Study to Evaluate the Safety and Tolerability of Andecali... | NCT01803282 | Trialant
NCT01803282
Sponsor
Gilead Sciences
Status
Completed
Last Update Posted
Jun 2, 2020Actual
Enrollment
236Actual
Phase
Phase 1
Conditions
Pancreatic Cancer
Non-small Cell Lung Cancer
Esophagogastric Cancer
Colorectal Cancer
Breast Cancer
Interventions
Andecaliximab
Gemcitabine
Nab-paclitaxel
Carboplatin
Pemetrexed
Leucovorin
Oxaliplatin
5-FU
Bevacizumab
Irinotecan
Paclitaxel
Countries
United States
Protocol Section
Identification Module
NCT ID
NCT01803282
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
GS-US-296-0101
Secondary IDs
Not provided
Brief Title
Study to Evaluate the Safety and Tolerability of Andecaliximab as Monotherapy and in Combination With Chemotherapy in Participants With Advanced Solid Tumors
Official Title
A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GS-5745 as Monotherapy and in Combination With Chemotherapy in Subjects With Advanced Solid Tumors
Acronym
Not provided
Organization
Gilead SciencesINDUSTRY
Status Module
Record Verification Date
May 2020
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Mar 29, 2013Actual
Primary Completion Date
Apr 23, 2019Actual
Completion Date
Apr 23, 2019Actual
First Submitted Date
Feb 27, 2013
First Submission Date that Met QC Criteria
Feb 28, 2013
First Posted Date
Mar 4, 2013Estimated
Results Waived
Not provided
Results First Submitted Date
Apr 20, 2020
Results First Submitted that Met QC Criteria
Apr 20, 2020
Results First Posted Date
May 4, 2020Actual
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
May 20, 2020
Last Update Posted Date
Jun 2, 2020Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Gilead SciencesINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The primary objective of the study is to determine the maximum tolerated dose of andecaliximab monotherapy and to evaluate the safety and tolerability of andecaliximab (formerly GS-5745) alone and in combination with chemotherapy.
The study consists of 2 parts (Parts A and B). Participants can only qualify for and participate in 1 part.
Part A is a sequential dose escalation to determine the maximum tolerated dose of andecaliximab in participants with advanced solid tumors that are refractory to or intolerant to standard therapy or for which no standard therapy exists. In Part A, participants will receive andecaliximab only.
Part B is a dose expansion to obtain additional safety and tolerability data for andecaliximab in participants with advanced pancreatic adenocarcinoma, lung adenocarcinoma, lung squamous cell carcinoma, esophagogastric adenocarcinoma, colorectal cancer, or breast cancer. In Part B, participants will receive andecaliximab in combination with standard-of-care chemotherapy.
Detailed Description
Not provided
Conditions Module
Conditions
Pancreatic Cancer
Non-small Cell Lung Cancer
Esophagogastric Cancer
Colorectal Cancer
Breast Cancer
Keywords
Solid Tumor
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 1
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
236Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Part A: ADX 200 mg
Experimental
Participants with advanced solid tumors who fail or are intolerant to standard therapy or for whom no standard therapy exists, will receive 200 mg ADX as monotherapy via IV infusion (approximately 30 minutes) every 2 weeks until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
Drug: Andecaliximab
Part A: ADX 600 mg
Experimental
Participants with advanced solid tumors who fail or are intolerant to standard therapy or for whom no standard therapy exists, will receive 600 mg ADX as monotherapy via IV infusion (approximately 30 minutes) every 2 weeks until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
Drug: Andecaliximab
Part A: ADX 1800 mg
Experimental
Participants with advanced solid tumors who fail or are intolerant to standard therapy or for whom no standard therapy exists, will receive 1800 mg ADX as monotherapy via IV infusion (approximately 30 minutes) every 2 weeks until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug
Drug: Andecaliximab
Part B: PAC, ADX 800 mg
Experimental
Participants with PAC will receive ADX 800 mg every 2 weeks via IV infusion in addition to the 28-day cycle chemotherapy (gemcitabine and nab paclitaxel, on Days 1, 8, and 15) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Andecaliximab
Drug
Administered intravenous infusion
Part A: ADX 1800 mg
Part A: ADX 200 mg
Part A: ADX 600 mg
Part B: BRCA, ADX 800 mg
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Percentage of Participants Experiencing Treatment-Emergent Adverse Events
Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days
Percentage of Participants Experiencing Laboratory Abnormalities
Treatment-emergent laboratory abnormalities were defined as values that increase at least one toxicity grade from baseline. Participants with any laboratory abnormality were reported.
Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days
Secondary Outcomes
Not provided
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Key Inclusion Criteria:
Part A: histologically or cytologically confirmed advanced malignant solid tumor that is refractory to or intolerant of standard therapy or for which no standard therapy is available
Part B: Pancreatic Adenocarcinoma
Presence of histologically confirmed inoperable locally advanced or metastatic pancreatic adenocarcinoma
Part B: NSCLC
Stage IIIB with malignant pleural effusion/pleural seeding or stage IV histologically confirmed NSCLC
Absence of known epidermal growth factor receptor (EGFR) mutation
Absence of known translocation or inversion events involving the ALK gene locus (resulting in EML4-ALK fusion)
Part B: Esophagogastric Adenocarcinoma:
Histologically confirmed inoperable advanced gastric adenocarcinoma (including adenocarcinoma of the gastrooesophageal junction) or relapsed gastric adenocarcinoma
Human epidermal growth factor receptor 2 (HER2)-negative tumor (primary tumor or metastatic lesion)
Part B: First-Line Colorectal Cancer
Histologically confirmed inoperable advanced adenocarcinoma of the colon or rectum
Radiographically measureable disease
No prior cytotoxic chemotherapy to treat their metastatic disease
Part B: Second-Line Colorectal Cancer
Histologically confirmed inoperable advanced adenocarcinoma of the colon or rectum
Radiographically measureable disease
Received first-line combination therapy containing oxaliplatin and fluoropyrimidine with or without bevacizumab for metastatic disease with documented evidence of disease progression during or after treatment completion
Part B: Breast Cancer
Histologically or cytologically confirmed metastatic breast cancer
Radiographically measureable disease
Previous hormonal therapy for metastatic breast cancer or cytotoxic adjuvant chemotherapy is allowed
Treatment with weekly single-agent paclitaxel is appropriate in the opinion of the treating physician
HER-2 negative tumor (primary tumor or metastatic lesion)
Adequate organ function
Key Exclusion Criteria:
Pregnant or lactating
Individuals with known central nervous system (CNS) metastases, unless metastases are treated and stable and the individual does not require systemic steroids
Myocardial infarction, symptomatic congestive heart failure, unstable angina, or serious uncontrolled cardiac arrhythmia within the last 6 months
Anti-tumor therapy within 28 days of study drug dosing; concurrent use of hormone therapy for breast or prostate cancer is permitted
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Shah MA, Starodub A, Sharma S, Berlin J, Patel M, Wainberg ZA, Chaves J, Gordon M, Windsor K, Brachmann CB, Huang X, Vosganian G, Maltzman JD, Smith V, Silverman JA, Lenz HJ, Bendell JC. Andecaliximab/GS-5745 Alone and Combined with mFOLFOX6 in Advanced Gastric and Gastroesophageal Junction Adenocarcinoma: Results from a Phase I Study. Clin Cancer Res. 2018 Aug 15;24(16):3829-3837. doi: 10.1158/1078-0432.CCR-17-2469. Epub 2018 Apr 24.
Result
Lenz H, Park H, Shah MA, Berlin JD, Bruetman D, Chaves J, et al. Results of a phase I study of andecaliximab in combination with mFOLFOX6 and bevacizumab in patients with previously untreated metastatic colorectal cancer. Annals of Oncology (2018) 29 (suppl_8): viii150-viii204
Result
Wainberg Z, Bendell J, Lenz H, Baron A, Berlin J, Bessudo A, et al. Results from a phase I study of andecaliximab in combination with FOLFIRI and bevacizumab in patients with second line metastatic colorectal cancer. Journal of Clinical Oncology 36, no. 15_suppl (May 20, 2018) 3578-3578
See Also Links
Not provided
Available IPD Information
Not provided
IPD Sharing Statement Module
Plan to Share IPD
No
Description
Not provided
Types
Not provided
Time Frame
Not provided
Access Criteria
Not provided
URL
Not provided
Results Section
Participant Flow Module
Pre-assignment Details
280 participants were screened.
Recruitment Details
Participants were enrolled at study sites in the United States. The first participant was screened on 29 March 2013. The last study visit occurred on 23 April 2019.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Part A: ADX 200 mg
Participants with advanced solid tumors who had failed or were intolerant to standard therapy or for whom no standard therapy existed, received 200 mg andecaliximab (ADX) as monotherapy via intravenous (IV) infusion (approximately 30 minutes) every 2 weeks until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
Aug 1, 2016
Mar 19, 2020
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Non-Randomized
Intervention Model
Sequential 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: Andecaliximab
Drug: Gemcitabine
Drug: Nab-paclitaxel
Part B: LAC, ADX 1200 mg
Experimental
Participants with lung adenocarcinoma (LAC) will receive ADX 1200 mg every 3 weeks via IV infusion in addition to the 21-day cycle chemotherapy (carboplatin and pemetrexed, on Day 1) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
Drug: Andecaliximab
Drug: Carboplatin
Drug: Pemetrexed
Part B: LSC, ADX 1200 mg
Experimental
Participants with lung squamous cell carcinoma (LSC) will receive ADX 1200 mg every 3 weeks via IV infusion in addition to the 21-day cycle chemotherapy (carboplatin and paclitaxel, on Day 1) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
Drug: Andecaliximab
Drug: Carboplatin
Drug: Paclitaxel
Part B: EGC, ADX 800 mg
Experimental
Participants with esophagogastric adenocarcinoma (EGC) will receive ADX 800 mg every 2 weeks via IV infusion in addition to the 28-day cycle chemotherapy (leucovorin+oxaliplatin+5-fluorouracil {5-FU} [mFOLFOX6], on Days 1 and 15) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
Drug: Andecaliximab
Drug: Leucovorin
Drug: Oxaliplatin
Drug: 5-FU
Part B: FL CRC, ADX 800 mg+BEV 5 mg/kg
Experimental
Participants with colorectal cancer (CRC) will receive first-line (FL) treatment with ADX 800 mg every 2 weeks via IV infusion in addition to the 28-day cycle chemotherapy (mFOLFOX6 and bevacizumab 5 mg/kg, on Days 1 and 15) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
Drug: Andecaliximab
Drug: Leucovorin
Drug: Oxaliplatin
Drug: 5-FU
Drug: Bevacizumab
Part B: FL CRC, ADX 800 mg+BEV 10 mg/kg
Experimental
Participants with CRC will receive FL treatment with ADX 800 mg every 2 weeks via IV infusion in addition to the 28-day cycle chemotherapy (mFOLFOX6 and bevacizumab 10 mg/kg, on Days 1 and 15) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
Drug: Andecaliximab
Drug: Leucovorin
Drug: Oxaliplatin
Drug: 5-FU
Drug: Bevacizumab
Part B: SL CRC, ADX 800 mg+BEV 5 mg/kg
Experimental
Participants with CRC will receive second-line (SL) treatment with ADX 800 mg every 2 weeks via IV infusion in addition to the 28-day cycle chemotherapy (leucovorin+irinotecan+5-FU [FOLFIRI] and bevacizumab 5 mg/kg, on Days 1 and 15) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
Drug: Andecaliximab
Drug: Leucovorin
Drug: 5-FU
Drug: Bevacizumab
Drug: Irinotecan
Part B: SL CRC, ADX 800 mg+BEV 10 mg/kg
Experimental
Participants with CRC will receive SL treatment with ADX 800 mg every 2 weeks via IV infusion in addition to the 28-day cycle chemotherapy (FOLFIRI and bevacizumab 10 mg/kg, on Days 1 and 15) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
Drug: Andecaliximab
Drug: Leucovorin
Drug: 5-FU
Drug: Bevacizumab
Drug: Irinotecan
Part B: BRCA, ADX 800 mg
Experimental
Participants with breast cancer (BRCA) will receive ADX 800 mg every 2 weeks via IV infusion in addition to the 28-day cycle chemotherapy (paclitaxel, on Days 1, 8, and 15) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
Drug: Andecaliximab
Drug: Paclitaxel
Part B: EGC, ADX 800 mg
Part B: FL CRC, ADX 800 mg+BEV 10 mg/kg
Part B: FL CRC, ADX 800 mg+BEV 5 mg/kg
Part B: LAC, ADX 1200 mg
Part B: LSC, ADX 1200 mg
Part B: PAC, ADX 800 mg
Part B: SL CRC, ADX 800 mg+BEV 10 mg/kg
Part B: SL CRC, ADX 800 mg+BEV 5 mg/kg
GS-5745
Gemcitabine
Drug
Administered intravenously on Days 1, 8, and 15 of each 28-day treatment cycle
Part B: PAC, ADX 800 mg
Nab-paclitaxel
Drug
Administered intravenously on Days 1, 8, and 15 of each 28-day treatment cycle
Part B: PAC, ADX 800 mg
Carboplatin
Drug
Administered intravenously on Day 1 of each 21-day treatment cycle
Part B: LAC, ADX 1200 mg
Part B: LSC, ADX 1200 mg
Pemetrexed
Drug
Administered intravenously on Day 1 of each 21-day treatment cycle
Part B: LAC, ADX 1200 mg
Leucovorin
Drug
Administered intravenously on Days 1 and 15 of each 28-day treatment cycle
Part B: EGC, ADX 800 mg
Part B: FL CRC, ADX 800 mg+BEV 10 mg/kg
Part B: FL CRC, ADX 800 mg+BEV 5 mg/kg
Part B: SL CRC, ADX 800 mg+BEV 10 mg/kg
Part B: SL CRC, ADX 800 mg+BEV 5 mg/kg
Oxaliplatin
Drug
Administered intravenously on Days 1 and 15 of each 28-day treatment cycle
Part B: EGC, ADX 800 mg
Part B: FL CRC, ADX 800 mg+BEV 10 mg/kg
Part B: FL CRC, ADX 800 mg+BEV 5 mg/kg
5-FU
Drug
Administered intravenously on Days 1 and 15 of each 28-day treatment cycle
Part B: EGC, ADX 800 mg
Part B: FL CRC, ADX 800 mg+BEV 10 mg/kg
Part B: FL CRC, ADX 800 mg+BEV 5 mg/kg
Part B: SL CRC, ADX 800 mg+BEV 10 mg/kg
Part B: SL CRC, ADX 800 mg+BEV 5 mg/kg
Bevacizumab
Drug
Administered intravenously on Days 1 and 15 of each 28-day treatment cycle
Part B: FL CRC, ADX 800 mg+BEV 10 mg/kg
Part B: FL CRC, ADX 800 mg+BEV 5 mg/kg
Part B: SL CRC, ADX 800 mg+BEV 10 mg/kg
Part B: SL CRC, ADX 800 mg+BEV 5 mg/kg
Irinotecan
Drug
Administered intravenously on Days 1 and 15 of each 28-day treatment cycle
Part B: SL CRC, ADX 800 mg+BEV 10 mg/kg
Part B: SL CRC, ADX 800 mg+BEV 5 mg/kg
Paclitaxel
Drug
Administered intravenously on Days 1, 8 and 15 of each 28-day treatment cycle (Breast cancer) or on Day 1 of each 21-day treatment cycle (NSCLC)
Part B: BRCA, ADX 800 mg
Part B: LSC, ADX 1200 mg
Scottsdale
Arizona
85258
United States
Comprehensive Blood and Cancer Center
Bakersfield
California
93309
United States
San Diego Pacific Oncology and Hematology Associates, Inc.
Encinitas
California
92024
United States
University of Southern California (USC)
Los Angeles
California
90033
United States
California Pacific Medical Center
San Francisco
California
94115
United States
UCLA Medical Center
Santa Monica
California
90404
United States
Florida Cancer Specialists
Sarasota
Florida
34232
United States
Parkview Research Center
Fort Wayne
Indiana
46845
United States
Indiana University Health Goshen Center for Cancer Care
Goshen
Indiana
46526
United States
Washington University School of Medicine
St Louis
Missouri
63110
United States
Cornell University
New York
New York
10021
United States
Greenville Health System, Institute for Translational Oncology Research
Greenville
South Carolina
29605
United States
Sarah Cannon Research Institute
Nashville
Tennessee
37203
United States
Vanderbilt
Nashville
Tennessee
37232
United States
UT Southwestern
Dallas
Texas
75390
United States
University of Utah
Salt Lake City
Utah
84112
United States
Northwest Medical Specialties
Tacoma
Washington
98405
United States
Result
Bendell J, Patel M, Brachmann C, Huang X, Maltzman J, Smith V, et al. Updated results of a phase 1 study combining the matrix metalloproteinase 9 inhibitor GS-5745 with gemcitabine and nab-paclitaxel in patients with advanced pancreatic cancer [Abstract 363] 2017 American Society of Clinical Oncology Gastrointestinal Cancers Symposium
Result
Brachmann C, Zhang Y, Zavodovskaya M, Hu J, Maltzman J, Smith V, et al. Evaluating collagen neoepitopes as pharmacodynamic biomarkers of GS-5745, an MMP9 inhibitor, in advanced gastric cancer [Abstract 58] 2017 American Society of Clinical Oncology Gastrointestinal Cancers Symposium
Result
Juric V, Mikels-Vigdal A, O'Sullivan C, Greenstein A, Stefanutti E, Barry-Hamilton V, et al. Inhibition of MMP9 improves anti-tumor immunity by changing the tumor microenvironment to promote T cell trafficking and activation. [Abstract 653/27]. 2017 American Association for Cancer Research Annual Meeting 110th Annual Meeting; 2017 01 April-05 April; Washington, DC
Result
Zavodovskaya M, Zhang Y, Xiao Y, Maltzman J, Smith V, Brachmann C, et al. Exploratory Serum Biomarker Analysis in Gastric Cancer Patients Treated with GS-5745, an MMP9 Inhibitor, in Combination with mFOLFOX6 [Abstract 4463/24]. 2017 American Association for Cancer Research Annual Meeting 110th Annual Meeting; 2017 01 April-05 April; Washington, DC
Result
Bendell J, Huang X, Smith V, Maltzman J, Starodub A. Results of a phase I study of GS-5745 in combination with gemcitabine and nab-paclitaxel in patients (pts) with advanced pancreatic cancer [abstract e15683] 2016. J Clin Oncol 34 supplemental
Result
Shah M, Starodub A, Wainberg Z, Smith V, Maltzman J, Bendell J. Results of a phase I study of GS-5745 in combination with mFOLFOX in patients with advanced unresectable gastric / GE junction tumors [Poster 4033]. American Society of Clinical Oncology (ASCO) 52nd Annual Meeting; 2016 03 June- 07 June; Chicago, IL
Result
Bendell J, Starodub A, Sharma S, Wainberg Z, Shah M, Thai D. Phase I Study of GS-5745 Alone and in Combination with Chemotherapy in Patients with Advanced Solid Tumors [Poster 4030]. American Society of Clinical Oncology (ASCO) 51st Annual Meeting; 2015 29 May-02 June; Chicago, IL
Marshall DC, Lyman SK, McCauley S, Kovalenko M, Spangler R, Liu C, Lee M, O'Sullivan C, Barry-Hamilton V, Ghermazien H, Mikels-Vigdal A, Garcia CA, Jorgensen B, Velayo AC, Wang R, Adamkewicz JI, Smith V. Selective Allosteric Inhibition of MMP9 Is Efficacious in Preclinical Models of Ulcerative Colitis and Colorectal Cancer. PLoS One. 2015 May 11;10(5):e0127063. doi: 10.1371/journal.pone.0127063. eCollection 2015.
FG001
Part A: ADX 600 mg
Participants with advanced solid tumors who had failed or were intolerant to standard therapy or for whom no standard therapy existed, received 600 mg ADX as monotherapy via IV infusion (approximately 30 minutes) every 2 weeks until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
FG002
Part A: ADX 1800 mg
Participants with advanced solid tumors who had failed or were intolerant to standard therapy or for whom no standard therapy existed, received 1800 mg ADX as monotherapy via IV infusion (approximately 30 minutes) every 2 weeks until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
FG003
Part B: PAC, ADX 800 mg
Participants with pancreatic adenocarcinoma (PAC) received ADX 800 mg every 2 weeks via IV infusion in addition to the 28-day cycle chemotherapy (gemcitabine and nab paclitaxel, on Days 1, 8, and 15) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
FG004
Part B: LAC, ADX 1200 mg
Participants with lung adenocarcinoma (LAC) received ADX 1200 mg every 3 weeks via IV infusion in addition to the 21-day cycle chemotherapy (carboplatin and pemetrexed, on Day 1) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
FG005
Part B: LSC, ADX 1200 mg
Participants with lung squamous cell carcinoma (LSC) received ADX 1200 mg every 3 weeks via IV infusion in addition to the 21-day cycle chemotherapy (carboplatin and paclitaxel, on Day 1) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
FG006
Part B: EGC, ADX 800 mg
Participants with esophagogastric adenocarcinoma (EGC) received ADX 800 mg every 2 weeks via IV infusion in addition to the 28-day cycle chemotherapy (leucovorin+oxaliplatin+5-fluorouracil {5-FU} [mFOLFOX6], on Days 1 and 15) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
FG007
Part B: FL CRC, ADX 800 mg+BEV 5 mg/kg
Participants with colorectal cancer (CRC) received first-line (FL) treatment with ADX 800 mg every 2 weeks via IV infusion in addition to the 28-day cycle chemotherapy (mFOLFOX6 and bevacizumab 5 mg/kg, on Days 1 and 15) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
FG008
Part B: FL CRC, ADX 800 mg+BEV 10 mg/kg
Participants with CRC received FL treatment with ADX 800 mg every 2 weeks via IV infusion in addition to the 28-day cycle chemotherapy (mFOLFOX6 and bevacizumab 10 mg/kg, on Days 1 and 15) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
FG009
Part B: SL CRC, ADX 800 mg+BEV 5 mg/kg
Participants with CRC received second-line (SL) treatment with ADX 800 mg every 2 weeks via IV infusion in addition to the 28-day cycle chemotherapy (leucovorin+irinotecan+5-FU [FOLFIRI] and bevacizumab 5 mg/kg, on Days 1 and 15) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
FG010
Part B: SL CRC, ADX 800 mg+BEV 10 mg/kg
Participants with CRC received SL treatment with ADX 800 mg every 2 weeks via IV infusion in addition to the 28-day cycle chemotherapy (FOLFIRI and bevacizumab 10 mg/kg, on Days 1 and 15) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
FG011
Part B: BRCA, ADX 800 mg
Participants with breast cancer (BRCA) received ADX 800 mg every 2 weeks via IV infusion in addition to the 28-day cycle chemotherapy (paclitaxel, on Days 1, 8, and 15) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
FG0004 subjects
FG0013 subjects
FG0026 subjects
FG00336 subjects
FG00411 subjects
FG00510 subjects
FG00641 subjects
FG00746 subjects
FG00811 subjects
FG00945 subjects
FG0108 subjects
FG01115 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
NOT COMPLETED
FG0004 subjects
FG0013 subjects
FG0026 subjects
FG00336 subjects
FG00411 subjects
FG00510 subjects
FG00641 subjects
FG00746 subjects
FG00811 subjects
FG00945 subjects
FG0108 subjects
FG01115 subjects
Type
Comment
Reasons
Progressive Disease
FG0004 subjects
FG0013 subjects
FG0026 subjects
FG00322 subjects
FG0045 subjects
FG0058 subjects
FG00623 subjects
FG00724 subjects
FG0083 subjects
FG00929 subjects
FG0106 subjects
FG01111 subjects
Death
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Withdrew Consent
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0036 subjects
FG004
Investigator's Discretion
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0037 subjects
FG004
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Non-Compliance with Study Drug
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG004
Unknown Reason
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Specified Criteria for Withdrawal
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Enrolled but Never Treated
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Part A: ADX 200 mg
Participants with advanced solid tumors who had failed or were intolerant to standard therapy or for whom no standard therapy existed, received 200 mg ADX as monotherapy via IV infusion (approximately 30 minutes) every 2 weeks until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
BG001
Part A: ADX 600 mg
Participants with advanced solid tumors who had failed or were intolerant to standard therapy or for whom no standard therapy existed, received 600 mg ADX as monotherapy via IV infusion (approximately 30 minutes) every 2 weeks until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
BG002
Part A: ADX 1800 mg
Participants with advanced solid tumors who had failed or were intolerant to standard therapy or for whom no standard therapy existed, received 1800 mg ADX as monotherapy via IV infusion (approximately 30 minutes) every 2 weeks until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
BG003
Part B: PAC, ADX 800 mg
Participants with PAC received ADX 800 mg every 2 weeks via IV infusion in addition to the 28-day cycle chemotherapy (gemcitabine and nab paclitaxel, on Days 1, 8, and 15) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
BG004
Part B: LAC, ADX 1200 mg
Participants with LAC received ADX 1200 mg every 3 weeks via IV infusion in addition to the 21-day cycle chemotherapy (carboplatin and pemetrexed, on Day 1) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
BG005
Part B: LSC, ADX 1200 mg
Participants with LSC received ADX 1200 mg every 3 weeks via IV infusion in addition to the 21-day cycle chemotherapy (carboplatin and paclitaxel, on Day 1) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
BG006
Part B: EGC, ADX 800 mg
Participants with EGC received ADX 800 mg every 2 weeks via IV infusion in addition to the 28-day cycle chemotherapy (mFOLFOX6, on Days 1 and 15) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
BG007
Part B: FL CRC, ADX 800 mg+BEV 5 mg/kg
Participants with CRC received FL treatment with ADX 800 mg every 2 weeks via IV infusion in addition to the 28-day cycle chemotherapy (mFOLFOX6 and bevacizumab 5 mg/kg, on Days 1 and 15) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
BG008
Part B: FL CRC, ADX 800 mg+BEV 10 mg/kg
Participants with CRC received FL treatment with ADX 800 mg every 2 weeks via IV infusion in addition to the 28-day cycle chemotherapy (mFOLFOX6 and bevacizumab 10 mg/kg, on Days 1 and 15) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
BG009
Part B: SL CRC, ADX 800 mg+BEV 5 mg/kg
Participants with CRC received SL treatment with ADX 800 mg every 2 weeks via IV infusion in addition to the 28-day cycle chemotherapy (FOLFIRI and bevacizumab 5 mg/kg, on Days 1 and 15) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
BG010
Part B: SL CRC, ADX 800 mg+BEV 10 mg/kg
Participants with CRC received SL treatment with ADX 800 mg every 2 weeks via IV infusion in addition to the 28-day cycle chemotherapy (FOLFIRI and bevacizumab 10 mg/kg, on Days 1 and 15) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
BG011
Part B: BRCA, ADX 800 mg
Participants with BRCA received ADX 800 mg every 2 weeks via IV infusion in addition to the 28-day cycle chemotherapy (paclitaxel, on Days 1, 8, and 15) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
BG012
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0004
BG0013
BG0026
BG00336
BG00410
BG00510
BG00640
BG00745
BG00811
BG00944
BG0108
BG01115
BG012232
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Customized
Count of Participants
Participants
No
Title
Denominators
Categories
Age
Title
Measurements
< 65 years
BG0002
BG0010
BG0024
BG003
Sex: Female, Male
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
Female
BG0001
BG0010
BG002
Race/Ethnicity, Customized
Count of Participants
Participants
No
Title
Denominators
Categories
Ethnicity
Title
Measurements
Hispanic or Latino
BG0000
BG0010
BG002
Race/Ethnicity, Customized
Count of Participants
Participants
No
Title
Denominators
Categories
Race
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Percentage of Participants Experiencing Treatment-Emergent Adverse Events
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
Posted
Number
percentage of participants
Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days
ID
Title
Description
OG000
Part A: ADX 200 mg
Participants with advanced solid tumors who had failed or were intolerant to standard therapy or for whom no standard therapy existed, received 200 mg ADX as monotherapy via IV infusion (approximately 30 minutes) every 2 weeks until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
OG001
Part A: ADX 600 mg
Participants with advanced solid tumors who had failed or were intolerant to standard therapy or for whom no standard therapy existed, received 600 mg ADX as monotherapy via IV infusion (approximately 30 minutes) every 2 weeks until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
OG002
Part A: ADX 1800 mg
Participants with advanced solid tumors who had failed or were intolerant to standard therapy or for whom no standard therapy existed, received 1800 mg ADX as monotherapy via IV infusion (approximately 30 minutes) every 2 weeks until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
OG003
Part B: PAC, ADX 800 mg
Participants with PAC received ADX 800 mg every 2 weeks via IV infusion in addition to the 28-day cycle chemotherapy (gemcitabine and nab paclitaxel, on Days 1, 8, and 15) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
OG004
Part B: LAC, ADX 1200 mg
Participants with LAC received ADX 1200 mg every 3 weeks via IV infusion in addition to the 21-day cycle chemotherapy (carboplatin and pemetrexed, on Day 1) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
OG005
Part B: LSC, ADX 1200 mg
Participants with LSC received ADX 1200 mg every 3 weeks via IV infusion in addition to the 21-day cycle chemotherapy (carboplatin and paclitaxel, on Day 1) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
OG006
Part B: EGC, ADX 800 mg
Participants with EGC received ADX 800 mg every 2 weeks via IV infusion in addition to the 28-day cycle chemotherapy (mFOLFOX6, on Days 1 and 15) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
OG007
Part B: FL CRC, ADX 800 mg+BEV 5 mg/kg
Participants with CRC received FL treatment with ADX 800 mg every 2 weeks via IV infusion in addition to the 28-day cycle chemotherapy (mFOLFOX6 and bevacizumab 5 mg/kg, on Days 1 and 15) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
OG008
Part B: FL CRC, ADX 800 mg+BEV 10 mg/kg
Participants with CRC received FL treatment with ADX 800 mg every 2 weeks via IV infusion in addition to the 28-day cycle chemotherapy (mFOLFOX6 and bevacizumab 10 mg/kg, on Days 1 and 15) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
OG009
Part B: SL CRC, ADX 800 mg+BEV 5 mg/kg
Participants with CRC received SL treatment with ADX 800 mg every 2 weeks via IV infusion in addition to the 28-day cycle chemotherapy (FOLFIRI and bevacizumab 5 mg/kg, on Days 1 and 15) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
OG010
Part B: SL CRC, ADX 800 mg+BEV 10 mg/kg
Participants with CRC received SL treatment with ADX 800 mg every 2 weeks via IV infusion in addition to the 28-day cycle chemotherapy (FOLFIRI and bevacizumab 10 mg/kg, on Days 1 and 15) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
OG011
Part B: BRCA, ADX 800 mg
Participants with BRCA received ADX 800 mg every 2 weeks via IV infusion in addition to the 28-day cycle chemotherapy (paclitaxel, on Days 1, 8, and 15) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
Units
Counts
Participants
OG0004
OG0013
OG0026
OG003
Title
Denominators
Categories
Title
Measurements
OG000100.0
OG001100.0
OG00283.3
OG003
Primary
Percentage of Participants Experiencing Laboratory Abnormalities
Treatment-emergent laboratory abnormalities were defined as values that increase at least one toxicity grade from baseline. Participants with any laboratory abnormality were reported.
Participants in the Safety Analysis Set were analyzed.
Posted
Number
percentage of participants
Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days
ID
Title
Description
OG000
Part A: ADX 200 mg
Participants with advanced solid tumors who had failed or were intolerant to standard therapy or for whom no standard therapy existed, received 200 mg ADX as monotherapy via IV infusion (approximately 30 minutes) every 2 weeks until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
OG001
Part A: ADX 600 mg
Participants with advanced solid tumors who had failed or were intolerant to standard therapy or for whom no standard therapy existed, received 600 mg ADX as monotherapy via IV infusion (approximately 30 minutes) every 2 weeks until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
OG002
Part A: ADX 1800 mg
Time Frame
Adverse Events: Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days All-cause Mortality: From Study Start date (29 March 2013) up to study completion date (23 April 2019) (6 years and 1 month)
Description
The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX).
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
Part A: ADX 200 mg
Participants with advanced solid tumors who had failed or were intolerant to standard therapy or for whom no standard therapy existed, received 200 mg ADX as monotherapy via IV infusion (approximately 30 minutes) every 2 weeks until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
1
4
0
4
4
4
EG001
Part A: ADX 600 mg
Participants with advanced solid tumors who had failed or were intolerant to standard therapy or for whom no standard therapy existed, received 600 mg ADX as monotherapy via IV infusion (approximately 30 minutes) every 2 weeks until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
0
3
0
3
3
3
EG002
Part A: ADX 1800 mg
Participants with advanced solid tumors who had failed or were intolerant to standard therapy or for whom no standard therapy existed, received 1800 mg ADX as monotherapy via IV infusion (approximately 30 minutes) every 2 weeks until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
1
6
2
6
5
6
EG003
Part B: PAC, ADX 800 mg
Participants with PAC received ADX 800 mg every 2 weeks via IV infusion in addition to the 28-day cycle chemotherapy (gemcitabine and nab paclitaxel, on Days 1, 8, and 15) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
8
36
19
36
36
36
EG004
Part B: LAC, ADX 1200 mg
Participants with LAC received ADX 1200 mg every 3 weeks via IV infusion in addition to the 21-day cycle chemotherapy (carboplatin and pemetrexed, on Day 1) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
4
10
5
10
9
10
EG005
Part B: LSC, ADX 1200 mg
Participants with LSC received ADX 1200 mg every 3 weeks via IV infusion in addition to the 21-day cycle chemotherapy (carboplatin and paclitaxel, on Day 1) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
3
10
6
10
10
10
EG006
Part B: EGC, ADX 800 mg
Participants with EGC received ADX 800 mg every 2 weeks via IV infusion in addition to the 28-day cycle chemotherapy (mFOLFOX6, on Days 1 and 15) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
13
40
19
40
40
40
EG007
Part B: FL CRC, ADX 800 mg+BEV 5 mg/kg
Participants with CRC received FL treatment with ADX 800 mg every 2 weeks via IV infusion in addition to the 28-day cycle chemotherapy (mFOLFOX6 and bevacizumab 5 mg/kg, on Days 1 and 15) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
22
45
17
45
45
45
EG008
Part B: FL CRC, ADX 800 mg+BEV 10 mg/kg
Participants with CRC received FL treatment with ADX 800 mg every 2 weeks via IV infusion in addition to the 28-day cycle chemotherapy (mFOLFOX6 and bevacizumab 10 mg/kg, on Days 1 and 15) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
5
11
3
11
11
11
EG009
Part B: SL CRC, ADX 800 mg+BEV 5 mg/kg
Participants with CRC received SL treatment with ADX 800 mg every 2 weeks via IV infusion in addition to the 28-day cycle chemotherapy (FOLFIRI and bevacizumab 5 mg/kg, on Days 1 and 15) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
25
44
13
44
44
44
EG010
Part B: SL CRC, ADX 800 mg+BEV 10 mg/kg
Participants with CRC received SL treatment with ADX 800 mg every 2 weeks via IV infusion in addition to the 28-day cycle chemotherapy (FOLFIRI and bevacizumab 10 mg/kg, on Days 1 and 15) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
5
8
4
8
8
8
EG011
Part B: BRCA, ADX 800 mg
Participants with BRCA received ADX 800 mg every 2 weeks via IV infusion in addition to the 28-day cycle chemotherapy (paclitaxel, on Days 1, 8, and 15) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
8
15
5
15
15
15
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG0030 affected36 at risk
EG0041 affected10 at risk
EG0051 affected10 at risk
EG0061 affected40 at risk
EG0070 affected45 at risk
EG0080 affected11 at risk
EG0090 affected44 at risk
EG0100 affected8 at risk
EG0110 affected15 at risk
Febrile neutropenia
Blood and lymphatic system disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Leukocytosis
Blood and lymphatic system disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Pancytopenia
Blood and lymphatic system disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Acute coronary syndrome
Cardiac disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Acute myocardial infarction
Cardiac disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Atrial flutter
Cardiac disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Cardiac arrest
Cardiac disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Pericardial effusion
Cardiac disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Adrenal haemorrhage
Endocrine disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Eyelid ptosis
Eye disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Abdominal discomfort
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Ascites
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Colitis ischaemic
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Duodenal obstruction
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0021 affected6 at risk
EG003
Duodenal perforation
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Enteritis
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Gastric haemorrhage
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Haematemesis
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Ileus
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Large intestinal obstruction
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Lower gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Obstruction gastric
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Oesophageal haemorrhage
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Proctalgia
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Small intestinal obstruction
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Catheter site extravasation
General disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Catheter site haematoma
General disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Chest pain
General disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Fatigue
General disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Performance status decreased
General disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Pyrexia
General disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Hepatic failure
Hepatobiliary disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Hyperbilirubinaemia
Hepatobiliary disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Abdominal abscess
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Bacteraemia
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Cellulitis of male external genital organ
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Cystitis
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Escherichia pyelonephritis
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Gangrene
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Influenza
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Large intestine infection
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Peritonitis bacterial
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Pneumonia streptococcal
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Pyelonephritis
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Rotavirus infection
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Sepsis
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Septic shock
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Skin infection
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Urosepsis
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Carbon monoxide poisoning
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Infusion related reaction
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Ligament sprain
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Post procedural complication
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Anticoagulation drug level above therapeutic
Investigations
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Diabetic ketoacidosis
Metabolism and nutrition disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Failure to thrive
Metabolism and nutrition disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Fluid overload
Metabolism and nutrition disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Flank pain
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Rhabdomyolysis
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Diffuse large B-cell lymphoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Metastases to meninges
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Cerebrovascular accident
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Haemorrhage intracranial
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Hypoaesthesia
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Transient ischaemic attack
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Tremor
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Unresponsive to stimuli
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Confusional state
Psychiatric disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Mental status changes
Psychiatric disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0021 affected6 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Hydronephrosis
Renal and urinary disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Nephrolithiasis
Renal and urinary disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Urinary retention
Renal and urinary disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Urinary tract obstruction
Renal and urinary disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Acute respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Aspiration
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Chronic obstructive pulmonary disease
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Haemoptysis
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Hypersensitivity pneumonitis
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0021 affected6 at risk
EG003
Pneumonia aspiration
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Pneumonitis
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Pneumothorax
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Pulmonary oedema
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Diabetic foot
Skin and subcutaneous tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Embolism
Vascular disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Haematoma
Vascular disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Shock haemorrhagic
Vascular disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG00311 affected36 at risk
EG0047 affected10 at risk
EG0052 affected10 at risk
EG00612 affected40 at risk
EG0079 affected45 at risk
EG0081 affected11 at risk
EG00911 affected44 at risk
EG0102 affected8 at risk
EG0113 affected15 at risk
Hypercoagulation
Blood and lymphatic system disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Leukocytosis
Blood and lymphatic system disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Leukopenia
Blood and lymphatic system disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Pancytopenia
Blood and lymphatic system disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Angina pectoris
Cardiac disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Bradycardia
Cardiac disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Palpitations
Cardiac disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0021 affected6 at risk
EG003
Sinus tachycardia
Cardiac disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Tachycardia
Cardiac disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Ear pain
Ear and labyrinth disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Tinnitus
Ear and labyrinth disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Conjunctival oedema
Eye disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Dry eye
Eye disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Erythema of eyelid
Eye disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Eye swelling
Eye disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Lacrimation increased
Eye disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Ocular hyperaemia
Eye disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Photopsia
Eye disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Vision blurred
Eye disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Abdominal discomfort
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0021 affected6 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Abdominal wall haematoma
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Anorectal discomfort
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Ascites
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Colitis
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Dental caries
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0002 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Dyschezia
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Erosive oesophagitis
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Flatulence
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Gingival bleeding
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Haematochezia
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Haemorrhoidal haemorrhage
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Haemorrhoids
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Mouth ulceration
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected4 at risk
EG0012 affected3 at risk
EG0022 affected6 at risk
EG003
Oral pain
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Proctalgia
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Rectal fissure
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Rectal haemorrhage
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Toothache
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected4 at risk
EG0010 affected3 at risk
EG0022 affected6 at risk
EG003
Asthenia
General disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected4 at risk
EG0011 affected3 at risk
EG0020 affected6 at risk
EG003
Axillary pain
General disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Catheter site pain
General disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Chest discomfort
General disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected4 at risk
EG0010 affected3 at risk
EG0021 affected6 at risk
EG003
Chest pain
General disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Chills
General disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Complication associated with device
General disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Early satiety
General disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Fatigue
General disorders
MedDRA 22.0
Systematic Assessment
EG0002 affected4 at risk
EG0012 affected3 at risk
EG0020 affected6 at risk
EG003
Gait disturbance
General disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Generalised oedema
General disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Influenza like illness
General disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Malaise
General disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Mucosal inflammation
General disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Oedema peripheral
General disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Pain
General disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Peripheral swelling
General disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Pyrexia
General disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Swelling
General disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Temperature intolerance
General disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Cholecystitis
Hepatobiliary disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Hepatic cirrhosis
Hepatobiliary disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Drug hypersensitivity
Immune system disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Hypersensitivity
Immune system disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Seasonal allergy
Immune system disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Abscess
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected3 at risk
EG0020 affected6 at risk
EG003
Bacteraemia
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Candida infection
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected3 at risk
EG0020 affected6 at risk
EG003
Cystitis
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Ear infection
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Eye infection
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Gastrointestinal infection
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Hepatitis C
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Herpes zoster
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Hordeolum
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Infected cyst
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Laryngitis
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Lung infection
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Nail infection
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Oral candidiasis
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Pyuria
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Sinusitis
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0021 affected6 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Wound infection
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Arthropod bite
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Gastrointestinal stoma complication
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Infusion related reaction
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Injection related reaction
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Limb injury
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Procedural pain
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Skin abrasion
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Skin laceration
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Stoma complication
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Wound dehiscence
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Activated partial thromboplastin time prolonged
Investigations
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected3 at risk
EG0020 affected6 at risk
EG003
Blood alkaline phosphatase increased
Investigations
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA 22.0
Systematic Assessment
EG0001 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Blood creatinine increased
Investigations
MedDRA 22.0
Systematic Assessment
EG0001 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Blood thyroid stimulating hormone increased
Investigations
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Carcinoembryonic antigen increased
Investigations
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Haemoglobin decreased
Investigations
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Heart rate irregular
Investigations
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
International normalised ratio increased
Investigations
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Liver function test increased
Investigations
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Lymphocyte count decreased
Investigations
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Neutrophil count decreased
Investigations
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Platelet count decreased
Investigations
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Prothrombin time prolonged
Investigations
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Weight decreased
Investigations
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Weight increased
Investigations
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
White blood cell count decreased
Investigations
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0021 affected6 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Fluid overload
Metabolism and nutrition disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Folate deficiency
Metabolism and nutrition disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Hypoalbuminaemia
Metabolism and nutrition disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Hypocalcaemia
Metabolism and nutrition disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Hypoglycaemia
Metabolism and nutrition disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Hypophosphataemia
Metabolism and nutrition disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Hypoproteinaemia
Metabolism and nutrition disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Malnutrition
Metabolism and nutrition disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected3 at risk
EG0021 affected6 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Bone pain
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Flank pain
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Joint stiffness
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0021 affected6 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0021 affected6 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Pain in jaw
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Pathological fracture
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Spondylitis
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Cardiac myxoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Intracranial tumour haemorrhage
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0021 affected6 at risk
EG003
Amnesia
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected3 at risk
EG0020 affected6 at risk
EG003
Ataxia
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Balance disorder
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected4 at risk
EG0011 affected3 at risk
EG0021 affected6 at risk
EG003
Dysaesthesia
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Dysgeusia
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Facial paralysis
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0021 affected6 at risk
EG003
Headache
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Hypoaesthesia
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Loss of consciousness
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Memory impairment
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Movement disorder
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Neuralgia
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Neuropathy peripheral
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected3 at risk
EG0020 affected6 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Peripheral sensory neuropathy
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Presyncope
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Sciatica
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Seizure
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Somnolence
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Syncope
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Taste disorder
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Toxic encephalopathy
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Tremor
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Vocal cord paralysis
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Agitation
Psychiatric disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Confusional state
Psychiatric disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Delirium
Psychiatric disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Depression
Psychiatric disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Dysuria
Renal and urinary disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Nephrolithiasis
Renal and urinary disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Pollakiuria
Renal and urinary disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Proteinuria
Renal and urinary disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Ureterolithiasis
Renal and urinary disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Urinary incontinence
Renal and urinary disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Urinary retention
Renal and urinary disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Chronic obstructive pulmonary disease
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected4 at risk
EG0010 affected3 at risk
EG0022 affected6 at risk
EG003
Dysphonia
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected4 at risk
EG0010 affected3 at risk
EG0023 affected6 at risk
EG003
Dyspnoea exertional
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Emphysema
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Haemoptysis
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Hiccups
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Lower respiratory tract congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Nasal dryness
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Organising pneumonia
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Paranasal sinus hypersecretion
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Pleuritic pain
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Productive cough
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Rhinitis allergic
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Sinus congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0021 affected6 at risk
EG003
Sputum discoloured
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Throat irritation
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Throat tightness
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Dermatitis acneiform
Skin and subcutaneous tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Granuloma annulare
Skin and subcutaneous tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Hyperhidrosis
Skin and subcutaneous tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Nail discolouration
Skin and subcutaneous tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Nail ridging
Skin and subcutaneous tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Night sweats
Skin and subcutaneous tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0021 affected6 at risk
EG003
Palmar-plantar erythrodysaesthesia syndrome
Skin and subcutaneous tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Rash generalised
Skin and subcutaneous tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Rash macular
Skin and subcutaneous tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Skin discolouration
Skin and subcutaneous tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Skin lesion
Skin and subcutaneous tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Skin ulcer
Skin and subcutaneous tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Urticaria
Skin and subcutaneous tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Aortic intramural haematoma
Vascular disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Embolism
Vascular disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Flushing
Vascular disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Haematoma
Vascular disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Hot flush
Vascular disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Hypertension
Vascular disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Hypotension
Vascular disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Peripheral coldness
Vascular disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected3 at risk
EG0020 affected6 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met:
The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or
The study has been completed at all study sites for at least 2 years
Participants with advanced solid tumors who had failed or were intolerant to standard therapy or for whom no standard therapy existed, received 1800 mg ADX as monotherapy via IV infusion (approximately 30 minutes) every 2 weeks until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
OG003
Part B: PAC, ADX 800 mg
Participants with PAC received ADX 800 mg every 2 weeks via IV infusion in addition to the 28-day cycle chemotherapy (gemcitabine and nab paclitaxel, on Days 1, 8, and 15) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
OG004
Part B: LAC, ADX 1200 mg
Participants with LAC received ADX 1200 mg every 3 weeks via IV infusion in addition to the 21-day cycle chemotherapy (carboplatin and pemetrexed, on Day 1) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
OG005
Part B: LSC, ADX 1200 mg
Participants with LSC received ADX 1200 mg every 3 weeks via IV infusion in addition to the 21-day cycle chemotherapy (carboplatin and paclitaxel, on Day 1) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
OG006
Part B: EGC, ADX 800 mg
Participants with EGC received ADX 800 mg every 2 weeks via IV infusion in addition to the 28-day cycle chemotherapy (mFOLFOX6, on Days 1 and 15) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
OG007
Part B: FL CRC, ADX 800 mg+BEV 5 mg/kg
Participants with CRC received FL treatment with ADX 800 mg every 2 weeks via IV infusion in addition to the 28-day cycle chemotherapy (mFOLFOX6 and bevacizumab 5 mg/kg, on Days 1 and 15) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
OG008
Part B: FL CRC, ADX 800 mg+BEV 10 mg/kg
Participants with CRC received FL treatment with ADX 800 mg every 2 weeks via IV infusion in addition to the 28-day cycle chemotherapy (mFOLFOX6 and bevacizumab 10 mg/kg, on Days 1 and 15) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
OG009
Part B: SL CRC, ADX 800 mg+BEV 5 mg/kg
Participants with CRC received SL treatment with ADX 800 mg every 2 weeks via IV infusion in addition to the 28-day cycle chemotherapy (FOLFIRI and bevacizumab 5 mg/kg, on Days 1 and 15) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
OG010
Part B: SL CRC, ADX 800 mg+BEV 10 mg/kg
Participants with CRC received SL treatment with ADX 800 mg every 2 weeks via IV infusion in addition to the 28-day cycle chemotherapy (FOLFIRI and bevacizumab 10 mg/kg, on Days 1 and 15) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
OG011
Part B: BRCA, ADX 800 mg
Participants with BRCA received ADX 800 mg every 2 weeks via IV infusion in addition to the 28-day cycle chemotherapy (paclitaxel, on Days 1, 8, and 15) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.