Assess Safety & Efficacy of Selumetinib When Given in Com... | NCT01809210 | Trialant
Toggle Sidebar
Studies Assess Safety & Efficacy of Selumetinib When Given in Combination With Standard First Line Treatment for Advanced Non-small Cell Lung Cancer NCT01809210 Show options Locally Advanced or Metastatic NSCL Cancer Stage IIIB IV selumetinib gemcitabine cisplatin carboplatin pemetrexed Obsolete or Duplicate NCT IDs Not provided
ID Type Description Link EudraCT number: 2012-005202-22
Assess Safety & Efficacy of Selumetinib When Given in Combination With Standard First Line Treatment for Advanced Non-small Cell Lung Cancer
A Phase I, Open Label, Multicentre Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of Selumetinib (AZD6244; ARRY-142886) in Combination With First Line Chemotherapy Regimens in Patients With Non-Small Cell Lung Cancer (NSCLC)
Overall Recruitment Status or Expanded Access Status Completed
First Submission Date that Met QC Criteria Mar 11, 2013
Results First Submitted Date Dec 9, 2016
Results First Submitted that Met QC Criteria Mar 12, 2018
Results First Posted Date Mar 13, 2018 Actual
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 Mar 12, 2018
Responsible Party, by Official Title Sponsor
Has Data Monitoring Committee (DMC) No
Pediatric Postmarket Surveillance of a Device Product Not provided
This is a Phase I, open label multicentre study of selumetinib administered orally in combination with first line chemotherapy regimens to patients with advanced/metastatic NSCLC. The study has been designed to allow an investigation of the optimal dose of selumetinib in combination with various standard first line double-platinum chemotherapy regimens. Initial assessment will be based on tolerability of selumetinib in combination with one or more selected regimens that are considered to be tolerated also being assessed for preliminary evidence of activity.
This study is a dose finding and optional cohort expansion; In addition all patients will be assessed for anti-cancer efficacy of the combination of selumetinib and chemotherapy.
A Phase I, Open Label, Multicentre Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of Selumetinib (AZD6244; ARRY-142886) in Combination with First Line Chemotherapy Regimens in Patients with Non-Small Cell Lung Cancer (NSCLC)
Locally Advanced or Metastatic NSCL Cancer Stage IIIB IV MEK1/2 inhibitor, Non Small Cell Lung Cancer, metastatic, first line treatment for Non Small Cell Lung Cancer Number of References to an Expanded Access Study Not provided
Target Follow-Up Duration Not provided
No data available
No data is available for this block.
Label Type Description Intervention Names Selumetinib+standard chemotherapy Experimental Selumetinib plus gemcitabine; or pemetrexed and cisplatin or carboplatin
Drug: selumetinib Drug: gemcitabine Drug: cisplatin Drug: carboplatin Drug: pemetrexed
Name Type Description Arm Group Labels Other Names selumetinib Drug 2 x 25mg capsules bd continuously in cohort 1 (with gemcitabine and cisplatin). If tolerated - next cohort 3 x 25mg capsules bd continuously. if higher doses are explored, required number of capsules will be provided. Option to administer on D2-19 of each 21 day cycle if required to assess tolerability of combinations with chemotherapy
Measure Description Time Frame Dose Limiting Toxicity (DLT) Events in Chemotherapy in Combination With Selumetinib Any toxicity not attributable to the disease or disease-related processess under investigation, considered related to the combination of chemotherapy plus selumetinib, which occurs within the timeframe and is dose limiting
The first dose on Cycle 1 Day 1 up to the time before dosing on Cycle 2 Day 1, assessed up to 3 weeks
Measure Description Time Frame Best Objective Response The best response a patient has had during their time in the study up until RECIST progression or last valuable assessment in the absence of RECIST progression. Per Response Evaluation Criteria In Solid Tumours (RECIST version 1.1) for target lesions (TL) and assessed by MRI or CT: Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for a Partial Response nor sufficient increase to qualify for Progressive Disease (PD); Progressive Disease (PD), >=20% increase in the sum of the longest diameter of target lesions, the sum must also demonstrate an absolute increase of >=5mm; Complete Response (CR), disappearance of all target lesions, any pathological lymph nodes selected as TLs must have a reduction in short axis to <10mm
Inclusion Criteria:
Provision of signed, written and dated consent prior to any study specific procedures
Male or female, aged 18 years or older
Histological or cytological confirmation of locally advanced or metastatic NSCLC (IIIB-IV)
Female patients must not be breast-feeding and have a negative pregnancy test prior to start of dosing or must have evidence of non-child-bearing potential
Patients must be eligible to receive treatment with the platinum doublet combination with which selumetinib is being combined and in accordance with the local product information
Exclusion Criteria:
Prior chemotherapy or other systemic anti-cancer treatment for advanced NSCLC.
Prior surgery or radiotherapy within 6 months or palliative radiotherapy within 4 weeks of start of study treatment.
Female patients who are breast-feeding or male or female patients of reproductive potential who are not employing an effective method of birth control
Another primary malignancy within 5 years of starting study treatment, except for adequately treated basal or squamous cell carcinoma of the skin or cancer of the cervix in situ.
As judged by the Investigator, any evidence of severe or uncontrolled systemic diseases, active bleeding diatheses, renal transplant, or active infection
Accepts Healthy Volunteers No
Name Affiliation Role Gabriella Mariani, MD AstraZeneca UK, MSD Study Director Emma Dean, BMEDSCI, BM, BS, PHD The Christie NHS Foundation Trust, UK Principal Investigator Fiona Blackhall, PhD, FRCP The Christie NHS Foundation Trust Clinical Trials Unit; UK Principal Investigator
Facility Status City State ZIP Country Contacts Research Site Glasgow G12 0YN United Kingdom Research Site
Label URL D1532C00070revisedCSP-2\_Redacted
Available IPD Information Not provided
No data available
No data is available for this block.
Data cut off (DCO) was 7 Jan 16. DCO was defined as the earliest of 12 (±1) weeks after last patient started, or 28 days after final patient discontinued, selumetinib or chemotherapy doublet regimen.
Patients were enrolled into dose-finding cohorts to evaluate escalating doses of selumetinib (AZD6244; ARRY-142886) to determine the maximum tolerated dose in combination with standard first-line chemotherapy regimens. Chemotherapy was administered on Day 1 (and Day 8 for gemcitabine) of each 3-week cycle.
ID Title Description FG000 Cohort 1 sel50, Gem, Cis selumetinib 50mg bd, gemcitabine 1250mg/m2 , cisplatin 75mg/m2
FG001 Cohort 2 sel50, Gem, Carb selumetinib 50mg bd, gemcitabine 1250mg/m2 , carboplatin 5 units
Title Milestones Reasons Not Completed Overall Study Type Comment Milestone Data STARTED
Baseline Analysis Population Description Not provided
No data available
No data is available for this block.
No data available
No data is available for this block.
No data available
No data is available for this block.
N/A
Intervention Model Description Not provided
Selumetinib+standard chemotherapy
gemcitabine Drug 1250 mg/m2 iv on Day 1 and 8 of each 21 day cycle. If combination not tolerated, option to give 1000 mg/m2 iv on Day 1 and Day 8 of each 21 day cycle
Selumetinib+standard chemotherapy
cisplatin Drug 75 mg/m2 iv on Day 1 of each 21 day cycle. If combination not tolerated, option to give 50 mg/m2 iv on Day 1 or 25mg/m2 iv on Day 1 and Day 8 of each 21 day cycle
Selumetinib+standard chemotherapy
carboplatin Drug If it is not possible to identify a tolerable combination of selumetinib, gemcitabine and cisplatin, cisplatin may be replaced with carboplatin (AUC5) iv on Day 1 of each 21 day cycle
Selumetinib+standard chemotherapy
pemetrexed Drug Gemcitabine may be replaced with pemetrexed 500 mg/m2 iv on Day 1 of each 21 day cycle.
Selumetinib+standard chemotherapy
Screening, week 6 and week 12
Percentage Change From Baseline at 6 Weeks in Target Lesion Size The percentage change in the sum of the diameters of target lesions
Week 6
Best Percentage Change From Baseline in Target Lesion Size The best percentage change in tumour size a patient has had during their time in the study up until RECIST progression or last valuable assessment in the absence of RECIST progression. Percentage change was derived at each visit by the percentage change in the sum of the diameters of target lesions
Screening, week 6 and week 12
Objective Response Rate (ORR) The number of patients who had at least 1 confirmed visit response of Complete Response (CR) or Partial Response (PR) prior to any evidence of progression. Per Response Evaluation Criteria In Solid Tumours (RECIST version 1.1) for target lesions (TL) and assessed by MRI or CT: Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Complete Response (CR), disappearance of all target lesions, any pathological lymph nodes selected as TLs must have a reduction in short axis to <10mm; Objective Response Rate (ORR) = CR + PR
Up until progression or last evaluable assessment in the absence of progression, up to 9 months
AUC (0-tau) Area under the concentration time curve (AUC) over a dosing interval at steady state (0-tau)
Cycle 2 Day1, pre-dose, 0.5, 1, 1.5, 2, 4, 8, 10 hours post dose
Cmax,ss Maximum plasma concentration at steady state
Cycle 2 Day1, pre-dose, 0.5, 1, 1.5, 2, 4, 8, 10 hours post dose
Tmax,ss Time to reach maximum plasma concentration at steady state
Cycle 2 Day1, pre-dose, 0.5, 1, 1.5, 2, 4, 8, 10 hours post dose
CL/F Apparent oral plasma clearance
Cycle 2 Day1, pre-dose, 0.5, 1, 1.5, 2, 4, 8, 10 hours post dose
Research Site Manchester M20 4BX United Kingdom
Research Site Newcastle upon Tyne NE7 7DN United Kingdom
FG002 Cohort 3 sel75, Gem, Cis selumetinib 75mg bd, gemcitabine 1250mg/m2 , cisplatin 75mg/m2
FG003 Cohort 4 sel150, Pem, Carb selumetinib 50mg bd, pemetrexed 500 mg/m2, carboplatin 5 units
FG004 Cohort 5 sel75, Pem, Carb selumetinib 75mg bd, pemetrexed 500 mg/m2, carboplatin 5 units
FG005 Cohort 6 sel75, Pem, Cis selumetinib 75mg bd, pemetrexed 500 mg/m2, cisplatin 75mg/m2
FG006 Cohort 7 sel100, Pem, Carb selumetinib 100mg bd, pemetrexed 500 mg/m2, carboplatin 5 units
FG000 3 subjects
FG001 9 subjects
FG002 7 subjects
FG003 3 subjects
FG004 6 subjects
FG005 15 subjects
FG006 12 subjects COMPLETED FG000 2 subjects FG001 8 subjects FG002 4 subjects FG003 2 subjects FG004 4 subjects FG005 12 subjects FG006 7 subjects
NOT COMPLETED FG000 1 subjects FG001 1 subjects FG002 3 subjects FG003 1 subjects FG004 2 subjects FG005 3 subjects FG006 5 subjects
Type Comment Reasons Withdrawal by Subject FG000 0 subjects FG001 0 subjects FG002 1 subjects FG003 1 subjects FG004 1 subjects FG005 0 subjects FG006 4 subjects Death FG000 1 subjects FG001 1 subjects FG002 2 subjects FG003 0 subjects FG004
Type of Units Analyzed
ID Title Description BG000 Cohort 1 sel50, Gem, Cis selumetinib 50mg bd, gemcitabine 1250mg/m2 , cisplatin 75mg/m2
BG001 Cohort 2 sel50, Gem, Carb selumetinib 50mg bd, gemcitabine 1250mg/m2 , carboplatin 5 units
BG002 Cohort 3 sel75, Gem, Cis selumetinib 75mg bd, gemcitabine 1250mg/m2 , cisplatin 75mg/m2
BG003 Cohort 4 sel150, Pem, Carb selumetinib 50mg bd, pemetrexed 500 mg/m2, carboplatin 5 units
BG004 Cohort 5 sel75, Pem, Carb selumetinib 75mg bd, pemetrexed 500 mg/m2, carboplatin 5 units
BG005 Cohort 6 sel75, Pem, Cis selumetinib 75mg bd, pemetrexed 500 mg/m2, cisplatin 75mg/m2
BG006 Cohort 7 sel100, Pem, Carb selumetinib 100mg bd, pemetrexed 500 mg/m2, carboplatin 5 units
BG007 Total Total of all reporting groups
Units Counts Participants BG000 3 BG001 9 BG002 7 BG003 3 BG004 6 BG005 15 BG006 12 BG007 55
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 BG000 58.7 ± 3.79 (56 to 63) BG001 69.2 ± 3.53 (65 to 76) BG002 55.1 ± 8.65 (39 to 65)
Sex: Female, Male Count of Participants Participants Title Denominators Categories
Race/Ethnicity, Customized Count of Participants Participants Title Denominators Categories Title Measurements Black Or African American
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 Dose Limiting Toxicity (DLT) Events in Chemotherapy in Combination With Selumetinib Any toxicity not attributable to the disease or disease-related processess under investigation, considered related to the combination of chemotherapy plus selumetinib, which occurs within the timeframe and is dose limiting
Safety analysis set - all patients who received at least 1 dose of selumetinib.
Posted Number participants The first dose on Cycle 1 Day 1 up to the time before dosing on Cycle 2 Day 1, assessed up to 3 weeks ID Title Description OG000 Cohort 1 sel50, Gem, Cis selumetinib 50mg bd, gemcitabine 1250mg/m2 , cisplatin 75mg/m2
OG001 Cohort 2 sel50, Gem, Carb selumetinib 50mg bd, gemcitabine 1250mg/m2 , carboplatin 5 units
OG002 Cohort 3 sel75, Gem, Cis selumetinib 75mg bd, gemcitabine 1250mg/m2 , cisplatin 75mg/m2
OG003 Cohort 4 sel150, Pem, Carb selumetinib 50mg bd, pemetrexed 500 mg/m2, carboplatin 5 units
OG004 Cohort 5 sel75, Pem, Carb selumetinib 75mg bd, pemetrexed 500 mg/m2, carboplatin 5 units
OG005 Cohort 6 sel75, Pem, Cis selumetinib 75mg bd, pemetrexed 500 mg/m2, cisplatin 75mg/m2
OG006 Cohort 7 sel100, Pem, Carb selumetinib 100mg bd, pemetrexed 500 mg/m2, carboplatin 5 units
Title Denominators Categories Evaluable patients
Secondary Best Objective Response The best response a patient has had during their time in the study up until RECIST progression or last valuable assessment in the absence of RECIST progression. Per Response Evaluation Criteria In Solid Tumours (RECIST version 1.1) for target lesions (TL) and assessed by MRI or CT: Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for a Partial Response nor sufficient increase to qualify for Progressive Disease (PD); Progressive Disease (PD), >=20% increase in the sum of the longest diameter of target lesions, the sum must also demonstrate an absolute increase of >=5mm; Complete Response (CR), disappearance of all target lesions, any pathological lymph nodes selected as TLs must have a reduction in short axis to <10mm
Tumour response analysis set - dosed patients with a baseline tumour assessment.
Posted Number participants Screening, week 6 and week 12 ID Title Description OG000 Cohort 1 sel50, Gem, Cis selumetinib 50mg bd, gemcitabine 1250mg/m2 , cisplatin 75mg/m2
OG001 Cohort 2 sel50, Gem, Carb selumetinib 50mg bd, gemcitabine 1250mg/m2 , carboplatin 5 units
OG002 Cohort 3 sel75, Gem, Cis
Secondary Percentage Change From Baseline at 6 Weeks in Target Lesion Size The percentage change in the sum of the diameters of target lesions
Tumour response analysis set - dosed patients with a baseline tumour assessment.
Posted Mean Standard Deviation % change Week 6 ID Title Description OG000 Cohort 1 sel50, Gem, Cis selumetinib 50mg bd, gemcitabine 1250mg/m2 , cisplatin 75mg/m2
OG001 Cohort 2 sel50, Gem, Carb selumetinib 50mg bd, gemcitabine 1250mg/m2 , carboplatin 5 units
OG002 Cohort 3 sel75, Gem, Cis selumetinib 75mg bd, gemcitabine 1250mg/m2 , cisplatin 75mg/m2
OG003 Cohort 4 sel150, Pem, Carb selumetinib 50mg bd, pemetrexed 500 mg/m2, carboplatin 5 units
OG004 Cohort 5 sel75, Pem, Carb
Secondary Best Percentage Change From Baseline in Target Lesion Size The best percentage change in tumour size a patient has had during their time in the study up until RECIST progression or last valuable assessment in the absence of RECIST progression. Percentage change was derived at each visit by the percentage change in the sum of the diameters of target lesions
Tumour response analysis set - dosed patients with a baseline tumour assessment.
Posted Mean Standard Deviation % change Screening, week 6 and week 12 ID Title Description OG000 Cohort 1 sel50, Gem, Cis selumetinib 50mg bd, gemcitabine 1250mg/m2 , cisplatin 75mg/m2
OG001 Cohort 2 sel50, Gem, Carb selumetinib 50mg bd, gemcitabine 1250mg/m2 , carboplatin 5 units
OG002 Cohort 3 sel75, Gem, Cis selumetinib 75mg bd, gemcitabine 1250mg/m2 , cisplatin 75mg/m2
OG003 Cohort 4 sel150, Pem, Carb selumetinib 50mg bd, pemetrexed 500 mg/m2, carboplatin 5 units
Secondary Objective Response Rate (ORR) The number of patients who had at least 1 confirmed visit response of Complete Response (CR) or Partial Response (PR) prior to any evidence of progression. Per Response Evaluation Criteria In Solid Tumours (RECIST version 1.1) for target lesions (TL) and assessed by MRI or CT: Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Complete Response (CR), disappearance of all target lesions, any pathological lymph nodes selected as TLs must have a reduction in short axis to <10mm; Objective Response Rate (ORR) = CR + PR
Tumour response analysis set - dosed patients with a baseline tumour assessment.
Posted Number participants Up until progression or last evaluable assessment in the absence of progression, up to 9 months ID Title Description OG000 Cohort 1 sel50, Gem, Cis selumetinib 50mg bd, gemcitabine 1250mg/m2 , cisplatin 75mg/m2
OG001 Cohort 2 sel50, Gem, Carb selumetinib 50mg bd, gemcitabine 1250mg/m2 , carboplatin 5 units
OG002 Cohort 3 sel75, Gem, Cis selumetinib 75mg bd, gemcitabine 1250mg/m2 , cisplatin 75mg/m2
Secondary AUC (0-tau) Area under the concentration time curve (AUC) over a dosing interval at steady state (0-tau)
Pharmacokinetic analysis set - patients with sufficient samples to provide an adequate PK profile for determination of PK parameters with no important adverse events or protocol deviations that may have impacted PK
Posted Geometric Mean Geometric Coefficient of Variation h*ng/mL Cycle 2 Day1, pre-dose, 0.5, 1, 1.5, 2, 4, 8, 10 hours post dose ID Title Description OG000 Cohort 1 sel50, Gem, Cis selumetinib 50mg bd, gemcitabine 1250mg/m2 , cisplatin 75mg/m2
OG001 Cohort 2 sel50, Gem, Carb selumetinib 50mg bd, gemcitabine 1250mg/m2 , carboplatin 5 units
OG002 Cohort 3 sel75, Gem, Cis selumetinib 75mg bd, gemcitabine 1250mg/m2 , cisplatin 75mg/m2
OG003 Cohort 4 sel150, Pem, Carb selumetinib 50mg bd, pemetrexed 500 mg/m2, carboplatin 5 units
Secondary Cmax,ss Maximum plasma concentration at steady state
Pharmacokinetic analysis set - patients with sufficient samples to provide an adequate PK profile for determination of PK parameters with no important adverse events or protocol deviations that may have impacted PK
Posted Geometric Mean Geometric Coefficient of Variation ng/mL Cycle 2 Day1, pre-dose, 0.5, 1, 1.5, 2, 4, 8, 10 hours post dose ID Title Description OG000 Cohort 1 sel50, Gem, Cis selumetinib 50mg bd, gemcitabine 1250mg/m2 , cisplatin 75mg/m2
OG001 Cohort 2 sel50, Gem, Carb selumetinib 50mg bd, gemcitabine 1250mg/m2 , carboplatin 5 units
OG002 Cohort 3 sel75, Gem, Cis selumetinib 75mg bd, gemcitabine 1250mg/m2 , cisplatin 75mg/m2
OG003 Cohort 4 sel150, Pem, Carb selumetinib 50mg bd, pemetrexed 500 mg/m2, carboplatin 5 units
OG004
Secondary Tmax,ss Time to reach maximum plasma concentration at steady state
Pharmacokinetic analysis set - patients with sufficient samples to provide an adequate PK profile for determination of PK parameters with no important adverse events or protocol deviations that may have impacted PK
Posted Median Full Range h Cycle 2 Day1, pre-dose, 0.5, 1, 1.5, 2, 4, 8, 10 hours post dose ID Title Description OG000 Cohort 1 sel50, Gem, Cis selumetinib 50mg bd, gemcitabine 1250mg/m2 , cisplatin 75mg/m2
OG001 Cohort 2 sel50, Gem, Carb selumetinib 50mg bd, gemcitabine 1250mg/m2 , carboplatin 5 units
OG002 Cohort 3 sel75, Gem, Cis selumetinib 75mg bd, gemcitabine 1250mg/m2 , cisplatin 75mg/m2
OG003 Cohort 4 sel150, Pem, Carb selumetinib 50mg bd, pemetrexed 500 mg/m2, carboplatin 5 units
OG004
Secondary CL/F Apparent oral plasma clearance
Pharmacokinetic analysis set - patients with sufficient samples to provide an adequate PK profile for determination of PK parameters with no important adverse events or protocol deviations that may have impacted PK
Posted Mean Standard Deviation L/h Cycle 2 Day1, pre-dose, 0.5, 1, 1.5, 2, 4, 8, 10 hours post dose ID Title Description OG000 Cohort 1 sel50, Gem, Cis selumetinib 50mg bd, gemcitabine 1250mg/m2 , cisplatin 75mg/m2
OG001 Cohort 2 sel50, Gem, Carb selumetinib 50mg bd, gemcitabine 1250mg/m2 , carboplatin 5 units
OG002 Cohort 3 sel75, Gem, Cis selumetinib 75mg bd, gemcitabine 1250mg/m2 , cisplatin 75mg/m2
OG003 Cohort 4 sel150, Pem, Carb selumetinib 50mg bd, pemetrexed 500 mg/m2, carboplatin 5 units
OG004 Cohort 5 sel75, Pem, Carb
Adverse Events are collected throughout the study, from informed consent until the end of follow-up, which is defined as 28 +/- 7 days after selumetinib is discontinued. Patients were expected to receive up to 6 cycles (18 wks) of chemotherapy.
All-Cause Mortality Comment Not provided
ID Title Description Deaths (Affected) Deaths (At Risk) Serious Events (Affected) Serious Events (At Risk) Other Events (Affected) Other Events (At Risk) EG000 Cohort 1 sel50, Gem, Cis selumetinib 50mg bd, gemcitabine 1250mg/m2 , cisplatin 75mg/m2
1 3 3 3 EG001 Cohort 2 sel50, Gem, Carb selumetinib 50mg bd, gemcitabine 1250mg/m2 , carboplatin 5 units
6 9 9 9 EG002 Cohort 3 sel75, Gem, Cis selumetinib 75mg bd, gemcitabine 1250mg/m2 , cisplatin 75mg/m2
3 7 7 7 EG003 Cohort 4 sel150, Pem, Carb selumetinib 50mg bd, pemetrexed 500 mg/m2, carboplatin 5 units
2 3 3 3 EG004 Cohort 5 sel75, Pem, Carb selumetinib 75mg bd, pemetrexed 500 mg/m2, carboplatin 5 units
3 6 6 6 EG005 Cohort 6 sel75, Pem, Cis selumetinib 75mg bd, pemetrexed 500 mg/m2, cisplatin 75mg/m2
9 15 15 15 EG006 Cohort 7 sel100, Pem, Carb selumetinib 100mg bd, pemetrexed 500 mg/m2, carboplatin 5 units
9 12 12 12
Term Organ System Source Vocabulary Assessment Type Notes Statistical Information Anaemia Blood and lymphatic system disorders MedDRA 18.1 Systematic Assessment EG000 1 events 1 affected 3 at risk EG001 7 events 5 affected 9 at risk EG002 0 events 0 affected 7 at risk EG003 1 events 1 affected 3 at risk EG004 1 events 1 affected 6 at risk EG005 0 events 0 affected 15 at risk EG006 4 events 4 affected 12 at risk Leukopenia Blood and lymphatic system disorders MedDRA 18.1 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 5 events 3 affected 9 at risk EG002 0 events 0 affected 7 at risk EG003 Neutropenia Blood and lymphatic system disorders MedDRA 18.1 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 9 events 5 affected 9 at risk EG002 2 events 2 affected 7 at risk EG003 Thrombocytopenia Blood and lymphatic system disorders MedDRA 18.1 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 5 events 3 affected 9 at risk EG002 0 events 0 affected 7 at risk EG003 Atrial fibrillation Cardiac disorders MedDRA 18.1 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 1 events 1 affected 9 at risk EG002 0 events 0 affected 7 at risk EG003 Palpitations Cardiac disorders MedDRA 18.1 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 1 events 1 affected 9 at risk EG002 0 events 0 affected 7 at risk EG003 Sinus tachycardia Cardiac disorders MedDRA 18.1 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 1 events 1 affected 9 at risk EG002 0 events 0 affected 7 at risk EG003 Tinnitus Ear and labyrinth disorders MedDRA 18.1 Systematic Assessment EG000 1 events 1 affected 3 at risk EG001 0 events 0 affected 9 at risk EG002 0 events 0 affected 7 at risk EG003 Conjunctival oedema Eye disorders MedDRA 18.1 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 9 at risk EG002 0 events 0 affected 7 at risk EG003 Dry eye Eye disorders MedDRA 18.1 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 9 at risk EG002 0 events 0 affected 7 at risk EG003 Eyelid oedema Eye disorders MedDRA 18.1 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 9 at risk EG002 0 events 0 affected 7 at risk EG003 Foreign body sensation in eyes Eye disorders MedDRA 18.1 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 1 events 1 affected 9 at risk EG002 0 events 0 affected 7 at risk EG003 Lacrimation increased Eye disorders MedDRA 18.1 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 9 at risk EG002 0 events 0 affected 7 at risk EG003 Periorbital oedema Eye disorders MedDRA 18.1 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 3 events 3 affected 9 at risk EG002 2 events 2 affected 7 at risk EG003 Retinopathy Eye disorders MedDRA 18.1 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 9 at risk EG002 0 events 0 affected 7 at risk EG003 Vision blurred Eye disorders MedDRA 18.1 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 9 at risk EG002 0 events 0 affected 7 at risk EG003 Visual acuity reduced Eye disorders MedDRA 18.1 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 9 at risk EG002 0 events 0 affected 7 at risk EG003 Abdominal distension Gastrointestinal disorders MedDRA 18.1 Systematic Assessment EG000 1 events 1 affected 3 at risk EG001 0 events 0 affected 9 at risk EG002 0 events 0 affected 7 at risk EG003 Abdominal pain Gastrointestinal disorders MedDRA 18.1 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 3 events 1 affected 9 at risk EG002 1 events 1 affected 7 at risk EG003 Abdominal tenderness Gastrointestinal disorders MedDRA 18.1 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 9 at risk EG002 0 events 0 affected 7 at risk EG003 Chapped lips Gastrointestinal disorders MedDRA 18.1 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 1 events 1 affected 9 at risk EG002 0 events 0 affected 7 at risk EG003 Constipation Gastrointestinal disorders MedDRA 18.1 Systematic Assessment EG000 1 events 1 affected 3 at risk EG001 6 events 5 affected 9 at risk EG002 5 events 4 affected 7 at risk EG003 Diarrhoea Gastrointestinal disorders MedDRA 18.1 Systematic Assessment EG000 4 events 2 affected 3 at risk EG001 21 events 5 affected 9 at risk EG002 7 events 4 affected 7 at risk EG003 Dry mouth Gastrointestinal disorders MedDRA 18.1 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 1 events 1 affected 9 at risk EG002 0 events 0 affected 7 at risk EG003 Dyspepsia Gastrointestinal disorders MedDRA 18.1 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 1 events 1 affected 9 at risk EG002 0 events 0 affected 7 at risk EG003 Faeces discoloured Gastrointestinal disorders MedDRA 18.1 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 1 events 1 affected 9 at risk EG002 0 events 0 affected 7 at risk EG003 Flatulence Gastrointestinal disorders MedDRA 18.1 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 1 events 1 affected 9 at risk EG002 0 events 0 affected 7 at risk EG003 Gastritis Gastrointestinal disorders MedDRA 18.1 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 9 at risk EG002 0 events 0 affected 7 at risk EG003 Gastrooesophageal reflux disease Gastrointestinal disorders MedDRA 18.1 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 2 events 2 affected 9 at risk EG002 0 events 0 affected 7 at risk EG003 Gingival bleeding Gastrointestinal disorders MedDRA 18.1 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 9 at risk EG002 1 events 1 affected 7 at risk EG003 Haematemesis Gastrointestinal disorders MedDRA 18.1 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 9 at risk EG002 0 events 0 affected 7 at risk EG003 Haemorrhoids Gastrointestinal disorders MedDRA 18.1 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 9 at risk EG002 0 events 0 affected 7 at risk EG003 Mouth ulceration Gastrointestinal disorders MedDRA 18.1 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 3 events 1 affected 9 at risk EG002 0 events 0 affected 7 at risk EG003 Nausea Gastrointestinal disorders MedDRA 18.1 Systematic Assessment EG000 9 events 3 affected 3 at risk EG001 13 events 5 affected 9 at risk EG002 22 events 5 affected 7 at risk EG003 Oesophagitis Gastrointestinal disorders MedDRA 18.1 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 1 events 1 affected 9 at risk EG002 0 events 0 affected 7 at risk EG003 Oral pain Gastrointestinal disorders MedDRA 18.1 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 9 at risk EG002 0 events 0 affected 7 at risk EG003 Rectal haemorrhage Gastrointestinal disorders MedDRA 18.1 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 9 at risk EG002 0 events 0 affected 7 at risk EG003 Retching Gastrointestinal disorders MedDRA 18.1 Systematic Assessment EG000 1 events 1 affected 3 at risk EG001 0 events 0 affected 9 at risk EG002 0 events 0 affected 7 at risk EG003 Salivary hypersecretion Gastrointestinal disorders MedDRA 18.1 Systematic Assessment EG000 1 events 1 affected 3 at risk EG001 0 events 0 affected 9 at risk EG002 0 events 0 affected 7 at risk EG003 Stomatitis Gastrointestinal disorders MedDRA 18.1 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 2 events 1 affected 9 at risk EG002 5 events 3 affected 7 at risk EG003 Tongue ulceration Gastrointestinal disorders MedDRA 18.1 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 1 events 1 affected 9 at risk EG002 0 events 0 affected 7 at risk EG003 Vomiting Gastrointestinal disorders MedDRA 18.1 Systematic Assessment EG000 8 events 3 affected 3 at risk EG001 8 events 4 affected 9 at risk EG002 19 events 4 affected 7 at risk EG003 Chills General disorders MedDRA 18.1 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 1 events 1 affected 9 at risk EG002 0 events 0 affected 7 at risk EG003 Face oedema General disorders MedDRA 18.1 Systematic Assessment EG000 1 events 1 affected 3 at risk EG001 0 events 0 affected 9 at risk EG002 0 events 0 affected 7 at risk EG003 Fat tissue increased General disorders MedDRA 18.1 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 9 at risk EG002 0 events 0 affected 7 at risk EG003 Fatigue General disorders MedDRA 18.1 Systematic Assessment EG000 3 events 2 affected 3 at risk EG001 8 events 6 affected 9 at risk EG002 4 events 3 affected 7 at risk EG003 Feeling cold General disorders MedDRA 18.1 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 9 at risk EG002 0 events 0 affected 7 at risk EG003 Gait disturbance General disorders MedDRA 18.1 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 1 events 1 affected 9 at risk EG002 0 events 0 affected 7 at risk EG003 Malaise General disorders MedDRA 18.1 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 1 events 1 affected 9 at risk EG002 0 events 0 affected 7 at risk EG003 Mucosal inflammation General disorders MedDRA 18.1 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 9 at risk EG002 1 events 1 affected 7 at risk EG003 Non-cardiac chest pain General disorders MedDRA 18.1 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 1 events 1 affected 9 at risk EG002 0 events 0 affected 7 at risk EG003 Oedema peripheral General disorders MedDRA 18.1 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 1 events 1 affected 9 at risk EG002 0 events 0 affected 7 at risk EG003 Peripheral swelling General disorders MedDRA 18.1 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 2 events 1 affected 9 at risk EG002 0 events 0 affected 7 at risk EG003 Pyrexia General disorders MedDRA 18.1 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 9 at risk EG002 2 events 2 affected 7 at risk EG003 Hypersensitivity Immune system disorders MedDRA 18.1 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 9 at risk EG002 0 events 0 affected 7 at risk EG003 Anal abscess Infections and infestations MedDRA 18.1 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 9 at risk EG002 0 events 0 affected 7 at risk EG003 Angular cheilitis Infections and infestations MedDRA 18.1 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 9 at risk EG002 0 events 0 affected 7 at risk EG003 Cellulitis Infections and infestations MedDRA 18.1 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 9 at risk EG002 0 events 0 affected 7 at risk EG003 Clostridium difficile colitis Infections and infestations MedDRA 18.1 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 1 events 1 affected 9 at risk EG002 0 events 0 affected 7 at risk EG003 Conjunctivitis Infections and infestations MedDRA 18.1 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 9 at risk EG002 0 events 0 affected 7 at risk EG003 Cystitis Infections and infestations MedDRA 18.1 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 1 events 1 affected 9 at risk EG002 0 events 0 affected 7 at risk EG003 Folliculitis Infections and infestations MedDRA 18.1 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 9 at risk EG002 0 events 0 affected 7 at risk EG003 Herpes zoster Infections and infestations MedDRA 18.1 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 9 at risk EG002 0 events 0 affected 7 at risk EG003 Localised infection Infections and infestations MedDRA 18.1 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 9 at risk EG002 0 events 0 affected 7 at risk EG003 Lower respiratory tract infection Infections and infestations MedDRA 18.1 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 4 events 4 affected 9 at risk EG002 1 events 1 affected 7 at risk EG003 Lower respiratory tract infection bacterial Infections and infestations MedDRA 18.1 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 1 events 1 affected 9 at risk EG002 0 events 0 affected 7 at risk EG003 Lung infection Infections and infestations MedDRA 18.1 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 9 at risk EG002 0 events 0 affected 7 at risk EG003 Mastitis Infections and infestations MedDRA 18.1 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 9 at risk EG002 0 events 0 affected 7 at risk EG003 Oral candidiasis Infections and infestations MedDRA 18.1 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 4 events 4 affected 9 at risk EG002 1 events 1 affected 7 at risk EG003 Oral herpes Infections and infestations MedDRA 18.1 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 9 at risk EG002 0 events 0 affected 7 at risk EG003 Paronychia Infections and infestations MedDRA 18.1 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 9 at risk EG002 0 events 0 affected 7 at risk EG003 Periorbital cellulitis Infections and infestations MedDRA 18.1 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 9 at risk EG002 1 events 1 affected 7 at risk EG003 Pneumonia Infections and infestations MedDRA 18.1 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 9 at risk EG002 0 events 0 affected 7 at risk EG003 Rash pustular Infections and infestations MedDRA 18.1 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 9 at risk EG002 0 events 0 affected 7 at risk EG003 Skin infection Infections and infestations MedDRA 18.1 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 9 at risk EG002 0 events 0 affected 7 at risk EG003 Upper respiratory tract infection Infections and infestations MedDRA 18.1 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 9 at risk EG002 2 events 2 affected 7 at risk EG003 Urinary tract infection Infections and infestations MedDRA 18.1 Systematic Assessment EG000 1 events 1 affected 3 at risk EG001 2 events 1 affected 9 at risk EG002 0 events 0 affected 7 at risk EG003 Vaginal infection Infections and infestations MedDRA 18.1 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 9 at risk EG002 0 events 0 affected 7 at risk EG003 Vulvovaginal candidiasis Infections and infestations MedDRA 18.1 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 9 at risk EG002 0 events 0 affected 7 at risk EG003 Arthropod bite Injury, poisoning and procedural complications MedDRA 18.1 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 9 at risk EG002 0 events 0 affected 7 at risk EG003 Contusion Injury, poisoning and procedural complications MedDRA 18.1 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 1 events 1 affected 9 at risk EG002 0 events 0 affected 7 at risk EG003 Humerus fracture Injury, poisoning and procedural complications MedDRA 18.1 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 9 at risk EG002 0 events 0 affected 7 at risk EG003 Alanine aminotransferase increased Investigations MedDRA 18.1 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 9 at risk EG002 0 events 0 affected 7 at risk EG003 Aspartate aminotransferase increased Investigations MedDRA 18.1 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 1 events 1 affected 9 at risk EG002 0 events 0 affected 7 at risk EG003 Breath sounds abnormal Investigations MedDRA 18.1 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 9 at risk EG002 1 events 1 affected 7 at risk EG003 Ejection fraction decreased Investigations MedDRA 18.1 Systematic Assessment EG000 1 events 1 affected 3 at risk EG001 0 events 0 affected 9 at risk EG002 0 events 0 affected 7 at risk EG003 Troponin I increased Investigations MedDRA 18.1 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 9 at risk EG002 0 events 0 affected 7 at risk EG003 Abnormal loss of weight Metabolism and nutrition disorders MedDRA 18.1 Systematic Assessment EG000 1 events 1 affected 3 at risk EG001 1 events 1 affected 9 at risk EG002 0 events 0 affected 7 at risk EG003 Abnormal weight gain Metabolism and nutrition disorders MedDRA 18.1 Systematic Assessment EG000 1 events 1 affected 3 at risk EG001 0 events 0 affected 9 at risk EG002 0 events 0 affected 7 at risk EG003 Decreased appetite Metabolism and nutrition disorders MedDRA 18.1 Systematic Assessment EG000 2 events 1 affected 3 at risk EG001 4 events 4 affected 9 at risk EG002 5 events 2 affected 7 at risk EG003 Dehydration Metabolism and nutrition disorders MedDRA 18.1 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 9 at risk EG002 1 events 1 affected 7 at risk EG003 Fluid overload Metabolism and nutrition disorders MedDRA 18.1 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 9 at risk EG002 0 events 0 affected 7 at risk EG003 Fluid retention Metabolism and nutrition disorders MedDRA 18.1 Systematic Assessment EG000 1 events 1 affected 3 at risk EG001 0 events 0 affected 9 at risk EG002 0 events 0 affected 7 at risk EG003 Hyperuricaemia Metabolism and nutrition disorders MedDRA 18.1 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 9 at risk EG002 0 events 0 affected 7 at risk EG003 Hypokalaemia Metabolism and nutrition disorders MedDRA 18.1 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 3 events 1 affected 9 at risk EG002 0 events 0 affected 7 at risk EG003 Hypomagnesaemia Metabolism and nutrition disorders MedDRA 18.1 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 9 at risk EG002 0 events 0 affected 7 at risk EG003 Hyponatraemia Metabolism and nutrition disorders MedDRA 18.1 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 1 events 1 affected 9 at risk EG002 0 events 0 affected 7 at risk EG003 Ketosis Metabolism and nutrition disorders MedDRA 18.1 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 9 at risk EG002 0 events 0 affected 7 at risk EG003 Arthralgia Musculoskeletal and connective tissue disorders MedDRA 18.1 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 2 events 2 affected 9 at risk EG002 0 events 0 affected 7 at risk EG003 Back pain Musculoskeletal and connective tissue disorders MedDRA 18.1 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 9 at risk EG002 0 events 0 affected 7 at risk EG003 Bone pain Musculoskeletal and connective tissue disorders MedDRA 18.1 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 9 at risk EG002 0 events 0 affected 7 at risk EG003 Joint swelling Musculoskeletal and connective tissue disorders MedDRA 18.1 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 9 at risk EG002 0 events 0 affected 7 at risk EG003 Muscle spasms Musculoskeletal and connective tissue disorders MedDRA 18.1 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 1 events 1 affected 9 at risk EG002 0 events 0 affected 7 at risk EG003 Muscular weakness Musculoskeletal and connective tissue disorders MedDRA 18.1 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 9 at risk EG002 0 events 0 affected 7 at risk EG003 Musculoskeletal chest pain Musculoskeletal and connective tissue disorders MedDRA 18.1 Systematic Assessment EG000 1 events 1 affected 3 at risk EG001 1 events 1 affected 9 at risk EG002 0 events 0 affected 7 at risk EG003 Myalgia Musculoskeletal and connective tissue disorders MedDRA 18.1 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 1 events 1 affected 9 at risk EG002 0 events 0 affected 7 at risk EG003 Pain in extremity Musculoskeletal and connective tissue disorders MedDRA 18.1 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 9 at risk EG002 0 events 0 affected 7 at risk EG003 Lipoma Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 18.1 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 9 at risk EG002 0 events 0 affected 7 at risk EG003 Tumour pain Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 18.1 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 9 at risk EG002 0 events 0 affected 7 at risk EG003 Ageusia Nervous system disorders MedDRA 18.1 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 9 at risk EG002 0 events 0 affected 7 at risk EG003 Aphonia Nervous system disorders MedDRA 18.1 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 1 events 1 affected 9 at risk EG002 0 events 0 affected 7 at risk EG003 Dizziness Nervous system disorders MedDRA 18.1 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 5 events 2 affected 9 at risk EG002 2 events 2 affected 7 at risk EG003 Dysarthria Nervous system disorders MedDRA 18.1 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 9 at risk EG002 0 events 0 affected 7 at risk EG003 Dysgeusia Nervous system disorders MedDRA 18.1 Systematic Assessment EG000 1 events 1 affected 3 at risk EG001 2 events 2 affected 9 at risk EG002 1 events 1 affected 7 at risk EG003 Headache Nervous system disorders MedDRA 18.1 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 2 events 2 affected 9 at risk EG002 1 events 1 affected 7 at risk EG003 Hemiparesis Nervous system disorders MedDRA 18.1 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 9 at risk EG002 0 events 0 affected 7 at risk EG003 Hypoaesthesia Nervous system disorders MedDRA 18.1 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 9 at risk EG002 0 events 0 affected 7 at risk EG003 Lethargy Nervous system disorders MedDRA 18.1 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 2 events 2 affected 9 at risk EG002 6 events 3 affected 7 at risk EG003 Migraine Nervous system disorders MedDRA 18.1 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 9 at risk EG002 0 events 0 affected 7 at risk EG003 Neuropathy peripheral Nervous system disorders MedDRA 18.1 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 1 events 1 affected 9 at risk EG002 1 events 1 affected 7 at risk EG003 Neurotoxicity Nervous system disorders MedDRA 18.1 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 1 events 1 affected 9 at risk EG002 0 events 0 affected 7 at risk EG003 Paraesthesia Nervous system disorders MedDRA 18.1 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 9 at risk EG002 1 events 1 affected 7 at risk EG003 Presyncope Nervous system disorders MedDRA 18.1 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 9 at risk EG002 0 events 0 affected 7 at risk EG003 Seizure Nervous system disorders MedDRA 18.1 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 9 at risk EG002 0 events 0 affected 7 at risk EG003 Syncope Nervous system disorders MedDRA 18.1 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 1 events 1 affected 9 at risk EG002 0 events 0 affected 7 at risk EG003 Tremor Nervous system disorders MedDRA 18.1 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 1 events 1 affected 9 at risk EG002 0 events 0 affected 7 at risk EG003 Depressed mood Psychiatric disorders MedDRA 18.1 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 9 at risk EG002 0 events 0 affected 7 at risk EG003 Depression Psychiatric disorders MedDRA 18.1 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 9 at risk EG002 1 events 1 affected 7 at risk EG003 Insomnia Psychiatric disorders MedDRA 18.1 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 1 events 1 affected 9 at risk EG002 0 events 0 affected 7 at risk EG003 Dysuria Renal and urinary disorders MedDRA 18.1 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 9 at risk EG002 0 events 0 affected 7 at risk EG003 Pollakiuria Renal and urinary disorders MedDRA 18.1 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 9 at risk EG002 0 events 0 affected 7 at risk EG003 Stress urinary incontinence Renal and urinary disorders MedDRA 18.1 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 9 at risk EG002 0 events 0 affected 7 at risk EG003 Urinary incontinence Renal and urinary disorders MedDRA 18.1 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 9 at risk EG002 0 events 0 affected 7 at risk EG003 Perineal fistula Reproductive system and breast disorders MedDRA 18.1 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 9 at risk EG002 0 events 0 affected 7 at risk EG003 Perineal ulceration Reproductive system and breast disorders MedDRA 18.1 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 9 at risk EG002 0 events 0 affected 7 at risk EG003 Vaginal haemorrhage Reproductive system and breast disorders MedDRA 18.1 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 9 at risk EG002 0 events 0 affected 7 at risk EG003 Vulvovaginal discomfort Reproductive system and breast disorders MedDRA 18.1 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 9 at risk EG002 0 events 0 affected 7 at risk EG003 Cough Respiratory, thoracic and mediastinal disorders MedDRA 18.1 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 9 at risk EG002 0 events 0 affected 7 at risk EG003 Dysphonia Respiratory, thoracic and mediastinal disorders MedDRA 18.1 Systematic Assessment EG000 1 events 1 affected 3 at risk EG001 0 events 0 affected 9 at risk EG002 0 events 0 affected 7 at risk EG003 Dyspnoea Respiratory, thoracic and mediastinal disorders MedDRA 18.1 Systematic Assessment EG000 1 events 1 affected 3 at risk EG001 1 events 1 affected 9 at risk EG002 1 events 1 affected 7 at risk EG003 Dyspnoea exertional Respiratory, thoracic and mediastinal disorders MedDRA 18.1 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 9 at risk EG002 0 events 0 affected 7 at risk EG003 Epistaxis Respiratory, thoracic and mediastinal disorders MedDRA 18.1 Systematic Assessment EG000 1 events 1 affected 3 at risk EG001 5 events 4 affected 9 at risk EG002 0 events 0 affected 7 at risk EG003 Haemoptysis Respiratory, thoracic and mediastinal disorders MedDRA 18.1 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 9 at risk EG002 2 events 2 affected 7 at risk EG003 Hiccups Respiratory, thoracic and mediastinal disorders MedDRA 18.1 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 9 at risk EG002 0 events 0 affected 7 at risk EG003 Oropharyngeal pain Respiratory, thoracic and mediastinal disorders MedDRA 18.1 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 2 events 2 affected 9 at risk EG002 0 events 0 affected 7 at risk EG003 Pneumothorax Respiratory, thoracic and mediastinal disorders MedDRA 18.1 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 9 at risk EG002 0 events 0 affected 7 at risk EG003 Productive cough Respiratory, thoracic and mediastinal disorders MedDRA 18.1 Systematic Assessment EG000 1 events 1 affected 3 at risk EG001 1 events 1 affected 9 at risk EG002 1 events 1 affected 7 at risk EG003 Pulmonary embolism Respiratory, thoracic and mediastinal disorders MedDRA 18.1 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 9 at risk EG002 0 events 0 affected 7 at risk EG003 Pulmonary oedema Respiratory, thoracic and mediastinal disorders MedDRA 18.1 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 9 at risk EG002 0 events 0 affected 7 at risk EG003 Respiratory failure Respiratory, thoracic and mediastinal disorders MedDRA 18.1 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 9 at risk EG002 0 events 0 affected 7 at risk EG003 Rhinorrhoea Respiratory, thoracic and mediastinal disorders MedDRA 18.1 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 9 at risk EG002 0 events 0 affected 7 at risk EG003 Wheezing Respiratory, thoracic and mediastinal disorders MedDRA 18.1 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 1 events 1 affected 9 at risk EG002 0 events 0 affected 7 at risk EG003 Acne Skin and subcutaneous tissue disorders MedDRA 18.1 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 9 at risk EG002 0 events 0 affected 7 at risk EG003 Alopecia Skin and subcutaneous tissue disorders MedDRA 18.1 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 1 events 1 affected 9 at risk EG002 1 events 1 affected 7 at risk EG003 Dermatitis acneiform Skin and subcutaneous tissue disorders MedDRA 18.1 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 1 events 1 affected 9 at risk EG002 0 events 0 affected 7 at risk EG003 Dry skin Skin and subcutaneous tissue disorders MedDRA 18.1 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 2 events 2 affected 9 at risk EG002 0 events 0 affected 7 at risk EG003 Erythema Skin and subcutaneous tissue disorders MedDRA 18.1 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 1 events 1 affected 9 at risk EG002 0 events 0 affected 7 at risk EG003 Hyperhidrosis Skin and subcutaneous tissue disorders MedDRA 18.1 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 1 events 1 affected 9 at risk EG002 0 events 0 affected 7 at risk EG003 Nail disorder Skin and subcutaneous tissue disorders MedDRA 18.1 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 9 at risk EG002 0 events 0 affected 7 at risk EG003 Pain of skin Skin and subcutaneous tissue disorders MedDRA 18.1 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 9 at risk EG002 0 events 0 affected 7 at risk EG003 Plantar erythema Skin and subcutaneous tissue disorders MedDRA 18.1 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 1 events 1 affected 9 at risk EG002 0 events 0 affected 7 at risk EG003 Pruritus Skin and subcutaneous tissue disorders MedDRA 18.1 Systematic Assessment EG000 1 events 1 affected 3 at risk EG001 0 events 0 affected 9 at risk EG002 0 events 0 affected 7 at risk EG003 Rash Skin and subcutaneous tissue disorders MedDRA 18.1 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 4 events 3 affected 9 at risk EG002 5 events 5 affected 7 at risk EG003 Rash generalised Skin and subcutaneous tissue disorders MedDRA 18.1 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 9 at risk EG002 0 events 0 affected 7 at risk EG003 Rash maculo-papular Skin and subcutaneous tissue disorders MedDRA 18.1 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 1 events 1 affected 9 at risk EG002 0 events 0 affected 7 at risk EG003 Rash papular Skin and subcutaneous tissue disorders MedDRA 18.1 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 1 events 1 affected 9 at risk EG002 0 events 0 affected 7 at risk EG003 Skin fissures Skin and subcutaneous tissue disorders MedDRA 18.1 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 9 at risk EG002 0 events 0 affected 7 at risk EG003 Skin lesion Skin and subcutaneous tissue disorders MedDRA 18.1 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 9 at risk EG002 0 events 0 affected 7 at risk EG003 Skin ulcer Skin and subcutaneous tissue disorders MedDRA 18.1 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 1 events 1 affected 9 at risk EG002 0 events 0 affected 7 at risk EG003 Deep vein thrombosis Vascular disorders MedDRA 18.1 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 9 at risk EG002 0 events 0 affected 7 at risk EG003 Flushing Vascular disorders MedDRA 18.1 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 9 at risk EG002 1 events 1 affected 7 at risk EG003 Hot flush Vascular disorders MedDRA 18.1 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 1 events 1 affected 9 at risk EG002 0 events 0 affected 7 at risk EG003 Hypertension Vascular disorders MedDRA 18.1 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 1 events 1 affected 9 at risk EG002 0 events 0 affected 7 at risk EG003 Peripheral coldness Vascular disorders MedDRA 18.1 Systematic Assessment EG000 0 events 0 affected 3 at risk EG001 0 events 0 affected 9 at risk EG002 0 events 0 affected 7 at risk EG003
Are all PI(s) employees of the sponsor? No
Results Disclosure Restriction on PI(s)? No
Title Organization Phone Extension Email Dr Gabriella Mariani , MD AstraZeneca +44 (0)207 6048000 ClinicalTrialTransparency@astrazeneca.com
ID Term D002289 Carcinoma, Non-Small-Cell Lung D009362 Neoplasm Metastasis
ID Term D002283 Carcinoma, Bronchogenic D001984 Bronchial Neoplasms D008175 Lung Neoplasms D012142 Respiratory Tract Neoplasms D013899 Thoracic Neoplasms D009371 Neoplasms by Site D009369 Neoplasms D008171 Lung Diseases D012140 Respiratory Tract Diseases D009385 Neoplastic Processes D010335 Pathologic Processes D013568 Pathological Conditions, Signs and Symptoms
ID Term C517975 AZD 6244 D000093542 Gemcitabine D002945 Cisplatin D016190 Carboplatin D000068437 Pemetrexed
ID Term D006571 Heterocyclic Compounds D003841 Deoxycytidine D003562 Cytidine D011741 Pyrimidine Nucleosides D011743 Pyrimidines D006573 Heterocyclic Compounds, 1-Ring D017606 Chlorine Compounds D007287 Inorganic Chemicals D017672 Nitrogen Compounds D017671 Platinum Compounds D056831 Coordination Complexes D009930 Organic Chemicals D006147 Guanine D007042 Hypoxanthines D011688 Purinones D011687 Purines D006574 Heterocyclic Compounds, 2-Ring D000072471 Heterocyclic Compounds, Fused-Ring D005971 Glutamates D024342 Amino Acids, Acidic D000596 Amino Acids D000602 Amino Acids, Peptides, and Proteins D000600 Amino Acids, Dicarboxylic
1 subjects
FG005 3 subjects
FG006 1 subjects BG003 64.7 ± 7.23 (60 to 73)
BG004 59.5 ± 5.28 (54 to 66)
BG005 61.8 ± 5.86 (54 to 71)
BG006 60.2 ± 8.39 (46 to 73)
BG007 61.5 ± 7.45 (39 to 76) 3
BG003 1
BG004 4
BG005 5
BG006 7
BG007 26 Male BG000 2 BG001 4 BG002 4 BG003 2 BG004 2 BG005 10 BG006 5 BG007 29
0
BG003 0
BG004 1
BG005 1
BG006 0
BG007 3 Other BG000 0 BG001 0 BG002 0 BG003 0 BG004 0 BG005 1 BG006 1 BG007 2
White BG000 2 BG001 9 BG002 7 BG003 3 BG004 5 BG005 13 BG006 11 BG007 50
3
OG004 6
OG005 15
OG006 12 3
OG004 6
OG005 12
OG006 6 Evaluable patients with a DLT Event Title Measurements OG000 0 OG001 2 OG002 1 OG003 0 OG004 0 OG005 1 OG006 1
selumetinib 75mg bd, gemcitabine 1250mg/m2 , cisplatin 75mg/m2
OG003 Cohort 4 sel150, Pem, Carb selumetinib 50mg bd, pemetrexed 500 mg/m2, carboplatin 5 units
OG004 Cohort 5 sel75, Pem, Carb selumetinib 75mg bd, pemetrexed 500 mg/m2, carboplatin 5 units
OG005 Cohort 6 sel75, Pem, Cis selumetinib 75mg bd, pemetrexed 500 mg/m2, cisplatin 75mg/m2
OG006 Cohort 7 sel100, Pem, Carb selumetinib 100mg bd, pemetrexed 500 mg/m2, carboplatin 5 units
Units Counts Participants OG000 3 OG001 9 OG002 7 OG003 3 OG004 6 OG005 15 OG006 12
Title Denominators Categories Complete response Title Measurements OG000 0 OG001 0 OG002 0 OG003 0 OG004 0 OG005 0 OG006 0
Partial response Unconfirmed complete or partial response Stable disease RECIST progression Death Incomplete post-baseline assessments
selumetinib 75mg bd, pemetrexed 500 mg/m2, carboplatin 5 units
OG005 Cohort 6 sel75, Pem, Cis selumetinib 75mg bd, pemetrexed 500 mg/m2, cisplatin 75mg/m2
OG006 Cohort 7 sel100, Pem, Carb selumetinib 100mg bd, pemetrexed 500 mg/m2, carboplatin 5 units
Units Counts Participants OG000 3 OG001 9 OG002 7 OG003 3 OG004 6 OG005 15 OG006 12
Title Denominators Categories Title Measurements OG000 -7.5 ± 19.79 OG001 -29.3 ± 11.15 OG002 -10.4 ± 24.45 OG003 -14.7 ± 1.91 OG004 -24.4 ± 32.60 OG005 -18.9 ± 10.55 OG006 -18.4 ± 19.58
OG004 Cohort 5 sel75, Pem, Carb selumetinib 75mg bd, pemetrexed 500 mg/m2, carboplatin 5 units
OG005 Cohort 6 sel75, Pem, Cis selumetinib 75mg bd, pemetrexed 500 mg/m2, cisplatin 75mg/m2
OG006 Cohort 7 sel100, Pem, Carb selumetinib 100mg bd, pemetrexed 500 mg/m2, carboplatin 5 units
Units Counts Participants OG000 3 OG001 9 OG002 7 OG003 3 OG004 6 OG005 15 OG006 12
Title Denominators Categories Title Measurements OG000 -11.9 ± 26.52 OG001 -34.6 ± 8.11 OG002 -41.3 ± 21.25 OG003 -28.3 ± 15.25 OG004 -34.7 ± 33.30 OG005 -24.4 ± 14.71 OG006 -25.4 ± 20.51
Cohort 4 sel150, Pem, Carb
selumetinib 50mg bd, pemetrexed 500 mg/m2, carboplatin 5 units
OG004 Cohort 5 sel75, Pem, Carb selumetinib 75mg bd, pemetrexed 500 mg/m2, carboplatin 5 units
OG005 Cohort 6 sel75, Pem, Cis selumetinib 75mg bd, pemetrexed 500 mg/m2, cisplatin 75mg/m2
OG006 Cohort 7 sel100, Pem, Carb selumetinib 100mg bd, pemetrexed 500 mg/m2, carboplatin 5 units
Units Counts Participants OG000 3 OG001 9 OG002 7 OG003 3 OG004 6 OG005 15 OG006 12
Title Denominators Categories Title Measurements OG000 1 ± 26.52 OG001 2 ± 8.11 OG002 2 ± 21.25 OG003 1 ± 15.25 OG004 1 ± 33.30 OG005 2 ± 14.71 OG006 2 ± 20.51
Cohort 5 sel75, Pem, Carb
selumetinib 75mg bd, pemetrexed 500 mg/m2, carboplatin 5 units
OG005 Cohort 6 sel75, Pem, Cis selumetinib 75mg bd, pemetrexed 500 mg/m2, cisplatin 75mg/m2
OG006 Cohort 7 sel100, Pem, Carb selumetinib 100mg bd, pemetrexed 500 mg/m2, carboplatin 5 units
Units Counts Participants OG000 3 OG001 9 OG002 7 OG003 3 OG004 6 OG005 15 OG006 12
Title Denominators Categories Title Measurements OG000 NA ± NA Not calculated as only 2 patients provided sufficient PK samples for AUC calculation and therefore geometric mean was not calculated. (Min 2130, Max 2240) OG001 3571 ± 42.13 OG002 3339 ± 15.08 OG003 4813 ± 30.93 OG004 4366 ± 48.14 OG005 4116 ± 33.92 OG006 5202 ± 52.94
Cohort 5 sel75, Pem, Carb
selumetinib 75mg bd, pemetrexed 500 mg/m2, carboplatin 5 units
OG005 Cohort 6 sel75, Pem, Cis selumetinib 75mg bd, pemetrexed 500 mg/m2, cisplatin 75mg/m2
OG006 Cohort 7 sel100, Pem, Carb selumetinib 100mg bd, pemetrexed 500 mg/m2, carboplatin 5 units
Units Counts Participants OG000 3 OG001 9 OG002 7 OG003 3 OG004 6 OG005 15 OG006 12
Title Denominators Categories Title Measurements OG000 476.7 ± 51.12 OG001 1222 ± 59.86 OG002 1487 ± 23.09 OG003 1615 ± 27.71 OG004 1375 ± 40.21 OG005 1364 ± 57.78 OG006 2309 ± 35.99
Cohort 5 sel75, Pem, Carb
selumetinib 75mg bd, pemetrexed 500 mg/m2, carboplatin 5 units
OG005 Cohort 6 sel75, Pem, Cis selumetinib 75mg bd, pemetrexed 500 mg/m2, cisplatin 75mg/m2
OG006 Cohort 7 sel100, Pem, Carb selumetinib 100mg bd, pemetrexed 500 mg/m2, carboplatin 5 units
Units Counts Participants OG000 3 OG001 9 OG002 7 OG003 3 OG004 6 OG005 15 OG006 12
Title Denominators Categories Title Measurements OG000 1.00 ± 51.12 (1.00 to 1.60) OG001 1.25 ± 23.09 (1.00 to 1.50) OG002 1.00 ± 57.78 (0.58 to 1.00) OG003 1.00 ± 59.86 (1.00 to 1.50) OG004 1.75 ± 27.71 (0.50 to 2.03) OG005 1.48 ± 40.21 (0.50 to 2.75) OG006 1.50 ± 35.99 (1.00 to 2.00)
selumetinib 75mg bd, pemetrexed 500 mg/m2, carboplatin 5 units
OG005 Cohort 6 sel75, Pem, Cis selumetinib 75mg bd, pemetrexed 500 mg/m2, cisplatin 75mg/m2
OG006 Cohort 7 sel100, Pem, Carb selumetinib 100mg bd, pemetrexed 500 mg/m2, carboplatin 5 units
Units Counts Participants OG000 3 OG001 9 OG002 7 OG003 3 OG004 6 OG005 15 OG006 12
Title Denominators Categories Title Measurements OG000 NA ± NA Not calculated as only 2 patients provided sufficient PK samples for CL/F calculation and therefore geometric mean was not calculated. (Min 22.3, Max 23.5) OG001 14.72 ± 5.156 OG002 22.64 ± 3.521 OG003 10.72 ± 3.328 OG004 18.82 ± 9.777 OG005 19.08 ± 5.881 OG006 21.02 ± 9.857
0 events
0 affected
3 at risk
EG004 0 events 0 affected 6 at risk
EG005 0 events 0 affected 15 at risk
EG006 1 events 1 affected 12 at risk 0 events
0 affected
3 at risk
EG004 0 events 0 affected 6 at risk
EG005 1 events 1 affected 15 at risk
EG006 1 events 1 affected 12 at risk 0 events
0 affected
3 at risk
EG004 0 events 0 affected 6 at risk
EG005 0 events 0 affected 15 at risk
EG006 4 events 4 affected 12 at risk 0 events
0 affected
3 at risk
EG004 0 events 0 affected 6 at risk
EG005 1 events 1 affected 15 at risk
EG006 0 events 0 affected 12 at risk 0 events
0 affected
3 at risk
EG004 0 events 0 affected 6 at risk
EG005 0 events 0 affected 15 at risk
EG006 0 events 0 affected 12 at risk 0 events
0 affected
3 at risk
EG004 0 events 0 affected 6 at risk
EG005 1 events 1 affected 15 at risk
EG006 0 events 0 affected 12 at risk 0 events
0 affected
3 at risk
EG004 0 events 0 affected 6 at risk
EG005 1 events 1 affected 15 at risk
EG006 0 events 0 affected 12 at risk 0 events
0 affected
3 at risk
EG004 0 events 0 affected 6 at risk
EG005 0 events 0 affected 15 at risk
EG006 1 events 1 affected 12 at risk 0 events
0 affected
3 at risk
EG004 0 events 0 affected 6 at risk
EG005 0 events 0 affected 15 at risk
EG006 0 events 0 affected 12 at risk 0 events
0 affected
3 at risk
EG004 0 events 0 affected 6 at risk
EG005 1 events 1 affected 15 at risk
EG006 0 events 0 affected 12 at risk 0 events
0 affected
3 at risk
EG004 0 events 0 affected 6 at risk
EG005 0 events 0 affected 15 at risk
EG006 1 events 1 affected 12 at risk 0 events
0 affected
3 at risk
EG004 0 events 0 affected 6 at risk
EG005 0 events 0 affected 15 at risk
EG006 0 events 0 affected 12 at risk 0 events
0 affected
3 at risk
EG004 1 events 1 affected 6 at risk
EG005 0 events 0 affected 15 at risk
EG006 0 events 0 affected 12 at risk 0 events
0 affected
3 at risk
EG004 0 events 0 affected 6 at risk
EG005 0 events 0 affected 15 at risk
EG006 1 events 1 affected 12 at risk 0 events
0 affected
3 at risk
EG004 0 events 0 affected 6 at risk
EG005 1 events 1 affected 15 at risk
EG006 0 events 0 affected 12 at risk 0 events
0 affected
3 at risk
EG004 0 events 0 affected 6 at risk
EG005 0 events 0 affected 15 at risk
EG006 1 events 1 affected 12 at risk 0 events
0 affected
3 at risk
EG004 1 events 1 affected 6 at risk
EG005 0 events 0 affected 15 at risk
EG006 0 events 0 affected 12 at risk 0 events
0 affected
3 at risk
EG004 0 events 0 affected 6 at risk
EG005 0 events 0 affected 15 at risk
EG006 0 events 0 affected 12 at risk 0 events
0 affected
3 at risk
EG004 0 events 0 affected 6 at risk
EG005 0 events 0 affected 15 at risk
EG006 1 events 1 affected 12 at risk 0 events
0 affected
3 at risk
EG004 0 events 0 affected 6 at risk
EG005 0 events 0 affected 15 at risk
EG006 1 events 1 affected 12 at risk 0 events
0 affected
3 at risk
EG004 2 events 1 affected 6 at risk
EG005 0 events 0 affected 15 at risk
EG006 1 events 1 affected 12 at risk 0 events
0 affected
3 at risk
EG004 0 events 0 affected 6 at risk
EG005 1 events 1 affected 15 at risk
EG006 0 events 0 affected 12 at risk 0 events
0 affected
3 at risk
EG004 0 events 0 affected 6 at risk
EG005 0 events 0 affected 15 at risk
EG006 1 events 1 affected 12 at risk 1 events
1 affected
3 at risk
EG004 0 events 0 affected 6 at risk
EG005 0 events 0 affected 15 at risk
EG006 0 events 0 affected 12 at risk 1 events
1 affected
3 at risk
EG004 0 events 0 affected 6 at risk
EG005 0 events 0 affected 15 at risk
EG006 0 events 0 affected 12 at risk 0 events
0 affected
3 at risk
EG004 0 events 0 affected 6 at risk
EG005 1 events 1 affected 15 at risk
EG006 1 events 1 affected 12 at risk 0 events
0 affected
3 at risk
EG004 0 events 0 affected 6 at risk
EG005 1 events 1 affected 15 at risk
EG006 1 events 1 affected 12 at risk 1 events
1 affected
3 at risk
EG004 0 events 0 affected 6 at risk
EG005 0 events 0 affected 15 at risk
EG006 0 events 0 affected 12 at risk 0 events
0 affected
3 at risk
EG004 0 events 0 affected 6 at risk
EG005 1 events 1 affected 15 at risk
EG006 0 events 0 affected 12 at risk 0 events
0 affected
3 at risk
EG004 0 events 0 affected 6 at risk
EG005 0 events 0 affected 15 at risk
EG006 0 events 0 affected 12 at risk 0 events
0 affected
3 at risk
EG004 0 events 0 affected 6 at risk
EG005 0 events 0 affected 15 at risk
EG006 0 events 0 affected 12 at risk 0 events
0 affected
3 at risk
EG004 0 events 0 affected 6 at risk
EG005 1 events 1 affected 15 at risk
EG006 0 events 0 affected 12 at risk 0 events
0 affected
3 at risk
EG004 0 events 0 affected 6 at risk
EG005 0 events 0 affected 15 at risk
EG006 0 events 0 affected 12 at risk 0 events
0 affected
3 at risk
EG004 0 events 0 affected 6 at risk
EG005 0 events 0 affected 15 at risk
EG006 0 events 0 affected 12 at risk 0 events
0 affected
3 at risk
EG004 1 events 1 affected 6 at risk
EG005 0 events 0 affected 15 at risk
EG006 6 events 6 affected 12 at risk 0 events
0 affected
3 at risk
EG004 1 events 1 affected 6 at risk
EG005 0 events 0 affected 15 at risk
EG006 4 events 4 affected 12 at risk 0 events
0 affected
3 at risk
EG004 0 events 0 affected 6 at risk
EG005 0 events 0 affected 15 at risk
EG006 0 events 0 affected 12 at risk 0 events
0 affected
3 at risk
EG004 0 events 0 affected 6 at risk
EG005 0 events 0 affected 15 at risk
EG006 0 events 0 affected 12 at risk 0 events
0 affected
3 at risk
EG004 0 events 0 affected 6 at risk
EG005 0 events 0 affected 15 at risk
EG006 0 events 0 affected 12 at risk 0 events
0 affected
3 at risk
EG004 0 events 0 affected 6 at risk
EG005 2 events 2 affected 15 at risk
EG006 0 events 0 affected 12 at risk 0 events
0 affected
3 at risk
EG004 1 events 1 affected 6 at risk
EG005 0 events 0 affected 15 at risk
EG006 0 events 0 affected 12 at risk 0 events
0 affected
3 at risk
EG004 0 events 0 affected 6 at risk
EG005 1 events 1 affected 15 at risk
EG006 1 events 1 affected 12 at risk 0 events
0 affected
3 at risk
EG004 0 events 0 affected 6 at risk
EG005 1 events 1 affected 15 at risk
EG006 0 events 0 affected 12 at risk 0 events
0 affected
3 at risk
EG004 0 events 0 affected 6 at risk
EG005 0 events 0 affected 15 at risk
EG006 0 events 0 affected 12 at risk 0 events
0 affected
3 at risk
EG004 0 events 0 affected 6 at risk
EG005 1 events 1 affected 15 at risk
EG006 0 events 0 affected 12 at risk 2 events
2 affected
3 at risk
EG004 1 events 1 affected 6 at risk
EG005 2 events 2 affected 15 at risk
EG006 6 events 6 affected 12 at risk 0 events
0 affected
3 at risk
EG004 0 events 0 affected 6 at risk
EG005 1 events 1 affected 15 at risk
EG006 0 events 0 affected 12 at risk 0 events
0 affected
3 at risk
EG004 0 events 0 affected 6 at risk
EG005 2 events 2 affected 15 at risk
EG006 1 events 1 affected 12 at risk 0 events
0 affected
3 at risk
EG004 0 events 0 affected 6 at risk
EG005 0 events 0 affected 15 at risk
EG006 1 events 1 affected 12 at risk 0 events
0 affected
3 at risk
EG004 0 events 0 affected 6 at risk
EG005 0 events 0 affected 15 at risk
EG006 0 events 0 affected 12 at risk 0 events
0 affected
3 at risk
EG004 1 events 1 affected 6 at risk
EG005 1 events 1 affected 15 at risk
EG006 0 events 0 affected 12 at risk 0 events
0 affected
3 at risk
EG004 0 events 0 affected 6 at risk
EG005 1 events 1 affected 15 at risk
EG006 0 events 0 affected 12 at risk 0 events
0 affected
3 at risk
EG004 0 events 0 affected 6 at risk
EG005 0 events 0 affected 15 at risk
EG006 0 events 0 affected 12 at risk 2 events
2 affected
3 at risk
EG004 2 events 2 affected 6 at risk
EG005 7 events 6 affected 15 at risk
EG006 13 events 9 affected 12 at risk 2 events
1 affected
3 at risk
EG004 8 events 3 affected 6 at risk
EG005 16 events 9 affected 15 at risk
EG006 8 events 6 affected 12 at risk 0 events
0 affected
3 at risk
EG004 0 events 0 affected 6 at risk
EG005 0 events 0 affected 15 at risk
EG006 0 events 0 affected 12 at risk 1 events
1 affected
3 at risk
EG004 0 events 0 affected 6 at risk
EG005 3 events 3 affected 15 at risk
EG006 5 events 3 affected 12 at risk 0 events
0 affected
3 at risk
EG004 0 events 0 affected 6 at risk
EG005 0 events 0 affected 15 at risk
EG006 0 events 0 affected 12 at risk 0 events
0 affected
3 at risk
EG004 0 events 0 affected 6 at risk
EG005 0 events 0 affected 15 at risk
EG006 1 events 1 affected 12 at risk 0 events
0 affected
3 at risk
EG004 0 events 0 affected 6 at risk
EG005 1 events 1 affected 15 at risk
EG006 0 events 0 affected 12 at risk 0 events
0 affected
3 at risk
EG004 0 events 0 affected 6 at risk
EG005 0 events 0 affected 15 at risk
EG006 0 events 0 affected 12 at risk 0 events
0 affected
3 at risk
EG004 0 events 0 affected 6 at risk
EG005 0 events 0 affected 15 at risk
EG006 0 events 0 affected 12 at risk 0 events
0 affected
3 at risk
EG004 0 events 0 affected 6 at risk
EG005 0 events 0 affected 15 at risk
EG006 1 events 1 affected 12 at risk 0 events
0 affected
3 at risk
EG004 0 events 0 affected 6 at risk
EG005 1 events 1 affected 15 at risk
EG006 0 events 0 affected 12 at risk 0 events
0 affected
3 at risk
EG004 0 events 0 affected 6 at risk
EG005 4 events 4 affected 15 at risk
EG006 3 events 3 affected 12 at risk 4 events
3 affected
3 at risk
EG004 8 events 5 affected 6 at risk
EG005 15 events 8 affected 15 at risk
EG006 14 events 10 affected 12 at risk 0 events
0 affected
3 at risk
EG004 0 events 0 affected 6 at risk
EG005 1 events 1 affected 15 at risk
EG006 0 events 0 affected 12 at risk 0 events
0 affected
3 at risk
EG004 0 events 0 affected 6 at risk
EG005 0 events 0 affected 15 at risk
EG006 2 events 2 affected 12 at risk 0 events
0 affected
3 at risk
EG004 0 events 0 affected 6 at risk
EG005 0 events 0 affected 15 at risk
EG006 1 events 1 affected 12 at risk 0 events
0 affected
3 at risk
EG004 0 events 0 affected 6 at risk
EG005 0 events 0 affected 15 at risk
EG006 0 events 0 affected 12 at risk 0 events
0 affected
3 at risk
EG004 0 events 0 affected 6 at risk
EG005 0 events 0 affected 15 at risk
EG006 0 events 0 affected 12 at risk 1 events
1 affected
3 at risk
EG004 1 events 1 affected 6 at risk
EG005 4 events 3 affected 15 at risk
EG006 3 events 2 affected 12 at risk 0 events
0 affected
3 at risk
EG004 0 events 0 affected 6 at risk
EG005 0 events 0 affected 15 at risk
EG006 0 events 0 affected 12 at risk 1 events
1 affected
3 at risk
EG004 9 events 4 affected 6 at risk
EG005 12 events 6 affected 15 at risk
EG006 13 events 7 affected 12 at risk 1 events
1 affected
3 at risk
EG004 1 events 1 affected 6 at risk
EG005 0 events 0 affected 15 at risk
EG006 0 events 0 affected 12 at risk 0 events
0 affected
3 at risk
EG004 0 events 0 affected 6 at risk
EG005 0 events 0 affected 15 at risk
EG006 0 events 0 affected 12 at risk 0 events
0 affected
3 at risk
EG004 0 events 0 affected 6 at risk
EG005 1 events 1 affected 15 at risk
EG006 0 events 0 affected 12 at risk 1 events
1 affected
3 at risk
EG004 2 events 2 affected 6 at risk
EG005 13 events 9 affected 15 at risk
EG006 11 events 7 affected 12 at risk 0 events
0 affected
3 at risk
EG004 0 events 0 affected 6 at risk
EG005 1 events 1 affected 15 at risk
EG006 0 events 0 affected 12 at risk 0 events
0 affected
3 at risk
EG004 0 events 0 affected 6 at risk
EG005 0 events 0 affected 15 at risk
EG006 0 events 0 affected 12 at risk 0 events
0 affected
3 at risk
EG004 0 events 0 affected 6 at risk
EG005 0 events 0 affected 15 at risk
EG006 0 events 0 affected 12 at risk 0 events
0 affected
3 at risk
EG004 0 events 0 affected 6 at risk
EG005 0 events 0 affected 15 at risk
EG006 1 events 1 affected 12 at risk 0 events
0 affected
3 at risk
EG004 0 events 0 affected 6 at risk
EG005 0 events 0 affected 15 at risk
EG006 0 events 0 affected 12 at risk 1 events
1 affected
3 at risk
EG004 2 events 2 affected 6 at risk
EG005 5 events 4 affected 15 at risk
EG006 5 events 4 affected 12 at risk 0 events
0 affected
3 at risk
EG004 4 events 2 affected 6 at risk
EG005 1 events 1 affected 15 at risk
EG006 0 events 0 affected 12 at risk 0 events
0 affected
3 at risk
EG004 0 events 0 affected 6 at risk
EG005 2 events 2 affected 15 at risk
EG006 0 events 0 affected 12 at risk 0 events
0 affected
3 at risk
EG004 0 events 0 affected 6 at risk
EG005 0 events 0 affected 15 at risk
EG006 1 events 1 affected 12 at risk 0 events
0 affected
3 at risk
EG004 0 events 0 affected 6 at risk
EG005 0 events 0 affected 15 at risk
EG006 1 events 1 affected 12 at risk 0 events
0 affected
3 at risk
EG004 0 events 0 affected 6 at risk
EG005 1 events 1 affected 15 at risk
EG006 1 events 1 affected 12 at risk 0 events
0 affected
3 at risk
EG004 1 events 1 affected 6 at risk
EG005 3 events 2 affected 15 at risk
EG006 0 events 0 affected 12 at risk 0 events
0 affected
3 at risk
EG004 0 events 0 affected 6 at risk
EG005 0 events 0 affected 15 at risk
EG006 0 events 0 affected 12 at risk 0 events
0 affected
3 at risk
EG004 0 events 0 affected 6 at risk
EG005 2 events 2 affected 15 at risk
EG006 3 events 2 affected 12 at risk 0 events
0 affected
3 at risk
EG004 0 events 0 affected 6 at risk
EG005 0 events 0 affected 15 at risk
EG006 0 events 0 affected 12 at risk 0 events
0 affected
3 at risk
EG004 1 events 1 affected 6 at risk
EG005 0 events 0 affected 15 at risk
EG006 0 events 0 affected 12 at risk 0 events
0 affected
3 at risk
EG004 0 events 0 affected 6 at risk
EG005 1 events 1 affected 15 at risk
EG006 0 events 0 affected 12 at risk 0 events
0 affected
3 at risk
EG004 0 events 0 affected 6 at risk
EG005 0 events 0 affected 15 at risk
EG006 1 events 1 affected 12 at risk 3 events
2 affected
3 at risk
EG004 0 events 0 affected 6 at risk
EG005 2 events 2 affected 15 at risk
EG006 0 events 0 affected 12 at risk 0 events
0 affected
3 at risk
EG004 0 events 0 affected 6 at risk
EG005 0 events 0 affected 15 at risk
EG006 0 events 0 affected 12 at risk 0 events
0 affected
3 at risk
EG004 0 events 0 affected 6 at risk
EG005 1 events 1 affected 15 at risk
EG006 0 events 0 affected 12 at risk 0 events
0 affected
3 at risk
EG004 0 events 0 affected 6 at risk
EG005 0 events 0 affected 15 at risk
EG006 1 events 1 affected 12 at risk 0 events
0 affected
3 at risk
EG004 0 events 0 affected 6 at risk
EG005 3 events 3 affected 15 at risk
EG006 4 events 3 affected 12 at risk 0 events
0 affected
3 at risk
EG004 1 events 1 affected 6 at risk
EG005 1 events 1 affected 15 at risk
EG006 1 events 1 affected 12 at risk 0 events
0 affected
3 at risk
EG004 1 events 1 affected 6 at risk
EG005 0 events 0 affected 15 at risk
EG006 1 events 1 affected 12 at risk 0 events
0 affected
3 at risk
EG004 0 events 0 affected 6 at risk
EG005 0 events 0 affected 15 at risk
EG006 0 events 0 affected 12 at risk 0 events
0 affected
3 at risk
EG004 2 events 1 affected 6 at risk
EG005 0 events 0 affected 15 at risk
EG006 1 events 1 affected 12 at risk 1 events
1 affected
3 at risk
EG004 0 events 0 affected 6 at risk
EG005 1 events 1 affected 15 at risk
EG006 1 events 1 affected 12 at risk 0 events
0 affected
3 at risk
EG004 1 events 1 affected 6 at risk
EG005 1 events 1 affected 15 at risk
EG006 0 events 0 affected 12 at risk 0 events
0 affected
3 at risk
EG004 1 events 1 affected 6 at risk
EG005 2 events 2 affected 15 at risk
EG006 0 events 0 affected 12 at risk 0 events
0 affected
3 at risk
EG004 0 events 0 affected 6 at risk
EG005 1 events 1 affected 15 at risk
EG006 2 events 2 affected 12 at risk 0 events
0 affected
3 at risk
EG004 0 events 0 affected 6 at risk
EG005 0 events 0 affected 15 at risk
EG006 1 events 1 affected 12 at risk 0 events
0 affected
3 at risk
EG004 1 events 1 affected 6 at risk
EG005 0 events 0 affected 15 at risk
EG006 0 events 0 affected 12 at risk 0 events
0 affected
3 at risk
EG004 0 events 0 affected 6 at risk
EG005 1 events 1 affected 15 at risk
EG006 0 events 0 affected 12 at risk 0 events
0 affected
3 at risk
EG004 0 events 0 affected 6 at risk
EG005 1 events 1 affected 15 at risk
EG006 0 events 0 affected 12 at risk 0 events
0 affected
3 at risk
EG004 1 events 1 affected 6 at risk
EG005 0 events 0 affected 15 at risk
EG006 0 events 0 affected 12 at risk 1 events
1 affected
3 at risk
EG004 1 events 1 affected 6 at risk
EG005 0 events 0 affected 15 at risk
EG006 0 events 0 affected 12 at risk 0 events
0 affected
3 at risk
EG004 0 events 0 affected 6 at risk
EG005 0 events 0 affected 15 at risk
EG006 0 events 0 affected 12 at risk 0 events
0 affected
3 at risk
EG004 0 events 0 affected 6 at risk
EG005 0 events 0 affected 15 at risk
EG006 0 events 0 affected 12 at risk 1 events
1 affected
3 at risk
EG004 0 events 0 affected 6 at risk
EG005 0 events 0 affected 15 at risk
EG006 0 events 0 affected 12 at risk 0 events
0 affected
3 at risk
EG004 0 events 0 affected 6 at risk
EG005 1 events 1 affected 15 at risk
EG006 0 events 0 affected 12 at risk 0 events
0 affected
3 at risk
EG004 1 events 1 affected 6 at risk
EG005 1 events 1 affected 15 at risk
EG006 0 events 0 affected 12 at risk 1 events
1 affected
3 at risk
EG004 0 events 0 affected 6 at risk
EG005 0 events 0 affected 15 at risk
EG006 0 events 0 affected 12 at risk 0 events
0 affected
3 at risk
EG004 3 events 3 affected 6 at risk
EG005 4 events 4 affected 15 at risk
EG006 2 events 2 affected 12 at risk 0 events
0 affected
3 at risk
EG004 0 events 0 affected 6 at risk
EG005 2 events 2 affected 15 at risk
EG006 1 events 1 affected 12 at risk 0 events
0 affected
3 at risk
EG004 0 events 0 affected 6 at risk
EG005 1 events 1 affected 15 at risk
EG006 0 events 0 affected 12 at risk 0 events
0 affected
3 at risk
EG004 0 events 0 affected 6 at risk
EG005 0 events 0 affected 15 at risk
EG006 0 events 0 affected 12 at risk 0 events
0 affected
3 at risk
EG004 1 events 1 affected 6 at risk
EG005 0 events 0 affected 15 at risk
EG006 0 events 0 affected 12 at risk 0 events
0 affected
3 at risk
EG004 1 events 1 affected 6 at risk
EG005 1 events 1 affected 15 at risk
EG006 0 events 0 affected 12 at risk 2 events
2 affected
3 at risk
EG004 0 events 0 affected 6 at risk
EG005 0 events 0 affected 15 at risk
EG006 0 events 0 affected 12 at risk 0 events
0 affected
3 at risk
EG004 1 events 1 affected 6 at risk
EG005 1 events 1 affected 15 at risk
EG006 0 events 0 affected 12 at risk 1 events
1 affected
3 at risk
EG004 0 events 0 affected 6 at risk
EG005 0 events 0 affected 15 at risk
EG006 0 events 0 affected 12 at risk 1 events
1 affected
3 at risk
EG004 0 events 0 affected 6 at risk
EG005 1 events 1 affected 15 at risk
EG006 0 events 0 affected 12 at risk 0 events
0 affected
3 at risk
EG004 2 events 2 affected 6 at risk
EG005 1 events 1 affected 15 at risk
EG006 1 events 1 affected 12 at risk 0 events
0 affected
3 at risk
EG004 1 events 1 affected 6 at risk
EG005 0 events 0 affected 15 at risk
EG006 0 events 0 affected 12 at risk 0 events
0 affected
3 at risk
EG004 1 events 1 affected 6 at risk
EG005 1 events 1 affected 15 at risk
EG006 0 events 0 affected 12 at risk 0 events
0 affected
3 at risk
EG004 0 events 0 affected 6 at risk
EG005 0 events 0 affected 15 at risk
EG006 0 events 0 affected 12 at risk 0 events
0 affected
3 at risk
EG004 0 events 0 affected 6 at risk
EG005 0 events 0 affected 15 at risk
EG006 1 events 1 affected 12 at risk 0 events
0 affected
3 at risk
EG004 2 events 1 affected 6 at risk
EG005 0 events 0 affected 15 at risk
EG006 0 events 0 affected 12 at risk 0 events
0 affected
3 at risk
EG004 1 events 1 affected 6 at risk
EG005 0 events 0 affected 15 at risk
EG006 0 events 0 affected 12 at risk 2 events
1 affected
3 at risk
EG004 2 events 2 affected 6 at risk
EG005 0 events 0 affected 15 at risk
EG006 0 events 0 affected 12 at risk 0 events
0 affected
3 at risk
EG004 0 events 0 affected 6 at risk
EG005 1 events 1 affected 15 at risk
EG006 0 events 0 affected 12 at risk 0 events
0 affected
3 at risk
EG004 0 events 0 affected 6 at risk
EG005 1 events 1 affected 15 at risk
EG006 0 events 0 affected 12 at risk 0 events
0 affected
3 at risk
EG004 0 events 0 affected 6 at risk
EG005 1 events 1 affected 15 at risk
EG006 0 events 0 affected 12 at risk 0 events
0 affected
3 at risk
EG004 0 events 0 affected 6 at risk
EG005 0 events 0 affected 15 at risk
EG006 0 events 0 affected 12 at risk 1 events
1 affected
3 at risk
EG004 0 events 0 affected 6 at risk
EG005 0 events 0 affected 15 at risk
EG006 1 events 1 affected 12 at risk 0 events
0 affected
3 at risk
EG004 0 events 0 affected 6 at risk
EG005 0 events 0 affected 15 at risk
EG006 1 events 1 affected 12 at risk 0 events
0 affected
3 at risk
EG004 0 events 0 affected 6 at risk
EG005 1 events 1 affected 15 at risk
EG006 2 events 2 affected 12 at risk 0 events
0 affected
3 at risk
EG004 1 events 1 affected 6 at risk
EG005 2 events 2 affected 15 at risk
EG006 5 events 5 affected 12 at risk 0 events
0 affected
3 at risk
EG004 0 events 0 affected 6 at risk
EG005 0 events 0 affected 15 at risk
EG006 1 events 1 affected 12 at risk 1 events
1 affected
3 at risk
EG004 0 events 0 affected 6 at risk
EG005 0 events 0 affected 15 at risk
EG006 0 events 0 affected 12 at risk 3 events
1 affected
3 at risk
EG004 2 events 2 affected 6 at risk
EG005 6 events 5 affected 15 at risk
EG006 1 events 1 affected 12 at risk 0 events
0 affected
3 at risk
EG004 0 events 0 affected 6 at risk
EG005 0 events 0 affected 15 at risk
EG006 1 events 1 affected 12 at risk 0 events
0 affected
3 at risk
EG004 0 events 0 affected 6 at risk
EG005 0 events 0 affected 15 at risk
EG006 0 events 0 affected 12 at risk 0 events
0 affected
3 at risk
EG004 0 events 0 affected 6 at risk
EG005 0 events 0 affected 15 at risk
EG006 0 events 0 affected 12 at risk 0 events
0 affected
3 at risk
EG004 0 events 0 affected 6 at risk
EG005 0 events 0 affected 15 at risk
EG006 2 events 2 affected 12 at risk 0 events
0 affected
3 at risk
EG004 0 events 0 affected 6 at risk
EG005 0 events 0 affected 15 at risk
EG006 1 events 1 affected 12 at risk 0 events
0 affected
3 at risk
EG004 1 events 1 affected 6 at risk
EG005 0 events 0 affected 15 at risk
EG006 0 events 0 affected 12 at risk 1 events
1 affected
3 at risk
EG004 0 events 0 affected 6 at risk
EG005 1 events 1 affected 15 at risk
EG006 0 events 0 affected 12 at risk 0 events
0 affected
3 at risk
EG004 0 events 0 affected 6 at risk
EG005 0 events 0 affected 15 at risk
EG006 0 events 0 affected 12 at risk 0 events
0 affected
3 at risk
EG004 0 events 0 affected 6 at risk
EG005 1 events 1 affected 15 at risk
EG006 1 events 1 affected 12 at risk 0 events
0 affected
3 at risk
EG004 0 events 0 affected 6 at risk
EG005 0 events 0 affected 15 at risk
EG006 3 events 3 affected 12 at risk 0 events
0 affected
3 at risk
EG004 0 events 0 affected 6 at risk
EG005 0 events 0 affected 15 at risk
EG006 1 events 1 affected 12 at risk 0 events
0 affected
3 at risk
EG004 1 events 1 affected 6 at risk
EG005 0 events 0 affected 15 at risk
EG006 0 events 0 affected 12 at risk 0 events
0 affected
3 at risk
EG004 2 events 1 affected 6 at risk
EG005 0 events 0 affected 15 at risk
EG006 0 events 0 affected 12 at risk 0 events
0 affected
3 at risk
EG004 0 events 0 affected 6 at risk
EG005 0 events 0 affected 15 at risk
EG006 1 events 1 affected 12 at risk 0 events
0 affected
3 at risk
EG004 0 events 0 affected 6 at risk
EG005 0 events 0 affected 15 at risk
EG006 1 events 1 affected 12 at risk 0 events
0 affected
3 at risk
EG004 1 events 1 affected 6 at risk
EG005 0 events 0 affected 15 at risk
EG006 0 events 0 affected 12 at risk 0 events
0 affected
3 at risk
EG004 1 events 1 affected 6 at risk
EG005 0 events 0 affected 15 at risk
EG006 0 events 0 affected 12 at risk 0 events
0 affected
3 at risk
EG004 0 events 0 affected 6 at risk
EG005 0 events 0 affected 15 at risk
EG006 1 events 1 affected 12 at risk 0 events
0 affected
3 at risk
EG004 0 events 0 affected 6 at risk
EG005 0 events 0 affected 15 at risk
EG006 1 events 1 affected 12 at risk 0 events
0 affected
3 at risk
EG004 2 events 2 affected 6 at risk
EG005 4 events 4 affected 15 at risk
EG006 0 events 0 affected 12 at risk 0 events
0 affected
3 at risk
EG004 0 events 0 affected 6 at risk
EG005 1 events 1 affected 15 at risk
EG006 0 events 0 affected 12 at risk 1 events
1 affected
3 at risk
EG004 3 events 3 affected 6 at risk
EG005 2 events 2 affected 15 at risk
EG006 2 events 2 affected 12 at risk 0 events
0 affected
3 at risk
EG004 1 events 1 affected 6 at risk
EG005 0 events 0 affected 15 at risk
EG006 1 events 1 affected 12 at risk 1 events
1 affected
3 at risk
EG004 4 events 3 affected 6 at risk
EG005 2 events 1 affected 15 at risk
EG006 1 events 1 affected 12 at risk 0 events
0 affected
3 at risk
EG004 0 events 0 affected 6 at risk
EG005 2 events 2 affected 15 at risk
EG006 0 events 0 affected 12 at risk 0 events
0 affected
3 at risk
EG004 0 events 0 affected 6 at risk
EG005 1 events 1 affected 15 at risk
EG006 0 events 0 affected 12 at risk 0 events
0 affected
3 at risk
EG004 0 events 0 affected 6 at risk
EG005 1 events 1 affected 15 at risk
EG006 0 events 0 affected 12 at risk 0 events
0 affected
3 at risk
EG004 0 events 0 affected 6 at risk
EG005 1 events 1 affected 15 at risk
EG006 0 events 0 affected 12 at risk 0 events
0 affected
3 at risk
EG004 1 events 1 affected 6 at risk
EG005 1 events 1 affected 15 at risk
EG006 0 events 0 affected 12 at risk 0 events
0 affected
3 at risk
EG004 2 events 2 affected 6 at risk
EG005 1 events 1 affected 15 at risk
EG006 0 events 0 affected 12 at risk 0 events
0 affected
3 at risk
EG004 0 events 0 affected 6 at risk
EG005 0 events 0 affected 15 at risk
EG006 1 events 1 affected 12 at risk 0 events
0 affected
3 at risk
EG004 0 events 0 affected 6 at risk
EG005 0 events 0 affected 15 at risk
EG006 1 events 1 affected 12 at risk 0 events
0 affected
3 at risk
EG004 0 events 0 affected 6 at risk
EG005 1 events 1 affected 15 at risk
EG006 0 events 0 affected 12 at risk 0 events
0 affected
3 at risk
EG004 0 events 0 affected 6 at risk
EG005 0 events 0 affected 15 at risk
EG006 0 events 0 affected 12 at risk 0 events
0 affected
3 at risk
EG004 0 events 0 affected 6 at risk
EG005 1 events 1 affected 15 at risk
EG006 0 events 0 affected 12 at risk 0 events
0 affected
3 at risk
EG004 0 events 0 affected 6 at risk
EG005 1 events 1 affected 15 at risk
EG006 1 events 1 affected 12 at risk 0 events
0 affected
3 at risk
EG004 0 events 0 affected 6 at risk
EG005 2 events 2 affected 15 at risk
EG006 2 events 2 affected 12 at risk 0 events
0 affected
3 at risk
EG004 0 events 0 affected 6 at risk
EG005 1 events 1 affected 15 at risk
EG006 3 events 3 affected 12 at risk 0 events
0 affected
3 at risk
EG004 1 events 1 affected 6 at risk
EG005 0 events 0 affected 15 at risk
EG006 0 events 0 affected 12 at risk 0 events
0 affected
3 at risk
EG004 1 events 1 affected 6 at risk
EG005 0 events 0 affected 15 at risk
EG006 0 events 0 affected 12 at risk 0 events
0 affected
3 at risk
EG004 0 events 0 affected 6 at risk
EG005 1 events 1 affected 15 at risk
EG006 0 events 0 affected 12 at risk 0 events
0 affected
3 at risk
EG004 0 events 0 affected 6 at risk
EG005 0 events 0 affected 15 at risk
EG006 1 events 1 affected 12 at risk 0 events
0 affected
3 at risk
EG004 0 events 0 affected 6 at risk
EG005 0 events 0 affected 15 at risk
EG006 0 events 0 affected 12 at risk 0 events
0 affected
3 at risk
EG004 0 events 0 affected 6 at risk
EG005 0 events 0 affected 15 at risk
EG006 1 events 1 affected 12 at risk 2 events
2 affected
3 at risk
EG004 2 events 1 affected 6 at risk
EG005 10 events 8 affected 15 at risk
EG006 6 events 6 affected 12 at risk 0 events
0 affected
3 at risk
EG004 1 events 1 affected 6 at risk
EG005 1 events 1 affected 15 at risk
EG006 1 events 1 affected 12 at risk 1 events
1 affected
3 at risk
EG004 1 events 1 affected 6 at risk
EG005 1 events 1 affected 15 at risk
EG006 4 events 2 affected 12 at risk 0 events
0 affected
3 at risk
EG004 0 events 0 affected 6 at risk
EG005 2 events 2 affected 15 at risk
EG006 0 events 0 affected 12 at risk 0 events
0 affected
3 at risk
EG004 2 events 1 affected 6 at risk
EG005 1 events 1 affected 15 at risk
EG006 0 events 0 affected 12 at risk 0 events
0 affected
3 at risk
EG004 0 events 0 affected 6 at risk
EG005 1 events 1 affected 15 at risk
EG006 0 events 0 affected 12 at risk 0 events
0 affected
3 at risk
EG004 0 events 0 affected 6 at risk
EG005 0 events 0 affected 15 at risk
EG006 0 events 0 affected 12 at risk 0 events
0 affected
3 at risk
EG004 0 events 0 affected 6 at risk
EG005 1 events 1 affected 15 at risk
EG006 0 events 0 affected 12 at risk 0 events
0 affected
3 at risk
EG004 0 events 0 affected 6 at risk
EG005 0 events 0 affected 15 at risk
EG006 0 events 0 affected 12 at risk 0 events
0 affected
3 at risk
EG004 0 events 0 affected 6 at risk
EG005 0 events 0 affected 15 at risk
EG006 0 events 0 affected 12 at risk 0 events
0 affected
3 at risk
EG004 1 events 1 affected 6 at risk
EG005 4 events 3 affected 15 at risk
EG006 1 events 1 affected 12 at risk 1 events
1 affected
3 at risk
EG004 0 events 0 affected 6 at risk
EG005 0 events 0 affected 15 at risk
EG006 0 events 0 affected 12 at risk 1
OG004 1
OG005 2
OG006 2 0
OG004 2
OG005 2
OG006 2 2
OG004 3
OG005 7
OG006 6 0
OG004 0
OG005 1
OG006 1 0
OG004 0
OG005 1
OG006 0 0
OG004 0
OG005 2
OG006 1