MSB0011359C (M7824) in Participants With Metastatic or Lo... | NCT02699515 | Trialant
NCT02699515
Sponsor
Merck KGaA, Darmstadt, Germany
Status
Completed
Last Update Posted
Nov 18, 2024Actual
Enrollment
114Actual
Phase
Phase 1
Conditions
Solid Tumors
Interventions
MSB0011359C
Countries
Japan
South Korea
Taiwan
Protocol Section
Identification Module
NCT ID
NCT02699515
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
200647-0008
Secondary IDs
Not provided
Brief Title
MSB0011359C (M7824) in Participants With Metastatic or Locally Advanced Solid Tumors
Official Title
A Phase I, Open-label, Multiple-ascending Dose Trial to Investigate the Safety, Tolerability, Pharmacokinetics, Biological and Clinical Activity of MSB0011359C (M7824) in Subjects With Metastatic or Locally Advanced Solid Tumors With Expansion to Selected Indications in Asia
Acronym
Not provided
Organization
Merck KGaA, Darmstadt, GermanyINDUSTRY
Status Module
Record Verification Date
Sep 2024
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
Mar 11, 2016Actual
Primary Completion Date
Feb 21, 2022Actual
Completion Date
Feb 21, 2022Actual
First Submitted Date
Mar 1, 2016
First Submission Date that Met QC Criteria
Mar 3, 2016
First Posted Date
Mar 4, 2016Estimated
Results Waived
Not provided
Results First Submitted Date
Apr 15, 2024
Results First Submitted that Met QC Criteria
Sep 26, 2024
Results First Posted Date
Nov 18, 2024Actual
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
Sep 26, 2024
Last Update Posted Date
Nov 18, 2024Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Merck KGaA, Darmstadt, GermanyINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The main purpose of this study was to assess the safety and tolerability of MSB0011359C. Study consists of dose-escalation part and an expansion part in participants with metastatic or locally advanced solid tumors, for which no standard effective therapy exists or a standard therapy had failed.
Detailed Description
Not provided
Conditions Module
Conditions
Solid Tumors
Keywords
MSB0011359C
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 1
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
114Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
MSB0011359C (M7824)
Experimental
Drug: MSB0011359C
Interventions
Name
Type
Description
Arm Group Labels
Other Names
MSB0011359C
Drug
Subjects with metastatic or locally advanced solid tumors received intravenous infusion of MSB0011359C over 1 hour once every two weeks for up to 12 months until confirmed progressive disease (PD), unacceptable toxicity, or any criterion for withdrawal from the trial or investigational medicinal product (IMP) occurs.
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Number of Participants With Dose Limiting Toxicity (DLT)
A DLT was defined as any grade greater than or equal to (>=) 3 adverse event suspected to be related to investigational medicinal product (IMP) by the Investigator and / or Sponsor occurring in the DLT evaluation period confirmed by the Safety Monitoring Committee (SMC) to be relevant for the IMP treatment.
Baseline up to Week 3
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) According to National Cancer Institute-Common Terminology Criteria for Adverse Event (NCI-CTCAE) Version 4.03
An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a product or medical device; the event needed not necessarily have a causal relationship with the treatment or usage. Serious AE: an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. TEAE: AE with onset after start of treatment or with onset date before the treatment start date but worsening after the treatment start date. TEAEs included both serious and non-serious TEAEs.
First study drug administration up to 30 days after the last drug administration assessed up to approximately 5 years
Number of Participants With Treatment-Related Adverse Events (TRAEs) According to NCI-CTCAE Version 4.03
An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a product or medical device; the event needed not necessarily have a causal relationship with the treatment or usage. Serious AE: an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. TEAE: AE with onset after start of treatment or with onset date before the treatment start date but worsening after the treatment start date. TEAEs included both serious and non-serious TEAEs. Treatment-related TEAEs: reasonably related to the study intervention. Number of participants with TEAEs and treatment related TEAEs were reported.
Secondary Outcomes
Measure
Description
Time Frame
Dose-Escalation Phase: Maximum Serum Concentration (Cmax) of M7824
Cmax is the maximum observed serum concentration obtained directly from the concentration versus time curve.
Pre-dose, 0, 4 hour post dose on Day 1, 2,8,15,29,43
Dose-Escalation Phase: Terminal Half Life (t1/2) of M7824
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Able and willing to give written informed consent and had signed the appropriate written informed consent form (ICF), prior to performance of any trial activities
Eligible male and female participants aged greater than or equal to (>=)20 years
Histologically or cytologically proven metastatic or locally advanced solid tumors, for which no effective standard therapy exists or standard therapy had failed
Eastern Cooperative Oncology Group performance status (ECOG) performance status of 0 to 1 at trial entry
Life expectancy >=12 weeks as judged by the Investigator.
Adequate hematological function defined by white blood cell (WBC) count >=3*10^9/Liter with absolute neutrophil count (ANC) >=1.5*10^9/Liter, lymphocyte count >=0.5* 10^9/Liter, platelet count >=75*10^9/Liter, and Hemoglobin (Hgb) >= 9 grams per deciliter (g/dL) (in absence of blood transfusion)
Adequate hepatic function defined by a total bilirubin level <=1.5 × Upper limit of normal (ULN), an AST level <= 2.5 × ULN, and an ALT level <= 2.5 × ULN
Adequate renal function defined by an estimated creatinine clearance >50 milliliter per minute (mL/min) according to the Cockcroft-Gault formula or by measure of creatinine clearance from 24 hour urine collection
Other protocol-defined exclusion criteria could apply.
Exclusion Criteria:
Concurrent treatment with non-permitted drugs and other interventions
Anticancer treatment within 28 days before the start of trial treatment, for example cyto reductive therapy, radiotherapy (with the exception of palliative bone directed radiotherapy), immune therapy, or cytokine therapy
Major surgery within 28 days before the start of trial treatment (excluding prior diagnostic biopsy)
Systemic therapy with immunosuppressive agents within 7 days before the start of trial treatment; or use of any investigational drug within 28 days before the start of trial treatment
Previous malignant disease other than the target malignancy to be investigated in this trial with the exception of cervical carcinoma in situ and superficial or non invasive bladder cancer (treated with curative intent) within the last 5 years or basal cell or squamous cell carcinoma in situ within the last 3 years
Rapidly progressive disease which, in the opinion of the Investigator, may predispose to inability to tolerate treatment or trial procedures
Active or history of central nervous system metastases, except as in the melanoma-specific Central nervous system (CNS) criteria listed above
Receipt of any organ transplantation, including allogeneic stem-cell transplantation, but with the exception of transplants that do not require immunosuppression (eg, corneal transplant, hair transplant)
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
20 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Medical Responsible
Merck KGaA, Darmstadt, Germany
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
NHO Kyushu Cancer Center
Fukuoka
Japan
National Cancer Center East, Department of Experimental Therapeutics
Lin CC, Doi T, Muro K, Hou MM, Esaki T, Hara H, Chung HC, Helwig C, Dussault I, Osada M, Kondo S. Bintrafusp Alfa, a Bifunctional Fusion Protein Targeting TGFbeta and PD-L1, in Patients with Esophageal Squamous Cell Carcinoma: Results from a Phase 1 Cohort in Asia. Target Oncol. 2021 Jul;16(4):447-459. doi: 10.1007/s11523-021-00810-9. Epub 2021 Apr 11.
Participants with metastatic or locally advanced solid tumors received intravenous (IV) infusion of M7824 at a dose of 3.0 milligrams per kilogram (mg/kg) over 1 hour once every two weeks for up to 12 months until confirmed progressive disease (PD), unacceptable toxicity, or any criterion for withdrawal from the study or investigational medicinal product (IMP) whichever occurs first.
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
0
More Info Module
Limitations and Caveats
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
Mar 3, 2020
Apr 15, 2024
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Germany
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
No data available
No data is available for this block.
N/A
Intervention Model
Single Group Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
MSB0011359C (M7824)
M7824
First study drug administration up to 30 days after the last drug administration assessed up to approximately 5 years
t1/2 was the time measured for the concentration to decrease by one half, determined as 0.693/Lambda z, here Lambda z was the terminal elimination rate constant determined by log-linear regression analysis of the measured serum concentrations of the terminal log-linear phase.
Pre-dose, 0, 4 hour post dose on Day 1, 2,8,15,29,43
Dose-Escalation Phase: Area Under the Serum Concentration Time Curve From Zero to Last Sampling Time (AUC0-t) of M7824
Area under the serum concentration versus time curve from time zero to the last sampling time t at which the concentration was at or above the lower limit of quantification (LLOQ). AUC0-t was calculated by linear trapezoidal summation.
Pre-dose, 0, 4 hour post dose on Day 1, 2, 8, 15, 29, 43
Dose-Escalation Phase: Area Under The Concentration Time Curve From Time Zero to Infinity (AUC0-inf) of M7824
The AUC(0-inf) was estimated by determining the total area under the curve of the concentration versus time curve extrapolated to infinity.
Pre-dose, 0, 4 hour post dose on Day 1, 2, 8, 15, 29, 43
Dose-Escalation Phase: Number of Participants With Positive Serum Titers of Anti-Drug Antibodies of M7824
The detection of antibodies to M7824 was performed using a validated electrochemiluminescence (ECL) immunoassay with tiered testing of screening, confirmatory and titration. Number of participants with positive anti-drug antibody (ADA) of M7824 were reported.
Predose, Day 15, 43, 85 and every 6-weekly until progression or end of the treatment whichever occur first, assessed up to 3 years
Dose-Escalation Part: Number of Participants With Best Overall Response (BOR) As Assessed By Investigator
BOR was assessed by investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1. BOR was defined as sum of complete response and partial response (CR+PR). For target lesions (TLs), CR was defined as the disappearance of all TLs; PR was defined as at least a 30 percent (%) decrease in the sum of largest diameter (SLD) of the TLs, taking as a reference the baseline SLD.
Date of randomization up to 2 years
Expansion Part: Best Overall Response (BOR) As Assessed By Investigator
BOR was assessed by investigator according to RECIST Version 1.1. BOR was defined as sum of CR and PR. For TLs, CR was defined as the disappearance of all TLs; PR was defined as at least a 30 percent (%) decrease in the SLD of the TLs, taking as a reference the baseline SLD.
Date of randomization up to 2 years
Expansion Part: BOR According to RECIST 1.1 As Adjudicated By The Independent Review Committee (IRC)
The BOR per Independent Endpoint Review Committee (IRC) adjudication was determined according to RECIST 1.1. BOR is defined as sum of CR and PR. For TLs, CR was defined as the disappearance of all TLs; PR was defined as at least a 30 percent (%) decrease in the SLD of the TLs, taking as a reference the baseline SLD.
Up to 2 years
Expansion Part: Duration of Response (DOR)
Duration of response according to RECIST 1.1 as adjudicated by the IRC was defined as the time from first confirmed response until the first documented disease progression that was subsequently confirmed. It was analyzed using Kaplan-Meier method.
Up to 2 years
Expansion Part: Disease Control Rate
The disease control rate was defined as the percentage of participants with BOR. The BOR per IRC adjudication was determined according to RECIST 1.1. BOR is defined as sum of CR and PR. For TLs, CR was defined as the disappearance of all TLs; PR was defined as at least a 30% decrease in the SLD of the TLs, taking as a reference the baseline SLD.
Up to 2 years
Expansion Part: Progression Free Survival (PFS) Time
PFS was defined as the time from date of randomization until date of the first documentation of progressive disease (PD) or death due to any cause in the absence of documented PD, whichever occurs first. PFS was assessed as RECIST v1.1 as adjudicated by IRC. PD is defined as at least a 20 % increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions.
Date of randomization until death or progressive disease assessed up to 2 years
Expansion Part: Overall Survival (OS) Time
OS was defined as the time from randomization to death due to any cause.
Date of randomization until death assessed up to 2 years
Kashiwa
Japan
National Cancer Center East, Department of hepatobiliary and pancreatic oncology
Kashiwa
Japan
Saitama Cancer Center
Kitaadachi-gun
Japan
NHO Shikoku Cancer Center
Matsuyama
Japan
Aichi Cancer Center Hospital
Nagoya
Japan
Kinki University Hospital
Sayama
Japan
National Cancer Center, Department of Experimental Therapeutics
Tokyo
Japan
National Cancer Center, Department of hepatobiliary and pancreatic oncology
Tokyo
Japan
Kanagawa Cancer Center, Department of Gastroenterology
Yokohama
Japan
Kanagawa Cancer Center, Department of Gastrointestinal Surgery
Yokohama
Japan
Asan Medical Center
Seoul
South Korea
Seoul National University Hospital
Seoul
South Korea
Severance Hospital
Seoul
South Korea
National Cheng Kung University Hospital
Tainan
Taiwan
Mackay Memorial Hospital
Taipei
Taiwan
National Taiwan University Hospital
Taipei
Taiwan
Chang Gung Memorial Hospital; Linkou
Taoyuan
Taiwan
Result
Yoo C, Oh DY, Choi HJ, Kudo M, Ueno M, Kondo S, Chen LT, Osada M, Helwig C, Dussault I, Ikeda M. Phase I study of bintrafusp alfa, a bifunctional fusion protein targeting TGF-beta and PD-L1, in patients with pretreated biliary tract cancer. J Immunother Cancer. 2020 May;8(1):e000564. doi: 10.1136/jitc-2020-000564.
Vugmeyster Y, Grisic AM, Wilkins JJ, Loos AH, Hallwachs R, Osada M, Venkatakrishnan K, Khandelwal A. Model-informed approach for risk management of bleeding toxicities for bintrafusp alfa, a bifunctional fusion protein targeting TGF-beta and PD-L1. Cancer Chemother Pharmacol. 2022 Oct;90(4):369-379. doi: 10.1007/s00280-022-04468-6. Epub 2022 Sep 6.
Wilkins JJ, Vugmeyster Y, Dussault I, Girard P, Khandelwal A. Population Pharmacokinetic Analysis of Bintrafusp Alfa in Different Cancer Types. Adv Ther. 2019 Sep;36(9):2414-2433. doi: 10.1007/s12325-019-01018-0. Epub 2019 Jul 5.
Participants with metastatic or locally advanced solid tumors received intravenous infusion of M7824 at a dose of 10 mg/kg over 1 hour once every two weeks for up to 12 months until confirmed PD, unacceptable toxicity, or any criterion for withdrawal from study or IMP whichever occurs first.
FG002
Dose Escalation Cohort: M7824 (20 mg/kg)
Participants with metastatic or locally advanced solid tumors received intravenous infusion of M7824 at a dose of 20 mg/kg over 1 hour once every two weeks for up to 12 months until confirmed PD, unacceptable toxicity, or any criterion for withdrawal from the study or IMP whichever occurs first.
FG003
Expansion Cohort: Biliary Tract Cancer
Participants received intravenous infusion of M7824 at a flat dose of 1200 over 1 hour once every two weeks until PD has been confirmed by a subsequent scan, unacceptable toxicity, or occurrence of any criterion for withdrawal from the study or the IMP occurs.
FG004
Expansion Cohort: Gastric Cancer (GC)
Participants received intravenous infusion of M7824 at a flat dose of 1200 over 1 hour once every two weeks until PD has been confirmed by a subsequent scan, unacceptable toxicity, or occurrence of any criterion for withdrawal from the study or the IMP occurs.
FG005
Expansion Cohort: Esophageal Squamous Cell Cancer
Participants received intravenous infusion of M7824 at a flat dose of 1200 over 1 hour once every two weeks until PD has been confirmed by a subsequent scan, unacceptable toxicity, or occurrence of any criterion for withdrawal from the study or the IMP occurs.
Participants received intravenous infusion of M7824 at a dose of 3 mg/kg over 1 hour once every two weeks until PD has been confirmed by a subsequent scan, unacceptable toxicity, or occurrence of any criterion for withdrawal from the study or the IMP occurs.
Participants received intravenous infusion of M7824 at a dose of 10 mg/kg over 1 hour once every two weeks until PD has been confirmed by a subsequent scan, unacceptable toxicity, or occurrence of any criterion for withdrawal from the study or the IMP occurs.
FG0004 subjects
FG0013 subjects
FG0027 subjects
FG00330 subjects
FG00431 subjects
FG00530 subjects
FG0063 subjects
FG0076 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0051 subjects
FG0060 subjects
FG0070 subjects
NOT COMPLETED
FG0004 subjects
FG0013 subjects
FG0027 subjects
FG00330 subjects
FG00431 subjects
FG00529 subjects
FG0063 subjects
FG0076 subjects
Type
Comment
Reasons
Death
FG0003 subjects
FG0013 subjects
FG0023 subjects
FG00323 subjects
FG00422 subjects
FG00523 subjects
FG0063 subjects
FG0075 subjects
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0023 subjects
FG0031 subjects
FG004
Other
FG0001 subjects
FG0010 subjects
FG0021 subjects
FG0036 subjects
FG004
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Dose Escalation Cohort: M7824 (3 mg/kg)
Participants with metastatic or locally advanced solid tumors received intravenous (IV) infusion of M7824 at a dose of 3.0 milligrams per kilogram (mg/kg) over 1 hour once every two weeks for up to 12 months until confirmed progressive disease (PD), unacceptable toxicity, or any criterion for withdrawal from the study or investigational medicinal product (IMP) whichever occurs first.
BG001
Dose Escalation Cohort: M7824 (10 mg/kg)
Participants with metastatic or locally advanced solid tumors received intravenous infusion of M7824 at a dose of 10 mg/kg over 1 hour once every two weeks for up to 12 months until confirmed PD, unacceptable toxicity, or any criterion for withdrawal from study or IMP whichever occurs first.
BG002
Expansion Cohort: Biliary Tract Cancer
Participants received intravenous infusion of M7824 at a flat dose of 1200 over 1 hour once every two weeks until PD has been confirmed by a subsequent scan, unacceptable toxicity, or occurrence of any criterion for withdrawal from the study or the IMP occurs.
BG003
Dose Escalation Cohort: M7824 (20 mg/kg)
Participants with metastatic or locally advanced solid tumors received intravenous infusion of M7824 at a dose of 20 mg/kg over 1 hour once every two weeks for up to 12 months until confirmed PD, unacceptable toxicity, or any criterion for withdrawal from the study or IMP whichever occurs first.
BG004
Expansion Cohort: Gastric Cancer (GC)
Participants received intravenous infusion of M7824 at a flat dose of 1200 over 1 hour once every two weeks until PD has been confirmed by a subsequent scan, unacceptable toxicity, or occurrence of any criterion for withdrawal from the study or the IMP occurs.
BG005
Expansion Cohort: Esophageal Squamous Cell Cancer
Participants received intravenous infusion of M7824 at a flat dose of 1200 over 1 hour once every two weeks until PD has been confirmed by a subsequent scan, unacceptable toxicity, or occurrence of any criterion for withdrawal from the study or the IMP occurs.
Participants received intravenous infusion of M7824 at a dose of 3 mg/kg over 1 hour once every two weeks until PD has been confirmed by a subsequent scan, unacceptable toxicity, or occurrence of any criterion for withdrawal from the study or the IMP occurs.
Participants received intravenous infusion of M7824 at a dose of 10 mg/kg over 1 hour once every two weeks until PD has been confirmed by a subsequent scan, unacceptable toxicity, or occurrence of any criterion for withdrawal from the study or the IMP occurs.
BG008
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0004
BG0013
BG00230
BG0037
BG00431
BG00530
BG0063
BG0076
BG008114
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
BG00051± 8.7
BG00157± 18.5
BG00263± 9.3
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0002
BG0013
BG002
Race/Ethnicity, Customized
Count of Participants
Participants
Title
Denominators
Categories
Ethnicity-Japanese
Title
Measurements
BG0004
BG0013
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Number of Participants With Dose Limiting Toxicity (DLT)
A DLT was defined as any grade greater than or equal to (>=) 3 adverse event suspected to be related to investigational medicinal product (IMP) by the Investigator and / or Sponsor occurring in the DLT evaluation period confirmed by the Safety Monitoring Committee (SMC) to be relevant for the IMP treatment.
DLT analysis set included all participants with data used for implementing the dose-escalation schedule. These participants received all study treatment administrations in the DLT evaluation period or stopped treatment because of DLTs in the DLT evaluation period.
Posted
Count of Participants
Participants
Baseline up to Week 3
ID
Title
Description
OG000
Dose Escalation Cohort: M7824 (3 mg/kg)
Participants with metastatic or locally advanced solid tumors received intravenous (IV) infusion of M7824 at a dose of 3.0 milligrams per kilogram (mg/kg) over 1 hour once every two weeks for up to 12 months until confirmed progressive disease (PD), unacceptable toxicity, or any criterion for withdrawal from the study or investigational medicinal product (IMP) whichever occurs first.
OG001
Dose Escalation Cohort: M7824 (10 mg/kg)
Participants with metastatic or locally advanced solid tumors received intravenous infusion of M7824 at a dose of 10 mg/kg over 1 hour once every two weeks for up to 12 months until confirmed PD, unacceptable toxicity, or any criterion for withdrawal from study or IMP whichever occurs first.
OG002
Dose Escalation Cohort: M7824 (20 mg/kg)
Participants with metastatic or locally advanced solid tumors received intravenous infusion of M7824 at a dose of 20 mg/kg over 1 hour once every two weeks for up to 12 months until confirmed PD, unacceptable toxicity, or any criterion for withdrawal from the study or IMP whichever occurs first.
Units
Counts
Participants
OG0004
OG0013
OG0026
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0021
Primary
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) According to National Cancer Institute-Common Terminology Criteria for Adverse Event (NCI-CTCAE) Version 4.03
An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a product or medical device; the event needed not necessarily have a causal relationship with the treatment or usage. Serious AE: an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. TEAE: AE with onset after start of treatment or with onset date before the treatment start date but worsening after the treatment start date. TEAEs included both serious and non-serious TEAEs.
Safety Analysis Set (SAF) included all participants who received at least 1 dose of study treatment.
Posted
Count of Participants
Participants
First study drug administration up to 30 days after the last drug administration assessed up to approximately 5 years
ID
Title
Description
OG000
Dose Escalation Cohort: M7824 (3 mg/kg)
Participants with metastatic or locally advanced solid tumors received intravenous (IV) infusion of M7824 at a dose of 3.0 milligrams per kilogram (mg/kg) over 1 hour once every two weeks for up to 12 months until confirmed progressive disease (PD), unacceptable toxicity, or any criterion for withdrawal from the study or investigational medicinal product (IMP) whichever occurs first.
OG001
Primary
Number of Participants With Treatment-Related Adverse Events (TRAEs) According to NCI-CTCAE Version 4.03
An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a product or medical device; the event needed not necessarily have a causal relationship with the treatment or usage. Serious AE: an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. TEAE: AE with onset after start of treatment or with onset date before the treatment start date but worsening after the treatment start date. TEAEs included both serious and non-serious TEAEs. Treatment-related TEAEs: reasonably related to the study intervention. Number of participants with TEAEs and treatment related TEAEs were reported.
Safety analysis set included all participants who received at least 1 dose of study treatment.
Posted
Count of Participants
Participants
First study drug administration up to 30 days after the last drug administration assessed up to approximately 5 years
ID
Title
Description
OG000
Dose Escalation Cohort: M7824 (3 mg/kg)
Participants with metastatic or locally advanced solid tumors received intravenous (IV) infusion of M7824 at a dose of 3.0 milligrams per kilogram (mg/kg) over 1 hour once every two weeks for up to 12 months until confirmed progressive disease (PD), unacceptable toxicity, or any criterion for withdrawal from the study or investigational medicinal product (IMP) whichever occurs first.
Secondary
Dose-Escalation Phase: Maximum Serum Concentration (Cmax) of M7824
Cmax is the maximum observed serum concentration obtained directly from the concentration versus time curve.
Pharmacokinetic analysis set included all participants who completed at least 1 infusion of M7824, and who provided at least 1 post dose sample with a measurable concentration of M7824. Here, "Number of participants analyzed" signifies those participants who were evaluable for this outcome measure.
Posted
Geometric Mean
Geometric Coefficient of Variation
Micrograms per milliliter (mcg/mL)
Pre-dose, 0, 4 hour post dose on Day 1, 2,8,15,29,43
ID
Title
Description
OG000
Pooled Escalation (M7824 3 mg/kg) and Expansion Cohort (Hepatocellular Carcinoma [3 mg/kg])
Participants with metastatic or locally advanced solid tumors received intravenous (IV) infusion of M7824 at a dose of 3.0 milligrams per kilogram (mg/kg) over 1 hour once every two weeks for up to 12 months until confirmed progressive disease (PD), unacceptable toxicity, or any criterion for withdrawal from the study or investigational medicinal product (IMP) whichever occurs first in Escalation Cohort or until PD has been confirmed by a subsequent scan, unacceptable toxicity, or occurrence of any criterion for withdrawal from the study or the IMP occurs in Expansion Cohort.
OG001
Pooled Escalation (M7824 10 mg/kg) and Expansion Cohort (Hepatocellular Carcinoma [10 mg/kg])
Participants with metastatic or locally advanced solid tumors received intravenous (IV) infusion of M7824 at a dose of 10.0 milligrams per kilogram (mg/kg) over 1 hour once every two weeks for up to 12 months until confirmed progressive disease (PD), unacceptable toxicity, or any criterion for withdrawal from the study or investigational medicinal product (IMP) whichever occurs first in Escalation Cohort or until PD has been confirmed by a subsequent scan, unacceptable toxicity, or occurrence of any criterion for withdrawal from the study or the IMP occurs in Expansion Cohort.
Secondary
Dose-Escalation Phase: Terminal Half Life (t1/2) of M7824
t1/2 was the time measured for the concentration to decrease by one half, determined as 0.693/Lambda z, here Lambda z was the terminal elimination rate constant determined by log-linear regression analysis of the measured serum concentrations of the terminal log-linear phase.
Pharmacokinetic analysis set included all participants who completed at least 1 infusion of M7824, and who provided at least 1 post dose sample with a measurable concentration of M7824. Here, "Number of participants analyzed" signifies those participants who were evaluable for this outcome measure.
Posted
Geometric Mean
Geometric Coefficient of Variation
hours
Pre-dose, 0, 4 hour post dose on Day 1, 2,8,15,29,43
ID
Title
Description
OG000
Pooled Escalation (M7824 3 mg/kg) and Expansion Cohort (Hepatocellular Carcinoma [3 mg/kg])
Participants with metastatic or locally advanced solid tumors received intravenous (IV) infusion of M7824 at a dose of 3.0 milligrams per kilogram (mg/kg) over 1 hour once every two weeks for up to 12 months until confirmed progressive disease (PD), unacceptable toxicity, or any criterion for withdrawal from the study or investigational medicinal product (IMP) whichever occurs first in Escalation Cohort or until PD has been confirmed by a subsequent scan, unacceptable toxicity, or occurrence of any criterion for withdrawal from the study or the IMP occurs in Expansion Cohort.
OG001
Pooled Escalation (M7824 10 mg/kg) and Expansion Cohort (Hepatocellular Carcinoma [10 mg/kg])
Secondary
Dose-Escalation Phase: Area Under the Serum Concentration Time Curve From Zero to Last Sampling Time (AUC0-t) of M7824
Area under the serum concentration versus time curve from time zero to the last sampling time t at which the concentration was at or above the lower limit of quantification (LLOQ). AUC0-t was calculated by linear trapezoidal summation.
Pharmacokinetic analysis set included all participants who completed at least 1 infusion of M7824, and who provided at least 1 post dose sample with a measurable concentration of M7824. Here, "Number of participants analyzed" signifies those participants who were evaluable for this outcome measure.
Posted
Geometric Mean
Geometric Coefficient of Variation
hour*microgram per milliliter(hr*mcg/mL)
Pre-dose, 0, 4 hour post dose on Day 1, 2, 8, 15, 29, 43
ID
Title
Description
OG000
Pooled Escalation (M7824 3 mg/kg) and Expansion Cohort (Hepatocellular Carcinoma [3 mg/kg])
Participants with metastatic or locally advanced solid tumors received intravenous (IV) infusion of M7824 at a dose of 3.0 milligrams per kilogram (mg/kg) over 1 hour once every two weeks for up to 12 months until confirmed progressive disease (PD), unacceptable toxicity, or any criterion for withdrawal from the study or investigational medicinal product (IMP) whichever occurs first in Escalation Cohort or until PD has been confirmed by a subsequent scan, unacceptable toxicity, or occurrence of any criterion for withdrawal from the study or the IMP occurs in Expansion Cohort.
OG001
Pooled Escalation (M7824 10 mg/kg) and Expansion Cohort (Hepatocellular Carcinoma [10 mg/kg])
Secondary
Dose-Escalation Phase: Area Under The Concentration Time Curve From Time Zero to Infinity (AUC0-inf) of M7824
The AUC(0-inf) was estimated by determining the total area under the curve of the concentration versus time curve extrapolated to infinity.
Pharmacokinetic analysis set included all participants who completed at least 1 infusion of M7824, and who provided at least 1 post dose sample with a measurable concentration of M7824. Here, "Number of participants analyzed" signifies those participants who were evaluable for this outcome measure.
Posted
Geometric Mean
Geometric Coefficient of Variation
hr*mcg/mL
Pre-dose, 0, 4 hour post dose on Day 1, 2, 8, 15, 29, 43
ID
Title
Description
OG000
Pooled Escalation (M7824 3 mg/kg) and Expansion Cohort (Hepatocellular Carcinoma [3 mg/kg])
Participants with metastatic or locally advanced solid tumors received intravenous (IV) infusion of M7824 at a dose of 3.0 milligrams per kilogram (mg/kg) over 1 hour once every two weeks for up to 12 months until confirmed progressive disease (PD), unacceptable toxicity, or any criterion for withdrawal from the study or investigational medicinal product (IMP) whichever occurs first in Escalation Cohort or until PD has been confirmed by a subsequent scan, unacceptable toxicity, or occurrence of any criterion for withdrawal from the study or the IMP occurs in Expansion Cohort.
OG001
Pooled Escalation (M7824 10 mg/kg) and Expansion Cohort (Hepatocellular Carcinoma [10 mg/kg])
Secondary
Dose-Escalation Phase: Number of Participants With Positive Serum Titers of Anti-Drug Antibodies of M7824
The detection of antibodies to M7824 was performed using a validated electrochemiluminescence (ECL) immunoassay with tiered testing of screening, confirmatory and titration. Number of participants with positive anti-drug antibody (ADA) of M7824 were reported.
Immunogenicity Analysis Set included participants who received at least 1 dose of study drug and who had at least 1 valid result of ADA at any time point.
Posted
Count of Participants
Participants
Predose, Day 15, 43, 85 and every 6-weekly until progression or end of the treatment whichever occur first, assessed up to 3 years
ID
Title
Description
OG000
Dose Escalation Cohort: M7824 (3 mg/kg)
Participants with metastatic or locally advanced solid tumors received intravenous (IV) infusion of M7824 at a dose of 3.0 milligrams per kilogram (mg/kg) over 1 hour once every two weeks for up to 12 months until confirmed progressive disease (PD), unacceptable toxicity, or any criterion for withdrawal from the study or investigational medicinal product (IMP) whichever occurs first.
OG001
Dose Escalation Cohort: M7824 (10 mg/kg)
Participants with metastatic or locally advanced solid tumors received intravenous infusion of M7824 at a dose of 10 mg/kg over 1 hour once every two weeks for up to 12 months until confirmed PD, unacceptable toxicity, or any criterion for withdrawal from study or IMP whichever occurs first.
Secondary
Dose-Escalation Part: Number of Participants With Best Overall Response (BOR) As Assessed By Investigator
BOR was assessed by investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1. BOR was defined as sum of complete response and partial response (CR+PR). For target lesions (TLs), CR was defined as the disappearance of all TLs; PR was defined as at least a 30 percent (%) decrease in the sum of largest diameter (SLD) of the TLs, taking as a reference the baseline SLD.
Full analysis set included all participants who received at least 1 dose of study treatment.
Posted
Count of Participants
Participants
Date of randomization up to 2 years
ID
Title
Description
OG000
Dose Escalation Cohort: M7824 (3 mg/kg)
Participants with metastatic or locally advanced solid tumors received intravenous (IV) infusion of M7824 at a dose of 3.0 milligrams per kilogram (mg/kg) over 1 hour once every two weeks for up to 12 months until confirmed progressive disease (PD), unacceptable toxicity, or any criterion for withdrawal from the study or investigational medicinal product (IMP) whichever occurs first.
OG001
Dose Escalation Cohort: M7824 (10 mg/kg)
Participants with metastatic or locally advanced solid tumors received intravenous infusion of M7824 at a dose of 10 mg/kg over 1 hour once every two weeks for up to 12 months until confirmed PD, unacceptable toxicity, or any criterion for withdrawal from study or IMP whichever occurs first.
Secondary
Expansion Part: Best Overall Response (BOR) As Assessed By Investigator
BOR was assessed by investigator according to RECIST Version 1.1. BOR was defined as sum of CR and PR. For TLs, CR was defined as the disappearance of all TLs; PR was defined as at least a 30 percent (%) decrease in the SLD of the TLs, taking as a reference the baseline SLD.
Full analysis set included all participants who received at least 1 dose of study treatment.
Posted
Count of Participants
Participants
Date of randomization up to 2 years
ID
Title
Description
OG000
Expansion Cohort: Biliary Tract Cancer
Participants received intravenous infusion of M7824 at a flat dose of 1200 over 1 hour once every two weeks until PD has been confirmed by a subsequent scan, unacceptable toxicity, or occurrence of any criterion for withdrawal from the study or the IMP occurs.
OG001
Expansion Cohort: Gastric Cancer (GC)
Participants received intravenous infusion of M7824 at a flat dose of 1200 over 1 hour once every two weeks until PD has been confirmed by a subsequent scan, unacceptable toxicity, or occurrence of any criterion for withdrawal from the study or the IMP occurs.
OG002
Expansion Cohort: Esophageal Squamous Cell Cancer
Secondary
Expansion Part: BOR According to RECIST 1.1 As Adjudicated By The Independent Review Committee (IRC)
The BOR per Independent Endpoint Review Committee (IRC) adjudication was determined according to RECIST 1.1. BOR is defined as sum of CR and PR. For TLs, CR was defined as the disappearance of all TLs; PR was defined as at least a 30 percent (%) decrease in the SLD of the TLs, taking as a reference the baseline SLD.
Full analysis set included all participants who received at least 1 dose of study treatment.
Posted
Count of Participants
Participants
Up to 2 years
ID
Title
Description
OG000
Expansion Cohort: Biliary Tract Cancer
Participants received intravenous infusion of M7824 at a flat dose of 1200 over 1 hour once every two weeks until PD has been confirmed by a subsequent scan, unacceptable toxicity, or occurrence of any criterion for withdrawal from the study or the IMP occurs.
OG001
Expansion Cohort: Gastric Cancer (GC)
Participants received intravenous infusion of M7824 at a flat dose of 1200 over 1 hour once every two weeks until PD has been confirmed by a subsequent scan, unacceptable toxicity, or occurrence of any criterion for withdrawal from the study or the IMP occurs.
OG002
Expansion Cohort: Esophageal Squamous Cell Cancer
Secondary
Expansion Part: Duration of Response (DOR)
Duration of response according to RECIST 1.1 as adjudicated by the IRC was defined as the time from first confirmed response until the first documented disease progression that was subsequently confirmed. It was analyzed using Kaplan-Meier method.
Full analysis set included all participants who received at least 1 dose of study treatment.
Posted
Median
95% Confidence Interval
Months
Up to 2 years
ID
Title
Description
OG000
Expansion Cohort: Biliary Tract Cancer
Participants received intravenous infusion of M7824 at a flat dose of 1200 over 1 hour once every two weeks until PD has been confirmed by a subsequent scan, unacceptable toxicity, or occurrence of any criterion for withdrawal from the study or the IMP occurs.
OG001
Expansion Cohort: Gastric Cancer (GC)
Participants received intravenous infusion of M7824 at a flat dose of 1200 over 1 hour once every two weeks until PD has been confirmed by a subsequent scan, unacceptable toxicity, or occurrence of any criterion for withdrawal from the study or the IMP occurs.
OG002
Expansion Cohort: Esophageal Squamous Cell Cancer
Participants received intravenous infusion of M7824 at a flat dose of 1200 over 1 hour once every two weeks until PD has been confirmed by a subsequent scan, unacceptable toxicity, or occurrence of any criterion for withdrawal from the study or the IMP occurs.
Secondary
Expansion Part: Disease Control Rate
The disease control rate was defined as the percentage of participants with BOR. The BOR per IRC adjudication was determined according to RECIST 1.1. BOR is defined as sum of CR and PR. For TLs, CR was defined as the disappearance of all TLs; PR was defined as at least a 30% decrease in the SLD of the TLs, taking as a reference the baseline SLD.
Full analysis set included all participants who received at least 1 dose of study treatment.
Posted
Number
95% Confidence Interval
Percentage of Participants
Up to 2 years
ID
Title
Description
OG000
Expansion Cohort: Biliary Tract Cancer
Participants received intravenous infusion of M7824 at a flat dose of 1200 over 1 hour once every two weeks until PD has been confirmed by a subsequent scan, unacceptable toxicity, or occurrence of any criterion for withdrawal from the study or the IMP occurs.
OG001
Expansion Cohort: Gastric Cancer (GC)
Participants received intravenous infusion of M7824 at a flat dose of 1200 over 1 hour once every two weeks until PD has been confirmed by a subsequent scan, unacceptable toxicity, or occurrence of any criterion for withdrawal from the study or the IMP occurs.
OG002
Expansion Cohort: Esophageal Squamous Cell Cancer
Secondary
Expansion Part: Progression Free Survival (PFS) Time
PFS was defined as the time from date of randomization until date of the first documentation of progressive disease (PD) or death due to any cause in the absence of documented PD, whichever occurs first. PFS was assessed as RECIST v1.1 as adjudicated by IRC. PD is defined as at least a 20 % increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions.
Full analysis set included all participants who received at least 1 dose of study treatment. Here, "Number of participants analyzed" signifies those participants who were evaluable for this outcome measure.
Posted
Median
95% Confidence Interval
Months
Date of randomization until death or progressive disease assessed up to 2 years
ID
Title
Description
OG000
Expansion Cohort: Biliary Tract Cancer
Participants received intravenous infusion of M7824 at a flat dose of 1200 over 1 hour once every two weeks until PD has been confirmed by a subsequent scan, unacceptable toxicity, or occurrence of any criterion for withdrawal from the study or the IMP occurs.
OG001
Expansion Cohort: Gastric Cancer (GC)
Participants received intravenous infusion of M7824 at a flat dose of 1200 over 1 hour once every two weeks until PD has been confirmed by a subsequent scan, unacceptable toxicity, or occurrence of any criterion for withdrawal from the study or the IMP occurs.
Secondary
Expansion Part: Overall Survival (OS) Time
OS was defined as the time from randomization to death due to any cause.
Full analysis set included all participants who received at least 1 dose of study treatment. "Number of participants analyzed" signifies those participants who were evaluable for this outcome measure.
Posted
Median
95% Confidence Interval
Months
Date of randomization until death assessed up to 2 years
ID
Title
Description
OG000
Expansion Cohort: Biliary Tract Cancer
Participants received intravenous infusion of M7824 at a flat dose of 1200 over 1 hour once every two weeks until PD has been confirmed by a subsequent scan, unacceptable toxicity, or occurrence of any criterion for withdrawal from the study or the IMP occurs.
OG001
Expansion Cohort: Gastric Cancer (GC)
Participants received intravenous infusion of M7824 at a flat dose of 1200 over 1 hour once every two weeks until PD has been confirmed by a subsequent scan, unacceptable toxicity, or occurrence of any criterion for withdrawal from the study or the IMP occurs.
OG002
Expansion Cohort: Esophageal Squamous Cell Cancer
Participants received intravenous infusion of M7824 at a flat dose of 1200 over 1 hour once every two weeks until PD has been confirmed by a subsequent scan, unacceptable toxicity, or occurrence of any criterion for withdrawal from the study or the IMP occurs.
Time Frame
First study drug administration up to 30 days after the last drug administration assessed up to approximately up to 5 years.
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
Expansion Cohort: Biliary Tract Cancer
Participants received intravenous infusion of M7824 at a flat dose of 1200 over 1 hour once every two weeks until PD has been confirmed by a subsequent scan, unacceptable toxicity, or occurrence of any criterion for withdrawal from the study or the IMP occurs.
23
30
18
30
28
30
EG001
Expansion Cohort: Gastric Cancer (GC)
Participants received intravenous infusion of M7824 at a flat dose of 1200 over 1 hour once every two weeks until PD has been confirmed by a subsequent scan, unacceptable toxicity, or occurrence of any criterion for withdrawal from the study or the IMP occurs.
22
31
18
31
30
31
EG002
Expansion Cohort: Esophageal Squamous Cell Cancer
Participants received intravenous infusion of M7824 at a flat dose of 1200 over 1 hour once every two weeks until PD has been confirmed by a subsequent scan, unacceptable toxicity, or occurrence of any criterion for withdrawal from the study or the IMP occurs.
24
30
14
30
30
30
EG003
Dose Escalation Cohort: M7824 (3 mg/kg)
Participants with metastatic or locally advanced solid tumors received intravenous (IV) infusion of M7824 at a dose of 3.0 milligrams per kilogram (mg/kg) over 1 hour once every two weeks for up to 12 months until confirmed progressive disease (PD), unacceptable toxicity, or any criterion for withdrawal from the study or investigational medicinal product (IMP) whichever occurs first.
3
4
4
4
4
4
EG004
Dose Escalation Cohort: M7824 (10 mg/kg)
Participants with metastatic or locally advanced solid tumors received intravenous infusion of M7824 at a dose of 10 mg/kg over 1 hour once every two weeks for up to 12 months until confirmed PD, unacceptable toxicity, or any criterion for withdrawal from study or IMP whichever occurs first.
3
3
0
3
3
3
EG005
Dose Escalation Cohort: M7824 (20 mg/kg)
Participants with metastatic or locally advanced solid tumors received intravenous infusion of M7824 at a dose of 20 mg/kg over 1 hour once every two weeks for up to 12 months until confirmed PD, unacceptable toxicity, or any criterion for withdrawal from the study or IMP whichever occurs first.
Participants received intravenous infusion of M7824 at a dose of 3 mg/kg over 1 hour once every two weeks until PD has been confirmed by a subsequent scan, unacceptable toxicity, or occurrence of any criterion for withdrawal from the study or the IMP occurs.
Participants received intravenous infusion of M7824 at a dose of 10 mg/kg over 1 hour once every two weeks until PD has been confirmed by a subsequent scan, unacceptable toxicity, or occurrence of any criterion for withdrawal from the study or the IMP occurs.
5
6
3
6
6
6
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Hypoacusis
Ear and labyrinth disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected30 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected30 at risk
EG0030 events0 affected4 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected7 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected6 at risk
Adrenal insufficiency
Endocrine disorders
MedDRA 23.0
Non-systematic Assessment
EG0002 events2 affected30 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Hypopituitarism
Endocrine disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected30 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Vitreous haemorrhage
Eye disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected30 at risk
EG0011 events1 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 23.0
Non-systematic Assessment
EG0001 events1 affected30 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Ascites
Gastrointestinal disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected30 at risk
EG0011 events1 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected30 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected30 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected30 at risk
EG003
Gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA 23.0
Non-systematic Assessment
EG0001 events1 affected30 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Haemorrhoids
Gastrointestinal disorders
MedDRA 23.0
Non-systematic Assessment
EG0001 events1 affected30 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Ileus
Gastrointestinal disorders
MedDRA 23.0
Non-systematic Assessment
EG0001 events1 affected30 at risk
EG0011 events1 affected31 at risk
EG0021 events1 affected30 at risk
EG003
Melaena
Gastrointestinal disorders
MedDRA 23.0
Non-systematic Assessment
EG0001 events1 affected30 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected30 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Obstruction gastric
Gastrointestinal disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected30 at risk
EG0011 events1 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Oesophageal haemorrhage
Gastrointestinal disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected30 at risk
EG0010 events0 affected31 at risk
EG0022 events1 affected30 at risk
EG003
Oesophageal stenosis
Gastrointestinal disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected30 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected30 at risk
EG003
Upper gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected30 at risk
EG0013 events3 affected31 at risk
EG0021 events1 affected30 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected30 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Disease progression
General disorders
MedDRA 23.0
Non-systematic Assessment
EG0001 events1 affected30 at risk
EG0014 events4 affected31 at risk
EG0021 events1 affected30 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected30 at risk
EG0011 events1 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Performance status decreased
General disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected30 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected30 at risk
EG003
Pyrexia
General disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected30 at risk
EG0011 events1 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Sudden death
General disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected30 at risk
EG0011 events1 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Cholangitis
Hepatobiliary disorders
MedDRA 23.0
Non-systematic Assessment
EG0004 events4 affected30 at risk
EG0011 events1 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Hyperbilirubinaemia
Hepatobiliary disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected30 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Jaundice
Hepatobiliary disorders
MedDRA 23.0
Non-systematic Assessment
EG0002 events2 affected30 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Jaundice cholestatic
Hepatobiliary disorders
MedDRA 23.0
Non-systematic Assessment
EG0001 events1 affected30 at risk
EG0011 events1 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Bacterial infection
Infections and infestations
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected30 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected30 at risk
EG003
Biliary tract infection
Infections and infestations
MedDRA 23.0
Non-systematic Assessment
EG0001 events1 affected30 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Device related infection
Infections and infestations
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected30 at risk
EG0011 events1 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Diarrhoea infectious
Infections and infestations
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected30 at risk
EG0011 events1 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Herpes zoster
Infections and infestations
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected30 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected30 at risk
EG003
Kaposi's varicelliform eruption
Infections and infestations
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected30 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected30 at risk
EG003
Liver abscess
Infections and infestations
MedDRA 23.0
Non-systematic Assessment
EG0001 events1 affected30 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected30 at risk
EG0010 events0 affected31 at risk
EG0023 events3 affected30 at risk
EG003
Septic shock
Infections and infestations
MedDRA 23.0
Non-systematic Assessment
EG0001 events1 affected30 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected30 at risk
EG0011 events1 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Foreign body in gastrointestinal tract
Injury, poisoning and procedural complications
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected30 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected30 at risk
EG003
Fractured sacrum
Injury, poisoning and procedural complications
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected30 at risk
EG0011 events1 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Incisional hernia
Injury, poisoning and procedural complications
MedDRA 23.0
Non-systematic Assessment
EG0001 events1 affected30 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 23.0
Non-systematic Assessment
EG0001 events1 affected30 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 23.0
Non-systematic Assessment
EG0002 events1 affected30 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Blood alkaline phosphatase increased
Investigations
MedDRA 23.0
Non-systematic Assessment
EG0001 events1 affected30 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Blood creatine phosphokinase increased
Investigations
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected30 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Gamma-glutamyltransferase increased
Investigations
MedDRA 23.0
Non-systematic Assessment
EG0001 events1 affected30 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 23.0
Non-systematic Assessment
EG0001 events1 affected30 at risk
EG0011 events1 affected31 at risk
EG0021 events1 affected30 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected30 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Angiosarcoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected30 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected30 at risk
EG003
Cancer pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected30 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Intracranial tumour haemorrhage
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected30 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Keratoacanthoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.0
Non-systematic Assessment
EG0001 events1 affected30 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Lip squamous cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.0
Non-systematic Assessment
EG0001 events1 affected30 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected30 at risk
EG003
Malignant ascites
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected30 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Metastases to central nervous system
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected30 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected30 at risk
EG003
Paraneoplastic syndrome
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected30 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Renal cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected30 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected30 at risk
EG003
Squamous cell carcinoma of skin
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.0
Non-systematic Assessment
EG0002 events1 affected30 at risk
EG0010 events0 affected31 at risk
EG0025 events1 affected30 at risk
EG003
Tumour associated fever
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.0
Non-systematic Assessment
EG0001 events1 affected30 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Tumour haemorrhage
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.0
Non-systematic Assessment
EG0001 events1 affected30 at risk
EG0011 events1 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Diplegia
Nervous system disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected30 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected30 at risk
EG003
Device malfunction
Product Issues
MedDRA 23.0
Non-systematic Assessment
EG0001 events1 affected30 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected30 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Haemoptysis
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected30 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected30 at risk
EG003
Interstitial lung disease
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Non-systematic Assessment
EG0002 events2 affected30 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected30 at risk
EG003
Pneumothorax
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected30 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected30 at risk
EG003
Pulmonary haemorrhage
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected30 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected30 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Lichenoid keratosis
Skin and subcutaneous tissue disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected30 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected30 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 23.0
Non-systematic Assessment
EG0001 events1 affected30 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected30 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected30 at risk
EG0011 events1 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Rash pruritic
Skin and subcutaneous tissue disorders
MedDRA 23.0
Non-systematic Assessment
EG0001 events1 affected30 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 23.0
Non-systematic Assessment
EG00015 events10 affected30 at risk
EG00116 events11 affected31 at risk
EG00211 events7 affected30 at risk
EG0033 events3 affected4 at risk
EG0040 events0 affected3 at risk
EG0052 events2 affected7 at risk
EG0060 events0 affected3 at risk
EG0071 events1 affected6 at risk
Disseminated intravascular coagulation
Blood and lymphatic system disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected30 at risk
EG0011 events1 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Iron deficiency anaemia
Blood and lymphatic system disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected30 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected30 at risk
EG003
Lymphadenitis
Blood and lymphatic system disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected30 at risk
EG0011 events1 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected30 at risk
EG0010 events0 affected31 at risk
EG0022 events1 affected30 at risk
EG003
Atrioventricular block first degree
Cardiac disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected30 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Palpitations
Cardiac disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected30 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Tachycardia
Cardiac disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected30 at risk
EG0011 events1 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Epidermal naevus
Congenital, familial and genetic disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected30 at risk
EG0011 events1 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Meniere's disease
Ear and labyrinth disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected30 at risk
EG0011 events1 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Tinnitus
Ear and labyrinth disorders
MedDRA 23.0
Non-systematic Assessment
EG0001 events1 affected30 at risk
EG0012 events2 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected30 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected30 at risk
EG003
Adrenal insufficiency
Endocrine disorders
MedDRA 23.0
Non-systematic Assessment
EG0001 events1 affected30 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Hyperthyroidism
Endocrine disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected30 at risk
EG0010 events0 affected31 at risk
EG0022 events2 affected30 at risk
EG003
Hypopituitarism
Endocrine disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected30 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Hypothyroidism
Endocrine disorders
MedDRA 23.0
Non-systematic Assessment
EG0002 events2 affected30 at risk
EG0010 events0 affected31 at risk
EG0026 events6 affected30 at risk
EG003
Thyroiditis
Endocrine disorders
MedDRA 23.0
Non-systematic Assessment
EG0001 events1 affected30 at risk
EG0011 events1 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Blepharitis
Eye disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected30 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected30 at risk
EG003
Cataract
Eye disorders
MedDRA 23.0
Non-systematic Assessment
EG0001 events1 affected30 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected30 at risk
EG003
Conjunctival haemorrhage
Eye disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected30 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected30 at risk
EG003
Diabetic retinopathy
Eye disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected30 at risk
EG0011 events1 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Dry eye
Eye disorders
MedDRA 23.0
Non-systematic Assessment
EG0001 events1 affected30 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Eye pruritus
Eye disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected30 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Eyelid ptosis
Eye disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected30 at risk
EG0011 events1 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Glaucoma
Eye disorders
MedDRA 23.0
Non-systematic Assessment
EG0001 events1 affected30 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Keratitis
Eye disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected30 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected30 at risk
EG003
Photophobia
Eye disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected30 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Retinal haemorrhage
Eye disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected30 at risk
EG0010 events0 affected31 at risk
EG0022 events2 affected30 at risk
EG003
Retinal vasculitis
Eye disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected30 at risk
EG0011 events1 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Vision blurred
Eye disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected30 at risk
EG0011 events1 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Vitreous floaters
Eye disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected30 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected30 at risk
EG003
Vitreous haemorrhage
Eye disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected30 at risk
EG0011 events1 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Abdominal discomfort
Gastrointestinal disorders
MedDRA 23.0
Non-systematic Assessment
EG0001 events1 affected30 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA 23.0
Non-systematic Assessment
EG0001 events1 affected30 at risk
EG0011 events1 affected31 at risk
EG0024 events1 affected30 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 23.0
Non-systematic Assessment
EG0006 events6 affected30 at risk
EG0016 events6 affected31 at risk
EG0024 events3 affected30 at risk
EG003
Abdominal pain lower
Gastrointestinal disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected30 at risk
EG0011 events1 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected30 at risk
EG0014 events2 affected31 at risk
EG0021 events1 affected30 at risk
EG003
Ascites
Gastrointestinal disorders
MedDRA 23.0
Non-systematic Assessment
EG0002 events2 affected30 at risk
EG0011 events1 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 23.0
Non-systematic Assessment
EG0004 events4 affected30 at risk
EG0017 events7 affected31 at risk
EG0026 events5 affected30 at risk
EG003
Dental caries
Gastrointestinal disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected30 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected30 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 23.0
Non-systematic Assessment
EG0001 events1 affected30 at risk
EG0015 events3 affected31 at risk
EG0022 events2 affected30 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA 23.0
Non-systematic Assessment
EG0001 events1 affected30 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected30 at risk
EG003
Duodenal ulcer
Gastrointestinal disorders
MedDRA 23.0
Non-systematic Assessment
EG0001 events1 affected30 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA 23.0
Non-systematic Assessment
EG0002 events2 affected30 at risk
EG0011 events1 affected31 at risk
EG0022 events1 affected30 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected30 at risk
EG0011 events1 affected31 at risk
EG0021 events1 affected30 at risk
EG003
Enterocolitis
Gastrointestinal disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected30 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Gastric ulcer
Gastrointestinal disorders
MedDRA 23.0
Non-systematic Assessment
EG0001 events1 affected30 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected30 at risk
EG003
Gastric varices
Gastrointestinal disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected30 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA 23.0
Non-systematic Assessment
EG0001 events1 affected30 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected30 at risk
EG003
Gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA 23.0
Non-systematic Assessment
EG0001 events1 affected30 at risk
EG0010 events0 affected31 at risk
EG0022 events2 affected30 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected30 at risk
EG0011 events1 affected31 at risk
EG0021 events1 affected30 at risk
EG003
Gingival bleeding
Gastrointestinal disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected30 at risk
EG0013 events3 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Gingival erosion
Gastrointestinal disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected30 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected30 at risk
EG003
Glossitis
Gastrointestinal disorders
MedDRA 23.0
Non-systematic Assessment
EG0001 events1 affected30 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Haemorrhoids
Gastrointestinal disorders
MedDRA 23.0
Non-systematic Assessment
EG0001 events1 affected30 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected30 at risk
EG003
Ileus
Gastrointestinal disorders
MedDRA 23.0
Non-systematic Assessment
EG0001 events1 affected30 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Large intestine polyp
Gastrointestinal disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected30 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Lip dry
Gastrointestinal disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected30 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected30 at risk
EG003
Loose tooth
Gastrointestinal disorders
MedDRA 23.0
Non-systematic Assessment
EG0001 events1 affected30 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Malignant gastrointestinal obstruction
Gastrointestinal disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected30 at risk
EG0011 events1 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Mouth haemorrhage
Gastrointestinal disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected30 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected30 at risk
EG003
Mouth ulceration
Gastrointestinal disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected30 at risk
EG0011 events1 affected31 at risk
EG0021 events1 affected30 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 23.0
Non-systematic Assessment
EG0005 events4 affected30 at risk
EG0015 events5 affected31 at risk
EG0024 events4 affected30 at risk
EG003
Oesophageal haemorrhage
Gastrointestinal disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected30 at risk
EG0010 events0 affected31 at risk
EG0023 events1 affected30 at risk
EG003
Oesophageal mucosal hyperplasia
Gastrointestinal disorders
MedDRA 23.0
Non-systematic Assessment
EG0001 events1 affected30 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Periodontal disease
Gastrointestinal disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected30 at risk
EG0011 events1 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Proctitis
Gastrointestinal disorders
MedDRA 23.0
Non-systematic Assessment
EG0001 events1 affected30 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA 23.0
Non-systematic Assessment
EG0001 events1 affected30 at risk
EG0010 events0 affected31 at risk
EG0023 events2 affected30 at risk
EG003
Stress ulcer
Gastrointestinal disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected30 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected30 at risk
EG003
Toothache
Gastrointestinal disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected30 at risk
EG0011 events1 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Upper gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected30 at risk
EG0013 events3 affected31 at risk
EG0021 events1 affected30 at risk
EG003
Varices oesophageal
Gastrointestinal disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected30 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 23.0
Non-systematic Assessment
EG0003 events3 affected30 at risk
EG0013 events3 affected31 at risk
EG0022 events2 affected30 at risk
EG003
Asthenia
General disorders
MedDRA 23.0
Non-systematic Assessment
EG0001 events1 affected30 at risk
EG0012 events1 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Catheter site pain
General disorders
MedDRA 23.0
Non-systematic Assessment
EG0001 events1 affected30 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Chest discomfort
General disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected30 at risk
EG0011 events1 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Chest pain
General disorders
MedDRA 23.0
Non-systematic Assessment
EG0001 events1 affected30 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Chills
General disorders
MedDRA 23.0
Non-systematic Assessment
EG0001 events1 affected30 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected30 at risk
EG003
Fatigue
General disorders
MedDRA 23.0
Non-systematic Assessment
EG0005 events5 affected30 at risk
EG0017 events6 affected31 at risk
EG0024 events3 affected30 at risk
EG003
Granuloma
General disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected30 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Impaired healing
General disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected30 at risk
EG0010 events0 affected31 at risk
EG0022 events1 affected30 at risk
EG003
Malaise
General disorders
MedDRA 23.0
Non-systematic Assessment
EG0002 events2 affected30 at risk
EG0013 events3 affected31 at risk
EG0024 events4 affected30 at risk
EG003
Medical device site pain
General disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected30 at risk
EG0011 events1 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Nodule
General disorders
MedDRA 23.0
Non-systematic Assessment
EG0001 events1 affected30 at risk
EG0011 events1 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected30 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Oedema
General disorders
MedDRA 23.0
Non-systematic Assessment
EG0001 events1 affected30 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Oedema peripheral
General disorders
MedDRA 23.0
Non-systematic Assessment
EG0005 events4 affected30 at risk
EG0012 events2 affected31 at risk
EG0022 events2 affected30 at risk
EG003
Pyrexia
General disorders
MedDRA 23.0
Non-systematic Assessment
EG00022 events13 affected30 at risk
EG00110 events7 affected31 at risk
EG0025 events5 affected30 at risk
EG003
Biliary dilatation
Hepatobiliary disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected30 at risk
EG0011 events1 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Cholangitis
Hepatobiliary disorders
MedDRA 23.0
Non-systematic Assessment
EG0002 events2 affected30 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Hepatic failure
Hepatobiliary disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected30 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Hepatic function abnormal
Hepatobiliary disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected30 at risk
EG0013 events2 affected31 at risk
EG0021 events1 affected30 at risk
EG003
Hepatitis cholestatic
Hepatobiliary disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected30 at risk
EG0011 events1 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Hepatitis chronic active
Hepatobiliary disorders
MedDRA 23.0
Non-systematic Assessment
EG0001 events1 affected30 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Hyperbilirubinaemia
Hepatobiliary disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected30 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Contrast media allergy
Immune system disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected30 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Drug hypersensitivity
Immune system disorders
MedDRA 23.0
Non-systematic Assessment
EG0001 events1 affected30 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Acarodermatitis
Infections and infestations
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected30 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected30 at risk
EG003
Bacteraemia
Infections and infestations
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected30 at risk
EG0011 events1 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Bacterial infection
Infections and infestations
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected30 at risk
EG0010 events0 affected31 at risk
EG0023 events1 affected30 at risk
EG003
Carbuncle
Infections and infestations
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected30 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected30 at risk
EG003
Cystitis
Infections and infestations
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected30 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Hordeolum
Infections and infestations
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected30 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Infection
Infections and infestations
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected30 at risk
EG0011 events1 affected31 at risk
EG0021 events1 affected30 at risk
EG003
Influenza
Infections and infestations
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected30 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Liver abscess
Infections and infestations
MedDRA 23.0
Non-systematic Assessment
EG0001 events1 affected30 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Medical device site infection
Infections and infestations
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected30 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected30 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 23.0
Non-systematic Assessment
EG0001 events1 affected30 at risk
EG0010 events0 affected31 at risk
EG0022 events1 affected30 at risk
EG003
Otitis media chronic
Infections and infestations
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected30 at risk
EG0011 events1 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Paronychia
Infections and infestations
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected30 at risk
EG0010 events0 affected31 at risk
EG0023 events2 affected30 at risk
EG003
Periodontitis
Infections and infestations
MedDRA 23.0
Non-systematic Assessment
EG0001 events1 affected30 at risk
EG0011 events1 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Peritonitis bacterial
Infections and infestations
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected30 at risk
EG0011 events1 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected30 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected30 at risk
EG003
Pitted keratolysis
Infections and infestations
MedDRA 23.0
Non-systematic Assessment
EG0001 events1 affected30 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected30 at risk
EG0011 events1 affected31 at risk
EG0021 events1 affected30 at risk
EG003
Pyelitis
Infections and infestations
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected30 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Rash pustular
Infections and infestations
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected30 at risk
EG0011 events1 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Sepsis
Infections and infestations
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected30 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected30 at risk
EG003
Sinusitis
Infections and infestations
MedDRA 23.0
Non-systematic Assessment
EG0001 events1 affected30 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Skin infection
Infections and infestations
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected30 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected30 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected30 at risk
EG0014 events4 affected31 at risk
EG0024 events3 affected30 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected30 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Wound infection
Infections and infestations
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected30 at risk
EG0011 events1 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Allergic transfusion reaction
Injury, poisoning and procedural complications
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected30 at risk
EG0011 events1 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Arthropod bite
Injury, poisoning and procedural complications
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected30 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Compression fracture
Injury, poisoning and procedural complications
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected30 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected30 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected30 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected30 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected30 at risk
EG0010 events0 affected31 at risk
EG0022 events2 affected30 at risk
EG003
Femur fracture
Injury, poisoning and procedural complications
MedDRA 23.0
Non-systematic Assessment
EG0001 events1 affected30 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Foreign body in gastrointestinal tract
Injury, poisoning and procedural complications
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected30 at risk
EG0010 events0 affected31 at risk
EG0026 events1 affected30 at risk
EG003
Fractured sacrum
Injury, poisoning and procedural complications
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected30 at risk
EG0011 events1 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Infusion related reaction
Injury, poisoning and procedural complications
MedDRA 23.0
Non-systematic Assessment
EG0002 events2 affected30 at risk
EG0012 events2 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Pelvic fracture
Injury, poisoning and procedural complications
MedDRA 23.0
Non-systematic Assessment
EG0001 events1 affected30 at risk
EG0011 events1 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Post-traumatic pain
Injury, poisoning and procedural complications
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected30 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected30 at risk
EG003
Procedural pain
Injury, poisoning and procedural complications
MedDRA 23.0
Non-systematic Assessment
EG0001 events1 affected30 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Radiation skin injury
Injury, poisoning and procedural complications
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected30 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected30 at risk
EG003
Scapula fracture
Injury, poisoning and procedural complications
MedDRA 23.0
Non-systematic Assessment
EG0001 events1 affected30 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Skin abrasion
Injury, poisoning and procedural complications
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected30 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected30 at risk
EG003
Spinal compression fracture
Injury, poisoning and procedural complications
MedDRA 23.0
Non-systematic Assessment
EG0001 events1 affected30 at risk
EG0012 events1 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Suture related complication
Injury, poisoning and procedural complications
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected30 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected30 at risk
EG003
Activated partial thromboplastin time prolonged
Investigations
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected30 at risk
EG0011 events1 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 23.0
Non-systematic Assessment
EG0003 events2 affected30 at risk
EG0013 events3 affected31 at risk
EG0023 events3 affected30 at risk
EG003
Amylase increased
Investigations
MedDRA 23.0
Non-systematic Assessment
EG0003 events2 affected30 at risk
EG0011 events1 affected31 at risk
EG0021 events1 affected30 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 23.0
Non-systematic Assessment
EG0004 events2 affected30 at risk
EG0011 events1 affected31 at risk
EG0023 events3 affected30 at risk
EG003
Bilirubin conjugated increased
Investigations
MedDRA 23.0
Non-systematic Assessment
EG0001 events1 affected30 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Blood alkaline phosphatase
Investigations
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected30 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected30 at risk
EG003
Blood alkaline phosphatase increased
Investigations
MedDRA 23.0
Non-systematic Assessment
EG0003 events2 affected30 at risk
EG0012 events2 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA 23.0
Non-systematic Assessment
EG0001 events1 affected30 at risk
EG0011 events1 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Blood creatine phosphokinase increased
Investigations
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected30 at risk
EG0011 events1 affected31 at risk
EG0023 events2 affected30 at risk
EG003
Blood creatinine increased
Investigations
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected30 at risk
EG0011 events1 affected31 at risk
EG0025 events2 affected30 at risk
EG003
Blood lactate dehydrogenase increased
Investigations
MedDRA 23.0
Non-systematic Assessment
EG0002 events1 affected30 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected30 at risk
EG003
Electrocardiogram QT prolonged
Investigations
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected30 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Gamma-glutamyltransferase increased
Investigations
MedDRA 23.0
Non-systematic Assessment
EG0003 events2 affected30 at risk
EG0012 events2 affected31 at risk
EG0022 events2 affected30 at risk
EG003
Glycosylated haemoglobin increased
Investigations
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected30 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected30 at risk
EG003
Haemoglobin decreased
Investigations
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected30 at risk
EG0011 events1 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Lipase increased
Investigations
MedDRA 23.0
Non-systematic Assessment
EG0004 events3 affected30 at risk
EG0011 events1 affected31 at risk
EG0023 events3 affected30 at risk
EG003
Lymphocyte count decreased
Investigations
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected30 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected30 at risk
EG003
Platelet count decreased
Investigations
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected30 at risk
EG0011 events1 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Weight decreased
Investigations
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected30 at risk
EG0013 events3 affected31 at risk
EG0022 events2 affected30 at risk
EG003
White blood cell count increased
Investigations
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected30 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected30 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 23.0
Non-systematic Assessment
EG0007 events7 affected30 at risk
EG0018 events7 affected31 at risk
EG0024 events4 affected30 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 23.0
Non-systematic Assessment
EG0002 events2 affected30 at risk
EG0010 events0 affected31 at risk
EG0022 events2 affected30 at risk
EG003
Hypermagnesaemia
Metabolism and nutrition disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected30 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected30 at risk
EG003
Hyperuricaemia
Metabolism and nutrition disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected30 at risk
EG0010 events0 affected31 at risk
EG0023 events2 affected30 at risk
EG003
Hypoalbuminaemia
Metabolism and nutrition disorders
MedDRA 23.0
Non-systematic Assessment
EG0007 events5 affected30 at risk
EG0016 events6 affected31 at risk
EG0022 events2 affected30 at risk
EG003
Hypocalcaemia
Metabolism and nutrition disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected30 at risk
EG0011 events1 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Hypoglycaemia
Metabolism and nutrition disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected30 at risk
EG0013 events2 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 23.0
Non-systematic Assessment
EG0001 events1 affected30 at risk
EG0014 events2 affected31 at risk
EG0021 events1 affected30 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected30 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected30 at risk
EG003
Hypophagia
Metabolism and nutrition disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected30 at risk
EG0011 events1 affected31 at risk
EG0021 events1 affected30 at risk
EG003
Hypophosphataemia
Metabolism and nutrition disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected30 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Hypoproteinaemia
Metabolism and nutrition disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected30 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Type 2 diabetes mellitus
Metabolism and nutrition disorders
MedDRA 23.0
Non-systematic Assessment
EG0001 events1 affected30 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Zinc deficiency
Metabolism and nutrition disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected30 at risk
EG0011 events1 affected31 at risk
EG0022 events1 affected30 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected30 at risk
EG0012 events2 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Arthritis
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected30 at risk
EG0011 events1 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Non-systematic Assessment
EG0001 events1 affected30 at risk
EG0014 events3 affected31 at risk
EG0021 events1 affected30 at risk
EG003
Bone pain
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected30 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected30 at risk
EG003
Intervertebral disc protrusion
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected30 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected30 at risk
EG003
Muscle swelling
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected30 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected30 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected30 at risk
EG0011 events1 affected31 at risk
EG0022 events2 affected30 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Non-systematic Assessment
EG0003 events2 affected30 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected30 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Non-systematic Assessment
EG0002 events2 affected30 at risk
EG0014 events1 affected31 at risk
EG0021 events1 affected30 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Non-systematic Assessment
EG0001 events1 affected30 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Non-systematic Assessment
EG0001 events1 affected30 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Osteoporosis
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected30 at risk
EG0011 events1 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Non-systematic Assessment
EG0002 events2 affected30 at risk
EG0011 events1 affected31 at risk
EG0022 events2 affected30 at risk
EG003
Pathological fracture
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Non-systematic Assessment
EG0002 events1 affected30 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Periarthritis
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Non-systematic Assessment
EG0001 events1 affected30 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Spinal pain
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected30 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected30 at risk
EG003
Benign neoplasm of skin
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.0
Non-systematic Assessment
EG0001 events1 affected30 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Cancer pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected30 at risk
EG0011 events1 affected31 at risk
EG0024 events4 affected30 at risk
EG003
Keratoacanthoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.0
Non-systematic Assessment
EG0008 events3 affected30 at risk
EG0019 events1 affected31 at risk
EG0024 events3 affected30 at risk
EG003
Malignant ascites
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected30 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Metastases to central nervous system
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected30 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected30 at risk
EG003
Papilloma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected30 at risk
EG0011 events1 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Seborrhoeic keratosis
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.0
Non-systematic Assessment
EG0002 events1 affected30 at risk
EG0011 events1 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Skin papilloma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected30 at risk
EG0011 events1 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Tumour associated fever
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected30 at risk
EG0012 events2 affected31 at risk
EG0023 events3 affected30 at risk
EG003
Tumour pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected30 at risk
EG0011 events1 affected31 at risk
EG0023 events3 affected30 at risk
EG003
Diplegia
Nervous system disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected30 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected30 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected30 at risk
EG0012 events2 affected31 at risk
EG0023 events2 affected30 at risk
EG003
Dysgeusia
Nervous system disorders
MedDRA 23.0
Non-systematic Assessment
EG0001 events1 affected30 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Femoral nerve palsy
Nervous system disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected30 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Headache
Nervous system disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected30 at risk
EG0015 events4 affected31 at risk
EG0021 events1 affected30 at risk
EG003
Hydrocephalus
Nervous system disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected30 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Hypoaesthesia
Nervous system disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected30 at risk
EG0011 events1 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Neuralgia
Nervous system disorders
MedDRA 23.0
Non-systematic Assessment
EG0001 events1 affected30 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Polyneuropathy
Nervous system disorders
MedDRA 23.0
Non-systematic Assessment
EG0001 events1 affected30 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Somnolence
Nervous system disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected30 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Device occlusion
Product Issues
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected30 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected30 at risk
EG003
Anxiety disorder
Psychiatric disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected30 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected30 at risk
EG003
Delirium
Psychiatric disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected30 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA 23.0
Non-systematic Assessment
EG0002 events2 affected30 at risk
EG0012 events2 affected31 at risk
EG0022 events2 affected30 at risk
EG003
Major depression
Psychiatric disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected30 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected30 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA 23.0
Non-systematic Assessment
EG0001 events1 affected30 at risk
EG0011 events1 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Dysuria
Renal and urinary disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected30 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected30 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA 23.0
Non-systematic Assessment
EG0001 events1 affected30 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected30 at risk
EG003
Pollakiuria
Renal and urinary disorders
MedDRA 23.0
Non-systematic Assessment
EG0001 events1 affected30 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Renal impairment
Renal and urinary disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected30 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected30 at risk
EG003
Urinary retention
Renal and urinary disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected30 at risk
EG0010 events0 affected31 at risk
EG0022 events2 affected30 at risk
EG003
Benign prostatic hyperplasia
Reproductive system and breast disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected30 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected30 at risk
EG003
Breast cyst
Reproductive system and breast disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected30 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Prostatomegaly
Reproductive system and breast disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected30 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected30 at risk
EG003
Acquired tracheo-oesophageal fistula
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected30 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected30 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Non-systematic Assessment
EG0003 events3 affected30 at risk
EG0012 events2 affected31 at risk
EG0023 events3 affected30 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected30 at risk
EG0011 events1 affected31 at risk
EG0023 events2 affected30 at risk
EG003
Eosinophilic pneumonia
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected30 at risk
EG0011 events1 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Non-systematic Assessment
EG0002 events2 affected30 at risk
EG0010 events0 affected31 at risk
EG0024 events3 affected30 at risk
EG003
Haemoptysis
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected30 at risk
EG0010 events0 affected31 at risk
EG0023 events3 affected30 at risk
EG003
Hiccups
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected30 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected30 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected30 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected30 at risk
EG003
Interstitial lung disease
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected30 at risk
EG0011 events1 affected31 at risk
EG0021 events1 affected30 at risk
EG003
Laryngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected30 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected30 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected30 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected30 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Non-systematic Assessment
EG0001 events1 affected30 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Non-systematic Assessment
EG0001 events1 affected30 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected30 at risk
EG003
Pneumonia aspiration
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected30 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected30 at risk
EG003
Productive cough
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Non-systematic Assessment
EG0001 events1 affected30 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Respiratory tract haemorrhage
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected30 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Acanthosis nigricans
Skin and subcutaneous tissue disorders
MedDRA 23.0
Non-systematic Assessment
EG0001 events1 affected30 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Acne
Skin and subcutaneous tissue disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected30 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected30 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected30 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected30 at risk
EG003
Blood blister
Skin and subcutaneous tissue disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected30 at risk
EG0011 events1 affected31 at risk
EG0021 events1 affected30 at risk
EG003
Dermal cyst
Skin and subcutaneous tissue disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected30 at risk
EG0011 events1 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Dermatitis acneiform
Skin and subcutaneous tissue disorders
MedDRA 23.0
Non-systematic Assessment
EG0001 events1 affected30 at risk
EG0011 events1 affected31 at risk
EG0021 events1 affected30 at risk
EG003
Drug eruption
Skin and subcutaneous tissue disorders
MedDRA 23.0
Non-systematic Assessment
EG0001 events1 affected30 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected30 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
MedDRA 23.0
Non-systematic Assessment
EG0001 events1 affected30 at risk
EG0011 events1 affected31 at risk
EG0022 events2 affected30 at risk
EG003
Eczema
Skin and subcutaneous tissue disorders
MedDRA 23.0
Non-systematic Assessment
EG0001 events1 affected30 at risk
EG0011 events1 affected31 at risk
EG0024 events3 affected30 at risk
EG003
Eczema asteatotic
Skin and subcutaneous tissue disorders
MedDRA 23.0
Non-systematic Assessment
EG0001 events1 affected30 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Hyperkeratosis
Skin and subcutaneous tissue disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected30 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected30 at risk
EG003
Keratosis pilaris
Skin and subcutaneous tissue disorders
MedDRA 23.0
Non-systematic Assessment
EG0001 events1 affected30 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Lichenoid keratosis
Skin and subcutaneous tissue disorders
MedDRA 23.0
Non-systematic Assessment
EG0001 events1 affected30 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected30 at risk
EG003
Milia
Skin and subcutaneous tissue disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected30 at risk
EG0011 events1 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Nail disorder
Skin and subcutaneous tissue disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected30 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Neurodermatitis
Skin and subcutaneous tissue disorders
MedDRA 23.0
Non-systematic Assessment
EG0001 events1 affected30 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected30 at risk
EG003
Papule
Skin and subcutaneous tissue disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected30 at risk
EG0011 events1 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 23.0
Non-systematic Assessment
EG0003 events2 affected30 at risk
EG0017 events7 affected31 at risk
EG0024 events3 affected30 at risk
EG003
Psoriasis
Skin and subcutaneous tissue disorders
MedDRA 23.0
Non-systematic Assessment
EG0001 events1 affected30 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 23.0
Non-systematic Assessment
EG0005 events4 affected30 at risk
EG0016 events5 affected31 at risk
EG0026 events5 affected30 at risk
EG003
Rash erythematous
Skin and subcutaneous tissue disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected30 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected30 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
MedDRA 23.0
Non-systematic Assessment
EG0008 events4 affected30 at risk
EG0019 events7 affected31 at risk
EG0027 events6 affected30 at risk
EG003
Rash pruritic
Skin and subcutaneous tissue disorders
MedDRA 23.0
Non-systematic Assessment
EG0001 events1 affected30 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Skin depigmentation
Skin and subcutaneous tissue disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected30 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected30 at risk
EG003
Skin fibrosis
Skin and subcutaneous tissue disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected30 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected30 at risk
EG003
Skin mass
Skin and subcutaneous tissue disorders
MedDRA 23.0
Non-systematic Assessment
EG0001 events1 affected30 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Solar dermatitis
Skin and subcutaneous tissue disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected30 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected30 at risk
EG003
Urticaria
Skin and subcutaneous tissue disorders
MedDRA 23.0
Non-systematic Assessment
EG0001 events1 affected30 at risk
EG0010 events0 affected31 at risk
EG0022 events2 affected30 at risk
EG003
Urticaria chronic
Skin and subcutaneous tissue disorders
MedDRA 23.0
Non-systematic Assessment
EG0001 events1 affected30 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected30 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected30 at risk
EG003
Hypertension
Vascular disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected30 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected30 at risk
EG003
Hypotension
Vascular disorders
MedDRA 23.0
Non-systematic Assessment
EG0002 events2 affected30 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected30 at risk
EG003
Data collection and analysis of Pharmacokinetics of Cmin was omitted and not conducted due to business reason.
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
Not provided
Results Disclosure Restriction on PI(s)?
Yes
Other Details
Not provided
Point of Contact
Title
Organization
Phone
Extension
Email
Communication Center
Merck Healthcare KGaA, Darmstadt Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Participants with metastatic or locally advanced solid tumors received intravenous infusion of M7824 at a dose of 10 mg/kg over 1 hour once every two weeks for up to 12 months until confirmed PD, unacceptable toxicity, or any criterion for withdrawal from study or IMP whichever occurs first.
OG002
Dose Escalation Cohort: M7824 (20 mg/kg)
Participants with metastatic or locally advanced solid tumors received intravenous infusion of M7824 at a dose of 20 mg/kg over 1 hour once every two weeks for up to 12 months until confirmed PD, unacceptable toxicity, or any criterion for withdrawal from the study or IMP whichever occurs first.
OG003
Expansion Cohort: Biliary Tract Cancer
Participants received intravenous infusion of M7824 at a flat dose of 1200 over 1 hour once every two weeks until PD has been confirmed by a subsequent scan, unacceptable toxicity, or occurrence of any criterion for withdrawal from the study or the IMP occurs.
OG004
Expansion Cohort: Gastric Cancer (GC)
Participants received intravenous infusion of M7824 at a flat dose of 1200 over 1 hour once every two weeks until PD has been confirmed by a subsequent scan, unacceptable toxicity, or occurrence of any criterion for withdrawal from the study or the IMP occurs.
OG005
Expansion Cohort: Esophageal Squamous Cell Cancer
Participants received intravenous infusion of M7824 at a flat dose of 1200 over 1 hour once every two weeks until PD has been confirmed by a subsequent scan, unacceptable toxicity, or occurrence of any criterion for withdrawal from the study or the IMP occurs.
Participants received intravenous infusion of M7824 at a dose of 3 mg/kg over 1 hour once every two weeks until PD has been confirmed by a subsequent scan, unacceptable toxicity, or occurrence of any criterion for withdrawal from the study or the IMP occurs.
Participants received intravenous infusion of M7824 at a dose of 10 mg/kg over 1 hour once every two weeks until PD has been confirmed by a subsequent scan, unacceptable toxicity, or occurrence of any criterion for withdrawal from the study or the IMP occurs.
Units
Counts
Participants
OG0004
OG0013
OG0027
OG00330
OG00431
OG00530
OG0063
OG0076
Title
Denominators
Categories
Title
Measurements
OG0004
OG0013
OG0026
OG00328
OG00430
OG00530
OG0062
OG0076
OG001
Dose Escalation Cohort: M7824 (10 mg/kg)
Participants with metastatic or locally advanced solid tumors received intravenous infusion of M7824 at a dose of 10 mg/kg over 1 hour once every two weeks for up to 12 months until confirmed PD, unacceptable toxicity, or any criterion for withdrawal from study or IMP whichever occurs first.
OG002
Dose Escalation Cohort: M7824 (20 mg/kg)
Participants with metastatic or locally advanced solid tumors received intravenous infusion of M7824 at a dose of 20 mg/kg over 1 hour once every two weeks for up to 12 months until confirmed PD, unacceptable toxicity, or any criterion for withdrawal from the study or IMP whichever occurs first.
OG003
Expansion Cohort: Biliary Tract Cancer
Participants received intravenous infusion of M7824 at a flat dose of 1200 over 1 hour once every two weeks until PD has been confirmed by a subsequent scan, unacceptable toxicity, or occurrence of any criterion for withdrawal from the study or the IMP occurs.
OG004
Expansion Cohort: Gastric Cancer (GC)
Participants received intravenous infusion of M7824 at a flat dose of 1200 over 1 hour once every two weeks until PD has been confirmed by a subsequent scan, unacceptable toxicity, or occurrence of any criterion for withdrawal from the study or the IMP occurs.
OG005
Expansion Cohort: Esophageal Squamous Cell Cancer
Participants received intravenous infusion of M7824 at a flat dose of 1200 over 1 hour once every two weeks until PD has been confirmed by a subsequent scan, unacceptable toxicity, or occurrence of any criterion for withdrawal from the study or the IMP occurs.
Participants received intravenous infusion of M7824 at a dose of 3 mg/kg over 1 hour once every two weeks until PD has been confirmed by a subsequent scan, unacceptable toxicity, or occurrence of any criterion for withdrawal from the study or the IMP occurs.
Participants received intravenous infusion of M7824 at a dose of 10 mg/kg over 1 hour once every two weeks until PD has been confirmed by a subsequent scan, unacceptable toxicity, or occurrence of any criterion for withdrawal from the study or the IMP occurs.
Units
Counts
Participants
OG0004
OG0013
OG0027
OG00330
OG00431
OG00530
OG0063
OG0076
Title
Denominators
Categories
Title
Measurements
OG0001
OG0012
OG0023
OG00319
OG00416
OG00519
OG0060
OG0070
OG002
Dose Escalation Cohort: M7824 (20 mg/kg)
Participants with metastatic or locally advanced solid tumors received intravenous infusion of M7824 at a dose of 20 mg/kg over 1 hour once every two weeks for up to 12 months until confirmed PD, unacceptable toxicity, or any criterion for withdrawal from the study or IMP whichever occurs first.
Units
Counts
Participants
OG0007
OG0019
OG0027
Title
Denominators
Categories
Title
Measurements
OG00054.6± 17.9
OG001211± 21.7
OG002331± 19.2
Participants with metastatic or locally advanced solid tumors received intravenous (IV) infusion of M7824 at a dose of 10.0 milligrams per kilogram (mg/kg) over 1 hour once every two weeks for up to 12 months until confirmed progressive disease (PD), unacceptable toxicity, or any criterion for withdrawal from the study or investigational medicinal product (IMP) whichever occurs first in Escalation Cohort or until PD has been confirmed by a subsequent scan, unacceptable toxicity, or occurrence of any criterion for withdrawal from the study or the IMP occurs in Expansion Cohort.
OG002
Dose Escalation Cohort: M7824 (20 mg/kg)
Participants with metastatic or locally advanced solid tumors received intravenous infusion of M7824 at a dose of 20 mg/kg over 1 hour once every two weeks for up to 12 months until confirmed PD, unacceptable toxicity, or any criterion for withdrawal from the study or IMP whichever occurs first.
Units
Counts
Participants
OG0004
OG0017
OG0025
Title
Denominators
Categories
Title
Measurements
OG000132± 12.8
OG001138± 17.4
OG002150± 24.4
Participants with metastatic or locally advanced solid tumors received intravenous (IV) infusion of M7824 at a dose of 10.0 milligrams per kilogram (mg/kg) over 1 hour once every two weeks for up to 12 months until confirmed progressive disease (PD), unacceptable toxicity, or any criterion for withdrawal from the study or investigational medicinal product (IMP) whichever occurs first in Escalation Cohort or until PD has been confirmed by a subsequent scan, unacceptable toxicity, or occurrence of any criterion for withdrawal from the study or the IMP occurs in Expansion Cohort.
OG002
Dose Escalation Cohort: M7824 (20 mg/kg)
Participants with metastatic or locally advanced solid tumors received intravenous infusion of M7824 at a dose of 20 mg/kg over 1 hour once every two weeks for up to 12 months until confirmed PD, unacceptable toxicity, or any criterion for withdrawal from the study or IMP whichever occurs first.
Units
Counts
Participants
OG0007
OG0018
OG0026
Title
Denominators
Categories
Title
Measurements
OG0007940± 16.7
OG00129200± 25.3
OG00251300± 24.7
Participants with metastatic or locally advanced solid tumors received intravenous (IV) infusion of M7824 at a dose of 10.0 milligrams per kilogram (mg/kg) over 1 hour once every two weeks for up to 12 months until confirmed progressive disease (PD), unacceptable toxicity, or any criterion for withdrawal from the study or investigational medicinal product (IMP) whichever occurs first in Escalation Cohort or until PD has been confirmed by a subsequent scan, unacceptable toxicity, or occurrence of any criterion for withdrawal from the study or the IMP occurs in Expansion Cohort.
OG002
Dose Escalation Cohort: M7824 (20 mg/kg)
Participants with metastatic or locally advanced solid tumors received intravenous infusion of M7824 at a dose of 20 mg/kg over 1 hour once every two weeks for up to 12 months until confirmed PD, unacceptable toxicity, or any criterion for withdrawal from the study or IMP whichever occurs first.
Units
Counts
Participants
OG0007
OG0017
OG0025
Title
Denominators
Categories
Title
Measurements
OG0009600± 15.2
OG00134600± 29.7
OG00261700± 26.6
OG002
Dose Escalation Cohort: M7824 (20 mg/kg)
Participants with metastatic or locally advanced solid tumors received intravenous infusion of M7824 at a dose of 20 mg/kg over 1 hour once every two weeks for up to 12 months until confirmed PD, unacceptable toxicity, or any criterion for withdrawal from the study or IMP whichever occurs first.
Units
Counts
Participants
OG0004
OG0013
OG0026
Title
Denominators
Categories
Title
Measurements
OG0001
OG0010
OG0023
OG002
Dose Escalation Cohort: M7824 (20 mg/kg)
Participants with metastatic or locally advanced solid tumors received intravenous infusion of M7824 at a dose of 20 mg/kg over 1 hour once every two weeks for up to 12 months until confirmed PD, unacceptable toxicity, or any criterion for withdrawal from the study or IMP whichever occurs first.
Units
Counts
Participants
OG0004
OG0013
OG0027
Title
Denominators
Categories
Complete response
Title
Measurements
OG0000
OG0010
OG0020
Partial response
Title
Measurements
OG0001
OG0010
OG0021
Stable disease
Title
Measurements
OG0002
OG0011
OG0020
Progressive disease
Title
Measurements
OG0001
OG0012
OG0024
Not evaluable
Title
Measurements
OG0000
OG0010
OG0022
Participants received intravenous infusion of M7824 at a flat dose of 1200 over 1 hour once every two weeks until PD has been confirmed by a subsequent scan, unacceptable toxicity, or occurrence of any criterion for withdrawal from the study or the IMP occurs.
Units
Counts
Participants
OG00030
OG00131
OG00230
Title
Denominators
Categories
Complete response
Title
Measurements
OG0001
OG0012
OG0020
Partial response
Title
Measurements
OG0006
OG0015
OG0026
Stable disease
Title
Measurements
OG0004
OG0015
OG0025
Progressive disease
Title
Measurements
OG00017
OG00116
OG00217
Not evaluable
Title
Measurements
OG0002
OG0013
OG0022
Participants received intravenous infusion of M7824 at a flat dose of 1200 over 1 hour once every two weeks until PD has been confirmed by a subsequent scan, unacceptable toxicity, or occurrence of any criterion for withdrawal from the study or the IMP occurs.
Participants with HCC received intravenous infusion of M7824 at a dose of 3 mg/kg over 1 hour once every two weeks until PD has been confirmed by a subsequent scan, unacceptable toxicity, or occurrence of any criterion for withdrawal from the study or the IMP occurs.
Participants received intravenous infusion of M7824 at a dose of 10 mg/kg over 1 hour once every two weeks until PD has been confirmed by a subsequent scan, unacceptable toxicity, or occurrence of any criterion for withdrawal from the study or the IMP occurs.
Units
Counts
Participants
OG00030
OG00131
OG00230
OG0033
OG0046
Title
Denominators
Categories
Complete response (CR)
Title
Measurements
OG0002
OG0013
OG0020
OG0030
OG0040
Partial Response (PR)
Title
Measurements
OG0004
OG0013
OG0023
OG003
Stable disease (SD)
Title
Measurements
OG0006
OG0012
OG0023
OG003
Non-CR/Non-PD
Title
Measurements
OG0000
OG0010
OG0023
OG003
Progressive disease (PD)
Title
Measurements
OG00016
OG00121
OG00218
OG003
Not evaluable (NE)
Title
Measurements
OG0002
OG0012
OG0023
OG003
Units
Counts
Participants
OG00030
OG00131
OG00230
Title
Denominators
Categories
Title
Measurements
OG000NA(8.3 to 34.5)Due to small number of events, Median from Kaplan-Meier survival curves could not derive.
OG00120.8(2.4 to 29.0)
OG0027.0(2.8 to 24.9)
Participants received intravenous infusion of M7824 at a flat dose of 1200 over 1 hour once every two weeks until PD has been confirmed by a subsequent scan, unacceptable toxicity, or occurrence of any criterion for withdrawal from the study or the IMP occurs.
Participants with HCC received intravenous infusion of M7824 at a dose of 3 mg/kg over 1 hour once every two weeks until PD has been confirmed by a subsequent scan, unacceptable toxicity, or occurrence of any criterion for withdrawal from the study or the IMP occurs.
Participants received intravenous infusion of M7824 at a dose of 3 mg/kg over 1 hour once every two weeks until PD has been confirmed by a subsequent scan, unacceptable toxicity, or occurrence of any criterion for withdrawal from the study or the IMP occurs.
Units
Counts
Participants
OG00030
OG00131
OG00230
OG0033
OG0046
Title
Denominators
Categories
Title
Measurements
OG00040.0(22.7 to 59.4)
OG00122.6(11.9 to 44.6)
OG00220(14.7 to 49.4)
OG0031(0.8 to 90.6)
OG0040(0.0 to 45.9)
OG002
Expansion Cohort: Esophageal Squamous Cell Cancer
Participants received intravenous infusion of M7824 at a flat dose of 1200 over 1 hour once every two weeks until PD has been confirmed by a subsequent scan, unacceptable toxicity, or occurrence of any criterion for withdrawal from the study or the IMP occurs.
Participants with HCC received intravenous infusion of M7824 at a dose of 3 mg/kg over 1 hour once every two weeks until PD has been confirmed by a subsequent scan, unacceptable toxicity, or occurrence of any criterion for withdrawal from the study or the IMP occurs.
Participants received intravenous infusion of M7824 at a dose of 3 mg/kg over 1 hour once every two weeks until PD has been confirmed by a subsequent scan, unacceptable toxicity, or occurrence of any criterion for withdrawal from the study or the IMP occurs.
Participants with HCC received intravenous infusion of M7824 at a dose of 3 mg/kg over 1 hour once every two weeks until PD has been confirmed by a subsequent scan, unacceptable toxicity, or occurrence of any criterion for withdrawal from the study or the IMP occurs.
Participants received intravenous infusion of M7824 at a dose of 10 mg/kg over 1 hour once every two weeks until PD has been confirmed by a subsequent scan, unacceptable toxicity, or occurrence of any criterion for withdrawal from the study or the IMP occurs.
Units
Counts
Participants
OG00019
OG00121
OG0026
OG0033
OG0046
Title
Denominators
Categories
Title
Measurements
OG00012.7(1.9 to 38.7)
OG00110.1(0.5 to 38.3)
OG00211.9(0.1 to 38.0)
OG0034.4(4.3 to 6.9)
OG0044.0(2.1 to NA)Due to small number of events, Upper limit from Kaplan-Meier survival curves could not derive.