A Study of LY2584702 With Erlotinib or Everolimus in Part... | NCT01115803 | Trialant
NCT01115803
Sponsor
Eli Lilly and Company
Status
Terminated
Last Update Posted
Feb 5, 2019Actual
Enrollment
29Actual
Phase
Phase 1
Conditions
Metastases, Neoplasm
Carcinoma, Non-small Cell Lung
Renal Cell Carcinoma
Neuroendocrine Tumors
Interventions
LY2584702
Erlotinib
Everolimus
Countries
United States
France
Protocol Section
Identification Module
NCT ID
Results Section
Participant Flow Module
Pre-assignment Details
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
NCT01115803
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
12531
Secondary IDs
ID
Type
Description
Link
I3G-MC-JGCB
Other Identifier
Eli Lilly and Company
Brief Title
A Study of LY2584702 With Erlotinib or Everolimus in Participants With Solid Tumors
Official Title
A Phase 1b Trial of LY2584702 in Combination With Erlotinib or Everolimus in Patients With Solid Tumors
Acronym
Not provided
Organization
Eli Lilly and CompanyINDUSTRY
Status Module
Record Verification Date
Jan 2019
Overall Recruitment Status or Expanded Access Status
Terminated
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Primary objective has been met; safety and pharmacokinetics have been characterized.
Expanded Access Info
No
Start Date
Mar 2010
Primary Completion Date
Jun 2011Actual
Completion Date
Jun 2011Actual
First Submitted Date
Apr 22, 2010
First Submission Date that Met QC Criteria
May 3, 2010
First Posted Date
May 4, 2010Estimated
Results Waived
Not provided
Results First Submitted Date
Sep 27, 2017
Results First Submitted that Met QC Criteria
Aug 1, 2018
Results First Posted Date
Jan 18, 2019Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Jan 17, 2019
Last Update Posted Date
Feb 5, 2019Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Eli Lilly and CompanyINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
Study I3G-MC-JGCB (JGCB) is a multicenter, nonrandomized, open-label, dose-escalation Phase 1b study of LY2584702 in combination with either erlotinib or everolimus.
Detailed Description
Study JGCB will consist of the following parts:
Part 1 - Dose Escalation to maximum tolerated dose in each arm.
Arm A - LY2584702 + Erlotinib in participants with advanced or metastatic cancer.
Arm B - LY2584702 + Everolimus in participants with advanced or metastatic cancer.
Part 2 - Dose Confirmation of maximum tolerated dose from each arm in Part 1.
Arm A - LY2584702 + Erlotinib in participants with advanced or metastatic non-small cell lung cancer.
Arm B - LY2584702 + Everolimus in participants with advanced renal cell carcinoma after treatment failure with sunitinib or sorafenib, or advanced neuroendocrine tumors.
Supplied as 25 milligrams (mg) and 100 mg capsules, administered orally for two 28-day cycles.
Arm A: LY2584702 + Erlotinib
Arm B: LY2584702 + Everolimus
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Recommended Dose for Phase 2 Studies
The recommended dose for the Phase 2 (Dose Confirmation Phase) study was determined by safety assessment. Doses were escalated following the assessment for toxicity based on Common Terminology Criteria for Adverse Events (CTCAE v4.0). Any adverse events (AE) that were possibly related to LY2584702 were considered toxicities. The Phase 2 dose of LY2584702 was not determined due to unacceptable toxicities of LY2584702 in combination with erlotinib or everolimus in Phase 1 of the study.
Baseline up to 6 cycles of 28 days
Secondary Outcomes
Measure
Description
Time Frame
Clinically Significant Effects (Number of Participants With Adverse Events)
Clinically significant events were defined as serious adverse events (SAEs) and other non-SAEs regardless of causality. A summary of serious and other non SAEs regardless of causality is located in the Reported Adverse Event module.
Baseline up to 7 months
Other Outcomes
Measure
Description
Time Frame
Number of Participants Who Died Due to Progressive Disease Within 30 Days of Study Drug Discontinuation
Within 30 days of study drug discontinuation
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Dose Escalation portion (Part 1): have histological or cytological evidence of a diagnosis of cancer that is advanced and/or metastatic disease (including Non-Hodgkin's Lymphoma) for which no proven effective therapy exists.
Dose Confirmation portion (Part 2): have histological or cytological evidence of:
Arm A: advanced or metastatic non-small cell lung cancer after failure of at least one prior chemotherapy regimen.
Arm B: advanced renal cell carcinoma after failure of treatment with sunitinib or sorafenib, or advanced neuroendocrine tumors.
Have the presence of measurable or nonmeasurable disease as defined by the Response Evaluation Criteria in Solid Tumors (RECIST 1.1) or the Revised Response Criteria for Malignant Lymphoma.
Dose Escalation portion (Part 1): participants may have measurable or nonmeasurable disease.
Dose Confirmation portion (Part 2): participants must have measurable disease.
Have adequate organ function including:
Hematologic: absolute neutrophil count (ANC) greater than or equal to 1.5 x 10⁹/liters (L), platelets greater than or equal to 100 x 10⁹/L, and hemoglobin greater than or equal to 8 grams/deciliter (g/dL).
Hepatic: bilirubin less than or equal to 1.5 times upper limits of normal (ULN); alanine transaminase (ALT) and aspartate transaminase (AST) less than or equal to 2.5 times ULN. If the liver has tumor involvement, AST and ALT equaling less than or equal to 5 times ULN are acceptable. Participants with bone metastases may enter with alkaline phosphatase values less than or equal to 5 times ULN, as long as other hepatic parameters meet inclusion criteria.
Renal: Serum creatinine less than or equal to 1.5 times ULN or calculated creatinine clearance >45 milliliter/minute (ml/mn).
Have a performance status of less than or equal to 1 on the Eastern Cooperative Oncology Group (ECOG) scale.
Have discontinued all previous therapies for cancer, including chemotherapy, radiotherapy, cancer-related hormonal therapy, or other investigational therapy for at least 2 weeks (3 weeks for myelosuppressive agents) prior to study enrollment, and have recovered from the acute effects of therapy. At the discretion of the investigator, participants with prostate cancers progressing under luteinizing hormone-releasing hormone (LHRH) agonists therapy, and participants with adrenal carcinomas using mitotane, may have that treatment continued while receiving study drug.
Exclusion Criteria:
Have received treatment with a drug that has not received regulatory approval for any indication within 14 or 21 days of the initial dose of study drug for a nonmyelosuppressive or myelosuppressive agent, respectively.
Have serious preexisting medical conditions that, in the opinion of the investigator, would preclude participation in this study.
Have symptomatic central nervous system (CNS) malignancy or metastasis. Participants with treated CNS metastases are eligible provided their disease is radiographically stable and asymptomatic, and they are not currently receiving corticosteroids and/or anticonvulsants. Screening of asymptomatic participants without history of CNS metastasis is not required.
Concomitant treatment by strong cytochrome P450 (CYP) 3A4 inhibitors or CYP3A4 inducers.
Have an acute or chronic leukemia.
Have received an autologous or allogeneic stem-cell transplant within 75 days of the initial dose of study drug. In addition, recipients of an allogeneic stem-cell transplant must have discontinued immunosuppressive therapy at least 24 hours before study drug administration with no more than Grade 1 acute graft-versus-host disease.
For Dose Confirmation portion (Part 2): have previously received erlotinib for Arm A or everolimus for Arm B.
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9AM - 5PM Eastern Time (UTC/GMT - 5 hours, EST)
Eli Lilly and Company
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Hollebecque A, Houede N, Cohen EE, Massard C, Italiano A, Westwood P, Bumgardner W, Miller J, Brail LH, Benhadji KA, Soria JC. A phase Ib trial of LY2584702 tosylate, a p70 S6 inhibitor, in combination with erlotinib or everolimus in patients with solid tumours. Eur J Cancer. 2014 Mar;50(5):876-84. doi: 10.1016/j.ejca.2013.12.006. Epub 2014 Jan 20.
See Also Links
Not provided
Available IPD Information
Not provided
IPD Sharing Statement Module
No data available
No data is available for this block.
A 2 phase study, a dose escalation phase and a dose confirmation phase. The dose confirmation phase was not initiated. Participant flow reports those participants who discontinued from study drug. Participants who completed 1 cycle of treatment, had the required assessment or an adverse event (AE) were considered to have completed the study.
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Arm A - 50 mg LY2584702 QD + 150 mg Erlotinib QD
50 milligrams (mg) LY2584702 administered orally once daily (QD) plus 150 mg erlotinib administered orally QD for two 28-day cycles.
FG001
Arm A - 50 mg LY2584702 BID + 150 mg Erlotinib QD
50 mg LY2584702 administered orally twice daily (BID) plus 150 mg erlotinib administered orally QD for two 28-day cycles.
FG002
Arm A - 100 mg LY2584702 BID + 150 mg Erlotinib QD
100 mg LY2584702 administered orally BID plus 150 mg erlotinib administered orally QD for two 28-day cycles.
FG003
Arm A - 75 mg LY2584702 BID + 150 mg Erlotinib QD
75 mg LY2584702 administered orally BID plus 150 mg erlotinib administered orally QD for two 28-day cycles.
FG004
Arm B - 50 mg LY2584702 QD + 10 mg Everolimus QD
50 mg LY2584702 administered orally QD plus 10 mg everolimus administered orally QD for two 28-day cycles.
FG005
Arm B - 100 mg LY2584702 QD + 10 mg Everolimus QD
100 mg LY2584702 administered orally QD plus 10 mg everolimus administered orally QD for two 28-day cycles.
FG006
Arm B - 50 mg LY2584702 BID + 10 mg Everolimus QD
50 mg LY2584702 administered orally BID plus 10 mg everolimus administered orally QD for two 28-day cycles.
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
FG0004 subjects
FG0015 subjects
FG0023 subjects
FG0035 subjects
FG0043 subjects
FG0053 subjects
FG0066 subjects
Received at Least 1 Dose of Study Drug
FG0004 subjects
FG0015 subjects
FG0023 subjects
FG0035 subjects
COMPLETED
FG0004 subjects
FG0015 subjects
FG0022 subjects
FG0035 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Baseline Characteristics Module
Baseline Analysis Population Description
Participants received at least 1 dose of study drug.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Arm A - 50 mg LY2584702 QD + 150 mg Erlotinib QD
50 milligrams (mg) LY2584702 administered orally once daily (QD) plus 150 mg erlotinib administered orally QD for two 28-day cycles.
BG001
Arm A - 50 mg LY2584702 BID + 150 mg Erlotinib QD
Denominators
Units
Counts
Participants
BG000
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Outcome Measures Module
Outcome Measures
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
Recommended Dose for Phase 2 Studies
The recommended dose for the Phase 2 (Dose Confirmation Phase) study was determined by safety assessment. Doses were escalated following the assessment for toxicity based on Common Terminology Criteria for Adverse Events (CTCAE v4.0). Any adverse events (AE) that were possibly related to LY2584702 were considered toxicities. The Phase 2 dose of LY2584702 was not determined due to unacceptable toxicities of LY2584702 in combination with erlotinib or everolimus in Phase 1 of the study.
All participants who received at least 1 dose of study drug.
Posted
Number
milligrams (mg)
Baseline up to 6 cycles of 28 days
ID
Title
Description
OG000
LY2584702 + Erlotinib
Escalating doses of LY2584702 began with 50 milligrams (mg) and increased up to 200 mg total daily dose were administered orally in combination with erlotinib.
Adverse Events Module
Frequency Threshold
5
Time Frame
Not provided
Description
Deaths due to progressive disease were not considered to be serious adverse events (SAE) unless the investigator deemed them to be related to the use of the study drug.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Arm A - 50 mg LY2584702 QD + 150 mg Erlotinib QD
50 milligram (mg) LY2584702 administered orally once daily (QD) plus 150 mg erlotinib administered orally QD for 2 28-day cycles.
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Pericardial effusion
Cardiac disorders
MedDRA v14.0
Systematic Assessment
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA v14.0
Systematic Assessment
More Info Module
Limitations and Caveats
Study terminated early. Dose confirmation, Part B, was not initiated.
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Point of Contact
Title
Organization
Phone
Extension
Email
Chief Medical Officer
Eli Lilly and Company
800-545-5979
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
ID
Term
D009362
Neoplasm Metastasis
D002289
Carcinoma, Non-Small-Cell Lung
D002292
Carcinoma, Renal Cell
D018358
Neuroendocrine Tumors
Ancestor Terms
ID
Term
D009385
Neoplastic Processes
D009369
Neoplasms
D010335
Pathologic Processes
D013568
Pathological Conditions, Signs and Symptoms
Browse Leaves
Not provided
Browse Branches
Not provided
Intervention Browse Module
MeSH Terms
ID
Term
C588151
LY2584702
D000069347
Erlotinib Hydrochloride
D000068338
Everolimus
Ancestor Terms
ID
Term
D011799
Quinazolines
D006574
Heterocyclic Compounds, 2-Ring
D000072471
Heterocyclic Compounds, Fused-Ring
D006571
Heterocyclic Compounds
Browse Leaves
Not provided
Browse Branches
Not provided
Non-Randomized
Intervention Model
Sequential Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
Erlotinib
Drug
Supplied as 25 mg, 100 mg, or 150 mg tablets, administered orally, daily for two 28-day cycles.
Starting dose is 150mg. Doses may be decreased in 50mg increments if necessary due to toxicity.
Arm A: LY2584702 + Erlotinib
Everolimus
Drug
Supplied as 5 mg or 10 mg tablets, administered orally, daily for two 28-day cycles.
Arm B: LY2584702 + Everolimus
Progression-Free Survival (PFS)
PFS was defined as the time from the date of enrollment to the date of objectively determined progressive disease (PD) or death whichever comes first. Censoring of PFS was defined as participants not known to have died as of the data cut-off date and who did not have objective PD, PFS was censored at the date of the last objective assessment; for participants who received subsequent systematic anticancer therapy (after discontinuation from study treatment) prior to objectively determined disease progression, PFS was censored at the date of the last objective progression-free disease assessment prior to post discontinuation of therapy. PFS was not analyzed due to different tumor types and different doses.
Baseline to disease progression or death or up to 166 days postbaseline
Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR) [Response Rate (RR)]
Response was determined using Response Evaluation Criteria In Solid Tumors (RECIST v1.1) criteria. CR was defined as the disappearance of all target and non-target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 millimeters (mm) and normalization of tumor marker level of non-target lesions; PR was defined as at least a 30% decrease in sum of longest diameter of target lesions.
Baseline to disease progression or death or up to 6 cycles of 28 days
Pharmacokinetics, Maximum Observed Plasma Concentration (Cmax) of LY2584702
Cycle 1 Day 1 (C1 D1): predose, 0.5, 1, 2, 3, 5, 8 hours postdose and Cycle 1 Day 8 (C1 D8): predose, 0.5, 1, 2, 3, 5, and 8 hours postdose of 28-day cycle
Pharmacokinetics, Area Under the Concentration Time Curve (AUC)
AUC from time 0 to 8 hours (AUC0-8) and AUC from time 0 to infinity (AUC0-∞).
Cycle 1 Days 1 (C1 D1) and Cycle 1 Day 8 (C1 D8) of 28-day cycle
Number of Participants With Complete Response (CR), Partial Response (PR) or Stable Disease (SD) [Best Overall Response (BOR) (CR+PR+SD)]
BOR was determined using Response Evaluation Criteria In Solid Tumors (RECIST v1.1) criteria. CR was defined as the disappearance of all target and non-target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 millimeters (mm) and normalization of tumor marker level of non-target lesions; PR was defined as at least a 30% decrease in sum of longest diameter (LD) of target lesions; Progressive Disease (PD) was defined as at least 20% increase in sum of LD of target lesions and minimum 5 mm increase over nadir. SD was defined as small changes that did not meet above criteria.
Baseline up to 112 Days
United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Bordeaux
33076
France
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Villejuif
94805
France
FG004
3 subjects
FG0053 subjects
FG0066 subjects
3 subjects
FG0053 subjects
FG0064 subjects
0 subjects
FG0050 subjects
FG0062 subjects
0 subjects
FG0040 subjects
FG0050 subjects
FG0061 subjects
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
Progressive Disease during Cycle1
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0061 subjects
50 mg LY2584702 administered orally twice daily (BID) plus 150 mg erlotinib administered orally QD for two 28-day cycles.
BG002
Arm A - 100 mg LY2584702 BID + 150 mg Erlotinib QD
100 mg LY2584702 administered orally BID plus 150 mg erlotinib administered orally QD for two 28-day cycles.
BG003
Arm A - 75 mg LY2584702 BID + 150 mg Erlotinib QD
75 mg LY2584702 administered orally BID plus 150 mg erlotinib administered orally QD for two 28-day cycles.
BG004
Arm B - 50 mg LY2584702 QD + 10 mg Everolimus QD
50 mg LY2584702 administered orally QD plus 10 mg everolimus administered orally QD for two 28-day cycles.
BG005
Arm B - 100 mg LY2584702 QD + 10 mg Everolimus QD
100 mg LY2584702 administered orally QD plus 10 mg everolimus administered orally QD for two 28-day cycles.
BG006
Arm B - 50 mg LY2584702 BID + 10 mg Everolimus QD
50 mg LY2584702 administered orally BID plus 10 mg everolimus administered orally QD for two 28-day cycles.
BG007
Total
Total of all reporting groups
4
BG0015
BG0023
BG0035
BG0043
BG0053
BG0066
BG00729
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00052.8± 7.97
BG00161.4± 7.86
BG00252.3± 11.02
BG00363.0± 3.39
BG00449.0± 7.55
BG00547.7± 16.01
BG00647.5± 16.17
BG00754.0± 11.65
Sex: Female, Male
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
Female
BG0003
BG0012
BG0022
BG0031
BG0042
BG0052
BG0063
BG00715
Male
BG0001
BG0013
BG0021
BG0034
BG004
Ethnicity (NIH/OMB)
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
Not Hispanic or Latino
BG0004
BG0013
BG0023
BG0035
BG004
Unknown or Not Reported
BG0000
BG0012
BG0020
BG0030
BG004
Race (NIH/OMB)
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
Asian
BG0000
BG0010
BG0020
BG0030
BG004
Native Hawaiian or Other Pacific Islander
BG0000
BG0010
BG0020
BG0030
BG004
Black or African American
BG0000
BG0010
BG0020
BG0030
BG004
White
BG0004
BG0013
BG0023
BG0035
BG004
More than one race
BG0000
BG0010
BG0020
BG0030
BG004
Unknown or Not Reported
BG0000
BG0012
BG0020
BG0030
BG004
Region of Enrollment
Count of Participants
Participants
No
Title
Denominators
Categories
United States
Title
Measurements
BG0000
BG0011
BG0021
BG0030
BG0040
BG0050
BG0062
BG0074
France
Title
Measurements
BG0004
BG0014
BG0022
BG003
OG001
LY2584702+Everolimus
Escalating doses of LY2584702 began with 50 mg and increased up to 100 mg total daily dose were administered orally in combination with everolimus.
Units
Counts
Participants
OG00017
OG00112
Title
Denominators
Categories
Title
Measurements
OG000NAThe Phase 2 dose of LY2584702 in combination with erlotinib was not determined.
OG001NAThe Phase 2 dose of LY2584702 in combination with everolimus was not determined.
Secondary
Clinically Significant Effects (Number of Participants With Adverse Events)
Clinically significant events were defined as serious adverse events (SAEs) and other non-SAEs regardless of causality. A summary of serious and other non SAEs regardless of causality is located in the Reported Adverse Event module.
All participants who received at least 1 dose of study drug.
Posted
Count of Participants
Participants
No
Baseline up to 7 months
ID
Title
Description
OG000
Arm A - 50 mg LY2584702 QD + 150 mg Erlotinib QD
50 milligrams (mg) LY2584702 administered orally once daily (QD) plus 150 mg erlotinib administered orally QD for two 28-day cycles.
OG001
Arm A - 50 mg LY2584702 BID + 150 mg Erlotinib QD
50 mg LY2584702 administered orally twice daily (BID) plus 150 mg erlotinib administered orally QD for two 28-day cycles.
OG002
Arm A - 100 mg LY2584702 BID + 150 mg Erlotinib QD
100 mg LY2584702 administered orally BID plus 150 mg erlotinib administered orally QD for two 28-day cycles.
OG003
Arm A - 75 mg LY2584702 BID + 150 mg Erlotinib QD
75 mg LY2584702 administered orally BID plus 150 mg erlotinib administered orally QD for two 28-day cycles.
OG004
Arm B - 50 mg LY2584702 QD + 10 mg Everolimus QD
50 mg LY2584702 administered orally QD plus 10 mg everolimus administered orally QD for two 28-day cycles.
OG005
Arm B - 100 mg LY2584702 QD + 10 mg Everolimus QD
100 mg LY2584702 administered orally QD plus 10 mg everolimus administered orally QD for two 28-day cycles.
OG006
Arm B - 50 mg LY2584702 BID + 10 mg Everolimus QD
50 mg LY2584702 administered orally BID plus 10 mg everolimus administered orally QD for two 28-day cycles.
Units
Counts
Participants
OG0004
OG0015
OG0023
OG003
Title
Denominators
Categories
SAEs
Title
Measurements
OG0001
OG0012
OG0022
OG003
Secondary
Progression-Free Survival (PFS)
PFS was defined as the time from the date of enrollment to the date of objectively determined progressive disease (PD) or death whichever comes first. Censoring of PFS was defined as participants not known to have died as of the data cut-off date and who did not have objective PD, PFS was censored at the date of the last objective assessment; for participants who received subsequent systematic anticancer therapy (after discontinuation from study treatment) prior to objectively determined disease progression, PFS was censored at the date of the last objective progression-free disease assessment prior to post discontinuation of therapy. PFS was not analyzed due to different tumor types and different doses.
Zero participants were analyzed as no data collected.
Posted
Baseline to disease progression or death or up to 166 days postbaseline
ID
Title
Description
OG000
Arm A - 50 mg LY2584702 QD + 150 mg Erlotinib QD
50 milligrams (mg) LY2584702 administered orally once daily (QD) plus 150 mg erlotinib administered orally QD for two 28-day cycles.
OG001
Arm A - 50 mg LY2584702 BID + 150 mg Erlotinib QD
50 mg LY2584702 administered orally twice daily (BID) plus 150 mg erlotinib administered orally QD for two 28-day cycles.
OG002
Arm A - 100 mg LY2584702 BID + 150 mg Erlotinib QD
100 mg LY2584702 administered orally BID plus 150 mg erlotinib administered orally QD for two 28-day cycles.
OG003
Arm A - 75 mg LY2584702 BID + 150 mg Erlotinib QD
75 mg LY2584702 administered orally BID plus 150 mg erlotinib administered orally QD for two 28-day cycles.
OG004
Arm B - 50 mg LY2584702 QD + 10 mg Everolimus QD
50 mg LY2584702 administered orally QD plus 10 mg everolimus administered orally QD for two 28-day cycles.
OG005
Arm B - 100 mg LY2584702 QD + 10 mg Everolimus QD
100 mg LY2584702 administered orally QD plus 10 mg everolimus administered orally QD for two 28-day cycles.
OG006
Arm B - 50 mg LY2584702 BID + 10 mg Everolimus QD
50 mg LY2584702 administered orally BID plus 10 mg everolimus administered orally QD for two 28-day cycles.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG003
Secondary
Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR) [Response Rate (RR)]
Response was determined using Response Evaluation Criteria In Solid Tumors (RECIST v1.1) criteria. CR was defined as the disappearance of all target and non-target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 millimeters (mm) and normalization of tumor marker level of non-target lesions; PR was defined as at least a 30% decrease in sum of longest diameter of target lesions.
All participants who received at least 1 dose of study drug and assessed for RR.
Posted
Number
90% Confidence Interval
percentage of participants
Baseline to disease progression or death or up to 6 cycles of 28 days
ID
Title
Description
OG000
Arm A - 50 mg LY2584702 QD + 150 mg Erlotinib QD
50 milligram (mg) LY2584702 administered orally once daily (QD) plus 150 mg erlotinib administered orally QD for two 2 28-day cycles.
OG001
Arm A - 50 mg LY2584702 (BID) + 150 mg Erlotinib QD
50 mg LY2584702 administered orally twice daily (BID) plus 150 mg erlotinib administered orally QD for two 28-day cycles.
OG002
Arm A - 100 mg LY2584702 BID + 150 mg Erlotinib QD
100 mg LY2584702 administered orally BID plus 150 mg erlotinib administered orally QD for two 28-day cycles.
OG003
Arm A - 75 mg LY2584702 BID + 150 mg Erlotinib QD
75 mg LY2584702 administered orally BID plus 150 mg erlotinib administered orally QD for two 28-day cycles.
OG004
Arm B - 50 mg LY2584702 QD + 10 mg Everolimus QD
50 mg LY2584702 administered orally QD plus 10 mg everolimus administered orally QD for two 28-day cycles.
OG005
Arm B - 100 mg LY2584702 QD + 10 mg Everolimus QD
100 mg LY2584702 administered orally QD plus 10 mg everolimus administered orally QD for two 28-day cycles.
OG006
Arm B - 50 mg LY2584702 BID + 10 mg Everolimus QD
50 mg LY2584702 administered orally BID plus 10 mg everolimus administered orally QD for two 28-day cycles.
Units
Counts
Participants
OG0004
OG0015
OG0022
OG003
Title
Denominators
Categories
Title
Measurements
OG0000(NA to NA)No participants achieved PR or CR; confidence interval could not be determined.
OG0010(NA to NA)No participants achieved PR or CR; confidence interval could not be determined.
OG002
Secondary
Pharmacokinetics, Maximum Observed Plasma Concentration (Cmax) of LY2584702
All participants who received at least 1 dose of study drug and had Cmax values.
Posted
Geometric Mean
Geometric Coefficient of Variation
nanograms per milliliter (ng/mL)
Cycle 1 Day 1 (C1 D1): predose, 0.5, 1, 2, 3, 5, 8 hours postdose and Cycle 1 Day 8 (C1 D8): predose, 0.5, 1, 2, 3, 5, and 8 hours postdose of 28-day cycle
ID
Title
Description
OG000
Arm A - 50 mg LY2584702 QD + 150 mg Erlotinib QD
50 milligram (mg) LY2584702 administered orally once daily (QD) plus 150 mg erlotinib administered orally QD for two 28-day cycles.
OG001
Arm A - 50 mg LY2584702 BID + 150 mg Erlotinib QD
50 mg LY2584702 administered orally twice daily (BID) plus 150 mg erlotinib administered orally QD for two 28-day cycles.
OG002
Arm A - 100 mg LY2584702 BID + 150 mg Erlotinib QD
100 mg LY2584702 administered orally BID plus 150 mg erlotinib administered orally QD for two 28-day cycles.
OG003
Arm A - 75 mg LY2584702 BID + 150 mg Erlotinib QD
75 mg LY2584702 administered orally BID plus 150 mg erlotinib administered orally QD for two 28-day cycles.
OG004
Arm B - 50 mg LY2584702 QD + 10 mg Everolimus QD
50 mg LY2584702 administered orally QD plus 10 mg everolimus administered orally QD for two 28-day cycles.
OG005
Arm B - 100 mg LY2584702 QD + 10 mg Everolimus QD
100 mg LY2584702 administered orally QD plus 10 mg everolimus administered orally QD for two 28-day cycles.
OG006
Arm B - 50 mg LY2584702 BID + 10 mg Everolimus QD
50 mg LY2584702 administered orally BID plus 10 mg everolimus administered orally QD for two 28-day cycles.
Units
Counts
Participants
OG0004
OG0014
OG0023
OG003
Title
Denominators
Categories
C1 D1, single dose
ParticipantsOG0003
ParticipantsOG0014
ParticipantsOG0023
ParticipantsOG003
Secondary
Pharmacokinetics, Area Under the Concentration Time Curve (AUC)
AUC from time 0 to 8 hours (AUC0-8) and AUC from time 0 to infinity (AUC0-∞).
All participants who received at least 1 dose of study drug and had AUC values.
Posted
Geometric Mean
Geometric Coefficient of Variation
nanograms*hours per milliliter (ng*h/mL)
Cycle 1 Days 1 (C1 D1) and Cycle 1 Day 8 (C1 D8) of 28-day cycle
ID
Title
Description
OG000
Arm A - 50 mg LY2584702 QD + 150 mg Erlotinib QD
50 milligram (mg) LY2584702 administered orally once daily (QD) plus 150 mg erlotinib administered orally QD for two 28-day cycles.
OG001
Arm A - 50 mg LY2584702 BID + 150 mg Erlotinib QD
50 mg LY2584702 administered orally twice daily (BID) plus 150 mg erlotinib administered orally QD for two 28-day cycles.
OG002
Arm A - 100 mg LY2584702 BID + 150 mg Erlotinib QD
100 mg LY2584702 administered orally BID plus 150 mg erlotinib administered orally QD for two 28-day cycles.
OG003
Arm A - 75 mg LY2584702 BID + 150 mg Erlotinib QD
75 mg LY2584702 administered orally BID plus 150 mg erlotinib administered orally QD for two 28-day cycles.
OG004
Arm B - 50 mg LY2584702 QD + 10 mg Everolimus QD
50 mg LY2584702 administered orally QD plus 10 mg everolimus administered orally QD for two 28-day cycles.
OG005
Arm B - 100 mg LY2584702 QD + 10 mg Everolimus QD
100 mg LY2584702 administered orally QD plus 10 mg everolimus administered orally QD for two 28-day cycles.
OG006
Arm B - 50 mg LY2584702 BID + 10 mg Everolimus QD
50 mg LY2584702 administered orally BID plus 10 mg everolimus administered orally QD for two 28-day cycles.
Units
Counts
Participants
OG0004
OG0014
OG0023
OG003
Title
Denominators
Categories
AUC0-8, D1, single dose
ParticipantsOG0003
ParticipantsOG0014
ParticipantsOG0023
ParticipantsOG003
Secondary
Number of Participants With Complete Response (CR), Partial Response (PR) or Stable Disease (SD) [Best Overall Response (BOR) (CR+PR+SD)]
BOR was determined using Response Evaluation Criteria In Solid Tumors (RECIST v1.1) criteria. CR was defined as the disappearance of all target and non-target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 millimeters (mm) and normalization of tumor marker level of non-target lesions; PR was defined as at least a 30% decrease in sum of longest diameter (LD) of target lesions; Progressive Disease (PD) was defined as at least 20% increase in sum of LD of target lesions and minimum 5 mm increase over nadir. SD was defined as small changes that did not meet above criteria.
All participants who received at least 1 dose of study drug and assessed for BOR.
Posted
Count of Participants
Participants
No
Baseline up to 112 Days
ID
Title
Description
OG000
Arm A - 50 mg LY2584702 QD + 150 mg Erlotinib QD
50 milligram (mg) LY2584702 administered orally once daily (QD) plus 150 mg erlotinib administered orally QD for two 28-day cycles.
OG001
Arm A - 50 mg LY2584702 BID + 150 mg Erlotinib QD
50 mg LY2584702 administered orally twice daily (BID) plus 150 mg erlotinib administered orally QD for two 28-day cycles.
OG002
Arm A - 100 mg LY2584702 BID + 150 mg Erlotinib QD
100 mg LY2584702 administered orally BID plus 150 mg erlotinib administered orally QD for two 28-day cycles.
OG003
Arm A - 75 mg LY2584702 BID + 150 mg Erlotinib QD
75 mg LY2584702 administered orally BID plus 150 mg erlotinib administered orally QD for two 28-day cycles.
OG004
Arm B - 50 mg LY2584702 QD + 10 mg Everolimus QD
50 mg LY2584702 administered orally QD plus 10 mg everolimus administered orally QD for two 28-day cycles.
OG005
Arm B - 100 mg LY2584702 QD + 10 mg Everolimus QD
100 mg LY2584702 administered orally QD plus 10 mg everolimus administered orally QD for two 28-day cycles.
OG006
Arm B - 50 mg LY2584702 BID + 10 mg Everolimus QD
50 mg LY2584702 administered orally BID plus 10 mg everolimus administered orally QD for two 28-day cycles.
Units
Counts
Participants
OG0004
OG0015
OG0022
OG003
Title
Denominators
Categories
Title
Measurements
OG0001
OG0011
OG0021
OG003
Other Pre-specified
Number of Participants Who Died Due to Progressive Disease Within 30 Days of Study Drug Discontinuation
Participants who received at least 1 dose of study drug.
Posted
Count of Participants
Participants
No
Within 30 days of study drug discontinuation
ID
Title
Description
OG000
Arm A - 50 mg LY2584702 QD + 150 mg Erlotinib QD
50 milligram (mg) LY2584702 administered orally once daily (QD) plus 150 mg erlotinib administered orally QD for two 2 28-day cycles.
OG001
Arm A - 50 mg LY2584702 BID + 150 mg Erlotinib QD
50 mg LY2584702 administered orally twice daily (BID) plus 150 mg erlotinib administered orally QD for two 28-day cycles.
OG002
Arm A - 100 mg LY2584702 BID + 150 mg Erlotinib QD
100 mg LY2584702 administered orally BID plus 150 mg erlotinib administered orally QD for two 28-day cycles.
OG003
Arm A - 75 mg LY2584702 BID + 150 mg Erlotinib QD
75 mg LY2584702 administered orally BID plus 150 mg erlotinib administered orally QD for two 28-day cycles.
OG004
Arm B - 50 mg LY2584702 QD + 10 mg Everolimus QD
50 mg LY2584702 administered orally QD plus 10 mg everolimus administered orally QD for two 28-day cycles.
OG005
Arm B - 100 mg LY2584702 QD + 10 mg Everolimus QD
100 mg LY2584702 administered orally QD plus 10 mg everolimus administered orally QD for two 28-day cycles.
OG006
Arm B - 50 mg LY2584702 BID + 10 mg Everolimus QD
50 mg LY2584702 administered orally BID plus 10 mg everolimus administered orally QD for two 28-day cycles.
Units
Counts
Participants
OG0004
OG0015
OG0023
OG003
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG003
1
4
4
4
EG001
Arm A - 50 mg LY2584702 BID + 150 mg Erlotinib QD
50 mg LY2584702 administered orally twice daily BID plus 150 mg erlotinib administered orally QD for 2 28-day cycles.
2
5
5
5
EG002
Arm A - 100 mg LY2584702 BID + 150 mg Erlotinib QD
100 mg LY2584702 administered orally BID plus 150 mg erlotinib administered orally QD for 2 28-day cycles.
2
3
3
3
EG003
Arm A - 75 mg LY2584702 BID + 150 mg Erlotinib QD
75 mg LY2584702 administered orally BID plus 150 mg erlotinib administered orally QD for 2 28-day cycles.
3
5
5
5
EG004
Arm B - 50 mg LY2584702 QD + 10 mg Everolimus QD
50 mg LY2584702 administered orally QD plus 150 mg everolimus administered orally QD for 2 28-day cycles.
2
3
3
3
EG005
Arm B - 100 mg LY2584702 QD + 10 mg Everolimus QD
100 mg LY2584702 administered orally QD plus 150 mg everolimus administered orally QD for 2 28-day cycles.
2
3
3
3
EG006
Arm B - 50 mg LY2584702 BID + 10 mg Everolimus QD
50 mg LY2584702 administered orally BID plus 150 mg everolimus administered orally QD for 2 28-day cycles.
2
6
6
6
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected5 at risk
EG0041 events1 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
Abdominal pain
Gastrointestinal disorders
MedDRA v14.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
Gastritis
Gastrointestinal disorders
MedDRA v14.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected3 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
Ileus
Gastrointestinal disorders
MedDRA v14.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected3 at risk
EG0060 events0 affected6 at risk
Nausea
Gastrointestinal disorders
MedDRA v14.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0012 events1 affected5 at risk
EG0020 events0 affected3 at risk
EG0031 events1 affected5 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected3 at risk
EG0060 events0 affected6 at risk
Vomiting
Gastrointestinal disorders
MedDRA v14.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0012 events1 affected5 at risk
EG0021 events1 affected3 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
Asthenia
General disorders
MedDRA v14.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected3 at risk
EG0060 events0 affected6 at risk
Pyrexia
General disorders
MedDRA v14.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected5 at risk
EG0041 events1 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
Peritonitis bacterial
Infections and infestations
MedDRA v14.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG0031 events1 affected5 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
Accidental overdose
Injury, poisoning and procedural complications
MedDRA v14.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
International normalised ratio increased
Investigations
MedDRA v14.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG0031 events1 affected5 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
Decreased appetite
Metabolism and nutrition disorders
MedDRA v14.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected5 at risk
EG0021 events1 affected3 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected3 at risk
EG0060 events0 affected6 at risk
Loss of consciousness
Nervous system disorders
MedDRA v14.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0061 events1 affected6 at risk
Urinary tract obstruction
Renal and urinary disorders
MedDRA v14.0
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
Interstitial lung disease
Respiratory, thoracic and mediastinal disorders
MedDRA v14.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected5 at risk
EG0041 events1 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA v14.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG0031 events1 affected5 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
Deep vein thrombosis
Vascular disorders
MedDRA v14.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0061 events1 affected6 at risk
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected5 at risk
EG0041 events1 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
Neutropenia
Blood and lymphatic system disorders
MedDRA v14.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected5 at risk
EG0041 events1 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
Vertigo
Ear and labyrinth disorders
MedDRA v14.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected3 at risk
EG0031 events1 affected5 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
Dry eye
Eye disorders
MedDRA v14.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG0031 events1 affected5 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
Eye pain
Eye disorders
MedDRA v14.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG0031 events1 affected5 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
Periorbital oedema
Eye disorders
MedDRA v14.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG0031 events1 affected5 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
Visual acuity reduced
Eye disorders
MedDRA v14.0
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected5 at risk
EG0041 events1 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
Abdominal pain
Gastrointestinal disorders
MedDRA v14.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected5 at risk
EG0022 events1 affected3 at risk
EG0031 events1 affected5 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected3 at risk
EG0060 events0 affected6 at risk
Abdominal pain upper
Gastrointestinal disorders
MedDRA v14.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
Aphthous stomatitis
Gastrointestinal disorders
MedDRA v14.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected3 at risk
EG0061 events1 affected6 at risk
Constipation
Gastrointestinal disorders
MedDRA v14.0
Systematic Assessment
EG0002 events2 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG0032 events2 affected5 at risk
EG0041 events1 affected3 at risk
EG0051 events1 affected3 at risk
EG0061 events1 affected6 at risk
Diarrhoea
Gastrointestinal disorders
MedDRA v14.0
Systematic Assessment
EG0002 events2 affected4 at risk
EG0013 events3 affected5 at risk
EG0023 events2 affected3 at risk
EG0036 events4 affected5 at risk
EG0044 events2 affected3 at risk
EG0053 events2 affected3 at risk
EG0064 events3 affected6 at risk
Dry mouth
Gastrointestinal disorders
MedDRA v14.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG0031 events1 affected5 at risk
EG0041 events1 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
Dyspepsia
Gastrointestinal disorders
MedDRA v14.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
Dysphagia
Gastrointestinal disorders
MedDRA v14.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected3 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
Flatulence
Gastrointestinal disorders
MedDRA v14.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected3 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
Gastritis
Gastrointestinal disorders
MedDRA v14.0
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA v14.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0061 events1 affected6 at risk
Gingival pain
Gastrointestinal disorders
MedDRA v14.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected3 at risk
EG0060 events0 affected6 at risk
Nausea
Gastrointestinal disorders
MedDRA v14.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0013 events3 affected5 at risk
EG0023 events1 affected3 at risk
EG0034 events4 affected5 at risk
EG0042 events2 affected3 at risk
EG0052 events2 affected3 at risk
EG0063 events3 affected6 at risk
Pancreatitis
Gastrointestinal disorders
MedDRA v14.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
Small intestinal obstruction
Gastrointestinal disorders
MedDRA v14.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected3 at risk
EG0060 events0 affected6 at risk
Stomatitis
Gastrointestinal disorders
MedDRA v14.0
Systematic Assessment
EG0002 events1 affected4 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected5 at risk
EG0041 events1 affected3 at risk
EG0053 events2 affected3 at risk
EG0064 events3 affected6 at risk
Vomiting
Gastrointestinal disorders
MedDRA v14.0
Systematic Assessment
EG0001 events1 affected4 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected3 at risk
EG0033 events3 affected5 at risk
EG0041 events1 affected3 at risk
EG0054 events2 affected3 at risk
EG0063 events3 affected6 at risk
Asthenia
General disorders
MedDRA v14.0
Systematic Assessment
EG0003 events3 affected4 at risk
EG0013 events3 affected5 at risk
EG0021 events1 affected3 at risk
EG0034 events4 affected5 at risk
EG0042 events2 affected3 at risk
EG0051 events1 affected3 at risk
EG0064 events4 affected6 at risk
Chills
General disorders
MedDRA v14.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG0031 events1 affected5 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
Fatigue
General disorders
MedDRA v14.0
Systematic Assessment
EG0002 events1 affected4 at risk
EG0011 events1 affected5 at risk
EG0021 events1 affected3 at risk
EG0031 events1 affected5 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0062 events2 affected6 at risk
Hyperthermia
General disorders
MedDRA v14.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG0031 events1 affected5 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
Non-cardiac chest pain
General disorders
MedDRA v14.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
Oedema peripheral
General disorders
MedDRA v14.0
Systematic Assessment
EG0001 events1 affected4 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected5 at risk
EG0041 events1 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
Pyrexia
General disorders
MedDRA v14.0
Systematic Assessment
EG0001 events1 affected4 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected3 at risk
EG0031 events1 affected5 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected3 at risk
EG0062 events2 affected6 at risk
Cytolytic hepatitis
Hepatobiliary disorders
MedDRA v14.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected3 at risk
EG0060 events0 affected6 at risk
Gallbladder pain
Hepatobiliary disorders
MedDRA v14.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG0031 events1 affected5 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
Hyperbilirubinaemia
Hepatobiliary disorders
MedDRA v14.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0061 events1 affected6 at risk
Folliculitis
Infections and infestations
MedDRA v14.0
Systematic Assessment
EG0001 events1 affected4 at risk
EG0011 events1 affected5 at risk
EG0021 events1 affected3 at risk
EG0031 events1 affected5 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
Herpes zoster
Infections and infestations
MedDRA v14.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG0031 events1 affected5 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
Rash pustular
Infections and infestations
MedDRA v14.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0061 events1 affected6 at risk
Rhinitis
Infections and infestations
MedDRA v14.0
Systematic Assessment
EG0002 events2 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected3 at risk
EG0061 events1 affected6 at risk
Tooth abscess
Infections and infestations
MedDRA v14.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0061 events1 affected6 at risk
Urinary tract infection
Infections and infestations
MedDRA v14.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG0031 events1 affected5 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
Vulvovaginal mycotic infection
Infections and infestations
MedDRA v14.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG0031 events1 affected1 at risk
EG0040 events0 affected2 at risk
EG0050 events0 affected2 at risk
EG0060 events0 affected3 at risk
Vulvovaginitis
Infections and infestations
MedDRA v14.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected2 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected2 at risk
EG0050 events0 affected2 at risk
EG0060 events0 affected3 at risk
Activated partial thromboplastin time prolonged
Investigations
MedDRA v14.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG0031 events1 affected5 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
Blood bilirubin increased
Investigations
MedDRA v14.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
Coagulation factor v level decreased
Investigations
MedDRA v14.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG0031 events1 affected5 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
Electrocardiogram repolarisation abnormality
Investigations
MedDRA v14.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
Gamma-glutamyltransferase increased
Investigations
MedDRA v14.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG0031 events1 affected5 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
International normalised ratio increased
Investigations
MedDRA v14.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected3 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
Weight decreased
Investigations
MedDRA v14.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected5 at risk
EG0021 events1 affected3 at risk
EG0030 events0 affected5 at risk
EG0041 events1 affected3 at risk
EG0051 events1 affected3 at risk
EG0062 events2 affected6 at risk
Decreased appetite
Metabolism and nutrition disorders
MedDRA v14.0
Systematic Assessment
EG0003 events2 affected4 at risk
EG0015 events5 affected5 at risk
EG0022 events2 affected3 at risk
EG0033 events3 affected5 at risk
EG0043 events2 affected3 at risk
EG0050 events0 affected3 at risk
EG0066 events5 affected6 at risk
Dehydration
Metabolism and nutrition disorders
MedDRA v14.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected5 at risk
EG0021 events1 affected3 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
Diabetes mellitus
Metabolism and nutrition disorders
MedDRA v14.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG0031 events1 affected5 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
Gout
Metabolism and nutrition disorders
MedDRA v14.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0022 events1 affected3 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA v14.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0061 events1 affected6 at risk
Hypertriglyceridaemia
Metabolism and nutrition disorders
MedDRA v14.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected3 at risk
EG0061 events1 affected6 at risk
Hypoalbuminaemia
Metabolism and nutrition disorders
MedDRA v14.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG0031 events1 affected5 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
Hypokalaemia
Metabolism and nutrition disorders
MedDRA v14.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected5 at risk
EG0041 events1 affected3 at risk
EG0051 events1 affected3 at risk
EG0060 events0 affected6 at risk
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA v14.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected5 at risk
EG0021 events1 affected3 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
Hyponatraemia
Metabolism and nutrition disorders
MedDRA v14.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected5 at risk
EG0021 events1 affected3 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
Hypophosphataemia
Metabolism and nutrition disorders
MedDRA v14.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected3 at risk
EG0030 events0 affected5 at risk
EG0041 events1 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA v14.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG0031 events1 affected5 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
Back pain
Musculoskeletal and connective tissue disorders
MedDRA v14.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected3 at risk
EG0031 events1 affected5 at risk
EG0041 events1 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA v14.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected3 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0061 events1 affected6 at risk
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA v14.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected3 at risk
EG0061 events1 affected6 at risk
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA v14.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected3 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA v14.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected3 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
Tendon pain
Musculoskeletal and connective tissue disorders
MedDRA v14.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0061 events1 affected6 at risk
Tumour pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA v14.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected5 at risk
EG0021 events1 affected3 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
Dysgeusia
Nervous system disorders
MedDRA v14.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected5 at risk
EG0021 events1 affected3 at risk
EG0031 events1 affected5 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
Anxiety
Psychiatric disorders
MedDRA v14.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG0031 events1 affected5 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected3 at risk
EG0060 events0 affected6 at risk
Insomnia
Psychiatric disorders
MedDRA v14.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG0031 events1 affected5 at risk
EG0041 events1 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
Cystitis noninfective
Renal and urinary disorders
MedDRA v14.0
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
Dysuria
Renal and urinary disorders
MedDRA v14.0
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
Haematuria
Renal and urinary disorders
MedDRA v14.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG0031 events1 affected5 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
Micturition disorder
Renal and urinary disorders
MedDRA v14.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG0031 events1 affected5 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
Proteinuria
Renal and urinary disorders
MedDRA v14.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
Renal failure
Renal and urinary disorders
MedDRA v14.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG0031 events1 affected5 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
Urinary incontinence
Renal and urinary disorders
MedDRA v14.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0061 events1 affected6 at risk
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA v14.0
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected3 at risk
EG0031 events1 affected5 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected3 at risk
EG0061 events1 affected6 at risk
Dysphonia
Respiratory, thoracic and mediastinal disorders
MedDRA v14.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected3 at risk
EG0030 events0 affected5 at risk
EG0041 events1 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA v14.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0023 events2 affected3 at risk
EG0031 events1 affected5 at risk
EG0042 events2 affected3 at risk
EG0050 events0 affected3 at risk
EG0061 events1 affected6 at risk
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA v14.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG0031 events1 affected5 at risk
EG0041 events1 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA v14.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0061 events1 affected6 at risk
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA v14.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0061 events1 affected6 at risk
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA v14.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected5 at risk
EG0041 events1 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
Alopecia
Skin and subcutaneous tissue disorders
MedDRA v14.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0061 events1 affected6 at risk
Dermatitis acneiform
Skin and subcutaneous tissue disorders
MedDRA v14.0
Systematic Assessment
EG0001 events1 affected4 at risk
EG0013 events3 affected5 at risk
EG0022 events2 affected3 at risk
EG0033 events3 affected5 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
Dry skin
Skin and subcutaneous tissue disorders
MedDRA v14.0
Systematic Assessment
EG0003 events2 affected4 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected3 at risk
EG0032 events2 affected5 at risk
EG0041 events1 affected3 at risk
EG0051 events1 affected3 at risk
EG0060 events0 affected6 at risk
Erythema
Skin and subcutaneous tissue disorders
MedDRA v14.0
Systematic Assessment
EG0002 events2 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
Hyperhidrosis
Skin and subcutaneous tissue disorders
MedDRA v14.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
Night sweats
Skin and subcutaneous tissue disorders
MedDRA v14.0
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0061 events1 affected6 at risk
Palmar-plantar erythrodysaesthesia syndrome
Skin and subcutaneous tissue disorders
MedDRA v14.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
Pruritus
Skin and subcutaneous tissue disorders
MedDRA v14.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected3 at risk
EG0031 events1 affected5 at risk
EG0042 events2 affected3 at risk
EG0050 events0 affected3 at risk
EG0061 events1 affected6 at risk
Rash macular
Skin and subcutaneous tissue disorders
MedDRA v14.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected3 at risk
EG0052 events2 affected3 at risk
EG0060 events0 affected6 at risk
Rash maculo-papular
Skin and subcutaneous tissue disorders
MedDRA v14.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected3 at risk
EG0060 events0 affected6 at risk
Skin exfoliation
Skin and subcutaneous tissue disorders
MedDRA v14.0
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected6 at risk
Restriction Type
GT60
Results Disclosure Restriction on PI(s)?
Yes
Other Details
Not provided
D002283
Carcinoma, Bronchogenic
D001984
Bronchial Neoplasms
D008175
Lung Neoplasms
D012142
Respiratory Tract Neoplasms
D013899
Thoracic Neoplasms
D009371
Neoplasms by Site
D008171
Lung Diseases
D012140
Respiratory Tract Diseases
D000230
Adenocarcinoma
D002277
Carcinoma
D009375
Neoplasms, Glandular and Epithelial
D009370
Neoplasms by Histologic Type
D007680
Kidney Neoplasms
D014571
Urologic Neoplasms
D014565
Urogenital Neoplasms
D052776
Female Urogenital Diseases
D005261
Female Urogenital Diseases and Pregnancy Complications
D000091642
Urogenital Diseases
D007674
Kidney Diseases
D014570
Urologic Diseases
D052801
Male Urogenital Diseases
D017599
Neuroectodermal Tumors
D009373
Neoplasms, Germ Cell and Embryonal
D009380
Neoplasms, Nerve Tissue
D020123
Sirolimus
D018942
Macrolides
D007783
Lactones
D009930
Organic Chemicals
1
BG0051
BG0063
BG00714
3
BG0053
BG0065
BG00726
0
BG0050
BG0061
BG0073
0
BG0050
BG0061
BG0071
0
BG0050
BG0060
BG0070
1
BG0050
BG0060
BG0071
2
BG0053
BG0064
BG00724
0
BG0050
BG0060
BG0070
0
BG0050
BG0061
BG0073
5
BG0043
BG0053
BG0064
BG00725
5
OG0043
OG0053
OG0066
3
OG0042
OG0052
OG0062
Non-SAEs
Title
Measurements
OG0004
OG0015
OG0023
OG0035
OG0043
OG0053
OG0066
0
OG0040
OG0050
OG0060
3
OG0043
OG0053
OG0063
0
(NA to NA)
No participants achieved PR or CR; confidence interval could not be determined.
OG0030(NA to NA)No participants achieved PR or CR; confidence interval could not be determined.
OG0040(NA to NA)No participants achieved PR or CR; confidence interval could not be determined.
OG0050(NA to NA)No participants achieved PR or CR; confidence interval could not be determined.
OG0060(NA to NA)No participants achieved PR or CR; confidence interval could not be determined.