EMD 525797 in Combination With Cetuximab and Irinotecan i... | NCT01008475 | Trialant
NCT01008475
Sponsor
Merck KGaA, Darmstadt, Germany
Status
Completed
Last Update Posted
Mar 30, 2016Estimated
Enrollment
232Actual
Phase
Phase 1Phase 2
Conditions
Metastatic Colorectal Cancer
Interventions
EMD 525797 250 mg
EMD 525797 500 mg
EMD 525797 750 mg
EMD 525797 1000 mg
Cetuximab
Irinotecan
Countries
Belgium
Bulgaria
Cyprus
Czechia
Germany
Greece
Hungary
Israel
Poland
Russia
Spain
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT01008475
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
EMR62242-004
Secondary IDs
Not provided
Brief Title
EMD 525797 in Combination With Cetuximab and Irinotecan in K-ras Wild Type Metastatic Colorectal Cancer
Official Title
An Open-label, Randomized, Controlled, Multicenter, Phase I/II Trial Investigating 2 EMD 525797 Doses in Combination With Cetuximab and Irinotecan Versus Cetuximab and Irinotecan Alone, as Second-line Treatment for Subjects With K-ras Wild Type Metastatic Colorectal Cancer (mCRC)
Acronym
POSEIDON
Organization
Merck KGaA, Darmstadt, GermanyINDUSTRY
Status Module
Record Verification Date
Feb 2016
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Oct 2009
Primary Completion Date
Apr 2015Actual
Completion Date
Apr 2015Actual
First Submitted Date
Oct 19, 2009
First Submission Date that Met QC Criteria
Nov 4, 2009
First Posted Date
Nov 5, 2009Estimated
Results Waived
Not provided
Results First Submitted Date
Feb 26, 2016
Results First Submitted that Met QC Criteria
Feb 26, 2016
Results First Posted Date
Mar 30, 2016Estimated
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
Feb 26, 2016
Last Update Posted Date
Mar 30, 2016Estimated
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)
No
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 purpose of this study is to assess the safety and clinical activity of the experimental drug EMD 525797 (study drug), a monoclonal antibody targeting alfa integrins, in combination with irinotecan and cetuximab in K-ras wildtype metastatic colorectal cancer patients.
Detailed Description
Not provided
Conditions Module
Conditions
Metastatic Colorectal Cancer
Keywords
EMD 525797
Cetuximab
Irinotecan
metastatic colorectal cancer
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 1Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
232Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Safety part: EMD 525797 250 mg + Standard of Care (SoC)
Experimental
EMD 525797 250 mg in combination with cetuximab and irinotecan
Drug: EMD 525797 250 mg
Drug: Cetuximab
Drug: Irinotecan
Safety part: EMD 525797 500 mg + SoC
Experimental
EMD 525797 500 mg in combination with cetuximab and irinotecan
Drug: EMD 525797 500 mg
Drug: Cetuximab
Drug: Irinotecan
Safety part: EMD 525797 750 mg + SoC
Experimental
EMD 525797 750 mg in combination with cetuximab and irinotecan
Drug: EMD 525797 750 mg
Drug: Cetuximab
Drug: Irinotecan
Safety part: EMD 525797 1000 mg + SoC
Experimental
EMD 525797 1000 mg in combination with cetuximab and irinotecan
Drug: EMD 525797 1000 mg
Drug: Cetuximab
Drug: Irinotecan
Randomized part: EMD 525797 500 mg + SoC
Experimental
EMD 525797 500 mg in combination with cetuximab and irinotecan
Interventions
Name
Type
Description
Arm Group Labels
Other Names
EMD 525797 250 mg
Drug
EMD 525797 will be administered at a target dose of 250 mg as a 1-hour intravenous infusion for every 2 week until radio-graphically documented PD (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator's assessment), or withdrawal of consent .
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Safety Part: Number of Subjects Experiencing DLTs (Dose Limiting Toxicity)
DLT was defined as any Grade 4 hematologic toxicity or Grade 3/4 non-hematologic toxicity assessed as related to trial treatment by the Investigator and/or Sponsor and confirmed by the safety monitoring committee (SMC) to be relevant to the combination treatment within the first cycle of therapy. Any Grade 3 or 4 non haematological toxicity, any Grade 4 hematological toxicity, treatment related deaths within the first 2 weeks of therapy. Toxicities excluded from DLT: alopecia, rash, nausea, vomiting and hypomagnesemia of Grade 3 or 4 severity, Grade 4 neutropenia or leukopenia lasting for =< 5 days and not associated with fever; Single laboratory values out of normal range without any clinical correlation and resolve within 7 days; Grade 3 or 4 diarrhoea without adequate supportive care. Adequate supportive care has been administered and Grade 4 diarrhea persists (investigator decision); isolated Grade 4 lymphocytopenia and thrombocytopenia without clinical correlation.
Time from the first dose of study drug up to 2 weeks
Randomized Part: Progression Free Survival (PFS)
PFS was defined as the time from the randomization date to first documented sign of objective radio-graphic disease progression (PD) as per Response Evaluation Criteria In Solid Tumors version 1. (RECIST 1.0) or death from any cause if reported within 12 weeks from the last tumor assessment. PD per RECIST v 1.0 was defined as at least 20% increase in the sum of the longest diameter of target lesions, taking as the reference the smallest sum of longest diameters recorded since treatment started, or unequivocal progression of existing non-target lesion or appearance of new lesions. Subjects who did not progress or died at the time of analyses, or subjects who died without previously radio-graphically documented PD and death was observed after more than 12 weeks of last tumor assessment without progression, these subjects were censored at their last tumor assessment date or date of randomization, whichever occurred last.
Time from randomization until progressive disease or death; assessed up to 18 months (i.e data cut-off date: 09 Oct 2013)
Secondary Outcomes
Measure
Description
Time Frame
Overall Survival (OS) Time
OS was defined as the time from the date of randomization to the date of death from any cause. For subjects who were still alive at the analysis cut off date or lost to follow up, survival was censored at the last recorded date the subject was known to be alive or at the analysis cut off date, whichever occurred first.
Time from randomization until death assessed up to 18 months (i.e data cut-off date: 09 Oct 2013)
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Subjects with histologically confirmed kras wildtype (WT) colorectal carcinoma (CRC) with documented distant metastasis
Prior oxaliplatin/fluoropyrimidine-containing regimen for the first-line treatment of metastatic disease
Failed an oxaliplatin regimen for metastatic colorectal carcinoma (mCRC). Failure is defined as either progressive disease (PD) (clinical or radiologic) within 6 months of the last dose of any agent of an oxaliplatin-based regimen or intolerance to an oxaliplatin regimen. Intolerance to an oxaliplatin regimen is defined as discontinuation due to any of the following: severe allergic reaction, persistent severe neurotoxicity, or delayed recovery from toxicity preventing retreatment
At least 1 radiographically documented measurable lesion in a previously non irradiated area according to Response Evaluation Criteria In Solid Tumors (RECIST, Version 1.0), i.e., this lesion must be adequately measurable in at least 1 dimension (longest diameter to be recorded) as greater than or equal to (>=) 2 centimeter (cm) by conventional techniques or >=1 cm by spiral computed tomography (CT) scan
Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1, or Karnofsky performance status (KPS) >= 80 percent (%)
Absolute Neutrophil Count (ANC) >=1.5 x 10^9/Liter
Platelets >=100 x 10^9/Liter
Hemoglobin >=9 gram per deciliter (g/dL) (without transfusions)
Bilirubin less than or equal to (<=) 1.5 x upper limit normal (ULN)
Aspartate transaminase (AST) <=5 x ULN and alanine transaminase (ALT) <=5 x ULN
Serum creatinine <=1.25 x ULN and/or creatinine clearance >=50 milliliter per minute (mL/min)
International Nationalized Ratio (INR), and partial thromboplastin time (PTT) within normal limits
Sodium and potassium within normal limits or <=10% above or below (supplementation permitted)
Exclusion Criteria:
Previous treatment with any inhibitor of Epidermal Growth Factor Receptor (EGFR)
Known brain metastasis and/or leptomeningeal disease
Radiotherapy (except localized radiotherapy for pain relief), major surgery, or any investigational drug in the 30 days before the start of trial treatment entry; planned major surgery during the trial
Concurrent chronic systemic immune or hormone therapy not indicated in this trial protocol (except for physiologic replacement; steroids up to 10 mg of prednisone equivalent or topical and inhaled steroids are allowed)
Clinically relevant coronary artery disease (New York Heart Association [NYHA] functional angina classification III/IV), congestive heart failure (NYHA III/IV), clinically relevant cardiomyopathy, history of myocardial infarction in the last 12 months, or high risk of uncontrolled arrhythmia
Uncontrolled hypertension defined as systolic blood pressure >=160 millimeter of mercury (mmHg) and/or diastolic blood pressure >=100 mmHg under resting conditions
History of coagulation disorder associated with bleeding or recurrent thrombotic events
History of recent peptic ulcer disease (endoscopically proven gastric, duodenal or esophageal ulcer) within 6 months of trial treatment start
Chronic inflammatory bowel disease, or acute/chronic ileus
Active infection (requiring i.v. antibiotics), including active tuberculosis, active or chronic Hepatitis B or C, or ongoing HIV infection
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Medical Responsible
Merck KGaA, Darmstadt, Germany
Study Director
Prof. Josep Tabernero
HU Vall d' Hebron, Servei d'oncologia. E difici General
Elez E, Kocakova I, Hohler T, Martens UM, Bokemeyer C, Van Cutsem E, Melichar B, Smakal M, Csoszi T, Topuzov E, Orlova R, Tjulandin S, Rivera F, Straub J, Bruns R, Quaratino S, Tabernero J. Abituzumab combined with cetuximab plus irinotecan versus cetuximab plus irinotecan alone for patients with KRAS wild-type metastatic colorectal cancer: the randomised phase I/II POSEIDON trial. Ann Oncol. 2015 Jan;26(1):132-140. doi: 10.1093/annonc/mdu474. Epub 2014 Oct 15.
See Also Links
Not provided
Available IPD Information
Not provided
IPD Sharing Statement Module
No data available
No data is available for this block.
Results Section
Participant Flow Module
Pre-assignment Details
This study consists of two parts, safety part and randomized part. A total of 16 subjects were included in the safety part and 216 subjects were included in the randomized part of the study. The subjects who participated in the safety part of the study were not included in the randomized part of the study.
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Safety Part: EMD 525797 250 mg + SoC
Cetuximab was administered at a dose of 400 mg/m^2 on Day 1 Cycle 1 (Week 1) as IV infusion for 2 hours, and then at a dose of 250 mg/m^2 on Day 8 (Week 2) once weekly; followed by EMD 525797 at a target dose of 250 mg as a 1-hour IV infusion for every 2 weeks, followed by Irinotecan at a dose of 180 mg/m^2 as IV infusion for 30-90 minutes for every 2 weeks until radio-graphically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator's assessment), or withdrawal of consent.
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
0
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
Drug: EMD 525797 500 mg
Drug: Cetuximab
Drug: Irinotecan
Randomized Part: EMD 525797 1000 mg + SoC
Experimental
EMD 525797 1000 mg (or dose as defined by safety monitoring committee (SMC)] in combination with cetuximab and irinotecan.
Drug: EMD 525797 1000 mg
Drug: Cetuximab
Drug: Irinotecan
Randomized Part: SoC
Other
Cetuximab and irinotecan
Drug: Cetuximab
Drug: Irinotecan
Safety part: EMD 525797 250 mg + Standard of Care (SoC)
EMD 525797 500 mg
Drug
Safety part: EMD 525797 will be administered at a target dose of 500 mg as a 1-hour intravenous infusion for every 2 weeks until radio-graphically documented PD (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator's assessment), or withdrawal of consent .
Randomized part: EMD 525797 will be administered at a target dose of 500 mg as a 1-hour intravenous infusion for every 2 weeks until radio-graphically documented PD (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator's assessment), or withdrawal of consent.
Randomized part: EMD 525797 500 mg + SoC
Safety part: EMD 525797 500 mg + SoC
EMD 525797 750 mg
Drug
EMD 525797 will be administered at a target dose of 750 mg as a 1-hour intravenous infusion for every 2 weeks until radio-graphically documented PD (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator's assessment), or withdrawal of consent .
Safety part: EMD 525797 750 mg + SoC
Abituzumab
EMD 525797 1000 mg
Drug
Safety part: EMD 525797 will be administered at a target dose of 1000 mg as a 1-hour intravenous infusion for every 2 weeks until radio-graphically documented PD (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator's assessment), or withdrawal of consent .
Randomized part: EMD 525797 will be administered at a target dose of 1000 mg as a 1-hour intravenous infusion for every 2 weeks until radio-graphically documented PD (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator's assessment), or withdrawal of consent.
Randomized Part: EMD 525797 1000 mg + SoC
Safety part: EMD 525797 1000 mg + SoC
Abituzumab
Cetuximab
Drug
Safety part: Cetuximab will be administered at a dose of 400 milligram per square meter (mg/m^2) on Day 1 Cycle 1 (Week 1) as IV infusion for 2 hours, and then at a dose of 250 mg/m^2 on Day 8 (Week 2) once weekly until DLT.
Randomized part: Cetuximab will be administered at a dose of 400 milligram per square meter (mg/m^2) on Day 1 Cycle 1 (Week 1) as IV infusion for 2 hours, and then at a dose of 250 mg/m^2 on Day 8 (Week 2) once weekly until radio-graphically documented PD (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator's assessment), or withdrawal of consent.
Randomized Part: EMD 525797 1000 mg + SoC
Randomized Part: SoC
Randomized part: EMD 525797 500 mg + SoC
Safety part: EMD 525797 1000 mg + SoC
Safety part: EMD 525797 250 mg + Standard of Care (SoC)
Safety part: EMD 525797 500 mg + SoC
Safety part: EMD 525797 750 mg + SoC
Irinotecan
Drug
Safety part: Irinotecan will be administered at a dose of 180 mg/m^2 as IV infusion for 30-90 minutes for every 2 weeks until radio-graphically documented PD (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator's assessment), or withdrawal of consent .
Randomized part: Irinotecan will be administered at a dose of 180 mg/m^2 as IV infusion for 30-90 minutes for every 2 weeks until radio-graphically documented PD (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator's assessment), or withdrawal of consent.
Randomized Part: EMD 525797 1000 mg + SoC
Randomized Part: SoC
Randomized part: EMD 525797 500 mg + SoC
Safety part: EMD 525797 1000 mg + SoC
Safety part: EMD 525797 250 mg + Standard of Care (SoC)
Safety part: EMD 525797 500 mg + SoC
Safety part: EMD 525797 750 mg + SoC
Time to Progression (TTP)
TTP was defined as the time from the date of randomization to the date of objective radiographic disease progression (PD). PD per RECIST v 1.0 was defined as at least 20% increase in the sum of the longest diameter of target lesions, taking as the reference the smallest sum of longest diameters recorded since treatment started, or unequivocal progression of existing non-target lesion or appearance of new lesions. For subjects who did not progress or who were without any post baseline tumor assessment, TTP was censored at their last tumor assessment date, or at the randomization date, whichever occurred last.
Time from randomization until disease progression assessed up to 18 months (i.e data cut-off date: 09 Oct 2013)
Number of Subjects With Tumor Response
Tumor response was defined as the presence of at least 1 confirmed complete response (CR) or confirmed partial response (PR) as judged by RECIST version 1.0. CR was defined for target lesions (TLs) as the disappearance of all lesions, and for non-target lesions (NTLs) as the disappearance of all non-target non-measurable lesions and/or normalization of serum levels of tumor markers. PR was defined for TLs as at least a 30 percent (%) decrease from baseline (BL) in the sum of longest diameter (SLD) of TLs.
Time from randomization up to 18 months (i.e data cut-off date: 09 Oct 2013)
Time to Treatment Failure (TTF)
TTF was defined as the time from randomization to treatment discontinuation for any reason. For subjects on drug at the analysis cut off date or lost to follow up, TTF was censored at the trial discontinuation date or at the analysis cut off date, whichever occurred first.
Time from randomization until discontinuation assessed up to 18 months (i.e data cut-off date: 09 Oct 2013)
Cetuximab was administered at a dose of 400 mg/m^2 on Day 1 Cycle 1 (Week 1) as IV infusion for 2 hours, and then at a dose of 250 mg/m^2 on Day 8 (Week 2) once weekly; followed by EMD 525797 at a target dose of 500 mg as a 1-hour IV infusion for every 2 weeks, followed by Irinotecan at a dose of 180 mg/m^2 as IV infusion for 30-90 minutes for every 2 weeks until radio-graphically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator's assessment), or withdrawal of consent.
FG002
Safety Part: EMD525797 750 mg + SoC
Cetuximab was administered at a dose of 400 mg/m^2 on Day 1 Cycle 1 (Week 1) as IV infusion for 2 hours, and then at a dose of 250 mg/m^2 on Day 8 (Week 2) once weekly; followed by EMD 525797 at a target dose of 750 mg as a 1-hour IV infusion for every 2 weeks, followed by Irinotecan at a dose of 180 mg/m^2 as IV infusion for 30-90 minutes for every 2 weeks until radio-graphically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator's assessment), or withdrawal of consent.
FG003
Safety Part: EMD 525797 1000 mg +SoC
Cetuximab was administered at a dose of 400 mg/m^2 on Day 1 Cycle 1 (Week 1) as IV infusion for 2 hours, and then at a dose of 250 mg/m^2 on Day 8 (Week 2) once weekly; followed by EMD 525797 at a target dose of 1000 mg as a 1-hour IV infusion for every 2 weeks, followed by Irinotecan at a dose of 180 mg/m^2 as IV infusion for 30-90 minutes for every 2 weeks until radio-graphically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator's assessment), or withdrawal of consent.
FG004
Randomized Part: Standard of Care (SoC)
Cetuximab was administered at a dose of 400 milligram per square meter (mg/m^2) on Day 1 Cycle 1 (Week 1) as intravenous (IV) infusion for 2 hours, and then at a dose of 250 mg/m^2 on Day 8 (Week 2) once weekly followed by irinotecan at a dose of 180 mg/m^2 as IV infusion for 30-90 minutes for every 2 weeks until radio-graphically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator's assessment), or withdrawal of consent.
FG005
Randomized Part: EMD 525797 500 mg + SoC
Cetuximab was administered at a dose of 400 mg/m^2 on Day 1 Cycle 1 (Week 1) as IV infusion for 2 hours, and then at a dose of 250 mg/m^2 on Day 8 (Week 2) once weekly; followed by EMD 525797 at a target dose of 500 mg as a 1-hour IV infusion for every 2 weeks, followed by Irinotecan at a dose of 180 mg/m^2 as IV infusion for 30-90 minutes for every 2 weeks until radio-graphically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator's assessment), or withdrawal of consent.
FG006
Randomized Part: EMD 525797 1000 mg + SoC
Cetuximab was administered at a dose of 400 mg/m^2 on Day 1 Cycle 1 (Week 1) as IV infusion for 2 hours, and then at a dose of 250 mg/m^2 on Day 8 (Week 2) once weekly; followed by EMD 525797 at a target dose of 1000 mg as a 1-hour IV infusion for every 2 weeks, followed by Irinotecan at a dose of 180 mg/m^2 as IV infusion for 30-90 minutes for every 2 weeks until radio-graphically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator's assessment), or withdrawal of consent.
FG0003 subjects
FG0013 subjects
FG0027 subjects
FG0033 subjects
FG00472 subjects
FG00573 subjects
FG00671 subjects
Safety Analysis Set
FG0003 subjects
FG0013 subjects
FG0027 subjects
FG0033 subjects
FG00473 subjects1 subject randomized to EMD525797 1000 mg group received only SoC. Hence, reported under SOC group.
FG00572 subjects
FG00669 subjects
COMPLETED
FG0003 subjects
FG0013 subjects
FG0027 subjects
FG0033 subjects
FG00467 subjects
FG00567 subjects
FG00667 subjects
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0045 subjects
FG0056 subjects
FG0064 subjects
Type
Comment
Reasons
Ongoing treatment at data cut-off date
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0045 subjects
FG0056 subjects
FG0064 subjects
All the subjects who were enrolled in to the study (safety and randomized part).
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Safety Part: EMD 525797 250 mg + Standard of Care (SoC)
Cetuximab was administered at a dose of 400 milligram per square meter (mg/m^2) on Day 1 as IV infusion for 2 hours, and then at a dose of 250 mg/m^2 on Day 8 once weekly followed by EMD 525797 at a target dose of 250 mg as a 1-hour IV infusion for every 2 weeks, followed by irinotecan at a dose of 180 mg/m^2 as IV infusion for 30-90 minutes for every 2 weeks until radio-graphically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator's assessment), or withdrawal of consent.
BG001
Safety Part: EMD 525797 500 mg + SoC
Cetuximab was administered at a dose of 400 milligram per square meter (mg/m^2) on Day 1 as IV infusion for 2 hours, and then at a dose of 250 mg/m^2 on Day 8 once weekly followed by EMD 525797 at a target dose of 500 mg as a 1-hour IV infusion for every 2 weeks, followed by irinotecan at a dose of 180 mg/m^2 as IV infusion for 30-90 minutes for every 2 weeks until radio-graphically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator's assessment), or withdrawal of consent.
BG002
Safety Part: EMD 525797 750 mg + SoC
Cetuximab was administered at a dose of 400 milligram per square meter (mg/m^2) on Day 1 as IV infusion for 2 hours, and then at a dose of 250 mg/m^2 on Day 8 once weekly followed by EMD 525797 at a target dose of 750 mg as a 1-hour IV infusion for every 2 weeks, followed by irinotecan at a dose of 180 mg/m^2 as IV infusion for 30-90 minutes for every 2 weeks until radio-graphically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator's assessment), or withdrawal of consent.
BG003
Safety Part: EMD 525797 1000 mg + SoC
Cetuximab was administered at a dose of 400 milligram per square meter (mg/m^2) on Day 1 as IV infusion for 2 hours, and then at a dose of 250 mg/m^2 on Day 8 once weekly followed by EMD 525797 at a target dose of 1000 mg as a 1-hour IV infusion for every 2 weeks, followed by irinotecan at a dose of 180 mg/m^2 as IV infusion for 30-90 minutes for every 2 weeks until radio-graphically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator's assessment), or withdrawal of consent.
BG004
Randomized Part: SoC
Cetuximab was administered at a dose of 400 milligram per square meter (mg/m^2) on Day 1 Cycle 1 (Week 1) as intravenous (IV) infusion for 2 hours, and then at a dose of 250 mg/m^2 on Day 8 (Week 2) once weekly followed by irinotecan at a dose of 180 mg/m^2 as IV infusion for 30-90 minutes for every 2 weeks until radio-graphically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator's assessment), or withdrawal of consent.
BG005
Randomized Part: EMD 525797 500 mg + SoC
Cetuximab was administered at a dose of 400 mg/m^2 on Day 1 Cycle 1 (Week 1) as IV infusion for 2 hours, and then at a dose of 250 mg/m^2 on Day 8 (Week 2) once weekly; followed by EMD 525797 at a target dose of 500 mg as a 1-hour IV infusion for every 2 weeks, followed by Irinotecan at a dose of 180 mg/m^2 as IV infusion for 30-90 minutes for every 2 weeks until radio-graphically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator's assessment), or withdrawal of consent.
BG006
Randomized Part: EMD 525797 1000 mg + SoC
Cetuximab was administered at a dose of 400 mg/m^2 on Day 1 Cycle 1 (Week 1) as IV infusion for 2 hours, and then at a dose of 250 mg/m^2 on Day 8 (Week 2) once weekly; followed by EMD 525797 at a target dose of 1000 mg as a 1-hour IV infusion for every 2 weeks, followed by Irinotecan at a dose of 180 mg/m^2 as IV infusion for 30-90 minutes for every 2 weeks until radio-graphically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator's assessment), or withdrawal of consent.
BG007
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0003
BG0013
BG0027
BG0033
BG00472
BG00573
BG00671
BG007232
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
BG00062.3± 11.5
BG00157.7± 11.2
BG00260.4± 6.2
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0002
BG0011
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
Safety Part: Number of Subjects Experiencing DLTs (Dose Limiting Toxicity)
DLT was defined as any Grade 4 hematologic toxicity or Grade 3/4 non-hematologic toxicity assessed as related to trial treatment by the Investigator and/or Sponsor and confirmed by the safety monitoring committee (SMC) to be relevant to the combination treatment within the first cycle of therapy. Any Grade 3 or 4 non haematological toxicity, any Grade 4 hematological toxicity, treatment related deaths within the first 2 weeks of therapy. Toxicities excluded from DLT: alopecia, rash, nausea, vomiting and hypomagnesemia of Grade 3 or 4 severity, Grade 4 neutropenia or leukopenia lasting for =< 5 days and not associated with fever; Single laboratory values out of normal range without any clinical correlation and resolve within 7 days; Grade 3 or 4 diarrhoea without adequate supportive care. Adequate supportive care has been administered and Grade 4 diarrhea persists (investigator decision); isolated Grade 4 lymphocytopenia and thrombocytopenia without clinical correlation.
Dose-escalation analysis set included subjects who received atleast 1 dose of EMD 525797 and who met atleast 1 of the following: Did not withdraw before the end of DLT evaluation period (2 weeks from 1st drug intake) for reasons other than DLT;those who experienced a DLT during this period and received 1 dose of EMD 525797 as per cohort allocation.
Posted
Number
subjects
Time from the first dose of study drug up to 2 weeks
ID
Title
Description
OG000
Safety Part: EMD 525797 250 mg + SoC
Cetuximab was administered at a dose of 400 mg/m^2 on Day 1 Cycle 1 (Week 1) as IV infusion for 2 hours, and then at a dose of 250 mg/m^2 on Day 8 (Week 2) once weekly; followed by EMD 525797 at a target dose of 250 mg as a 1-hour IV infusion for every 2 weeks, followed by Irinotecan at a dose of 180 mg/m^2 as IV infusion for 30-90 minutes for every 2 weeks until radio-graphically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator's assessment), or withdrawal of consent.
OG001
Safety Part: EMD 525797 500 mg + SoC
Cetuximab was administered at a dose of 400 mg/m^2 on Day 1 Cycle 1 (Week 1) as IV infusion for 2 hours, and then at a dose of 250 mg/m^2 on Day 8 (Week 2) once weekly; followed by EMD 525797 at a target dose of 500 mg as a 1-hour IV infusion for every 2 weeks, followed by Irinotecan at a dose of 180 mg/m^2 as IV infusion for 30-90 minutes for every 2 weeks until radio-graphically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator's assessment), or withdrawal of consent.
OG002
Safety Part: EMD525797 750 mg + SoC
Cetuximab was administered at a dose of 400 mg/m^2 on Day 1 Cycle 1 (Week 1) as IV infusion for 2 hours, and then at a dose of 250 mg/m^2 on Day 8 (Week 2) once weekly; followed by EMD 525797 at a target dose of 750 mg as a 1-hour IV infusion for every 2 weeks, followed by Irinotecan at a dose of 180 mg/m^2 as IV infusion for 30-90 minutes for every 2 weeks until radio-graphically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator's assessment), or withdrawal of consent.
OG003
Safety Part: EMD 525797 1000 mg +SoC
Cetuximab was administered at a dose of 400 mg/m^2 on Day 1 Cycle 1 (Week 1) as IV infusion for 2 hours, and then at a dose of 250 mg/m^2 on Day 8 (Week 2) once weekly; followed by EMD 525797 at a target dose of 1000 mg as a 1-hour IV infusion for every 2 weeks, followed by Irinotecan at a dose of 180 mg/m^2 as IV infusion for 30-90 minutes for every 2 weeks until radio-graphically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator's assessment), or withdrawal of consent.
Units
Counts
Participants
OG0003
OG0013
OG0027
OG003
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG003
Primary
Randomized Part: Progression Free Survival (PFS)
PFS was defined as the time from the randomization date to first documented sign of objective radio-graphic disease progression (PD) as per Response Evaluation Criteria In Solid Tumors version 1. (RECIST 1.0) or death from any cause if reported within 12 weeks from the last tumor assessment. PD per RECIST v 1.0 was defined as at least 20% increase in the sum of the longest diameter of target lesions, taking as the reference the smallest sum of longest diameters recorded since treatment started, or unequivocal progression of existing non-target lesion or appearance of new lesions. Subjects who did not progress or died at the time of analyses, or subjects who died without previously radio-graphically documented PD and death was observed after more than 12 weeks of last tumor assessment without progression, these subjects were censored at their last tumor assessment date or date of randomization, whichever occurred last.
Intention-to-treat (ITT) analysis set included all the subjects who were randomized into the treatment groups.
Posted
Median
95% Confidence Interval
months
Time from randomization until progressive disease or death; assessed up to 18 months (i.e data cut-off date: 09 Oct 2013)
ID
Title
Description
OG000
Standard of Care (SoC)
Cetuximab was administered at a dose of 400 milligram per square meter (mg/m^2) on Day 1 Cycle 1 (Week 1) as intravenous (IV) infusion for 2 hours, and then at a dose of 250 mg/m^2 on Day 8 (Week 2) once weekly followed by irinotecan at a dose of 180 mg/m^2 as IV infusion for 30-90 minutes for every 2 weeks until radiographically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator's assessment), or withdrawal of consent.
Secondary
Overall Survival (OS) Time
OS was defined as the time from the date of randomization to the date of death from any cause. For subjects who were still alive at the analysis cut off date or lost to follow up, survival was censored at the last recorded date the subject was known to be alive or at the analysis cut off date, whichever occurred first.
ITT analysis set included all the subjects who were randomized into the trial.
Posted
Median
95% Confidence Interval
months
Time from randomization until death assessed up to 18 months (i.e data cut-off date: 09 Oct 2013)
ID
Title
Description
OG000
Standard of Care (SoC)
Cetuximab was administered at a dose of 400 milligram per square meter (mg/m^2) on Day 1 Cycle 1 (Week 1) as intravenous (IV) infusion for 2 hours, and then at a dose of 250 mg/m^2 on Day 8 (Week 2) once weekly followed by irinotecan at a dose of 180 mg/m^2 as IV infusion for 30-90 minutes for every 2 weeks until radiographically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator's assessment), or withdrawal of consent.
OG001
EMD 525797 500 mg + SoC
Cetuximab was administered at a dose of 400 mg/m^2 on Day 1 Cycle 1 (Week 1) as IV infusion for 2 hours, and then at a dose of 250 mg/m^2 on Day 8 (Week 2) once weekly; followed by EMD 525797 at a target dose of 500 mg as a 1-hour IV infusion for every 2 weeks, followed by Irinotecan at a dose of 180 mg/m^2 as IV infusion for 30-90 minutes for every 2 weeks until radiographically documented PD (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator's assessment), or withdrawal of consent.
Secondary
Time to Progression (TTP)
TTP was defined as the time from the date of randomization to the date of objective radiographic disease progression (PD). PD per RECIST v 1.0 was defined as at least 20% increase in the sum of the longest diameter of target lesions, taking as the reference the smallest sum of longest diameters recorded since treatment started, or unequivocal progression of existing non-target lesion or appearance of new lesions. For subjects who did not progress or who were without any post baseline tumor assessment, TTP was censored at their last tumor assessment date, or at the randomization date, whichever occurred last.
ITT analysis set included all the subjects who were randomized into the trial.
Posted
Median
95% Confidence Interval
months
Time from randomization until disease progression assessed up to 18 months (i.e data cut-off date: 09 Oct 2013)
ID
Title
Description
OG000
Standard of Care (SoC)
Cetuximab was administered at a dose of 400 milligram per square meter (mg/m^2) on Day 1 Cycle 1 (Week 1) as intravenous (IV) infusion for 2 hours, and then at a dose of 250 mg/m^2 on Day 8 (Week 2) once weekly followed by irinotecan at a dose of 180 mg/m^2 as IV infusion for 30-90 minutes for every 2 weeks until radiographically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator's assessment), or withdrawal of consent.
OG001
EMD 525797 500 mg + SoC
Secondary
Number of Subjects With Tumor Response
Tumor response was defined as the presence of at least 1 confirmed complete response (CR) or confirmed partial response (PR) as judged by RECIST version 1.0. CR was defined for target lesions (TLs) as the disappearance of all lesions, and for non-target lesions (NTLs) as the disappearance of all non-target non-measurable lesions and/or normalization of serum levels of tumor markers. PR was defined for TLs as at least a 30 percent (%) decrease from baseline (BL) in the sum of longest diameter (SLD) of TLs.
ITT analysis set included all the subjects who were randomized into the trial.
Posted
Number
Subjects
Time from randomization up to 18 months (i.e data cut-off date: 09 Oct 2013)
ID
Title
Description
OG000
Standard of Care (SoC)
Cetuximab was administered at a dose of 400 milligram per square meter (mg/m^2) on Day 1 Cycle 1 (Week 1) as intravenous (IV) infusion for 2 hours, and then at a dose of 250 mg/m^2 on Day 8 (Week 2) once weekly followed by irinotecan at a dose of 180 mg/m^2 as IV infusion for 30-90 minutes for every 2 weeks until radiographically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator's assessment), or withdrawal of consent.
OG001
EMD 525797 500 mg + SoC
Cetuximab was administered at a dose of 400 mg/m^2 on Day 1 Cycle 1 (Week 1) as IV infusion for 2 hours, and then at a dose of 250 mg/m^2 on Day 8 (Week 2) once weekly; followed by EMD 525797 at a target dose of 500 mg as a 1-hour IV infusion for every 2 weeks, followed by Irinotecan at a dose of 180 mg/m^2 as IV infusion for 30-90 minutes for every 2 weeks until radiographically documented PD (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator's assessment), or withdrawal of consent.
Secondary
Time to Treatment Failure (TTF)
TTF was defined as the time from randomization to treatment discontinuation for any reason. For subjects on drug at the analysis cut off date or lost to follow up, TTF was censored at the trial discontinuation date or at the analysis cut off date, whichever occurred first.
ITT analysis set included all the subjects who were randomized into the trial.
Posted
Median
95% Confidence Interval
months
Time from randomization until discontinuation assessed up to 18 months (i.e data cut-off date: 09 Oct 2013)
ID
Title
Description
OG000
Standard of Care (SoC)
Cetuximab was administered at a dose of 400 milligram per square meter (mg/m^2) on Day 1 Cycle 1 (Week 1) as intravenous (IV) infusion for 2 hours, and then at a dose of 250 mg/m^2 on Day 8 (Week 2) once weekly followed by irinotecan at a dose of 180 mg/m^2 as IV infusion for 30-90 minutes for every 2 weeks until radiographically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator's assessment), or withdrawal of consent.
OG001
EMD 525797 500 mg + SoC
Cetuximab was administered at a dose of 400 mg/m^2 on Day 1 Cycle 1 (Week 1) as IV infusion for 2 hours, and then at a dose of 250 mg/m^2 on Day 8 (Week 2) once weekly; followed by EMD 525797 at a target dose of 500 mg as a 1-hour IV infusion for every 2 weeks, followed by Irinotecan at a dose of 180 mg/m^2 as IV infusion for 30-90 minutes for every 2 weeks until radiographically documented PD (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator's assessment), or withdrawal of consent.
Time Frame
From the first dose of study drug administration up to 50 days after the last dose of study drug administration
Description
The safety analysis set included all subjects who received at least 1 dose of the trial medication. 1 subject who was randomized to EMD525797 1000 mg group received only SoC, therefore this subjects was reported under the SOC group.
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
Safety Part: EMD 525797 250 mg + SoC
Cetuximab was administered at a dose of 400 mg/m^2 on Day 1 Cycle 1 (Week 1) as IV infusion for 2 hours, and then at a dose of 250 mg/m^2 on Day 8 (Week 2) once weekly; followed by EMD 525797 at a target dose of 250 mg as a 1-hour IV infusion for every 2 weeks, followed by Irinotecan at a dose of 180 mg/m^2 as IV infusion for 30-90 minutes for every 2 weeks until radio-graphically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator's assessment), or withdrawal of consent.
2
3
3
3
EG001
Safety Part: EMD 525797 500 mg + SoC
Cetuximab was administered at a dose of 400 mg/m^2 on Day 1 Cycle 1 (Week 1) as IV infusion for 2 hours, and then at a dose of 250 mg/m^2 on Day 8 (Week 2) once weekly; followed by EMD 525797 at a target dose of 500 mg as a 1-hour IV infusion for every 2 weeks, followed by Irinotecan at a dose of 180 mg/m^2 as IV infusion for 30-90 minutes for every 2 weeks until radio-graphically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator's assessment), or withdrawal of consent.
2
3
3
3
EG002
Safety Part: EMD525797 750 mg + SoC
Cetuximab was administered at a dose of 400 mg/m^2 on Day 1 Cycle 1 (Week 1) as IV infusion for 2 hours, and then at a dose of 250 mg/m^2 on Day 8 (Week 2) once weekly; followed by EMD 525797 at a target dose of 750 mg as a 1-hour IV infusion for every 2 weeks, followed by Irinotecan at a dose of 180 mg/m^2 as IV infusion for 30-90 minutes for every 2 weeks until radio-graphically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator's assessment), or withdrawal of consent.
3
7
7
7
EG003
Safety Part: EMD 525797 1000 mg +SoC
Cetuximab was administered at a dose of 400 mg/m^2 on Day 1 Cycle 1 (Week 1) as IV infusion for 2 hours, and then at a dose of 250 mg/m^2 on Day 8 (Week 2) once weekly; followed by EMD 525797 at a target dose of 1000 mg as a 1-hour IV infusion for every 2 weeks, followed by Irinotecan at a dose of 180 mg/m^2 as IV infusion for 30-90 minutes for every 2 weeks until radio-graphically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator's assessment), or withdrawal of consent.
3
3
3
3
EG004
Standard of Care (SoC)
Cetuximab was administered at a dose of 400 milligram per square meter (mg/m^2) on Day 1 Cycle 1 (Week 1) as intravenous (IV) infusion for 2 hours, and then at a dose of 250 mg/m^2 on Day 8 (Week 2) once weekly followed by irinotecan at a dose of 180 mg/m^2 as IV infusion for 30-90 minutes for every 2 weeks until radiographically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator's assessment), or withdrawal of consent.
30
73
72
73
EG005
EMD 525797 500 mg + SoC
Cetuximab was administered at a dose of 400 mg/m^2 on Day 1 Cycle 1 (Week 1) as IV infusion for 2 hours, and then at a dose of 250 mg/m^2 on Day 8 (Week 2) once weekly; followed by EMD 525797 at a target dose of 500 mg as a 1-hour IV infusion for every 2 weeks, followed by Irinotecan at a dose of 180 mg/m^2 as IV infusion for 30-90 minutes for every 2 weeks until radiographically documented PD (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator's assessment), or withdrawal of consent.
27
72
72
72
EG006
EMD 525797 1000 mg + SoC
Cetuximab was administered at a dose of 400 mg/m^2 on Day 1 Cycle 1 (Week 1) as IV infusion for 2 hours, and then at a dose of 250 mg/m^2 on Day 8 (Week 2) once weekly; followed by EMD 525797 at a target dose of 1000 mg as a 1-hour IV infusion for every 2 weeks, followed by Irinotecan at a dose of 180 mg/m^2 as IV infusion for 30-90 minutes for every 2 weeks until radio-graphically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator's assessment), or withdrawal of consent.
34
69
68
69
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG0030 events0 affected3 at risk
EG0041 events1 affected73 at risk
EG0051 events1 affected72 at risk
EG0061 events1 affected69 at risk
Febrile Neutropenia
Blood and lymphatic system disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Leukopenia
Blood and lymphatic system disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Atrial Fibrillation
Cardiac disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Cardiac Failure Acute
Cardiac disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Tachyarrhythmia
Cardiac disorders
MedDRA 15.0
Non-systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Tachycardia
Cardiac disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Inappropriate Antidiuretic Hormone Secretion
Endocrine disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Abdominal Hernia
Gastrointestinal disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Abdominal Pain
Gastrointestinal disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected7 at risk
EG003
Ascites
Gastrointestinal disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Colitis
Gastrointestinal disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Colonic Obstruction
Gastrointestinal disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected7 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Enteritis
Gastrointestinal disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Enterovesical Fistula
Gastrointestinal disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Gastrointestinal Haemorrhage
Gastrointestinal disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Gastrointestinal Stenosis
Gastrointestinal disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Gastrointestinal Toxicity
Gastrointestinal disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Gastrointestinal Ulcer Haemorrhage
Gastrointestinal disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Intestinal Obstruction
Gastrointestinal disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Intestinal Perforation
Gastrointestinal disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected7 at risk
EG003
Periodontitis
Gastrointestinal disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Subileus
Gastrointestinal disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected7 at risk
EG003
Asthenia
General disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Death
General disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Device Malfunction
General disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Disease Progression
General disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Fatigue
General disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
General Physical Health Deterioration
General disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected7 at risk
EG003
Mucosal Inflammation
General disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0021 events1 affected7 at risk
EG003
Multi-Organ Failure
General disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Performance Status Decreased
General disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Pyrexia
General disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Cholecystitis
Hepatobiliary disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Hepatic Failure
Hepatobiliary disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Hyperbilirubinaemia
Hepatobiliary disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Jaundice Cholestatic
Hepatobiliary disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Anaphylactic Shock
Immune system disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Hypersensitivity
Immune system disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Abdominal Sepsis
Infections and infestations
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Abdominal Wall Abscess
Infections and infestations
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Device Related Infection
Infections and infestations
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Device Related Sepsis
Infections and infestations
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Erysipelas
Infections and infestations
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Febrile Infection
Infections and infestations
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Gastrointestinal Infection
Infections and infestations
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Infection
Infections and infestations
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Peritonitis
Infections and infestations
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected7 at risk
EG003
Rectal Abscess
Infections and infestations
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Sepsis
Infections and infestations
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Septic Shock
Infections and infestations
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Urinary Tract Infection
Infections and infestations
MedDRA 15.0
Non-systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Femoral Neck Fracture
Injury, poisoning and procedural complications
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Overdose
Injury, poisoning and procedural complications
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Blood Bilirubin Increased
Investigations
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Blood Creatinine Increased
Investigations
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Coagulation Factor Increased
Investigations
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Gamma-Glutamyltransferase Increased
Investigations
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
General Physical Condition Abnormal
Investigations
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected7 at risk
EG003
Neutrophil Count Decreased
Investigations
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Cachexia
Metabolism and nutrition disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Decreased Appetite
Metabolism and nutrition disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Diabetes Mellitus
Metabolism and nutrition disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Electrolyte Imbalance
Metabolism and nutrition disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Neck Pain
Musculoskeletal and connective tissue disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Pathological Fracture
Musculoskeletal and connective tissue disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Cerebrovascular Accident
Nervous system disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Coma
Nervous system disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Epilepsy
Nervous system disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Headache
Nervous system disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Polyneuropathy
Nervous system disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Syncope
Nervous system disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Renal Failure
Renal and urinary disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Renal Failure Acute
Renal and urinary disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Bronchospasm
Respiratory, thoracic and mediastinal disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Dyspnoea Exertional
Respiratory, thoracic and mediastinal disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Pulmonary Embolism
Respiratory, thoracic and mediastinal disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Respiratory Disorder
Respiratory, thoracic and mediastinal disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Respiratory Failure
Respiratory, thoracic and mediastinal disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Rash Maculo-Papular
Skin and subcutaneous tissue disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Toxic Skin Eruption
Skin and subcutaneous tissue disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Thrombosis Prophylaxis
Surgical and medical procedures
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Deep Vein Thrombosis
Vascular disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Venous Thrombosis Limb
Vascular disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Agranulocytosis
Blood and lymphatic system disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG0030 events0 affected3 at risk
EG0041 events1 affected73 at risk
EG0050 events0 affected72 at risk
EG0060 events0 affected69 at risk
Anaemia
Blood and lymphatic system disorders
MedDRA 15.0
Non-systematic Assessment
EG0003 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Anaemia Of Malignant Disease
Blood and lymphatic system disorders
MedDRA 15.0
Non-systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Aplastic Anaemia
Blood and lymphatic system disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Granulocytopenia
Blood and lymphatic system disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Haemorrhagic Anaemia
Blood and lymphatic system disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Hypochromic Anaemia
Blood and lymphatic system disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Iron Deficiency Anaemia
Blood and lymphatic system disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Leukocytosis
Blood and lymphatic system disorders
MedDRA 15.0
Non-systematic Assessment
EG0009 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Leukopenia
Blood and lymphatic system disorders
MedDRA 15.0
Non-systematic Assessment
EG0003 events2 affected3 at risk
EG0011 events1 affected3 at risk
EG0026 events3 affected7 at risk
EG003
Lymphadenitis
Blood and lymphatic system disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Lymphadenopathy
Blood and lymphatic system disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Lymphopenia
Blood and lymphatic system disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Microcytic Anaemia
Blood and lymphatic system disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA 15.0
Non-systematic Assessment
EG0003 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected7 at risk
EG003
Normochromic Normocytic Anaemia
Blood and lymphatic system disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Splenic Vein Thrombosis
Blood and lymphatic system disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Thrombocytosis
Blood and lymphatic system disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Angina Pectoris
Cardiac disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Atrial Tachycardia
Cardiac disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Left Ventricular Dysfunction
Cardiac disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Myocardial Ischaemia
Cardiac disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Right Ventricular Dysfunction
Cardiac disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Sinus Tachycardia
Cardiac disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Supraventricular Extrasystoles
Cardiac disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Tachycardia
Cardiac disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Ventricular Extrasystoles
Cardiac disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Congenital Hair Disorder
Congenital, familial and genetic disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Trichomegaly
Congenital, familial and genetic disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
External Ear Inflammation
Ear and labyrinth disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Hypoacusis
Ear and labyrinth disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Tinnitus
Ear and labyrinth disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRA 15.0
Non-systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Vertigo Positional
Ear and labyrinth disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Hyperthyroidism
Endocrine disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Hypothyroidism
Endocrine disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Blepharitis
Eye disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Conjunctivitis
Eye disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected7 at risk
EG003
Dry Eye
Eye disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Erythema Of Eyelid
Eye disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Eye Pain
Eye disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Eyelid Oedema
Eye disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Eyelid Pain
Eye disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Eyelids Pruritus
Eye disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Iritis
Eye disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Meibomianitis
Eye disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Miosis
Eye disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Ocular Hyperaemia
Eye disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Ocular Icterus
Eye disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Vision Blurred
Eye disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Visual Acuity Reduced
Eye disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Visual Impairment
Eye disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Abdominal Discomfort
Gastrointestinal disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Abdominal Distension
Gastrointestinal disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Abdominal Pain
Gastrointestinal disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0021 events1 affected7 at risk
EG003
Abdominal Pain Lower
Gastrointestinal disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Abdominal Pain Upper
Gastrointestinal disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Abdominal Tenderness
Gastrointestinal disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Anal Haemorrhage
Gastrointestinal disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Anorectal Discomfort
Gastrointestinal disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Aphthous Stomatitis
Gastrointestinal disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Ascites
Gastrointestinal disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Cheilitis
Gastrointestinal disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Colitis
Gastrointestinal disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0022 events2 affected7 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 15.0
Non-systematic Assessment
EG0002 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG00210 events4 affected7 at risk
EG003
Dry Mouth
Gastrointestinal disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA 15.0
Non-systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Enteritis
Gastrointestinal disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Enterovesical Fistula
Gastrointestinal disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Faecal Vomiting
Gastrointestinal disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Flatulence
Gastrointestinal disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected7 at risk
EG003
Food Poisoning
Gastrointestinal disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Frequent Bowel Movements
Gastrointestinal disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Gastritis Erosive
Gastrointestinal disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Gastrointestinal Disorder
Gastrointestinal disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Gastrointestinal Motility Disorder
Gastrointestinal disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Gastrointestinal Toxicity
Gastrointestinal disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Gastrooesophageal Reflux Disease
Gastrointestinal disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Gastrooesophageal Sphincter Insufficiency
Gastrointestinal disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Gingival Bleeding
Gastrointestinal disorders
MedDRA 15.0
Non-systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Haematochezia
Gastrointestinal disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Haemorrhoidal Haemorrhage
Gastrointestinal disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Haemorrhoids
Gastrointestinal disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Intestinal Fistula
Gastrointestinal disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Intestinal Haemorrhage
Gastrointestinal disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Intestinal Villi Atrophy
Gastrointestinal disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Lip Ulceration
Gastrointestinal disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Mesenteric Vein Thrombosis
Gastrointestinal disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Mouth Ulceration
Gastrointestinal disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Mucous Stools
Gastrointestinal disorders
MedDRA 15.0
Non-systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 15.0
Non-systematic Assessment
EG0005 events2 affected3 at risk
EG0014 events2 affected3 at risk
EG0022 events2 affected7 at risk
EG003
Odynophagia
Gastrointestinal disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Oral Pain
Gastrointestinal disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Pancreatitis Acute
Gastrointestinal disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Paraesthesia Oral
Gastrointestinal disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Periodontal Disease
Gastrointestinal disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected7 at risk
EG003
Proctalgia
Gastrointestinal disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Rectal Discharge
Gastrointestinal disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Rectal Haemorrhage
Gastrointestinal disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Rectal Tenesmus
Gastrointestinal disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0023 events2 affected7 at risk
EG003
Subileus
Gastrointestinal disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Tongue Ulceration
Gastrointestinal disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Tooth Discolouration
Gastrointestinal disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Tooth Disorder
Gastrointestinal disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Toothache
Gastrointestinal disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0013 events1 affected3 at risk
EG0021 events1 affected7 at risk
EG003
Asthenia
General disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0012 events1 affected3 at risk
EG0023 events3 affected7 at risk
EG003
Catheter Site Erythema
General disorders
MedDRA 15.0
Non-systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Catheter Site Rash
General disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Chest Pain
General disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Chills
General disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Extravasation
General disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Fatigue
General disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0023 events2 affected7 at risk
EG003
Feeling Cold
General disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
General Physical Health Deterioration
General disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Impaired Healing
General disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Influenza Like Illness
General disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Injection Site Pain
General disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Localised Oedema
General disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Malaise
General disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Mucosal Inflammation
General disorders
MedDRA 15.0
Non-systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0023 events3 affected7 at risk
EG003
Non-Cardiac Chest Pain
General disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Oedema Peripheral
General disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected7 at risk
EG003
Performance Status Decreased
General disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Pyrexia
General disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Secretion Discharge
General disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Xerosis
General disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected7 at risk
EG003
Biliary Colic
Hepatobiliary disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Cholestasis
Hepatobiliary disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Hepatic Pain
Hepatobiliary disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected7 at risk
EG003
Hepatic Vein Thrombosis
Hepatobiliary disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Hepatomegaly
Hepatobiliary disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Hyperbilirubinaemia
Hepatobiliary disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Jaundice
Hepatobiliary disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Contrast Media Allergy
Immune system disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Drug Hypersensitivity
Immune system disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected7 at risk
EG003
Hypersensitivity
Immune system disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Abdominal Wall Abscess
Infections and infestations
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Abscess
Infections and infestations
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Anal Abscess
Infections and infestations
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Catheter Site Infection
Infections and infestations
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Cystitis
Infections and infestations
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected7 at risk
EG003
Device Related Infection
Infections and infestations
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Escherichia Urinary Tract Infection
Infections and infestations
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Eye Infection
Infections and infestations
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Folliculitis
Infections and infestations
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Fungal Skin Infection
Infections and infestations
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Furuncle
Infections and infestations
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Gastroenteritis Viral
Infections and infestations
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Gastrointestinal Infection
Infections and infestations
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Genital Candidiasis
Infections and infestations
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Herpes Zoster
Infections and infestations
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Hordeolum
Infections and infestations
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Infected Fistula
Infections and infestations
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Infected Skin Ulcer
Infections and infestations
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Infection
Infections and infestations
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Influenza
Infections and infestations
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Keratitis Herpetic
Infections and infestations
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Laryngitis
Infections and infestations
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Localised Infection
Infections and infestations
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Lower Respiratory Tract Infection
Infections and infestations
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Lung Infection
Infections and infestations
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Lyme Disease
Infections and infestations
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Nail Bed Infection
Infections and infestations
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Oesophageal Candidiasis
Infections and infestations
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Oral Candidiasis
Infections and infestations
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Oral Fungal Infection
Infections and infestations
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Oral Herpes
Infections and infestations
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Oral Infection
Infections and infestations
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Otitis Externa
Infections and infestations
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Paronychia
Infections and infestations
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Pharyngotonsillitis
Infections and infestations
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Postoperative Wound Infection
Infections and infestations
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Pulpitis Dental
Infections and infestations
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Rash Pustular
Infections and infestations
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Rhinitis
Infections and infestations
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Sepsis
Infections and infestations
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Severe Acute Respiratory Syndrome
Infections and infestations
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Streptococcal Urinary Tract Infection
Infections and infestations
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Subcutaneous Abscess
Infections and infestations
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected7 at risk
EG003
Tinea Pedis
Infections and infestations
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Tonsillitis
Infections and infestations
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Upper Respiratory Tract Infection
Infections and infestations
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Urinary Tract Infection
Infections and infestations
MedDRA 15.0
Non-systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected7 at risk
EG003
Viral Infection
Infections and infestations
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Viral Upper Respiratory Tract Infection
Infections and infestations
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Vulvovaginal Mycotic Infection
Infections and infestations
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Contrast Media Reaction
Injury, poisoning and procedural complications
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Head Injury
Injury, poisoning and procedural complications
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Incisional Hernia
Injury, poisoning and procedural complications
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Infusion Related Reaction
Injury, poisoning and procedural complications
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Post Procedural Discharge
Injury, poisoning and procedural complications
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Post Procedural Haemorrhage
Injury, poisoning and procedural complications
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Procedural Pain
Injury, poisoning and procedural complications
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Radius Fracture
Injury, poisoning and procedural complications
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Sunburn
Injury, poisoning and procedural complications
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Suture Related Complication
Injury, poisoning and procedural complications
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected7 at risk
EG003
Wound
Injury, poisoning and procedural complications
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Activated Partial Thromboplastin Time
Investigations
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Activated Partial Thromboplastin Time Prolonged
Investigations
MedDRA 15.0
Non-systematic Assessment
EG0005 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Alanine Aminotransferase Increased
Investigations
MedDRA 15.0
Non-systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Aspartate Aminotransferase Increased
Investigations
MedDRA 15.0
Non-systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Blood Alkaline Phosphatase Increased
Investigations
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Blood Bilirubin Increased
Investigations
MedDRA 15.0
Non-systematic Assessment
EG0002 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Blood Glucose Increased
Investigations
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Blood Iron Decreased
Investigations
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Blood Lactate Dehydrogenase Increased
Investigations
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Blood Magnesium Decreased
Investigations
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Blood Pressure Increased
Investigations
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Blood Thyroid Stimulating Hormone Decreased
Investigations
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Blood Thyroid Stimulating Hormone Increased
Investigations
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Body Temperature Increased
Investigations
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
C-Reactive Protein Increased
Investigations
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Creatinine Renal Clearance Decreased
Investigations
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Ejection Fraction Decreased
Investigations
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Electrocardiogram T Wave Inversion
Investigations
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Eosinophil Count Increased
Investigations
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Gamma-Glutamyltransferase Increased
Investigations
MedDRA 15.0
Non-systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Haematocrit Decreased
Investigations
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Haemoglobin Decreased
Investigations
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected7 at risk
EG003
International Normalised Ratio Increased
Investigations
MedDRA 15.0
Non-systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Neutrophil Count Decreased
Investigations
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Neutrophil Count Increased
Investigations
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Platelet Count Increased
Investigations
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Red Blood Cell Count Decreased
Investigations
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Thrombin Time Prolonged
Investigations
MedDRA 15.0
Non-systematic Assessment
EG0002 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Transaminases Increased
Investigations
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Urine Output Decreased
Investigations
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Weight Decreased
Investigations
MedDRA 15.0
Non-systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Weight Increased
Investigations
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
White Blood Cell Count Increased
Investigations
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Cachexia
Metabolism and nutrition disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Decreased Appetite
Metabolism and nutrition disorders
MedDRA 15.0
Non-systematic Assessment
EG0001 events1 affected3 at risk
EG0011 events1 affected3 at risk
EG0023 events3 affected7 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Diabetes Mellitus
Metabolism and nutrition disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Hypercholesterolaemia
Metabolism and nutrition disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Hypermagnesaemia
Metabolism and nutrition disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Hypoalbuminaemia
Metabolism and nutrition disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Hypocalcaemia
Metabolism and nutrition disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Hypoglycaemia
Metabolism and nutrition disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA 15.0
Non-systematic Assessment
EG0005 events1 affected3 at risk
EG0011 events1 affected3 at risk
EG0021 events1 affected7 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Hypophosphataemia
Metabolism and nutrition disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Hypoproteinaemia
Metabolism and nutrition disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Iron Deficiency
Metabolism and nutrition disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Malnutrition
Metabolism and nutrition disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Plasma Protein Metabolism Disorder
Metabolism and nutrition disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Type 2 Diabetes Mellitus
Metabolism and nutrition disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Back Pain
Musculoskeletal and connective tissue disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0012 events1 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Flank Pain
Musculoskeletal and connective tissue disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Groin Pain
Musculoskeletal and connective tissue disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Inguinal Mass
Musculoskeletal and connective tissue disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Joint Swelling
Musculoskeletal and connective tissue disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Mobility Decreased
Musculoskeletal and connective tissue disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Muscle Spasms
Musculoskeletal and connective tissue disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Muscle Twitching
Musculoskeletal and connective tissue disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Muscular Weakness
Musculoskeletal and connective tissue disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Musculoskeletal Chest Pain
Musculoskeletal and connective tissue disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Musculoskeletal Pain
Musculoskeletal and connective tissue disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Osteopenia
Musculoskeletal and connective tissue disorders
MedDRA 15.0
Non-systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Osteoporosis
Musculoskeletal and connective tissue disorders
MedDRA 15.0
Non-systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Pain In Extremity
Musculoskeletal and connective tissue disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected7 at risk
EG003
Soft Tissue Disorder
Musculoskeletal and connective tissue disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Synovitis
Musculoskeletal and connective tissue disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Cholinergic Syndrome
Nervous system disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0022 events1 affected7 at risk
EG003
Diabetic Neuropathy
Nervous system disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0022 events2 affected7 at risk
EG003
Dizziness Postural
Nervous system disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Dysgeusia
Nervous system disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Encephalopathy
Nervous system disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Epilepsy
Nervous system disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Headache
Nervous system disorders
MedDRA 15.0
Non-systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Hepatic Encephalopathy
Nervous system disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Hypoaesthesia
Nervous system disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Hypogeusia
Nervous system disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Lethargy
Nervous system disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Neuropathy Peripheral
Nervous system disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Neurotoxicity
Nervous system disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Peripheral Motor Neuropathy
Nervous system disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Peripheral Sensory Neuropathy
Nervous system disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected7 at risk
EG003
Polyneuropathy
Nervous system disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0022 events2 affected7 at risk
EG003
Radiculitis
Nervous system disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Sciatica
Nervous system disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Speech Disorder
Nervous system disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Toxic Neuropathy
Nervous system disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Tremor
Nervous system disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Visual Field Defect
Nervous system disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Agitation
Psychiatric disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected7 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Confusional State
Psychiatric disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Decreased Interest
Psychiatric disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Depressed Mood
Psychiatric disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Depression
Psychiatric disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Depressive Symptom
Psychiatric disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Emotional Disorder
Psychiatric disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Anuria
Renal and urinary disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Dysuria
Renal and urinary disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Glycosuria
Renal and urinary disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0021 events1 affected7 at risk
EG003
Leukocyturia
Renal and urinary disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Nephrolithiasis
Renal and urinary disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Oliguria
Renal and urinary disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Polyuria
Renal and urinary disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Proteinuria
Renal and urinary disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Renal Colic
Renal and urinary disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Renal Pain
Renal and urinary disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Urethral Obstruction
Renal and urinary disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Urinary Retention
Renal and urinary disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Balanitis
Reproductive system and breast disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Breast Mass
Reproductive system and breast disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected7 at risk
EG003
Breast Pain
Reproductive system and breast disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Haematospermia
Reproductive system and breast disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Pelvic Pain
Reproductive system and breast disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Vulvovaginal Pruritus
Reproductive system and breast disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Asthmatic Crisis
Respiratory, thoracic and mediastinal disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Bronchial Secretion Retention
Respiratory, thoracic and mediastinal disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected7 at risk
EG003
Dysphonia
Respiratory, thoracic and mediastinal disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Dyspnoea Exertional
Respiratory, thoracic and mediastinal disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA 15.0
Non-systematic Assessment
EG0004 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Haemoptysis
Respiratory, thoracic and mediastinal disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Hiccups
Respiratory, thoracic and mediastinal disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Nasal Congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Nasal Dryness
Respiratory, thoracic and mediastinal disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Obstructive Airways Disorder
Respiratory, thoracic and mediastinal disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Oropharyngeal Pain
Respiratory, thoracic and mediastinal disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Productive Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Pulmonary Embolism
Respiratory, thoracic and mediastinal disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Pulmonary Toxicity
Respiratory, thoracic and mediastinal disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Respiratory Disorder
Respiratory, thoracic and mediastinal disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Rhinitis Allergic
Respiratory, thoracic and mediastinal disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Sputum Discoloured
Respiratory, thoracic and mediastinal disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Throat Irritation
Respiratory, thoracic and mediastinal disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Acne
Skin and subcutaneous tissue disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0026 events2 affected7 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
MedDRA 15.0
Non-systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0022 events1 affected7 at risk
EG003
Dermal Cyst
Skin and subcutaneous tissue disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Dermatitis
Skin and subcutaneous tissue disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Dermatitis Acneiform
Skin and subcutaneous tissue disorders
MedDRA 15.0
Non-systematic Assessment
EG0003 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0027 events3 affected7 at risk
EG003
Dermatitis Allergic
Skin and subcutaneous tissue disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Dermatitis Atopic
Skin and subcutaneous tissue disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Drug Eruption
Skin and subcutaneous tissue disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Dry Skin
Skin and subcutaneous tissue disorders
MedDRA 15.0
Non-systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Eczema
Skin and subcutaneous tissue disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0023 events1 affected7 at risk
EG003
Exfoliative Rash
Skin and subcutaneous tissue disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Hyperhidrosis
Skin and subcutaneous tissue disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Hyperkeratosis
Skin and subcutaneous tissue disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Hypertrichosis
Skin and subcutaneous tissue disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Ingrowing Nail
Skin and subcutaneous tissue disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Intertrigo
Skin and subcutaneous tissue disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Nail Disorder
Skin and subcutaneous tissue disorders
MedDRA 15.0
Non-systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Nail Toxicity
Skin and subcutaneous tissue disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Night Sweats
Skin and subcutaneous tissue disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Onychoclasis
Skin and subcutaneous tissue disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected7 at risk
EG003
Palmar-Plantar Erythrodysaesthesia Syndrome
Skin and subcutaneous tissue disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Panniculitis
Skin and subcutaneous tissue disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Penile Ulceration
Skin and subcutaneous tissue disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Petechiae
Skin and subcutaneous tissue disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Pigmentation Disorder
Skin and subcutaneous tissue disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Prurigo
Skin and subcutaneous tissue disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 15.0
Non-systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0022 events1 affected7 at risk
EG003
Pruritus Generalised
Skin and subcutaneous tissue disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 15.0
Non-systematic Assessment
EG0004 events1 affected3 at risk
EG0015 events3 affected3 at risk
EG0023 events1 affected7 at risk
EG003
Rash Generalised
Skin and subcutaneous tissue disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Rash Maculo-Papular
Skin and subcutaneous tissue disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Rash Papular
Skin and subcutaneous tissue disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Rash Pruritic
Skin and subcutaneous tissue disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Rash Vesicular
Skin and subcutaneous tissue disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Skin Chapped
Skin and subcutaneous tissue disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Skin Erosion
Skin and subcutaneous tissue disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Skin Exfoliation
Skin and subcutaneous tissue disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Skin Fissures
Skin and subcutaneous tissue disorders
MedDRA 15.0
Non-systematic Assessment
EG0002 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Skin Irritation
Skin and subcutaneous tissue disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Skin Ulcer
Skin and subcutaneous tissue disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Subcutaneous Nodule
Skin and subcutaneous tissue disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Toxic Skin Eruption
Skin and subcutaneous tissue disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Aortic Thrombosis
Vascular disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Circulatory Collapse
Vascular disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Deep Vein Thrombosis
Vascular disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Flushing
Vascular disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Haematoma
Vascular disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Hypertension
Vascular disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected7 at risk
EG003
Hypotension
Vascular disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Orthostatic Hypotension
Vascular disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Pallor
Vascular disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Peripheral Ischaemia
Vascular disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Phlebitis
Vascular disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Thrombophlebitis
Vascular disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Thrombosis
Vascular disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Venous Insufficiency
Vascular disorders
MedDRA 15.0
Non-systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Venous Thrombosis
Vascular disorders
MedDRA 15.0
Non-systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected7 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
Not provided
Point of Contact
Title
Organization
Phone
Extension
Email
Merck KGaA Communication Center
Merck KGaA
+49-6151-72-5200
service@merckgroup.com
ID
Term
D015179
Colorectal Neoplasms
Ancestor Terms
ID
Term
D007414
Intestinal Neoplasms
D005770
Gastrointestinal Neoplasms
D004067
Digestive System Neoplasms
D009371
Neoplasms by Site
D009369
Neoplasms
D004066
Digestive System Diseases
D005767
Gastrointestinal Diseases
D003108
Colonic Diseases
D007410
Intestinal Diseases
D012002
Rectal Diseases
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
C000592911
Abituzumab
D000068818
Cetuximab
D000077146
Irinotecan
Ancestor Terms
ID
Term
D061067
Antibodies, Monoclonal, Humanized
D000911
Antibodies, Monoclonal
D000906
Antibodies
D007136
Immunoglobulins
D007162
Immunoproteins
D001798
Blood Proteins
D011506
Proteins
D000602
Amino Acids, Peptides, and Proteins
D012712
Serum Globulins
D005916
Globulins
D002166
Camptothecin
D000470
Alkaloids
D006571
Heterocyclic Compounds
Browse Leaves
Not provided
Browse Branches
Not provided
63.0
± 7.2
BG00456.2± 12.11
BG00558.9± 12.18
BG00659.9± 10.63
BG00758.5± 11.49
4
BG0032
BG00427
BG00536
BG00623
BG00795
Male
BG0001
BG0012
BG0023
BG0031
BG00445
BG00537
BG00648
BG007137
3
0
OG001
EMD 525797 500 mg + SoC
Cetuximab was administered at a dose of 400 mg/m^2 on Day 1 Cycle 1 (Week 1) as IV infusion for 2 hours, and then at a dose of 250 mg/m^2 on Day 8 (Week 2) once weekly; followed by EMD 525797 at a target dose of 500 mg as a 1-hour IV infusion for every 2 weeks, followed by Irinotecan at a dose of 180 mg/m^2 as IV infusion for 30-90 minutes for every 2 weeks until radiographically documented PD (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator's assessment), or withdrawal of consent.
OG002
EMD 525797 1000 mg + SoC
Cetuximab was administered at a dose of 400 mg/m^2 on Day 1 Cycle 1 (Week 1) as IV infusion for 2 hours, and then at a dose of 250 mg/m^2 on Day 8 (Week 2) once weekly; followed by EMD 525797 at a target dose of 1000 mg as a 1-hour IV infusion for every 2 weeks, followed by Irinotecan at a dose of 180 mg/m^2 as IV infusion for 30-90 minutes for every 2 weeks until radio-graphically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator's assessment), or withdrawal of consent.
Units
Counts
Participants
OG00072
OG00173
OG00271
Title
Denominators
Categories
Title
Measurements
OG0005.6(4.2 to 6.9)
OG0015.4(4.1 to 6.0)
OG0025.6(4.1 to 6.9)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Cox Proportional Hazard
1.13
2-Sided
95
0.78
1.64
No
Superiority or Other
OG000
OG002
Cox Proportional Hazard
1.11
2-Sided
95
0.77
1.61
No
Superiority or Other
OG002
EMD 525797 1000 mg + SoC
Cetuximab was administered at a dose of 400 mg/m^2 on Day 1 Cycle 1 (Week 1) as IV infusion for 2 hours, and then at a dose of 250 mg/m^2 on Day 8 (Week 2) once weekly; followed by EMD 525797 at a target dose of 1000 mg as a 1-hour IV infusion for every 2 weeks, followed by Irinotecan at a dose of 180 mg/m^2 as IV infusion for 30-90 minutes for every 2 weeks until radio-graphically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator's assessment), or withdrawal of consent.
Units
Counts
Participants
OG00072
OG00173
OG00271
Title
Denominators
Categories
Title
Measurements
OG00011.6(9.8 to 15.7)
OG00115.0(10.9 to 19.2)
OG00214.4(9.8 to 19.3)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Cox Proportional Hazard
0.83
2-Sided
95
0.54
1.28
No
Superiority or Other
OG000
OG002
Cox Proportional Hazard
0.80
2-Sided
95
0.52
1.25
No
Superiority or Other
Cetuximab was administered at a dose of 400 mg/m^2 on Day 1 Cycle 1 (Week 1) as IV infusion for 2 hours, and then at a dose of 250 mg/m^2 on Day 8 (Week 2) once weekly; followed by EMD 525797 at a target dose of 500 mg as a 1-hour IV infusion for every 2 weeks, followed by Irinotecan at a dose of 180 mg/m^2 as IV infusion for 30-90 minutes for every 2 weeks until radiographically documented PD (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator's assessment), or withdrawal of consent.
OG002
EMD 525797 1000 mg + SoC
Cetuximab was administered at a dose of 400 mg/m^2 on Day 1 Cycle 1 (Week 1) as IV infusion for 2 hours, and then at a dose of 250 mg/m^2 on Day 8 (Week 2) once weekly; followed by EMD 525797 at a target dose of 1000 mg as a 1-hour IV infusion for every 2 weeks, followed by Irinotecan at a dose of 180 mg/m^2 as IV infusion for 30-90 minutes for every 2 weeks until radio-graphically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator's assessment), or withdrawal of consent.
Units
Counts
Participants
OG00072
OG00173
OG00271
Title
Denominators
Categories
Title
Measurements
OG0005.8(4.4 to 7.2)
OG0015.6(4.2 to 8.3)
OG0026.5(4.2 to 7.1)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Cox Proportional Hazard
1.11
2-Sided
95
0.75
1.65
No
Superiority or Other
OG000
OG002
Cox Proportional Hazard
1.11
2-Sided
95
0.75
1.65
No
Superiority or Other
OG002
EMD 525797 1000 mg + SoC
Cetuximab was administered at a dose of 400 mg/m^2 on Day 1 Cycle 1 (Week 1) as IV infusion for 2 hours, and then at a dose of 250 mg/m^2 on Day 8 (Week 2) once weekly; followed by EMD 525797 at a target dose of 1000 mg as a 1-hour IV infusion for every 2 weeks, followed by Irinotecan at a dose of 180 mg/m^2 as IV infusion for 30-90 minutes for every 2 weeks until radio-graphically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator's assessment), or withdrawal of consent.
Units
Counts
Participants
OG00072
OG00173
OG00271
Title
Denominators
Categories
CR
Title
Measurements
OG0002
OG0011
OG0020
PR
Title
Measurements
OG00017
OG00119
OG00218
OG002
EMD 525797 1000 mg + SoC
Cetuximab was administered at a dose of 400 mg/m^2 on Day 1 Cycle 1 (Week 1) as IV infusion for 2 hours, and then at a dose of 250 mg/m^2 on Day 8 (Week 2) once weekly; followed by EMD 525797 at a target dose of 1000 mg as a 1-hour IV infusion for every 2 weeks, followed by Irinotecan at a dose of 180 mg/m^2 as IV infusion for 30-90 minutes for every 2 weeks until radio-graphically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator's assessment), or withdrawal of consent.