AZD2014 and Fulvestrant in Patients With ER+ Advanced Met... | NCT01597388 | Trialant
NCT01597388
Sponsor
AstraZeneca
Status
Completed
Last Update Posted
Feb 24, 2026Actual
Enrollment
99Actual
Phase
Phase 1
Conditions
Advanced Metastatic Breast Cancer
Interventions
AZD2014
Fulvestrant
Countries
United States
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
NCT01597388
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
D2270C00005
Secondary IDs
ID
Type
Description
Link
BRE-196
264477
Other Identifier
Parexel International (IRL) Limited
Brief Title
AZD2014 and Fulvestrant in Patients With ER+ Advanced Metastatic Breast Cancer
Official Title
A Phase I, Open-label, Multicentre, Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of AZD2014 Administered Orally in Combination With Intramuscular (IM) Fulvestrant to Patients With Estrogen Receptor Positive (ER+) Advanced, Metastatic Breast Cancer
Acronym
Not provided
Organization
AstraZenecaINDUSTRY
Status Module
Record Verification Date
Feb 2026
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
May 8, 2012Actual
Primary Completion Date
Aug 4, 2016Actual
Completion Date
Jan 13, 2026Actual
First Submitted Date
Mar 28, 2012
First Submission Date that Met QC Criteria
May 10, 2012
First Posted Date
May 14, 2012Estimated
Results Waived
Not provided
Results First Submitted Date
Sep 18, 2017
Results First Submitted that Met QC Criteria
Oct 16, 2018
Results First Posted Date
Oct 17, 2018Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Feb 6, 2026
Last Update Posted Date
Feb 24, 2026Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
AstraZenecaINDUSTRY
Collaborators
Not provided
Oversight Module
No data available
No data is available for this block.
Description Module
Brief Summary
The purpose of this study is to assess safety and tolerability of AZD2014 when given in combination with Fulvestrant
Detailed Description
A Phase I, Open-label, Multicentre, Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of AZD2014 Administered Orally in Combination with Intramuscular (IM) Fulvestrant to Patients with Estrogen Receptor Positive (ER+) Advanced, Metastatic Breast Cancer.
Conditions Module
Conditions
Advanced Metastatic Breast Cancer
Keywords
Estrogen receptor positive
Advanced metastatic breast cancer
Estrogen receptor positive advanced metastatic breast cancer
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 1
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
99Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
AZD2014 with Fulvestrant
Experimental
AZD2014 with Fulvestrant
Drug: AZD2014
Drug: Fulvestrant
Interventions
Name
Type
Description
Arm Group Labels
Other Names
AZD2014
Drug
Single dose followed by multiple dosing or twice daily dosing for 2 days folllowed by 5 days off each week, or twice daily dosing on the first and fourth day of the week
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Adverse Events
Up to 12 Months
Adverse Events Leading to Dose Reduction of AZD2014
Up to 28 Days
Clinically Important Changes in Haematology Parameters
Up to 12 Months
Clinically Important Changes in Clinical Chemistry Parameters
Up to 12 Months
Left Ventricular Ejection Fraction
24 hours
QTcF Over 24 Hours
24 hours
Post-Baseline Glucose Elevation
28 Days
Sitting Diastolic Blood Pressure
28 Days
Sitting Systolic Blood Pressure
28 Days
Respiratory Rate
28 Days
Heart Rate
28 Days
Body Temperature
Secondary Outcomes
Measure
Description
Time Frame
AZD2014 Peak Plasma Concentration (Cmax) Following Single Dose, Fasted, no Fulvestrant.
1 Day
Time to AZD2014 Peak Plasma Concentration (Tmax) Following Single Dose, Fasted, no Fulvestrant.
1 Day
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Provision of signed and dated written informed consent prior to any study specific procedures, sampling analysis
Aged at least 18
At least one lesion (measurable and/or non-measurable) that can be accurately assessed at baseline by computerised tomography (CT) magnetic resonance imaging (MRI) or plain X-ray and is suitable for repeated assessment
Histological or cytological confirmation of an ER+ advanced metastatic breast cancer tumour that is eligible for treatment with fulvestrant
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Patients must have evidence of non-child-bearing potential.
Exclusion Criteria:
Prior chemotherapy, biological therapy, radiation therapy, androgens, thalidomide, immunotherapy, other anticancer agents, and any investigational agents within 14 days of starting study treatment (not including palliative radiotherapy at focal sites)
Major surgery within 4 weeks prior to entry to the study (excluding placement of vascular access), or minor surgery within 2 weeks of entry into the study.
Patients with severe cardiac condition of ischemia, impaired ventricular function and arrhythmias, evidence of severe or uncontrolled systemic or current unstable or uncompensated respiratory or cardiac conditions.
Patients with diabetes type 1 or uncontrolled type II (HbA1c > 8% assessed locally)
Accepts Healthy Volunteers
No
Sex
Female
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
100 Years
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Not provided
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Research Site
Sarasota
Florida
34232
United States
Research Site
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
No data available
No data is available for this block.
Not provided
Recruitment Details
One hundred ten (110) patients enrolled in the study; 100 patients were assigned to a treatment schedule and 10 patients were screen failures. One patient withdrew from the study prior to receiving study drug and was excluded from the safety analysis set.
Patients were treated at 5 sites in the US from 21 May 2012 until 4 August 2016.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
35 mg BID Continuous
Participants took 35 mg of AZD2014 twice daily continuously in 28 day cycles. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
FG001
50 mg BID Continuous
Participants took 50 mg of AZD2014 twice daily continuously in 28 day cycles. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
FG002
75 mg QD Continuous
Participants took 75 mg of AZD2014 one time each day continuously in 28 day cycles. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycles.
FG003
100 mg QD Continuous
Participants took 100 mg of AZD2014 one time each day continuously in 28 day cycles. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycles.
FG004
125 mg BID Intermittent Days 1 and 2 (Fasted)
Participants took 125 mg of AZD2014 twice daily on Days 1 and 2 of each week in 28 day cycles (4 weeks) in a fasted condition. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
FG005
125 mg BID Intermittent Days 1 and 2 (Fed)
Participants took 125 mg of AZD2014 twice daily on Days 1 and 2 of each week in 28 day cycles (4 weeks) after eating. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
FG006
170 mg BID Intermittent Days 1 and 2 (Fasted)
Participants took 170 mg of AZD2014 twice daily on Days 1 and 2 of each week in 28 day cycles (4 weeks) in a fasted condition. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
FG007
170 mg BID Intermittent Days 1 and 2 (Fed)
Participants took 170 mg of AZD2014 twice daily on Days 1 and 2 of each week in 28 day cycles (4 weeks) after eating. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
FG008
125 mg BID Intermittent Days 1 and 4 (Fasted)
Participants took 125 mg of AZD2014 twice daily on Days 1 and 4 of each week in 28 day cycles (4 weeks) in a fasted condition. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
FG0006 subjects
FG00113 subjects
FG00214 subjects
FG00310 subjects
FG00437 subjects
FG0054 subjects
FG0068 subjects
FG0075 subjects
FG0082 subjects
COMPLETED
FG0006 subjects
FG00113 subjects
FG00214 subjects
FG00310 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
35 mg BID Continuous
Participants took 35 mg of AZD2014 twice daily continuously in 28 day cycles. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
BG001
50 mg BID Continuous
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
Adverse Events
The analysis population consisted of all participants who received at least one dose of AZD2014.
Posted
Number
Participants
Up to 12 Months
ID
Title
Description
OG000
35 mg BID Continuous
Participants took 35 mg of AZD2014 twice daily continuously in 28 day cycles. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
OG001
50 mg BID Continuous
Participants took 50 mg of AZD2014 twice daily continuously in 28 day cycles. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
Adverse Events Module
Frequency Threshold
5
Time Frame
Up to 1 year
Description
Not provided
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
35 mg BID Continuous
Participants took 35 mg of AZD2014 twice daily continuously in 28 day cycles. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Evans Syndrome
Blood and lymphatic system disorders
MedDRA v19.0
Non-systematic Assessment
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA v19.0
Non-systematic Assessment
More Info Module
Limitations and Caveats
Not provided
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
Point of Contact
Title
Organization
Phone
Extension
Email
Julie Charlton
AstraZeneca
+ 01625-582828
ClinicalTrialTransparancy@astrazeneca.com
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
No data available
No data is available for this block.
Intervention Browse Module
MeSH Terms
ID
Term
C585537
vistusertib
D000077267
Fulvestrant
Ancestor Terms
ID
Term
D004958
Estradiol
D004963
Estrenes
D004962
Estranes
D013256
Steroids
D000072473
Browse Leaves
Not provided
Browse Branches
Not provided
Non-Randomized
Intervention Model
Single Group Assignment
Intervention Model Description
Not provided
Primary Purpose
Basic Science
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
AZD2014 with Fulvestrant
Fulvestrant
Drug
IM monthly after loading dose
AZD2014 with Fulvestrant
faslodex
28 Days
Oxygen Saturation
28 Days
AZD2014 Peak Plasma Concentration at Steady State (Cmax,ss) on Cycle 0 Days -5 to -1, Continuous Dosing, no Fulvestrant
5 Days
AZD2014 Area Under the Plasma Concentration Time Curve (AUC 0-12) Cycle 0 Days -5 to -1, Continuous Dosing, no Fulvestrant
5 Days
AZD2014 Area Under the Plasma Concentration Time Curve (AUC 0-24) Cycle 0 Days -5 to -1, Continuous Dosing, no Fulvestrant
5 Days
AZD2014 Area Under the Plasma Concentration Time Curve (AUC 0-t) Cycle 0 Days -5 to -1, Continuous Dosing, no Fulvestrant
5 Days
AZD2014 Area Under the Plasma Concentration Time Curve (AUC 0-∞) Cycle 0 Days -5 to -1, Continuous Dosing, no Fulvestrant
5 Days
AZD2014 Peak Plasma Concentration at Steady State (Cmax,ss) on Cycle 1 Day 15, BID Intermittent Dosing, With Fulvestrant
15 Days
Time to AZD2014 Peak Plasma Concentration at Steady State (Tmax,ss) on Cycle 1 Day 15, BID Intermittent Dosing, With Fulvestrant
15 Days
AZD2014 Area Under the Plasma Concentration Time Curve (AUC 0-12) Cycle 1 Day 15 Intermittent Dosing, With Fulvestrant
15 Days
AZD2014 Peak Plasma Concentration at Steady State (Cmax,ss) on Cycle 1 Day 22, Continuous Dosing, With Fulvestrant
22 Days
Time to AZD2014 Peak Plasma Concentration at Steady State (Tmax,ss) on Cycle 1 Day 22, Continuous Dosing, With Fulvestrant
22 Days
AZD2014 Area Under the Plasma Concentration Time Curve (AUC 0-12) Cycle 1 Day 22 Continuous Dosing, With Fulvestrant
15 Days
Area Under the Plasma Concentration-time Curve for AZD2014 From 0 to 12 Hours (AUC 0-12) Following Single Dose, Fasted, no Fulvestrant.
1 Day
Area Under the Plasma Concentration-time Curve for AZD2014 From 0 to Infinity (AUC 0-∞) Following Single Dose, Fasted, no Fulvestrant.
1 Day
Objective Response Rate
Objective Response Rate (ORR) is defined as the number (%) of patients with a confirmed overall response of either complete response (CR) or partial response (PR).
Up to 12 months
Best Objective Response (BOR)
Best objective response was the best response a patient had following start of treatment but prior to starting any subsequent cancer therapy and prior to RECIST v1.1 progression or the last evaluable assessment in the absence of RECIST v1.1 progression.
Up to 12 months
Duration of Response (DoR)
Duration of response is defined as the time from the date of first documented response until the date of documented progression or death in the absence of disease progression.
Up to 12 months
Clinical Benefit Rate (CBR) at 24 Weeks
The Clinical Benefit Rate (CBR) at 24 weeks is defined as the percentage of patients who had a confirmed BOR of CR or PR in the first 24 weeks or who demonstrated SD for a minimum interval of 24 weeks (minus 1 week to allow for an early assessment within the assessment window, i.e., 161 days) following the start of treatment.
Up to 12 months
Percentage Change From Baseline at 16 Weeks in Target Lesion (TL) Size.
Baseline was defined as last evaluable assessment prior to starting treatment. Tumour size was the sum of the longest diameters of the target lesions. TLs are measurable tumour lesions.
Up to 12 months
Progression Free Survival
Up to 12 months
Progression Free Survival at 26 Weeks
Up to 12 months
Detroit
Michigan
48201
United States
Research Site
Oklahoma City
Oklahoma
73104
United States
Research Site
Greenville
South Carolina
29605
United States
Research Site
Nashville
Tennessee
37203
United States
37 subjects
FG0054 subjects
FG0068 subjects
FG0075 subjects
FG0082 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
Participants took 50 mg of AZD2014 twice daily continuously in 28 day cycles. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
BG002
75 mg QD Continuous
Participants took 75 mg of AZD2014 one time each day continuously in 28 day cycles. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycles.
BG003
100 mg QD Continuous
Participants took 100 mg of AZD2014 one time each day continuously in 28 day cycles. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycles.
BG004
125 mg BID Intermittent Days 1 and 2 (Fasted)
Participants took 125 mg of AZD2014 twice daily on Days 1 and 2 of each week in 28 day cycles (4 weeks) in a fasted condition. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
BG005
125 mg BID Intermittent Days 1 and 2 (Fed)
Participants took 125 mg of AZD2014 twice daily on Days 1 and 2 of each week in 28 day cycles (4 weeks) after eating. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
BG006
170 mg BID Intermittent Days 1 and 2 (Fasted)
Participants took 170 mg of AZD2014 twice daily on Days 1 and 4 of each week in 28 day cycles (4 weeks) in a fasted condition. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
BG007
170 mg BID Intermittent Days 1 and 2 (Fed)
Participants took 170 mg of AZD2014 twice daily on Days 1 and 2 of each week in 28 day cycles (4 weeks) after eating. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
BG008
125 mg BID Intermittent Days 1 and 4 (Fasted)
Participants took 125 mg of AZD2014 twice daily on Days 1 and 4 of each week in 28 day cycles (4 weeks) in a fasted condition. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
BG009
Total
Total of all reporting groups
6
BG00113
BG00214
BG00310
BG00437
BG0054
BG0068
BG0075
BG0082
BG00999
Standard Deviation
Years
Title
Denominators
Categories
Title
Measurements
BG00060.5± 9.16
BG00163.3± 12.53
BG00261.1± 7.46
BG00360.1± 10.46
BG00460.1± 10.05
BG00555.8± 6.29
BG00654.4± 9.44
BG00758.4± 9.26
BG00855.0± NAThe standard deviation was not calculated because there were only 2 participants in this group.
BG00959.9± 9.88
Age, Continuous
Median
Full Range
Years
Title
Denominators
Categories
Title
Measurements
BG00058.5(48 to 72)
BG00164.0(32 to 82)
BG00261.0(50 to 76)
BG00362.0(39 to 73)
BG00461.0(40 to 77)
BG00555.0(50 to 63)
BG00655.5(34 to 64)
BG00759.0(43 to 67)
BG00855.0(43 to 67)
BG00961.0(32 to 82)
Age, Customized
Count of Participants
Participants
Title
Denominators
Categories
≥18 and <50 years
Title
Measurements
BG0001
BG0011
BG0020
BG0031
BG0047
BG0050
BG0061
BG0071
BG0081
BG00913
≥50 to <65 years
Title
Measurements
BG0003
BG0016
BG0028
BG003
≥65 years
Title
Measurements
BG0002
BG0016
BG0026
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0006
BG00113
BG00214
BG00310
BG00437
BG0054
BG0068
BG0075
BG0082
BG00999
Male
BG0000
BG0010
BG0020
BG0030
BG004
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0000
BG0010
BG0020
BG0031
BG0040
BG0050
BG0060
BG0070
BG0080
BG0091
Not Hispanic or Latino
BG0000
BG0011
BG0022
BG0030
BG004
Unknown or Not Reported
BG0006
BG00112
BG00212
BG0039
BG004
Race/Ethnicity, Customized
Count of Participants
Participants
Title
Denominators
Categories
White
Title
Measurements
BG0006
BG00111
BG00212
BG00310
BG00435
BG0052
BG0067
BG0075
BG0082
BG00990
Black or African American
Title
Measurements
BG0000
BG0012
BG0022
BG003
Other
Title
Measurements
BG0000
BG0010
BG0020
BG003
Region of Enrollment
Count of Participants
Participants
Title
Denominators
Categories
United States
Title
Measurements
BG0006
BG00113
BG00214
BG00310
BG00437
BG0054
BG0068
BG0075
BG0082
BG00999
Weight
Mean
Standard Deviation
kg
Title
Denominators
Categories
Title
Measurements
BG00077.42± 15.953
BG00173.29± 18.845
BG00274.51± 19.236
BG00374.53± 23.776
BG00467.62± 15.511
BG00579.88± 17.854
BG00668.95± 14.115
BG00777.98± 12.586
BG00877.45± NAThe standard deviation was not calculated because there were only 2 participants in this arm.
BG00971.96± 17.134
ECOG Performance Status (PS)
ECOG PS = 0 Fully active; PS = 1 Restricted in physically strenuous activity; PS = 2 Ambulatory and capable of self-care; PS = Capable of only limited self care; PS = 4 Completely disabled
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
PS = 0
BG0003
BG00111
BG0028
BG0035
BG00416
BG0052
BG0065
BG0071
BG0081
BG00952
PS = 1
BG0003
BG0012
BG0026
BG0035
BG004
PS = 2
BG0000
BG0010
BG0020
BG0030
BG004
PS = 3
BG0000
BG0010
BG0020
BG0030
BG004
PS = 4
BG0000
BG0010
BG0020
BG0030
BG004
Tumour Grade
G1 = Well differentiated; G2 = Moderately differentiated; G3 = Poorly differentiated; G4 = Undifferentiated; Gx = Not assessable
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
G1
BG0000
BG0010
BG0020
BG0031
BG0041
BG0051
BG0060
BG0071
BG0080
BG0094
G2
BG0003
BG0015
BG0026
BG0036
BG004
G3
BG0001
BG0014
BG0023
BG0032
BG004
G4
BG0000
BG0010
BG0020
BG0030
BG004
Gx
BG0001
BG0013
BG0025
BG0031
BG004
Missing
BG0001
BG0011
BG0020
BG0030
BG004
Histology Type
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Cannot be determined
BG0000
BG0011
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
BG0091
Invasive carcinoma (NOS)
BG0000
BG0011
BG0021
BG0031
BG004
Invasive ductal
BG0004
BG0016
BG0027
BG0035
BG004
Invasive ductal/extensive intraductal component
BG0000
BG0010
BG0020
BG0031
BG004
Invasive lobular
BG0002
BG0013
BG0021
BG0031
BG004
Other
BG0000
BG0012
BG0025
BG0032
BG004
Malignant pleural effusion
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Absent
BG0005
BG00112
BG00214
BG0037
BG00433
BG0051
BG0067
BG0075
BG0082
BG00986
Present
BG0001
BG0011
BG0020
BG0033
BG004
Time from Diagnosis to Enrollment
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
≤ 6 months
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
BG0090
> 6 to ≤ 12 months
BG0000
BG0010
BG0021
BG0030
BG004
> 12 to ≤ 24 months
BG0000
BG0011
BG0020
BG0031
BG004
> 24 months
BG0006
BG00112
BG00213
BG0039
BG004
Time from most recent progression to enrollment
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
≤ 3 months
BG0005
BG00111
BG00212
BG0038
BG00428
BG0053
BG0068
BG0075
BG0082
BG00982
During screening, after informed consent
BG0001
BG0010
BG0020
BG0030
BG004
> 3 to ≤ 12 months
BG0000
BG0011
BG0022
BG0032
BG004
> 12 months
BG0000
BG0011
BG0020
BG0030
BG004
Overall disease classification
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Metastatic
BG0006
BG00113
BG00214
BG0039
BG00437
BG0054
BG0068
BG0075
BG0082
BG00998
Locally advanced
BG0000
BG0010
BG0020
BG0031
BG004
Estrogen Receptor Positive (ER+)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Yes
BG0006
BG00113
BG00214
BG00310
BG00437
BG0054
BG0068
BG0075
BG0082
BG00999
No
BG0000
BG0010
BG0020
BG0030
BG004
Progesterone Receptor Positive (PR+)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Yes
BG0003
BG0017
BG0027
BG0037
BG00430
BG0054
BG0064
BG0071
BG0082
BG00965
No
BG0003
BG0016
BG0027
BG0033
BG004
Human Epidermal Growth Factor Receptor Positive (HER+)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Yes
BG0000
BG0011
BG0020
BG0031
BG0044
BG0050
BG0062
BG0071
BG0080
BG0099
No
BG0006
BG00112
BG00214
BG0039
BG004
OG002
75 mg QD Continuous
Participants took 75 mg of AZD2014 one time per day continuously in 28 day cycles. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
OG003
100 mg QD Continuous
Participants took 100 mg of AZD2014 one time per day in 28 day cycles (4 weeks). Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
OG004
125 mg BID Intermittent Days 1 and 2 (Fasted)
Participants took 125 mg of AZD2014 twice daily on Days 1 and 2 of each week in 28 day cycles (4 weeks) in a fasted condition. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
OG005
125 mg BID Intermittent Days 1 and 2 (Fed)
Participants took 125 mg of AZD2014 twice daily on Days 1 and 2 of each week in 28 day cycles (4 weeks) after eating. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
OG006
170 mg BID Intermittent Days 1 and 2 (Fasted)
Participants took 170 mg of AZD2014 twice daily on Days 1 and 2 of each week in 28 day cycles (4 weeks) in a fasted condition. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
OG007
170 mg BID Intermittent Days 1 and 2 (Fed)
Participants took 170 mg of AZD2014 twice daily on Days 1 and 2 of each week in 28 day cycles (4 weeks) after eating. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
OG008
125 mg BID Intermittent Days 1 and 4 (Fasted)
Participants took 125 mg of AZD2014 twice daily on Days 1 and 4 of each week in 28 day cycles (4 weeks) in a fasted condition. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
Units
Counts
Participants
OG0006
OG00113
OG00214
OG00310
OG00437
OG0054
OG0068
OG0075
OG0082
Title
Denominators
Categories
Any Adverse Event (AE)
Title
Measurements
OG0006
OG00113
OG00214
OG00310
OG00437
OG0054
OG0068
OG0075
OG0082
Any AE, Causally Related to AZD2014
Title
Measurements
OG0005
OG00112
OG00214
OG003
Any AE, Causally Related to Fulvestrant Only
Title
Measurements
OG0002
OG0013
OG0026
OG003
Any AE of CTCAE Grade ≥ 3 (G3)
Title
Measurements
OG0003
OG0018
OG00210
OG003
AEs of CTCAE G3, Causally Related to AZD2014
Title
Measurements
OG0002
OG0018
OG0027
OG003
Any AE of CTCAE G3, Related to Fulvestrant Only
Title
Measurements
OG0000
OG0010
OG0020
OG003
Any Adverse Event with Outcome of Death
Title
Measurements
OG0000
OG0010
OG0021
OG003
AE with Outcome of Death, Related to AZD2014
Title
Measurements
OG0000
OG0010
OG0020
OG003
AE Outcome of Death, Related to Fulvestrant Only
Title
Measurements
OG0000
OG0010
OG0020
OG003
Any Serious Adverse Event (SAE)
Title
Measurements
OG0000
OG0011
OG0023
OG003
Any SAE, Causally Related to AZD2014
Title
Measurements
OG0000
OG0010
OG0021
OG003
Any SAE, Causally Related to Fulvestrant Only
Title
Measurements
OG0000
OG0010
OG0020
OG003
Any AE Leading to Discontinuation of AZD2014
Title
Measurements
OG0002
OG0014
OG0022
OG003
Any SAE Leading to Discontinuation of AZD2014
Title
Measurements
OG0000
OG0010
OG0021
OG003
Primary
Adverse Events Leading to Dose Reduction of AZD2014
The analysis population consisted of all participants who received at least one dose of AZD2014.
Posted
Number
Participants
Up to 28 Days
ID
Title
Description
OG000
35 mg BID Continuous
Participants took 35 mg of AZD2014 twice daily continuously in 28 day cycles. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
OG001
50 mg BID Continuous
Participants took 50 mg of AZD2014 twice daily continuously in 28 day cycles. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
OG002
75 mg QD Continuous
Participants took 75 mg of AZD2014 one time per day continuously in 28 day cycles. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
OG003
100 mg QD Continuous
Participants took 100 mg of AZD2014 one time per day in 28 day cycles (4 weeks). Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
OG004
125 mg BID Intermittent Days 1 and 2 (Fasted)
Participants took 125 mg of AZD2014 twice daily on Days 1 and 2 of each week in 28 day cycles (4 weeks) in a fasted condition. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
OG005
125 mg BID Intermittent Days 1 and 2 (Fed)
Participants took 125 mg of AZD2014 twice daily on Days 1 and 2 of each week in 28 day cycles (4 weeks) after eating. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
OG006
170 mg BID Intermittent Days 1 and 2 (Fasted)
Participants took 170 mg of AZD2014 twice daily on Days 1 and 2 of each week in 28 day cycles (4 weeks) in a fasted condition. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
OG007
170 mg BID Intermittent Days 1 and 2 (Fed)
Participants took 170 mg of AZD2014 twice daily on Days 1 and 2 of each week in 28 day cycles (4 weeks) after eating. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
OG008
125 mg BID Intermittent Days 1 and 4 (Fasted)
Participants took 125 mg of AZD2014 twice daily on Days 1 and 4 of each week in 28 day cycles (4 weeks) in a fasted condition. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
Units
Counts
Participants
OG0006
OG00113
OG00214
OG003
Title
Denominators
Categories
Title
Measurements
OG0001
OG0017
OG0024
OG003
Primary
Clinically Important Changes in Haematology Parameters
The analysis population consisted of all participants who received at least one dose of AZD2014.
Posted
Number
Participants
Up to 12 Months
ID
Title
Description
OG000
35 mg BID Continuous
Participants took 35 mg of AZD2014 twice daily continuously in 28 day cycles. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
OG001
50 mg BID Continuous
Participants took 50 mg of AZD2014 twice daily continuously in 28 day cycles. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
OG002
75 mg QD Continuous
Participants took 75 mg of AZD2014 one time per day continuously in 28 day cycles. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
OG003
100 mg QD Continuous
Participants took 100 mg of AZD2014 one time per day in 28 day cycles (4 weeks). Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
OG004
125 mg BID Intermittent Days 1 and 2 (Fasted)
Participants took 125 mg of AZD2014 twice daily on Days 1 and 2 of each week in 28 day cycles (4 weeks) in a fasted condition. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
OG005
125 mg BID Intermittent Days 1 and 2 (Fed)
Participants took 125 mg of AZD2014 twice daily on Days 1 and 2 of each week in 28 day cycles (4 weeks) after eating. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
OG006
170 mg BID Intermittent Days 1 and 2 (Fasted)
Participants took 170 mg of AZD2014 twice daily on Days 1 and 2 of each week in 28 day cycles (4 weeks) in a fasted condition. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
OG007
170 mg BID Intermittent Days 1 and 2 (Fed)
Participants took 170 mg of AZD2014 twice daily on Days 1 and 2 of each week in 28 day cycles (4 weeks) after eating. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
OG008
125 mg BID Intermittent Days 1 and 4 (Fasted)
Participants took 125 mg of AZD2014 twice daily on Days 1 and 4 of each week in 28 day cycles (4 weeks) in a fasted condition. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
Units
Counts
Participants
OG0006
OG00113
OG00214
OG003
Title
Denominators
Categories
Change in Hemoglobin ≥ 2 CTCAE Grades
Title
Measurements
OG0000
OG0010
OG0020
OG003
Primary
Clinically Important Changes in Clinical Chemistry Parameters
The analysis population consisted of all participants who received at least one dose of AZD2014.
Posted
Number
Participants
Up to 12 Months
ID
Title
Description
OG000
35 mg BID Continuous
Participants took 35 mg of AZD2014 twice daily continuously in 28 day cycles. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
OG001
50 mg BID Continuous
Participants took 50 mg of AZD2014 twice daily continuously in 28 day cycles. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
OG002
75 mg QD Continuous
Participants took 75 mg of AZD2014 one time per day continuously in 28 day cycles. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
OG003
100 mg QD Continuous
Participants took 100 mg of AZD2014 one time per day in 28 day cycles (4 weeks). Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
OG004
125 mg BID Intermittent Days 1 and 2 (Fasted)
Participants took 125 mg of AZD2014 twice daily on Days 1 and 2 of each week in 28 day cycles (4 weeks) in a fasted condition. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
OG005
125 mg BID Intermittent Days 1 and 2 (Fed)
Participants took 125 mg of AZD2014 twice daily on Days 1 and 2 of each week in 28 day cycles (4 weeks) after eating. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
OG006
170 mg BID Intermittent Days 1 and 2 (Fasted)
Participants took 170 mg of AZD2014 twice daily on Days 1 and 2 of each week in 28 day cycles (4 weeks) in a fasted condition. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
OG007
170 mg BID Intermittent Days 1 and 2 (Fed)
Participants took 170 mg of AZD2014 twice daily on Days 1 and 2 of each week in 28 day cycles (4 weeks) after eating. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
OG008
125 mg BID Intermittent Days 1 and 4 (Fasted)
Participants took 125 mg of AZD2014 twice daily on Days 1 and 4 of each week in 28 day cycles (4 weeks) in a fasted condition. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
Units
Counts
Participants
OG0006
OG00113
OG00214
OG003
Title
Denominators
Categories
Change in ALT ≥ 2 CTCAE Grades
Title
Measurements
OG0000
OG0011
OG0023
OG003
Primary
Left Ventricular Ejection Fraction
The analysis population consisted of all participants who received at least one dose of AZD2014.
Posted
Mean
Standard Deviation
% Left Ventricular Ejection Fraction
24 hours
ID
Title
Description
OG000
35 mg BID Continuous
Participants took 35 mg of AZD2014 twice daily continuously in 28 day cycles. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
OG001
50 mg BID Continuous
Participants took 50 mg of AZD2014 twice daily continuously in 28 day cycles. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
OG002
75 mg QD Continuous
Participants took 75 mg of AZD2014 one time per day continuously in 28 day cycles. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
OG003
100 mg QD Continuous
Participants took 100 mg of AZD2014 one time per day in 28 day cycles (4 weeks). Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
OG004
125 mg BID Intermittent Days 1 and 2 (Fasted)
Participants took 125 mg of AZD2014 twice daily on Days 1 and 2 of each week in 28 day cycles (4 weeks) in a fasted condition. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
OG005
125 mg BID Intermittent Days 1 and 2 (Fed)
Participants took 125 mg of AZD2014 twice daily on Days 1 and 2 of each week in 28 day cycles (4 weeks) after eating. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
OG006
170 mg BID Intermittent Days 1 and 2 (Fasted)
Participants took 170 mg of AZD2014 twice daily on Days 1 and 2 of each week in 28 day cycles (4 weeks) in a fasted condition. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
OG007
170 mg BID Intermittent Days 1 and 2 (Fed)
Participants took 170 mg of AZD2014 twice daily on Days 1 and 2 of each week in 28 day cycles (4 weeks) after eating. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
OG008
125 mg BID Intermittent Days 1 and 4 (Fasted)
Participants took 125 mg of AZD2014 twice daily on Days 1 and 4 of each week in 28 day cycles (4 weeks) in a fasted condition. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
Units
Counts
Participants
OG0006
OG00113
OG00214
OG003
Title
Denominators
Categories
Screening
Title
Measurements
OG00059.2± 4.5
OG00164.0± 5.4
OG00260.9± 6.2
OG003
Primary
QTcF Over 24 Hours
The analysis population consisted of all participants who received at least one dose of AZD2014.
Posted
Mean
Standard Deviation
msec
24 hours
ID
Title
Description
OG000
35 mg BID Continuous
Participants took 35 mg of AZD2014 twice daily continuously in 28 day cycles. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
OG001
50 mg BID Continuous
Participants took 50 mg of AZD2014 twice daily continuously in 28 day cycles. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
OG002
75 mg QD Continuous
Participants took 75 mg of AZD2014 one time per day continuously in 28 day cycles. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
OG003
100 mg QD Continuous
Participants took 100 mg of AZD2014 one time per day in 28 day cycles (4 weeks). Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
OG004
125 mg BID Intermittent Days 1 and 2 (Fasted)
Participants took 125 mg of AZD2014 twice daily on Days 1 and 2 of each week in 28 day cycles (4 weeks) in a fasted condition. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
OG005
125 mg BID Intermittent Days 1 and 2 (Fed)
Participants took 125 mg of AZD2014 twice daily on Days 1 and 2 of each week in 28 day cycles (4 weeks) after eating. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
OG006
170 mg BID Intermittent Days 1 and 2 (Fasted)
Participants took 170 mg of AZD2014 twice daily on Days 1 and 2 of each week in 28 day cycles (4 weeks) in a fasted condition. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
OG007
170 mg BID Intermittent Days 1 and 2 (Fed)
Participants took 170 mg of AZD2014 twice daily on Days 1 and 2 of each week in 28 day cycles (4 weeks) after eating. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
OG008
125 mg BID Intermittent Days 1 and 4 (Fasted)
Participants took 125 mg of AZD2014 twice daily on Days 1 and 4 of each week in 28 day cycles (4 weeks) in a fasted condition. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
Units
Counts
Participants
OG0006
OG00113
OG00214
OG003
Title
Denominators
Categories
Baseline
Title
Measurements
OG000423.12± 11.070
OG001421.92± 22.715
OG002412.78± 14.222
OG003
Primary
Post-Baseline Glucose Elevation
The analysis population consisted of all participants who received at least one dose of AZD2014.
Posted
Number
Participants
28 Days
ID
Title
Description
OG000
35 mg BID Continuous
Participants took 35 mg of AZD2014 twice daily continuously in 28 day cycles. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
OG001
50 mg BID Continuous
Participants took 50 mg of AZD2014 twice daily continuously in 28 day cycles. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
OG002
75 mg QD Continuous
Participants took 75 mg of AZD2014 one time per day continuously in 28 day cycles. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
OG003
100 mg QD Continuous
Participants took 100 mg of AZD2014 one time per day in 28 day cycles (4 weeks). Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
OG004
125 mg BID Intermittent Days 1 and 2 (Fasted)
Participants took 125 mg of AZD2014 twice daily on Days 1 and 2 of each week in 28 day cycles (4 weeks) in a fasted condition. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
OG005
125 mg BID Intermittent Days 1 and 2 (Fed)
Participants took 125 mg of AZD2014 twice daily on Days 1 and 2 of each week in 28 day cycles (4 weeks) after eating. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
OG006
170 mg BID Intermittent Days 1 and 2 (Fasted)
Participants took 170 mg of AZD2014 twice daily on Days 1 and 2 of each week in 28 day cycles (4 weeks) in a fasted condition. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
OG007
170 mg BID Intermittent Days 1 and 2 (Fed)
Participants took 170 mg of AZD2014 twice daily on Days 1 and 2 of each week in 28 day cycles (4 weeks) after eating. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
OG008
125 mg BID Intermittent Days 1 and 4 (Fasted)
Participants took 125 mg of AZD2014 twice daily on Days 1 and 4 of each week in 28 day cycles (4 weeks) in a fasted condition. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
Units
Counts
Participants
OG0006
OG00113
OG00214
OG003
Title
Denominators
Categories
Participants with ≥ 1 post-baseline elevation
Title
Measurements
OG0003
OG0016
OG0027
OG003
Primary
Sitting Diastolic Blood Pressure
The analysis population consisted of all participants who received at least one dose of AZD2014.
Posted
Mean
Standard Deviation
mmHg
28 Days
ID
Title
Description
OG000
35 mg BID Continuous
Participants took 35 mg of AZD2014 twice daily continuously in 28 day cycles. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
OG001
50 mg BID Continuous
Participants took 50 mg of AZD2014 twice daily continuously in 28 day cycles. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
OG002
75 mg QD Continuous
Participants took 75 mg of AZD2014 one time per day continuously in 28 day cycles. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
OG003
100 mg QD Continuous
Participants took 100 mg of AZD2014 one time per day in 28 day cycles (4 weeks). Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
OG004
125 mg BID Intermittent Days 1 and 2 (Fasted)
Participants took 125 mg of AZD2014 twice daily on Days 1 and 2 of each week in 28 day cycles (4 weeks) in a fasted condition. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
OG005
125 mg BID Intermittent Days 1 and 2 (Fed)
Participants took 125 mg of AZD2014 twice daily on Days 1 and 2 of each week in 28 day cycles (4 weeks) after eating. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
OG006
170 mg BID Intermittent Days 1 and 2 (Fasted)
Participants took 170 mg of AZD2014 twice daily on Days 1 and 2 of each week in 28 day cycles (4 weeks) in a fasted condition. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
OG007
170 mg BID Intermittent Days 1 and 2 (Fed)
Participants took 170 mg of AZD2014 twice daily on Days 1 and 2 of each week in 28 day cycles (4 weeks) after eating. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
OG008
125 mg BID Intermittent Days 1 and 4 (Fasted)
Participants took 125 mg of AZD2014 twice daily on Days 1 and 4 of each week in 28 day cycles (4 weeks) in a fasted condition. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
Units
Counts
Participants
OG0006
OG00113
OG00214
OG003
Title
Denominators
Categories
Baseline
Title
Measurements
OG00072.8± 7.31
OG00175.4± 10.43
OG00277.4± 7.71
OG003
Primary
Sitting Systolic Blood Pressure
The analysis population consisted of all participants who received at least one dose of AZD2014.
Posted
Mean
Standard Deviation
mmHg
28 Days
ID
Title
Description
OG000
35 mg BID Continuous
Participants took 35 mg of AZD2014 twice daily continuously in 28 day cycles. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
OG001
50 mg BID Continuous
Participants took 50 mg of AZD2014 twice daily continuously in 28 day cycles. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
OG002
75 mg QD Continuous
Participants took 75 mg of AZD2014 one time per day continuously in 28 day cycles. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
OG003
100 mg QD Continuous
Participants took 100 mg of AZD2014 one time per day in 28 day cycles (4 weeks). Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
OG004
125 mg BID Intermittent Days 1 and 2 (Fasted)
Participants took 125 mg of AZD2014 twice daily on Days 1 and 2 of each week in 28 day cycles (4 weeks) in a fasted condition. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
OG005
125 mg BID Intermittent Days 1 and 2 (Fed)
Participants took 125 mg of AZD2014 twice daily on Days 1 and 2 of each week in 28 day cycles (4 weeks) after eating. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
OG006
170 mg BID Intermittent Days 1 and 2 (Fasted)
Participants took 170 mg of AZD2014 twice daily on Days 1 and 2 of each week in 28 day cycles (4 weeks) in a fasted condition. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
OG007
170 mg BID Intermittent Days 1 and 2 (Fed)
Participants took 170 mg of AZD2014 twice daily on Days 1 and 2 of each week in 28 day cycles (4 weeks) after eating. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
OG008
125 mg BID Intermittent Days 1 and 4 (Fasted)
Participants took 125 mg of AZD2014 twice daily on Days 1 and 4 of each week in 28 day cycles (4 weeks) in a fasted condition. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
Units
Counts
Participants
OG0006
OG00113
OG00214
OG003
Title
Denominators
Categories
Baseline
Title
Measurements
OG000114.2± 9.13
OG001126.3± 14.65
OG002127.4± 14.09
OG003
Primary
Respiratory Rate
The analysis population consisted of all participants who received at least one dose of AZD2014.
Posted
Mean
Standard Deviation
breaths/min
28 Days
ID
Title
Description
OG000
35 mg BID Continuous
Participants took 35 mg of AZD2014 twice daily continuously in 28 day cycles. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
OG001
50 mg BID Continuous
Participants took 50 mg of AZD2014 twice daily continuously in 28 day cycles. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
OG002
75 mg QD Continuous
Participants took 75 mg of AZD2014 one time per day continuously in 28 day cycles. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
OG003
100 mg QD Continuous
Participants took 100 mg of AZD2014 one time per day in 28 day cycles (4 weeks). Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
OG004
125 mg BID Intermittent Days 1 and 2 (Fasted)
Participants took 125 mg of AZD2014 twice daily on Days 1 and 2 of each week in 28 day cycles (4 weeks) in a fasted condition. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
OG005
125 mg BID Intermittent Days 1 and 2 (Fed)
Participants took 125 mg of AZD2014 twice daily on Days 1 and 2 of each week in 28 day cycles (4 weeks) after eating. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
OG006
170 mg BID Intermittent Days 1 and 2 (Fasted)
Participants took 170 mg of AZD2014 twice daily on Days 1 and 2 of each week in 28 day cycles (4 weeks) in a fasted condition. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
OG007
170 mg BID Intermittent Days 1 and 2 (Fed)
Participants took 170 mg of AZD2014 twice daily on Days 1 and 2 of each week in 28 day cycles (4 weeks) after eating. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
OG008
125 mg BID Intermittent Days 1 and 4 (Fasted)
Participants took 125 mg of AZD2014 twice daily on Days 1 and 4 of each week in 28 day cycles (4 weeks) in a fasted condition. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
Units
Counts
Participants
OG0006
OG00113
OG00214
OG003
Title
Denominators
Categories
Baseline
Title
Measurements
OG00018.3± 2.66
OG00117.5± 1.85
OG00218.3± 1.33
OG003
Primary
Heart Rate
The analysis population consisted of all participants who received at least one dose of AZD2014.
Posted
Mean
Standard Deviation
beats/min
28 Days
ID
Title
Description
OG000
35 mg BID Continuous
Participants took 35 mg of AZD2014 twice daily continuously in 28 day cycles. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
OG001
50 mg BID Continuous
Participants took 50 mg of AZD2014 twice daily continuously in 28 day cycles. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
OG002
75 mg QD Continuous
Participants took 75 mg of AZD2014 one time per day continuously in 28 day cycles. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
OG003
100 mg QD Continuous
Participants took 100 mg of AZD2014 one time per day in 28 day cycles (4 weeks). Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
OG004
125 mg BID Intermittent Days 1 and 2 (Fasted)
Participants took 125 mg of AZD2014 twice daily on Days 1 and 2 of each week in 28 day cycles (4 weeks) in a fasted condition. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
OG005
125 mg BID Intermittent Days 1 and 2 (Fed)
Participants took 125 mg of AZD2014 twice daily on Days 1 and 2 of each week in 28 day cycles (4 weeks) after eating. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
OG006
170 mg BID Intermittent Days 1 and 2 (Fasted)
Participants took 170 mg of AZD2014 twice daily on Days 1 and 2 of each week in 28 day cycles (4 weeks) in a fasted condition. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
OG007
170 mg BID Intermittent Days 1 and 2 (Fed)
Participants took 170 mg of AZD2014 twice daily on Days 1 and 2 of each week in 28 day cycles (4 weeks) after eating. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
OG008
125 mg BID Intermittent Days 1 and 4 (Fasted)
Participants took 125 mg of AZD2014 twice daily on Days 1 and 4 of each week in 28 day cycles (4 weeks) in a fasted condition. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
Units
Counts
Participants
OG0006
OG00113
OG00214
OG003
Title
Denominators
Categories
Baseline
Title
Measurements
OG00087.5± 11.36
OG00184.5± 13.31
OG00282.7± 14.14
OG003
Primary
Body Temperature
The analysis population consisted of all participants who received at least one dose of AZD2014.
Posted
Mean
Standard Deviation
°C
28 Days
ID
Title
Description
OG000
35 mg BID Continuous
Participants took 35 mg of AZD2014 twice daily continuously in 28 day cycles. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
OG001
50 mg BID Continuous
Participants took 50 mg of AZD2014 twice daily continuously in 28 day cycles. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
OG002
75 mg QD Continuous
Participants took 75 mg of AZD2014 one time per day continuously in 28 day cycles. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
OG003
100 mg QD Continuous
Participants took 100 mg of AZD2014 one time per day in 28 day cycles (4 weeks). Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
OG004
125 mg BID Intermittent Days 1 and 2 (Fasted)
Participants took 125 mg of AZD2014 twice daily on Days 1 and 2 of each week in 28 day cycles (4 weeks) in a fasted condition. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
OG005
125 mg BID Intermittent Days 1 and 2 (Fed)
Participants took 125 mg of AZD2014 twice daily on Days 1 and 2 of each week in 28 day cycles (4 weeks) after eating. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
OG006
170 mg BID Intermittent Days 1 and 2 (Fasted)
Participants took 170 mg of AZD2014 twice daily on Days 1 and 2 of each week in 28 day cycles (4 weeks) in a fasted condition. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
OG007
170 mg BID Intermittent Days 1 and 2 (Fed)
Participants took 170 mg of AZD2014 twice daily on Days 1 and 2 of each week in 28 day cycles (4 weeks) after eating. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
OG008
125 mg BID Intermittent Days 1 and 4 (Fasted)
Participants took 125 mg of AZD2014 twice daily on Days 1 and 4 of each week in 28 day cycles (4 weeks) in a fasted condition. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
Units
Counts
Participants
OG0006
OG00113
OG00214
OG003
Title
Denominators
Categories
Baseline
Title
Measurements
OG00036.35± 0.327
OG00136.44± 0.399
OG00236.46± 0.303
OG003
Primary
Oxygen Saturation
The analysis population consisted of all participants who received at least one dose of AZD2014.
Posted
Mean
Standard Deviation
% Arterial Oxygen Saturation
28 Days
ID
Title
Description
OG000
35 mg BID Continuous
Participants took 35 mg of AZD2014 twice daily continuously in 28 day cycles. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
OG001
50 mg BID Continuous
Participants took 50 mg of AZD2014 twice daily continuously in 28 day cycles. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
OG002
75 mg QD Continuous
Participants took 75 mg of AZD2014 one time per day continuously in 28 day cycles. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
OG003
100 mg QD Continuous
Participants took 100 mg of AZD2014 one time per day in 28 day cycles (4 weeks). Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
OG004
125 mg BID Intermittent Days 1 and 2 (Fasted)
Participants took 125 mg of AZD2014 twice daily on Days 1 and 2 of each week in 28 day cycles (4 weeks) in a fasted condition. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
OG005
125 mg BID Intermittent Days 1 and 2 (Fed)
Participants took 125 mg of AZD2014 twice daily on Days 1 and 2 of each week in 28 day cycles (4 weeks) after eating. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
OG006
170 mg BID Intermittent Days 1 and 2 (Fasted)
Participants took 170 mg of AZD2014 twice daily on Days 1 and 2 of each week in 28 day cycles (4 weeks) in a fasted condition. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
OG007
170 mg BID Intermittent Days 1 and 2 (Fed)
Participants took 170 mg of AZD2014 twice daily on Days 1 and 2 of each week in 28 day cycles (4 weeks) after eating. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
OG008
125 mg BID Intermittent Days 1 and 4 (Fasted)
Participants took 125 mg of AZD2014 twice daily on Days 1 and 4 of each week in 28 day cycles (4 weeks) in a fasted condition. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
Units
Counts
Participants
OG0006
OG00113
OG00214
OG003
Title
Denominators
Categories
Baseline
Title
Measurements
OG00097.0± 0.89
OG00197.2± 1.59
OG00296.8± 1.85
OG003
Primary
AZD2014 Peak Plasma Concentration at Steady State (Cmax,ss) on Cycle 0 Days -5 to -1, Continuous Dosing, no Fulvestrant
Posted
Mean
Standard Deviation
ng/mL
5 Days
ID
Title
Description
OG000
35 mg BID Continuous
Participants took 35 mg of AZD2014 twice daily continuously in Cycle 0 on Days -5 to -1.
OG001
50 mg BID Continuous
Participants took 50 mg of AZD2014 twice daily continuously in Cycle 0 on Days -5 to -1.
OG002
75 mg QD Continuous
Participants took 75 mg of AZD2014 one time each day continuously in Cycle 0 on Days -5 to -1.
OG003
100 mg QD Continuous
Participants took 100 mg of AZD2014 one time each day continuously in Cycle 0 on Days -5 to -1.
Units
Counts
Participants
OG0005
OG00113
OG00214
OG00310
Title
Denominators
Categories
Title
Measurements
OG000971.2± 413.6
OG0011023± 339.4
OG0021895± 965.6
OG003
Primary
AZD2014 Area Under the Plasma Concentration Time Curve (AUC 0-12) Cycle 0 Days -5 to -1, Continuous Dosing, no Fulvestrant
Posted
Mean
Standard Deviation
h*ng/mL
5 Days
ID
Title
Description
OG000
35 mg BID Continuous
Participants took 35 mg of AZD2014 twice daily continuously in Cycle 0 on Days -5 to -1.
OG001
50 mg BID Continuous
Participants took 50 mg of AZD2014 twice daily continuously in Cycle 0 on Days -5 to -1.
OG002
75 mg QD Continuous
Participants took 75 mg of AZD2014 one time each day continuously in Cycle 0 on Days -5 to -1.
OG003
100 mg QD Continuous
Participants took 100 mg of AZD2014 one time each day continuously in Cycle 0 on Days -5 to -1.
Units
Counts
Participants
OG0005
OG00113
OG00214
OG00310
Title
Denominators
Categories
Title
Measurements
OG0003478± 1398
OG0015080± 1985
OG0029723± 6408
OG003
Primary
AZD2014 Area Under the Plasma Concentration Time Curve (AUC 0-24) Cycle 0 Days -5 to -1, Continuous Dosing, no Fulvestrant
Posted
Mean
Standard Deviation
h*ng/mL
5 Days
ID
Title
Description
OG000
35 mg BID Continuous
Participants took 35 mg of AZD2014 twice daily continuously in Cycle 0 on Days -5 to -1.
OG001
50 mg BID Continuous
Participants took 50 mg of AZD2014 twice daily continuously in Cycle 0 on Days -5 to -1.
OG002
75 mg QD Continuous
Participants took 75 mg of AZD2014 one time each day continuously in Cycle 0 on Days -5 to -1.
OG003
100 mg QD Continuous
Participants took 100 mg of AZD2014 one time each day continuously in Cycle 0 on Days -5 to -1.
Units
Counts
Participants
OG0005
OG00113
OG00214
OG00310
Title
Denominators
Categories
Title
Measurements
OG0003697± 1426
OG0016006± 2838
OG00211650± 8685
OG003
Primary
AZD2014 Area Under the Plasma Concentration Time Curve (AUC 0-t) Cycle 0 Days -5 to -1, Continuous Dosing, no Fulvestrant
Posted
Mean
Standard Deviation
h*ng/mL
5 Days
ID
Title
Description
OG000
35 mg BID Continuous
Participants took 35 mg of AZD2014 twice daily continuously in Cycle 0 on Days -5 to -1.
OG001
50 mg BID Continuous
Participants took 50 mg of AZD2014 twice daily continuously in Cycle 0 on Days -5 to -1.
OG002
75 mg QD Continuous
Participants took 75 mg of AZD2014 one time each day continuously in Cycle 0 on Days -5 to -1.
OG003
100 mg QD Continuous
Participants took 100 mg of AZD2014 one time each day continuously in Cycle 0 on Days -5 to -1.
Units
Counts
Participants
OG0005
OG00113
OG00214
OG00310
Title
Denominators
Categories
Title
Measurements
OG0003458± 1433
OG0015832± 2926
OG00211500± 8761
OG003
Primary
AZD2014 Area Under the Plasma Concentration Time Curve (AUC 0-∞) Cycle 0 Days -5 to -1, Continuous Dosing, no Fulvestrant
Posted
Mean
Standard Deviation
h*ng/mL
5 Days
ID
Title
Description
OG000
35 mg BID Continuous
Participants took 35 mg of AZD2014 twice daily continuously in Cycle 0 on Days -5 to -1.
OG001
50 mg BID Continuous
Participants took 50 mg of AZD2014 twice daily continuously in Cycle 0 on Days -5 to -1.
OG002
75 mg QD Continuous
Participants took 75 mg of AZD2014 one time each day continuously in Cycle 0 on Days -5 to -1.
OG003
100 mg QD Continuous
Participants took 100 mg of AZD2014 one time each day continuously in Cycle 0 on Days -5 to -1.
Units
Counts
Participants
OG0005
OG00113
OG00214
OG00310
Title
Denominators
Categories
Title
Measurements
OG0003731± 1412
OG0016392± 3350
OG00212360± 9950
OG003
Primary
AZD2014 Peak Plasma Concentration at Steady State (Cmax,ss) on Cycle 1 Day 15, BID Intermittent Dosing, With Fulvestrant
Posted
Mean
Standard Deviation
ng/mL
15 Days
ID
Title
Description
OG000
125 mg BID Intermittent Days 1 and 2 (Fasted)
Participants took 125 mg of AZD2014 twice daily on Days 1 and 2 of each week in 28 day cycles (4 weeks) in a fasted condition. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
OG001
125 mg BID Intermittent Days 1 and 2 (Fed)
Participants took 125 mg of AZD2014 twice daily on Days 1 and 2 of each week in 28 day cycles (4 weeks) after eating. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
OG002
170 mg BID Intermittent Days 1 and 2 (Fasted)
Participants took 170 mg of AZD2014 twice daily on Days 1 and 2 of each week in 28 day cycles (4 weeks) in a fasted condition. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
OG003
170 mg BID Intermittent Days 1 and 2 (Fed)
Participants took 170 mg of AZD2014 twice daily on Days 1 and 2 of each week in 28 day cycles (4 weeks) after eating. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
Units
Counts
Participants
OG00033
OG0013
OG0026
OG003
Title
Denominators
Categories
Title
Measurements
OG0003165± 1052
OG0011933± 793.9
OG0024238± 1440
OG003
Primary
Time to AZD2014 Peak Plasma Concentration at Steady State (Tmax,ss) on Cycle 1 Day 15, BID Intermittent Dosing, With Fulvestrant
Posted
Median
Full Range
hours
15 Days
ID
Title
Description
OG000
125 mg BID Intermittent Days 1 and 2 (Fasted)
Participants took 125 mg of AZD2014 twice daily on Days 1 and 2 of each week in 28 day cycles (4 weeks) in a fasted condition. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
OG001
125 mg BID Intermittent Days 1 and 2 (Fed)
Participants took 125 mg of AZD2014 twice daily on Days 1 and 2 of each week in 28 day cycles (4 weeks) after eating. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
OG002
170 mg BID Intermittent Days 1 and 2 (Fasted)
Participants took 170 mg of AZD2014 twice daily on Days 1 and 2 of each week in 28 day cycles (4 weeks) in a fasted condition. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
OG003
170 mg BID Intermittent Days 1 and 2 (Fed)
Participants took 170 mg of AZD2014 twice daily on Days 1 and 2 of each week in 28 day cycles (4 weeks) after eating. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
Units
Counts
Participants
OG00033
OG0013
OG0026
OG003
Title
Denominators
Categories
Title
Measurements
OG0001.1± 1052(0.5 to 4)
OG0012.0± 793.9(1.07 to 6.15)
OG0021.5± 1440(0.5 to 8)
Primary
AZD2014 Area Under the Plasma Concentration Time Curve (AUC 0-12) Cycle 1 Day 15 Intermittent Dosing, With Fulvestrant
Posted
Mean
Standard Deviation
h*ng/mL
15 Days
ID
Title
Description
OG000
125 mg BID Intermittent Days 1 and 2 (Fasted)
Participants took 125 mg of AZD2014 twice daily on Days 1 and 2 of each week in 28 day cycles (4 weeks) in a fasted condition. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
OG001
125 mg BID Intermittent Days 1 and 2 (Fed)
Participants took 125 mg of AZD2014 twice daily on Days 1 and 2 of each week in 28 day cycles (4 weeks) after eating. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
OG002
170 mg BID Intermittent Days 1 and 2 (Fasted)
Participants took 170 mg of AZD2014 twice daily on Days 1 and 2 of each week in 28 day cycles (4 weeks) in a fasted condition. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
OG003
170 mg BID Intermittent Days 1 and 2 (Fed)
Participants took 170 mg of AZD2014 twice daily on Days 1 and 2 of each week in 28 day cycles (4 weeks) after eating. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
Units
Counts
Participants
OG0005
OG00113
OG00214
OG003
Title
Denominators
Categories
Title
Measurements
OG00019810± 6562
OG00113760± 5737
OG00226570± 8600
OG003
Primary
AZD2014 Peak Plasma Concentration at Steady State (Cmax,ss) on Cycle 1 Day 22, Continuous Dosing, With Fulvestrant
Posted
Mean
Standard Deviation
ng/mL
22 Days
ID
Title
Description
OG000
35 mg BID Continuous
Participants took 35 mg of AZD2014 twice daily continuously in 28 day cycles. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
OG001
50 mg BID Continuous
Participants took 50 mg of AZD2014 twice daily continuously in 28 day cycles. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
OG002
75 mg QD Continuous
Participants took 100 mg of AZD2014 one time per day continuously in 28 day cycles (4 weeks). Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
OG003
100 mg QD Continuously
Participants took 100 mg of AZD2014 one time per day continuously in 28 day cycles (4 weeks). Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
Units
Counts
Participants
OG0006
OG00110
OG00211
OG003
Title
Denominators
Categories
Title
Measurements
OG0001374± 447.9
OG0011785± 866
OG0022409± 1305
OG003
Primary
Time to AZD2014 Peak Plasma Concentration at Steady State (Tmax,ss) on Cycle 1 Day 22, Continuous Dosing, With Fulvestrant
Posted
Median
Full Range
hours
22 Days
ID
Title
Description
OG000
35 mg BID Continuous
Participants took 35 mg of AZD2014 twice daily continuously in 28 day cycles. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
OG001
50 mg BID Continuous
Participants took 50 mg of AZD2014 twice daily continuously in 28 day cycles. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
OG002
75 mg QD Continuous
Participants took 100 mg of AZD2014 one time per day continuously in 28 day cycles (4 weeks). Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
OG003
100 mg QD Continuously
Participants took 100 mg of AZD2014 one time per day continuously in 28 day cycles (4 weeks). Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
Units
Counts
Participants
OG0006
OG00110
OG00211
OG003
Title
Denominators
Categories
Title
Measurements
OG0001.3± 447.9(0.5 to 4)
OG0011.0± 866(0.5 to 2)
OG0021.5± 1305(0.5 to 6.12)
Primary
AZD2014 Area Under the Plasma Concentration Time Curve (AUC 0-12) Cycle 1 Day 22 Continuous Dosing, With Fulvestrant
Posted
Mean
Standard Deviation
h*ng/mL
15 Days
ID
Title
Description
OG000
35 mg BID Continuous
Participants took 35 mg of AZD2014 twice daily continuously in 28 day cycles (4 weeks). Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
OG001
50 mg BID Continuous
Participants took 50 mg of AZD2014 twice daily continuously in 28 day cycles (4 weeks). Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
OG002
75 mg QD Continuous
Participants took 75 mg of AZD2014 one time per day continuously in 28 day cycles. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
OG003
100 mg QD Continuous
Participants took 100 mg of AZD2014 one time per day in 28 day cycles (4 weeks). Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
Units
Counts
Participants
OG0006
OG00110
OG00211
OG003
Title
Denominators
Categories
Title
Measurements
OG0008611± 3864
OG00111810± 7107
OG00213510± 8937
OG003
Secondary
AZD2014 Peak Plasma Concentration (Cmax) Following Single Dose, Fasted, no Fulvestrant.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng/mL
1 Day
ID
Title
Description
OG000
35 mg
Participants received a single dose of 35 mg of AZD2014 in fasted condition.
OG001
50 mg
Participants received a single dose of 50 mg of AZD2014 in fasted condition.
OG002
75 mg
Participants received a single dose of 75 mg of AZD2014 in fasted condition.
OG003
100 mg
Participants received a single dose of 100 mg of AZD2014 in fasted condition.
Units
Counts
Participants
OG0005
OG00113
OG00214
OG00310
Title
Denominators
Categories
Title
Measurements
OG000889.4± 52.72
OG001968.5± 36.45
OG0021678± 55.72
OG003
Secondary
Time to AZD2014 Peak Plasma Concentration (Tmax) Following Single Dose, Fasted, no Fulvestrant.
Posted
Median
Full Range
hour
1 Day
ID
Title
Description
OG000
35 mg
Participants received a single dose of 35 mg of AZD2014 in fasted condition.
OG001
50 mg
Participants received a single dose of 50 mg of AZD2014 in fasted condition.
OG002
75 mg
Participants received a single dose of 75 mg of AZD2014 in fasted condition.
OG003
100 mg
Participants received a single dose of 100 mg of AZD2014 in fasted condition.
Units
Counts
Participants
OG0005
OG00113
OG00214
OG00310
Title
Denominators
Categories
Title
Measurements
OG0001.00± 52.72(0.50 to 1.50)
OG0011.00± 36.45(0.45 to 4.00)
OG0021.10± 55.72(0.50 to 4.00)
Secondary
Area Under the Plasma Concentration-time Curve for AZD2014 From 0 to 12 Hours (AUC 0-12) Following Single Dose, Fasted, no Fulvestrant.
Posted
Geometric Mean
Geometric Coefficient of Variation
h*ng/mL
1 Day
ID
Title
Description
OG000
35 mg
Participants received a single dose of 35 mg of AZD2014 in fasted condition.
OG001
50 mg
Participants received a single dose of 50 mg of AZD2014 in fasted condition.
OG002
75 mg
Participants received a single dose of 75 mg of AZD2014 in fasted condition.
OG003
100 mg
Participants received a single dose of 100 mg of AZD2014 in fasted condition.
Units
Counts
Participants
OG0005
OG00113
OG00214
OG00310
Title
Denominators
Categories
Title
Measurements
OG0003233± 46.26(0.50 to 1.50)
OG0014666± 48.2(0.45 to 4.00)
OG0028185± 65.21(0.50 to 4.00)
Secondary
Area Under the Plasma Concentration-time Curve for AZD2014 From 0 to Infinity (AUC 0-∞) Following Single Dose, Fasted, no Fulvestrant.
Posted
Geometric Mean
Geometric Coefficient of Variation
h*ng/mL
1 Day
ID
Title
Description
OG000
35 mg
Participants received a single dose of 35 mg of AZD2014 in fasted condition.
OG001
50 mg
Participants received a single dose of 50 mg of AZD2014 in fasted condition.
OG002
75 mg
Participants received a single dose of 75 mg of AZD2014 in fasted condition.
OG003
100 mg
Participants received a single dose of 100 mg of AZD2014 in fasted condition.
Units
Counts
Participants
OG0005
OG00113
OG00214
OG00310
Title
Denominators
Categories
Title
Measurements
OG0003494± 43.96(0.50 to 1.50)
OG0015543± 63.41(0.45 to 4.00)
OG0029843± 75.43(0.50 to 4.00)
Secondary
Objective Response Rate
Objective Response Rate (ORR) is defined as the number (%) of patients with a confirmed overall response of either complete response (CR) or partial response (PR).
The population consisted of all patients receiving at least one dose of AZD 2014 and fulvestrant with measurable disease at baseline per RECIST v1.1.
Posted
Number
Participants
Up to 12 months
ID
Title
Description
OG000
35 mg BID Continuous
Participants took 35 mg of AZD2014 twice daily continuously in 28 day cycles. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
OG001
50 mg BID Continuous
Participants took 50 mg of AZD2014 twice daily continuously in 28 day cycles. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
OG002
75 mg QD Continuous
Participants took 75 mg of AZD2014 one time per day continuously in 28 day cycles. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
OG003
100 mg QD Continuous
Participants took 100 mg of AZD2014 one time per day continuously in 28 day cycles. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
OG004
125 mg BID Intermittent Days 1 and 2 (Fasted)
Participants took 125 mg of AZD2014 twice daily on Days 1 and 2 of each week in 28 day cycles (4 weeks) in a fasted condition. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
OG005
125 mg BID Intermittent Days 1 and 2 (Fed)
Participants took 125 mg of AZD2014 twice daily on Days 1 and 2 of each week in 28 day cycles (4 weeks) after eating. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
OG006
170 mg BID Intermittent Days 1 and 2 (Fasted)
Participants took 170 mg of AZD2014 twice daily on Days 1 and 2 of each week in 28 day cycles (4 weeks) in a fasted condition. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
OG007
170 mg BID Intermittent Days 1 and 2 (Fed)
Participants took 170 mg of AZD2014 twice daily on Days 1 and 2 of each week in 28 day cycles (4 weeks) after eating. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
OG008
125 mg BID Intermittent Days 1 and 4 (Fasted)
Participants took 125 mg of AZD2014 twice daily on Days 1 and 4 of each week in 28 day cycles (4 weeks) in a fasted condition. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
Units
Counts
Participants
OG0002
OG00111
OG00213
OG003
Title
Denominators
Categories
Title
Measurements
OG0000
OG0012
OG0022
OG003
Secondary
Best Objective Response (BOR)
Best objective response was the best response a patient had following start of treatment but prior to starting any subsequent cancer therapy and prior to RECIST v1.1 progression or the last evaluable assessment in the absence of RECIST v1.1 progression.
The population consisted of all patients receiving at least one dose of AZD 2014 and fulvestrant with measurable disease at baseline per RECIST v1.1.
Posted
Number
Participants
Up to 12 months
ID
Title
Description
OG000
35 mg BID Continuous
Participants took 35 mg of AZD2014 twice daily continuously in 28 day cycles. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
OG001
50 mg BID Continuous
Participants took 50 mg of AZD2014 twice daily continuously in 28 day cycles. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
OG002
75 mg QD Continuous
Participants took 75 mg of AZD2014 one time per day continuously in 28 day cycles. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
OG003
100 mg QD Continuous
Participants took 100 mg of AZD2014 one time per day continuously in 28 day cycles. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
OG004
125 mg BID Intermittent Days 1 and 2 (Fasted)
Participants took 125 mg of AZD2014 twice daily on Days 1 and 2 of each week in 28 day cycles (4 weeks) in a fasted condition. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
OG005
125 mg BID Intermittent Days 1 and 2 (Fed)
Participants took 125 mg of AZD2014 twice daily on Days 1 and 2 of each week in 28 day cycles (4 weeks) after eating. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
OG006
170 mg BID Intermittent Days 1 and 2 (Fasted)
Participants took 170 mg of AZD2014 twice daily on Days 1 and 2 of each week in 28 day cycles (4 weeks) in a fasted condition. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
OG007
170 mg BID Intermittent Days 1 and 2 (Fed)
Participants took 170 mg of AZD2014 twice daily on Days 1 and 2 of each week in 28 day cycles (4 weeks) after eating. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
OG008
125 mg BID Intermittent Days 1 and 4 (Fasted)
Participants took 125 mg of AZD2014 twice daily on Days 1 and 4 of each week in 28 day cycles (4 weeks) in a fasted condition. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
Units
Counts
Participants
OG0002
OG00111
OG00213
OG003
Title
Denominators
Categories
Complete Response
Title
Measurements
OG0000
OG0010
OG0020
OG003
Secondary
Duration of Response (DoR)
Duration of response is defined as the time from the date of first documented response until the date of documented progression or death in the absence of disease progression.
The number of participants analyzed for Duration of Response is zero in cohorts which had no responders [35 mg BID Continuous and 170 mg BID Intermittent Days 1 and 2 (fed)]
Posted
Median
Inter-Quartile Range
Months
Up to 12 months
ID
Title
Description
OG000
35 mg BID Continuous
Participants took 35 mg of AZD2014 twice daily continuously in 28 day cycles. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
OG001
50 mg BID Continuous
Participants took 50 mg of AZD2014 twice daily continuously in 28 day cycles. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
OG002
75 mg QD Continuous
Participants took 75 mg of AZD2014 one time per day continuously in 28 day cycles. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
OG003
100 mg QD Continuous
Participants took 100 mg of AZD2014 one time per day continuously in 28 day cycles. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
OG004
125 mg BID Intermittent Days 1 and 2 (Fasted)
Participants took 125 mg of AZD2014 twice daily on Days 1 and 2 of each week in 28 day cycles (4 weeks) in a fasted condition. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
OG005
125 mg BID Intermittent Days 1 and 2 (Fed)
Participants took 125 mg of AZD2014 twice daily on Days 1 and 2 of each week in 28 day cycles (4 weeks) after eating. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
OG006
170 mg BID Intermittent Days 1 and 2 (Fasted)
Participants took 170 mg of AZD2014 twice daily on Days 1 and 2 of each week in 28 day cycles (4 weeks) in a fasted condition. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
OG007
170 mg BID Intermittent Days 1 and 2 (Fed)
Participants took 170 mg of AZD2014 twice daily on Days 1 and 2 of each week in 28 day cycles (4 weeks) after eating. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
OG008
125 mg BID Intermittent Days 1 and 4 (Fasted)
Participants took 125 mg of AZD2014 twice daily on Days 1 and 4 of each week in 28 day cycles (4 weeks) in a fasted condition. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
Units
Counts
Participants
OG0000
OG0012
OG0022
OG003
Title
Denominators
Categories
Title
Measurements
OG0015.1(3.9 to 6.3)
OG0029.7(3.3 to 16.0)
OG003NA(NA to NA)Median and interquartile range can not be calculated because there was only one participant in the cohort.
Secondary
Clinical Benefit Rate (CBR) at 24 Weeks
The Clinical Benefit Rate (CBR) at 24 weeks is defined as the percentage of patients who had a confirmed BOR of CR or PR in the first 24 weeks or who demonstrated SD for a minimum interval of 24 weeks (minus 1 week to allow for an early assessment within the assessment window, i.e., 161 days) following the start of treatment.
The "tumour assessment" analysis set consisted of all participants who received at least one dose of AZD2014 and fulvestrant and had a baseline tumour assessment.
Posted
Number
Participants
Up to 12 months
ID
Title
Description
OG000
35 mg BID Continuous
Participants took 35 mg of AZD2014 twice daily continuously in 28 day cycles. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
OG001
50 mg BID Continuous
Participants took 50 mg of AZD2014 twice daily continuously in 28 day cycles. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
OG002
75 mg QD Continuous
Participants took 75 mg of AZD2014 one time per day continuously in 28 day cycles. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
OG003
100 mg QD Continuous
Participants took 100 mg of AZD2014 one time per day continuously in 28 day cycles. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
OG004
125 mg BID Intermittent Days 1 and 2 (Fasted)
Participants took 125 mg of AZD2014 twice daily on Days 1 and 2 of each week in 28 day cycles (4 weeks) in a fasted condition. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
OG005
125 mg BID Intermittent Days 1 and 2 (Fed)
Participants took 125 mg of AZD2014 twice daily on Days 1 and 2 of each week in 28 day cycles (4 weeks) after eating. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
OG006
170 mg BID Intermittent Days 1 and 2 (Fasted)
Participants took 170 mg of AZD2014 twice daily on Days 1 and 2 of each week in 28 day cycles (4 weeks) in a fasted condition. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
OG007
170 mg BID Intermittent Days 1 and 2 (Fed)
Participants took 170 mg of AZD2014 twice daily on Days 1 and 2 of each week in 28 day cycles (4 weeks) after eating. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
OG008
125 mg BID Intermittent Days 1 and 4 (Fasted)
Participants took 125 mg of AZD2014 twice daily on Days 1 and 4 of each week in 28 day cycles (4 weeks) in a fasted condition. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
Units
Counts
Participants
OG0006
OG00113
OG00214
OG003
Title
Denominators
Categories
Yes
Title
Measurements
OG0002
OG0016(3.6 to 6.3)
OG0024(3.3 to 16.0)
OG003
Secondary
Percentage Change From Baseline at 16 Weeks in Target Lesion (TL) Size.
Baseline was defined as last evaluable assessment prior to starting treatment. Tumour size was the sum of the longest diameters of the target lesions. TLs are measurable tumour lesions.
The "evaluable for response" analysis set consisted of all participants who received at least one dose of AZD2014 and fulvestrant and had measurable disease at baseline per RECIST v1.1.
Posted
Mean
Standard Deviation
Percentage Change
Up to 12 months
ID
Title
Description
OG000
35 mg BID Continuous
Participants took 35 mg of AZD2014 twice daily continuously in 28 day cycles. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
OG001
50 mg BID Continuous
Participants took 50 mg of AZD2014 twice daily continuously in 28 day cycles. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
OG002
75 mg QD Continuous
Participants took 75 mg of AZD2014 one time per day continuously in 28 day cycles. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
OG003
100 mg QD Continuous
Participants took 100 mg of AZD2014 one time per day continuously in 28 day cycles. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
OG004
125 mg BID Intermittent Days 1 and 2 (Fasted)
Participants took 125 mg of AZD2014 twice daily on Days 1 and 2 of each week in 28 day cycles (4 weeks) in a fasted condition. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
OG005
125 mg BID Intermittent Days 1 and 2 (Fed)
Participants took 125 mg of AZD2014 twice daily on Days 1 and 2 of each week in 28 day cycles (4 weeks) after eating. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
OG006
170 mg BID Intermittent Days 1 and 2 (Fasted)
Participants took 170 mg of AZD2014 twice daily on Days 1 and 2 of each week in 28 day cycles (4 weeks) in a fasted condition. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
OG007
170 mg BID Intermittent Days 1 and 2 (Fed)
Participants took 170 mg of AZD2014 twice daily on Days 1 and 2 of each week in 28 day cycles (4 weeks) after eating. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
OG008
125 mg BID Intermittent Days 1 and 4 (Fasted)
Participants took 125 mg of AZD2014 twice daily on Days 1 and 4 of each week in 28 day cycles (4 weeks) in a fasted condition. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
Units
Counts
Participants
OG0002
OG00110
OG00212
OG003
Title
Denominators
Categories
Title
Measurements
OG000NA± NAMean change in tumour size and standard deviation are not reported when data are available for less than 3 patients.
OG001-9.37± 39.544
OG002-5.83± 52.781
Secondary
Progression Free Survival
The "tumour assessment" analysis set consisted of all participants who received at least one dose of AZD2014 and fulvestrant and had a baseline tumour assessment.
Posted
Median
80% Confidence Interval
Weeks
Up to 12 months
ID
Title
Description
OG000
35 mg BID Continuous
Participants took 35 mg of AZD2014 twice daily continuously in 28 day cycles. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
OG001
50 mg BID Continuous
Participants took 50 mg of AZD2014 twice daily continuously in 28 day cycles. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
OG002
75 mg QD Continuous
Participants took 75 mg of AZD2014 one time per day continuously in 28 day cycles. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
OG003
100 mg QD Continuous
Participants took 100 mg of AZD2014 one time per day continuously in 28 day cycles. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
OG004
125 mg BID Intermittent Days 1 and 2 (Fasted)
Participants took 125 mg of AZD2014 twice daily on Days 1 and 2 of each week in 28 day cycles (4 weeks) in a fasted condition. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
OG005
125 mg BID Intermittent Days 1 and 2 (Fed)
Participants took 125 mg of AZD2014 twice daily on Days 1 and 2 of each week in 28 day cycles (4 weeks) after eating. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
OG006
170 mg BID Intermittent Days 1 and 2 (Fasted)
Participants took 170 mg of AZD2014 twice daily on Days 1 and 2 of each week in 28 day cycles (4 weeks) in a fasted condition. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
OG007
170 mg BID Intermittent Days 1 and 2 (Fed)
Participants took 170 mg of AZD2014 twice daily on Days 1 and 2 of each week in 28 day cycles (4 weeks) after eating. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
OG008
125 mg BID Intermittent Days 1 and 4 (Fasted)
Participants took 125 mg of AZD2014 twice daily on Days 1 and 4 of each week in 28 day cycles (4 weeks) in a fasted condition. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
Units
Counts
Participants
OG0006
OG00113
OG00214
OG003
Title
Denominators
Categories
Title
Measurements
OG00049.4± NA(8.14 to 82.86)
OG00135.6± 39.544(25.57 to 44.43)
OG00217.3± 52.781(16.00 to 21.00)
Secondary
Progression Free Survival at 26 Weeks
The "tumour assessment" analysis set consisted of all participants who received at least one dose of AZD2014 and fulvestrant and had a baseline tumour assessment.
Posted
Number
80% Confidence Interval
Percentage
Up to 12 months
ID
Title
Description
OG000
35 mg BID Continuous
Participants took 35 mg of AZD2014 twice daily continuously in 28 day cycles. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
OG001
50 mg BID Continuous
Participants took 50 mg of AZD2014 twice daily continuously in 28 day cycles. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
OG002
75 mg QD Continuous
Participants took 75 mg of AZD2014 one time per day continuously in 28 day cycles. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
OG003
100 mg QD Continuous
Participants took 100 mg of AZD2014 one time per day continuously in 28 day cycles. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
OG004
125 mg BID Intermittent Days 1 and 2 (Fasted)
Participants took 125 mg of AZD2014 twice daily on Days 1 and 2 of each week in 28 day cycles (4 weeks) in a fasted condition. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
OG005
125 mg BID Intermittent Days 1 and 2 (Fed)
Participants took 125 mg of AZD2014 twice daily on Days 1 and 2 of each week in 28 day cycles (4 weeks) after eating. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
OG006
170 mg BID Intermittent Days 1 and 2 (Fasted)
Participants took 170 mg of AZD2014 twice daily on Days 1 and 2 of each week in 28 day cycles (4 weeks) in a fasted condition. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
OG007
170 mg BID Intermittent Days 1 and 2 (Fed)
Participants took 170 mg of AZD2014 twice daily on Days 1 and 2 of each week in 28 day cycles (4 weeks) after eating. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
OG008
125 mg BID Intermittent Days 1 and 4 (Fasted)
Participants took 125 mg of AZD2014 twice daily on Days 1 and 4 of each week in 28 day cycles (4 weeks) in a fasted condition. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
Units
Counts
Participants
OG0006
OG00113
OG00214
OG003
Title
Denominators
Categories
Title
Measurements
OG00033± NA(9.3 to 66.7)
OG00138± 39.544(20.1 to 59.8)
OG00221± 52.781(8.1 to 41.7)
0
6
6
6
EG001
50 mg BID Continuous
Participants took 50 mg of AZD2014 twice daily continuously in 28 day cycles. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
1
13
13
13
EG002
75 mg QD Continuous
Participants took 75 mg of AZD2014 one time each day continuously in 28 day cycles. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycles.
3
14
14
14
EG003
100 mg QD Continuous
Participants took 100 mg of AZD2014 one time each day continuously in 28 day cycles. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycles.
1
10
10
10
EG004
125 mg BID Intermittent Days 1 and 2 (Fasted)
Participants took 125 mg of AZD2014 twice daily on Days 1 and 2 of each week in 28 day cycles (4 weeks) in a fasted condition. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
7
37
37
37
EG005
125 mg BID Intermittent Days 1 and 2 (Fed)
Participants took 125 mg of AZD2014 twice daily on Days 1 and 2 of each week in 28 day cycles (4 weeks) after eating. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
0
4
4
4
EG006
170 mg BID Intermittent Days 1 and 2 (Fasted)
Participants took 170 mg of AZD2014 twice daily on Days 1 and 2 of each week in 28 day cycles (4 weeks) in a fasted condition. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
3
8
8
8
EG007
170 mg BID Intermittent Days 1 and 2 (Fed)
Participants took 170 mg of AZD2014 twice daily on Days 1 and 2 of each week in 28 day cycles (4 weeks) after eating. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
1
5
5
5
EG008
125 mg BID Intermittent Days 1 and 4 (Fasted)
Participants took 125 mg of AZD2014 twice daily on Days 1 and 4 of each week in 28 day cycles (4 weeks) in a fasted condition. Participants also received intramuscular fulvestrant 500 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
0
2
2
2
EG0000 events0 affected6 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected14 at risk
EG0030 events0 affected10 at risk
EG0040 events0 affected37 at risk
EG0050 events0 affected4 at risk
EG0061 events1 affected8 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected2 at risk
Febrile Neutropenia
Blood and lymphatic system disorders
MedDRA v19.0
Non-systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected13 at risk
EG0021 events1 affected14 at risk
EG0030 events0 affected10 at risk
EG0040 events0 affected37 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected2 at risk
Ascities
Gastrointestinal disorders
MedDRA v19.0
Non-systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected14 at risk
EG0030 events0 affected10 at risk
EG0041 events1 affected37 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected2 at risk
Colitis
Gastrointestinal disorders
MedDRA v19.0
Non-systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected14 at risk
EG0030 events0 affected10 at risk
EG0041 events1 affected37 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected2 at risk
Diarrhoea
Gastrointestinal disorders
MedDRA v19.0
Non-systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected14 at risk
EG0030 events0 affected10 at risk
EG0041 events1 affected37 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected2 at risk
Dysphagia
Gastrointestinal disorders
MedDRA v19.0
Non-systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected14 at risk
EG0030 events0 affected10 at risk
EG0040 events0 affected37 at risk
EG0050 events0 affected4 at risk
EG0061 events1 affected8 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected2 at risk
Enteritis
Gastrointestinal disorders
MedDRA v19.0
Non-systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected14 at risk
EG0030 events0 affected10 at risk
EG0041 events1 affected37 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected2 at risk
Nausea
Gastrointestinal disorders
MedDRA v19.0
Non-systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected14 at risk
EG0030 events0 affected10 at risk
EG0042 events1 affected37 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected2 at risk
Vomiting
Gastrointestinal disorders
MedDRA v19.0
Non-systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected14 at risk
EG0030 events0 affected10 at risk
EG0042 events1 affected37 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected2 at risk
Fatigue
General disorders
MedDRA v19.0
Non-systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected14 at risk
EG0030 events0 affected10 at risk
EG0040 events0 affected37 at risk
EG0050 events0 affected4 at risk
EG0061 events1 affected8 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected2 at risk
Diverticulitis
Infections and infestations
MedDRA v19.0
Non-systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected14 at risk
EG0030 events0 affected10 at risk
EG0041 events1 affected37 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected2 at risk
Pneumonia
Infections and infestations
MedDRA v19.0
Non-systematic Assessment
EG0000 events0 affected6 at risk
EG0012 events1 affected13 at risk
EG0020 events0 affected14 at risk
EG0030 events0 affected10 at risk
EG0040 events0 affected37 at risk
EG0050 events0 affected4 at risk
EG0061 events1 affected8 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected2 at risk
Sepsis
Infections and infestations
MedDRA v19.0
Non-systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected13 at risk
EG0021 events1 affected14 at risk
EG0030 events0 affected10 at risk
EG0040 events0 affected37 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected2 at risk
Spinal Compression Fracture
Injury, poisoning and procedural complications
MedDRA v19.0
Non-systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected13 at risk
EG0021 events1 affected14 at risk
EG0030 events0 affected10 at risk
EG0040 events0 affected37 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected2 at risk
Subdural Haematoma
Injury, poisoning and procedural complications
MedDRA v19.0
Non-systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected14 at risk
EG0030 events0 affected10 at risk
EG0041 events1 affected37 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected2 at risk
Dehydration
Metabolism and nutrition disorders
MedDRA v19.0
Non-systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected14 at risk
EG0030 events0 affected10 at risk
EG0040 events0 affected37 at risk
EG0050 events0 affected4 at risk
EG0062 events1 affected8 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected2 at risk
Hypercalcaemia
Metabolism and nutrition disorders
MedDRA v19.0
Non-systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected14 at risk
EG0030 events0 affected10 at risk
EG0041 events1 affected37 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected2 at risk
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA v19.0
Non-systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected14 at risk
EG0030 events0 affected10 at risk
EG0040 events0 affected37 at risk
EG0050 events0 affected4 at risk
EG0061 events1 affected8 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected2 at risk
Musculoskeletal Chest Pain
Musculoskeletal and connective tissue disorders
MedDRA v19.0
Non-systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected14 at risk
EG0030 events0 affected10 at risk
EG0040 events0 affected37 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected8 at risk
EG0071 events1 affected5 at risk
EG0080 events0 affected2 at risk
Acute Kidney Injury
Renal and urinary disorders
MedDRA v19.0
Non-systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected13 at risk
EG0021 events1 affected14 at risk
EG0030 events0 affected10 at risk
EG0040 events0 affected37 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected2 at risk
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA v19.0
Non-systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected14 at risk
EG0031 events1 affected10 at risk
EG0040 events0 affected37 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected2 at risk
Pulmonary Embolism
Respiratory, thoracic and mediastinal disorders
MedDRA v19.0
Non-systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected13 at risk
EG0020 events0 affected14 at risk
EG0030 events0 affected10 at risk
EG0040 events0 affected37 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected2 at risk
EG0001 events1 affected6 at risk
EG0013 events3 affected13 at risk
EG0024 events3 affected14 at risk
EG0031 events1 affected10 at risk
EG0044 events3 affected37 at risk
EG0050 events0 affected4 at risk
EG0062 events2 affected8 at risk
EG0070 events0 affected5 at risk
EG0082 events1 affected2 at risk
Anaemia of Malignant Disease
Blood and lymphatic system disorders
MedDRA v19.0
Non-systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected14 at risk
EG0030 events0 affected10 at risk
EG0044 events4 affected37 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected8 at risk
EG0071 events1 affected5 at risk
EG0080 events0 affected2 at risk
Neutropenia
Blood and lymphatic system disorders
MedDRA v19.0
Non-systematic Assessment
EG0001 events1 affected6 at risk
EG0012 events1 affected13 at risk
EG0020 events0 affected14 at risk
EG0030 events0 affected10 at risk
EG0044 events4 affected37 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected8 at risk
EG0071 events1 affected5 at risk
EG0080 events0 affected2 at risk
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA v19.0
Non-systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected13 at risk
EG0020 events0 affected14 at risk
EG0030 events0 affected10 at risk
EG0043 events3 affected37 at risk
EG0051 events1 affected4 at risk
EG0061 events1 affected8 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected2 at risk
Vision Blurred
Eye disorders
MedDRA v19.0
Non-systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected13 at risk
EG0021 events1 affected14 at risk
EG0031 events1 affected10 at risk
EG0040 events0 affected37 at risk
EG0050 events0 affected4 at risk
EG0062 events2 affected8 at risk
EG0071 events1 affected5 at risk
EG0080 events0 affected2 at risk
Abdominal Distension
Gastrointestinal disorders
MedDRA v19.0
Non-systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected14 at risk
EG0030 events0 affected10 at risk
EG0045 events4 affected37 at risk
EG0050 events0 affected4 at risk
EG0061 events1 affected8 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected2 at risk
Abdominal Pain
Gastrointestinal disorders
MedDRA v19.0
Non-systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected14 at risk
EG0030 events0 affected10 at risk
EG0048 events7 affected37 at risk
EG0050 events0 affected4 at risk
EG0061 events1 affected8 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected2 at risk
Abdominal Pain, Upper
Gastrointestinal disorders
MedDRA v19.0
Non-systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected13 at risk
EG0023 events2 affected14 at risk
EG0030 events0 affected10 at risk
EG0045 events5 affected37 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected2 at risk
Constipation
Gastrointestinal disorders
MedDRA v19.0
Non-systematic Assessment
EG0001 events1 affected6 at risk
EG0012 events2 affected13 at risk
EG0023 events2 affected14 at risk
EG0031 events1 affected10 at risk
EG00411 events11 affected37 at risk
EG0050 events0 affected4 at risk
EG0061 events1 affected8 at risk
EG0070 events0 affected5 at risk
EG0081 events1 affected2 at risk
Diarrhoea
Gastrointestinal disorders
MedDRA v19.0
Non-systematic Assessment
EG0002 events2 affected6 at risk
EG0018 events8 affected13 at risk
EG00210 events7 affected14 at risk
EG0038 events5 affected10 at risk
EG00426 events19 affected37 at risk
EG0050 events0 affected4 at risk
EG00612 events7 affected8 at risk
EG0071 events1 affected5 at risk
EG0082 events2 affected2 at risk
Dry Mouth
Gastrointestinal disorders
MedDRA v19.0
Non-systematic Assessment
EG0001 events1 affected6 at risk
EG0012 events2 affected13 at risk
EG0021 events1 affected14 at risk
EG0033 events2 affected10 at risk
EG0045 events5 affected37 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected8 at risk
EG0073 events2 affected5 at risk
EG0080 events0 affected2 at risk
Dyspepsia
Gastrointestinal disorders
MedDRA v19.0
Non-systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected13 at risk
EG0021 events1 affected14 at risk
EG0031 events1 affected10 at risk
EG0044 events3 affected37 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected8 at risk
EG0071 events1 affected5 at risk
EG0081 events1 affected2 at risk
Gastrooesophageal Reflux Disease
Gastrointestinal disorders
MedDRA v19.0
Non-systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected13 at risk
EG0021 events1 affected14 at risk
EG0032 events2 affected10 at risk
EG0047 events6 affected37 at risk
EG0051 events1 affected4 at risk
EG0061 events1 affected8 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected2 at risk
Nausea
Gastrointestinal disorders
MedDRA v19.0
Non-systematic Assessment
EG0000 events0 affected6 at risk
EG0019 events7 affected13 at risk
EG0028 events7 affected14 at risk
EG00315 events9 affected10 at risk
EG00439 events28 affected37 at risk
EG0053 events3 affected4 at risk
EG00615 events8 affected8 at risk
EG0074 events3 affected5 at risk
EG0082 events2 affected2 at risk
Oral Pain
Gastrointestinal disorders
MedDRA v19.0
Non-systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected13 at risk
EG0022 events2 affected14 at risk
EG0032 events1 affected10 at risk
EG00411 events8 affected37 at risk
EG0050 events0 affected4 at risk
EG0061 events1 affected8 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected2 at risk
Stomatitis
Gastrointestinal disorders
MedDRA v19.0
Non-systematic Assessment
EG0004 events3 affected6 at risk
EG00112 events9 affected13 at risk
EG0026 events6 affected14 at risk
EG00310 events7 affected10 at risk
EG00416 events13 affected37 at risk
EG0051 events1 affected4 at risk
EG0066 events4 affected8 at risk
EG0076 events2 affected5 at risk
EG0082 events2 affected2 at risk
Vomiting
Gastrointestinal disorders
MedDRA v19.0
Non-systematic Assessment
EG0000 events0 affected6 at risk
EG0015 events4 affected13 at risk
EG0025 events4 affected14 at risk
EG0034 events3 affected10 at risk
EG00429 events19 affected37 at risk
EG0055 events3 affected4 at risk
EG00618 events8 affected8 at risk
EG0074 events3 affected5 at risk
EG0081 events1 affected2 at risk
Asthenia
General disorders
MedDRA v19.0
Non-systematic Assessment
EG0000 events0 affected6 at risk
EG0012 events2 affected13 at risk
EG0023 events3 affected14 at risk
EG0033 events2 affected10 at risk
EG00410 events10 affected37 at risk
EG0051 events1 affected4 at risk
EG0064 events4 affected8 at risk
EG0071 events1 affected5 at risk
EG0080 events0 affected2 at risk
Fatigue
General disorders
MedDRA v19.0
Non-systematic Assessment
EG0003 events3 affected3 at risk
EG00113 events7 affected13 at risk
EG00210 events9 affected14 at risk
EG00310 events7 affected10 at risk
EG00424 events23 affected37 at risk
EG0054 events3 affected4 at risk
EG0066 events5 affected8 at risk
EG0075 events4 affected5 at risk
EG0082 events2 affected2 at risk
Oedema Peripheral
General disorders
MedDRA v19.0
Non-systematic Assessment
EG0001 events1 affected6 at risk
EG0015 events3 affected13 at risk
EG0028 events6 affected14 at risk
EG0030 events0 affected10 at risk
EG0047 events7 affected37 at risk
EG0050 events0 affected4 at risk
EG0063 events3 affected8 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected2 at risk
Pain
General disorders
MedDRA v19.0
Non-systematic Assessment
EG0001 events1 affected6 at risk
EG0013 events3 affected13 at risk
EG0020 events0 affected14 at risk
EG0030 events0 affected10 at risk
EG0043 events3 affected37 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected2 at risk
Pyrexia
General disorders
MedDRA v19.0
Non-systematic Assessment
EG0000 events0 affected6 at risk
EG0014 events1 affected13 at risk
EG0023 events3 affected14 at risk
EG0034 events4 affected10 at risk
EG0048 events6 affected37 at risk
EG0050 events0 affected4 at risk
EG0062 events2 affected8 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected2 at risk
Sinusitis
Infections and infestations
MedDRA v19.0
Non-systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected13 at risk
EG0020 events0 affected14 at risk
EG0031 events1 affected10 at risk
EG0041 events1 affected37 at risk
EG0050 events0 affected4 at risk
EG0064 events3 affected8 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected2 at risk
Urinary Tract Infection
Infections and infestations
MedDRA v19.0
Non-systematic Assessment
EG0002 events2 affected6 at risk
EG0010 events0 affected13 at risk
EG0022 events2 affected14 at risk
EG0033 events2 affected10 at risk
EG00410 events8 affected37 at risk
EG0050 events0 affected4 at risk
EG0062 events2 affected8 at risk
EG0072 events2 affected5 at risk
EG0080 events0 affected2 at risk
Fall
Injury, poisoning and procedural complications
MedDRA v19.0
Non-systematic Assessment
EG0000 events0 affected6 at risk
EG0012 events1 affected13 at risk
EG0021 events1 affected14 at risk
EG0030 events0 affected10 at risk
EG0042 events2 affected37 at risk
EG0050 events0 affected4 at risk
EG0064 events2 affected8 at risk
EG0070 events0 affected5 at risk
EG0081 events1 affected2 at risk
Alanine Aminotransferase Increased
Investigations
MedDRA v19.0
Non-systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected13 at risk
EG0021 events1 affected14 at risk
EG0033 events2 affected10 at risk
EG0045 events5 affected37 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected8 at risk
EG0071 events1 affected5 at risk
EG0081 events1 affected2 at risk
Aspartate Aminotransferase Increased
Investigations
MedDRA v19.0
Non-systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected13 at risk
EG0022 events2 affected14 at risk
EG0032 events2 affected10 at risk
EG0049 events8 affected37 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected8 at risk
EG0071 events1 affected5 at risk
EG0081 events1 affected2 at risk
Blood Creatinine Increased
Investigations
MedDRA v19.0
Non-systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected13 at risk
EG0022 events2 affected14 at risk
EG0031 events1 affected10 at risk
EG0046 events6 affected37 at risk
EG0051 events1 affected4 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected2 at risk
Breath Sounds Abnormal
Investigations
MedDRA v19.0
Non-systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected13 at risk
EG0020 events0 affected14 at risk
EG0031 events1 affected10 at risk
EG0041 events1 affected37 at risk
EG0050 events0 affected4 at risk
EG0065 events4 affected8 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected2 at risk
Transaminases Increased
Investigations
MedDRA v19.0
Non-systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected13 at risk
EG0021 events1 affected14 at risk
EG0031 events1 affected10 at risk
EG0042 events1 affected37 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected8 at risk
EG0072 events2 affected5 at risk
EG0080 events0 affected2 at risk
Weight Decreased
Investigations
MedDRA v19.0
Non-systematic Assessment
EG0002 events2 affected6 at risk
EG0012 events2 affected13 at risk
EG0021 events1 affected14 at risk
EG0031 events1 affected10 at risk
EG00410 events10 affected37 at risk
EG0052 events2 affected4 at risk
EG0062 events2 affected8 at risk
EG0073 events3 affected5 at risk
EG0080 events0 affected2 at risk
Decreased Appetite
Metabolism and nutrition disorders
MedDRA v19.0
Non-systematic Assessment
EG0001 events1 affected6 at risk
EG0015 events5 affected13 at risk
EG0023 events3 affected14 at risk
EG0034 events4 affected10 at risk
EG00416 events15 affected37 at risk
EG0051 events1 affected4 at risk
EG0064 events3 affected8 at risk
EG0073 events3 affected5 at risk
EG0080 events0 affected2 at risk
Dehydration
Metabolism and nutrition disorders
MedDRA v19.0
Non-systematic Assessment
EG0000 events0 affected6 at risk
EG0015 events4 affected13 at risk
EG0022 events2 affected14 at risk
EG0031 events1 affected10 at risk
EG0046 events6 affected37 at risk
EG0050 events0 affected4 at risk
EG0061 events1 affected8 at risk
EG0071 events1 affected5 at risk
EG0080 events0 affected2 at risk
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA v19.0
Non-systematic Assessment
EG0000 events0 affected6 at risk
EG0015 events3 affected13 at risk
EG0024 events2 affected14 at risk
EG0034 events2 affected10 at risk
EG0049 events5 affected37 at risk
EG0050 events0 affected4 at risk
EG0068 events4 affected8 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected2 at risk
Hypoalbuminaemia
Metabolism and nutrition disorders
MedDRA v19.0
Non-systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected14 at risk
EG0034 events2 affected10 at risk
EG0045 events5 affected37 at risk
EG0051 events1 affected4 at risk
EG0061 events1 affected8 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected2 at risk
Hypokalaemia
Metabolism and nutrition disorders
MedDRA v19.0
Non-systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected13 at risk
EG0022 events2 affected14 at risk
EG0033 events1 affected10 at risk
EG00411 events7 affected37 at risk
EG0051 events1 affected4 at risk
EG0061 events1 affected8 at risk
EG0073 events2 affected5 at risk
EG0080 events0 affected2 at risk
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA v19.0
Non-systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected13 at risk
EG0021 events1 affected14 at risk
EG0030 events0 affected10 at risk
EG0042 events2 affected37 at risk
EG0050 events0 affected4 at risk
EG0064 events3 affected8 at risk
EG0072 events1 affected5 at risk
EG0080 events0 affected2 at risk
Hypophosphataemia
Metabolism and nutrition disorders
MedDRA v19.0
Non-systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected14 at risk
EG0031 events1 affected10 at risk
EG0047 events5 affected37 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected2 at risk
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA v19.0
Non-systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected13 at risk
EG0025 events3 affected14 at risk
EG0039 events4 affected10 at risk
EG0046 events6 affected37 at risk
EG0050 events0 affected4 at risk
EG0062 events2 affected8 at risk
EG0072 events2 affected5 at risk
EG0081 events1 affected2 at risk
Back Pain
Musculoskeletal and connective tissue disorders
MedDRA v19.0
Non-systematic Assessment
EG0002 events2 affected6 at risk
EG0012 events2 affected13 at risk
EG0022 events2 affected14 at risk
EG0032 events2 affected10 at risk
EG0048 events7 affected37 at risk
EG0050 events0 affected4 at risk
EG0061 events1 affected8 at risk
EG0071 events1 affected5 at risk
EG0080 events0 affected2 at risk
Bone Pain
Musculoskeletal and connective tissue disorders
MedDRA v19.0
Non-systematic Assessment
EG0002 events1 affected6 at risk
EG0010 events0 affected13 at risk
EG0021 events1 affected14 at risk
EG0031 events1 affected10 at risk
EG0041 events1 affected37 at risk
EG0050 events0 affected4 at risk
EG0061 events1 affected8 at risk
EG0070 events0 affected5 at risk
EG0081 events1 affected2 at risk
Muscle Spasms
Musculoskeletal and connective tissue disorders
MedDRA v19.0
Non-systematic Assessment
EG0001 events1 affected6 at risk
EG0011 events1 affected13 at risk
EG0023 events2 affected14 at risk
EG0031 events1 affected10 at risk
EG0043 events3 affected37 at risk
EG0050 events0 affected4 at risk
EG0063 events3 affected8 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected2 at risk
Muscular Weakness
Musculoskeletal and connective tissue disorders
MedDRA v19.0
Non-systematic Assessment
EG0000 events0 affected6 at risk
EG0012 events1 affected13 at risk
EG0020 events0 affected14 at risk
EG0032 events1 affected10 at risk
EG0043 events2 affected37 at risk
EG0051 events1 affected4 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected2 at risk
Musculoskeletal Pain
Musculoskeletal and connective tissue disorders
MedDRA v19.0
Non-systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected13 at risk
EG0020 events0 affected14 at risk
EG0031 events1 affected10 at risk
EG0043 events3 affected37 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected2 at risk
Pain in Extremity
Musculoskeletal and connective tissue disorders
MedDRA v19.0
Non-systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected13 at risk
EG0024 events3 affected14 at risk
EG0033 events2 affected10 at risk
EG0047 events6 affected37 at risk
EG0050 events0 affected4 at risk
EG0063 events2 affected8 at risk
EG0071 events1 affected5 at risk
EG0082 events1 affected2 at risk
Dizziness
Nervous system disorders
MedDRA v19.0
Non-systematic Assessment
EG0000 events0 affected6 at risk
EG0012 events2 affected13 at risk
EG0021 events1 affected14 at risk
EG0034 events3 affected10 at risk
EG00410 events8 affected37 at risk
EG0051 events1 affected4 at risk
EG0064 events3 affected8 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected2 at risk
Dysgeusia
Nervous system disorders
MedDRA v19.0
Non-systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected13 at risk
EG0020 events0 affected14 at risk
EG0031 events1 affected10 at risk
EG0047 events7 affected37 at risk
EG0052 events2 affected4 at risk
EG0060 events0 affected8 at risk
EG0072 events1 affected5 at risk
EG0080 events0 affected2 at risk
Headache
Nervous system disorders
MedDRA v19.0
Non-systematic Assessment
EG0000 events0 affected6 at risk
EG0013 events3 affected13 at risk
EG0022 events2 affected14 at risk
EG0033 events3 affected10 at risk
EG00413 events12 affected37 at risk
EG0050 events0 affected4 at risk
EG0069 events4 affected8 at risk
EG0070 events0 affected5 at risk
EG0081 events1 affected2 at risk
Peripheral Neuropathy
Nervous system disorders
MedDRA v19.0
Non-systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected13 at risk
EG0022 events2 affected14 at risk
EG0031 events1 affected10 at risk
EG0042 events2 affected37 at risk
EG0050 events0 affected4 at risk
EG0061 events1 affected8 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected2 at risk
Anxiety
Psychiatric disorders
MedDRA v19.0
Non-systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected13 at risk
EG0022 events2 affected14 at risk
EG0031 events1 affected10 at risk
EG0043 events3 affected37 at risk
EG0050 events0 affected4 at risk
EG0061 events1 affected8 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected2 at risk
Confusional State
Psychiatric disorders
MedDRA v19.0
Non-systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected13 at risk
EG0020 events0 affected14 at risk
EG0030 events0 affected10 at risk
EG0044 events4 affected37 at risk
EG0051 events1 affected4 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected2 at risk
Depression
Psychiatric disorders
MedDRA v19.0
Non-systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected14 at risk
EG0030 events0 affected10 at risk
EG0043 events3 affected37 at risk
EG0050 events0 affected4 at risk
EG0062 events2 affected8 at risk
EG0071 events1 affected5 at risk
EG0080 events0 affected2 at risk
Insomnia
Psychiatric disorders
MedDRA v19.0
Non-systematic Assessment
EG0000 events0 affected6 at risk
EG0012 events2 affected13 at risk
EG0020 events0 affected14 at risk
EG0030 events0 affected10 at risk
EG0044 events4 affected37 at risk
EG0051 events1 affected4 at risk
EG0061 events1 affected8 at risk
EG0070 events0 affected5 at risk
EG0081 events1 affected2 at risk
Dysuria
Renal and urinary disorders
MedDRA v19.0
Non-systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected13 at risk
EG0021 events1 affected14 at risk
EG0030 events0 affected10 at risk
EG0044 events3 affected37 at risk
EG0050 events0 affected4 at risk
EG0061 events1 affected8 at risk
EG0071 events1 affected5 at risk
EG0080 events0 affected2 at risk
Pelvic Pain
Reproductive system and breast disorders
MedDRA v19.0
Non-systematic Assessment
EG0002 events2 affected6 at risk
EG0010 events0 affected13 at risk
EG0021 events1 affected14 at risk
EG0030 events0 affected10 at risk
EG0042 events2 affected37 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected5 at risk
EG0081 events1 affected2 at risk
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA v19.0
Non-systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected13 at risk
EG0023 events2 affected14 at risk
EG0038 events4 affected10 at risk
EG0044 events4 affected37 at risk
EG0050 events0 affected4 at risk
EG0064 events4 affected8 at risk
EG0071 events1 affected5 at risk
EG0081 events1 affected2 at risk
Dysphonia
Respiratory, thoracic and mediastinal disorders
MedDRA v19.0
Non-systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected14 at risk
EG0030 events0 affected10 at risk
EG0042 events2 affected37 at risk
EG0050 events0 affected4 at risk
EG0061 events1 affected8 at risk
EG0071 events1 affected5 at risk
EG0080 events0 affected2 at risk
Dyspnoea, Exertional
Respiratory, thoracic and mediastinal disorders
MedDRA v19.0
Non-systematic Assessment
EG0001 events1 affected6 at risk
EG0012 events2 affected13 at risk
EG0023 events3 affected14 at risk
EG0032 events2 affected10 at risk
EG0047 events7 affected37 at risk
EG0051 events1 affected4 at risk
EG0061 events1 affected8 at risk
EG0070 events0 affected5 at risk
EG0081 events1 affected2 at risk
Oropharyngeal Pain
Respiratory, thoracic and mediastinal disorders
MedDRA v19.0
Non-systematic Assessment
EG0000 events0 affected6 at risk
EG0012 events2 affected13 at risk
EG0020 events0 affected14 at risk
EG0031 events1 affected10 at risk
EG0045 events5 affected37 at risk
EG0050 events0 affected4 at risk
EG0061 events1 affected8 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected2 at risk
Productive Cough
Respiratory, thoracic and mediastinal disorders
MedDRA v19.0
Non-systematic Assessment
EG0001 events1 affected6 at risk
EG0011 events1 affected13 at risk
EG0020 events0 affected14 at risk
EG0031 events1 affected10 at risk
EG0041 events1 affected37 at risk
EG0051 events1 affected4 at risk
EG0061 events1 affected8 at risk
EG0071 events1 affected5 at risk
EG0080 events0 affected2 at risk
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA v19.0
Non-systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected14 at risk
EG0030 events0 affected10 at risk
EG0043 events3 affected37 at risk
EG0051 events1 affected4 at risk
EG0063 events3 affected8 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected2 at risk
Sinus Congestion
Respiratory, thoracic and mediastinal disorders
MedDRA v19.0
Non-systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected13 at risk
EG0021 events1 affected14 at risk
EG0031 events1 affected10 at risk
EG0042 events2 affected37 at risk
EG0051 events1 affected4 at risk
EG0061 events1 affected8 at risk
EG0071 events1 affected5 at risk
EG0080 events0 affected2 at risk
Wheezing
Respiratory, thoracic and mediastinal disorders
MedDRA v19.0
Non-systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected13 at risk
EG0021 events1 affected14 at risk
EG0030 events0 affected10 at risk
EG0042 events2 affected37 at risk
EG0050 events0 affected4 at risk
EG0061 events1 affected8 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected2 at risk
Alopecia
Skin and subcutaneous tissue disorders
MedDRA v19.0
Non-systematic Assessment
EG0001 events1 affected6 at risk
EG0011 events1 affected13 at risk
EG0023 events2 affected14 at risk
EG0030 events0 affected10 at risk
EG0044 events4 affected37 at risk
EG0050 events0 affected4 at risk
EG0062 events2 affected8 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected2 at risk
Dermatitis Acneiform
Skin and subcutaneous tissue disorders
MedDRA v19.0
Non-systematic Assessment
EG0000 events0 affected6 at risk
EG0013 events3 affected13 at risk
EG0022 events1 affected14 at risk
EG0030 events0 affected10 at risk
EG0042 events2 affected37 at risk
EG0050 events0 affected4 at risk
EG0062 events1 affected8 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected2 at risk
Dry Skin
Skin and subcutaneous tissue disorders
MedDRA v19.0
Non-systematic Assessment
EG0003 events3 affected6 at risk
EG0015 events5 affected13 at risk
EG0026 events4 affected14 at risk
EG0031 events1 affected10 at risk
EG0042 events2 affected37 at risk
EG0051 events1 affected4 at risk
EG0062 events2 affected8 at risk
EG0071 events1 affected5 at risk
EG0083 events2 affected2 at risk
Pruritus
Skin and subcutaneous tissue disorders
MedDRA v19.0
Non-systematic Assessment
EG0006 events4 affected6 at risk
EG0019 events6 affected13 at risk
EG0022 events2 affected14 at risk
EG0032 events2 affected10 at risk
EG0046 events6 affected37 at risk
EG0050 events0 affected4 at risk
EG0063 events2 affected8 at risk
EG0071 events1 affected5 at risk
EG0082 events2 affected2 at risk
Pruritus Generalised
Skin and subcutaneous tissue disorders
MedDRA v19.0
Non-systematic Assessment
EG0000 events0 affected6 at risk
EG0013 events3 affected13 at risk
EG0020 events0 affected14 at risk
EG0032 events2 affected10 at risk
EG0041 events1 affected37 at risk
EG0051 events1 affected4 at risk
EG0061 events1 affected8 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected2 at risk
Rash
Skin and subcutaneous tissue disorders
MedDRA v19.0
Non-systematic Assessment
EG0000 events0 affected6 at risk
EG0015 events3 affected13 at risk
EG0021 events1 affected14 at risk
EG0030 events0 affected10 at risk
EG0042 events2 affected37 at risk
EG0051 events1 affected4 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected5 at risk
EG0081 events1 affected2 at risk
Rash Erythematous
Skin and subcutaneous tissue disorders
MedDRA v19.0
Non-systematic Assessment
EG0000 events0 affected6 at risk
EG0014 events3 affected13 at risk
EG0021 events1 affected14 at risk
EG0033 events2 affected10 at risk
EG0041 events1 affected37 at risk
EG0050 events0 affected4 at risk
EG0061 events1 affected8 at risk
EG0070 events0 affected5 at risk
EG0081 events1 affected2 at risk
Rash, Maculo-Papular
Skin and subcutaneous tissue disorders
MedDRA v19.0
Non-systematic Assessment
EG0002 events2 affected6 at risk
EG0018 events6 affected13 at risk
EG0025 events4 affected14 at risk
EG0032 events2 affected10 at risk
EG0044 events4 affected37 at risk
EG0050 events0 affected4 at risk
EG0063 events2 affected8 at risk
EG0070 events0 affected5 at risk
EG0082 events2 affected2 at risk
Deep Vein Thrombosis
Vascular disorders
MedDRA v19.0
Non-systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected13 at risk
EG0021 events1 affected14 at risk
EG0030 events0 affected10 at risk
EG0042 events2 affected37 at risk
EG0050 events0 affected4 at risk
EG0061 events1 affected8 at risk
EG0071 events1 affected5 at risk
EG0080 events0 affected2 at risk
Hypotension
Vascular disorders
MedDRA v19.0
Non-systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected13 at risk
EG0021 events1 affected14 at risk
EG0030 events0 affected10 at risk
EG0047 events6 affected37 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected2 at risk
Not provided
Results Disclosure Restriction on PI(s)?
No
Other Details
Not provided
Fused-Ring Compounds
D011083
Polycyclic Compounds
D045166
Estradiol Congeners
D012739
Gonadal Steroid Hormones
D042341
Gonadal Hormones
D006728
Hormones
D006730
Hormones, Hormone Substitutes, and Hormone Antagonists
5
BG00418
BG0054
BG0067
BG0073
BG0080
BG00954
4
BG00412
BG0050
BG0060
BG0071
BG0081
BG00932
0
BG0050
BG0060
BG0070
BG0080
BG0090
24
BG0054
BG0065
BG0074
BG0082
BG00942
13
BG0050
BG0063
BG0071
BG0080
BG00956
0
BG0042
BG0051
BG0061
BG0070
BG0080
BG0098
0
BG0040
BG0051
BG0060
BG0070
BG0080
BG0091
21
BG0052
BG0063
BG0074
BG0081
BG00947
0
BG0050
BG0060
BG0070
BG0080
BG0090
0
BG0050
BG0060
BG0070
BG0080
BG0090
0
BG0050
BG0060
BG0070
BG0080
BG0090
14
BG0051
BG0062
BG0071
BG0081
BG00939
8
BG0051
BG0061
BG0072
BG0081
BG00923
0
BG0050
BG0061
BG0070
BG0080
BG0091
10
BG0051
BG0064
BG0070
BG0080
BG00925
4
BG0050
BG0060
BG0071
BG0080
BG0097
4
BG0051
BG0060
BG0070
BG0080
BG0098
17
BG0051
BG0065
BG0074
BG0081
BG00950
3
BG0050
BG0060
BG0070
BG0080
BG0094
2
BG0050
BG0060
BG0070
BG0080
BG0099
11
BG0052
BG0063
BG0071
BG0081
BG00927
4
BG0053
BG0061
BG0070
BG0080
BG00913
0
BG0050
BG0060
BG0070
BG0080
BG0091
4
BG0050
BG0060
BG0070
BG0080
BG0096
33
BG0054
BG0068
BG0075
BG0082
BG00992
1
BG0050
BG0060
BG0070
BG0080
BG0092
5
BG0051
BG0060
BG0070
BG0080
BG00911
3
BG0050
BG0060
BG0070
BG0080
BG0094
0
BG0050
BG0060
BG0070
BG0080
BG0091
0
BG0050
BG0060
BG0070
BG0080
BG0090
7
BG0050
BG0064
BG0074
BG0080
BG00934
33
BG0054
BG0066
BG0074
BG0082
BG00990
9
OG00435
OG0054
OG0068
OG0075
OG0082
3
OG00412
OG0050
OG0062
OG0070
OG0081
6
OG00424
OG0053
OG0066
OG0073
OG0081
5
OG00416
OG0050
OG0066
OG0072
OG0080
0
OG0040
OG0050
OG0060
OG0070
OG0080
0
OG0040
OG0050
OG0060
OG0070
OG0080
0
OG0040
OG0050
OG0060
OG0070
OG0080
0
OG0040
OG0050
OG0060
OG0070
OG0080
1
OG0047
OG0050
OG0063
OG0071
OG0080
0
OG0042
OG0050
OG0061
OG0070
OG0080
0
OG0040
OG0050
OG0060
OG0070
OG0080
3
OG0042
OG0050
OG0062
OG0070
OG0080
0
OG0041
OG0050
OG0061
OG0070
OG0080
10
OG00437
OG0054
OG0068
OG0075
OG0082
6
OG00412
OG0050
OG0064
OG0073
OG0082
10
OG00437
OG0054
OG0068
OG0075
OG0082
0
OG0040
OG0050
OG0060
OG0070
OG0080
Change in Hemoglobin to CTCAE Grade 3 or 4
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
Change in Leukocytes ≥ 2 CTCAE Grades
Title
Measurements
OG0000
OG0014
OG0022
OG0031
OG0049
OG0052
OG0062
OG0073
OG0080
Change in Leukocytes to CTCAE Grade 3 or 4
Title
Measurements
OG0000
OG0011
OG0021
OG0030
OG0041
OG0050
OG0060
OG0070
OG0080
Change in Lymphocytes ≥ 2 CTCAE Grades
Title
Measurements
OG0002
OG0016
OG0028
OG0035
OG00410
OG0050
OG0061
OG0072
OG0081
Change in Lymphocytes to CTCAE Grade 3 or 4
Title
Measurements
OG0000
OG0013
OG0023
OG0030
OG0047
OG0051
OG0061
OG0071
OG0081
Change in Neutrophils ≥ 2 CTCAE Grades
Title
Measurements
OG0001
OG0014
OG0021
OG0033
OG00412
OG0051
OG0061
OG0071
OG0080
Change in Neutrophils to CTCAE Grade 3 or 4
Title
Measurements
OG0000
OG0011
OG0021
OG0030
OG0042
OG0050
OG0060
OG0070
OG0080
Change in Platelets ≥ 2 CTCAE Grades
Title
Measurements
OG0000
OG0010
OG0022
OG0030
OG0042
OG0051
OG0061
OG0070
OG0080
Change in Platelets to CTCAE Grade 3 or 4
Title
Measurements
OG0000
OG0010
OG0021
OG0030
OG0041
OG0051
OG0061
OG0070
OG0080
Change in aPTT ≥ 2 CTCAE Grades
Title
Measurements
OG0000
OG0011
OG0020
OG0030
OG0043
OG0050
OG0061
OG0071
OG0080
Change in aPTT to CTCAE Grade 3 or 4
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0041
OG0050
OG0060
OG0071
OG0080
Change in INR ≥ 2 CTCAE Grades
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0041
OG0050
OG0060
OG0070
OG0080
Change in INR to CTCAE Grade 3 or 4
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
10
OG00437
OG0054
OG0068
OG0075
OG0082
3
OG0040
OG0051
OG0060
OG0070
OG0080
Change in ALT to CTCAE Grade 3 or 4
Title
Measurements
OG0000
OG0010
OG0022
OG0031
OG0040
OG0051
OG0060
OG0070
OG0080
Change in AST ≥ 2 CTCAE Grades
Title
Measurements
OG0000
OG0012
OG0023
OG0032
OG0042
OG0050
OG0060
OG0070
OG0081
Change in AST to CTCAE Grade 3 or 4
Title
Measurements
OG0000
OG0010
OG0025
OG0032
OG0043
OG0051
OG0060
OG0070
OG0081
Change in Alk Phosphatase ≥ 2 CTCAE Grades
Title
Measurements
OG0000
OG0012
OG0021
OG0030
OG0041
OG0050
OG0061
OG0070
OG0080
Change in Alk Phosphatase to CTCAE Grade 3 or 4
Title
Measurements
OG0000
OG0011
OG0021
OG0030
OG0041
OG0050
OG0061
OG0070
OG0080
Change in Albumin ≥ 2 CTCAE Grades
Title
Measurements
OG0000
OG0011
OG0022
OG0032
OG0046
OG0051
OG0062
OG0071
OG0080
Change in Albumin to CTCAE Grade 3 or 4
Title
Measurements
OG0000
OG0010
OG0021
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
Change in Bilirubin ≥ 2 CTCAE Grades
Title
Measurements
OG0001
OG0010
OG0021
OG0030
OG0043
OG0050
OG0062
OG0071
OG0080
Change in Bilirubin to CTCAE Grade 3 or 4
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0041
OG0050
OG0060
OG0070
OG0080
Change in Creatinine ≥ 2 CTCAE Grades
Title
Measurements
OG0000
OG0011
OG0021
OG0031
OG0041
OG0050
OG0060
OG0070
OG0080
Change in Creatinine to CTCAE Grade 3 or 4
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0041
OG0050
OG0060
OG0070
OG0080
Change in Phosphate ≥ 2 CTCAE Grades
Title
Measurements
OG0001
OG0012
OG0020
OG0032
OG00415
OG0051
OG0061
OG0072
OG0080
Change in Phosphate to CTCAE Grade 3 or 4
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0047
OG0050
OG0060
OG0071
OG0080
Change in Urate ≥ 2 CTCAE Grades
Title
Measurements
OG0000
OG0011
OG0020
OG0030
OG0041
OG0051
OG0060
OG0070
OG0080
Change in Urate to CTCAE Grade 3 or 4
Title
Measurements
OG0000
OG0011
OG0020
OG0030
OG0041
OG0051
OG0060
OG0070
OG0080
Change in Calcium ≥ 2 CTCAE Grades
Title
Measurements
OG0000
OG0013
OG0021
OG0030
OG0046
OG0051
OG0062
OG0072
OG0080
Change in Calcium to CTCAE Grade 3 or 4
Title
Measurements
OG0000
OG0011
OG0021
OG0030
OG0041
OG0050
OG0061
OG0071
OG0080
Change in Sodium ≥ 2 CTCAE Grades
Title
Measurements
OG0000
OG0011
OG0020
OG0033
OG0041
OG0050
OG0060
OG0070
OG0080
Change in Sodium to CTCAE Grade 3 or 4
Title
Measurements
OG0000
OG0010
OG0020
OG0032
OG0041
OG0050
OG0060
OG0070
OG0080
Change in Potassium ≥ 2 CTCAE Grades
Title
Measurements
OG0001
OG0011
OG0022
OG0035
OG0045
OG0051
OG0060
OG0070
OG0080
Change in Potassium to CTCAE Grade 3 or 4
Title
Measurements
OG0000
OG0010
OG0021
OG0035
OG0045
OG0051
OG0060
OG0070
OG0080
Change in Magnesium ≥ 2 CTCAE Grades
Title
Measurements
OG0000
OG0011
OG0020
OG0032
OG0041
OG0050
OG0062
OG0070
OG0080
Change in Magnesium to CTCAE Grade 3 or 4
Title
Measurements
OG0000
OG0010
OG0020
OG0032
OG0041
OG0050
OG0061
OG0070
OG0080
Change in Fasting Glucose ≥ 2 CTCAE Grades
Title
Measurements
OG0001
OG0011
OG0021
OG0031
OG0047
OG0051
OG0064
OG0070
OG0080
Change in Fasting Glucose to CTCAE Grade 3 or 4
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0042
OG0050
OG0060
OG0071
OG0080
Change in NonFasting Glucose ≥ 2 CTCAE Grades
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0042
OG0050
OG0060
OG0072
OG0080
Change in Non Fasting Glucose to CTCAE Gr.3 or 4
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0042
OG0050
OG0060
OG0071
OG0080
10
OG00437
OG0054
OG0068
OG0075
OG0082
61.4
± 9.8
OG00462.6± 4.1
OG00562.5± 2.9
OG00666.9± 4.6
OG00763.8± 5.2
OG008NA± NAMean and standard deviation were not calculated because there were \< 3 participants in this arm.
End of Study
Title
Measurements
OG000NA± NAMean and SD were not calculated because data was available from \< 3 participants.
OG00164.0± 2.0
OG00262.3± 4.1
OG00361.8± 8.3
OG00462.5± 2.9
OG005NA± NAData not collected
OG006NA± NAData not collected
OG007NA± NAData not collected
OG008NA± NAMean and standard deviation were not calculated because there were \< 3 participants in this arm.
Change from Baseline to End of Study
Title
Measurements
OG000NA± NAMean and SD were not
OG0011.4± 5.9
OG002-1.5± 2.4
OG0030.0± 7.6
OG004-1.3± 3.9
OG005NA± NAData not collected
OG006NA± NAData not collected
OG007NA± NAData not collected
OG008NA± NAMean and standard deviation were not calculated because there were \< 3 participants in this arm.
10
OG00437
OG0054
OG0068
OG0075
OG0082
415.95
± 14.849
OG004419.95± 20.502
OG005427.13± 32.995
OG006424.84± 6.932
OG007435.26± 7.971
OG008NA± NAMean and standard deviation were not calculated because there were \< 3 participants in this arm.
0.25 Hours Postdose
Title
Measurements
OG000429.66± 5.707
OG001420.13± 18.333
OG002413.04± 14.934
OG003418.44± 16.145
OG004NA± NAData not collected
OG005NA± NAData not collected
OG006NA± NAData not collected
OG007NA± NAData not collected
OG008NA± NAMean and standard deviation were not calculated because there were \< 3 participants in this arm.
0.5 Hours Postdose
Title
Measurements
OG000431.84± 7.504
OG001419.18± 21.362
OG002415.08± 14.762
OG003418.91± 14.437
OG004413.28± 19.715
OG005418.90± 14.897
OG006415.67± 16.874
OG007420.06± 18.388
OG008NA± NAMean and standard deviation were not calculated because there were \< 3 participants in this arm.
1 Hour Postdose
Title
Measurements
OG000431.00± 10.149
OG001422.21± 21.863
OG002416.08± 17.581
OG003416.20± 14.530
OG004416.22± 19.738
OG005427.77± 10.186
OG006419.61± 16.514
OG007421.20± 21.336
OG008NA± NAMean and standard deviation were not calculated because there were \< 3 participants in this arm.
1.5 Hours Postdose
Title
Measurements
OG000431.82± 8.569
OG001425.15± 22.106
OG002415.36± 16.394
OG003415.33± 15.020
OG004417.10± 19.672
OG005434.33± 14.199
OG006420.43± 15.627
OG007427.48± 20.863
OG008NA± NAMean and standard deviation were not calculated because there were \< 3 participants in this arm.
2 Hours Postdose
Title
Measurements
OG000433.02± 11.921
OG001423.31± 22.678
OG002415.84± 17.508
OG003414.01± 17.988
OG004414.99± 17.250
OG005424.00± 22.528
OG006418.60± 15.144
OG007422.94± 18.036
OG008NA± NAMean and standard deviation were not calculated because there were \< 3 participants in this arm.
4 Hours Postdose
Title
Measurements
OG000422.00± 10.583
OG001419.97± 21.322
OG002411.18± 15.886
OG003410.88± 13.815
OG004414.04± 17.351
OG005424.43± 17.832
OG006426.60± 16.724
OG007422.40± 10.397
OG008NA± NAMean and standard deviation were not calculated because there were \< 3 participants in this arm.
6 Hours Postdose
Title
Measurements
OG000421.50± 15.453
OG001419.14± 21.269
OG002411.85± 13.387
OG003414.74± 16.413
OG004412.80± 17.342
OG005417.00± 20.421
OG006422.94± 18.577
OG007418.34± 13.781
OG008NA± NAMean and standard deviation were not calculated because there were \< 3 participants in this arm.
8 Hours Postdose
Title
Measurements
OG000424.86± 12.688
OG001420.16± 20.437
OG002411.16± 15.587
OG003413.56± 15.072
OG004414.17± 18.533
OG005419.90± 22.274
OG006416.80± 15.144
OG007425.54± 12.246
OG008NA± NAMean and standard deviation were not calculated because there were \< 3 participants in this arm.
12 Hours Postdose
Title
Measurements
OG000427.74± 15.157
OG001425.46± 21.533
OG002409.67± 19.176
OG003414.59± 15.760
OG004414.09± 18.188
OG005431.70± 16.896
OG006420.66± 10.462
OG007432.46± 16.503
OG008NA± NAMean and standard deviation were not calculated because there were \< 3 participants in this arm.
24 Hours Postdose
Title
Measurements
OG000425.54± 10.519
OG001421.45± 16.339
OG002409.33± 16.313
OG003415.29± 16.968
OG004422.73± 17.900
OG005426.77± 16.591
OG006NA± NAData not collected
OG007NA± NAData not collected
OG008NA± NAMean and standard deviation were not calculated because there were \< 3 participants in this arm.
10
OG00437
OG0054
OG0068
OG0075
OG0082
5
OG00429
OG0053
OG0066
OG0075
OG0080
Subjects with Max Post-Baseline CTCAE Grade ≥ 1
Title
Measurements
OG0002
OG0015
OG0025
OG0033
OG00417
OG0052
OG0062
OG0074
OG0080
Subjects with Max Post-Baseline CTCAE Grade ≥ 2
Title
Measurements
OG0001
OG0010
OG0020
OG0031
OG0047
OG0051
OG0061
OG0070
OG0080
Subjects with Max Post-Baseline CTCAE Grade ≥ 3
Title
Measurements
OG0000
OG0011
OG0022
OG0031
OG0045
OG0050
OG0063
OG0071
OG0080
Subjects with Max Post-Baseline CTCAE Grade ≥ 4
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
10
OG00437
OG0054
OG0068
OG0075
OG0082
74.9
± 8.36
OG00474.4± 11.68
OG00573.8± 8.62
OG00675.5± 13.32
OG00776.6± 8.59
OG008NA± NAMean and standard deviation were not calculated because there were \< 3 participants in this arm.
Cycle 1, Day 1
Title
Measurements
OG00074.8± 9.43
OG00177.4± 9.82
OG00275.4± 6.91
OG00376.5± 8.03
OG00474.4± 11.68
OG00573.8± 8.62
OG00675.5± 12.32
OG00776.6± 8.59
OG008NA± NAMean and standard deviation were not calculated because there were \< 3 participants in this arm.
Cycle 1, Day 8
Title
Measurements
OG00074.5± 5.96
OG00174.3± 8.58
OG00275.3± 8.84
OG00372.6± 12.68
OG00472.4± 11.77
OG00570.8± 5.38
OG00678.3± 10.64
OG00775.8± 7.63
OG008NA± NAMean and standard deviation were not calculated because there were \< 3 participants in this arm.
Cycle 1, Day 15
Title
Measurements
OG00074.7± 2.16
OG00172.8± 8.64
OG00275.4± 7.86
OG00368.7± 7.12
OG00473.1± 11.09
OG00570.0± 7.87
OG00674.2± 14.11
OG00769.0± 9.59
OG008NA± NAMean and standard deviation were not calculated because there were \< 3 participants in this arm.
Cycle 1, Day 22
Title
Measurements
OG00072.5± 7.48
OG00173.9± 9.37
OG00276.2± 6.20
OG00377.0± 5.40
OG00470.9± 11.76
OG00574.8± 10.24
OG00675.0± 12.40
OG00773.2± 13.10
OG008NA± NAMean and standard deviation were not calculated because there were \< 3 participants in this arm.
Cycle 2, Day 1
Title
Measurements
OG00072.0± 8.00
OG00173.3± 10.49
OG00272.7± 8.91
OG00374.1± 7.36
OG00471.4± 10.43
OG00573.3± 4.57
OG00672.5± 12.42
OG00768.0± 5.29
OG008NA± NAMean and standard deviation were not calculated because there were \< 3 participants in this arm.
10
OG00437
OG0054
OG0068
OG0075
OG0082
125.2
± 20.82
OG004124.4± 19.04
OG005122.3± 14.31
OG006120.8± 17.65
OG007137.8± 19.18
OG008NA± NAMean and standard deviation were not calculated because there were \< 3 participants in this arm.
Cycle 1, Day 1
Title
Measurements
OG000113.5± 17.02
OG001125.1± 15.68
OG002122.6± 18.05
OG003124.7± 14.51
OG004124.4± 19.04
OG005122.3± 14.31
OG006120.8± 17.65
OG007137.8± 19.18
OG008NA± NAMean and standard deviation were not calculated because there were \< 3 participants in this arm.
Cycle 1, Day 8
Title
Measurements
OG000124.0± 5.93
OG001120.4± 9.12
OG002123.7± 16.41
OG003122.2± 20.67
OG004122.2± 13.88
OG005115.3± 13.30
OG006127.9± 17.59
OG007124.8± 21.56
OG008NA± NAMean and standard deviation were not calculated because there were \< 3 participants in this arm.
Cycle 1, Day 15
Title
Measurements
OG000119.7± 6.59
OG001115.5± 17.50
OG002121.6± 17.68
OG003115.2± 9.17
OG004122.8± 14.96
OG005112.8± 13.10
OG006128.3± 15.87
OG007126.6± 10.97
OG008NA± NAMean and standard deviation were not calculated because there were \< 3 participants in this arm.
Cycle 1, Day 22
Title
Measurements
OG000116.7± 12.09
OG001124.7± 16.92
OG002123.5± 21.17
OG003125.4± 16.67
OG004116.6± 16.62
OG005115.5± 15.50
OG006119.9± 19.18
OG007109.2± 8.32
OG008NA± NAMean and standard deviation were not calculated because there were \< 3 participants in this arm.
Cycle 2, Day 1
Title
Measurements
OG000111.7± 17.83
OG001119.7± 17.59
OG002123.6± 24.89
OG003116.6± 10.31
OG004119.3± 17.81
OG005112.5± 9.00
OG006113.2± 18.54
OG007117.0± 9.06
OG008NA± NAMean and standard deviation were not calculated because there were \< 3 participants in this arm.
10
OG00437
OG0054
OG0068
OG0075
OG0082
17.8
± 2.39
OG00417.5± 0.96
OG00517.5± 0.58
OG00618.1± 0.83
OG00717.6± 0.89
OG008NA± NAMean and standard deviation were not calculated because there were \< 3 participants in this arm.
Cycle 1, Day 1
Title
Measurements
OG00016.0± 1.63
OG00116.6± 1.43
OG00217.7± 1.33
OG00317.3± 1.34
OG00417.5± 0.96
OG00517.5± 0.58
OG00618.1± 0.83
OG00717.6± 0.89
OG008NA± NAMean and standard deviation were not calculated because there were \< 3 participants in this arm.
Cycle 1, Day 8
Title
Measurements
OG00017.3± 1.63
OG00116.4± 1.89
OG00217.6± 1.34
OG00317.5± 0.85
OG00417.2± 1.47
OG00516.8± 0.96
OG00617.3± 1.89
OG00718.0± 0.00
OG008NA± NAMean and standard deviation were not calculated because there were \< 3 participants in this arm.
Cycle 1, Day 15
Title
Measurements
OG00017.2± 0.98
OG00117.1± 1.38
OG00218.5± 1.20
OG00317.9± 1.66
OG00417.6± 1.03
OG00517.0± 0.82
OG00617.7± 0.82
OG00717.4± 0.89
OG008NA± NAMean and standard deviation were not calculated because there were \< 3 participants in this arm.
Cycle 1, Day 22
Title
Measurements
OG00017.3± 2.07
OG00117.8± 1.03
OG00218.0± 1.15
OG00317.1± 1.07
OG00417.6± 1.54
OG00517.8± 1.26
OG00617.6± 0.79
OG00718.0± 0.00
OG008NA± NAMean and standard deviation were not calculated because there were \< 3 participants in this arm.
Cycle 2, Day 1
Title
Measurements
OG00017.3± 1.63
OG00117.6± 1.16
OG00217.8± 0.99
OG00318.3± 1.28
OG00417.3± 2.11
OG00517.8± 1.26
OG00617.3± 1.03
OG00717.5± 1.00
OG008NA± NAMean and standard deviation were not calculated because there were \< 3 participants in this arm.
10
OG00437
OG0054
OG0068
OG0075
OG0082
81.0
± 13.11
OG00483.5± 15.32
OG00573.5± 10.75
OG00686.1± 21.40
OG00779.6± 5.32
OG008NA± NAMean and standard deviation were not calculated because there were \< 3 participants in this arm.
Cycle 1, Day 1
Title
Measurements
OG00087.3± 4.92
OG00177.7± 14.28
OG00287.3± 19.53
OG00386.8± 12.90
OG00483.5± 15.32
OG00573.5± 10.75
OG00686.1± 21.40
OG00779.6± 5.32
OG008NA± NAMean and standard deviation were not calculated because there were \< 3 participants in this arm.
Cycle 1, Day 8
Title
Measurements
OG00080.8± 11.39
OG00181.2± 15.93
OG00285.4± 19.97
OG00392.6± 12.47
OG00484.4± 15.61
OG00571.5± 6.61
OG00679.4± 15.78
OG00775.5± 12.01
OG008NA± NAMean and standard deviation were not calculated because there were \< 3 participants in this arm.
Cycle 1, Day 15
Title
Measurements
OG00080.2± 9.97
OG00189.3± 16.83
OG00286.7± 18.48
OG00382.8± 8.60
OG00481.3± 14.79
OG00583.3± 15.33
OG00682.5± 17.65
OG00777.4± 7.92
OG008NA± NAMean and standard deviation were not calculated because there were \< 3 participants in this arm.
Cycle 1, Day 22
Title
Measurements
OG00082.4± 13.58
OG00187.8± 16.95
OG00285.3± 20.23
OG00386.1± 11.18
OG00484.6± 17.27
OG00577.8± 7.80
OG00687.4± 25.97
OG00788.8± 11.43
OG008NA± NAMean and standard deviation were not calculated because there were \< 3 participants in this arm.
Cycle 2, Day 1
Title
Measurements
OG00083.5± 11.81
OG00189.7± 11.63
OG00284.0± 16.39
OG00387.9± 12.45
OG00485.7± 15.53
OG00578.0± 15.75
OG00683.0± 13.94
OG00785.0± 12.68
OG008NA± NAMean and standard deviation were not calculated because there were \< 3 participants in this arm.
10
OG00437
OG0054
OG0068
OG0075
OG0082
36.48
± 0.297
OG00436.57± 0.320
OG00536.60± 0.183
OG00636.39± 0.482
OG00736.40± 0.394
OG008NA± NAMean and standard deviation were not calculated because there were \< 3 participants in this arm
Cycle 1, Day 1
Title
Measurements
OG00036.33± 0.189
OG00136.57± 0.465
OG00236.34± 0.318
OG00336.46± 0.306
OG00436.57± 0.320
OG00536.60± 0.183
OG00636.39± 0.482
OG00736.40± 0.394
OG008NA± NAMean and standard deviation were not calculated because there were \< 3 participants in this arm
Cycle 1, Day 8
Title
Measurements
OG00036.33± 0.308
OG00136.42± 0.217
OG00236.59± 0.493
OG00336.35± 0.372
OG00436.51± 0.370
OG00536.25± 0.129
OG00636.36± 0.276
OG00736.88± 0.359
OG008NA± NAMean and standard deviation were not calculated because there were \< 3 participants in this arm
Cycle 1, Day 15
Title
Measurements
OG00036.48± 0.313
OG00136.74± 0.323
OG00236.45± 0.333
OG00336.35± 0.299
OG00436.50± 0.400
OG00536.30± 0.216
OG00636.77± 0.489
OG00736.42± 0.130
OG008NA± NAMean and standard deviation were not calculated because there were \< 3 participants in this arm
Cycle 1, Day 22
Title
Measurements
OG00036.13± 0.403
OG00136.38± 0.360
OG00236.38± 0.414
OG00336.26± 0.450
OG00436.54± 0.550
OG00536.65± 0.465
OG00636.66± 0.341
OG00736.88± 0.319
OG008NA± NAMean and standard deviation were not calculated because there were \< 3 participants in this arm
Cycle 2, Day 1
Title
Measurements
OG00036.25± 0.315
OG00136.55± 0.238
OG00236.57± 0.312
OG00336.54± 0.444
OG00436.56± 0.292
OG00536.90± 0.294
OG00636.50± 0.456
OG00736.54± 0.152
OG008NA± NAMean and standard deviation were not calculated because there were \< 3 participants in this arm
10
OG00437
OG0054
OG0068
OG0075
OG0082
96.7
± 2.41
OG00497.8± 1.49
OG00597.0± 1.83
OG00697.0± 0.93
OG00797.6± 1.14
OG008NA± NAMean and standard deviation were not calculated because there were \< 3 participants in this arm
Cycle 1, Day 1
Title
Measurements
OG00097.5± 1.00
OG00197.7± 1.90
OG00297.4± 1.16
OG00396.9± 1.90
OG00497.8± 1.49
OG00597.0± 1.83
OG00697.0± 0.93
OG00797.6± 1.14
OG008NA± NAMean and standard deviation were not calculated because there were \< 3 participants in this arm
Cycle 1, Day 8
Title
Measurements
OG00098.3± 1.21
OG00197.5± 1.98
OG00297.1± 1.66
OG00397.1± 1.37
OG00497.8± 1.70
OG00597.0± 2.16
OG00697.7± 1.50
OG00798.3± 2.06
OG008NA± NAMean and standard deviation were not calculated because there were \< 3 participants in this arm
Cycle 1, Day 15
Title
Measurements
OG00097.7± 0.82
OG00196.5± 1.94
OG00297.3± 1.50
OG00397.1± 1.17
OG00498.0± 1.34
OG00597.0± 1.41
OG00697.0± 1.26
OG00796.8± 1.48
OG008NA± NAMean and standard deviation were not calculated because there were \< 3 participants in this arm
Cycle 1, Day 22
Title
Measurements
OG00096.8± 1.72
OG00197.3± 1.82
OG00296.8± 1.77
OG00397.6± 1.51
OG00498.1± 1.63
OG00597.5± 3.11
OG00697.9± 1.57
OG00798.0± 1.63
OG008NA± NAMean and standard deviation were not calculated because there were \< 3 participants in this arm
Cycle 2, Day 1
Title
Measurements
OG00097.5± 0.55
OG00197.3± 2.09
OG00296.9± 1.26
OG00397.3± 1.04
OG00498.2± 1.39
OG00596.5± 2.52
OG00696.2± 3.31
OG00797.0± 2.16
OG008NA± NAMean and standard deviation were not calculated because there were \< 3 participants in this arm
2166
± 964.3
12590
± 4900
15790
± 7286
15660
± 7345
17360
± 9479
5
2454
± 838.4
5
OG0033.0± 838.4(1 to 4)
10
16150
± 5591
6
2327
± 1257
6
OG0031.5± 1257(0.5 to 6)
6
15580
± 6024
1942
± 56.46
OG0031.80± 56.46(0.50 to 4.02)
OG00311470± 53.45(0.50 to 4.02)
OG00315110± 63.32(0.50 to 4.02)
4
OG00427
OG0053
OG0065
OG0073
OG0081
1
OG0042
OG0051
OG0061
OG0070
OG0081
4
OG00427
OG0053
OG0065
OG0073
OG0081
0
OG0040
OG0050
OG0060
OG0070
OG0080
Partial Response
Title
Measurements
OG0000
OG0012
OG0022
OG0031
OG0042
OG0051
OG0061
OG0070
OG0081
Stable Disease ≥ 8 weeks
Title
Measurements
OG0001
OG0014
OG0027
OG0031
OG00417
OG0052
OG0063
OG0071
OG0080
Progression
Title
Measurements
OG0001
OG0012
OG0023
OG0030
OG0047
OG0050
OG0060
OG0071
OG0080
Not Evaluable
Title
Measurements
OG0000
OG0013
OG0021
OG0032
OG0041
OG0050
OG0061
OG0071
OG0080
1
OG0042
OG0051
OG0061
OG0070
OG0081
OG004NA(3.6 to NA)Median and upper limit of the interquartile range can not be calculated for Duration of Response because response was ongoing for one participant at the time of data cut-off.
OG005NA(NA to NA)Median and interquartile range can not be calculated because there was only one participant in the cohort.
OG006NA(NA to NA)Median and interquartile range can not be calculated because there was only one participant in the cohort.
OG00810.4(NA to NA)Median and interquartile range can not be calculated because there was only one participant in the cohort.
10
OG00437
OG0058
OG0065
OG0075
OG0082
7
(39.1 to 39.1)
OG00411(3.6 to NA)
OG0052(6.4 to 6.4)
OG0063(12.0 to 12.0)
OG0072
OG0082(10.4 to 10.4)
No
Title
Measurements
OG0004
OG0017
OG00210
OG0033
OG00426
OG0052
OG0065
OG0073
OG0080
2
OG00426
OG0053
OG0065
OG0072
OG0081
OG003NA± NAMean change in tumour size and standard deviation are not reported when data are available for less than 3 patients.
OG004-0.46± 28.208
OG005-3.57± 28.476
OG006-10.96± 19.012
OG007NA± NAMean change in tumour size and standard deviation are not reported when data are available for less than 3 patients.
OG008NA± NAMean change in tumour size and standard deviation are not reported when data are available for less than 3 patients.
10
OG00437
OG0054
OG0068
OG0075
OG0082
OG00378.3± NA(57.00 to 178.14)
OG00422.6± 28.208(16.14 to 25.14)
OG00533.9± 28.476(17.14 to NA)The upper bound of the 80% C.I. was not a finite number
OG00660.1± 19.012(16.00 to NA)The upper bound of the 80% C.I. was not a finite number
OG00783.4± NA(7.14 to 83.43)
OG008NA± NA(61.86 to NA)The median could not be determined because only 1 progression event occurred in this arm. The upper bound of the 80% C.I. was not a finite number