Study to Evaluate GSK3052230 in Combination With Paclitax... | NCT01868022 | Trialant
NCT01868022
Sponsor
GlaxoSmithKline
Status
Completed
Last Update Posted
Aug 19, 2019Actual
Enrollment
65Actual
Phase
Phase 1
Conditions
Neoplasms
Interventions
GSK3052230
paclitaxel
carboplatin
docetaxel
pemetrexed
cisplatin
Countries
United States
Belgium
Denmark
Netherlands
Russia
Spain
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT01868022
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
117360
Secondary IDs
ID
Type
Description
Link
2013-000354-21
EudraCT Number
Brief Title
Study to Evaluate GSK3052230 in Combination With Paclitaxel and Carboplatin, or Docetaxel or as Single Agent in Subjects With Solid Malignancies and Deregulated Fibroblast Growth Factor (FGF) Pathway Signaling
Official Title
Multi-arm, Non-randomized, Open-Label Phase IB Study to Evaluate GSK3052230 in Combination With Paclitaxel and Carboplatin, or Docetaxel or as Single Agent in Subjects With Solid Malignancies and Deregulated FGF Pathway Signaling
Acronym
Not provided
Organization
GlaxoSmithKlineINDUSTRY
Status Module
Record Verification Date
Aug 2019
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Oct 9, 2013Actual
Primary Completion Date
Oct 24, 2017Actual
Completion Date
Oct 24, 2017Actual
First Submitted Date
May 30, 2013
First Submission Date that Met QC Criteria
May 30, 2013
First Posted Date
Jun 4, 2013Estimated
Results Waived
Not provided
Results First Submitted Date
Aug 15, 2018
Results First Submitted that Met QC Criteria
Feb 7, 2019
Results First Posted Date
Feb 11, 2019Actual
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
Aug 2, 2019
Last Update Posted Date
Aug 19, 2019Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
GlaxoSmithKlineINDUSTRY
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
This phase IB trial aims to identify anticancer activity of GSK3052230 in subjects with malignancies with abnormal dependence on FGF pathway signaling. Combination doses of GSK3052230 with standard of care chemotherapy in the first and second line or greater setting of metastatic squamous non-small cell lung cancer (NSCLC) and first line malignant pleural mesothelioma subjects will be studied in the 3+3 dose-escalation design. This will be a multi-arm, multicenter, non-randomized, parallel-group, uncontrolled, open-label Phase IB study designed to evaluate the safety, tolerability and preliminary activity of GSK3052230 in combination with paclitaxel + carboplatin (Arm A), in combination with docetaxel (Arm B), or in combination with pemetrexed + cisplatin (Arm C). Approximately 70 subjects will be enrolled in the study (approximately up to 120 may be enrolled).
Detailed Description
Not provided
Conditions Module
Conditions
Neoplasms
Keywords
FGFR1
FP1039
GSK3052230
docetaxel
FGFR
carboplatin
HGS1036
squamous non-small cell lung cancer
paclitaxel
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
65Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Arm A: GSK3052230 + paclitaxel/carboplatin
Experimental
Subject will receive GSK3052230 as 30-minute intravenous (i.v.) infusion once a week (Day 1, Day 8, Day 15) of each 21-day cycle + paclitaxel (constant infusion for 3 hrs) and carboplatin (constant infusion for 30 to 60 minutes) iv on Day 1 of each 21-day cycle. The number of cycles of paclitaxel/carboplatin will be limited to 4 to 6 cycles.
Drug: GSK3052230
Drug: paclitaxel
Drug: carboplatin
Arm B: GSK3052230 + docetaxel
Experimental
Subject will receive GSK3052230 as 30-minute intravenous (i.v.) infusion once a week (Day 1, Day 8, Day 15) of each 21-day cycle + docetaxel as 1 hour iv infusion on Day 1 of each 21-day cycle. Subjects may continue to receive docetaxel until disease progression or as long as they are considered to derive benefit from treatment.
Drug: GSK3052230
Drug: docetaxel
Arm C: GSK3052230 + pemetrexed and cisplatin
Experimental
Subject will receive GSK3052230 as 30 minute iv infusion once a week (Day 1, Day 8, Day 15) of each 21 day cycle + pemetrexed iv infusion over 10 minutes on Day 1 of each 21 day cycle followed 30 minutes later by iv Cisplatin infused over 2 hours
Drug: GSK3052230
Drug: pemetrexed
Drug: cisplatin
Interventions
Name
Type
Description
Arm Group Labels
Other Names
GSK3052230
Drug
A clear to opalescent, colorless to pale yellow solution for IV infusion once weekly (Day 1, Day 8, Day 15) in each 21-day cycle with unit dose strengths/dose level of 5, 10, 15, and 20 mg/kg supplied in a sterile 25 mL glass vial.
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Number of Participants With Non-serious Adverse Events (AEs) and Serious AEs (SAEs)
An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, protocol-specific events including drug-induced liver injury with hyperbilirubinaemia, any new primary cancers, cardiac toxicity including Left Ventricular Ejection Fraction (LVEF) changes or treatment emergent cardiac valve toxicity and treatment emergent acute anterior uveitis were categorized as SAE. Participants having non-serious AE or SAE were included in the analysis. The All Treated Subjects Population comprised of all participants who received at least one dose of study treatment.
Median of 28.5 weeks
Number of Participants With Severe AEs and SAEs
The severity of AEs were graded utilizing National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 4.3. Grade 1 represents mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 represents moderate; minimal, local or noninvasive intervention indicated. Grade 3 represents severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling. Grade 4 represents life-threatening consequences; urgent intervention indicated. Grade 5 represents death related to AE.
Median of 28.5 weeks
Number of Participants Withdrew Due to AEs
An AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. The AEs leading to permanent discontinuation from the study has been reported.
Median of 28.5 weeks
Number of Participants With Dose Reduction
Secondary Outcomes
Measure
Description
Time Frame
Progression Free Survival (PFS) as Assessed by Investigator
PFS is defined as the interval between first dose of GSK3052230 and the earliest date of disease progression or death due to any cause by investigator assessment per RECIST 1.1 (for Arm A and B participants) or modified RECIST (for Arm C participants). For participants who do not progress or die, PFS was censored at the time of last radiological scan. Participants who discontinued study with no post-treatment tumor assessment were censored at date of first dose of study drug. Mean and 95 percent CI has been reported. NA indicates that data were not available as only 1 participant had event, other two censored therefore there is no confidence interval.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria
Signed written informed consent
Histologically or cytologically confirmed diagnosis: Arm A and B- stage IV recurrent metastatic squamous NSCLC with Fibroblast growth factor receptor 1 (FGFR1) gene amplification by central laboratory testing. Arm C- recurrent after local therapy or unresectable MPM with measurable lesions.
For specific arms the following requirements:
Arm A: Subjects who have received no prior therapy for Stage IIIB or Stage IV or recurrent metastatic disease. Note, to avoid any undue delay of initiating systemic chemotherapy for these subjects with newly diagnosed metastatic disease, it is allowed to initiate the first cycle of chemotherapy while eligibility for the study is still being determined, as long as the first dose of GSK3052230 is given no later than Cycle 2 Day 1 of chemotherapy. In addition, subjects with Stage IIIB or Stage IV disease and recurrence after previous NSCLC that has been treated with surgery and adjuvant chemotherapy or a radio- chemotherapy regimen with curative intent are eligible, provided 6 months has passed since this treatment ended.
Arm B: Subjects who have documented tumor progression (based on radiological imaging) or intolerability after receiving at least one prior line of platinum containing combination chemotherapy for Stage IIIB or Stage IV or recurrent metastatic disease. Note: Prior treatment should not include docetaxel but may have included paclitaxel.
Arm C: Subjects who have received no prior systemic therapy for MPM.
- Availability of archival tumor tissue required for assessment of deregulated FGF pathway signalling, but not limited to, FGFR1 amplification or FGF2 or FGFR1 expression. If archival tissue is not available, a fresh biopsy is required. In Arms A and B, subjects will be prospectively screened for FGFR1 gene amplification using a Fluorescence in situ hybridization (FISH) assay for the dose expansion and the MTD/MFD cohorts only. For inclusion in this study, based on the central laboratory testing, FGFR1 gene amplification must meet one of the following criteria: a ratio of FGFR1/CEN 8 of >=2; or average number of FGFR1 signals per tumor nucleus of >=6; or the percentage of tumor nuclei containing >=5 FGFR1 signals is >=50%.
In Arm C, FGF2 expression by IHC will be evaluated retrospectively in tissue samples by a central laboratory and is not a requirement for study entry.
Measurable disease per RECIST version 1.1 (Arm A and B) and modified RECIST for Arm C.
Male or female >=18 years of age.
Women of childbearing potential must have a negative serum pregnancy test within 7 days of first dose of study treatment and agree to use effective contraception, from 14 days prior to the first dose of study treatment, throughout the study, and for 6 months following the last dose of chemotherapy or 4 weeks after the last dose of GSK3052230, whichever is latest. .
Men with a female partner of childbearing potential must have either had a prior vasectomy or agree to use effective contraception for at least 2 weeks prior to administration of the first dose of study treatment and for at least 6 months after the last dose of chemotherapy to allow for clearance of any altered sperm.
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1 for Arm A and C subjects and 0-2 for Arm B.
French subjects: In France, a subject will be eligible for inclusion in this study only if either affiliated to or a beneficiary of a social security category
Must have adequate organ function as defined by the following baseline values: Absolute neutrophil count >=1.5 x 10^9/Liter, Hemoglobin >=9 gram (g)/decilitre(dL), Platelets >=100 x 10^9/L, Partial thromboplastin time (PTT) <=1.25 x upper limit of normal (ULN), Albumin >=2.5 g/dL, Serum total bilirubin <=1.25 times ULN (for Arm B: <=ULN ), Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) <=2.5 times ULN (for Arm B: <=1.5 times ULN), Serum Creatinine <=1.5 x ULN, Or Measured or Calculated Creatinine Clearance >=45 mL/min (Arm A or B), >=65 mL/min (Arm C), Left ventricular ejection fraction >=50% by ECHO.
Exclusion Criteria
For Arms A and C: Treatment with any FGFR inhibitor. For Arm B: Treatment with any anti-cancer therapy (for biological anti-cancer therapies see criteria below) during the preceding 4 weeks or within 4 half-lives of the therapy, whichever is longer.
Receipt of any biological therapy within 6 weeks of the first dose of GSK3052230
Unresolved toxicity of National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.03 (NCI CTCAE version 4.03) Grade 2 or higher from previous anti-cancer therapy, except alopecia.
Active malignancy other than the cancer under study. Subjects with a history of completely resected non-melanomatous skin carcinoma or successfully treated in situ carcinoma are eligible.
Presence of uncontrolled infection
Prior major surgery or trauma within 28 days before first dose of study drug
Presence of any non-healing wound, fracture, or ulcer
Any prohibited medication(s) as described in protocol
Conditions likely to increase the potential for abdominal perforation or fistula formation, including but not limited to:
Luminal intestinal cancers or bulky abdominal disease. Presence or history of abdominal fistula, gastrointestinal perforation, peptic ulcer disease or intra-abdominal abscess within the six months prior to the first dose of GSK3052230.
Other risk factors for perforation, such as acute diverticulitis, obstruction or previous abdominal or pelvic radiation.
Symptomatic leptomeningeal or brain metastases or spinal cord compression Note: Subjects previously treated for these conditions are eligible if they meet both of the criteria below: (1) have had stable CNS disease for at least 4 weeks after local therapy as assessed by imaging (contrast enhanced magnetic resonance imaging [MRI] or computed tomography [CT]) prior to Day 1, and (2) are asymptomatic and off corticosteroids, or are on stable dose of corticosteroids for at least 4 weeks prior to Day 1.
Have a known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to study drugs (GSK3052230, docetaxel, paclitaxel, carboplatin, pemetrexed, cisplatin) and or their excipients that contraindicate their participation.
Known human immunodeficiency virus-positive serology, acquired immunodeficiency syndrome (AIDS), or an AIDS-related illness.
Prior organ or allogeneic stem cell transplant
The following cardiac abnormalities:
Corrected QT (QTc) interval >=480 millisecond. History of acute coronary syndromes (including unstable angina) within the past 24 weeks Coronary angioplasty or stenting within the past 24 weeks. Class II, III, or IV heart failure as defined by the New York Heart Association (NYHA) functional classification system.
Abnormal cardiac valve morphology (>= Grade 2) documented by echocardiogram (subjects with Grade 1 abnormalities [i.e., mild regurgitation/stenosis] can be entered on study).
History of known arrhythmias (except sinus arrhythmia and atrial fibrillation that is controlled) within the past 24 weeks.
Presence or history of hemoptysis (>1/2 teaspoon of red blood) 2 weeks prior to the first dose of GSK3052230
Any serious and/or unstable pre-existing medical, psychiatric disorder or other conditions that could interfere with subject's safety, obtaining informed consent or compliance to the study procedures.
Current active liver or biliary disease (with the exception of Gilbert's syndrome or asymptomatic gallstones, liver metastases or otherwise stable chronic liver disease per investigator's assessment).
Pregnant, lactating or actively breast feeding females.
French subjects: The French subject has participated in any study using an investigational study treatment(s) during the previous 30 days.
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
GSK Clinical Trials
GlaxoSmithKline
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
GSK Investigational Site
Duarte
California
91010
United States
GSK Investigational Site
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
Plan to Share IPD
Yes
Description
IPD for this study will be made available via the Clinical Study Data Request site.
Types
Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame
IPD is available via the Clinical Study Data Request site (click on the link provided below)
Access Criteria
Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
Total 65 participants were enrolled in 3 Arms. In Arm A 20 participants were enrolled across 3 cohorts, Arm B 9 participants were enrolled across 3 cohorts, Arm C 36 participants were enrolled across 3 cohorts.The study was conducted at 22 centers across 7 countries from 9-Oct-2013 to 24-Oct-2017.
Recruitment Details
This was a non-randomized, parallel-group study in participants (par.) with Solid Malignancies and Deregulated Fibroblast growth factor (FGF) Pathway Signaling. Participants administered GSK3052230 in combination with paclitaxel + carboplatin (Arm A) or in combination with docetaxel (Arm B) or in combination with pemetrexed + cisplatin (Arm C).
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
5 mg/kg GSK3052230 + Paclitaxel + Carboplatin: Arm A
Participants in Arm A received 5 milligram per kilogram (mg/kg) GSK3052230 along with 200 mg per meter square (mg/m^2) of Paclitaxel plus Area under curve (AUC) 6 that is (i.e.) 900 mg Carboplatin
FG001
10 mg/kg GSK3052230 + Paclitaxel + Carboplatin: Arm A
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
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
Dec 14, 2015
Mar 22, 2018
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
France
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
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
Arm A: GSK3052230 + paclitaxel/carboplatin
Arm B: GSK3052230 + docetaxel
Arm C: GSK3052230 + pemetrexed and cisplatin
paclitaxel
Drug
paclitaxel will be from commercial stock.
Arm A: GSK3052230 + paclitaxel/carboplatin
carboplatin
Drug
carboplatin will be from commercial stock.
Arm A: GSK3052230 + paclitaxel/carboplatin
docetaxel
Drug
docetaxel will be from commercial stock.
Arm B: GSK3052230 + docetaxel
pemetrexed
Drug
pemetrexed will be from commercial stock
Arm C: GSK3052230 + pemetrexed and cisplatin
cisplatin
Drug
cisplatin will be from commercial stock
Arm C: GSK3052230 + pemetrexed and cisplatin
Dose reduction and delays were done due to toxicity, or in the interest of participant's safety per investigator discretion. Requirement for more than 2 dose reductions resulted in permanent discontinuation of chemotherapy. Participants with dose reduction has been reported.
Median of 28.5 weeks
Number of Participants With Dose Delays
Dose reduction and delays were done due to toxicity, or in the interest of participant's safety per investigator discretion. Requirement for more than 2 dose reductions resulted in permanent discontinuation of chemotherapy. Participants with dose delay has been reported.
Median of 28.5 weeks
Treatment Duration With GSK3052230
The number of participants administered study treatment were summarized according to the duration of therapy. The extent of treatment exposure is calculated as the number of cycles administered. The duration of exposure to study treatment is calculated from first day to last day of treatment plus 1 day. Median and full range (minimum and maximum) has been reported.
Median of 28.5 weeks
Number of Participants With Dose-Limiting Toxicities (DLT)
DLT is defined as toxicities due to GSK3052230 or due to the combination of GSK3052230 with chemotherapy within Cycle 1 (first 21 days of period on study) that are unlikely to be due to another cause, such as the known effects of cytotoxics chemotherapy alone, disease progression, or accident, and protocol-specified criteria. Clinically significant toxicities that persist or occur beyond Cycle 1 that the investigator and GlaxoSmithKline (GSK) medical monitor consider dose-limiting may also be designated a DLT for the purpose of establishing Maximum tolerated dose (MTD). Number of participants with DLTs has been reported.
Median of 28.5 weeks
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
Blood pressure was measured in a semi-supine position after 5 minutes of rest. Blood pressure was measured before start of first chemotherapy infusion and within 20 minutes before start of GSK3052230 infusion on Day 1 of every cycle and Baseline. Baseline is defined as the most recent, non-missing value prior to or on the first study GSK3052230 treatment dose date. Change from Baseline is calculated as visit value minus Baseline value. The worst-case post-Baseline values has been presented. NA indicates that data were not available as standard deviation could not be calculated for a single participant. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).
Baseline and up to Median of 28.5 weeks
Change From Baseline in Heart Rate
Heart rate was measured in a semi-supine position after 5 minutes of rest. Heart rate was measured before start of first chemotherapy infusion and within 20 minutes before start of GSK3052230 infusion on Day 1 of every cycle and Baseline. Baseline is defined as the most recent, non-missing value prior to or on the first study GSK3052230 treatment dose date. Change from Baseline is calculated as visit value minus Baseline value. The worst-case post-Baseline values has been presented.
Baseline and up to Median of 28.5 weeks
Change From Baseline in Temperature
Temperature was measured in a semi-supine position after 5 minutes of rest. Temperature was measured before start of first chemotherapy infusion and within 20 minutes before start of GSK3052230 infusion on Day 1 of every cycle and Baseline. Baseline is defined as the most recent, non-missing value prior to or on the first study GSK3052230 treatment dose date. Change from Baseline is calculated as visit value minus Baseline value. The worst-case post-Baseline values has been presented.
Baseline and up to Median of 28.5 weeks
Number of Participants With Clinically Significant Findings for 12-lead Electrocardiogram (ECG)
A single 12-lead ECG was performed at the specified timepoints during the study where the participant was instructed to be in semi-recumbent position for 5 minutes before obtaining the ECG. An ECG machine that automatically calculated the heart rate and measures like the PR, QRS, QT, and corrected QT intervals. Number of participants with worst-case post-Baseline abnormal clinically significant findings and abnormal not clinically significant findings in ECG results has been reported.
Median of 28.5 weeks
Number of Participants With Abnormal Echocardiogram (ECHO) Findings
Echocardiography scans were obtained at given time points using an echocardiogram and the findings for left ventricular ejection fraction (LVEF) were obtained. LVEF values at end of treatment (EOT) were recorded as no change or any increase and any decrease values. Only those participants available at the specified time points were analyzed.
Median of 28.5 weeks
Number of Participants With Clinical Chemistry Changes From Baseline With Respect to the Normal Range
Clinical chemistry parameters included potassium, sodium, chloride (Cl), total carbon dioxide (CO2), total and ionized calcium, magnesium, phosphate, albumin, glucose (fasting), Blood urea nitrogen (BUN), creatinine (Cr), uric acid, creatinine clearance, aspartate aminotransferase (AST), alanine aminotransferase (ALT), gamma glutamyl transferase (GGT), alkaline phosphatase, Total bilirubin (T. Bil), and Direct bilirubin (D. Bil), total T3 and T4, free T4, amylase, lipase, prothrombin time, partial thromboplastin time, international normalized ratio, and fibrinogen. Baseline is defined as the most recent, non-missing value prior to or on the first study GSK3052230 treatment dose date. Change from Baseline is calculated as visit value minus Baseline value. Clinical chemistry parameters with change from Baseline with respect to normal range only has been presented. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).
Median of 28.5 weeks
Number of Participants With the Abnormal Urinalysis Findings
Urinalysis parameters included urine protein, urine glucose, urine ketones and occult blood were assessed. Dipstick test was performed for routine urinalysis. Abnormal values such as trace, 1+, 2+, 3+, 4+, >1000, >=1000, and >10 have been reported.
Up to Cycle 16 (each cycle was of 21 days)
Number of Participants With Hematology Change From Baseline With Respect to the Normal Range
Hematology parameters included platelet Count, red blood cell (RBC) Count, hemoglobin, absolute white blood cell (WBC) Count, absolute neutrophils (Neu), absolute lymphocytes (Lym), absolute monocytes (Mono), absolute eosinophils (Eos), absolute basophils (Baso). Baseline is defined as the most recent, non-missing value prior to or on the first study GSK3052230 treatment dose date. Change from Baseline is calculated as visit value minus Baseline value. Hematology parameters with worst-case change from Baseline with respect to normal range only has been presented. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).
Median of 28.5 weeks
Number of Participants With Maximum Tolerated Dose (MTD) or Maximum Feasible Dose (MFD)
The MTD is defined as the highest dose level tested at which < 33 percent of participants experience a DLT. In cases when MTD is not reached dose was described as the MFD.
Median of 28.5 weeks
Number of Participants With Best Response
Best response defined as complete response (CR:disappearance of all target. Any pathological lymph nodes < 10 millimeter [mm] in the short axis) or partial response (PR at least a 30 percent decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters), stable disease (SD neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease) or progressive disease (PR at least a 20 percent increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started. In addition, the sum must have an absolute increase from nadir of 5 mm) according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 or modified RECIST. Best response as per RECIST version 1.1 for Arm A and B participants has been reported. Best response according to RECIST version 1.1 or modified RECIST for Arm C participants has been reported.
Median of 28.5 weeks
Number of Participants With Overall Response Rate (ORR)
Overall Response Rate (ORR) is defined as the percentage of participants achieving a confirmed Complete response (CR) or Partial response (PR) from the start of treatment until disease progression as per RECIST version 1.1 or modified RECIST for participants in Arm C. This was determined based on Investigator assessments of response. 95% confidence intervals (CI) are calculated based on the unconditional exact method. ORR as per RECIST vesrion 1.1 for Arm A and B has been reported. ORR as per RECIST version 1.1 and modified RECIST version 1.1 for Arm C has been reported. The study population used for decision-making at the interim analyses during the dose expansion cohorts of the study arms is termed as the All Evaluable Participants Population. NA indicates 0 participants met ORR criteria therefore no dispersion.
Median of 28.5 weeks
Median of 28.5 weeks
Clearance of GSK3052230
Serial blood sample were collected at an indicated time points. A nonlinear mixed effects model was used to determine clearances. The Pharmacokinetic Population (PK) consisted of all participants in the All Treated Subject Population for whom a blood sample for pharmacokinetics was obtained and analyzed. Plasma GSK3052230 concentration-time data were to be combined with data from other studies to be analyzed using a population PK approach. However, other studies with GSK3052230 were not performed and thus no population PK analyses were done.
Cycle(C)1 Day (D) 1 Pre-dose, End of infusion, 1 and 2 hours post-dose;C1 D8 Pre-dose,end of infusion; C2 D1 Pre-dose, End of infusion, 1 and 2 hours post-dose;C4 D1 Predose, end of infusion;C6 D1 Pre-dose, end of infusion,C12 D1 Pre-dose, end of infusion
Volume of Distribution of GSK3052230
Serial blood sample were collected at an indicated time points. A nonlinear mixed effects model was used to determine volume distribution. Plasma GSK3052230 concentration-time data were to be combined with data from other studies to be analyzed using a population PK approach. However, other studies with GSK3052230 were not performed and thus no population PK analyses were done.
Cycle(C)1 Day (D) 1 Pre-dose, End of infusion, 1 and 2 hours post-dose;C1 D8 Pre-dose,end of infusion; C2 D1 Pre-dose, End of infusion, 1 and 2 hours post-dose;C4 D1 Predose, end of infusion;C6 D1 Pre-dose, end of infusion,C12 D1 Pre-dose, end of infusion
Number of Participants With Relevant Covariates That Influence Exposure of GSK3052230
Relevant covariates included parameters like age, weight and disease related covariates. Plasma GSK3052230 concentration-time data were to be combined with data from other studies to be analyzed using a population PK approach. However, other studies with GSK3052230 were not performed and thus no population PK analyses were done.
Cycle(C)1 Day (D) 1 Pre-dose, End of infusion, 1 and 2 hours post-dose;C1 D8 Pre-dose,end of infusion; C2 D1 Pre-dose, End of infusion, 1 and 2 hours post-dose;C4 D1 Predose, end of infusion;C6 D1 Pre-dose, end of infusion,C12 D1 Pre-dose, end of infusion
Change From Baseline in Forced Vital Capacity (FVC) in of Arm C Participants With Malignant Pleural Mesothelioma (MPM)
FVC is the total amount of air exhaled during the Forced Expiratory Volume test. Baseline is defined as the most recent, non-missing value prior to or on the first study GSK3052230 treatment dose date. Change from Baseline is calculated as visit value minus Baseline value. Assessment of FVC was done on Day 1 of every odd cycle for Arm C participants with MPM. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates that data were not available as standard deviation could not be calculated for a single participant.
Up to 31 cycles (each cycle was of 21 days)
Sacramento
California
95817
United States
GSK Investigational Site
Chicago
Illinois
60637
United States
GSK Investigational Site
Peoria
Illinois
61615-7822
United States
GSK Investigational Site
Detroit
Michigan
48201
United States
GSK Investigational Site
St Louis
Missouri
63110
United States
GSK Investigational Site
New York
New York
10065
United States
GSK Investigational Site
Chapel Hill
North Carolina
27599-7600
United States
GSK Investigational Site
Columbus
Ohio
43210
United States
GSK Investigational Site
Charleston
South Carolina
29425
United States
GSK Investigational Site
Leuven
3000
Belgium
GSK Investigational Site
Koebenhavn Oe
2100
Denmark
GSK Investigational Site
Amsterdam
1066 CX
Netherlands
GSK Investigational Site
Arkhangelsk
163045
Russia
GSK Investigational Site
Ryazan
390011
Russia
GSK Investigational Site
Saint Petersburg
197 089
Russia
GSK Investigational Site
Saint Petersburg
197758
Russia
GSK Investigational Site
Saint Petersburg
198255
Russia
GSK Investigational Site
Vsevolozhsk
188663
Russia
GSK Investigational Site
Badajoz
06080
Spain
GSK Investigational Site
Barcelona
08028
Spain
GSK Investigational Site
Barcelona
08035
Spain
GSK Investigational Site
Madrid
28034
Spain
GSK Investigational Site
Madrid
28040
Spain
GSK Investigational Site
Málaga
29010
Spain
GSK Investigational Site
Seville
41013
Spain
GSK Investigational Site
Leicester
Leicestershire
LE1 5WW
United Kingdom
GSK Investigational Site
London
SE1 9RT
United Kingdom
GSK Investigational Site
Nottingham
NG5 1PB
United Kingdom
Participants in Arm A received 10 mg/kg GSK3052230 along with 200 mg/m^2 of Paclitaxel plus AUC 6 i.e. 900 mg Carboplatin
FG002
20 mg/kg GSK3052230 + Paclitaxel + Carboplatin: Arm A
Participants in Arm A received 20 mg/kg GSK3052230 along with 200 mg/m^2 of Paclitaxel plus AUC 6 i.e. 900 mg Carboplatin
FG003
5 mg/kg GSK3052230 + Docetaxel: Arm B
Participants in Arm B received 5 mg/kg GSK3052230 along with 75 mg/m^2 Docetaxel
FG004
10 mg/kg GSK3052230 + Docetaxel: Arm B
Participants in Arm B received 10 mg/kg GSK3052230 along with 75 mg/m^2 Docetaxel
FG005
20 mg/kg GSK3052230 + Docetaxel: Arm B
Participants in Arm B received 20 mg/kg GSK3052230 along with 75 mg/m^2 Docetaxel
FG006
10 mg/kg GSK3052230 + Pemetrexed + Cisplatin: Arm C
Participants in Arm C received 10 mg/kg GSK3052230 along with 500 mg/m^2 Pemetrexed plus 75 mg/m^2 Cisplatin
FG007
15 mg/kg GSK3052230 + Pemetrexed + Cisplatin: Arm C
Participants in Arm C received 15 mg/kg GSK3052230 along with 500 mg/m^2 Pemetrexed plus 75 mg/m^2 Cisplatin
FG008
20 mg/kg GSK3052230 + Pemetrexed + Cisplatin: Arm C
Participants in Arm C received 20 mg/kg GSK3052230 along with 500 mg/m^2 Pemetrexed plus 75 mg/m^2 Cisplatin
FG0003 subjects
FG0013 subjects
FG00214 subjects
FG0033 subjects
FG0043 subjects
FG0053 subjects
FG0063 subjects
FG00725 subjects
FG0088 subjects
COMPLETED
FG0003 subjects
FG0013 subjects
FG00213 subjects
FG0032 subjects
FG0041 subjects
FG0052 subjects
FG0063 subjects
FG00716 subjects
FG0086 subjects
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0031 subjects
FG0042 subjects
FG0051 subjects
FG0060 subjects
FG0079 subjects
FG0082 subjects
Type
Comment
Reasons
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0031 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0071 subjects
FG0080 subjects
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Physician Decision
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Study closed/terminated
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Ongoing
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
5 mg/kg GSK3052230 + Paclitaxel + Carboplatin: Arm A
Participants in Arm A received 5 milligram per kilogram (mg/kg) GSK3052230 along with 200 mg per meter square (mg/m^2) of Paclitaxel plus Area under curve (AUC) 6 that is (i.e.) 900 mg Carboplatin
BG001
10 mg/kg GSK3052230 + Paclitaxel + Carboplatin: Arm A
Participants in Arm A received 10 mg/kg GSK3052230 along with 200 mg/m^2 of Paclitaxel plus AUC 6 i.e. 900 mg Carboplatin
BG002
20 mg/kg GSK3052230 + Paclitaxel + Carboplatin: Arm A
Participants in Arm A received 20 mg/kg GSK3052230 along with 200 mg/m^2 of Paclitaxel plus AUC 6 i.e. 900 mg Carboplatin
BG003
5 mg/kg GSK3052230 + Docetaxel: Arm B
Participants in Arm B received 5 mg/kg GSK3052230 along with 75 mg/m^2 Docetaxel
BG004
10 mg/kg GSK3052230 + Docetaxel: Arm B
Participants in Arm B received 10 mg/kg GSK3052230 along with 75 mg/m^2 Docetaxel
BG005
20 mg/kg GSK3052230 + Docetaxel: Arm B
Participants in Arm B received 20 mg/kg GSK3052230 along with 75 mg/m^2 Docetaxel
BG006
10 mg/kg GSK3052230 + Pemetrexed + Cisplatin: Arm C
Participants in Arm C received 10 mg/kg GSK3052230 along with 500 mg/m^2 Pemetrexed plus 75 mg/m^2 Cisplatin
BG007
15 mg/kg GSK3052230 + Pemetrexed + Cisplatin: Arm C
Participants in Arm C received 15 mg/kg GSK3052230 along with 500 mg/m^2 Pemetrexed plus 75 mg/m^2 Cisplatin
BG008
20 mg/kg GSK3052230 + Pemetrexed + Cisplatin: Arm C
Participants in Arm C received 20 mg/kg GSK3052230 along with 500 mg/m^2 Pemetrexed plus 75 mg/m^2 Cisplatin
BG009
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0003
BG0013
BG00214
BG0033
BG0043
BG0053
BG0063
BG00725
BG0088
BG00965
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
Years
Title
Denominators
Categories
Title
Measurements
BG00071.0± 5.29
BG00171.7± 5.03
BG00265.0± 7.55
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0000
BG0010
BG002
Race/Ethnicity, Customized
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
White - Arabic/North African Heritage
BG0001
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
Number of Participants With Non-serious Adverse Events (AEs) and Serious AEs (SAEs)
An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, protocol-specific events including drug-induced liver injury with hyperbilirubinaemia, any new primary cancers, cardiac toxicity including Left Ventricular Ejection Fraction (LVEF) changes or treatment emergent cardiac valve toxicity and treatment emergent acute anterior uveitis were categorized as SAE. Participants having non-serious AE or SAE were included in the analysis. The All Treated Subjects Population comprised of all participants who received at least one dose of study treatment.
All Treated Subjects Population
Posted
Count of Participants
Participants
Median of 28.5 weeks
ID
Title
Description
OG000
5 mg/kg GSK3052230 + Paclitaxel + Carboplatin: Arm A
Participants in Arm A received 5 milligram per kilogram (mg/kg) GSK3052230 along with 200 mg per meter square (mg/m^2) of Paclitaxel plus Area under curve (AUC) 6 that is (i.e.) 900 mg Carboplatin
OG001
10 mg/kg GSK3052230 + Paclitaxel + Carboplatin: Arm A
Participants in Arm A received 10 mg/kg GSK3052230 along with 200 mg/m^2 of Paclitaxel plus AUC 6 i.e. 900 mg Carboplatin
OG002
20 mg/kg GSK3052230 + Paclitaxel + Carboplatin: Arm A
Participants in Arm A received 20 mg/kg GSK3052230 along with 200 mg/m^2 of Paclitaxel plus AUC 6 i.e. 900 mg Carboplatin
OG003
5 mg/kg GSK3052230 + Docetaxel: Arm B
Participants in Arm B received 5 mg/kg GSK3052230 along with 75 mg/m^2 Docetaxel
OG004
10 mg/kg GSK3052230 + Docetaxel: Arm B
Participants in Arm B received 10 mg/kg GSK3052230 along with 75 mg/m^2 Docetaxel
OG005
20 mg/kg GSK3052230 + Docetaxel: Arm B
Participants in Arm B received 20 mg/kg GSK3052230 along with 75 mg/m^2 Docetaxel
OG006
10 mg/kg GSK3052230 + Pemetrexed + Cisplatin: Arm C
Participants in Arm C received 10 mg/kg GSK3052230 along with 500 mg/m^2 Pemetrexed plus 75 mg/m^2 Cisplatin
OG007
15 mg/kg GSK3052230 + Pemetrexed + Cisplatin: Arm C
Participants in Arm C received 15 mg/kg GSK3052230 along with 500 mg/m^2 Pemetrexed plus 75 mg/m^2 Cisplatin
OG008
20 mg/kg GSK3052230 + Pemetrexed + Cisplatin: Arm C
Participants in Arm C received 20 mg/kg GSK3052230 along with 500 mg/m^2 Pemetrexed plus 75 mg/m^2 Cisplatin
Units
Counts
Participants
OG0003
OG0013
OG00214
OG003
Title
Denominators
Categories
Non-serious AEs
Title
Measurements
OG0003
OG0013
OG00214
OG003
Primary
Number of Participants With Severe AEs and SAEs
The severity of AEs were graded utilizing National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 4.3. Grade 1 represents mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 represents moderate; minimal, local or noninvasive intervention indicated. Grade 3 represents severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling. Grade 4 represents life-threatening consequences; urgent intervention indicated. Grade 5 represents death related to AE.
All Treated Subjects Population
Posted
Count of Participants
Participants
Median of 28.5 weeks
ID
Title
Description
OG000
5 mg/kg GSK3052230 + Paclitaxel + Carboplatin: Arm A
Participants in Arm A received 5 milligram per kilogram (mg/kg) GSK3052230 along with 200 mg per meter square (mg/m^2) of Paclitaxel plus Area under curve (AUC) 6 that is (i.e.) 900 mg Carboplatin
OG001
10 mg/kg GSK3052230 + Paclitaxel + Carboplatin: Arm A
Participants in Arm A received 10 mg/kg GSK3052230 along with 200 mg/m^2 of Paclitaxel plus AUC 6 i.e. 900 mg Carboplatin
OG002
20 mg/kg GSK3052230 + Paclitaxel + Carboplatin: Arm A
Primary
Number of Participants Withdrew Due to AEs
An AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. The AEs leading to permanent discontinuation from the study has been reported.
All Treated Subjects Population
Posted
Count of Participants
Participants
Median of 28.5 weeks
ID
Title
Description
OG000
5 mg/kg GSK3052230 + Paclitaxel + Carboplatin: Arm A
Participants in Arm A received 5 milligram per kilogram (mg/kg) GSK3052230 along with 200 mg per meter square (mg/m^2) of Paclitaxel plus Area under curve (AUC) 6 that is (i.e.) 900 mg Carboplatin
OG001
10 mg/kg GSK3052230 + Paclitaxel + Carboplatin: Arm A
Participants in Arm A received 10 mg/kg GSK3052230 along with 200 mg/m^2 of Paclitaxel plus AUC 6 i.e. 900 mg Carboplatin
OG002
20 mg/kg GSK3052230 + Paclitaxel + Carboplatin: Arm A
Participants in Arm A received 20 mg/kg GSK3052230 along with 200 mg/m^2 of Paclitaxel plus AUC 6 i.e. 900 mg Carboplatin
OG003
Primary
Number of Participants With Dose Reduction
Dose reduction and delays were done due to toxicity, or in the interest of participant's safety per investigator discretion. Requirement for more than 2 dose reductions resulted in permanent discontinuation of chemotherapy. Participants with dose reduction has been reported.
All Treated Subjects Population
Posted
Count of Participants
Participants
Median of 28.5 weeks
ID
Title
Description
OG000
5 mg/kg GSK3052230 + Paclitaxel + Carboplatin: Arm A
Participants in Arm A received 5 milligram per kilogram (mg/kg) GSK3052230 along with 200 mg per meter square (mg/m^2) of Paclitaxel plus Area under curve (AUC) 6 that is (i.e.) 900 mg Carboplatin
OG001
10 mg/kg GSK3052230 + Paclitaxel + Carboplatin: Arm A
Participants in Arm A received 10 mg/kg GSK3052230 along with 200 mg/m^2 of Paclitaxel plus AUC 6 i.e. 900 mg Carboplatin
OG002
20 mg/kg GSK3052230 + Paclitaxel + Carboplatin: Arm A
Participants in Arm A received 20 mg/kg GSK3052230 along with 200 mg/m^2 of Paclitaxel plus AUC 6 i.e. 900 mg Carboplatin
OG003
Primary
Number of Participants With Dose Delays
Dose reduction and delays were done due to toxicity, or in the interest of participant's safety per investigator discretion. Requirement for more than 2 dose reductions resulted in permanent discontinuation of chemotherapy. Participants with dose delay has been reported.
All Treated Subjects Population
Posted
Count of Participants
Participants
Median of 28.5 weeks
ID
Title
Description
OG000
5 mg/kg GSK3052230 + Paclitaxel + Carboplatin: Arm A
Participants in Arm A received 5 milligram per kilogram (mg/kg) GSK3052230 along with 200 mg per meter square (mg/m^2) of Paclitaxel plus Area under curve (AUC) 6 that is (i.e.) 900 mg Carboplatin
OG001
10 mg/kg GSK3052230 + Paclitaxel + Carboplatin: Arm A
Participants in Arm A received 10 mg/kg GSK3052230 along with 200 mg/m^2 of Paclitaxel plus AUC 6 i.e. 900 mg Carboplatin
OG002
20 mg/kg GSK3052230 + Paclitaxel + Carboplatin: Arm A
Participants in Arm A received 20 mg/kg GSK3052230 along with 200 mg/m^2 of Paclitaxel plus AUC 6 i.e. 900 mg Carboplatin
OG003
Primary
Treatment Duration With GSK3052230
The number of participants administered study treatment were summarized according to the duration of therapy. The extent of treatment exposure is calculated as the number of cycles administered. The duration of exposure to study treatment is calculated from first day to last day of treatment plus 1 day. Median and full range (minimum and maximum) has been reported.
All Treated Subjects Population
Posted
Median
Full Range
Cycles
Median of 28.5 weeks
ID
Title
Description
OG000
5 mg/kg GSK3052230 + Paclitaxel + Carboplatin: Arm A
Participants in Arm A received 5 milligram per kilogram (mg/kg) GSK3052230 along with 200 mg per meter square (mg/m^2) of Paclitaxel plus Area under curve (AUC) 6 that is (i.e.) 900 mg Carboplatin
OG001
10 mg/kg GSK3052230 + Paclitaxel + Carboplatin: Arm A
Participants in Arm A received 10 mg/kg GSK3052230 along with 200 mg/m^2 of Paclitaxel plus AUC 6 i.e. 900 mg Carboplatin
OG002
20 mg/kg GSK3052230 + Paclitaxel + Carboplatin: Arm A
Participants in Arm A received 20 mg/kg GSK3052230 along with 200 mg/m^2 of Paclitaxel plus AUC 6 i.e. 900 mg Carboplatin
Primary
Number of Participants With Dose-Limiting Toxicities (DLT)
DLT is defined as toxicities due to GSK3052230 or due to the combination of GSK3052230 with chemotherapy within Cycle 1 (first 21 days of period on study) that are unlikely to be due to another cause, such as the known effects of cytotoxics chemotherapy alone, disease progression, or accident, and protocol-specified criteria. Clinically significant toxicities that persist or occur beyond Cycle 1 that the investigator and GlaxoSmithKline (GSK) medical monitor consider dose-limiting may also be designated a DLT for the purpose of establishing Maximum tolerated dose (MTD). Number of participants with DLTs has been reported.
All Treated Subjects Population
Posted
Count of Participants
Participants
Median of 28.5 weeks
ID
Title
Description
OG000
5 mg/kg GSK3052230 + Paclitaxel + Carboplatin: Arm A
Participants in Arm A received 5 milligram per kilogram (mg/kg) GSK3052230 along with 200 mg per meter square (mg/m^2) of Paclitaxel plus Area under curve (AUC) 6 that is (i.e.) 900 mg Carboplatin
OG001
10 mg/kg GSK3052230 + Paclitaxel + Carboplatin: Arm A
Participants in Arm A received 10 mg/kg GSK3052230 along with 200 mg/m^2 of Paclitaxel plus AUC 6 i.e. 900 mg Carboplatin
OG002
20 mg/kg GSK3052230 + Paclitaxel + Carboplatin: Arm A
Primary
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
Blood pressure was measured in a semi-supine position after 5 minutes of rest. Blood pressure was measured before start of first chemotherapy infusion and within 20 minutes before start of GSK3052230 infusion on Day 1 of every cycle and Baseline. Baseline is defined as the most recent, non-missing value prior to or on the first study GSK3052230 treatment dose date. Change from Baseline is calculated as visit value minus Baseline value. The worst-case post-Baseline values has been presented. NA indicates that data were not available as standard deviation could not be calculated for a single participant. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).
All Treated Subjects Population
Posted
Mean
Standard Deviation
Millimeters of mercury (mmHg)
Baseline and up to Median of 28.5 weeks
ID
Title
Description
OG000
5 mg/kg GSK3052230 + Paclitaxel + Carboplatin: Arm A
Participants in Arm A received 5 milligram per kilogram (mg/kg) GSK3052230 along with 200 mg per meter square (mg/m^2) of Paclitaxel plus Area under curve (AUC) 6 that is (i.e.) 900 mg Carboplatin
OG001
10 mg/kg GSK3052230 + Paclitaxel + Carboplatin: Arm A
Participants in Arm A received 10 mg/kg GSK3052230 along with 200 mg/m^2 of Paclitaxel plus AUC 6 i.e. 900 mg Carboplatin
Primary
Change From Baseline in Heart Rate
Heart rate was measured in a semi-supine position after 5 minutes of rest. Heart rate was measured before start of first chemotherapy infusion and within 20 minutes before start of GSK3052230 infusion on Day 1 of every cycle and Baseline. Baseline is defined as the most recent, non-missing value prior to or on the first study GSK3052230 treatment dose date. Change from Baseline is calculated as visit value minus Baseline value. The worst-case post-Baseline values has been presented.
All Treated Subjects Population. Number of par. analyzed > number of par. started in the study, as these were bi-directional vital signs tests. Heart rate had both clinically significant low and high ranges and there were par. who experienced both worst case post-Baseline values.Only those par. available at the specified time points were analyzed.
Posted
Mean
Standard Deviation
Beats per minute (bpm)
Baseline and up to Median of 28.5 weeks
Heart rate readings
Heart rate readings
ID
Title
Description
OG000
5 mg/kg GSK3052230 + Paclitaxel + Carboplatin: Arm A
Participants in Arm A received 5 milligram per kilogram (mg/kg) GSK3052230 along with 200 mg per meter square (mg/m^2) of Paclitaxel plus Area under curve (AUC) 6 that is (i.e.) 900 mg Carboplatin
OG001
10 mg/kg GSK3052230 + Paclitaxel + Carboplatin: Arm A
Participants in Arm A received 10 mg/kg GSK3052230 along with 200 mg/m^2 of Paclitaxel plus AUC 6 i.e. 900 mg Carboplatin
Primary
Change From Baseline in Temperature
Temperature was measured in a semi-supine position after 5 minutes of rest. Temperature was measured before start of first chemotherapy infusion and within 20 minutes before start of GSK3052230 infusion on Day 1 of every cycle and Baseline. Baseline is defined as the most recent, non-missing value prior to or on the first study GSK3052230 treatment dose date. Change from Baseline is calculated as visit value minus Baseline value. The worst-case post-Baseline values has been presented.
All Treated Subjects Population. Number of par. analyzed > number of par. started in the study, as these were bi-directional vital signs tests. Heart rate had both clinically significant low and high ranges and there were par. who experienced both worst case post-Baseline values.Only those par. available at the specified time points were analyzed.
Posted
Mean
Standard Deviation
Degree Celsius
Baseline and up to Median of 28.5 weeks
Temperature readings
Temperature readings
ID
Title
Description
OG000
5 mg/kg GSK3052230 + Paclitaxel + Carboplatin: Arm A
Participants in Arm A received 5 milligram per kilogram (mg/kg) GSK3052230 along with 200 mg per meter square (mg/m^2) of Paclitaxel plus Area under curve (AUC) 6 that is (i.e.) 900 mg Carboplatin
OG001
10 mg/kg GSK3052230 + Paclitaxel + Carboplatin: Arm A
Participants in Arm A received 10 mg/kg GSK3052230 along with 200 mg/m^2 of Paclitaxel plus AUC 6 i.e. 900 mg Carboplatin
Primary
Number of Participants With Clinically Significant Findings for 12-lead Electrocardiogram (ECG)
A single 12-lead ECG was performed at the specified timepoints during the study where the participant was instructed to be in semi-recumbent position for 5 minutes before obtaining the ECG. An ECG machine that automatically calculated the heart rate and measures like the PR, QRS, QT, and corrected QT intervals. Number of participants with worst-case post-Baseline abnormal clinically significant findings and abnormal not clinically significant findings in ECG results has been reported.
All Treated Subjects Population
Posted
Count of Participants
Participants
Median of 28.5 weeks
ID
Title
Description
OG000
5 mg/kg GSK3052230 + Paclitaxel + Carboplatin: Arm A
Participants in Arm A received 5 milligram per kilogram (mg/kg) GSK3052230 along with 200 mg per meter square (mg/m^2) of Paclitaxel plus Area under curve (AUC) 6 that is (i.e.) 900 mg Carboplatin
OG001
10 mg/kg GSK3052230 + Paclitaxel + Carboplatin: Arm A
Participants in Arm A received 10 mg/kg GSK3052230 along with 200 mg/m^2 of Paclitaxel plus AUC 6 i.e. 900 mg Carboplatin
OG002
20 mg/kg GSK3052230 + Paclitaxel + Carboplatin: Arm A
Primary
Number of Participants With Abnormal Echocardiogram (ECHO) Findings
Echocardiography scans were obtained at given time points using an echocardiogram and the findings for left ventricular ejection fraction (LVEF) were obtained. LVEF values at end of treatment (EOT) were recorded as no change or any increase and any decrease values. Only those participants available at the specified time points were analyzed.
All Treated Subjects Population
Posted
Count of Participants
Participants
Median of 28.5 weeks
ID
Title
Description
OG000
5 mg/kg GSK3052230 + Paclitaxel + Carboplatin: Arm A
Participants in Arm A received 5 milligram per kilogram (mg/kg) GSK3052230 along with 200 mg per meter square (mg/m^2) of Paclitaxel plus Area under curve (AUC) 6 that is (i.e.) 900 mg Carboplatin
OG001
10 mg/kg GSK3052230 + Paclitaxel + Carboplatin: Arm A
Participants in Arm A received 10 mg/kg GSK3052230 along with 200 mg/m^2 of Paclitaxel plus AUC 6 i.e. 900 mg Carboplatin
OG002
20 mg/kg GSK3052230 + Paclitaxel + Carboplatin: Arm A
Participants in Arm A received 20 mg/kg GSK3052230 along with 200 mg/m^2 of Paclitaxel plus AUC 6 i.e. 900 mg Carboplatin
Primary
Number of Participants With Clinical Chemistry Changes From Baseline With Respect to the Normal Range
Clinical chemistry parameters included potassium, sodium, chloride (Cl), total carbon dioxide (CO2), total and ionized calcium, magnesium, phosphate, albumin, glucose (fasting), Blood urea nitrogen (BUN), creatinine (Cr), uric acid, creatinine clearance, aspartate aminotransferase (AST), alanine aminotransferase (ALT), gamma glutamyl transferase (GGT), alkaline phosphatase, Total bilirubin (T. Bil), and Direct bilirubin (D. Bil), total T3 and T4, free T4, amylase, lipase, prothrombin time, partial thromboplastin time, international normalized ratio, and fibrinogen. Baseline is defined as the most recent, non-missing value prior to or on the first study GSK3052230 treatment dose date. Change from Baseline is calculated as visit value minus Baseline value. Clinical chemistry parameters with change from Baseline with respect to normal range only has been presented. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).
All Treated Subjects Population
Posted
Count of Participants
Participants
Median of 28.5 weeks
ID
Title
Description
OG000
5 mg/kg GSK3052230 + Paclitaxel + Carboplatin: Arm A
Participants in Arm A received 5 milligram per kilogram (mg/kg) GSK3052230 along with 200 mg per meter square (mg/m^2) of Paclitaxel plus Area under curve (AUC) 6 that is (i.e.) 900 mg Carboplatin
OG001
10 mg/kg GSK3052230 + Paclitaxel + Carboplatin: Arm A
Primary
Number of Participants With the Abnormal Urinalysis Findings
Urinalysis parameters included urine protein, urine glucose, urine ketones and occult blood were assessed. Dipstick test was performed for routine urinalysis. Abnormal values such as trace, 1+, 2+, 3+, 4+, >1000, >=1000, and >10 have been reported.
All Treated Subjects Population
Posted
Count of Participants
Participants
Up to Cycle 16 (each cycle was of 21 days)
ID
Title
Description
OG000
5 mg/kg GSK3052230 + Paclitaxel + Carboplatin: Arm A
Participants in Arm A received 5 milligram per kilogram (mg/kg) GSK3052230 along with 200 mg per meter square (mg/m^2) of Paclitaxel plus Area under curve (AUC) 6 that is (i.e.) 900 mg Carboplatin
OG001
10 mg/kg GSK3052230 + Paclitaxel + Carboplatin: Arm A
Participants in Arm A received 10 mg/kg GSK3052230 along with 200 mg/m^2 of Paclitaxel plus AUC 6 i.e. 900 mg Carboplatin
OG002
20 mg/kg GSK3052230 + Paclitaxel + Carboplatin: Arm A
Participants in Arm A received 20 mg/kg GSK3052230 along with 200 mg/m^2 of Paclitaxel plus AUC 6 i.e. 900 mg Carboplatin
OG003
Primary
Number of Participants With Hematology Change From Baseline With Respect to the Normal Range
Hematology parameters included platelet Count, red blood cell (RBC) Count, hemoglobin, absolute white blood cell (WBC) Count, absolute neutrophils (Neu), absolute lymphocytes (Lym), absolute monocytes (Mono), absolute eosinophils (Eos), absolute basophils (Baso). Baseline is defined as the most recent, non-missing value prior to or on the first study GSK3052230 treatment dose date. Change from Baseline is calculated as visit value minus Baseline value. Hematology parameters with worst-case change from Baseline with respect to normal range only has been presented. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).
All Treated Subjects Population
Posted
Count of Participants
Participants
Median of 28.5 weeks
ID
Title
Description
OG000
5 mg/kg GSK3052230 + Paclitaxel + Carboplatin: Arm A
Participants in Arm A received 5 milligram per kilogram (mg/kg) GSK3052230 along with 200 mg per meter square (mg/m^2) of Paclitaxel plus Area under curve (AUC) 6 that is (i.e.) 900 mg Carboplatin
OG001
10 mg/kg GSK3052230 + Paclitaxel + Carboplatin: Arm A
Participants in Arm A received 10 mg/kg GSK3052230 along with 200 mg/m^2 of Paclitaxel plus AUC 6 i.e. 900 mg Carboplatin
OG002
Primary
Number of Participants With Maximum Tolerated Dose (MTD) or Maximum Feasible Dose (MFD)
The MTD is defined as the highest dose level tested at which < 33 percent of participants experience a DLT. In cases when MTD is not reached dose was described as the MFD.
All Treated Subjects Population
Posted
Count of Participants
Participants
Median of 28.5 weeks
ID
Title
Description
OG000
20 mg/kg GSK3052230 + Paclitaxel + Carboplatin: Arm A
Participants in Arm A received 20 mg/kg GSK3052230 along with 200 mg/m^2 of Paclitaxel plus AUC 6 i.e. 900 mg Carboplatin
OG001
20 mg/kg GSK3052230 + Docetaxel: Arm B
Participants in Arm B received 20 mg/kg GSK3052230 along with 75 mg/m^2 Docetaxel
OG002
15 mg/kg GSK3052230 + Pemetrexed + Carboplatin: Arm C
Participants in Arm C received 15 mg/kg GSK3052230 along with 500 mg/m^2 Pemetrexed plus 75 mg/m^2 Cisplatin
Units
Counts
Primary
Number of Participants With Best Response
Best response defined as complete response (CR:disappearance of all target. Any pathological lymph nodes < 10 millimeter [mm] in the short axis) or partial response (PR at least a 30 percent decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters), stable disease (SD neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease) or progressive disease (PR at least a 20 percent increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started. In addition, the sum must have an absolute increase from nadir of 5 mm) according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 or modified RECIST. Best response as per RECIST version 1.1 for Arm A and B participants has been reported. Best response according to RECIST version 1.1 or modified RECIST for Arm C participants has been reported.
All Evaluable Subjects Population
Posted
Count of Participants
Participants
Median of 28.5 weeks
ID
Title
Description
OG000
5 mg/kg GSK3052230 + Paclitaxel + Carboplatin: Arm A
Participants in Arm A received 5 milligram per kilogram (mg/kg) GSK3052230 along with 200 mg per meter square (mg/m^2) of Paclitaxel plus Area under curve (AUC) 6 that is (i.e.) 900 mg Carboplatin
OG001
10 mg/kg GSK3052230 + Paclitaxel + Carboplatin: Arm A
Primary
Number of Participants With Overall Response Rate (ORR)
Overall Response Rate (ORR) is defined as the percentage of participants achieving a confirmed Complete response (CR) or Partial response (PR) from the start of treatment until disease progression as per RECIST version 1.1 or modified RECIST for participants in Arm C. This was determined based on Investigator assessments of response. 95% confidence intervals (CI) are calculated based on the unconditional exact method. ORR as per RECIST vesrion 1.1 for Arm A and B has been reported. ORR as per RECIST version 1.1 and modified RECIST version 1.1 for Arm C has been reported. The study population used for decision-making at the interim analyses during the dose expansion cohorts of the study arms is termed as the All Evaluable Participants Population. NA indicates 0 participants met ORR criteria therefore no dispersion.
All Evaluable Subjects Population
Posted
Count of Participants
Participants
Median of 28.5 weeks
ID
Title
Description
OG000
5 mg/kg GSK3052230 + Paclitaxel + Carboplatin: Arm A
Participants in Arm A received 5 milligram per kilogram (mg/kg) GSK3052230 along with 200 mg per meter square (mg/m^2) of Paclitaxel plus Area under curve (AUC) 6 that is (i.e.) 900 mg Carboplatin
OG001
10 mg/kg GSK3052230 + Paclitaxel + Carboplatin: Arm A
Participants in Arm A received 10 mg/kg GSK3052230 along with 200 mg/m^2 of Paclitaxel plus AUC 6 i.e. 900 mg Carboplatin
Secondary
Progression Free Survival (PFS) as Assessed by Investigator
PFS is defined as the interval between first dose of GSK3052230 and the earliest date of disease progression or death due to any cause by investigator assessment per RECIST 1.1 (for Arm A and B participants) or modified RECIST (for Arm C participants). For participants who do not progress or die, PFS was censored at the time of last radiological scan. Participants who discontinued study with no post-treatment tumor assessment were censored at date of first dose of study drug. Mean and 95 percent CI has been reported. NA indicates that data were not available as only 1 participant had event, other two censored therefore there is no confidence interval.
All Evaluable Subjects Population
Posted
Median
95% Confidence Interval
Months
Median of 28.5 weeks
ID
Title
Description
OG000
5 mg/kg GSK3052230 + Paclitaxel + Carboplatin: Arm A
Participants in Arm A received 5 milligram per kilogram (mg/kg) GSK3052230 along with 200 mg per meter square (mg/m^2) of Paclitaxel plus Area under curve (AUC) 6 that is (i.e.) 900 mg Carboplatin
OG001
10 mg/kg GSK3052230 + Paclitaxel + Carboplatin: Arm A
Participants in Arm A received 10 mg/kg GSK3052230 along with 200 mg/m^2 of Paclitaxel plus AUC 6 i.e. 900 mg Carboplatin
OG002
20 mg/kg GSK3052230 + Paclitaxel + Carboplatin: Arm A
Secondary
Clearance of GSK3052230
Serial blood sample were collected at an indicated time points. A nonlinear mixed effects model was used to determine clearances. The Pharmacokinetic Population (PK) consisted of all participants in the All Treated Subject Population for whom a blood sample for pharmacokinetics was obtained and analyzed. Plasma GSK3052230 concentration-time data were to be combined with data from other studies to be analyzed using a population PK approach. However, other studies with GSK3052230 were not performed and thus no population PK analyses were done.
Pharmacokinetic Population
Posted
Cycle(C)1 Day (D) 1 Pre-dose, End of infusion, 1 and 2 hours post-dose;C1 D8 Pre-dose,end of infusion; C2 D1 Pre-dose, End of infusion, 1 and 2 hours post-dose;C4 D1 Predose, end of infusion;C6 D1 Pre-dose, end of infusion,C12 D1 Pre-dose, end of infusion
ID
Title
Description
OG000
5 mg/kg GSK3052230 + Paclitaxel + Carboplatin: Arm A
Participants in Arm A received 5 milligram per kilogram (mg/kg) GSK3052230 along with 200 mg per meter square (mg/m^2) of Paclitaxel plus Area under curve (AUC) 6 that is (i.e.) 900 mg Carboplatin
OG001
10 mg/kg GSK3052230 + Paclitaxel + Carboplatin: Arm A
Participants in Arm A received 10 mg/kg GSK3052230 along with 200 mg/m^2 of Paclitaxel plus AUC 6 i.e. 900 mg Carboplatin
OG002
Secondary
Volume of Distribution of GSK3052230
Serial blood sample were collected at an indicated time points. A nonlinear mixed effects model was used to determine volume distribution. Plasma GSK3052230 concentration-time data were to be combined with data from other studies to be analyzed using a population PK approach. However, other studies with GSK3052230 were not performed and thus no population PK analyses were done.
Pharmacokinetic Population
Posted
Cycle(C)1 Day (D) 1 Pre-dose, End of infusion, 1 and 2 hours post-dose;C1 D8 Pre-dose,end of infusion; C2 D1 Pre-dose, End of infusion, 1 and 2 hours post-dose;C4 D1 Predose, end of infusion;C6 D1 Pre-dose, end of infusion,C12 D1 Pre-dose, end of infusion
ID
Title
Description
OG000
5 mg/kg GSK3052230 + Paclitaxel + Carboplatin: Arm A
Participants in Arm A received 5 milligram per kilogram (mg/kg) GSK3052230 along with 200 mg per meter square (mg/m^2) of Paclitaxel plus Area under curve (AUC) 6 that is (i.e.) 900 mg Carboplatin
OG001
10 mg/kg GSK3052230 + Paclitaxel + Carboplatin: Arm A
Participants in Arm A received 10 mg/kg GSK3052230 along with 200 mg/m^2 of Paclitaxel plus AUC 6 i.e. 900 mg Carboplatin
OG002
20 mg/kg GSK3052230 + Paclitaxel + Carboplatin: Arm A
Secondary
Number of Participants With Relevant Covariates That Influence Exposure of GSK3052230
Relevant covariates included parameters like age, weight and disease related covariates. Plasma GSK3052230 concentration-time data were to be combined with data from other studies to be analyzed using a population PK approach. However, other studies with GSK3052230 were not performed and thus no population PK analyses were done.
Pharmacokinetic Population
Posted
Cycle(C)1 Day (D) 1 Pre-dose, End of infusion, 1 and 2 hours post-dose;C1 D8 Pre-dose,end of infusion; C2 D1 Pre-dose, End of infusion, 1 and 2 hours post-dose;C4 D1 Predose, end of infusion;C6 D1 Pre-dose, end of infusion,C12 D1 Pre-dose, end of infusion
ID
Title
Description
OG000
5 mg/kg GSK3052230 + Paclitaxel + Carboplatin: Arm A
Participants in Arm A received 5 milligram per kilogram (mg/kg) GSK3052230 along with 200 mg per meter square (mg/m^2) of Paclitaxel plus Area under curve (AUC) 6 that is (i.e.) 900 mg Carboplatin
OG001
10 mg/kg GSK3052230 + Paclitaxel + Carboplatin: Arm A
Participants in Arm A received 10 mg/kg GSK3052230 along with 200 mg/m^2 of Paclitaxel plus AUC 6 i.e. 900 mg Carboplatin
OG002
20 mg/kg GSK3052230 + Paclitaxel + Carboplatin: Arm A
Secondary
Change From Baseline in Forced Vital Capacity (FVC) in of Arm C Participants With Malignant Pleural Mesothelioma (MPM)
FVC is the total amount of air exhaled during the Forced Expiratory Volume test. Baseline is defined as the most recent, non-missing value prior to or on the first study GSK3052230 treatment dose date. Change from Baseline is calculated as visit value minus Baseline value. Assessment of FVC was done on Day 1 of every odd cycle for Arm C participants with MPM. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates that data were not available as standard deviation could not be calculated for a single participant.
All Treated Subjects Population
Posted
Mean
Standard Deviation
Liters
Up to 31 cycles (each cycle was of 21 days)
ID
Title
Description
OG000
10 mg/kg GSK3052230 + Pemetrexed + Cisplatin: Arm C
Participants in Arm C received 10 mg/kg GSK3052230 along with 500 mg/m^2 Pemetrexed plus 75 mg/m^2 Cisplatin
OG001
15 mg/kg GSK3052230 + Pemetrexed + Cisplatin: Arm C
Participants in Arm C received 15 mg/kg GSK3052230 along with 500 mg/m^2 Pemetrexed plus 75 mg/m^2 Cisplatin
OG002
20 mg/kg GSK3052230 + Pemetrexed + Cisplatin: Arm C
Time Frame
Serious adverse events (SAEs) and non-serious adverse events (AEs) were be collected from the start of study treatment and up to Median of 28.5 weeks.
Description
All Treated Subjects Population
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
5 mg/kg GSK3052230 + Paclitaxel + Carboplatin: Arm A
Participants in Arm A received 5 milligram per kilogram (mg/kg) GSK3052230 along with 200 mg per meter square (mg/m^2) of Paclitaxel plus Area under curve (AUC) 6 that is (i.e.) 900 mg Carboplatin
0
3
0
3
3
3
EG001
10 mg/kg GSK3052230 + Paclitaxel + Carboplatin: Arm A
Participants in Arm A received 10 mg/kg GSK3052230 along with 200 mg/m^2 of Paclitaxel plus AUC 6 i.e. 900 mg Carboplatin
0
3
3
3
3
3
EG002
20 mg/kg GSK3052230 + Paclitaxel + Carboplatin: Arm A
Participants in Arm A received 20 mg/kg GSK3052230 along with 200 mg/m^2 of Paclitaxel plus AUC 6 i.e. 900 mg Carboplatin
0
14
5
14
14
14
EG003
5 mg/kg GSK3052230 + Docetaxel: Arm B
Participants in Arm B received 5 mg/kg GSK3052230 along with 75 mg/m^2 Docetaxel
0
3
2
3
3
3
EG004
10 mg/kg GSK3052230 + Docetaxel: Arm B
Participants in Arm B received 10 mg/kg GSK3052230 along with 75 mg/m^2 Docetaxel
0
3
3
3
3
3
EG005
20 mg/kg GSK3052230 + Docetaxel: Arm B
Participants in Arm B received 20 mg/kg GSK3052230 along with 75 mg/m^2 Docetaxel
0
3
1
3
3
3
EG006
10 mg/kg GSK3052230 + Pemetrexed + Cisplatin: Arm C
Participants in Arm C received 10 mg/kg GSK3052230 along with 500 mg/m^2 Pemetrexed plus 75 mg/m^2 Cisplatin
0
3
0
3
3
3
EG007
15 mg/kg GSK3052230 + Pemetrexed + Cisplatin: Arm C
Participants in Arm C received 15 mg/kg GSK3052230 along with 500 mg/m^2 Pemetrexed plus 75 mg/m^2 Cisplatin
0
25
5
25
24
25
EG008
20 mg/kg GSK3052230 + Pemetrexed + Cisplatin: Arm C
Participants in Arm C received 20 mg/kg GSK3052230 along with 500 mg/m^2 Pemetrexed plus 75 mg/m^2 Cisplatin
1
8
4
8
8
8
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Febrile neutropenia
Blood and lymphatic system disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0023 events2 affected14 at risk
EG0030 events0 affected3 at risk
EG0042 events2 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected25 at risk
EG0080 events0 affected8 at risk
Neutropenia
Blood and lymphatic system disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0012 events1 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Respiratory tract infection
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0022 events2 affected14 at risk
EG003
Lung infection
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected14 at risk
EG003
Stenotrophomonas infection
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected14 at risk
EG003
Asthenia
General disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected14 at risk
EG003
Pyrexia
General disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected14 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Diabetes mellitus
Metabolism and nutrition disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected14 at risk
EG003
Ataxia
Nervous system disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected14 at risk
EG003
Confusional state
Psychiatric disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Myocardial infarction
Cardiac disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Pericardial effusion
Cardiac disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Intestinal ischaemia
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Intestinal perforation
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Infusion related reaction
Injury, poisoning and procedural complications
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Femur fracture
Injury, poisoning and procedural complications
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Clostridium difficile infection
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Pneumonia pseudomonal
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Blood creatinine increased
Investigations
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Nervous system disorder
Nervous system disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Neutropenia
Blood and lymphatic system disorders
MedDRA 20.1
Systematic Assessment
EG0004 events2 affected3 at risk
EG00114 events1 affected3 at risk
EG00250 events12 affected14 at risk
EG0032 events1 affected3 at risk
EG0040 events0 affected3 at risk
EG00510 events2 affected3 at risk
EG0060 events0 affected3 at risk
EG00730 events6 affected25 at risk
EG0086 events2 affected8 at risk
Anaemia
Blood and lymphatic system disorders
MedDRA 20.1
Systematic Assessment
EG0002 events2 affected3 at risk
EG0011 events1 affected3 at risk
EG0028 events5 affected14 at risk
EG003
Leukopenia
Blood and lymphatic system disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG00212 events3 affected14 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0028 events3 affected14 at risk
EG003
Pancytopenia
Blood and lymphatic system disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0022 events1 affected14 at risk
EG003
Asthenia
General disorders
MedDRA 20.1
Systematic Assessment
EG0004 events2 affected3 at risk
EG0018 events2 affected3 at risk
EG00213 events3 affected14 at risk
EG003
Fatigue
General disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG00212 events5 affected14 at risk
EG003
Oedema peripheral
General disorders
MedDRA 20.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0024 events3 affected14 at risk
EG003
Pyrexia
General disorders
MedDRA 20.1
Systematic Assessment
EG0002 events2 affected3 at risk
EG0010 events0 affected3 at risk
EG0022 events2 affected14 at risk
EG003
Chest pain
General disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0022 events1 affected14 at risk
EG003
Chills
General disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0022 events2 affected14 at risk
EG003
Gait disturbance
General disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0021 events1 affected14 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0014 events1 affected3 at risk
EG0021 events1 affected14 at risk
EG003
Pain
General disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0022 events2 affected14 at risk
EG003
Device related thrombosis
General disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected14 at risk
EG003
Influenza like illness
General disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected14 at risk
EG003
Mucosal inflammation
General disorders
MedDRA 20.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Neuropathy peripheral
Nervous system disorders
MedDRA 20.1
Systematic Assessment
EG0002 events2 affected3 at risk
EG0010 events0 affected3 at risk
EG0024 events4 affected14 at risk
EG003
Dysaesthesia
Nervous system disorders
MedDRA 20.1
Systematic Assessment
EG0004 events3 affected3 at risk
EG0011 events1 affected3 at risk
EG0023 events1 affected14 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0023 events3 affected14 at risk
EG003
Headache
Nervous system disorders
MedDRA 20.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0022 events2 affected14 at risk
EG003
Neurotoxicity
Nervous system disorders
MedDRA 20.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0011 events1 affected3 at risk
EG0024 events1 affected14 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA 20.1
Systematic Assessment
EG0002 events2 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected14 at risk
EG003
Peripheral sensory neuropathy
General disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0025 events3 affected14 at risk
EG003
Dysgeusia
General disorders
MedDRA 20.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected14 at risk
EG003
Syncope
General disorders
MedDRA 20.1
Systematic Assessment
EG0002 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected14 at risk
EG003
Ataxia
General disorders
MedDRA 20.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Balance disorder
General disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected14 at risk
EG003
Presyncope
General disorders
MedDRA 20.1
Systematic Assessment
EG0002 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Somnolence
General disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected14 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0004 events1 affected3 at risk
EG0012 events2 affected3 at risk
EG0028 events7 affected14 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0003 events2 affected3 at risk
EG0012 events2 affected3 at risk
EG0024 events4 affected14 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0002 events2 affected3 at risk
EG0014 events1 affected3 at risk
EG0025 events3 affected14 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0026 events5 affected14 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0022 events2 affected14 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Anorectal discomfort
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected14 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected14 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected14 at risk
EG003
Proctalgia
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0022 events1 affected14 at risk
EG003
Retching
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected14 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 20.1
Systematic Assessment
EG0004 events3 affected3 at risk
EG0013 events1 affected3 at risk
EG0026 events4 affected14 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0025 events3 affected14 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 20.1
Systematic Assessment
EG0002 events2 affected3 at risk
EG0010 events0 affected3 at risk
EG0022 events2 affected14 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0022 events1 affected14 at risk
EG003
Bone pain
Musculoskeletal and connective tissue disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0022 events1 affected14 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA 20.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
MedDRA 20.1
Systematic Assessment
EG0003 events3 affected3 at risk
EG0011 events1 affected3 at risk
EG0029 events7 affected14 at risk
EG003
Hyperhidrosis
Skin and subcutaneous tissue disorders
MedDRA 20.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Night sweats
Skin and subcutaneous tissue disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected14 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected14 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0023 events1 affected14 at risk
EG003
Rash erythematous
Skin and subcutaneous tissue disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected14 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected14 at risk
EG003
Rash papular
Skin and subcutaneous tissue disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected14 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 20.1
Systematic Assessment
EG0003 events2 affected3 at risk
EG0012 events2 affected3 at risk
EG0025 events4 affected14 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0026 events3 affected14 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0023 events3 affected14 at risk
EG003
Hypophosphataemia
Metabolism and nutrition disorders
MedDRA 20.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected14 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected14 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0022 events1 affected14 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected14 at risk
EG003
Hypoalbuminaemia
Metabolism and nutrition disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected14 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 20.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 20.1
Systematic Assessment
EG0004 events2 affected3 at risk
EG0010 events0 affected3 at risk
EG00211 events5 affected14 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 20.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0011 events1 affected3 at risk
EG0024 events3 affected14 at risk
EG003
Dysphonia
Respiratory, thoracic and mediastinal disorders
MedDRA 20.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected14 at risk
EG003
Respiratory disorder
Respiratory, thoracic and mediastinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0024 events2 affected14 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected14 at risk
EG003
Haemoptysis
Respiratory, thoracic and mediastinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0023 events1 affected14 at risk
EG003
Productive cough
Respiratory, thoracic and mediastinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0022 events1 affected14 at risk
EG003
Respiratory tract infection
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0012 events1 affected3 at risk
EG0022 events2 affected14 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0023 events3 affected14 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0013 events2 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0002 events1 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Conjunctivitis viral
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Genital herpes
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected14 at risk
EG003
Lung infection
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0022 events1 affected14 at risk
EG003
Mastitis
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected14 at risk
EG003
Oropharyngeal candidiasis
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 20.1
Systematic Assessment
EG0002 events2 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected14 at risk
EG003
Neutrophil count decreased
Investigations
MedDRA 20.1
Systematic Assessment
EG0004 events2 affected3 at risk
EG0012 events1 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Blood creatinine increased
Investigations
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0012 events1 affected3 at risk
EG0022 events1 affected14 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected14 at risk
EG003
Blood alkaline phosphatase increased
Investigations
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected14 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected14 at risk
EG003
Blood urea decreased
Investigations
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected14 at risk
EG003
Gamma-glutamyltransferase increased
Investigations
MedDRA 20.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected14 at risk
EG003
International normalised ratio increased
Investigations
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected14 at risk
EG003
Platelet count decreased
Investigations
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0026 events1 affected14 at risk
EG003
Weight decreased
Investigations
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected14 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA 20.1
Systematic Assessment
EG0002 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0024 events4 affected14 at risk
EG003
Depression
Psychiatric disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0022 events2 affected14 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected14 at risk
EG003
Infusion related reaction
Injury, poisoning and procedural complications
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0024 events4 affected14 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected14 at risk
EG003
Cystoid macular oedema
Eye disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected14 at risk
EG003
Eyelid oedema
Eye disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected14 at risk
EG003
Retinal neovascularisation
Eye disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected14 at risk
EG003
Hypertension
Vascular disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0022 events2 affected14 at risk
EG003
Thrombosis
Vascular disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected14 at risk
EG003
Venous thrombosis limb
Vascular disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected14 at risk
EG003
Cardiomegaly
Cardiac disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected14 at risk
EG003
Tachycardia
Cardiac disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected14 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0022 events1 affected14 at risk
EG003
Drug hypersensitivity
Immune system disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected14 at risk
EG003
Pollakiuria
Renal and urinary disorders
MedDRA 20.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Erectile dysfunction
Reproductive system and breast disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Toothache
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Dermatitis acneiform
Skin and subcutaneous tissue disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Erythema multiforme
Skin and subcutaneous tissue disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Nail disorder
Skin and subcutaneous tissue disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Nail ridging
Skin and subcutaneous tissue disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Rash pruritic
Skin and subcutaneous tissue disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Swelling face
Skin and subcutaneous tissue disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Urticaria
Skin and subcutaneous tissue disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Candida infection
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Oral herpes
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Paronychia
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Rhinitis
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Arthritis
Musculoskeletal and connective tissue disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Leukocytosis
Blood and lymphatic system disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Lymph node palpable
Investigations
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Lymphocyte count decreased
Investigations
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected14 at risk
EG003
White blood cell count decreased
Investigations
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Pneumonitis
Respiratory, thoracic and mediastinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Pneumothorax
Respiratory, thoracic and mediastinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Flushing
Vascular disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Hypotension
Vascular disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Acute coronary syndrome
Cardiac disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Angina pectoris
Cardiac disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Arrhythmia supraventricular
Cardiac disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Ventricular tachycardia
Cardiac disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Peripheral motor neuropathy
Nervous system disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Tinnitus
Ear and labyrinth disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Lacrimation increased
Eye disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Thrombosis in device
Product Issues
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Dysuria
Renal and urinary disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Malaise
General disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Haemorrhoids
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Salivary duct inflammation
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Ileus
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Hypoaesthesia
Nervous system disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Tremor
Nervous system disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Cognitive disorder
Nervous system disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Disturbance in attention
Nervous system disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Myoclonus
Nervous system disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Blood albumin decreased
Investigations
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Blood calcium decreased
Investigations
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Blood fibrinogen increased
Investigations
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Blood magnesium decreased
Investigations
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Blood urea increased
Investigations
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Bilirubin conjugated increased
Investigations
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Creatinine renal clearance decreased
Investigations
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Electrocardiogram repolarisation abnormality
Investigations
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Protein total decreased
Investigations
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Hiccups
Respiratory, thoracic and mediastinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Pleuritic pain
Respiratory, thoracic and mediastinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Hypercapnia
Respiratory, thoracic and mediastinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Monocytosis
Blood and lymphatic system disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Joint swelling
Musculoskeletal and connective tissue disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Dry eye
Eye disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Vision blurred
Eye disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Viral upper respiratory tract infection
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Device related infection
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Conjunctivitis
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Influenza
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Tracheitis
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Confusional state
Psychiatric disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Delirium
Psychiatric disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Sleep disorder
Psychiatric disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Conduction disorder
Cardiac disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Palpitations
Cardiac disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Left ventricular hypertrophy
Cardiac disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Ventricular extrasystoles
Cardiac disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Pleural mesothelioma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected14 at risk
EG003
Nephrolithiasis
Renal and urinary disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected14 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
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Participants in Arm A received 20 mg/kg GSK3052230 along with 200 mg/m^2 of Paclitaxel plus AUC 6 i.e. 900 mg Carboplatin
OG003
5 mg/kg GSK3052230 + Docetaxel: Arm B
Participants in Arm B received 5 mg/kg GSK3052230 along with 75 mg/m^2 Docetaxel
OG004
10 mg/kg GSK3052230 + Docetaxel: Arm B
Participants in Arm B received 10 mg/kg GSK3052230 along with 75 mg/m^2 Docetaxel
OG005
20 mg/kg GSK3052230 + Docetaxel: Arm B
Participants in Arm B received 20 mg/kg GSK3052230 along with 75 mg/m^2 Docetaxel
OG006
10 mg/kg GSK3052230 + Pemetrexed + Cisplatin: Arm C
Participants in Arm C received 10 mg/kg GSK3052230 along with 500 mg/m^2 Pemetrexed plus 75 mg/m^2 Cisplatin
OG007
15 mg/kg GSK3052230 + Pemetrexed + Cisplatin: Arm C
Participants in Arm C received 15 mg/kg GSK3052230 along with 500 mg/m^2 Pemetrexed plus 75 mg/m^2 Cisplatin
OG008
20 mg/kg GSK3052230 + Pemetrexed + Cisplatin: Arm C
Participants in Arm C received 20 mg/kg GSK3052230 along with 500 mg/m^2 Pemetrexed plus 75 mg/m^2 Cisplatin
Units
Counts
Participants
OG0003
OG0013
OG00214
OG0033
OG0043
OG0053
OG0063
OG00725
OG0088
Title
Denominators
Categories
Title
Measurements
Grade 1
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0071
OG0080
Grade 2
OG0000
OG0010
OG0022
OG0030
OG004
Grade 3
OG0001
OG0011
OG0028
OG0032
OG004
Grade 4
OG0002
OG0012
OG0024
OG0031
OG004
Grade 5
OG0000
OG0010
OG0020
OG0030
OG004
5 mg/kg GSK3052230 + Docetaxel: Arm B
Participants in Arm B received 5 mg/kg GSK3052230 along with 75 mg/m^2 Docetaxel
OG004
10 mg/kg GSK3052230 + Docetaxel: Arm B
Participants in Arm B received 10 mg/kg GSK3052230 along with 75 mg/m^2 Docetaxel
OG005
20 mg/kg GSK3052230 + Docetaxel: Arm B
Participants in Arm B received 20 mg/kg GSK3052230 along with 75 mg/m^2 Docetaxel
OG006
10 mg/kg GSK3052230 + Pemetrexed + Cisplatin: Arm C
Participants in Arm C received 10 mg/kg GSK3052230 along with 500 mg/m^2 Pemetrexed plus 75 mg/m^2 Cisplatin
OG007
15 mg/kg GSK3052230 + Pemetrexed + Cisplatin: Arm C
Participants in Arm C received 15 mg/kg GSK3052230 along with 500 mg/m^2 Pemetrexed plus 75 mg/m^2 Cisplatin
OG008
20 mg/kg GSK3052230 + Pemetrexed + Cisplatin: Arm C
Participants in Arm C received 20 mg/kg GSK3052230 along with 500 mg/m^2 Pemetrexed plus 75 mg/m^2 Cisplatin
Units
Counts
Participants
OG0003
OG0013
OG00214
OG0033
OG0043
OG0053
OG0063
OG00725
OG0088
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0041
OG0050
OG0062
OG0071
OG0083
5 mg/kg GSK3052230 + Docetaxel: Arm B
Participants in Arm B received 5 mg/kg GSK3052230 along with 75 mg/m^2 Docetaxel
OG004
10 mg/kg GSK3052230 + Docetaxel: Arm B
Participants in Arm B received 10 mg/kg GSK3052230 along with 75 mg/m^2 Docetaxel
OG005
20 mg/kg GSK3052230 + Docetaxel: Arm B
Participants in Arm B received 20 mg/kg GSK3052230 along with 75 mg/m^2 Docetaxel
OG006
10 mg/kg GSK3052230 + Pemetrexed + Cisplatin: Arm C
Participants in Arm C received 10 mg/kg GSK3052230 along with 500 mg/m^2 Pemetrexed plus 75 mg/m^2 Cisplatin
OG007
15 mg/kg GSK3052230 + Pemetrexed + Cisplatin: Arm C
Participants in Arm C received 15 mg/kg GSK3052230 along with 500 mg/m^2 Pemetrexed plus 75 mg/m^2 Cisplatin
OG008
20 mg/kg GSK3052230 + Pemetrexed + Cisplatin: Arm C
Participants in Arm C received 20 mg/kg GSK3052230 along with 500 mg/m^2 Pemetrexed plus 75 mg/m^2 Cisplatin
Units
Counts
Participants
OG0003
OG0013
OG00214
OG0033
OG0043
OG0053
OG0063
OG00725
OG0088
Title
Denominators
Categories
Title
Measurements
OG0001
OG0010
OG0023
OG0031
OG0040
OG0052
OG0060
OG0072
OG0080
5 mg/kg GSK3052230 + Docetaxel: Arm B
Participants in Arm B received 5 mg/kg GSK3052230 along with 75 mg/m^2 Docetaxel
OG004
10 mg/kg GSK3052230 + Docetaxel: Arm B
Participants in Arm B received 10 mg/kg GSK3052230 along with 75 mg/m^2 Docetaxel
OG005
20 mg/kg GSK3052230 + Docetaxel: Arm B
Participants in Arm B received 20 mg/kg GSK3052230 along with 75 mg/m^2 Docetaxel
OG006
10 mg/kg GSK3052230 + Pemetrexed + Cisplatin: Arm C
Participants in Arm C received 10 mg/kg GSK3052230 along with 500 mg/m^2 Pemetrexed plus 75 mg/m^2 Cisplatin
OG007
15 mg/kg GSK3052230 + Pemetrexed + Cisplatin: Arm C
Participants in Arm C received 15 mg/kg GSK3052230 along with 500 mg/m^2 Pemetrexed plus 75 mg/m^2 Cisplatin
OG008
20 mg/kg GSK3052230 + Pemetrexed + Cisplatin: Arm C
Participants in Arm C received 20 mg/kg GSK3052230 along with 500 mg/m^2 Pemetrexed plus 75 mg/m^2 Cisplatin
Units
Counts
Participants
OG0003
OG0013
OG00214
OG0033
OG0043
OG0053
OG0063
OG00725
OG0088
Title
Denominators
Categories
Title
Measurements
OG0000
OG0012
OG0024
OG0032
OG0041
OG0050
OG0062
OG00712
OG0081
OG003
5 mg/kg GSK3052230 + Docetaxel: Arm B
Participants in Arm B received 5 mg/kg GSK3052230 along with 75 mg/m^2 Docetaxel
OG004
10 mg/kg GSK3052230 + Docetaxel: Arm B
Participants in Arm B received 10 mg/kg GSK3052230 along with 75 mg/m^2 Docetaxel
OG005
20 mg/kg GSK3052230 + Docetaxel: Arm B
Participants in Arm B received 20 mg/kg GSK3052230 along with 75 mg/m^2 Docetaxel
OG006
10 mg/kg GSK3052230 + Pemetrexed + Cisplatin: Arm C
Participants in Arm C received 10 mg/kg GSK3052230 along with 500 mg/m^2 Pemetrexed plus 75 mg/m^2 Cisplatin
OG007
15 mg/kg GSK3052230 + Pemetrexed + Cisplatin: Arm C
Participants in Arm C received 15 mg/kg GSK3052230 along with 500 mg/m^2 Pemetrexed plus 75 mg/m^2 Cisplatin
OG008
20 mg/kg GSK3052230 + Pemetrexed + Cisplatin: Arm C
Participants in Arm C received 20 mg/kg GSK3052230 along with 500 mg/m^2 Pemetrexed plus 75 mg/m^2 Cisplatin
Units
Counts
Participants
OG0003
OG0013
OG00214
OG0033
OG0043
OG0053
OG0063
OG00725
OG0088
Title
Denominators
Categories
Title
Measurements
OG0007.0(3 to 8)
OG00115.0(5 to 20)
OG0028.0(2 to 13)
OG0036.0(2 to 7)
OG0044.0(2 to 14)
OG0056.0(3 to 8)
OG0066.0(4 to 8)
OG00711.0(1 to 23)
OG0083.0(1 to 32)
Participants in Arm A received 20 mg/kg GSK3052230 along with 200 mg/m^2 of Paclitaxel plus AUC 6 i.e. 900 mg Carboplatin
OG003
5 mg/kg GSK3052230 + Docetaxel: Arm B
Participants in Arm B received 5 mg/kg GSK3052230 along with 75 mg/m^2 Docetaxel
OG004
10 mg/kg GSK3052230 + Docetaxel: Arm B
Participants in Arm B received 10 mg/kg GSK3052230 along with 75 mg/m^2 Docetaxel
OG005
20 mg/kg GSK3052230 + Docetaxel: Arm B
Participants in Arm B received 20 mg/kg GSK3052230 along with 75 mg/m^2 Docetaxel
OG006
10 mg/kg GSK3052230 + Pemetrexed + Cisplatin: Arm C
Participants in Arm C received 10 mg/kg GSK3052230 along with 500 mg/m^2 Pemetrexed plus 75 mg/m^2 Cisplatin
OG007
15 mg/kg GSK3052230 + Pemetrexed + Cisplatin: Arm C
Participants in Arm C received 15 mg/kg GSK3052230 along with 500 mg/m^2 Pemetrexed plus 75 mg/m^2 Cisplatin
OG008
20 mg/kg GSK3052230 + Pemetrexed + Cisplatin: Arm C
Participants in Arm C received 20 mg/kg GSK3052230 along with 500 mg/m^2 Pemetrexed plus 75 mg/m^2 Cisplatin
Units
Counts
Participants
OG0003
OG0013
OG00214
OG0033
OG0043
OG0053
OG0063
OG00725
OG0088
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0071
OG0083
OG002
20 mg/kg GSK3052230 + Paclitaxel + Carboplatin: Arm A
Participants in Arm A received 20 mg/kg GSK3052230 along with 200 mg/m^2 of Paclitaxel plus AUC 6 i.e. 900 mg Carboplatin
OG003
5 mg/kg GSK3052230 + Docetaxel: Arm B
Participants in Arm B received 5 mg/kg GSK3052230 along with 75 mg/m^2 Docetaxel
OG004
10 mg/kg GSK3052230 + Docetaxel: Arm B
Participants in Arm B received 10 mg/kg GSK3052230 along with 75 mg/m^2 Docetaxel
OG005
20 mg/kg GSK3052230 + Docetaxel: Arm B
Participants in Arm B received 20 mg/kg GSK3052230 along with 75 mg/m^2 Docetaxel
OG006
10 mg/kg GSK3052230 + Pemetrexed + Cisplatin: Arm C
Participants in Arm C received 10 mg/kg GSK3052230 along with 500 mg/m^2 Pemetrexed plus 75 mg/m^2 Cisplatin
OG007
15 mg/kg GSK3052230 + Pemetrexed + Cisplatin: Arm C
Participants in Arm C received 15 mg/kg GSK3052230 along with 500 mg/m^2 Pemetrexed plus 75 mg/m^2 Cisplatin
OG008
20 mg/kg GSK3052230 + Pemetrexed + Cisplatin: Arm C
Participants in Arm C received 20 mg/kg GSK3052230 along with 500 mg/m^2 Pemetrexed plus 75 mg/m^2 Cisplatin
Units
Counts
Participants
OG0003
OG0013
OG00214
OG0033
OG0043
OG0053
OG0063
OG00725
OG0088
Title
Denominators
Categories
DBP, n=3, 2, 9, 3, 2, 2, 3, 21, 5
ParticipantsOG0003
ParticipantsOG0012
ParticipantsOG0029
ParticipantsOG0033
ParticipantsOG0042
ParticipantsOG0052
ParticipantsOG0063
ParticipantsOG00721
ParticipantsOG0085
Title
Measurements
OG0006.3± 16.17
OG0010.5± 12.02
OG0022.0± 10.39
OG003
SBP, n=3, 1, 13, 2, 2, 2, 3, 21, 4
ParticipantsOG0003
ParticipantsOG0011
ParticipantsOG00213
ParticipantsOG0032
OG002
20 mg/kg GSK3052230 + Paclitaxel + Carboplatin: Arm A
Participants in Arm A received 20 mg/kg GSK3052230 along with 200 mg/m^2 of Paclitaxel plus AUC 6 i.e. 900 mg Carboplatin
OG003
5 mg/kg GSK3052230 + Docetaxel: Arm B
Participants in Arm B received 5 mg/kg GSK3052230 along with 75 mg/m^2 Docetaxel
OG004
10 mg/kg GSK3052230 + Docetaxel: Arm B
Participants in Arm B received 10 mg/kg GSK3052230 along with 75 mg/m^2 Docetaxel
OG005
20 mg/kg GSK3052230 + Docetaxel: Arm B
Participants in Arm B received 20 mg/kg GSK3052230 along with 75 mg/m^2 Docetaxel
OG006
10 mg/kg GSK3052230 + Pemetrexed + Cisplatin: Arm C
Participants in Arm C received 10 mg/kg GSK3052230 along with 500 mg/m^2 Pemetrexed plus 75 mg/m^2 Cisplatin
OG007
15 mg/kg GSK3052230 + Pemetrexed + Cisplatin: Arm C
Participants in Arm C received 15 mg/kg GSK3052230 along with 500 mg/m^2 Pemetrexed plus 75 mg/m^2 Cisplatin
OG008
20 mg/kg GSK3052230 + Pemetrexed + Cisplatin: Arm C
Participants in Arm C received 20 mg/kg GSK3052230 along with 500 mg/m^2 Pemetrexed plus 75 mg/m^2 Cisplatin
Units
Counts
Participants
OG0003
OG0013
OG00214
OG0033
OG0043
OG0053
OG0063
OG00725
OG0087
Heart rate readings
OG0003
OG0014
OG00217
OG0033
OG004
Title
Denominators
Categories
Title
Measurements
OG000-0.3± 15.31
OG0013.2± 24.74
OG0028.0± 23.67
OG00328.0± 42.79
OG00410.5± 19.33
OG0050.6± 3.06
OG006-5.0± 1.73
OG0072.8± 20.49
OG00824.4± 21.56
OG002
20 mg/kg GSK3052230 + Paclitaxel + Carboplatin: Arm A
Participants in Arm A received 20 mg/kg GSK3052230 along with 200 mg/m^2 of Paclitaxel plus AUC 6 i.e. 900 mg Carboplatin
OG003
5 mg/kg GSK3052230 + Docetaxel: Arm B
Participants in Arm B received 5 mg/kg GSK3052230 along with 75 mg/m^2 Docetaxel
OG004
10 mg/kg GSK3052230 + Docetaxel: Arm B
Participants in Arm B received 10 mg/kg GSK3052230 along with 75 mg/m^2 Docetaxel
OG005
20 mg/kg GSK3052230 + Docetaxel: Arm B
Participants in Arm B received 20 mg/kg GSK3052230 along with 75 mg/m^2 Docetaxel
OG006
10 mg/kg GSK3052230 + Pemetrexed + Cisplatin: Arm C
Participants in Arm C received 10 mg/kg GSK3052230 along with 500 mg/m^2 Pemetrexed plus 75 mg/m^2 Cisplatin
OG007
15 mg/kg GSK3052230 + Pemetrexed + Cisplatin: Arm C
Participants in Arm C received 15 mg/kg GSK3052230 along with 500 mg/m^2 Pemetrexed plus 75 mg/m^2 Cisplatin
OG008
20 mg/kg GSK3052230 + Pemetrexed + Cisplatin: Arm C
Participants in Arm C received 20 mg/kg GSK3052230 along with 500 mg/m^2 Pemetrexed plus 75 mg/m^2 Cisplatin
Units
Counts
Participants
OG0003
OG0013
OG00214
OG0032
OG0043
OG0053
OG0063
OG00725
OG0088
Temperature readings
OG0003
OG0014
OG00214
OG0032
OG004
Title
Denominators
Categories
Title
Measurements
OG000-0.30± 0.361
OG001-0.38± 0.608
OG0020.35± 0.917
OG0030.10± 0.283
OG0041.03± 1.795
OG005-0.03± 0.058
OG006-0.23± 0.208
OG007-0.16± 0.899
OG0080.12± 0.742
Participants in Arm A received 20 mg/kg GSK3052230 along with 200 mg/m^2 of Paclitaxel plus AUC 6 i.e. 900 mg Carboplatin
OG003
5 mg/kg GSK3052230 + Docetaxel: Arm B
Participants in Arm B received 5 mg/kg GSK3052230 along with 75 mg/m^2 Docetaxel
OG004
10 mg/kg GSK3052230 + Docetaxel: Arm B
Participants in Arm B received 10 mg/kg GSK3052230 along with 75 mg/m^2 Docetaxel
OG005
20 mg/kg GSK3052230 + Docetaxel: Arm B
Participants in Arm B received 20 mg/kg GSK3052230 along with 75 mg/m^2 Docetaxel
OG006
10 mg/kg GSK3052230 + Pemetrexed + Cisplatin: Arm C
Participants in Arm C received 10 mg/kg GSK3052230 along with 500 mg/m^2 Pemetrexed plus 75 mg/m^2 Cisplatin
OG007
15 mg/kg GSK3052230 + Pemetrexed + Cisplatin: Arm C
Participants in Arm C received 15 mg/kg GSK3052230 along with 500 mg/m^2 Pemetrexed plus 75 mg/m^2 Cisplatin
OG008
20 mg/kg GSK3052230 + Pemetrexed + Cisplatin: Arm C
Participants in Arm C received 20 mg/kg GSK3052230 along with 500 mg/m^2 Pemetrexed plus 75 mg/m^2 Cisplatin
Units
Counts
Participants
OG0003
OG0013
OG00214
OG0033
OG0043
OG0053
OG0063
OG00725
OG0088
Title
Denominators
Categories
Abnormal not clinically significant
Title
Measurements
OG0000
OG0012
OG0028
OG0032
OG0042
OG0053
OG0061
OG00712
OG0082
Abnormal clinically significant
Title
Measurements
OG0000
OG0010
OG0021
OG003
OG003
5 mg/kg GSK3052230 + Docetaxel: Arm B
Participants in Arm B received 5 mg/kg GSK3052230 along with 75 mg/m^2 Docetaxel
OG004
10 mg/kg GSK3052230 + Docetaxel: Arm B
Participants in Arm B received 10 mg/kg GSK3052230 along with 75 mg/m^2 Docetaxel
OG005
20 mg/kg GSK3052230 + Docetaxel: Arm B
Participants in Arm B received 20 mg/kg GSK3052230 along with 75 mg/m^2 Docetaxel
OG006
10 mg/kg GSK3052230 + Pemetrexed + Cisplatin: Arm C
Participants in Arm C received 10 mg/kg GSK3052230 along with 500 mg/m^2 Pemetrexed plus 75 mg/m^2 Cisplatin
OG007
15 mg/kg GSK3052230 + Pemetrexed + Cisplatin: Arm C
Participants in Arm C received 15 mg/kg GSK3052230 along with 500 mg/m^2 Pemetrexed plus 75 mg/m^2 Cisplatin
OG008
20 mg/kg GSK3052230 + Pemetrexed + Cisplatin: Arm C
Participants in Arm C received 20 mg/kg GSK3052230 along with 500 mg/m^2 Pemetrexed plus 75 mg/m^2 Cisplatin
Units
Counts
Participants
OG0001
OG0010
OG0022
OG0031
OG0040
OG0052
OG0060
OG0075
OG0082
Title
Denominators
Categories
No change or any increase
Title
Measurements
OG0000
OG0021
OG0030
OG0051
OG0072
OG0082
Any Decrease
Title
Measurements
OG0001
OG0021
OG0031
OG005
Participants in Arm A received 10 mg/kg GSK3052230 along with 200 mg/m^2 of Paclitaxel plus AUC 6 i.e. 900 mg Carboplatin
OG002
20 mg/kg GSK3052230 + Paclitaxel + Carboplatin: Arm A
Participants in Arm A received 20 mg/kg GSK3052230 along with 200 mg/m^2 of Paclitaxel plus AUC 6 i.e. 900 mg Carboplatin
OG003
5 mg/kg GSK3052230 + Docetaxel: Arm B
Participants in Arm B received 5 mg/kg GSK3052230 along with 75 mg/m^2 Docetaxel
OG004
10 mg/kg GSK3052230 + Docetaxel: Arm B
Participants in Arm B received 10 mg/kg GSK3052230 along with 75 mg/m^2 Docetaxel
OG005
20 mg/kg GSK3052230 + Docetaxel: Arm B
Participants in Arm B received 20 mg/kg GSK3052230 along with 75 mg/m^2 Docetaxel
OG006
10 mg/kg GSK3052230 + Pemetrexed + Cisplatin: Arm C
Participants in Arm C received 10 mg/kg GSK3052230 along with 500 mg/m^2 Pemetrexed plus 75 mg/m^2 Cisplatin
OG007
15 mg/kg GSK3052230 + Pemetrexed + Cisplatin: Arm C
Participants in Arm C received 15 mg/kg GSK3052230 along with 500 mg/m^2 Pemetrexed plus 75 mg/m^2 Cisplatin
OG008
20 mg/kg GSK3052230 + Pemetrexed + Cisplatin: Arm C
Participants in Arm C received 20 mg/kg GSK3052230 along with 500 mg/m^2 Pemetrexed plus 75 mg/m^2 Cisplatin
Units
Counts
Participants
OG0003
OG0013
OG00214
OG0033
OG0043
OG0053
OG0063
OG00725
OG0088
Title
Denominators
Categories
D.Bil, decrease to low, n=2,2,8,1,2,2,1,12,6
ParticipantsOG0002
ParticipantsOG0012
ParticipantsOG0028
ParticipantsOG0031
ParticipantsOG0042
ParticipantsOG0052
ParticipantsOG0061
ParticipantsOG00712
ParticipantsOG0086
Title
Measurements
OG0000
OG0010
OG0020
OG003
D.Bil, normal or no change, n=2,2,8,1,2,2,1,12,6
ParticipantsOG0002
ParticipantsOG0012
ParticipantsOG0028
ParticipantsOG0031
D.Bil, increase to high, n=2,2,8,1,2,2,1,12,6
ParticipantsOG0002
ParticipantsOG0012
ParticipantsOG0028
ParticipantsOG0031
Cl, decrease to low, n=3,3,14,3,3,3,3,25,8
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG00214
ParticipantsOG0033
Cl, normal or no change, n=3,3,14,3,3,3,3,25,8
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG00214
ParticipantsOG0033
Cl, increase to high, n=3,3,14,3,3,3,3,25,8
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG00214
ParticipantsOG0033
CO2, decrease to low, n=3,3,14,3,3,3,3,25,8
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG00214
ParticipantsOG0033
CO2, normal or no change, n=3,3,14,3,3,3,3,25,8
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG00214
ParticipantsOG0033
CO2, increase to high, n=3,3,14,3,3,3,3,25,8
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG00214
ParticipantsOG0033
Cr CL, decrease to low, n=3,3,9,2,1,3,3,15,4
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG0029
ParticipantsOG0032
Cr CL, normal or no change, n=3,3,9,2,1,3,3,15,4
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG0029
ParticipantsOG0032
Cr CL, increase to high, n=3,3,9,2,1,3,3,15,4
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG0029
ParticipantsOG0032
T4 free, decrease to low, n=0,1,6,0,1,0,2,16,3
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG0026
ParticipantsOG0030
T4 free, normal or no change,=0,1,6,0,1,0,2,16,3
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG0026
ParticipantsOG0030
T4 free, increase to high, n=0,1,6,0,1,0,2,16,3
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG0026
ParticipantsOG0030
T4 total, decrease to low, n=0,0,0,0,0,0,1,4,1
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
T4 total, normal or no change, n=0,0,0,0,0,0,1,4,1
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG003
T4 total, increase to high, n=0,0,0,0,0,0,1,4,1
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Total T3, decrease to low, n=0,1,1,0,1,0,1,6,3
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG0021
ParticipantsOG0030
Total T3, normal or no change, n=0,1,1,0,1,0,1,6,3
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG0021
ParticipantsOG003
Total T3, increase to high, n=0,1,1,0,1,0,1,6,3
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG0021
ParticipantsOG0030
Urea/BUN, decrease to low, n=3,2,13,3,2,3,3,25,8
ParticipantsOG0003
ParticipantsOG0012
ParticipantsOG00213
ParticipantsOG003
Urea/BUN,normal or no change,n=3,2,13,3,2,3,3,25,8
ParticipantsOG0003
ParticipantsOG0012
ParticipantsOG00213
ParticipantsOG003
Urea/BUN, increase to high, n=3,2,13,3,2,3,3,25,8
ParticipantsOG0003
ParticipantsOG0012
ParticipantsOG00213
ParticipantsOG003
5 mg/kg GSK3052230 + Docetaxel: Arm B
Participants in Arm B received 5 mg/kg GSK3052230 along with 75 mg/m^2 Docetaxel
OG004
10 mg/kg GSK3052230 + Docetaxel: Arm B
Participants in Arm B received 10 mg/kg GSK3052230 along with 75 mg/m^2 Docetaxel
OG005
20 mg/kg GSK3052230 + Docetaxel: Arm B
Participants in Arm B received 20 mg/kg GSK3052230 along with 75 mg/m^2 Docetaxel
OG006
10 mg/kg GSK3052230 + Pemetrexed + Cisplatin: Arm C
Participants in Arm C received 10 mg/kg GSK3052230 along with 500 mg/m^2 Pemetrexed plus 75 mg/m^2 Cisplatin
OG007
15 mg/kg GSK3052230 + Pemetrexed + Cisplatin: Arm C
Participants in Arm C received 15 mg/kg GSK3052230 along with 500 mg/m^2 Pemetrexed plus 75 mg/m^2 Cisplatin
OG008
20 mg/kg GSK3052230 + Pemetrexed + Cisplatin: Arm C
Participants in Arm C received 20 mg/kg GSK3052230 along with 500 mg/m^2 Pemetrexed plus 75 mg/m^2 Cisplatin
Units
Counts
Participants
OG0003
OG0013
OG00214
OG0033
OG0043
OG0053
OG0063
OG00725
OG0088
Title
Denominators
Categories
Cycle 1 Day 1, Urine glucose, >1000
Title
Measurements
OG0000
OG0010
OG0021
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
Cycle 1 Day 1, Urine glucose, 2+
Title
Measurements
OG0000
OG0010
OG0020
OG003
Cycle 1 Day 1, Urine glucose, trace
Title
Measurements
OG0000
OG0010
OG0020
OG003
Cycle 2 Day 1, Urine glucose, trace
Title
Measurements
OG0000
OG0010
OG0020
OG003
Cycle 4 Day 1, Urine glucose, >=1000
Title
Measurements
OG0000
OG0010
OG0021
OG003
Cycle 4 Day 1, Urine glucose, 4+
Title
Measurements
OG0000
OG0010
OG0020
OG003
Cycle 1 Day 1, Urine ketones, trace
Title
Measurements
OG0000
OG0010
OG0021
OG003
Cycle 4 Day 1, Urine ketones, trace
Title
Measurements
OG0000
OG0010
OG0021
OG003
Cycle 28, Day 1, Urine ketones, trace
Title
Measurements
OG0000
OG0010
OG0020
OG003
Cycle 1 Day 1, Occult Blood, 1+
Title
Measurements
OG0000
OG0010
OG0022
OG003
Cycle 1 Day 1, Occult Blood, 3+
Title
Measurements
OG0000
OG0010
OG0020
OG003
Cycle 2 Day 1, Occult Blood, 1+
Title
Measurements
OG0000
OG0010
OG0020
OG003
Cycle 2 Day 1, Occult Blood, trace
Title
Measurements
OG0000
OG0010
OG0020
OG003
Cycle 4 Day 1, Occult Blood, trace
Title
Measurements
OG0001
OG0010
OG0020
OG003
Cycle 4 Day 1, Occult Blood, 1+
Title
Measurements
OG0000
OG0010
OG0020
OG003
Cycle 4 Day 1, Occult Blood, 2+
Title
Measurements
OG0000
OG0010
OG0020
OG003
Cycle 8 Day 1, Occult Blood, 1+
Title
Measurements
OG0000
OG0010
OG0020
OG003
Cycle 1 Day 1, Urine protein, 1+
Title
Measurements
OG0000
OG0010
OG0021
OG003
Cycle 1 Day 1, Urine protein, trace
Title
Measurements
OG0000
OG0011
OG0022
OG003
Cycle 2, Day 1, Urine protein, trace
Title
Measurements
OG0000
OG0010
OG0021
OG003
Cycle 2, Day 1, Urine protein, 2+
Title
Measurements
OG0000
OG0010
OG0020
OG003
Cycle 4, Day 1, Urine protein, trace
Title
Measurements
OG0000
OG0010
OG0020
OG003
Cycle 8, Day 1, Urine protein, trace
Title
Measurements
OG0000
OG0010
OG0020
OG003
Cycle 12, Day 1, Urine protein, trace
Title
Measurements
OG0000
OG0010
OG0020
OG003
Cycle 16, Day 1, Urine protein, trace
Title
Measurements
OG0000
OG0011
OG0020
OG003
20 mg/kg GSK3052230 + Paclitaxel + Carboplatin: Arm A
Participants in Arm A received 20 mg/kg GSK3052230 along with 200 mg/m^2 of Paclitaxel plus AUC 6 i.e. 900 mg Carboplatin
OG003
5 mg/kg GSK3052230 + Docetaxel: Arm B
Participants in Arm B received 5 mg/kg GSK3052230 along with 75 mg/m^2 Docetaxel
OG004
10 mg/kg GSK3052230 + Docetaxel: Arm B
Participants in Arm B received 10 mg/kg GSK3052230 along with 75 mg/m^2 Docetaxel
OG005
20 mg/kg GSK3052230 + Docetaxel: Arm B
Participants in Arm B received 20 mg/kg GSK3052230 along with 75 mg/m^2 Docetaxel
OG006
10 mg/kg GSK3052230 + Pemetrexed + Cisplatin: Arm C
Participants in Arm C received 10 mg/kg GSK3052230 along with 500 mg/m^2 Pemetrexed plus 75 mg/m^2 Cisplatin
OG007
15 mg/kg GSK3052230 + Pemetrexed + Cisplatin: Arm C
Participants in Arm C received 15 mg/kg GSK3052230 along with 500 mg/m^2 Pemetrexed plus 75 mg/m^2 Cisplatin
OG008
20 mg/kg GSK3052230 + Pemetrexed + Cisplatin: Arm C
Participants in Arm C received 20 mg/kg GSK3052230 along with 500 mg/m^2 Pemetrexed plus 75 mg/m^2 Cisplatin
Units
Counts
Participants
OG0003
OG0013
OG00214
OG0033
OG0043
OG0053
OG0063
OG00725
OG0088
Title
Denominators
Categories
Baso, decrease to low, n=3,3,14,3,3,3,3,22,8
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG00214
ParticipantsOG0033
ParticipantsOG0043
ParticipantsOG0053
ParticipantsOG0063
ParticipantsOG00722
ParticipantsOG0088
Title
Measurements
OG0000
OG0010
OG0021
OG003
Baso, normal or no change, n=3,3,14,3,3,3,3,22,8
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG00214
ParticipantsOG0033
Baso, increase to high, n=3,3,14,3,3,3,3,22,8
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG00214
ParticipantsOG0033
Eos, decrease to low, n=3,3,14,3,3,3,3,24,8
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG00214
ParticipantsOG0033
Eos, normal or no change, n=3,3,14,3,3,3,3,24,8
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG00214
ParticipantsOG0033
Eos, increase to high, n=3,3,14,3,3,3,3,24,8
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG00214
ParticipantsOG0033
Mono, decrease to low, n=3,3,14,3,3,3,3,25,8
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG00214
ParticipantsOG0033
Mono, normal or no change, n=3,3,14,3,3,3,3,25,8
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG00214
ParticipantsOG0033
Mono, increase to high, n=3,3,14,3,3,3,3,25,8
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG00214
ParticipantsOG0033
RBC, decrease to low, n=3,3,14,3,3,3,3,25,8
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG00214
ParticipantsOG0033
RBC, normal or no change, n=3,3,14,3,3,3,3,25,8
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG00214
ParticipantsOG0033
RBC, increase to high, n=3,3,14,3,3,3,3,25,8
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG00214
ParticipantsOG0033
Participants
OG00014
OG0013
OG00225
Title
Denominators
Categories
Title
Measurements
OG00014
OG0013
OG00225
Participants in Arm A received 10 mg/kg GSK3052230 along with 200 mg/m^2 of Paclitaxel plus AUC 6 i.e. 900 mg Carboplatin
OG002
20 mg/kg GSK3052230 + Paclitaxel + Carboplatin: Arm A
Participants in Arm A received 20 mg/kg GSK3052230 along with 200 mg/m^2 of Paclitaxel plus AUC 6 i.e. 900 mg Carboplatin
OG003
5 mg/kg GSK3052230 + Docetaxel: Arm B
Participants in Arm B received 5 mg/kg GSK3052230 along with 75 mg/m^2 Docetaxel
OG004
10 mg/kg GSK3052230 + Docetaxel: Arm B
Participants in Arm B received 10 mg/kg GSK3052230 along with 75 mg/m^2 Docetaxel
OG005
20 mg/kg GSK3052230 + Docetaxel: Arm B
Participants in Arm B received 20 mg/kg GSK3052230 along with 75 mg/m^2 Docetaxel
OG006
10 mg/kg GSK3052230 + Pemetrexed + Cisplatin: Arm C
Participants in Arm C received 10 mg/kg GSK3052230 along with 500 mg/m^2 Pemetrexed plus 75 mg/m^2 Cisplatin
OG007
15 mg/kg GSK3052230 + Pemetrexed + Cisplatin: Arm C
Participants in Arm C received 15 mg/kg GSK3052230 along with 500 mg/m^2 Pemetrexed plus 75 mg/m^2 Cisplatin
OG008
20 mg/kg GSK3052230 + Pemetrexed + Cisplatin: Arm C
Participants in Arm C received 20 mg/kg GSK3052230 along with 500 mg/m^2 Pemetrexed plus 75 mg/m^2 Cisplatin
Units
Counts
Participants
OG0003
OG0013
OG00213
OG0033
OG0043
OG0053
OG0063
OG00725
OG0088
Title
Denominators
Categories
Complete Response
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
Partial Response
Title
Measurements
OG0001
OG0012
OG0026
OG003
Stable disease, discontinued
Title
Measurements
OG0001
OG0011
OG0025
OG003
Stable disease, ongoing
Title
Measurements
OG0000
OG0010
OG0020
OG003
Progressive disease
Title
Measurements
OG0001
OG0010
OG0022
OG003
OG002
20 mg/kg GSK3052230 + Paclitaxel + Carboplatin: Arm A
Participants in Arm A received 20 mg/kg GSK3052230 along with 200 mg/m^2 of Paclitaxel plus AUC 6 i.e. 900 mg Carboplatin
OG003
5 mg/kg GSK3052230 + Docetaxel: Arm B
Participants in Arm B received 5 mg/kg GSK3052230 along with 75 mg/m^2 Docetaxel
OG004
10 mg/kg GSK3052230 + Docetaxel: Arm B
Participants in Arm B received 10 mg/kg GSK3052230 along with 75 mg/m^2 Docetaxel
OG005
20 mg/kg GSK3052230 + Docetaxel: Arm B
Participants in Arm B received 20 mg/kg GSK3052230 along with 75 mg/m^2 Docetaxel
OG006
10 mg/kg GSK3052230 + Pemetrexed + Cisplatin: Arm C
Participants in Arm C received 10 mg/kg GSK3052230 along with 500 mg/m^2 Pemetrexed plus 75 mg/m^2 Cisplatin
OG007
15 mg/kg GSK3052230 + Pemetrexed + Cisplatin: Arm C
Participants in Arm C received 15 mg/kg GSK3052230 along with 500 mg/m^2 Pemetrexed plus 75 mg/m^2 Cisplatin
OG008
20 mg/kg GSK3052230 + Pemetrexed + Cisplatin: Arm C
Participants in Arm C received 20 mg/kg GSK3052230 along with 500 mg/m^2 Pemetrexed plus 75 mg/m^2 Cisplatin
Units
Counts
Participants
OG0003
OG0013
OG00213
OG0033
OG0043
OG0053
OG0063
OG00725
OG0088
Title
Denominators
Categories
Title
Measurements
OG0001
OG0012
OG0026
OG0030
OG0040
OG0050
OG0062
OG00711
OG0081
Participants in Arm A received 20 mg/kg GSK3052230 along with 200 mg/m^2 of Paclitaxel plus AUC 6 i.e. 900 mg Carboplatin
OG003
5 mg/kg GSK3052230 + Docetaxel: Arm B
Participants in Arm B received 5 mg/kg GSK3052230 along with 75 mg/m^2 Docetaxel
OG004
10 mg/kg GSK3052230 + Docetaxel: Arm B
Participants in Arm B received 10 mg/kg GSK3052230 along with 75 mg/m^2 Docetaxel
OG005
20 mg/kg GSK3052230 + Docetaxel: Arm B
Participants in Arm B received 20 mg/kg GSK3052230 along with 75 mg/m^2 Docetaxel
OG006
10 mg/kg GSK3052230 + Pemetrexed + Cisplatin: Arm C
Participants in Arm C received 10 mg/kg GSK3052230 along with 500 mg/m^2 Pemetrexed plus 75 mg/m^2 Cisplatin
OG007
15 mg/kg GSK3052230 + Pemetrexed + Cisplatin: Arm C
Participants in Arm C received 15 mg/kg GSK3052230 along with 500 mg/m^2 Pemetrexed plus 75 mg/m^2 Cisplatin
OG008
20 mg/kg GSK3052230 + Pemetrexed + Cisplatin: Arm C
Participants in Arm C received 20 mg/kg GSK3052230 along with 500 mg/m^2 Pemetrexed plus 75 mg/m^2 Cisplatin
Units
Counts
Participants
OG0003
OG0013
OG00213
OG0033
OG0043
OG0053
OG0063
OG00725
OG0088
Title
Denominators
Categories
Title
Measurements
OG0004.1(1.4 to 5.5)
OG001NA(5.0 to NA)NA indicates that data were not available as only 1 participant had event, other two censored therefore there is no confidence interval
OG0025.5(3.7 to 6.2)
OG0034.6(1.3 to 4.6)
OG0049.5(NA to NA)NA indicates that data were not available as only 1 participant had event, other two censored therefore there is no confidence interval
OG0055.1(4.0 to 6.2)
OG0064.6(NA to NA)NA indicates that data were not available as only 1 participant had event, other two censored therefore there is no confidence interval
OG0077.4(6.7 to 13.4)
OG0084.1(0.9 to 8.3)
20 mg/kg GSK3052230 + Paclitaxel + Carboplatin: Arm A
Participants in Arm A received 20 mg/kg GSK3052230 along with 200 mg/m^2 of Paclitaxel plus AUC 6 i.e. 900 mg Carboplatin
OG003
5 mg/kg GSK3052230 + Docetaxel: Arm B
Participants in Arm B received 5 mg/kg GSK3052230 along with 75 mg/m^2 Docetaxel
OG004
10 mg/kg GSK3052230 + Docetaxel: Arm B
Participants in Arm B received 10 mg/kg GSK3052230 along with 75 mg/m^2 Docetaxel
OG005
20 mg/kg GSK3052230 + Docetaxel: Arm B
Participants in Arm B received 20 mg/kg GSK3052230 along with 75 mg/m^2 Docetaxel
OG006
10 mg/kg GSK3052230 + Pemetrexed + Cisplatin: Arm C
Participants in Arm C received 10 mg/kg GSK3052230 along with 500 mg/m^2 Pemetrexed plus 75 mg/m^2 Cisplatin
OG007
15 mg/kg GSK3052230 + Pemetrexed + Cisplatin: Arm C
Participants in Arm C received 15 mg/kg GSK3052230 along with 500 mg/m^2 Pemetrexed plus 75 mg/m^2 Cisplatin
OG008
20 mg/kg GSK3052230 + Pemetrexed + Cisplatin: Arm C
Participants in Arm C received 20 mg/kg GSK3052230 along with 500 mg/m^2 Pemetrexed plus 75 mg/m^2 Cisplatin
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
Participants in Arm A received 20 mg/kg GSK3052230 along with 200 mg/m^2 of Paclitaxel plus AUC 6 i.e. 900 mg Carboplatin
OG003
5 mg/kg GSK3052230 + Docetaxel: Arm B
Participants in Arm B received 5 mg/kg GSK3052230 along with 75 mg/m^2 Docetaxel
OG004
10 mg/kg GSK3052230 + Docetaxel: Arm B
Participants in Arm B received 10 mg/kg GSK3052230 along with 75 mg/m^2 Docetaxel
OG005
20 mg/kg GSK3052230 + Docetaxel: Arm B
Participants in Arm B received 20 mg/kg GSK3052230 along with 75 mg/m^2 Docetaxel
OG006
10 mg/kg GSK3052230 + Pemetrexed + Cisplatin: Arm C
Participants in Arm C received 10 mg/kg GSK3052230 along with 500 mg/m^2 Pemetrexed plus 75 mg/m^2 Cisplatin
OG007
15 mg/kg GSK3052230 + Pemetrexed + Cisplatin: Arm C
Participants in Arm C received 15 mg/kg GSK3052230 along with 500 mg/m^2 Pemetrexed plus 75 mg/m^2 Cisplatin
OG008
20 mg/kg GSK3052230 + Pemetrexed + Cisplatin: Arm C
Participants in Arm C received 20 mg/kg GSK3052230 along with 500 mg/m^2 Pemetrexed plus 75 mg/m^2 Cisplatin
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
Participants in Arm A received 20 mg/kg GSK3052230 along with 200 mg/m^2 of Paclitaxel plus AUC 6 i.e. 900 mg Carboplatin
OG003
5 mg/kg GSK3052230 + Docetaxel: Arm B
Participants in Arm B received 5 mg/kg GSK3052230 along with 75 mg/m^2 Docetaxel
OG004
10 mg/kg GSK3052230 + Docetaxel: Arm B
Participants in Arm B received 10 mg/kg GSK3052230 along with 75 mg/m^2 Docetaxel
OG005
20 mg/kg GSK3052230 + Docetaxel: Arm B
Participants in Arm B received 20 mg/kg GSK3052230 along with 75 mg/m^2 Docetaxel
OG006
10 mg/kg GSK3052230 + Pemetrexed + Cisplatin: Arm C
Participants in Arm C received 10 mg/kg GSK3052230 along with 500 mg/m^2 Pemetrexed plus 75 mg/m^2 Cisplatin
OG007
15 mg/kg GSK3052230 + Pemetrexed + Cisplatin: Arm C
Participants in Arm C received 15 mg/kg GSK3052230 along with 500 mg/m^2 Pemetrexed plus 75 mg/m^2 Cisplatin
OG008
20 mg/kg GSK3052230 + Pemetrexed + Cisplatin: Arm C
Participants in Arm C received 20 mg/kg GSK3052230 along with 500 mg/m^2 Pemetrexed plus 75 mg/m^2 Cisplatin
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
Participants in Arm C received 20 mg/kg GSK3052230 along with 500 mg/m^2 Pemetrexed plus 75 mg/m^2 Cisplatin
Units
Counts
Participants
OG0003
OG00125
OG0028
Title
Denominators
Categories
Cycle 3,Day 1, n=3, 24, 4
ParticipantsOG0003
ParticipantsOG00124
ParticipantsOG0024
Title
Measurements
OG0000.303± 0.4688
OG0010.280± 0.2911
OG0020.138± 0.6762
Cycle 4,Day 1, n=1, 4, 1
ParticipantsOG0001
ParticipantsOG0014
ParticipantsOG0021
Title
Measurements
OG000
Cycle 5,Day 1, n=1, 23, 3
ParticipantsOG0001
ParticipantsOG00123
ParticipantsOG0023
Title
Measurements
OG000
Cycle 6,Day 1, n=1, 5, 2
ParticipantsOG0001
ParticipantsOG0015
ParticipantsOG0022
Title
Measurements
OG000
Cycle 7,Day 1, n=1, 15, 2
ParticipantsOG0001
ParticipantsOG00115
ParticipantsOG0022
Title
Measurements
OG000
Cycle 8,Day 1, n=0, 3, 1
ParticipantsOG0000
ParticipantsOG0013
ParticipantsOG0021
Title
Measurements
OG001
Cycle 9,Day 1, n=0, 15, 1
ParticipantsOG0000
ParticipantsOG00115
ParticipantsOG0021
Title
Measurements
OG001
Cycle 10,Day 1, n=0, 3, 0
ParticipantsOG0000
ParticipantsOG0013
ParticipantsOG0020
Title
Measurements
OG001
Cycle 11,Day 1, n=0, 12, 2
ParticipantsOG0000
ParticipantsOG00112
ParticipantsOG0022
Title
Measurements
OG001
Cycle 12,Day 1, n=0, 2, 1
ParticipantsOG0000
ParticipantsOG0012
ParticipantsOG0021
Title
Measurements
OG001
Cycle 13,Day 1, n=0, 8, 2
ParticipantsOG0000
ParticipantsOG0018
ParticipantsOG0022
Title
Measurements
OG001
Cycle 14,Day 1, n=0, 3, 1
ParticipantsOG0000
ParticipantsOG0013
ParticipantsOG0021
Title
Measurements
OG001
Cycle 15,Day 1, n=0, 6, 1
ParticipantsOG0000
ParticipantsOG0016
ParticipantsOG0021
Title
Measurements
OG001
Cycle 17,Day 1, n=0, 4, 1
ParticipantsOG0000
ParticipantsOG0014
ParticipantsOG0021
Title
Measurements
OG001
Cycle 19,Day 1, n=0, 1, 1
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG0021
Title
Measurements
OG001
Cycle 21,Day 1, n=0, 1, 1
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG0021
Title
Measurements
OG001
Cycle 23,Day 1, n=0, 1, 1
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG0021
Title
Measurements
OG001
Cycle 25,Day 1, n=0, 0, 1
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0021
Title
Measurements
OG002
Cycle 27,Day 1, n=0, 0, 1
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0021
Title
Measurements
OG002
Cycle 31,Day 1, n=0, 0, 1
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0021
Title
Measurements
OG002
0 events
0 affected
3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected25 at risk
EG0080 events0 affected8 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected25 at risk
EG0080 events0 affected8 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected25 at risk
EG0080 events0 affected8 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected25 at risk
EG0080 events0 affected8 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected3 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected25 at risk
EG0080 events0 affected8 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected25 at risk
EG0080 events0 affected8 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
EG0071 events1 affected25 at risk
EG0080 events0 affected8 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected25 at risk
EG0080 events0 affected8 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected25 at risk
EG0080 events0 affected8 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected25 at risk
EG0080 events0 affected8 at risk
1 events
1 affected
3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected25 at risk
EG0080 events0 affected8 at risk
1 events
1 affected
3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected25 at risk
EG0080 events0 affected8 at risk
0 events
0 affected
3 at risk
EG0041 events1 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected25 at risk
EG0080 events0 affected8 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected25 at risk
EG0081 events1 affected8 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected25 at risk
EG0081 events1 affected8 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
EG0071 events1 affected25 at risk
EG0080 events0 affected8 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
EG0071 events1 affected25 at risk
EG0082 events1 affected8 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected25 at risk
EG0081 events1 affected8 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
EG0071 events1 affected25 at risk
EG0080 events0 affected8 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
EG0071 events1 affected25 at risk
EG0080 events0 affected8 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
EG0071 events1 affected25 at risk
EG0080 events0 affected8 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected25 at risk
EG0081 events1 affected8 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
EG0071 events1 affected25 at risk
EG0080 events0 affected8 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected25 at risk
EG0081 events1 affected8 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected25 at risk
EG0082 events1 affected8 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
EG0072 events1 affected25 at risk
EG0080 events0 affected8 at risk
0 events
0 affected
3 at risk
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EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected25 at risk
EG0080 events0 affected8 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected3 at risk
EG0052 events1 affected3 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected25 at risk
EG0080 events0 affected8 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected3 at risk
EG0056 events1 affected3 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected25 at risk
EG0080 events0 affected8 at risk
0 events
0 affected
3 at risk
EG0041 events1 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
EG0072 events2 affected25 at risk
EG0080 events0 affected8 at risk
1 events
1 affected
3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected25 at risk
EG0080 events0 affected8 at risk
1 events
1 affected
3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected25 at risk
EG0080 events0 affected8 at risk
3 events
2 affected
3 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected3 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected25 at risk
EG0080 events0 affected8 at risk
0 events
0 affected
3 at risk
EG0042 events1 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
EG0071 events1 affected25 at risk
EG0081 events1 affected8 at risk
0 events
0 affected
3 at risk
EG0041 events1 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected25 at risk
EG0080 events0 affected8 at risk
1 events
1 affected
3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected25 at risk
EG0080 events0 affected8 at risk
1 events
1 affected
3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected25 at risk
EG0080 events0 affected8 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected3 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected25 at risk
EG0080 events0 affected8 at risk
1 events
1 affected
3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected25 at risk
EG0080 events0 affected8 at risk
0 events
0 affected
3 at risk
EG0041 events1 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected25 at risk
EG0080 events0 affected8 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected3 at risk
EG0052 events1 affected3 at risk
EG0062 events1 affected3 at risk
EG0074 events2 affected25 at risk
EG0082 events1 affected8 at risk
0 events
0 affected
3 at risk
EG0041 events1 affected3 at risk
EG0050 events0 affected3 at risk
EG0062 events2 affected3 at risk
EG0078 events4 affected25 at risk
EG0080 events0 affected8 at risk
0 events
0 affected
3 at risk
EG0041 events1 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected25 at risk
EG0080 events0 affected8 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected3 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected25 at risk
EG0080 events0 affected8 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0061 events1 affected3 at risk
EG0070 events0 affected25 at risk
EG0080 events0 affected8 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0061 events1 affected3 at risk
EG0078 events3 affected25 at risk
EG0082 events1 affected8 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
EG0071 events1 affected25 at risk
EG0081 events1 affected8 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
EG0072 events2 affected25 at risk
EG0080 events0 affected8 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected25 at risk
EG0083 events2 affected8 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
EG0071 events1 affected25 at risk
EG0081 events1 affected8 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected25 at risk
EG0081 events1 affected8 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected25 at risk
EG0081 events1 affected8 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
EG0072 events2 affected25 at risk
EG0081 events1 affected8 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
EG0072 events2 affected25 at risk
EG0083 events1 affected8 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected25 at risk
EG0081 events1 affected8 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected25 at risk
EG0081 events1 affected8 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected25 at risk
EG0081 events1 affected8 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
EG0071 events1 affected25 at risk
EG0081 events1 affected8 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
EG0071 events1 affected25 at risk
EG0081 events1 affected8 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
EG0071 events1 affected25 at risk
EG0081 events1 affected8 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
EG0072 events2 affected25 at risk
EG0080 events0 affected8 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
EG0072 events1 affected25 at risk
EG0082 events1 affected8 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected25 at risk
EG0081 events1 affected8 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected25 at risk
EG0081 events1 affected8 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected25 at risk
EG0081 events1 affected8 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected25 at risk
EG0081 events1 affected8 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
EG0078 events4 affected25 at risk
EG0081 events1 affected8 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0061 events1 affected3 at risk
EG0073 events3 affected25 at risk
EG0081 events1 affected8 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
EG0073 events2 affected25 at risk
EG0080 events0 affected8 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected25 at risk
EG0081 events1 affected8 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected25 at risk
EG0081 events1 affected8 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected25 at risk
EG0081 events1 affected8 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected25 at risk
EG0081 events1 affected8 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
EG0072 events1 affected25 at risk
EG0081 events1 affected8 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected25 at risk
EG0081 events1 affected8 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0061 events1 affected3 at risk
EG0070 events0 affected25 at risk
EG0080 events0 affected8 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
EG0072 events2 affected25 at risk
EG0080 events0 affected8 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0061 events1 affected3 at risk
EG0070 events0 affected25 at risk
EG0080 events0 affected8 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0061 events1 affected3 at risk
EG0074 events4 affected25 at risk
EG0080 events0 affected8 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
EG0073 events2 affected25 at risk
EG0081 events1 affected8 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0061 events1 affected3 at risk
EG0071 events1 affected25 at risk
EG0080 events0 affected8 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected25 at risk
EG0081 events1 affected8 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected25 at risk
EG0081 events1 affected8 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected25 at risk
EG0081 events1 affected8 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0061 events1 affected3 at risk
EG0070 events0 affected25 at risk
EG0080 events0 affected8 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected25 at risk
EG0081 events1 affected8 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected25 at risk
EG0081 events1 affected8 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected25 at risk
EG0081 events1 affected8 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
EG0071 events1 affected25 at risk
EG0081 events1 affected8 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0061 events1 affected3 at risk
EG0071 events1 affected25 at risk
EG0080 events0 affected8 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0061 events1 affected3 at risk
EG0070 events0 affected25 at risk
EG0080 events0 affected8 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected25 at risk
EG0082 events1 affected8 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected25 at risk
EG0081 events1 affected8 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected25 at risk
EG0081 events1 affected8 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected25 at risk
EG0081 events1 affected8 at risk
0
OG0050
OG0062
OG0077
OG0081
2
OG0050
OG0061
OG00717
OG0084
1
OG0053
OG0060
OG0070
OG0082
0
OG0050
OG0060
OG0070
OG0081
-0.6
± 3.06
OG0046.0± 2.83
OG0053.5± 9.19
OG0062.3± 7.64
OG00712.8± 8.38
OG00810.6± 2.30
ParticipantsOG0042
ParticipantsOG0052
ParticipantsOG0063
ParticipantsOG00721
ParticipantsOG0084
Title
Measurements
OG000-12.3± 15.31
OG001-14.0± NANA indicates that data were not available as standard deviation could not be calculated for a single participant.
OG0029.6± 10.16
OG00310.5± 14.85
OG00417.5± 3.54
OG0056.0± 22.63
OG0063.0± 13.00
OG00712.5± 13.21
OG00818.7± 15.97
4
OG0053
OG0063
OG00726
OG0087
3
OG0053
OG0063
OG00727
OG0088
0
OG0040
OG0050
OG0060
OG0073
OG0083
1
OG0073
OG0080
0
OG0040
OG0051
OG0060
OG0070
OG0080
ParticipantsOG0042
ParticipantsOG0052
ParticipantsOG0061
ParticipantsOG00712
ParticipantsOG0086
Title
Measurements
OG0002
OG0011
OG0027
OG0031
OG0042
OG0051
OG0061
OG0077
OG0085
ParticipantsOG0042
ParticipantsOG0052
ParticipantsOG0061
ParticipantsOG00712
ParticipantsOG0086
Title
Measurements
OG0000
OG0011
OG0021
OG0030
OG0040
OG0050
OG0060
OG0075
OG0081
ParticipantsOG0043
ParticipantsOG0053
ParticipantsOG0063
ParticipantsOG00725
ParticipantsOG0088
Title
Measurements
OG0001
OG0011
OG0025
OG0030
OG0042
OG0051
OG0062
OG0079
OG0083
ParticipantsOG0043
ParticipantsOG0053
ParticipantsOG0063
ParticipantsOG00725
ParticipantsOG0088
Title
Measurements
OG0002
OG0010
OG0028
OG0033
OG0041
OG0052
OG0061
OG00715
OG0085
ParticipantsOG0043
ParticipantsOG0053
ParticipantsOG0063
ParticipantsOG00725
ParticipantsOG0088
Title
Measurements
OG0000
OG0012
OG0021
OG0030
OG0040
OG0050
OG0060
OG0072
OG0082
ParticipantsOG0043
ParticipantsOG0053
ParticipantsOG0063
ParticipantsOG00725
ParticipantsOG0088
Title
Measurements
OG0000
OG0011
OG0023
OG0031
OG0040
OG0050
OG0061
OG0072
OG0080
ParticipantsOG0043
ParticipantsOG0053
ParticipantsOG0063
ParticipantsOG00725
ParticipantsOG0088
Title
Measurements
OG0002
OG0011
OG0028
OG0032
OG0043
OG0051
OG0062
OG00717
OG0085
ParticipantsOG0043
ParticipantsOG0053
ParticipantsOG0063
ParticipantsOG00725
ParticipantsOG0088
Title
Measurements
OG0001
OG0012
OG0026
OG0030
OG0040
OG0052
OG0060
OG0077
OG0083
ParticipantsOG0041
ParticipantsOG0053
ParticipantsOG0063
ParticipantsOG00715
ParticipantsOG0084
Title
Measurements
OG0001
OG0012
OG0021
OG0030
OG0040
OG0050
OG0061
OG0079
OG0080
ParticipantsOG0041
ParticipantsOG0053
ParticipantsOG0063
ParticipantsOG00715
ParticipantsOG0084
Title
Measurements
OG0002
OG0011
OG0028
OG0031
OG0041
OG0053
OG0062
OG0076
OG0084
ParticipantsOG0041
ParticipantsOG0053
ParticipantsOG0063
ParticipantsOG00715
ParticipantsOG0084
Title
Measurements
OG0000
OG0010
OG0020
OG0031
OG0040
OG0050
OG0060
OG0071
OG0080
ParticipantsOG0041
ParticipantsOG0050
ParticipantsOG0062
ParticipantsOG00716
ParticipantsOG0083
Title
Measurements
OG0010
OG0021
OG0040
OG0060
OG0071
OG0081
ParticipantsOG0041
ParticipantsOG0050
ParticipantsOG0062
ParticipantsOG00716
ParticipantsOG0083
Title
Measurements
OG0011
OG0025
OG0041
OG0062
OG00712
OG0082
ParticipantsOG0041
ParticipantsOG0050
ParticipantsOG0062
ParticipantsOG00716
ParticipantsOG0083
Title
Measurements
OG0010
OG0020
OG0040
OG0060
OG0073
OG0080
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0061
ParticipantsOG0074
ParticipantsOG0081
Title
Measurements
OG0060
OG0071
OG0080
0
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0061
ParticipantsOG0074
ParticipantsOG0081
Title
Measurements
OG0061
OG0071
OG0080
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0061
ParticipantsOG0074
ParticipantsOG0081
Title
Measurements
OG0060
OG0072
OG0081
ParticipantsOG0041
ParticipantsOG0050
ParticipantsOG0061
ParticipantsOG0076
ParticipantsOG0083
Title
Measurements
OG0010
OG0020
OG0040
OG0060
OG0073
OG0082
0
ParticipantsOG0041
ParticipantsOG0050
ParticipantsOG0061
ParticipantsOG0076
ParticipantsOG0083
Title
Measurements
OG0011
OG0021
OG0041
OG0061
OG0072
OG0081
ParticipantsOG0041
ParticipantsOG0050
ParticipantsOG0061
ParticipantsOG0076
ParticipantsOG0083
Title
Measurements
OG0010
OG0020
OG0040
OG0060
OG0071
OG0080
3
ParticipantsOG0042
ParticipantsOG0053
ParticipantsOG0063
ParticipantsOG00725
ParticipantsOG0088
Title
Measurements
OG0001
OG0010
OG0020
OG0031
OG0040
OG0050
OG0060
OG0074
OG0081
3
ParticipantsOG0042
ParticipantsOG0053
ParticipantsOG0063
ParticipantsOG00725
ParticipantsOG0088
Title
Measurements
OG0002
OG0012
OG0028
OG0031
OG0042
OG0052
OG0061
OG00711
OG0083
3
ParticipantsOG0042
ParticipantsOG0053
ParticipantsOG0063
ParticipantsOG00725
ParticipantsOG0088
Title
Measurements
OG0000
OG0010
OG0025
OG0031
OG0040
OG0051
OG0062
OG00710
OG0084
1
OG0040
OG0050
OG0060
OG0070
OG0080
0
OG0040
OG0050
OG0060
OG0070
OG0081
0
OG0040
OG0050
OG0060
OG0070
OG0081
0
OG0040
OG0050
OG0060
OG0070
OG0080
0
OG0040
OG0050
OG0060
OG0070
OG0081
0
OG0040
OG0050
OG0060
OG0071
OG0082
0
OG0040
OG0050
OG0060
OG0070
OG0080
0
OG0040
OG0050
OG0060
OG0070
OG0081
0
OG0040
OG0050
OG0060
OG0070
OG0081
0
OG0040
OG0050
OG0060
OG0071
OG0080
0
OG0040
OG0050
OG0060
OG0071
OG0081
0
OG0040
OG0050
OG0060
OG0070
OG0081
0
OG0040
OG0050
OG0060
OG0070
OG0081
0
OG0040
OG0050
OG0060
OG0070
OG0080
0
OG0040
OG0050
OG0060
OG0071
OG0080
0
OG0040
OG0050
OG0060
OG0071
OG0080
0
OG0040
OG0050
OG0060
OG0070
OG0082
0
OG0041
OG0050
OG0060
OG0071
OG0080
0
OG0041
OG0050
OG0060
OG0070
OG0081
0
OG0040
OG0050
OG0060
OG0070
OG0081
0
OG0040
OG0050
OG0060
OG0072
OG0081
0
OG0040
OG0050
OG0060
OG0073
OG0080
0
OG0040
OG0050
OG0060
OG0071
OG0080
0
OG0040
OG0050
OG0060
OG0070
OG0080
0
OG0041
OG0050
OG0060
OG0075
OG0081
ParticipantsOG0043
ParticipantsOG0053
ParticipantsOG0063
ParticipantsOG00722
ParticipantsOG0088
Title
Measurements
OG0003
OG0013
OG0029
OG0033
OG0041
OG0053
OG0063
OG00713
OG0086
ParticipantsOG0043
ParticipantsOG0053
ParticipantsOG0063
ParticipantsOG00722
ParticipantsOG0088
Title
Measurements
OG0000
OG0010
OG0024
OG0030
OG0041
OG0050
OG0060
OG0074
OG0081
ParticipantsOG0043
ParticipantsOG0053
ParticipantsOG0063
ParticipantsOG00724
ParticipantsOG0088
Title
Measurements
OG0000
OG0010
OG0021
OG0030
OG0041
OG0050
OG0060
OG0078
OG0083
ParticipantsOG0043
ParticipantsOG0053
ParticipantsOG0063
ParticipantsOG00724
ParticipantsOG0088
Title
Measurements
OG0003
OG0013
OG00211
OG0033
OG0043
OG0053
OG0063
OG00714
OG0085
ParticipantsOG0043
ParticipantsOG0053
ParticipantsOG0063
ParticipantsOG00724
ParticipantsOG0088
Title
Measurements
OG0000
OG0010
OG0022
OG0030
OG0040
OG0050
OG0060
OG0075
OG0081
ParticipantsOG0043
ParticipantsOG0053
ParticipantsOG0063
ParticipantsOG00725
ParticipantsOG0088
Title
Measurements
OG0003
OG0012
OG00211
OG0030
OG0042
OG0051
OG0062
OG0076
OG0083
ParticipantsOG0043
ParticipantsOG0053
ParticipantsOG0063
ParticipantsOG00725
ParticipantsOG0088
Title
Measurements
OG0001
OG0010
OG0024
OG0032
OG0040
OG0050
OG0062
OG00712
OG0083
ParticipantsOG0043
ParticipantsOG0053
ParticipantsOG0063
ParticipantsOG00725
ParticipantsOG0088
Title
Measurements
OG0000
OG0013
OG0025
OG0031
OG0043
OG0052
OG0060
OG00710
OG0085
ParticipantsOG0043
ParticipantsOG0053
ParticipantsOG0063
ParticipantsOG00725
ParticipantsOG0088
Title
Measurements
OG0003
OG0012
OG00210
OG0030
OG0041
OG0052
OG0061
OG00717
OG0083
ParticipantsOG0043
ParticipantsOG0053
ParticipantsOG0063
ParticipantsOG00725
ParticipantsOG0088
Title
Measurements
OG0000
OG0011
OG0024
OG0033
OG0042
OG0051
OG0062
OG0079
OG0084
ParticipantsOG0043
ParticipantsOG0053
ParticipantsOG0063
ParticipantsOG00725
ParticipantsOG0088
Title
Measurements
OG0000
OG0010
OG0021
OG0030
OG0041
OG0050
OG0060
OG0073
OG0081
0
OG0040
OG0050
OG0062
OG00711
OG0081
2
OG0042
OG0052
OG0061
OG00710
OG0082
0
OG0040
OG0050
OG0060
OG0072
OG0080
1
OG0040
OG0050
OG0060
OG0071
OG0081
-0.340
± NA
NA indicates that data were not available as standard deviation could not be calculated for a single participant
OG0010.413± 0.1144
OG0020.600± NANA indicates that data were not available as standard deviation could not be calculated for a single participant
0.240
± NA
NA indicates that data were not available as standard deviation could not be calculated for a single participant
OG0010.238± 0.4178
OG0020.587± 0.3592
0.310
± NA
NA indicates that data were not available as standard deviation could not be calculated for a single participant
OG0010.464± 0.3544
OG0020.110± 0.8061
0.530
± NA
NA indicates that data were not available as standard deviation could not be calculated for a single participant
OG0010.399± 0.478
OG0020.575± 0.0778
0.263
± 0.2371
OG0020.640± NANA indicates that data were not available as standard deviation could not be calculated for a single participant
0.353
± 0.4621
OG0021.130± NANA indicates that data were not available as standard deviation could not be calculated for a single participant
0.063
± 0.0751
0.347
± 0.391
OG0020.510± 0.6081
0.225
± 0.2333
OG0020.580± NANA indicates that data were not available as standard deviation could not be calculated for a single participant
0.389
± 0.42
OG0020.555± 0.5162
-0.207
± 0.65770
OG0020.910± NANA indicates that data were not available as standard deviation could not be calculated for a single participant
0.247
± 0.3406
OG002-0.030± NANA indicates that data were not available as standard deviation could not be calculated for a single participant
0.158
± 0.3402
OG0020.560± NANA indicates that data were not available as standard deviation could not be calculated for a single participant
-0.02
± NA
NA indicates that data were not available as standard deviation could not be calculated for a single participant
OG0020.620± NANA indicates that data were not available as standard deviation could not be calculated for a single participant
-0.27
± NA
NA indicates that data were not available as standard deviation could not be calculated for a single participant
OG0020.560± NANA indicates that data were not available as standard deviation could not be calculated for a single participant
-0.62
± NA
NA indicates that data were not available as standard deviation could not be calculated for a single participant
OG0020.510± NANA indicates that data were not available as standard deviation could not be calculated for a single participant
0.430
± NA
NA indicates that data were not available as standard deviation could not be calculated for a single participant
0.220
± NA
NA indicates that data were not available as standard deviation could not be calculated for a single participant
0.270
± NA
NA indicates that data were not available as standard deviation could not be calculated for a single participant