count of Participants
Participants
From first dose to 30 days post last dose (Up to 2 months)
ID
Title
Description
OG000
Neoadjuvant
Nivolumab administered intravenously (IV) over 30 minutes at 240 mg for 2 doses, on Day 1 and Day 15
Units
Counts
Participants
OG000123
Title
Denominators
Categories
Endocrine AEs
Title
Measurements
OG0003
Gastrointestinal AEs
Title
Measurements
OG0004
Hepatic AEs
Primary
Neoadjuvant: Number of Participants With Drug-Related Serious Adverse Events (SAEs)
Number of participants with any grade of drug-related serious adverse events (SAEs) in Neoadjuvant cohort
All treated participants in the neoadjuvant cohort
Posted
Count of Participants
Participants
From first dose to 30 days post last dose (Up to 2 months)
ID
Title
Description
OG000
Neoadjuvant
Nivolumab administered intravenously (IV) over 30 minutes at 240 mg for 2 doses, on Day 1 and Day 15
Units
Counts
Participants
OG000123
Primary
Neoadjuvant: Rate of Surgery Delay
Rate of surgery delay is defined as the percentage of participants in the neoadjuvant cohort with surgery delayed > 4 weeks from the planned surgery date or planned start date for chemoradiation due to a drug-related adverse event.
Participants with the following diseases will be assessed:
HPV positive squamous cell carcinoma of the Head and Neck (SCCHN);
HPV negative SCCHN;
Cervical Carcinoma;
Vaginal/Vulvar Carcinoma;
Merkel Cell Carcinoma
All tumor reduction evaluable participants in the neoadjuvant cohort
Posted
Number
95% Confidence Interval
Percentage of participants
Day 29
ID
Title
Description
OG000
Neoadjuvant
Nivolumab administered intravenously (IV) over 30 minutes at 240 mg for 2 doses, on Day 1 and Day 15
Objective response rate (ORR) is defined as the percentage of participants with a best overall response (BOR) of confirmed complete response (CR) or partial response (PR) using RECIST 1.1 criteria. An ORR in excess of 10% will be considered of clinical interest, and an ORR of 25% or greater will be considered of strong clinical interest.
Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm.
Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Participants with the following diseases will be assessed:
EBV positive related gastric cancer;
HPV positive SCCHN;
Other anogenital HPV associated cancers;
GYN (Cervical, Vaginal, Vulvar) carcinoma;
Merkel cell carcinoma (MCC);
Nasopharyngeal carcinoma (NPC)
All treated participants in the metastatic cohorts
Posted
Number
95% Confidence Interval
Percentage of participants
From the date of first dose to the date of the initial objectively documented tumor progression or the date of the last tumor assessment prior to subsequent therapy (Up to 65 months)
ID
Title
Description
OG000
Metastatic Monotherapy
Nivolumab IV over 30 minutes at 240 mg every 2 weeks for a maximum of 24 months or until disease progression, unacceptable toxicity, or withdrawal of consent, whichever comes first
OG001
Metastatic Combo A
Secondary
Metastatic: Investigator-Assessed Duration of Response (DoR)
Duration of response (DoR) is defined as the time from first confirmed response (complete response or partial response) to the date of the initial objectively documented tumor progression as determined per investigator assessment using RECIST 1.1 criteria or death due to any cause, whichever occurs first. Participants with the following diseases will be assessed:
EBV positive related gastric cancer;
HPV positive SCCHN;
Other anogenital HPV associated cancers;
GYN (Cervical, Vaginal, Vulvar) carcinoma;
Merkel cell carcinoma (MCC);
Nasopharyngeal carcinoma (NPC) NOTE: "Cervical, Randomized" and "Cervical, Pooled" are not mutually exclusive categories.
All complete and partial responders in the metastatic cohorts
Posted
Median
95% Confidence Interval
Months
From first confirmed response (complete response or partial response) to the date of the initial objectively documented tumor progression or death due to any cause, whichever occurs first (Up to 83 months)
ID
Title
Description
OG000
Metastatic Monotherapy
Nivolumab IV over 30 minutes at 240 mg every 2 weeks for a maximum of 24 months or until disease progression, unacceptable toxicity, or withdrawal of consent, whichever comes first
OG001
Metastatic Combo A
Nivolumab 3 mg/kg IV over 30 minutes every 2 weeks + Ipilimumab 1 mg/kg IV over 30 minutes every 6 weeks for a maximum of 24 months or until disease progression, unacceptable toxicity, or withdrawal of consent, whichever comes first
Secondary
Metastatic: Overall Survival (OS)
Overall survival (OS) is defined as the time from first dosing date to the date of death. A participant who has not died will be censored at last known date alive. Participants with the following diseases will be assessed:
EBV positive related gastric cancer;
HPV positive SCCHN;
Other anogenital HPV associated cancers;
GYN (Cervical, Vaginal, Vulvar) carcinoma;
Merkel cell carcinoma (MCC);
Nasopharyngeal carcinoma (NPC) Note: "Cervical, Randomized" and "Cervical, Pooled" are not mutually exclusive categories
All treated participants in the metastatic cohorts
Posted
Median
95% Confidence Interval
Months
From the first dosing date to the date of death (Up to 83 months)
ID
Title
Description
OG000
Metastatic Monotherapy
Nivolumab IV over 30 minutes at 240 mg every 2 weeks for a maximum of 24 months or until disease progression, unacceptable toxicity, or withdrawal of consent, whichever comes first
OG001
Metastatic Combo A
Nivolumab 3 mg/kg IV over 30 minutes every 2 weeks + Ipilimumab 1 mg/kg IV over 30 minutes every 6 weeks for a maximum of 24 months or until disease progression, unacceptable toxicity, or withdrawal of consent, whichever comes first
Investigator-assessed progression free survival (PFS) is defined as the time from first dosing date to the date of the first documented tumor progression, as determined by investigators (per RECIST 1.1), or death due to any cause, whichever occurs first. Participants with the following diseases will be assessed:
EBV positive related gastric cancer;
HPV positive SCCHN;
Other anogenital HPV associated cancers;
GYN (Cervical, Vaginal, Vulvar) carcinoma;
Merkel cell carcinoma (MCC);
Nasopharyngeal carcinoma (NPC) Note: "Cervical, Randomized" and "Cervical, Pooled" are not mutually exclusive categories
All treated participants in the metastatic cohorts
Posted
Median
95% Confidence Interval
Months
From the first dosing date to the date of the first documented tumor progression or death due to any cause, whichever occurs first (Up to 83 months)
ID
Title
Description
OG000
Metastatic Monotherapy
Nivolumab IV over 30 minutes at 240 mg every 2 weeks for a maximum of 24 months or until disease progression, unacceptable toxicity, or withdrawal of consent, whichever comes first
OG001
Metastatic Combo A
Nivolumab 3 mg/kg IV over 30 minutes every 2 weeks + Ipilimumab 1 mg/kg IV over 30 minutes every 6 weeks for a maximum of 24 months or until disease progression, unacceptable toxicity, or withdrawal of consent, whichever comes first
ORR is defined as the percentage of participants with a best overall response (BOR) of confirmed complete response (CR) or partial response (PR) using RECIST 1.1 criteria. An ORR in excess of 10% will be considered of clinical interest, and an ORR of 25% or greater will be considered of strong clinical interest.
Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm.
Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Participants with the following diseases will be assessed:
EBV positive related gastric cancer;
HPV positive SCCHN;
Other anogenital HPV associated cancers;
GYN (Cervical, Vaginal, Vulvar) carcinoma;
Merkel cell carcinoma (MCC);
Nasopharyngeal carcinoma (NPC) Note: "Cervical, Randomized" and "Cervical, Pooled" are not mutually exclusive categories
All treated participants in the metastatic cohorts
Posted
Number
95% Confidence Interval
Percentage of participants
From the date of first dose to the date of the initial objectively documented tumor progression or the date of the last tumor assessment prior to subsequent therapy (Up to 83 months)
ID
Title
Description
OG000
Metastatic Monotherapy
Nivolumab IV over 30 minutes at 240 mg every 2 weeks for a maximum of 24 months or until disease progression, unacceptable toxicity, or withdrawal of consent, whichever comes first
OG001
Time Frame
SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
Description
Not provided
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Metastatic Monotherapy
Nivolumab IV over 30 minutes at 240 mg every 2 weeks for a maximum of 24 months or until disease progression, unacceptable toxicity, or withdrawal of consent, whichever comes first
82
113
59
113
110
113
EG001
Metastatic Combo A
Nivolumab 3 mg/kg IV over 30 minutes every 2 weeks + Ipilimumab 1 mg/kg IV over 30 minutes every 6 weeks for a maximum of 24 months or until disease progression, unacceptable toxicity, or withdrawal of consent, whichever comes first
133
195
130
195
189
195
EG002
Metastatic Combo B
Nivolumab 1 mg/kg IV over 30 minutes + Ipilimumab 3 mg/kg IV over 30 minutes every 3 weeks for 4 doses followed by Nivolumab 240 mg IV over 30 minutes every 2 weeks for a maximum of 24 months or until disease progression, unacceptable toxicity, or withdrawal of consent, whichever comes first
86
133
99
133
129
133
EG003
Metastatic Combo C
Nivolumab 240 mg IV over 30 minutes + BMS-986016 (Relatlimab) 80 mg IV over 60 minutes administered every 2 weeks for a maximum of 24 months, or until disease progression, unacceptable toxicity, or withdrawal of consent, whichever comes first
7
8
5
8
7
8
EG004
Metastatic Combo D
Daratumumab 16 mg/kg IV weekly for the first 8 weeks. Starting at Week 3, Nivolumab 240 mg IV over 30 minutes every 2 weeks. Daratumumab 16 mg/kg every 2 weeks from Weeks 9-24. Starting at Week 25, Nivolumab 480 mg IV flat dose over 30 minutes every 4 weeks; daratumumab 16 mg/kg every 4 weeks for a maximum of 24 months or until progression, unacceptable toxicity, or withdrawal of consent, whichever comes first
5
6
5
6
5
6
EG005
Neoadjuvant
Nivolumab IV over 30 minutes at 240 mg for 2 doses, on Day 1 and Day 15
40
123
40
123
108
123
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
25.1
Systematic Assessment
EG0001 affected113 at risk
EG0011 affected195 at risk
EG0025 affected133 at risk
EG0030 affected8 at risk
EG0040 affected6 at risk
EG0051 affected123 at risk
Febrile neutropenia
Blood and lymphatic system disorders
25.1
Systematic Assessment
EG0000 affected113 at risk
EG0011 affected195 at risk
EG0020 affected133 at risk
EG003
Iron deficiency anaemia
Blood and lymphatic system disorders
25.1
Systematic Assessment
EG0001 affected113 at risk
EG0010 affected195 at risk
EG0020 affected133 at risk
EG003
Lymph node pain
Blood and lymphatic system disorders
25.1
Systematic Assessment
EG0000 affected113 at risk
EG0010 affected195 at risk
EG0021 affected133 at risk
EG003
Acute coronary syndrome
Cardiac disorders
25.1
Systematic Assessment
EG0000 affected113 at risk
EG0010 affected195 at risk
EG0020 affected133 at risk
EG003
Acute myocardial infarction
Cardiac disorders
25.1
Systematic Assessment
EG0000 affected113 at risk
EG0010 affected195 at risk
EG0020 affected133 at risk
EG003
Angina pectoris
Cardiac disorders
25.1
Systematic Assessment
EG0000 affected113 at risk
EG0011 affected195 at risk
EG0020 affected133 at risk
EG003
Atrial fibrillation
Cardiac disorders
25.1
Systematic Assessment
EG0001 affected113 at risk
EG0012 affected195 at risk
EG0020 affected133 at risk
EG003
Autoimmune pericarditis
Cardiac disorders
25.1
Systematic Assessment
EG0000 affected113 at risk
EG0011 affected195 at risk
EG0020 affected133 at risk
EG003
Cardiac arrest
Cardiac disorders
25.1
Systematic Assessment
EG0000 affected113 at risk
EG0010 affected195 at risk
EG0022 affected133 at risk
EG003
Cardiac failure
Cardiac disorders
25.1
Systematic Assessment
EG0002 affected113 at risk
EG0010 affected195 at risk
EG0020 affected133 at risk
EG003
Cardiac tamponade
Cardiac disorders
25.1
Systematic Assessment
EG0000 affected113 at risk
EG0011 affected195 at risk
EG0020 affected133 at risk
EG003
Coronary artery disease
Cardiac disorders
25.1
Systematic Assessment
EG0000 affected113 at risk
EG0011 affected195 at risk
EG0020 affected133 at risk
EG003
Mitral valve incompetence
Cardiac disorders
25.1
Systematic Assessment
EG0001 affected113 at risk
EG0010 affected195 at risk
EG0020 affected133 at risk
EG003
Myocardial infarction
Cardiac disorders
25.1
Systematic Assessment
EG0000 affected113 at risk
EG0010 affected195 at risk
EG0020 affected133 at risk
EG003
Myocarditis
Cardiac disorders
25.1
Systematic Assessment
EG0000 affected113 at risk
EG0011 affected195 at risk
EG0021 affected133 at risk
EG003
Pericardial effusion
Cardiac disorders
25.1
Systematic Assessment
EG0000 affected113 at risk
EG0012 affected195 at risk
EG0022 affected133 at risk
EG003
Sinus bradycardia
Cardiac disorders
25.1
Systematic Assessment
EG0000 affected113 at risk
EG0011 affected195 at risk
EG0020 affected133 at risk
EG003
Supraventricular tachycardia
Cardiac disorders
25.1
Systematic Assessment
EG0000 affected113 at risk
EG0011 affected195 at risk
EG0020 affected133 at risk
EG003
Adrenal insufficiency
Endocrine disorders
25.1
Systematic Assessment
EG0001 affected113 at risk
EG0014 affected195 at risk
EG0020 affected133 at risk
EG003
Glucocorticoid deficiency
Endocrine disorders
25.1
Systematic Assessment
EG0000 affected113 at risk
EG0011 affected195 at risk
EG0020 affected133 at risk
EG003
Hyperthyroidism
Endocrine disorders
25.1
Systematic Assessment
EG0000 affected113 at risk
EG0011 affected195 at risk
EG0021 affected133 at risk
EG003
Hypophysitis
Endocrine disorders
25.1
Systematic Assessment
EG0000 affected113 at risk
EG0010 affected195 at risk
EG0023 affected133 at risk
EG003
Hypothyroidism
Endocrine disorders
25.1
Systematic Assessment
EG0000 affected113 at risk
EG0011 affected195 at risk
EG0020 affected133 at risk
EG003
Inappropriate antidiuretic hormone secretion
Endocrine disorders
25.1
Systematic Assessment
EG0000 affected113 at risk
EG0010 affected195 at risk
EG0021 affected133 at risk
EG003
Thyroid disorder
Endocrine disorders
25.1
Systematic Assessment
EG0000 affected113 at risk
EG0010 affected195 at risk
EG0021 affected133 at risk
EG003
Uveitis
Eye disorders
25.1
Systematic Assessment
EG0000 affected113 at risk
EG0010 affected195 at risk
EG0021 affected133 at risk
EG003
Abdominal distension
Gastrointestinal disorders
25.1
Systematic Assessment
EG0000 affected113 at risk
EG0010 affected195 at risk
EG0021 affected133 at risk
EG003
Abdominal pain
Gastrointestinal disorders
25.1
Systematic Assessment
EG0000 affected113 at risk
EG0013 affected195 at risk
EG0022 affected133 at risk
EG003
Abdominal pain lower
Gastrointestinal disorders
25.1
Systematic Assessment
EG0000 affected113 at risk
EG0010 affected195 at risk
EG0020 affected133 at risk
EG003
Anal fistula
Gastrointestinal disorders
25.1
Systematic Assessment
EG0000 affected113 at risk
EG0010 affected195 at risk
EG0021 affected133 at risk
EG003
Anorectal disorder
Gastrointestinal disorders
25.1
Systematic Assessment
EG0000 affected113 at risk
EG0010 affected195 at risk
EG0021 affected133 at risk
EG003
Ascites
Gastrointestinal disorders
25.1
Systematic Assessment
EG0001 affected113 at risk
EG0011 affected195 at risk
EG0021 affected133 at risk
EG003
Colitis
Gastrointestinal disorders
25.1
Systematic Assessment
EG0001 affected113 at risk
EG0013 affected195 at risk
EG00211 affected133 at risk
EG003
Constipation
Gastrointestinal disorders
25.1
Systematic Assessment
EG0000 affected113 at risk
EG0011 affected195 at risk
EG0020 affected133 at risk
EG003
Diarrhoea
Gastrointestinal disorders
25.1
Systematic Assessment
EG0001 affected113 at risk
EG0019 affected195 at risk
EG0024 affected133 at risk
EG003
Dysphagia
Gastrointestinal disorders
25.1
Systematic Assessment
EG0001 affected113 at risk
EG0013 affected195 at risk
EG0020 affected133 at risk
EG003
Gastritis
Gastrointestinal disorders
25.1
Systematic Assessment
EG0000 affected113 at risk
EG0011 affected195 at risk
EG0022 affected133 at risk
EG003
Gastrointestinal haemorrhage
Gastrointestinal disorders
25.1
Systematic Assessment
EG0001 affected113 at risk
EG0011 affected195 at risk
EG0020 affected133 at risk
EG003
Gastrointestinal motility disorder
Gastrointestinal disorders
25.1
Systematic Assessment
EG0000 affected113 at risk
EG0011 affected195 at risk
EG0020 affected133 at risk
EG003
Glossodynia
Gastrointestinal disorders
25.1
Systematic Assessment
EG0000 affected113 at risk
EG0010 affected195 at risk
EG0020 affected133 at risk
EG003
Ileus
Gastrointestinal disorders
25.1
Systematic Assessment
EG0000 affected113 at risk
EG0010 affected195 at risk
EG0022 affected133 at risk
EG003
Immune-mediated enterocolitis
Gastrointestinal disorders
25.1
Systematic Assessment
EG0001 affected113 at risk
EG0011 affected195 at risk
EG0023 affected133 at risk
EG003
Immune-mediated pancreatitis
Gastrointestinal disorders
25.1
Systematic Assessment
EG0000 affected113 at risk
EG0011 affected195 at risk
EG0020 affected133 at risk
EG003
Intestinal obstruction
Gastrointestinal disorders
25.1
Systematic Assessment
EG0001 affected113 at risk
EG0010 affected195 at risk
EG0027 affected133 at risk
EG003
Intestinal perforation
Gastrointestinal disorders
25.1
Systematic Assessment
EG0000 affected113 at risk
EG0011 affected195 at risk
EG0020 affected133 at risk
EG003
Large intestinal obstruction
Gastrointestinal disorders
25.1
Systematic Assessment
EG0000 affected113 at risk
EG0011 affected195 at risk
EG0020 affected133 at risk
EG003
Mouth haemorrhage
Gastrointestinal disorders
25.1
Systematic Assessment
EG0000 affected113 at risk
EG0010 affected195 at risk
EG0020 affected133 at risk
EG003
Nausea
Gastrointestinal disorders
25.1
Systematic Assessment
EG0000 affected113 at risk
EG0012 affected195 at risk
EG0021 affected133 at risk
EG003
Oesophageal motility disorder
Gastrointestinal disorders
25.1
Systematic Assessment
EG0001 affected113 at risk
EG0010 affected195 at risk
EG0020 affected133 at risk
EG003
Oesophagitis
Gastrointestinal disorders
25.1
Systematic Assessment
EG0000 affected113 at risk
EG0010 affected195 at risk
EG0021 affected133 at risk
EG003
Pancreatitis
Gastrointestinal disorders
25.1
Systematic Assessment
EG0000 affected113 at risk
EG0010 affected195 at risk
EG0021 affected133 at risk
EG003
Proctalgia
Gastrointestinal disorders
25.1
Systematic Assessment
EG0000 affected113 at risk
EG0011 affected195 at risk
EG0020 affected133 at risk
EG003
Small intestinal obstruction
Gastrointestinal disorders
25.1
Systematic Assessment
EG0002 affected113 at risk
EG0011 affected195 at risk
EG0021 affected133 at risk
EG003
Stomatitis
Gastrointestinal disorders
25.1
Systematic Assessment
EG0000 affected113 at risk
EG0011 affected195 at risk
EG0020 affected133 at risk
EG003
Vomiting
Gastrointestinal disorders
25.1
Systematic Assessment
EG0000 affected113 at risk
EG0014 affected195 at risk
EG0022 affected133 at risk
EG003
Asthenia
General disorders
25.1
Systematic Assessment
EG0001 affected113 at risk
EG0011 affected195 at risk
EG0020 affected133 at risk
EG003
Chills
General disorders
25.1
Systematic Assessment
EG0000 affected113 at risk
EG0010 affected195 at risk
EG0020 affected133 at risk
EG003
Complication associated with device
General disorders
25.1
Systematic Assessment
EG0001 affected113 at risk
EG0010 affected195 at risk
EG0020 affected133 at risk
EG003
Death
General disorders
25.1
Systematic Assessment
EG0001 affected113 at risk
EG0012 affected195 at risk
EG0021 affected133 at risk
EG003
Disease progression
General disorders
25.1
Systematic Assessment
EG0001 affected113 at risk
EG0011 affected195 at risk
EG0020 affected133 at risk
EG003
Facial pain
General disorders
25.1
Systematic Assessment
EG0000 affected113 at risk
EG0010 affected195 at risk
EG0020 affected133 at risk
EG003
Fatigue
General disorders
25.1
Systematic Assessment
EG0000 affected113 at risk
EG0011 affected195 at risk
EG0021 affected133 at risk
EG003
General physical health deterioration
General disorders
25.1
Systematic Assessment
EG0001 affected113 at risk
EG0010 affected195 at risk
EG0020 affected133 at risk
EG003
Hyperthermia
General disorders
25.1
Systematic Assessment
EG0001 affected113 at risk
EG0010 affected195 at risk
EG0020 affected133 at risk
EG003
Malaise
General disorders
25.1
Systematic Assessment
EG0002 affected113 at risk
EG0010 affected195 at risk
EG0020 affected133 at risk
EG003
Mucosal inflammation
General disorders
25.1
Systematic Assessment
EG0000 affected113 at risk
EG0010 affected195 at risk
EG0020 affected133 at risk
EG003
Multiple organ dysfunction syndrome
General disorders
25.1
Systematic Assessment
EG0000 affected113 at risk
EG0010 affected195 at risk
EG0020 affected133 at risk
EG003
Non-cardiac chest pain
General disorders
25.1
Systematic Assessment
EG0001 affected113 at risk
EG0010 affected195 at risk
EG0020 affected133 at risk
EG003
Oedema peripheral
General disorders
25.1
Systematic Assessment
EG0000 affected113 at risk
EG0012 affected195 at risk
EG0020 affected133 at risk
EG003
Pain
General disorders
25.1
Systematic Assessment
EG0001 affected113 at risk
EG0012 affected195 at risk
EG0020 affected133 at risk
EG003
Performance status decreased
General disorders
25.1
Systematic Assessment
EG0000 affected113 at risk
EG0010 affected195 at risk
EG0021 affected133 at risk
EG003
Pyrexia
General disorders
25.1
Systematic Assessment
EG0003 affected113 at risk
EG0015 affected195 at risk
EG0027 affected133 at risk
EG003
Sudden death
General disorders
25.1
Systematic Assessment
EG0000 affected113 at risk
EG0010 affected195 at risk
EG0021 affected133 at risk
EG003
Systemic inflammatory response syndrome
General disorders
25.1
Systematic Assessment
EG0000 affected113 at risk
EG0010 affected195 at risk
EG0021 affected133 at risk
EG003
Autoimmune cholangitis
Hepatobiliary disorders
25.1
Systematic Assessment
EG0000 affected113 at risk
EG0010 affected195 at risk
EG0021 affected133 at risk
EG003
Autoimmune hepatitis
Hepatobiliary disorders
25.1
Systematic Assessment
EG0000 affected113 at risk
EG0011 affected195 at risk
EG0023 affected133 at risk
EG003
Bile duct stenosis
Hepatobiliary disorders
25.1
Systematic Assessment
EG0000 affected113 at risk
EG0011 affected195 at risk
EG0020 affected133 at risk
EG003
Biliary obstruction
Hepatobiliary disorders
25.1
Systematic Assessment
EG0000 affected113 at risk
EG0011 affected195 at risk
EG0020 affected133 at risk
EG003
Biliary tract disorder
Hepatobiliary disorders
25.1
Systematic Assessment
EG0001 affected113 at risk
EG0010 affected195 at risk
EG0020 affected133 at risk
EG003
Cholecystitis
Hepatobiliary disorders
25.1
Systematic Assessment
EG0001 affected113 at risk
EG0010 affected195 at risk
EG0020 affected133 at risk
EG003
Gallbladder rupture
Hepatobiliary disorders
25.1
Systematic Assessment
EG0000 affected113 at risk
EG0011 affected195 at risk
EG0020 affected133 at risk
EG003
Hepatic cytolysis
Hepatobiliary disorders
25.1
Systematic Assessment
EG0002 affected113 at risk
EG0010 affected195 at risk
EG0020 affected133 at risk
EG003
Hepatic function abnormal
Hepatobiliary disorders
25.1
Systematic Assessment
EG0000 affected113 at risk
EG0010 affected195 at risk
EG0021 affected133 at risk
EG003
Hepatitis
Hepatobiliary disorders
25.1
Systematic Assessment
EG0000 affected113 at risk
EG0010 affected195 at risk
EG0021 affected133 at risk
EG003
Hepatitis toxic
Hepatobiliary disorders
25.1
Systematic Assessment
EG0000 affected113 at risk
EG0011 affected195 at risk
EG0020 affected133 at risk
EG003
Hepatotoxicity
Hepatobiliary disorders
25.1
Systematic Assessment
EG0000 affected113 at risk
EG0010 affected195 at risk
EG0026 affected133 at risk
EG003
Hypertransaminasaemia
Hepatobiliary disorders
25.1
Systematic Assessment
EG0000 affected113 at risk
EG0010 affected195 at risk
EG0023 affected133 at risk
EG003
Anaphylactic reaction
Immune system disorders
25.1
Systematic Assessment
EG0001 affected113 at risk
EG0010 affected195 at risk
EG0020 affected133 at risk
EG003
Hypersensitivity
Immune system disorders
25.1
Systematic Assessment
EG0000 affected113 at risk
EG0011 affected195 at risk
EG0021 affected133 at risk
EG003
Sarcoidosis
Immune system disorders
25.1
Systematic Assessment
EG0001 affected113 at risk
EG0010 affected195 at risk
EG0020 affected133 at risk
EG003
Abscess neck
Infections and infestations
25.1
Systematic Assessment
EG0000 affected113 at risk
EG0010 affected195 at risk
EG0020 affected133 at risk
EG003
Arthritis bacterial
Infections and infestations
25.1
Systematic Assessment
EG0000 affected113 at risk
EG0011 affected195 at risk
EG0020 affected133 at risk
EG003
Bacteraemia
Infections and infestations
25.1
Systematic Assessment
EG0001 affected113 at risk
EG0010 affected195 at risk
EG0020 affected133 at risk
EG003
COVID-19
Infections and infestations
25.1
Systematic Assessment
EG0000 affected113 at risk
EG0011 affected195 at risk
EG0020 affected133 at risk
EG003
Catheter site infection
Infections and infestations
25.1
Systematic Assessment
EG0000 affected113 at risk
EG0011 affected195 at risk
EG0020 affected133 at risk
EG003
Cellulitis
Infections and infestations
25.1
Systematic Assessment
EG0001 affected113 at risk
EG0011 affected195 at risk
EG0020 affected133 at risk
EG003
Clostridial sepsis
Infections and infestations
25.1
Systematic Assessment
EG0000 affected113 at risk
EG0011 affected195 at risk
EG0020 affected133 at risk
EG003
Clostridium difficile colitis
Infections and infestations
25.1
Systematic Assessment
EG0000 affected113 at risk
EG0010 affected195 at risk
EG0020 affected133 at risk
EG003
Device related infection
Infections and infestations
25.1
Systematic Assessment
EG0002 affected113 at risk
EG0010 affected195 at risk
EG0020 affected133 at risk
EG003
Device related sepsis
Infections and infestations
25.1
Systematic Assessment
EG0001 affected113 at risk
EG0010 affected195 at risk
EG0020 affected133 at risk
EG003
Encephalitis
Infections and infestations
25.1
Systematic Assessment
EG0000 affected113 at risk
EG0010 affected195 at risk
EG0021 affected133 at risk
EG003
Gastroenteritis
Infections and infestations
25.1
Systematic Assessment
EG0001 affected113 at risk
EG0010 affected195 at risk
EG0020 affected133 at risk
EG003
Gastroenteritis bacterial
Infections and infestations
25.1
Systematic Assessment
EG0001 affected113 at risk
EG0010 affected195 at risk
EG0020 affected133 at risk
EG003
Kidney infection
Infections and infestations
25.1
Systematic Assessment
EG0000 affected113 at risk
EG0010 affected195 at risk
EG0021 affected133 at risk
EG003
Large intestine infection
Infections and infestations
25.1
Systematic Assessment
EG0000 affected113 at risk
EG0010 affected195 at risk
EG0020 affected133 at risk
EG003
Localised infection
Infections and infestations
25.1
Systematic Assessment
EG0000 affected113 at risk
EG0011 affected195 at risk
EG0020 affected133 at risk
EG003
Lower respiratory tract infection
Infections and infestations
25.1
Systematic Assessment
EG0000 affected113 at risk
EG0013 affected195 at risk
EG0020 affected133 at risk
EG003
Medical device site infection
Infections and infestations
25.1
Systematic Assessment
EG0000 affected113 at risk
EG0010 affected195 at risk
EG0020 affected133 at risk
EG003
Meningitis
Infections and infestations
25.1
Systematic Assessment
EG0000 affected113 at risk
EG0011 affected195 at risk
EG0020 affected133 at risk
EG003
Meningitis aseptic
Infections and infestations
25.1
Systematic Assessment
EG0000 affected113 at risk
EG0011 affected195 at risk
EG0020 affected133 at risk
EG003
Osteomyelitis
Infections and infestations
25.1
Systematic Assessment
EG0001 affected113 at risk
EG0010 affected195 at risk
EG0020 affected133 at risk
EG003
Otitis media
Infections and infestations
25.1
Systematic Assessment
EG0001 affected113 at risk
EG0010 affected195 at risk
EG0020 affected133 at risk
EG003
Periorbital infection
Infections and infestations
25.1
Systematic Assessment
EG0000 affected113 at risk
EG0011 affected195 at risk
EG0020 affected133 at risk
EG003
Pneumonia
Infections and infestations
25.1
Systematic Assessment
EG0002 affected113 at risk
EG0013 affected195 at risk
EG0021 affected133 at risk
EG003
Pneumonia aspiration
Infections and infestations
25.1
Systematic Assessment
EG0001 affected113 at risk
EG0010 affected195 at risk
EG0020 affected133 at risk
EG003
Pneumonia bacterial
Infections and infestations
25.1
Systematic Assessment
EG0001 affected113 at risk
EG0010 affected195 at risk
EG0020 affected133 at risk
EG003
Post procedural infection
Infections and infestations
25.1
Systematic Assessment
EG0001 affected113 at risk
EG0010 affected195 at risk
EG0020 affected133 at risk
EG003
Postoperative wound infection
Infections and infestations
25.1
Systematic Assessment
EG0000 affected113 at risk
EG0010 affected195 at risk
EG0020 affected133 at risk
EG003
Pulmonary sepsis
Infections and infestations
25.1
Systematic Assessment
EG0000 affected113 at risk
EG0011 affected195 at risk
EG0020 affected133 at risk
EG003
Pyelonephritis
Infections and infestations
25.1
Systematic Assessment
EG0001 affected113 at risk
EG0011 affected195 at risk
EG0024 affected133 at risk
EG003
Pyelonephritis acute
Infections and infestations
25.1
Systematic Assessment
EG0000 affected113 at risk
EG0010 affected195 at risk
EG0021 affected133 at risk
EG003
Respiratory tract infection
Infections and infestations
25.1
Systematic Assessment
EG0000 affected113 at risk
EG0011 affected195 at risk
EG0020 affected133 at risk
EG003
Sepsis
Infections and infestations
25.1
Systematic Assessment
EG0003 affected113 at risk
EG0016 affected195 at risk
EG0024 affected133 at risk
EG003
Septic shock
Infections and infestations
25.1
Systematic Assessment
EG0000 affected113 at risk
EG0011 affected195 at risk
EG0021 affected133 at risk
EG003
Sinusitis
Infections and infestations
25.1
Systematic Assessment
EG0000 affected113 at risk
EG0011 affected195 at risk
EG0020 affected133 at risk
EG003
Skin infection
Infections and infestations
25.1
Systematic Assessment
EG0000 affected113 at risk
EG0011 affected195 at risk
EG0022 affected133 at risk
EG003
Soft tissue infection
Infections and infestations
25.1
Systematic Assessment
EG0000 affected113 at risk
EG0010 affected195 at risk
EG0021 affected133 at risk
EG003
Tuberculosis
Infections and infestations
25.1
Systematic Assessment
EG0000 affected113 at risk
EG0010 affected195 at risk
EG0021 affected133 at risk
EG003
Upper respiratory tract infection
Infections and infestations
25.1
Systematic Assessment
EG0000 affected113 at risk
EG0011 affected195 at risk
EG0020 affected133 at risk
EG003
Urinary tract infection
Infections and infestations
25.1
Systematic Assessment
EG0003 affected113 at risk
EG00111 affected195 at risk
EG0027 affected133 at risk
EG003
Urosepsis
Infections and infestations
25.1
Systematic Assessment
EG0000 affected113 at risk
EG0011 affected195 at risk
EG0021 affected133 at risk
EG003
Vascular device infection
Infections and infestations
25.1
Systematic Assessment
EG0001 affected113 at risk
EG0012 affected195 at risk
EG0020 affected133 at risk
EG003
Fracture
Injury, poisoning and procedural complications
25.1
Systematic Assessment
EG0000 affected113 at risk
EG0010 affected195 at risk
EG0021 affected133 at risk
EG003
Hip fracture
Injury, poisoning and procedural complications
25.1
Systematic Assessment
EG0001 affected113 at risk
EG0010 affected195 at risk
EG0020 affected133 at risk
EG003
Post procedural fistula
Injury, poisoning and procedural complications
25.1
Systematic Assessment
EG0000 affected113 at risk
EG0010 affected195 at risk
EG0020 affected133 at risk
EG003
Post procedural haemorrhage
Injury, poisoning and procedural complications
25.1
Systematic Assessment
EG0000 affected113 at risk
EG0010 affected195 at risk
EG0020 affected133 at risk
EG003
Postoperative wound complication
Injury, poisoning and procedural complications
25.1
Systematic Assessment
EG0000 affected113 at risk
EG0010 affected195 at risk
EG0020 affected133 at risk
EG003
Procedural pain
Injury, poisoning and procedural complications
25.1
Systematic Assessment
EG0000 affected113 at risk
EG0010 affected195 at risk
EG0022 affected133 at risk
EG003
Recall phenomenon
Injury, poisoning and procedural complications
25.1
Systematic Assessment
EG0000 affected113 at risk
EG0010 affected195 at risk
EG0021 affected133 at risk
EG003
Spinal compression fracture
Injury, poisoning and procedural complications
25.1
Systematic Assessment
EG0000 affected113 at risk
EG0011 affected195 at risk
EG0020 affected133 at risk
EG003
Subdural haematoma
Injury, poisoning and procedural complications
25.1
Systematic Assessment
EG0000 affected113 at risk
EG0011 affected195 at risk
EG0020 affected133 at risk
EG003
Transfusion reaction
Injury, poisoning and procedural complications
25.1
Systematic Assessment
EG0000 affected113 at risk
EG0011 affected195 at risk
EG0020 affected133 at risk
EG003
Alanine aminotransferase increased
Investigations
25.1
Systematic Assessment
EG0000 affected113 at risk
EG0011 affected195 at risk
EG0021 affected133 at risk
EG003
Aspartate aminotransferase increased
Investigations
25.1
Systematic Assessment
EG0000 affected113 at risk
EG0011 affected195 at risk
EG0020 affected133 at risk
EG003
Blood bilirubin increased
Investigations
25.1
Systematic Assessment
EG0001 affected113 at risk
EG0010 affected195 at risk
EG0020 affected133 at risk
EG003
Blood creatinine increased
Investigations
25.1
Systematic Assessment
EG0000 affected113 at risk
EG0011 affected195 at risk
EG0021 affected133 at risk
EG003
Blood magnesium decreased
Investigations
25.1
Systematic Assessment
EG0000 affected113 at risk
EG0010 affected195 at risk
EG0021 affected133 at risk
EG003
Blood pressure decreased
Investigations
25.1
Systematic Assessment
EG0001 affected113 at risk
EG0010 affected195 at risk
EG0020 affected133 at risk
EG003
Cytomegalovirus test positive
Investigations
25.1
Systematic Assessment
EG0001 affected113 at risk
EG0010 affected195 at risk
EG0020 affected133 at risk
EG003
General physical condition abnormal
Investigations
25.1
Systematic Assessment
EG0000 affected113 at risk
EG0010 affected195 at risk
EG0020 affected133 at risk
EG003
International normalised ratio increased
Investigations
25.1
Systematic Assessment
EG0000 affected113 at risk
EG0011 affected195 at risk
EG0020 affected133 at risk
EG003
Lipase increased
Investigations
25.1
Systematic Assessment
EG0000 affected113 at risk
EG0012 affected195 at risk
EG0022 affected133 at risk
EG003
Liver function test increased
Investigations
25.1
Systematic Assessment
EG0000 affected113 at risk
EG0011 affected195 at risk
EG0021 affected133 at risk
EG003
Respiratory syncytial virus test positive
Investigations
25.1
Systematic Assessment
EG0000 affected113 at risk
EG0011 affected195 at risk
EG0020 affected133 at risk
EG003
Troponin I increased
Investigations
25.1
Systematic Assessment
EG0000 affected113 at risk
EG0010 affected195 at risk
EG0020 affected133 at risk
EG003
Troponin increased
Investigations
25.1
Systematic Assessment
EG0000 affected113 at risk
EG0011 affected195 at risk
EG0020 affected133 at risk
EG003
Urine output decreased
Investigations
25.1
Systematic Assessment
EG0000 affected113 at risk
EG0011 affected195 at risk
EG0020 affected133 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
25.1
Systematic Assessment
EG0001 affected113 at risk
EG0010 affected195 at risk
EG0020 affected133 at risk
EG003
Dehydration
Metabolism and nutrition disorders
25.1
Systematic Assessment
EG0001 affected113 at risk
EG0014 affected195 at risk
EG0022 affected133 at risk
EG003
Diabetic ketoacidosis
Metabolism and nutrition disorders
25.1
Systematic Assessment
EG0000 affected113 at risk
EG0010 affected195 at risk
EG0021 affected133 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
25.1
Systematic Assessment
EG0001 affected113 at risk
EG0014 affected195 at risk
EG0021 affected133 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
25.1
Systematic Assessment
EG0000 affected113 at risk
EG0011 affected195 at risk
EG0021 affected133 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
25.1
Systematic Assessment
EG0000 affected113 at risk
EG0011 affected195 at risk
EG0020 affected133 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
25.1
Systematic Assessment
EG0000 affected113 at risk
EG0012 affected195 at risk
EG0021 affected133 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
25.1
Systematic Assessment
EG0000 affected113 at risk
EG0012 affected195 at risk
EG0021 affected133 at risk
EG003
Hypophagia
Metabolism and nutrition disorders
25.1
Systematic Assessment
EG0001 affected113 at risk
EG0010 affected195 at risk
EG0020 affected133 at risk
EG003
Type 1 diabetes mellitus
Metabolism and nutrition disorders
25.1
Systematic Assessment
EG0000 affected113 at risk
EG0012 affected195 at risk
EG0020 affected133 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
25.1
Systematic Assessment
EG0000 affected113 at risk
EG0012 affected195 at risk
EG0020 affected133 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
25.1
Systematic Assessment
EG0001 affected113 at risk
EG0012 affected195 at risk
EG0021 affected133 at risk
EG003
Fistula
Musculoskeletal and connective tissue disorders
25.1
Systematic Assessment
EG0000 affected113 at risk
EG0010 affected195 at risk
EG0021 affected133 at risk
EG003
Flank pain
Musculoskeletal and connective tissue disorders
25.1
Systematic Assessment
EG0000 affected113 at risk
EG0012 affected195 at risk
EG0020 affected133 at risk
EG003
Intervertebral disc protrusion
Musculoskeletal and connective tissue disorders
25.1
Systematic Assessment
EG0001 affected113 at risk
EG0010 affected195 at risk
EG0020 affected133 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
25.1
Systematic Assessment
EG0000 affected113 at risk
EG0012 affected195 at risk
EG0020 affected133 at risk
EG003
Myositis
Musculoskeletal and connective tissue disorders
25.1
Systematic Assessment
EG0000 affected113 at risk
EG0011 affected195 at risk
EG0020 affected133 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
25.1
Systematic Assessment
EG0000 affected113 at risk
EG0014 affected195 at risk
EG0020 affected133 at risk
EG003
Pathological fracture
Musculoskeletal and connective tissue disorders
25.1
Systematic Assessment
EG0000 affected113 at risk
EG0011 affected195 at risk
EG0020 affected133 at risk
EG003
Acute myeloid leukaemia
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
25.1
Systematic Assessment
EG0001 affected113 at risk
EG0010 affected195 at risk
EG0020 affected133 at risk
EG003
Extranodal marginal zone B-cell lymphoma (MALT type)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
25.1
Systematic Assessment
EG0000 affected113 at risk
EG0010 affected195 at risk
EG0020 affected133 at risk
EG003
Infected neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
25.1
Systematic Assessment
EG0000 affected113 at risk
EG0011 affected195 at risk
EG0022 affected133 at risk
EG003
Lung adenocarcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
25.1
Systematic Assessment
EG0000 affected113 at risk
EG0010 affected195 at risk
EG0021 affected133 at risk
EG003
Lung neoplasm malignant
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
25.1
Systematic Assessment
EG0001 affected113 at risk
EG0010 affected195 at risk
EG0020 affected133 at risk
EG003
Malignant melanoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
25.1
Systematic Assessment
EG0000 affected113 at risk
EG0010 affected195 at risk
EG0020 affected133 at risk
EG003
Malignant neoplasm progression
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
25.1
Systematic Assessment
EG00024 affected113 at risk
EG00139 affected195 at risk
EG00221 affected133 at risk
EG003
Metastases to central nervous system
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
25.1
Systematic Assessment
EG0000 affected113 at risk
EG0011 affected195 at risk
EG0020 affected133 at risk
EG003
Metastasis
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
25.1
Systematic Assessment
EG0002 affected113 at risk
EG0010 affected195 at risk
EG0020 affected133 at risk
EG003
Neuroendocrine carcinoma of the skin
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
25.1
Systematic Assessment
EG0000 affected113 at risk
EG0010 affected195 at risk
EG0020 affected133 at risk
EG003
Prostate cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
25.1
Systematic Assessment
EG0000 affected113 at risk
EG0011 affected195 at risk
EG0020 affected133 at risk
EG003
Squamous cell carcinoma of skin
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
25.1
Systematic Assessment
EG0000 affected113 at risk
EG0011 affected195 at risk
EG0020 affected133 at risk
EG003
Transitional cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
25.1
Systematic Assessment
EG0001 affected113 at risk
EG0010 affected195 at risk
EG0020 affected133 at risk
EG003
Tumour haemorrhage
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
25.1
Systematic Assessment
EG0000 affected113 at risk
EG0011 affected195 at risk
EG0021 affected133 at risk
EG003
Tumour obstruction
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
25.1
Systematic Assessment
EG0000 affected113 at risk
EG0010 affected195 at risk
EG0020 affected133 at risk
EG003
Tumour pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
25.1
Systematic Assessment
EG0001 affected113 at risk
EG0010 affected195 at risk
EG0021 affected133 at risk
EG003
Basal ganglia infarction
Nervous system disorders
25.1
Systematic Assessment
EG0000 affected113 at risk
EG0010 affected195 at risk
EG0020 affected133 at risk
EG003
Bell's palsy
Nervous system disorders
25.1
Systematic Assessment
EG0000 affected113 at risk
EG0010 affected195 at risk
EG0021 affected133 at risk
EG003
Carotid artery aneurysm
Nervous system disorders
25.1
Systematic Assessment
EG0001 affected113 at risk
EG0010 affected195 at risk
EG0020 affected133 at risk
EG003
Cerebral haemorrhage
Nervous system disorders
25.1
Systematic Assessment
EG0000 affected113 at risk
EG0011 affected195 at risk
EG0020 affected133 at risk
EG003
Cerebral infarction
Nervous system disorders
25.1
Systematic Assessment
EG0001 affected113 at risk
EG0010 affected195 at risk
EG0020 affected133 at risk
EG003
Cerebral ischaemia
Nervous system disorders
25.1
Systematic Assessment
EG0000 affected113 at risk
EG0011 affected195 at risk
EG0020 affected133 at risk
EG003
Cerebrovascular accident
Nervous system disorders
25.1
Systematic Assessment
EG0001 affected113 at risk
EG0011 affected195 at risk
EG0020 affected133 at risk
EG003
Depressed level of consciousness
Nervous system disorders
25.1
Systematic Assessment
EG0000 affected113 at risk
EG0011 affected195 at risk
EG0020 affected133 at risk
EG003
Dizziness
Nervous system disorders
25.1
Systematic Assessment
EG0000 affected113 at risk
EG0011 affected195 at risk
EG0020 affected133 at risk
EG003
Embolic stroke
Nervous system disorders
25.1
Systematic Assessment
EG0000 affected113 at risk
EG0011 affected195 at risk
EG0020 affected133 at risk
EG003
Encephalopathy
Nervous system disorders
25.1
Systematic Assessment
EG0000 affected113 at risk
EG0010 affected195 at risk
EG0021 affected133 at risk
EG003
Guillain-Barre syndrome
Nervous system disorders
25.1
Systematic Assessment
EG0001 affected113 at risk
EG0010 affected195 at risk
EG0020 affected133 at risk
EG003
Haemorrhage intracranial
Nervous system disorders
25.1
Systematic Assessment
EG0000 affected113 at risk
EG0011 affected195 at risk
EG0020 affected133 at risk
EG003
Headache
Nervous system disorders
25.1
Systematic Assessment
EG0000 affected113 at risk
EG0010 affected195 at risk
EG0021 affected133 at risk
EG003
Intraventricular haemorrhage
Nervous system disorders
25.1
Systematic Assessment
EG0000 affected113 at risk
EG0011 affected195 at risk
EG0020 affected133 at risk
EG003
Monoparesis
Nervous system disorders
25.1
Systematic Assessment
EG0001 affected113 at risk
EG0010 affected195 at risk
EG0020 affected133 at risk
EG003
Myasthenia gravis
Nervous system disorders
25.1
Systematic Assessment
EG0000 affected113 at risk
EG0010 affected195 at risk
EG0020 affected133 at risk
EG003
Peripheral motor neuropathy
Nervous system disorders
25.1
Systematic Assessment
EG0001 affected113 at risk
EG0010 affected195 at risk
EG0020 affected133 at risk
EG003
Peripheral sensory neuropathy
Nervous system disorders
25.1
Systematic Assessment
EG0000 affected113 at risk
EG0011 affected195 at risk
EG0020 affected133 at risk
EG003
Seizure
Nervous system disorders
25.1
Systematic Assessment
EG0000 affected113 at risk
EG0010 affected195 at risk
EG0020 affected133 at risk
EG003
Spinal cord compression
Nervous system disorders
25.1
Systematic Assessment
EG0000 affected113 at risk
EG0013 affected195 at risk
EG0020 affected133 at risk
EG003
Syncope
Nervous system disorders
25.1
Systematic Assessment
EG0001 affected113 at risk
EG0013 affected195 at risk
EG0020 affected133 at risk
EG003
Device occlusion
Product Issues
25.1
Systematic Assessment
EG0001 affected113 at risk
EG0012 affected195 at risk
EG0021 affected133 at risk
EG003
Confusional state
Psychiatric disorders
25.1
Systematic Assessment
EG0000 affected113 at risk
EG0013 affected195 at risk
EG0021 affected133 at risk
EG003
Mental status changes
Psychiatric disorders
25.1
Systematic Assessment
EG0000 affected113 at risk
EG0011 affected195 at risk
EG0020 affected133 at risk
EG003
Acute kidney injury
Renal and urinary disorders
25.1
Systematic Assessment
EG0002 affected113 at risk
EG0015 affected195 at risk
EG0028 affected133 at risk
EG003
Autoimmune nephritis
Renal and urinary disorders
25.1
Systematic Assessment
EG0000 affected113 at risk
EG0010 affected195 at risk
EG0021 affected133 at risk
EG003
Haematuria
Renal and urinary disorders
25.1
Systematic Assessment
EG0000 affected113 at risk
EG0010 affected195 at risk
EG0021 affected133 at risk
EG003
Hydronephrosis
Renal and urinary disorders
25.1
Systematic Assessment
EG0000 affected113 at risk
EG0012 affected195 at risk
EG0022 affected133 at risk
EG003
Oliguria
Renal and urinary disorders
25.1
Systematic Assessment
EG0000 affected113 at risk
EG0011 affected195 at risk
EG0020 affected133 at risk
EG003
Renal colic
Renal and urinary disorders
25.1
Systematic Assessment
EG0001 affected113 at risk
EG0010 affected195 at risk
EG0020 affected133 at risk
EG003
Renal failure
Renal and urinary disorders
25.1
Systematic Assessment
EG0000 affected113 at risk
EG0013 affected195 at risk
EG0020 affected133 at risk
EG003
Renal haematoma
Renal and urinary disorders
25.1
Systematic Assessment
EG0001 affected113 at risk
EG0010 affected195 at risk
EG0020 affected133 at risk
EG003
Ureteric stenosis
Renal and urinary disorders
25.1
Systematic Assessment
EG0000 affected113 at risk
EG0010 affected195 at risk
EG0021 affected133 at risk
EG003
Urinary incontinence
Renal and urinary disorders
25.1
Systematic Assessment
EG0000 affected113 at risk
EG0011 affected195 at risk
EG0020 affected133 at risk
EG003
Urinary retention
Renal and urinary disorders
25.1
Systematic Assessment
EG0000 affected113 at risk
EG0010 affected195 at risk
EG0021 affected133 at risk
EG003
Urinary tract obstruction
Renal and urinary disorders
25.1
Systematic Assessment
EG0000 affected113 at risk
EG0012 affected195 at risk
EG0021 affected133 at risk
EG003
Urogenital fistula
Renal and urinary disorders
25.1
Systematic Assessment
EG0001 affected113 at risk
EG0011 affected195 at risk
EG0020 affected133 at risk
EG003
Female genital tract fistula
Reproductive system and breast disorders
25.1
Systematic Assessment
EG0000 affected113 at risk
EG0011 affected195 at risk
EG0022 affected133 at risk
EG003
Pelvic pain
Reproductive system and breast disorders
25.1
Systematic Assessment
EG0000 affected113 at risk
EG0011 affected195 at risk
EG0021 affected133 at risk
EG003
Prostatic obstruction
Reproductive system and breast disorders
25.1
Systematic Assessment
EG0000 affected113 at risk
EG0011 affected195 at risk
EG0020 affected133 at risk
EG003
Vaginal haemorrhage
Reproductive system and breast disorders
25.1
Systematic Assessment
EG0000 affected113 at risk
EG0010 affected195 at risk
EG0022 affected133 at risk
EG003
Vulval disorder
Reproductive system and breast disorders
25.1
Systematic Assessment
EG0000 affected113 at risk
EG0011 affected195 at risk
EG0020 affected133 at risk
EG003
Acute respiratory distress syndrome
Respiratory, thoracic and mediastinal disorders
25.1
Systematic Assessment
EG0000 affected113 at risk
EG0011 affected195 at risk
EG0020 affected133 at risk
EG003
Aspiration
Respiratory, thoracic and mediastinal disorders
25.1
Systematic Assessment
EG0000 affected113 at risk
EG0013 affected195 at risk
EG0020 affected133 at risk
EG003
Asthma
Respiratory, thoracic and mediastinal disorders
25.1
Systematic Assessment
EG0000 affected113 at risk
EG0010 affected195 at risk
EG0021 affected133 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
25.1
Systematic Assessment
EG0004 affected113 at risk
EG0012 affected195 at risk
EG0020 affected133 at risk
EG003
Haemoptysis
Respiratory, thoracic and mediastinal disorders
25.1
Systematic Assessment
EG0000 affected113 at risk
EG0010 affected195 at risk
EG0020 affected133 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
25.1
Systematic Assessment
EG0000 affected113 at risk
EG0011 affected195 at risk
EG0020 affected133 at risk
EG003
Immune-mediated lung disease
Respiratory, thoracic and mediastinal disorders
25.1
Systematic Assessment
EG0000 affected113 at risk
EG0010 affected195 at risk
EG0021 affected133 at risk
EG003
Laryngeal oedema
Respiratory, thoracic and mediastinal disorders
25.1
Systematic Assessment
EG0001 affected113 at risk
EG0010 affected195 at risk
EG0020 affected133 at risk
EG003
Lung disorder
Respiratory, thoracic and mediastinal disorders
25.1
Systematic Assessment
EG0001 affected113 at risk
EG0010 affected195 at risk
EG0020 affected133 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
25.1
Systematic Assessment
EG0001 affected113 at risk
EG0013 affected195 at risk
EG0021 affected133 at risk
EG003
Pneumonitis
Respiratory, thoracic and mediastinal disorders
25.1
Systematic Assessment
EG0004 affected113 at risk
EG0017 affected195 at risk
EG00210 affected133 at risk
EG003
Pneumothorax
Respiratory, thoracic and mediastinal disorders
25.1
Systematic Assessment
EG0001 affected113 at risk
EG0012 affected195 at risk
EG0021 affected133 at risk
EG003
Productive cough
Respiratory, thoracic and mediastinal disorders
25.1
Systematic Assessment
EG0001 affected113 at risk
EG0010 affected195 at risk
EG0020 affected133 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
25.1
Systematic Assessment
EG0001 affected113 at risk
EG0012 affected195 at risk
EG0022 affected133 at risk
EG003
Pulmonary haemorrhage
Respiratory, thoracic and mediastinal disorders
25.1
Systematic Assessment
EG0000 affected113 at risk
EG0010 affected195 at risk
EG0020 affected133 at risk
EG003
Stridor
Respiratory, thoracic and mediastinal disorders
25.1
Systematic Assessment
EG0000 affected113 at risk
EG0010 affected195 at risk
EG0020 affected133 at risk
EG003
Hyperhidrosis
Skin and subcutaneous tissue disorders
25.1
Systematic Assessment
EG0000 affected113 at risk
EG0010 affected195 at risk
EG0020 affected133 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
25.1
Systematic Assessment
EG0000 affected113 at risk
EG0012 affected195 at risk
EG0020 affected133 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
25.1
Systematic Assessment
EG0000 affected113 at risk
EG0010 affected195 at risk
EG0021 affected133 at risk
EG003
Rash pruritic
Skin and subcutaneous tissue disorders
25.1
Systematic Assessment
EG0000 affected113 at risk
EG0010 affected195 at risk
EG0021 affected133 at risk
EG003
Debridement
Surgical and medical procedures
25.1
Systematic Assessment
EG0000 affected113 at risk
EG0010 affected195 at risk
EG0020 affected133 at risk
EG003
Arterial haemorrhage
Vascular disorders
25.1
Systematic Assessment
EG0000 affected113 at risk
EG0011 affected195 at risk
EG0020 affected133 at risk
EG003
Deep vein thrombosis
Vascular disorders
25.1
Systematic Assessment
EG0000 affected113 at risk
EG0012 affected195 at risk
EG0021 affected133 at risk
EG003
Embolism
Vascular disorders
25.1
Systematic Assessment
EG0000 affected113 at risk
EG0011 affected195 at risk
EG0020 affected133 at risk
EG003
Haematoma
Vascular disorders
25.1
Systematic Assessment
EG0000 affected113 at risk
EG0010 affected195 at risk
EG0020 affected133 at risk
EG003
Hypotension
Vascular disorders
25.1
Systematic Assessment
EG0002 affected113 at risk
EG0011 affected195 at risk
EG0021 affected133 at risk
EG003
Iliac vein stenosis
Vascular disorders
25.1
Systematic Assessment
EG0000 affected113 at risk
EG0011 affected195 at risk
EG0020 affected133 at risk
EG003
Lymphoedema
Vascular disorders
25.1
Systematic Assessment
EG0001 affected113 at risk
EG0010 affected195 at risk
EG0020 affected133 at risk
EG003
Orthostatic hypotension
Vascular disorders
25.1
Systematic Assessment
EG0001 affected113 at risk
EG0010 affected195 at risk
EG0020 affected133 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
25.1
Systematic Assessment
EG00028 affected113 at risk
EG00153 affected195 at risk
EG00242 affected133 at risk
EG0032 affected8 at risk
EG0042 affected6 at risk
EG00511 affected123 at risk
Ear pain
Ear and labyrinth disorders
25.1
Systematic Assessment
EG0003 affected113 at risk
EG0014 affected195 at risk
EG0021 affected133 at risk
EG003
Vertigo
Ear and labyrinth disorders
25.1
Systematic Assessment
EG0006 affected113 at risk
EG0011 affected195 at risk
EG0021 affected133 at risk
EG003
Hyperthyroidism
Endocrine disorders
25.1
Systematic Assessment
EG0002 affected113 at risk
EG0019 affected195 at risk
EG00221 affected133 at risk
EG003
Hypothyroidism
Endocrine disorders
25.1
Systematic Assessment
EG00017 affected113 at risk
EG00139 affected195 at risk
EG00231 affected133 at risk
EG003
Abdominal pain
Gastrointestinal disorders
25.1
Systematic Assessment
EG00018 affected113 at risk
EG00128 affected195 at risk
EG00230 affected133 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
25.1
Systematic Assessment
EG00012 affected113 at risk
EG0019 affected195 at risk
EG0025 affected133 at risk
EG003
Colitis
Gastrointestinal disorders
25.1
Systematic Assessment
EG0002 affected113 at risk
EG0016 affected195 at risk
EG0027 affected133 at risk
EG003
Constipation
Gastrointestinal disorders
25.1
Systematic Assessment
EG00027 affected113 at risk
EG00151 affected195 at risk
EG00237 affected133 at risk
EG003
Diarrhoea
Gastrointestinal disorders
25.1
Systematic Assessment
EG00031 affected113 at risk
EG00161 affected195 at risk
EG00254 affected133 at risk
EG003
Dry mouth
Gastrointestinal disorders
25.1
Systematic Assessment
EG0008 affected113 at risk
EG00113 affected195 at risk
EG0026 affected133 at risk
EG003
Dyspepsia
Gastrointestinal disorders
25.1
Systematic Assessment
EG0004 affected113 at risk
EG00111 affected195 at risk
EG0027 affected133 at risk
EG003
Dysphagia
Gastrointestinal disorders
25.1
Systematic Assessment
EG00010 affected113 at risk
EG00112 affected195 at risk
EG0022 affected133 at risk
EG003
Nausea
Gastrointestinal disorders
25.1
Systematic Assessment
EG00025 affected113 at risk
EG00145 affected195 at risk
EG00248 affected133 at risk
EG003
Stomatitis
Gastrointestinal disorders
25.1
Systematic Assessment
EG0007 affected113 at risk
EG0015 affected195 at risk
EG0024 affected133 at risk
EG003
Tongue ulceration
Gastrointestinal disorders
25.1
Systematic Assessment
EG0000 affected113 at risk
EG0011 affected195 at risk
EG0021 affected133 at risk
EG003
Vomiting
Gastrointestinal disorders
25.1
Systematic Assessment
EG00021 affected113 at risk
EG00131 affected195 at risk
EG00233 affected133 at risk
EG003
Asthenia
General disorders
25.1
Systematic Assessment
EG00018 affected113 at risk
EG00126 affected195 at risk
EG00223 affected133 at risk
EG003
Chest pain
General disorders
25.1
Systematic Assessment
EG0006 affected113 at risk
EG0012 affected195 at risk
EG0021 affected133 at risk
EG003
Chills
General disorders
25.1
Systematic Assessment
EG0006 affected113 at risk
EG00110 affected195 at risk
EG0029 affected133 at risk
EG003
Face oedema
General disorders
25.1
Systematic Assessment
EG0002 affected113 at risk
EG0016 affected195 at risk
EG0021 affected133 at risk
EG003
Facial pain
General disorders
25.1
Systematic Assessment
EG0003 affected113 at risk
EG0010 affected195 at risk
EG0020 affected133 at risk
EG003
Fatigue
General disorders
25.1
Systematic Assessment
EG00047 affected113 at risk
EG00181 affected195 at risk
EG00246 affected133 at risk
EG003
Gait disturbance
General disorders
25.1
Systematic Assessment
EG0000 affected113 at risk
EG0012 affected195 at risk
EG0021 affected133 at risk
EG003
Inflammation
General disorders
25.1
Systematic Assessment
EG0001 affected113 at risk
EG0010 affected195 at risk
EG0020 affected133 at risk
EG003
Influenza like illness
General disorders
25.1
Systematic Assessment
EG0004 affected113 at risk
EG00112 affected195 at risk
EG0022 affected133 at risk
EG003
Localised oedema
General disorders
25.1
Systematic Assessment
EG0000 affected113 at risk
EG0012 affected195 at risk
EG0020 affected133 at risk
EG003
Malaise
General disorders
25.1
Systematic Assessment
EG0004 affected113 at risk
EG0013 affected195 at risk
EG0020 affected133 at risk
EG003
Mucosal inflammation
General disorders
25.1
Systematic Assessment
EG0004 affected113 at risk
EG0016 affected195 at risk
EG0025 affected133 at risk
EG003
Non-cardiac chest pain
General disorders
25.1
Systematic Assessment
EG0005 affected113 at risk
EG0013 affected195 at risk
EG0023 affected133 at risk
EG003
Oedema peripheral
General disorders
25.1
Systematic Assessment
EG00016 affected113 at risk
EG00121 affected195 at risk
EG00220 affected133 at risk
EG003
Pain
General disorders
25.1
Systematic Assessment
EG0003 affected113 at risk
EG0019 affected195 at risk
EG0024 affected133 at risk
EG003
Pyrexia
General disorders
25.1
Systematic Assessment
EG00014 affected113 at risk
EG00134 affected195 at risk
EG00233 affected133 at risk
EG003
Bronchitis
Infections and infestations
25.1
Systematic Assessment
EG0008 affected113 at risk
EG0013 affected195 at risk
EG0021 affected133 at risk
EG003
Candida infection
Infections and infestations
25.1
Systematic Assessment
EG0003 affected113 at risk
EG0015 affected195 at risk
EG0020 affected133 at risk
EG003
Conjunctivitis
Infections and infestations
25.1
Systematic Assessment
EG0006 affected113 at risk
EG0014 affected195 at risk
EG0023 affected133 at risk
EG003
Eye infection
Infections and infestations
25.1
Systematic Assessment
EG0000 affected113 at risk
EG0010 affected195 at risk
EG0020 affected133 at risk
EG003
Mucosal infection
Infections and infestations
25.1
Systematic Assessment
EG0002 affected113 at risk
EG0011 affected195 at risk
EG0020 affected133 at risk
EG003
Nasopharyngitis
Infections and infestations
25.1
Systematic Assessment
EG00010 affected113 at risk
EG00114 affected195 at risk
EG0023 affected133 at risk
EG003
Oral bacterial infection
Infections and infestations
25.1
Systematic Assessment
EG0000 affected113 at risk
EG0010 affected195 at risk
EG0020 affected133 at risk
EG003
Otitis externa
Infections and infestations
25.1
Systematic Assessment
EG0000 affected113 at risk
EG0010 affected195 at risk
EG0020 affected133 at risk
EG003
Respiratory tract infection
Infections and infestations
25.1
Systematic Assessment
EG0003 affected113 at risk
EG0017 affected195 at risk
EG0022 affected133 at risk
EG003
Rhinitis
Infections and infestations
25.1
Systematic Assessment
EG0006 affected113 at risk
EG0014 affected195 at risk
EG0023 affected133 at risk
EG003
Tracheitis
Infections and infestations
25.1
Systematic Assessment
EG0000 affected113 at risk
EG0010 affected195 at risk
EG0020 affected133 at risk
EG003
Upper respiratory tract infection
Infections and infestations
25.1
Systematic Assessment
EG0007 affected113 at risk
EG00127 affected195 at risk
EG0028 affected133 at risk
EG003
Urinary tract infection
Infections and infestations
25.1
Systematic Assessment
EG0009 affected113 at risk
EG00121 affected195 at risk
EG00231 affected133 at risk
EG003
Fall
Injury, poisoning and procedural complications
25.1
Systematic Assessment
EG0000 affected113 at risk
EG0011 affected195 at risk
EG0022 affected133 at risk
EG003
Fracture
Injury, poisoning and procedural complications
25.1
Systematic Assessment
EG0000 affected113 at risk
EG0010 affected195 at risk
EG0020 affected133 at risk
EG003
Infusion related reaction
Injury, poisoning and procedural complications
25.1
Systematic Assessment
EG0005 affected113 at risk
EG00111 affected195 at risk
EG0024 affected133 at risk
EG003
Jaw fracture
Injury, poisoning and procedural complications
25.1
Systematic Assessment
EG0000 affected113 at risk
EG0010 affected195 at risk
EG0020 affected133 at risk
EG003
Procedural pain
Injury, poisoning and procedural complications
25.1
Systematic Assessment
EG0003 affected113 at risk
EG0013 affected195 at risk
EG0020 affected133 at risk
EG003
Radiation skin injury
Injury, poisoning and procedural complications
25.1
Systematic Assessment
EG0001 affected113 at risk
EG0011 affected195 at risk
EG0020 affected133 at risk
EG003
Alanine aminotransferase increased
Investigations
25.1
Systematic Assessment
EG0008 affected113 at risk
EG00126 affected195 at risk
EG00222 affected133 at risk
EG003
Amylase increased
Investigations
25.1
Systematic Assessment
EG0006 affected113 at risk
EG00120 affected195 at risk
EG00212 affected133 at risk
EG003
Aspartate aminotransferase increased
Investigations
25.1
Systematic Assessment
EG00010 affected113 at risk
EG00125 affected195 at risk
EG00220 affected133 at risk
EG003
Blood alkaline phosphatase increased
Investigations
25.1
Systematic Assessment
EG0005 affected113 at risk
EG00110 affected195 at risk
EG0027 affected133 at risk
EG003
Blood creatinine increased
Investigations
25.1
Systematic Assessment
EG00011 affected113 at risk
EG00119 affected195 at risk
EG00213 affected133 at risk
EG003
Breath sounds abnormal
Investigations
25.1
Systematic Assessment
EG0000 affected113 at risk
EG0010 affected195 at risk
EG0020 affected133 at risk
EG003
Lipase increased
Investigations
25.1
Systematic Assessment
EG00017 affected113 at risk
EG00127 affected195 at risk
EG00217 affected133 at risk
EG003
Lymphocyte count decreased
Investigations
25.1
Systematic Assessment
EG0001 affected113 at risk
EG00116 affected195 at risk
EG0023 affected133 at risk
EG003
Platelet count decreased
Investigations
25.1
Systematic Assessment
EG0000 affected113 at risk
EG00111 affected195 at risk
EG0020 affected133 at risk
EG003
Troponin increased
Investigations
25.1
Systematic Assessment
EG0001 affected113 at risk
EG0010 affected195 at risk
EG0020 affected133 at risk
EG003
Weight decreased
Investigations
25.1
Systematic Assessment
EG00010 affected113 at risk
EG00124 affected195 at risk
EG0028 affected133 at risk
EG003
White blood cell count decreased
Investigations
25.1
Systematic Assessment
EG0002 affected113 at risk
EG00110 affected195 at risk
EG0024 affected133 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
25.1
Systematic Assessment
EG00024 affected113 at risk
EG00148 affected195 at risk
EG00232 affected133 at risk
EG003
Dehydration
Metabolism and nutrition disorders
25.1
Systematic Assessment
EG0001 affected113 at risk
EG0019 affected195 at risk
EG0023 affected133 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
25.1
Systematic Assessment
EG0003 affected113 at risk
EG0019 affected195 at risk
EG0024 affected133 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
25.1
Systematic Assessment
EG0003 affected113 at risk
EG00116 affected195 at risk
EG0029 affected133 at risk
EG003
Hypoalbuminaemia
Metabolism and nutrition disorders
25.1
Systematic Assessment
EG0002 affected113 at risk
EG00114 affected195 at risk
EG00216 affected133 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
25.1
Systematic Assessment
EG0006 affected113 at risk
EG00120 affected195 at risk
EG00215 affected133 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
25.1
Systematic Assessment
EG00010 affected113 at risk
EG00114 affected195 at risk
EG00217 affected133 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
25.1
Systematic Assessment
EG0004 affected113 at risk
EG00124 affected195 at risk
EG00214 affected133 at risk
EG003
Hypophosphataemia
Metabolism and nutrition disorders
25.1
Systematic Assessment
EG0005 affected113 at risk
EG00120 affected195 at risk
EG0023 affected133 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
25.1
Systematic Assessment
EG00024 affected113 at risk
EG00135 affected195 at risk
EG00226 affected133 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
25.1
Systematic Assessment
EG00017 affected113 at risk
EG00128 affected195 at risk
EG00219 affected133 at risk
EG003
Flank pain
Musculoskeletal and connective tissue disorders
25.1
Systematic Assessment
EG0006 affected113 at risk
EG0017 affected195 at risk
EG0027 affected133 at risk
EG003
Groin pain
Musculoskeletal and connective tissue disorders
25.1
Systematic Assessment
EG0002 affected113 at risk
EG0013 affected195 at risk
EG0022 affected133 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
25.1
Systematic Assessment
EG0002 affected113 at risk
EG00110 affected195 at risk
EG0024 affected133 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
25.1
Systematic Assessment
EG0008 affected113 at risk
EG00111 affected195 at risk
EG0022 affected133 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
25.1
Systematic Assessment
EG0004 affected113 at risk
EG0015 affected195 at risk
EG0022 affected133 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
25.1
Systematic Assessment
EG00010 affected113 at risk
EG00119 affected195 at risk
EG00210 affected133 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
25.1
Systematic Assessment
EG0003 affected113 at risk
EG0017 affected195 at risk
EG0021 affected133 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
25.1
Systematic Assessment
EG00012 affected113 at risk
EG00113 affected195 at risk
EG0029 affected133 at risk
EG003
Squamous cell carcinoma of skin
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
25.1
Systematic Assessment
EG0003 affected113 at risk
EG0011 affected195 at risk
EG0020 affected133 at risk
EG003
Tumour pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
25.1
Systematic Assessment
EG0007 affected113 at risk
EG0015 affected195 at risk
EG0023 affected133 at risk
EG003
Dizziness
Nervous system disorders
25.1
Systematic Assessment
EG00012 affected113 at risk
EG00119 affected195 at risk
EG00215 affected133 at risk
EG003
Dysgeusia
Nervous system disorders
25.1
Systematic Assessment
EG0007 affected113 at risk
EG0013 affected195 at risk
EG0023 affected133 at risk
EG003
Headache
Nervous system disorders
25.1
Systematic Assessment
EG00013 affected113 at risk
EG00131 affected195 at risk
EG00222 affected133 at risk
EG003
Paraesthesia
Nervous system disorders
25.1
Systematic Assessment
EG0002 affected113 at risk
EG0013 affected195 at risk
EG0022 affected133 at risk
EG003
Peripheral sensory neuropathy
Nervous system disorders
25.1
Systematic Assessment
EG0002 affected113 at risk
EG0014 affected195 at risk
EG0024 affected133 at risk
EG003
Anxiety
Psychiatric disorders
25.1
Systematic Assessment
EG00010 affected113 at risk
EG0018 affected195 at risk
EG0024 affected133 at risk
EG003
Confusional state
Psychiatric disorders
25.1
Systematic Assessment
EG0001 affected113 at risk
EG0015 affected195 at risk
EG0022 affected133 at risk
EG003
Insomnia
Psychiatric disorders
25.1
Systematic Assessment
EG00010 affected113 at risk
EG00123 affected195 at risk
EG0028 affected133 at risk
EG003
Pelvic pain
Reproductive system and breast disorders
25.1
Systematic Assessment
EG0002 affected113 at risk
EG0016 affected195 at risk
EG0027 affected133 at risk
EG003
Vaginal haemorrhage
Reproductive system and breast disorders
25.1
Systematic Assessment
EG0001 affected113 at risk
EG0016 affected195 at risk
EG0027 affected133 at risk
EG003
Aspiration
Respiratory, thoracic and mediastinal disorders
25.1
Systematic Assessment
EG0000 affected113 at risk
EG0014 affected195 at risk
EG0020 affected133 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
25.1
Systematic Assessment
EG00026 affected113 at risk
EG00149 affected195 at risk
EG00217 affected133 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
25.1
Systematic Assessment
EG00021 affected113 at risk
EG00130 affected195 at risk
EG00213 affected133 at risk
EG003
Dyspnoea exertional
Respiratory, thoracic and mediastinal disorders
25.1
Systematic Assessment
EG0007 affected113 at risk
EG0014 affected195 at risk
EG0021 affected133 at risk
EG003
Laryngeal inflammation
Respiratory, thoracic and mediastinal disorders
25.1
Systematic Assessment
EG0000 affected113 at risk
EG0010 affected195 at risk
EG0020 affected133 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
25.1
Systematic Assessment
EG0005 affected113 at risk
EG00111 affected195 at risk
EG0024 affected133 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
25.1
Systematic Assessment
EG0006 affected113 at risk
EG00110 affected195 at risk
EG0023 affected133 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
25.1
Systematic Assessment
EG0004 affected113 at risk
EG0014 affected195 at risk
EG0021 affected133 at risk
EG003
Pneumonitis
Respiratory, thoracic and mediastinal disorders
25.1
Systematic Assessment
EG0008 affected113 at risk
EG0019 affected195 at risk
EG0029 affected133 at risk
EG003
Productive cough
Respiratory, thoracic and mediastinal disorders
25.1
Systematic Assessment
EG0003 affected113 at risk
EG0017 affected195 at risk
EG0027 affected133 at risk
EG003
Upper-airway cough syndrome
Respiratory, thoracic and mediastinal disorders
25.1
Systematic Assessment
EG0000 affected113 at risk
EG0016 affected195 at risk
EG0021 affected133 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
25.1
Systematic Assessment
EG00010 affected113 at risk
EG00114 affected195 at risk
EG00212 affected133 at risk
EG003
Night sweats
Skin and subcutaneous tissue disorders
25.1
Systematic Assessment
EG0001 affected113 at risk
EG0013 affected195 at risk
EG0021 affected133 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
25.1
Systematic Assessment
EG00023 affected113 at risk
EG00160 affected195 at risk
EG00235 affected133 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
25.1
Systematic Assessment
EG00017 affected113 at risk
EG00149 affected195 at risk
EG00216 affected133 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
25.1
Systematic Assessment
EG0008 affected113 at risk
EG00120 affected195 at risk
EG00225 affected133 at risk
EG003
Skin ulcer
Skin and subcutaneous tissue disorders
25.1
Systematic Assessment
EG0000 affected113 at risk
EG0012 affected195 at risk
EG0021 affected133 at risk
EG003
Haematoma
Vascular disorders
25.1
Systematic Assessment
EG0002 affected113 at risk
EG0012 affected195 at risk
EG0020 affected133 at risk
EG003
Hypertension
Vascular disorders
25.1
Systematic Assessment
EG00010 affected113 at risk
EG0017 affected195 at risk
EG0025 affected133 at risk
EG003
Hypotension
Vascular disorders
25.1
Systematic Assessment
EG0005 affected113 at risk
EG00110 affected195 at risk
EG0024 affected133 at risk
EG003
Lymphoedema
Vascular disorders
25.1
Systematic Assessment
EG0004 affected113 at risk
EG0014 affected195 at risk
EG0025 affected133 at risk
EG003
Venous thrombosis
Vascular disorders
25.1
Systematic Assessment
EG0001 affected113 at risk
EG0010 affected195 at risk
EG0020 affected133 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
Nivolumab 3 mg/kg IV over 30 minutes every 2 weeks + Ipilimumab 1 mg/kg IV over 30 minutes every 6 weeks for a maximum of 24 months or until disease progression, unacceptable toxicity, or withdrawal of consent, whichever comes first
OG002
Metastatic Combo B
Nivolumab 1 mg/kg IV over 30 minutes + Ipilimumab 3 mg/kg IV over 30 minutes every 3 weeks for 4 doses followed by Nivolumab 240 mg IV over 30 minutes every 2 weeks for a maximum of 24 months or until disease progression, unacceptable toxicity, or withdrawal of consent, whichever comes first
OG003
Metastatic Combo C
Nivolumab 240 mg IV over 30 minutes + BMS-986016 (Relatlimab) 80 mg IV over 60 minutes administered every 2 weeks for a maximum of 24 months, or until disease progression, unacceptable toxicity, or withdrawal of consent, whichever comes first
OG004
Metastatic Combo D
Daratumumab 16 mg/kg IV weekly for the first 8 weeks. Starting at Week 3, Nivolumab 240 mg IV over 30 minutes every 2 weeks. Daratumumab 16 mg/kg every 2 weeks from Weeks 9-24. Starting at Week 25, Nivolumab 480 mg IV flat dose over 30 minutes every 4 weeks; daratumumab 16 mg/kg every 4 weeks for a maximum of 24 months or until progression, unacceptable toxicity, or withdrawal of consent, whichever comes first
Units
Counts
Participants
OG000113
OG001195
OG002133
OG0038
OG0046
Title
Denominators
Categories
EBV positive related gastric cancer
ParticipantsOG00014
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
ParticipantsOG0040
Title
Measurements
OG00014.3(1.8 to 42.8)
HPV positive SCCHN
ParticipantsOG00026
ParticipantsOG00142
ParticipantsOG0020
ParticipantsOG0038
Other anogenital HPV associated cancers
ParticipantsOG0000
ParticipantsOG00123
ParticipantsOG00221
ParticipantsOG0030
SCCHN I-O naive
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Cervical
ParticipantsOG00019
ParticipantsOG00145
ParticipantsOG00245
ParticipantsOG0030
Cervical first line
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG00244
ParticipantsOG0030
Cervical second line
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG00223
ParticipantsOG0030
Vaginal/Vulvar
ParticipantsOG0005
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
MCC
ParticipantsOG00025
ParticipantsOG00143
ParticipantsOG0020
ParticipantsOG0030
NPC
ParticipantsOG00024
ParticipantsOG00142
ParticipantsOG0020
ParticipantsOG0030
OG002
Metastatic Combo B
Nivolumab 1 mg/kg IV over 30 minutes + Ipilimumab 3 mg/kg IV over 30 minutes every 3 weeks for 4 doses followed by Nivolumab 240 mg IV over 30 minutes every 2 weeks for a maximum of 24 months or until disease progression, unacceptable toxicity, or withdrawal of consent, whichever comes first
OG003
Metastatic Combo C
Nivolumab 240 mg IV over 30 minutes + BMS-986016 (Relatlimab) 80 mg IV over 60 minutes administered every 2 weeks for a maximum of 24 months, or until disease progression, unacceptable toxicity, or withdrawal of consent, whichever comes first
OG004
Metastatic Combo D
Daratumumab 16 mg/kg IV weekly for the first 8 weeks. Starting at Week 3, Nivolumab 240 mg IV over 30 minutes every 2 weeks. Daratumumab 16 mg/kg every 2 weeks from Weeks 9-24. Starting at Week 25, Nivolumab 480 mg IV flat dose over 30 minutes every 4 weeks; daratumumab 16 mg/kg every 4 weeks for a maximum of 24 months or until progression, unacceptable toxicity, or withdrawal of consent, whichever comes first
Units
Counts
Participants
OG00030
OG00172
OG00250
OG0030
OG0041
Title
Denominators
Categories
EBV positive related gastric cancer
ParticipantsOG0002
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
ParticipantsOG0040
Title
Measurements
OG000NA(NA to NA)Median not reached as insufficient progression events among responders
HPV positive SCCHN
ParticipantsOG0003
ParticipantsOG00113
ParticipantsOG0020
ParticipantsOG0030
Other anogenital HPV associated cancers
ParticipantsOG0000
ParticipantsOG0018
ParticipantsOG0025
ParticipantsOG0030
SCCHN I-O naive
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Cervical, Randomized
ParticipantsOG0005
ParticipantsOG00114
ParticipantsOG00218
ParticipantsOG0030
Cervical, Pooled
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG00245
ParticipantsOG0030
Vaginal/Vulvar
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
MCC
ParticipantsOG00015
ParticipantsOG00125
ParticipantsOG0020
ParticipantsOG0030
NPC
ParticipantsOG0004
ParticipantsOG00112
ParticipantsOG0020
ParticipantsOG0030
Nivolumab 1 mg/kg IV over 30 minutes + Ipilimumab 3 mg/kg IV over 30 minutes every 3 weeks for 4 doses followed by Nivolumab 240 mg IV over 30 minutes every 2 weeks for a maximum of 24 months or until disease progression, unacceptable toxicity, or withdrawal of consent, whichever comes first
OG003
Metastatic Combo C
Nivolumab 240 mg IV over 30 minutes + BMS-986016 (Relatlimab) 80 mg IV over 60 minutes administered every 2 weeks for a maximum of 24 months, or until disease progression, unacceptable toxicity, or withdrawal of consent, whichever comes first
OG004
Metastatic Combo D
Daratumumab 16 mg/kg IV weekly for the first 8 weeks. Starting at Week 3, Nivolumab 240 mg IV over 30 minutes every 2 weeks. Daratumumab 16 mg/kg every 2 weeks from Weeks 9-24. Starting at Week 25, Nivolumab 480 mg IV flat dose over 30 minutes every 4 weeks; daratumumab 16 mg/kg every 4 weeks for a maximum of 24 months or until progression, unacceptable toxicity, or withdrawal of consent, whichever comes first
Units
Counts
Participants
OG000113
OG001195
OG002133
OG0038
OG0046
Title
Denominators
Categories
EBV positive related gastric cancer
ParticipantsOG00014
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
ParticipantsOG0040
Title
Measurements
OG0009.99(3.09 to 30.13)
HPV positive SCCHN
ParticipantsOG00026
ParticipantsOG00142
ParticipantsOG0020
ParticipantsOG0038
Other anogenital HPV associated cancers
ParticipantsOG0000
ParticipantsOG00123
ParticipantsOG00221
ParticipantsOG0030
SCCHN I-O naive
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Cervical, Randomized
ParticipantsOG00019
ParticipantsOG00145
ParticipantsOG00245
ParticipantsOG0030
Cervical, Pooled
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG002112
ParticipantsOG0030
Vaginal/Vulvar
ParticipantsOG0005
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
MCC
ParticipantsOG00025
ParticipantsOG00143
ParticipantsOG0020
ParticipantsOG0030
NPC
ParticipantsOG00024
ParticipantsOG00142
ParticipantsOG0020
ParticipantsOG0030
OG002
Metastatic Combo B
Nivolumab 1 mg/kg IV over 30 minutes + Ipilimumab 3 mg/kg IV over 30 minutes every 3 weeks for 4 doses followed by Nivolumab 240 mg IV over 30 minutes every 2 weeks for a maximum of 24 months or until disease progression, unacceptable toxicity, or withdrawal of consent, whichever comes first
OG003
Metastatic Combo C
Nivolumab 240 mg IV over 30 minutes + BMS-986016 (Relatlimab) 80 mg IV over 60 minutes administered every 2 weeks for a maximum of 24 months, or until disease progression, unacceptable toxicity, or withdrawal of consent, whichever comes first
OG004
Metastatic Combo D
Daratumumab 16 mg/kg IV weekly for the first 8 weeks. Starting at Week 3, Nivolumab 240 mg IV over 30 minutes every 2 weeks. Daratumumab 16 mg/kg every 2 weeks from Weeks 9-24. Starting at Week 25, Nivolumab 480 mg IV flat dose over 30 minutes every 4 weeks; daratumumab 16 mg/kg every 4 weeks for a maximum of 24 months or until progression, unacceptable toxicity, or withdrawal of consent, whichever comes first
Units
Counts
Participants
OG000113
OG001195
OG002133
OG0038
OG0046
Title
Denominators
Categories
EBV positive related gastric cancer
ParticipantsOG00014
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
ParticipantsOG0040
Title
Measurements
OG0002.94(1.05 to 3.75)
HPV positive SCCHN
ParticipantsOG00026
ParticipantsOG00142
ParticipantsOG0020
ParticipantsOG0038
Other anogenital HPV associated cancers
ParticipantsOG0000
ParticipantsOG00123
ParticipantsOG00221
ParticipantsOG0030
SCCHN I-O naive
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Cervical, Randomized
ParticipantsOG00019
ParticipantsOG00145
ParticipantsOG00245
ParticipantsOG0030
Cervical, Pooled
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG002112
ParticipantsOG0030
Vaginal/Vulvar
ParticipantsOG0005
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
MCC
ParticipantsOG00025
ParticipantsOG00143
ParticipantsOG0020
ParticipantsOG0030
NPC
ParticipantsOG00024
ParticipantsOG00142
ParticipantsOG0020
ParticipantsOG0030
Metastatic Combo A
Nivolumab 3 mg/kg IV over 30 minutes every 2 weeks + Ipilimumab 1 mg/kg IV over 30 minutes every 6 weeks for a maximum of 24 months or until disease progression, unacceptable toxicity, or withdrawal of consent, whichever comes first
OG002
Metastatic Combo B
Nivolumab 1 mg/kg IV over 30 minutes + Ipilimumab 3 mg/kg IV over 30 minutes every 3 weeks for 4 doses followed by Nivolumab 240 mg IV over 30 minutes every 2 weeks for a maximum of 24 months or until disease progression, unacceptable toxicity, or withdrawal of consent, whichever comes first
OG003
Metastatic Combo C
Nivolumab 240 mg IV over 30 minutes + BMS-986016 (Relatlimab) 80 mg IV over 60 minutes administered every 2 weeks for a maximum of 24 months, or until disease progression, unacceptable toxicity, or withdrawal of consent, whichever comes first
OG004
Metastatic Combo D
Daratumumab 16 mg/kg IV weekly for the first 8 weeks. Starting at Week 3, Nivolumab 240 mg IV over 30 minutes every 2 weeks. Daratumumab 16 mg/kg every 2 weeks from Weeks 9-24. Starting at Week 25, Nivolumab 480 mg IV flat dose over 30 minutes every 4 weeks; daratumumab 16 mg/kg every 4 weeks for a maximum of 24 months or until progression, unacceptable toxicity, or withdrawal of consent, whichever comes first
Units
Counts
Participants
OG000113
OG001195
OG002133
OG0038
OG0046
Title
Denominators
Categories
EBV positive related gastric cancer
ParticipantsOG00014
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
ParticipantsOG0040
Title
Measurements
OG00014.3(1.8 to 42.8)
HPV positive SCCHN
ParticipantsOG00026
ParticipantsOG00142
ParticipantsOG0020
ParticipantsOG0038
Other anogenital HPV associated cancers
ParticipantsOG0000
ParticipantsOG00123
ParticipantsOG00221
ParticipantsOG0030
SCCHN I-O naive
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Cervical, Randomized
ParticipantsOG00019
ParticipantsOG00145
ParticipantsOG00245
ParticipantsOG0030
Cervical, Pooled
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG002112
ParticipantsOG0030
Vaginal/Vulvar
ParticipantsOG0005
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
MCC
ParticipantsOG00025
ParticipantsOG00143
ParticipantsOG0020
ParticipantsOG0030
NPC
ParticipantsOG00024
ParticipantsOG00142
ParticipantsOG0020
ParticipantsOG0030
0 affected
8 at risk
EG0040 affected6 at risk
EG0052 affected123 at risk
0 affected
8 at risk
EG0040 affected6 at risk
EG0050 affected123 at risk
0 affected
8 at risk
EG0040 affected6 at risk
EG0050 affected123 at risk
0 affected
8 at risk
EG0040 affected6 at risk
EG0051 affected123 at risk
0 affected
8 at risk
EG0040 affected6 at risk
EG0051 affected123 at risk
1 affected
8 at risk
EG0040 affected6 at risk
EG0050 affected123 at risk
0 affected
8 at risk
EG0040 affected6 at risk
EG0050 affected123 at risk
0 affected
8 at risk
EG0040 affected6 at risk
EG0050 affected123 at risk
0 affected
8 at risk
EG0040 affected6 at risk
EG0050 affected123 at risk
0 affected
8 at risk
EG0040 affected6 at risk
EG0050 affected123 at risk
0 affected
8 at risk
EG0040 affected6 at risk
EG0050 affected123 at risk
0 affected
8 at risk
EG0040 affected6 at risk
EG0051 affected123 at risk
0 affected
8 at risk
EG0040 affected6 at risk
EG0050 affected123 at risk
1 affected
8 at risk
EG0040 affected6 at risk
EG0050 affected123 at risk
0 affected
8 at risk
EG0040 affected6 at risk
EG0050 affected123 at risk
0 affected
8 at risk
EG0040 affected6 at risk
EG0050 affected123 at risk
0 affected
8 at risk
EG0040 affected6 at risk
EG0050 affected123 at risk
0 affected
8 at risk
EG0040 affected6 at risk
EG0050 affected123 at risk
0 affected
8 at risk
EG0040 affected6 at risk
EG0050 affected123 at risk
0 affected
8 at risk
EG0040 affected6 at risk
EG0050 affected123 at risk
0 affected
8 at risk
EG0040 affected6 at risk
EG0050 affected123 at risk
0 affected
8 at risk
EG0040 affected6 at risk
EG0050 affected123 at risk
0 affected
8 at risk
EG0040 affected6 at risk
EG0050 affected123 at risk
0 affected
8 at risk
EG0040 affected6 at risk
EG0050 affected123 at risk
0 affected
8 at risk
EG0040 affected6 at risk
EG0050 affected123 at risk
0 affected
8 at risk
EG0040 affected6 at risk
EG0050 affected123 at risk
0 affected
8 at risk
EG0040 affected6 at risk
EG0050 affected123 at risk
0 affected
8 at risk
EG0040 affected6 at risk
EG0051 affected123 at risk
0 affected
8 at risk
EG0040 affected6 at risk
EG0051 affected123 at risk
0 affected
8 at risk
EG0040 affected6 at risk
EG0050 affected123 at risk
0 affected
8 at risk
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EG0040 affected6 at risk
EG0053 affected123 at risk
0 affected
8 at risk
EG0041 affected6 at risk
EG0058 affected123 at risk
1 affected
8 at risk
EG0040 affected6 at risk
EG0059 affected123 at risk
0 affected
8 at risk
EG0041 affected6 at risk
EG0050 affected123 at risk
1 affected
8 at risk
EG0041 affected6 at risk
EG0052 affected123 at risk
0 affected
8 at risk
EG0040 affected6 at risk
EG0050 affected123 at risk
0 affected
8 at risk
EG0040 affected6 at risk
EG0054 affected123 at risk
0 affected
8 at risk
EG0041 affected6 at risk
EG0053 affected123 at risk
2 affected
8 at risk
EG0041 affected6 at risk
EG0057 affected123 at risk
2 affected
8 at risk
EG0041 affected6 at risk
EG0053 affected123 at risk
0 affected
8 at risk
EG0040 affected6 at risk
EG0051 affected123 at risk
1 affected
8 at risk
EG0040 affected6 at risk
EG0051 affected123 at risk
0 affected
8 at risk
EG0040 affected6 at risk
EG0051 affected123 at risk
0 affected
8 at risk
EG0041 affected6 at risk
EG0056 affected123 at risk
1 affected
8 at risk
EG0040 affected6 at risk
EG0050 affected123 at risk
0 affected
8 at risk
EG0040 affected6 at risk
EG0050 affected123 at risk
0 affected
8 at risk
EG0040 affected6 at risk
EG0053 affected123 at risk
1 affected
8 at risk
EG0040 affected6 at risk
EG0051 affected123 at risk
0 affected
8 at risk
EG0041 affected6 at risk
EG0053 affected123 at risk
1 affected
8 at risk
EG0040 affected6 at risk
EG0051 affected123 at risk
0 affected
8 at risk
EG0041 affected6 at risk
EG00511 affected123 at risk
1 affected
8 at risk
EG0040 affected6 at risk
EG0057 affected123 at risk
0 affected
8 at risk
EG0040 affected6 at risk
EG0056 affected123 at risk
0 affected
8 at risk
EG0042 affected6 at risk
EG0050 affected123 at risk
1 affected
8 at risk
EG0040 affected6 at risk
EG0052 affected123 at risk
1 affected
8 at risk
EG0040 affected6 at risk
EG00512 affected123 at risk
0 affected
8 at risk
EG0041 affected6 at risk
EG0054 affected123 at risk
1 affected
8 at risk
EG0041 affected6 at risk
EG0052 affected123 at risk
0 affected
8 at risk
EG0041 affected6 at risk
EG0050 affected123 at risk
ParticipantsOG0040
Title
Measurements
OG00011.5(2.4 to 30.2)
OG00131.0(17.6 to 47.1)
OG0030(0.0 to 36.9)
ParticipantsOG0040
Title
Measurements
OG00134.8(16.4 to 57.3)
OG00228.6(11.3 to 52.2)
Participants
OG004
6
Title
Measurements
OG00416.7(0.4 to 64.1)
Participants
OG004
0
Title
Measurements
OG00026.3(9.1 to 51.2)
OG00131.1(18.2 to 46.6)
OG00240.0(25.7 to 55.7)
ParticipantsOG0040
Title
Measurements
OG00236.4(22.4 to 52.2)
ParticipantsOG0040
Title
Measurements
OG00239.1(19.7 to 61.5)
Participants
OG004
0
Title
Measurements
OG00020.0(0.5 to 71.6)
Participants
OG004
0
Title
Measurements
OG00064.0(42.5 to 82.0)
OG00158.1(42.1 to 73.0)
Participants
OG004
0
Title
Measurements
OG00016.7(4.7 to 37.4)
OG00126.2(13.9 to 42.0)
ParticipantsOG0040
Title
Measurements
OG00044.25(24.90 to NA)Upper limit not calculable as upper CI bound does not cross 50% threshold
OG00134.46(10.45 to NA)Upper limit not calculable as upper CI bound does not cross 50% threshold
ParticipantsOG0040
Title
Measurements
OG00118.23(3.68 to 27.93)
OG0023.71(3.58 to NA)Upper limit not calculable as upper CI bound does not cross 50% threshold
Participants
OG004
1
Title
Measurements
OG004NA(NA to NA)Median not reached as insufficient progression events among responders
ParticipantsOG0040
Title
Measurements
OG000NA(35.29 to NA)Median not reached as insufficient progression events among responders and Upper limit not calculable as upper CI bound does not cross 50% threshold
OG001NA(8.67 to NA)Median not reached as insufficient progression events among responders and Upper limit not calculable as upper CI bound does not cross 50% threshold
OG00234.07(15.28 to NA)Upper limit not calculable as upper CI bound does not cross 50% threshold
ParticipantsOG0040
Title
Measurements
OG00234.07(15.28 to NA)Upper limit not calculable as upper CI bound does not cross 50% threshold
Participants
OG004
0
Title
Measurements
OG0004.96(NA to NA)Lower limit and Upper limit not calculable as upper CI bound does not cross 50% threshold
Participants
OG004
0
Title
Measurements
OG00060.62(16.72 to NA)Upper limit not calculable as upper CI bound does not cross 50% threshold
OG00125.86(10.38 to NA)Upper limit not calculable as upper CI bound does not cross 50% threshold
Participants
OG004
0
Title
Measurements
OG0009.46(3.68 to NA)Upper limit not calculable as upper CI bound does not cross 50% threshold
OG00119.63(5.55 to NA)Upper limit not calculable as upper CI bound does not cross 50% threshold
ParticipantsOG0040
Title
Measurements
OG00020.44(13.90 to 36.50)
OG00117.08(9.49 to 26.78)
OG0038.84(2.50 to 35.06)
ParticipantsOG0040
Title
Measurements
OG00112.12(6.83 to 29.54)
OG00214.06(4.37 to 30.59)
Participants
OG004
6
Title
Measurements
OG0044.21(1.68 to NA)Upper limit not calculable as upper CI bound does not cross 50% threshold
ParticipantsOG0040
Title
Measurements
OG00021.55(8.25 to 44.85)
OG00117.12(10.22 to 34.79)
OG00222.74(14.62 to 32.82)
ParticipantsOG0040
Title
Measurements
OG00220.93(14.39 to 29.04)
Participants
OG004
0
Title
Measurements
OG00010.28(3.88 to 23.72)
Participants
OG004
0
Title
Measurements
OG00080.66(23.26 to NA)Upper limit not calculable as upper CI bound does not cross 50% threshold
OG00129.83(8.51 to 48.33)
Participants
OG004
0
Title
Measurements
OG00022.74(12.62 to 35.29)
OG00123.66(16.82 to 41.43)
ParticipantsOG0040
Title
Measurements
OG0003.25(1.84 to 6.93)
OG0013.71(1.77 to 6.80)
OG0033.81(1.77 to 7.39)
ParticipantsOG0040
Title
Measurements
OG0014.63(1.94 to 14.29)
OG0023.58(2.04 to 7.49)
Participants
OG004
6
Title
Measurements
OG0041.81(1.08 to NA)Upper limit not calculable as upper CI bound does not cross 50% threshold