Trial Outcomes & Findings for AZD2014 and Fulvestrant in Patients With ER+ Advanced Metastatic Breast Cancer (NCT NCT01597388)
NCT ID: NCT01597388
Last Updated: 2025-11-17
Results Overview
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE1
Target enrollment
99 participants
Primary outcome timeframe
5 Days
Results posted on
2025-11-17
Participant Flow
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.
Participant milestones
| Measure |
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
13
|
14
|
10
|
37
|
4
|
8
|
5
|
2
|
|
Overall Study
COMPLETED
|
6
|
13
|
14
|
10
|
37
|
4
|
8
|
5
|
2
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
AZD2014 and Fulvestrant in Patients With ER+ Advanced Metastatic Breast Cancer
Baseline characteristics by cohort
| Measure |
35 mg BID Continuous
n=6 Participants
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.
|
50 mg BID Continuous
n=13 Participants
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.
|
75 mg QD Continuous
n=14 Participants
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.
|
100 mg QD Continuous
n=10 Participants
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.
|
125 mg BID Intermittent Days 1 and 2 (Fasted)
n=37 Participants
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.
|
125 mg BID Intermittent Days 1 and 2 (Fed)
n=4 Participants
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.
|
170 mg BID Intermittent Days 1 and 2 (Fasted)
n=8 Participants
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.
|
170 mg BID Intermittent Days 1 and 2 (Fed)
n=5 Participants
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.
|
125 mg BID Intermittent Days 1 and 4 (Fasted)
n=2 Participants
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.
|
Total
n=99 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
60.5 Years
STANDARD_DEVIATION 9.16 • n=202 Participants
|
63.3 Years
STANDARD_DEVIATION 12.53 • n=283 Participants
|
61.1 Years
STANDARD_DEVIATION 7.46 • n=120 Participants
|
62.0 Years
n=122 Participants
|
61.0 Years
n=79 Participants
|
55.0 Years
n=806 Participants
|
55.5 Years
n=43 Participants
|
59.0 Years
n=33 Participants
|
55.0 Years
n=39 Participants
|
61.0 Years
n=35 Participants
|
|
Age, Customized
≥18 and <50 years
|
1 Participants
n=202 Participants
|
1 Participants
n=283 Participants
|
0 Participants
n=120 Participants
|
1 Participants
n=122 Participants
|
7 Participants
n=79 Participants
|
0 Participants
n=806 Participants
|
1 Participants
n=43 Participants
|
1 Participants
n=33 Participants
|
1 Participants
n=39 Participants
|
13 Participants
n=35 Participants
|
|
Age, Customized
≥50 to <65 years
|
3 Participants
n=202 Participants
|
6 Participants
n=283 Participants
|
8 Participants
n=120 Participants
|
5 Participants
n=122 Participants
|
18 Participants
n=79 Participants
|
4 Participants
n=806 Participants
|
7 Participants
n=43 Participants
|
3 Participants
n=33 Participants
|
0 Participants
n=39 Participants
|
54 Participants
n=35 Participants
|
|
Age, Customized
≥65 years
|
2 Participants
n=202 Participants
|
6 Participants
n=283 Participants
|
6 Participants
n=120 Participants
|
4 Participants
n=122 Participants
|
12 Participants
n=79 Participants
|
0 Participants
n=806 Participants
|
0 Participants
n=43 Participants
|
1 Participants
n=33 Participants
|
1 Participants
n=39 Participants
|
32 Participants
n=35 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=202 Participants
|
13 Participants
n=283 Participants
|
14 Participants
n=120 Participants
|
10 Participants
n=122 Participants
|
37 Participants
n=79 Participants
|
4 Participants
n=806 Participants
|
8 Participants
n=43 Participants
|
5 Participants
n=33 Participants
|
2 Participants
n=39 Participants
|
99 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=202 Participants
|
0 Participants
n=283 Participants
|
0 Participants
n=120 Participants
|
0 Participants
n=122 Participants
|
0 Participants
n=79 Participants
|
0 Participants
n=806 Participants
|
0 Participants
n=43 Participants
|
0 Participants
n=33 Participants
|
0 Participants
n=39 Participants
|
0 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=202 Participants
|
0 Participants
n=283 Participants
|
0 Participants
n=120 Participants
|
1 Participants
n=122 Participants
|
0 Participants
n=79 Participants
|
0 Participants
n=806 Participants
|
0 Participants
n=43 Participants
|
0 Participants
n=33 Participants
|
0 Participants
n=39 Participants
|
1 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=202 Participants
|
1 Participants
n=283 Participants
|
2 Participants
n=120 Participants
|
0 Participants
n=122 Participants
|
24 Participants
n=79 Participants
|
4 Participants
n=806 Participants
|
5 Participants
n=43 Participants
|
4 Participants
n=33 Participants
|
2 Participants
n=39 Participants
|
42 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=202 Participants
|
12 Participants
n=283 Participants
|
12 Participants
n=120 Participants
|
9 Participants
n=122 Participants
|
13 Participants
n=79 Participants
|
0 Participants
n=806 Participants
|
3 Participants
n=43 Participants
|
1 Participants
n=33 Participants
|
0 Participants
n=39 Participants
|
56 Participants
n=35 Participants
|
|
Race/Ethnicity, Customized
White
|
6 Participants
n=202 Participants
|
11 Participants
n=283 Participants
|
12 Participants
n=120 Participants
|
10 Participants
n=122 Participants
|
35 Participants
n=79 Participants
|
2 Participants
n=806 Participants
|
7 Participants
n=43 Participants
|
5 Participants
n=33 Participants
|
2 Participants
n=39 Participants
|
90 Participants
n=35 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
0 Participants
n=202 Participants
|
2 Participants
n=283 Participants
|
2 Participants
n=120 Participants
|
0 Participants
n=122 Participants
|
2 Participants
n=79 Participants
|
1 Participants
n=806 Participants
|
1 Participants
n=43 Participants
|
0 Participants
n=33 Participants
|
0 Participants
n=39 Participants
|
8 Participants
n=35 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=202 Participants
|
0 Participants
n=283 Participants
|
0 Participants
n=120 Participants
|
0 Participants
n=122 Participants
|
0 Participants
n=79 Participants
|
1 Participants
n=806 Participants
|
0 Participants
n=43 Participants
|
0 Participants
n=33 Participants
|
0 Participants
n=39 Participants
|
1 Participants
n=35 Participants
|
|
Region of Enrollment
United States
|
6 Participants
n=202 Participants
|
13 Participants
n=283 Participants
|
14 Participants
n=120 Participants
|
10 Participants
n=122 Participants
|
37 Participants
n=79 Participants
|
4 Participants
n=806 Participants
|
8 Participants
n=43 Participants
|
5 Participants
n=33 Participants
|
2 Participants
n=39 Participants
|
99 Participants
n=35 Participants
|
|
Weight
|
77.42 kg
STANDARD_DEVIATION 15.953 • n=202 Participants
|
73.29 kg
STANDARD_DEVIATION 18.845 • n=283 Participants
|
74.51 kg
STANDARD_DEVIATION 19.236 • n=120 Participants
|
74.53 kg
STANDARD_DEVIATION 23.776 • n=122 Participants
|
67.62 kg
STANDARD_DEVIATION 15.511 • n=79 Participants
|
79.88 kg
STANDARD_DEVIATION 17.854 • n=806 Participants
|
68.95 kg
STANDARD_DEVIATION 14.115 • n=43 Participants
|
77.98 kg
STANDARD_DEVIATION 12.586 • n=33 Participants
|
77.45 kg
STANDARD_DEVIATION NA • n=39 Participants
|
71.96 kg
STANDARD_DEVIATION 17.134 • n=35 Participants
|
|
ECOG Performance Status (PS)
PS = 0
|
3 Participants
n=202 Participants
|
11 Participants
n=283 Participants
|
8 Participants
n=120 Participants
|
5 Participants
n=122 Participants
|
16 Participants
n=79 Participants
|
2 Participants
n=806 Participants
|
5 Participants
n=43 Participants
|
1 Participants
n=33 Participants
|
1 Participants
n=39 Participants
|
52 Participants
n=35 Participants
|
|
Tumour Grade
G3
|
1 Participants
n=202 Participants
|
4 Participants
n=283 Participants
|
3 Participants
n=120 Participants
|
2 Participants
n=122 Participants
|
8 Participants
n=79 Participants
|
1 Participants
n=806 Participants
|
1 Participants
n=43 Participants
|
2 Participants
n=33 Participants
|
1 Participants
n=39 Participants
|
23 Participants
n=35 Participants
|
|
ECOG Performance Status (PS)
PS = 1
|
3 Participants
n=202 Participants
|
2 Participants
n=283 Participants
|
6 Participants
n=120 Participants
|
5 Participants
n=122 Participants
|
21 Participants
n=79 Participants
|
2 Participants
n=806 Participants
|
3 Participants
n=43 Participants
|
4 Participants
n=33 Participants
|
1 Participants
n=39 Participants
|
47 Participants
n=35 Participants
|
|
ECOG Performance Status (PS)
PS = 2
|
0 Participants
n=202 Participants
|
0 Participants
n=283 Participants
|
0 Participants
n=120 Participants
|
0 Participants
n=122 Participants
|
0 Participants
n=79 Participants
|
0 Participants
n=806 Participants
|
0 Participants
n=43 Participants
|
0 Participants
n=33 Participants
|
0 Participants
n=39 Participants
|
0 Participants
n=35 Participants
|
|
ECOG Performance Status (PS)
PS = 3
|
0 Participants
n=202 Participants
|
0 Participants
n=283 Participants
|
0 Participants
n=120 Participants
|
0 Participants
n=122 Participants
|
0 Participants
n=79 Participants
|
0 Participants
n=806 Participants
|
0 Participants
n=43 Participants
|
0 Participants
n=33 Participants
|
0 Participants
n=39 Participants
|
0 Participants
n=35 Participants
|
|
ECOG Performance Status (PS)
PS = 4
|
0 Participants
n=202 Participants
|
0 Participants
n=283 Participants
|
0 Participants
n=120 Participants
|
0 Participants
n=122 Participants
|
0 Participants
n=79 Participants
|
0 Participants
n=806 Participants
|
0 Participants
n=43 Participants
|
0 Participants
n=33 Participants
|
0 Participants
n=39 Participants
|
0 Participants
n=35 Participants
|
|
Tumour Grade
G4
|
0 Participants
n=202 Participants
|
0 Participants
n=283 Participants
|
0 Participants
n=120 Participants
|
0 Participants
n=122 Participants
|
0 Participants
n=79 Participants
|
0 Participants
n=806 Participants
|
1 Participants
n=43 Participants
|
0 Participants
n=33 Participants
|
0 Participants
n=39 Participants
|
1 Participants
n=35 Participants
|
|
Tumour Grade
G1
|
0 Participants
n=202 Participants
|
0 Participants
n=283 Participants
|
0 Participants
n=120 Participants
|
1 Participants
n=122 Participants
|
1 Participants
n=79 Participants
|
1 Participants
n=806 Participants
|
0 Participants
n=43 Participants
|
1 Participants
n=33 Participants
|
0 Participants
n=39 Participants
|
4 Participants
n=35 Participants
|
|
Tumour Grade
G2
|
3 Participants
n=202 Participants
|
5 Participants
n=283 Participants
|
6 Participants
n=120 Participants
|
6 Participants
n=122 Participants
|
14 Participants
n=79 Participants
|
1 Participants
n=806 Participants
|
2 Participants
n=43 Participants
|
1 Participants
n=33 Participants
|
1 Participants
n=39 Participants
|
39 Participants
n=35 Participants
|
|
Tumour Grade
Gx
|
1 Participants
n=202 Participants
|
3 Participants
n=283 Participants
|
5 Participants
n=120 Participants
|
1 Participants
n=122 Participants
|
10 Participants
n=79 Participants
|
1 Participants
n=806 Participants
|
4 Participants
n=43 Participants
|
0 Participants
n=33 Participants
|
0 Participants
n=39 Participants
|
25 Participants
n=35 Participants
|
|
Tumour Grade
Missing
|
1 Participants
n=202 Participants
|
1 Participants
n=283 Participants
|
0 Participants
n=120 Participants
|
0 Participants
n=122 Participants
|
4 Participants
n=79 Participants
|
0 Participants
n=806 Participants
|
0 Participants
n=43 Participants
|
1 Participants
n=33 Participants
|
0 Participants
n=39 Participants
|
7 Participants
n=35 Participants
|
|
Histology Type
Cannot be determined
|
0 Participants
n=202 Participants
|
1 Participants
n=283 Participants
|
0 Participants
n=120 Participants
|
0 Participants
n=122 Participants
|
0 Participants
n=79 Participants
|
0 Participants
n=806 Participants
|
0 Participants
n=43 Participants
|
0 Participants
n=33 Participants
|
0 Participants
n=39 Participants
|
1 Participants
n=35 Participants
|
|
Histology Type
Invasive carcinoma (NOS)
|
0 Participants
n=202 Participants
|
1 Participants
n=283 Participants
|
1 Participants
n=120 Participants
|
1 Participants
n=122 Participants
|
4 Participants
n=79 Participants
|
1 Participants
n=806 Participants
|
0 Participants
n=43 Participants
|
0 Participants
n=33 Participants
|
0 Participants
n=39 Participants
|
8 Participants
n=35 Participants
|
|
Histology Type
Invasive ductal
|
4 Participants
n=202 Participants
|
6 Participants
n=283 Participants
|
7 Participants
n=120 Participants
|
5 Participants
n=122 Participants
|
17 Participants
n=79 Participants
|
1 Participants
n=806 Participants
|
5 Participants
n=43 Participants
|
4 Participants
n=33 Participants
|
1 Participants
n=39 Participants
|
50 Participants
n=35 Participants
|
|
Histology Type
Invasive ductal/extensive intraductal component
|
0 Participants
n=202 Participants
|
0 Participants
n=283 Participants
|
0 Participants
n=120 Participants
|
1 Participants
n=122 Participants
|
3 Participants
n=79 Participants
|
0 Participants
n=806 Participants
|
0 Participants
n=43 Participants
|
0 Participants
n=33 Participants
|
0 Participants
n=39 Participants
|
4 Participants
n=35 Participants
|
|
Histology Type
Invasive lobular
|
2 Participants
n=202 Participants
|
3 Participants
n=283 Participants
|
1 Participants
n=120 Participants
|
1 Participants
n=122 Participants
|
2 Participants
n=79 Participants
|
0 Participants
n=806 Participants
|
0 Participants
n=43 Participants
|
0 Participants
n=33 Participants
|
0 Participants
n=39 Participants
|
9 Participants
n=35 Participants
|
|
Histology Type
Other
|
0 Participants
n=202 Participants
|
2 Participants
n=283 Participants
|
5 Participants
n=120 Participants
|
2 Participants
n=122 Participants
|
11 Participants
n=79 Participants
|
2 Participants
n=806 Participants
|
3 Participants
n=43 Participants
|
1 Participants
n=33 Participants
|
1 Participants
n=39 Participants
|
27 Participants
n=35 Participants
|
|
Malignant pleural effusion
Absent
|
5 Participants
n=202 Participants
|
12 Participants
n=283 Participants
|
14 Participants
n=120 Participants
|
7 Participants
n=122 Participants
|
33 Participants
n=79 Participants
|
1 Participants
n=806 Participants
|
7 Participants
n=43 Participants
|
5 Participants
n=33 Participants
|
2 Participants
n=39 Participants
|
86 Participants
n=35 Participants
|
|
Malignant pleural effusion
Present
|
1 Participants
n=202 Participants
|
1 Participants
n=283 Participants
|
0 Participants
n=120 Participants
|
3 Participants
n=122 Participants
|
4 Participants
n=79 Participants
|
3 Participants
n=806 Participants
|
1 Participants
n=43 Participants
|
0 Participants
n=33 Participants
|
0 Participants
n=39 Participants
|
13 Participants
n=35 Participants
|
|
Time from Diagnosis to Enrollment
≤ 6 months
|
0 Participants
n=202 Participants
|
0 Participants
n=283 Participants
|
0 Participants
n=120 Participants
|
0 Participants
n=122 Participants
|
0 Participants
n=79 Participants
|
0 Participants
n=806 Participants
|
0 Participants
n=43 Participants
|
0 Participants
n=33 Participants
|
0 Participants
n=39 Participants
|
0 Participants
n=35 Participants
|
|
Time from Diagnosis to Enrollment
> 6 to ≤ 12 months
|
0 Participants
n=202 Participants
|
0 Participants
n=283 Participants
|
1 Participants
n=120 Participants
|
0 Participants
n=122 Participants
|
0 Participants
n=79 Participants
|
0 Participants
n=806 Participants
|
0 Participants
n=43 Participants
|
0 Participants
n=33 Participants
|
0 Participants
n=39 Participants
|
1 Participants
n=35 Participants
|
|
Time from Diagnosis to Enrollment
> 12 to ≤ 24 months
|
0 Participants
n=202 Participants
|
1 Participants
n=283 Participants
|
0 Participants
n=120 Participants
|
1 Participants
n=122 Participants
|
4 Participants
n=79 Participants
|
0 Participants
n=806 Participants
|
0 Participants
n=43 Participants
|
0 Participants
n=33 Participants
|
0 Participants
n=39 Participants
|
6 Participants
n=35 Participants
|
|
Time from Diagnosis to Enrollment
> 24 months
|
6 Participants
n=202 Participants
|
12 Participants
n=283 Participants
|
13 Participants
n=120 Participants
|
9 Participants
n=122 Participants
|
33 Participants
n=79 Participants
|
4 Participants
n=806 Participants
|
8 Participants
n=43 Participants
|
5 Participants
n=33 Participants
|
2 Participants
n=39 Participants
|
92 Participants
n=35 Participants
|
|
Time from most recent progression to enrollment
≤ 3 months
|
5 Participants
n=202 Participants
|
11 Participants
n=283 Participants
|
12 Participants
n=120 Participants
|
8 Participants
n=122 Participants
|
28 Participants
n=79 Participants
|
3 Participants
n=806 Participants
|
8 Participants
n=43 Participants
|
5 Participants
n=33 Participants
|
2 Participants
n=39 Participants
|
82 Participants
n=35 Participants
|
|
Time from most recent progression to enrollment
During screening, after informed consent
|
1 Participants
n=202 Participants
|
0 Participants
n=283 Participants
|
0 Participants
n=120 Participants
|
0 Participants
n=122 Participants
|
1 Participants
n=79 Participants
|
0 Participants
n=806 Participants
|
0 Participants
n=43 Participants
|
0 Participants
n=33 Participants
|
0 Participants
n=39 Participants
|
2 Participants
n=35 Participants
|
|
Time from most recent progression to enrollment
> 3 to ≤ 12 months
|
0 Participants
n=202 Participants
|
1 Participants
n=283 Participants
|
2 Participants
n=120 Participants
|
2 Participants
n=122 Participants
|
5 Participants
n=79 Participants
|
1 Participants
n=806 Participants
|
0 Participants
n=43 Participants
|
0 Participants
n=33 Participants
|
0 Participants
n=39 Participants
|
11 Participants
n=35 Participants
|
|
Time from most recent progression to enrollment
> 12 months
|
0 Participants
n=202 Participants
|
1 Participants
n=283 Participants
|
0 Participants
n=120 Participants
|
0 Participants
n=122 Participants
|
3 Participants
n=79 Participants
|
0 Participants
n=806 Participants
|
0 Participants
n=43 Participants
|
0 Participants
n=33 Participants
|
0 Participants
n=39 Participants
|
4 Participants
n=35 Participants
|
|
Overall disease classification
Metastatic
|
6 Participants
n=202 Participants
|
13 Participants
n=283 Participants
|
14 Participants
n=120 Participants
|
9 Participants
n=122 Participants
|
37 Participants
n=79 Participants
|
4 Participants
n=806 Participants
|
8 Participants
n=43 Participants
|
5 Participants
n=33 Participants
|
2 Participants
n=39 Participants
|
98 Participants
n=35 Participants
|
|
Overall disease classification
Locally advanced
|
0 Participants
n=202 Participants
|
0 Participants
n=283 Participants
|
0 Participants
n=120 Participants
|
1 Participants
n=122 Participants
|
0 Participants
n=79 Participants
|
0 Participants
n=806 Participants
|
0 Participants
n=43 Participants
|
0 Participants
n=33 Participants
|
0 Participants
n=39 Participants
|
1 Participants
n=35 Participants
|
|
Estrogen Receptor Positive (ER+)
Yes
|
6 Participants
n=202 Participants
|
13 Participants
n=283 Participants
|
14 Participants
n=120 Participants
|
10 Participants
n=122 Participants
|
37 Participants
n=79 Participants
|
4 Participants
n=806 Participants
|
8 Participants
n=43 Participants
|
5 Participants
n=33 Participants
|
2 Participants
n=39 Participants
|
99 Participants
n=35 Participants
|
|
Estrogen Receptor Positive (ER+)
No
|
0 Participants
n=202 Participants
|
0 Participants
n=283 Participants
|
0 Participants
n=120 Participants
|
0 Participants
n=122 Participants
|
0 Participants
n=79 Participants
|
0 Participants
n=806 Participants
|
0 Participants
n=43 Participants
|
0 Participants
n=33 Participants
|
0 Participants
n=39 Participants
|
0 Participants
n=35 Participants
|
|
Progesterone Receptor Positive (PR+)
Yes
|
3 Participants
n=202 Participants
|
7 Participants
n=283 Participants
|
7 Participants
n=120 Participants
|
7 Participants
n=122 Participants
|
30 Participants
n=79 Participants
|
4 Participants
n=806 Participants
|
4 Participants
n=43 Participants
|
1 Participants
n=33 Participants
|
2 Participants
n=39 Participants
|
65 Participants
n=35 Participants
|
|
Progesterone Receptor Positive (PR+)
No
|
3 Participants
n=202 Participants
|
6 Participants
n=283 Participants
|
7 Participants
n=120 Participants
|
3 Participants
n=122 Participants
|
7 Participants
n=79 Participants
|
0 Participants
n=806 Participants
|
4 Participants
n=43 Participants
|
4 Participants
n=33 Participants
|
0 Participants
n=39 Participants
|
34 Participants
n=35 Participants
|
|
Human Epidermal Growth Factor Receptor Positive (HER+)
Yes
|
0 Participants
n=202 Participants
|
1 Participants
n=283 Participants
|
0 Participants
n=120 Participants
|
1 Participants
n=122 Participants
|
4 Participants
n=79 Participants
|
0 Participants
n=806 Participants
|
2 Participants
n=43 Participants
|
1 Participants
n=33 Participants
|
0 Participants
n=39 Participants
|
9 Participants
n=35 Participants
|
|
Human Epidermal Growth Factor Receptor Positive (HER+)
No
|
6 Participants
n=202 Participants
|
12 Participants
n=283 Participants
|
14 Participants
n=120 Participants
|
9 Participants
n=122 Participants
|
33 Participants
n=79 Participants
|
4 Participants
n=806 Participants
|
6 Participants
n=43 Participants
|
4 Participants
n=33 Participants
|
2 Participants
n=39 Participants
|
90 Participants
n=35 Participants
|
PRIMARY outcome
Timeframe: Up to 12 MonthsPopulation: The analysis population consisted of all participants who received at least one dose of AZD2014.
Outcome measures
| Measure |
50 mg BID Continuous
n=13 Participants
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.
|
35 mg BID Continuous
n=6 Participants
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.
|
75 mg
n=14 Participants
Participants received a single dose of 75 mg of AZD2014 in fasted condition.
|
100 mg
n=10 Participants
Participants received a single dose of 100 mg of AZD2014 in fasted condition.
|
170 mg BID Intermittent Days 1 and 2 (Fed)
n=5 Participants
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.
|
125 mg BID Intermittent Days 1 and 4 (Fasted)
n=2 Participants
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.
|
125 mg BID Intermittent Days 1 and 2 (Fasted)
n=37 Participants
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.
|
125 mg BID Intermittent Days 1 and 2 (Fed)
n=4 Participants
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.
|
170 mg BID Intermittent Days 1 and 2 (Fasted)
n=8 Participants
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.
|
|---|---|---|---|---|---|---|---|---|---|
|
Adverse Events
Any Adverse Event (AE)
|
13 Participants
|
6 Participants
|
14 Participants
|
10 Participants
|
5 Participants
|
2 Participants
|
37 Participants
|
4 Participants
|
8 Participants
|
|
Adverse Events
Any AE, Causally Related to AZD2014
|
12 Participants
|
5 Participants
|
14 Participants
|
9 Participants
|
5 Participants
|
2 Participants
|
35 Participants
|
4 Participants
|
8 Participants
|
|
Adverse Events
Any AE, Causally Related to Fulvestrant Only
|
3 Participants
|
2 Participants
|
6 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
12 Participants
|
0 Participants
|
2 Participants
|
|
Adverse Events
Any AE of CTCAE Grade ≥ 3 (G3)
|
8 Participants
|
3 Participants
|
10 Participants
|
6 Participants
|
3 Participants
|
1 Participants
|
24 Participants
|
3 Participants
|
6 Participants
|
|
Adverse Events
AEs of CTCAE G3, Causally Related to AZD2014
|
8 Participants
|
2 Participants
|
7 Participants
|
5 Participants
|
2 Participants
|
0 Participants
|
16 Participants
|
0 Participants
|
6 Participants
|
|
Adverse Events
Any AE of CTCAE G3, Related to Fulvestrant Only
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Adverse Events
Any Adverse Event with Outcome of Death
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Adverse Events
AE with Outcome of Death, Related to AZD2014
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Adverse Events
AE Outcome of Death, Related to Fulvestrant Only
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Adverse Events
Any Serious Adverse Event (SAE)
|
1 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
7 Participants
|
0 Participants
|
3 Participants
|
|
Adverse Events
Any SAE, Causally Related to AZD2014
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
|
Adverse Events
Any SAE, Causally Related to Fulvestrant Only
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Adverse Events
Any AE Leading to Discontinuation of AZD2014
|
4 Participants
|
2 Participants
|
2 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
|
Adverse Events
Any SAE Leading to Discontinuation of AZD2014
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Up to 28 DaysPopulation: The analysis population consisted of all participants who received at least one dose of AZD2014.
Outcome measures
| Measure |
50 mg BID Continuous
n=13 Participants
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.
|
35 mg BID Continuous
n=6 Participants
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.
|
75 mg
n=14 Participants
Participants received a single dose of 75 mg of AZD2014 in fasted condition.
|
100 mg
n=10 Participants
Participants received a single dose of 100 mg of AZD2014 in fasted condition.
|
170 mg BID Intermittent Days 1 and 2 (Fed)
n=5 Participants
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.
|
125 mg BID Intermittent Days 1 and 4 (Fasted)
n=2 Participants
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.
|
125 mg BID Intermittent Days 1 and 2 (Fasted)
n=37 Participants
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.
|
125 mg BID Intermittent Days 1 and 2 (Fed)
n=4 Participants
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.
|
170 mg BID Intermittent Days 1 and 2 (Fasted)
n=8 Participants
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.
|
|---|---|---|---|---|---|---|---|---|---|
|
Adverse Events Leading to Dose Reduction of AZD2014
|
7 Participants
|
1 Participants
|
4 Participants
|
6 Participants
|
3 Participants
|
2 Participants
|
12 Participants
|
0 Participants
|
4 Participants
|
PRIMARY outcome
Timeframe: Up to 12 MonthsPopulation: The analysis population consisted of all participants who received at least one dose of AZD2014.
Outcome measures
| Measure |
50 mg BID Continuous
n=13 Participants
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.
|
35 mg BID Continuous
n=6 Participants
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.
|
75 mg
n=14 Participants
Participants received a single dose of 75 mg of AZD2014 in fasted condition.
|
100 mg
n=10 Participants
Participants received a single dose of 100 mg of AZD2014 in fasted condition.
|
170 mg BID Intermittent Days 1 and 2 (Fed)
n=5 Participants
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.
|
125 mg BID Intermittent Days 1 and 4 (Fasted)
n=2 Participants
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.
|
125 mg BID Intermittent Days 1 and 2 (Fasted)
n=37 Participants
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.
|
125 mg BID Intermittent Days 1 and 2 (Fed)
n=4 Participants
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.
|
170 mg BID Intermittent Days 1 and 2 (Fasted)
n=8 Participants
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.
|
|---|---|---|---|---|---|---|---|---|---|
|
Clinically Important Changes in Haematology Parameters
Change in Hemoglobin ≥ 2 CTCAE Grades
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Clinically Important Changes in Haematology Parameters
Change in Hemoglobin to CTCAE Grade 3 or 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Clinically Important Changes in Haematology Parameters
Change in Leukocytes ≥ 2 CTCAE Grades
|
4 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
9 Participants
|
2 Participants
|
2 Participants
|
|
Clinically Important Changes in Haematology Parameters
Change in Leukocytes to CTCAE Grade 3 or 4
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Clinically Important Changes in Haematology Parameters
Change in Lymphocytes ≥ 2 CTCAE Grades
|
6 Participants
|
2 Participants
|
8 Participants
|
5 Participants
|
2 Participants
|
1 Participants
|
10 Participants
|
0 Participants
|
1 Participants
|
|
Clinically Important Changes in Haematology Parameters
Change in Lymphocytes to CTCAE Grade 3 or 4
|
3 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
7 Participants
|
1 Participants
|
1 Participants
|
|
Clinically Important Changes in Haematology Parameters
Change in Neutrophils ≥ 2 CTCAE Grades
|
4 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
12 Participants
|
1 Participants
|
1 Participants
|
|
Clinically Important Changes in Haematology Parameters
Change in Neutrophils to CTCAE Grade 3 or 4
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Clinically Important Changes in Haematology Parameters
Change in Platelets ≥ 2 CTCAE Grades
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
|
Clinically Important Changes in Haematology Parameters
Change in Platelets to CTCAE Grade 3 or 4
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Clinically Important Changes in Haematology Parameters
Change in aPTT ≥ 2 CTCAE Grades
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
|
Clinically Important Changes in Haematology Parameters
Change in aPTT to CTCAE Grade 3 or 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Clinically Important Changes in Haematology Parameters
Change in INR ≥ 2 CTCAE Grades
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Clinically Important Changes in Haematology Parameters
Change in INR to CTCAE Grade 3 or 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to 12 MonthsPopulation: The analysis population consisted of all participants who received at least one dose of AZD2014.
Outcome measures
| Measure |
50 mg BID Continuous
n=13 Participants
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.
|
35 mg BID Continuous
n=6 Participants
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.
|
75 mg
n=14 Participants
Participants received a single dose of 75 mg of AZD2014 in fasted condition.
|
100 mg
n=10 Participants
Participants received a single dose of 100 mg of AZD2014 in fasted condition.
|
170 mg BID Intermittent Days 1 and 2 (Fed)
n=5 Participants
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.
|
125 mg BID Intermittent Days 1 and 4 (Fasted)
n=2 Participants
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.
|
125 mg BID Intermittent Days 1 and 2 (Fasted)
n=37 Participants
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.
|
125 mg BID Intermittent Days 1 and 2 (Fed)
n=4 Participants
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.
|
170 mg BID Intermittent Days 1 and 2 (Fasted)
n=8 Participants
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.
|
|---|---|---|---|---|---|---|---|---|---|
|
Clinically Important Changes in Clinical Chemistry Parameters
Change in Alk Phosphatase ≥ 2 CTCAE Grades
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Clinically Important Changes in Clinical Chemistry Parameters
Change in ALT ≥ 2 CTCAE Grades
|
1 Participants
|
0 Participants
|
3 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Clinically Important Changes in Clinical Chemistry Parameters
Change in ALT to CTCAE Grade 3 or 4
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Clinically Important Changes in Clinical Chemistry Parameters
Change in AST ≥ 2 CTCAE Grades
|
2 Participants
|
0 Participants
|
3 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Clinically Important Changes in Clinical Chemistry Parameters
Change in AST to CTCAE Grade 3 or 4
|
0 Participants
|
0 Participants
|
5 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
|
Clinically Important Changes in Clinical Chemistry Parameters
Change in Albumin to CTCAE Grade 3 or 4
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Clinically Important Changes in Clinical Chemistry Parameters
Change in Bilirubin ≥ 2 CTCAE Grades
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
2 Participants
|
|
Clinically Important Changes in Clinical Chemistry Parameters
Change in Bilirubin to CTCAE Grade 3 or 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Clinically Important Changes in Clinical Chemistry Parameters
Change in Creatinine ≥ 2 CTCAE Grades
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Clinically Important Changes in Clinical Chemistry Parameters
Change in Creatinine to CTCAE Grade 3 or 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Clinically Important Changes in Clinical Chemistry Parameters
Change in Phosphate ≥ 2 CTCAE Grades
|
2 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
15 Participants
|
1 Participants
|
1 Participants
|
|
Clinically Important Changes in Clinical Chemistry Parameters
Change in Phosphate to CTCAE Grade 3 or 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
7 Participants
|
0 Participants
|
0 Participants
|
|
Clinically Important Changes in Clinical Chemistry Parameters
Change in Urate ≥ 2 CTCAE Grades
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Clinically Important Changes in Clinical Chemistry Parameters
Change in Urate to CTCAE Grade 3 or 4
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Clinically Important Changes in Clinical Chemistry Parameters
Change in Calcium ≥ 2 CTCAE Grades
|
3 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
6 Participants
|
1 Participants
|
2 Participants
|
|
Clinically Important Changes in Clinical Chemistry Parameters
Change in Calcium to CTCAE Grade 3 or 4
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Clinically Important Changes in Clinical Chemistry Parameters
Change in Sodium ≥ 2 CTCAE Grades
|
1 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Clinically Important Changes in Clinical Chemistry Parameters
Change in Sodium to CTCAE Grade 3 or 4
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Clinically Important Changes in Clinical Chemistry Parameters
Change in Potassium ≥ 2 CTCAE Grades
|
1 Participants
|
1 Participants
|
2 Participants
|
5 Participants
|
0 Participants
|
0 Participants
|
5 Participants
|
1 Participants
|
0 Participants
|
|
Clinically Important Changes in Clinical Chemistry Parameters
Change in Potassium to CTCAE Grade 3 or 4
|
0 Participants
|
0 Participants
|
1 Participants
|
5 Participants
|
0 Participants
|
0 Participants
|
5 Participants
|
1 Participants
|
0 Participants
|
|
Clinically Important Changes in Clinical Chemistry Parameters
Change in Magnesium ≥ 2 CTCAE Grades
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
|
Clinically Important Changes in Clinical Chemistry Parameters
Change in Magnesium to CTCAE Grade 3 or 4
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Clinically Important Changes in Clinical Chemistry Parameters
Change in Fasting Glucose ≥ 2 CTCAE Grades
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
7 Participants
|
1 Participants
|
4 Participants
|
|
Clinically Important Changes in Clinical Chemistry Parameters
Change in Fasting Glucose to CTCAE Grade 3 or 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Clinically Important Changes in Clinical Chemistry Parameters
Change in NonFasting Glucose ≥ 2 CTCAE Grades
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Clinically Important Changes in Clinical Chemistry Parameters
Change in Non Fasting Glucose to CTCAE Gr.3 or 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Clinically Important Changes in Clinical Chemistry Parameters
Change in Alk Phosphatase to CTCAE Grade 3 or 4
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Clinically Important Changes in Clinical Chemistry Parameters
Change in Albumin ≥ 2 CTCAE Grades
|
1 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
6 Participants
|
1 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: 24 hoursPopulation: The analysis population consisted of all participants who received at least one dose of AZD2014.
Outcome measures
| Measure |
50 mg BID Continuous
n=13 Participants
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.
|
35 mg BID Continuous
n=6 Participants
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.
|
75 mg
n=14 Participants
Participants received a single dose of 75 mg of AZD2014 in fasted condition.
|
100 mg
n=10 Participants
Participants received a single dose of 100 mg of AZD2014 in fasted condition.
|
170 mg BID Intermittent Days 1 and 2 (Fed)
n=5 Participants
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.
|
125 mg BID Intermittent Days 1 and 4 (Fasted)
n=2 Participants
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.
|
125 mg BID Intermittent Days 1 and 2 (Fasted)
n=37 Participants
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.
|
125 mg BID Intermittent Days 1 and 2 (Fed)
n=4 Participants
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.
|
170 mg BID Intermittent Days 1 and 2 (Fasted)
n=8 Participants
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.
|
|---|---|---|---|---|---|---|---|---|---|
|
Left Ventricular Ejection Fraction
Screening
|
64.0 % Left Ventricular Ejection Fraction
Standard Deviation 5.4
|
59.2 % Left Ventricular Ejection Fraction
Standard Deviation 4.5
|
60.9 % Left Ventricular Ejection Fraction
Standard Deviation 6.2
|
61.4 % Left Ventricular Ejection Fraction
Standard Deviation 9.8
|
63.8 % Left Ventricular Ejection Fraction
Standard Deviation 5.2
|
NA % Left Ventricular Ejection Fraction
Standard Deviation NA
Mean and standard deviation were not calculated because there were \< 3 participants in this arm.
|
62.6 % Left Ventricular Ejection Fraction
Standard Deviation 4.1
|
62.5 % Left Ventricular Ejection Fraction
Standard Deviation 2.9
|
66.9 % Left Ventricular Ejection Fraction
Standard Deviation 4.6
|
|
Left Ventricular Ejection Fraction
Change from Baseline to End of Study
|
1.4 % Left Ventricular Ejection Fraction
Standard Deviation 5.9
|
NA % Left Ventricular Ejection Fraction
Standard Deviation NA
Mean and SD were not
|
-1.5 % Left Ventricular Ejection Fraction
Standard Deviation 2.4
|
0.0 % Left Ventricular Ejection Fraction
Standard Deviation 7.6
|
NA % Left Ventricular Ejection Fraction
Standard Deviation NA
Data not collected
|
NA % Left Ventricular Ejection Fraction
Standard Deviation NA
Mean and standard deviation were not calculated because there were \< 3 participants in this arm.
|
-1.3 % Left Ventricular Ejection Fraction
Standard Deviation 3.9
|
NA % Left Ventricular Ejection Fraction
Standard Deviation NA
Data not collected
|
NA % Left Ventricular Ejection Fraction
Standard Deviation NA
Data not collected
|
|
Left Ventricular Ejection Fraction
End of Study
|
64.0 % Left Ventricular Ejection Fraction
Standard Deviation 2.0
|
NA % Left Ventricular Ejection Fraction
Standard Deviation NA
Mean and SD were not calculated because data was available from \< 3 participants.
|
62.3 % Left Ventricular Ejection Fraction
Standard Deviation 4.1
|
61.8 % Left Ventricular Ejection Fraction
Standard Deviation 8.3
|
NA % Left Ventricular Ejection Fraction
Standard Deviation NA
Data not collected
|
NA % Left Ventricular Ejection Fraction
Standard Deviation NA
Mean and standard deviation were not calculated because there were \< 3 participants in this arm.
|
62.5 % Left Ventricular Ejection Fraction
Standard Deviation 2.9
|
NA % Left Ventricular Ejection Fraction
Standard Deviation NA
Data not collected
|
NA % Left Ventricular Ejection Fraction
Standard Deviation NA
Data not collected
|
PRIMARY outcome
Timeframe: 24 hoursPopulation: The analysis population consisted of all participants who received at least one dose of AZD2014.
Outcome measures
| Measure |
50 mg BID Continuous
n=13 Participants
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.
|
35 mg BID Continuous
n=6 Participants
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.
|
75 mg
n=14 Participants
Participants received a single dose of 75 mg of AZD2014 in fasted condition.
|
100 mg
n=10 Participants
Participants received a single dose of 100 mg of AZD2014 in fasted condition.
|
170 mg BID Intermittent Days 1 and 2 (Fed)
n=5 Participants
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.
|
125 mg BID Intermittent Days 1 and 4 (Fasted)
n=2 Participants
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.
|
125 mg BID Intermittent Days 1 and 2 (Fasted)
n=37 Participants
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.
|
125 mg BID Intermittent Days 1 and 2 (Fed)
n=4 Participants
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.
|
170 mg BID Intermittent Days 1 and 2 (Fasted)
n=8 Participants
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.
|
|---|---|---|---|---|---|---|---|---|---|
|
QTcF Over 24 Hours
4 Hours Postdose
|
419.97 msec
Standard Deviation 21.322
|
422.00 msec
Standard Deviation 10.583
|
411.18 msec
Standard Deviation 15.886
|
410.88 msec
Standard Deviation 13.815
|
422.40 msec
Standard Deviation 10.397
|
NA msec
Standard Deviation NA
Mean and standard deviation were not calculated because there were \< 3 participants in this arm.
|
414.04 msec
Standard Deviation 17.351
|
424.43 msec
Standard Deviation 17.832
|
426.60 msec
Standard Deviation 16.724
|
|
QTcF Over 24 Hours
Baseline
|
421.92 msec
Standard Deviation 22.715
|
423.12 msec
Standard Deviation 11.070
|
412.78 msec
Standard Deviation 14.222
|
415.95 msec
Standard Deviation 14.849
|
435.26 msec
Standard Deviation 7.971
|
NA msec
Standard Deviation NA
Mean and standard deviation were not calculated because there were \< 3 participants in this arm.
|
419.95 msec
Standard Deviation 20.502
|
427.13 msec
Standard Deviation 32.995
|
424.84 msec
Standard Deviation 6.932
|
|
QTcF Over 24 Hours
0.25 Hours Postdose
|
420.13 msec
Standard Deviation 18.333
|
429.66 msec
Standard Deviation 5.707
|
413.04 msec
Standard Deviation 14.934
|
418.44 msec
Standard Deviation 16.145
|
NA msec
Standard Deviation NA
Data not collected
|
NA msec
Standard Deviation NA
Mean and standard deviation were not calculated because there were \< 3 participants in this arm.
|
NA msec
Standard Deviation NA
Data not collected
|
NA msec
Standard Deviation NA
Data not collected
|
NA msec
Standard Deviation NA
Data not collected
|
|
QTcF Over 24 Hours
0.5 Hours Postdose
|
419.18 msec
Standard Deviation 21.362
|
431.84 msec
Standard Deviation 7.504
|
415.08 msec
Standard Deviation 14.762
|
418.91 msec
Standard Deviation 14.437
|
420.06 msec
Standard Deviation 18.388
|
NA msec
Standard Deviation NA
Mean and standard deviation were not calculated because there were \< 3 participants in this arm.
|
413.28 msec
Standard Deviation 19.715
|
418.90 msec
Standard Deviation 14.897
|
415.67 msec
Standard Deviation 16.874
|
|
QTcF Over 24 Hours
1 Hour Postdose
|
422.21 msec
Standard Deviation 21.863
|
431.00 msec
Standard Deviation 10.149
|
416.08 msec
Standard Deviation 17.581
|
416.20 msec
Standard Deviation 14.530
|
421.20 msec
Standard Deviation 21.336
|
NA msec
Standard Deviation NA
Mean and standard deviation were not calculated because there were \< 3 participants in this arm.
|
416.22 msec
Standard Deviation 19.738
|
427.77 msec
Standard Deviation 10.186
|
419.61 msec
Standard Deviation 16.514
|
|
QTcF Over 24 Hours
1.5 Hours Postdose
|
425.15 msec
Standard Deviation 22.106
|
431.82 msec
Standard Deviation 8.569
|
415.36 msec
Standard Deviation 16.394
|
415.33 msec
Standard Deviation 15.020
|
427.48 msec
Standard Deviation 20.863
|
NA msec
Standard Deviation NA
Mean and standard deviation were not calculated because there were \< 3 participants in this arm.
|
417.10 msec
Standard Deviation 19.672
|
434.33 msec
Standard Deviation 14.199
|
420.43 msec
Standard Deviation 15.627
|
|
QTcF Over 24 Hours
2 Hours Postdose
|
423.31 msec
Standard Deviation 22.678
|
433.02 msec
Standard Deviation 11.921
|
415.84 msec
Standard Deviation 17.508
|
414.01 msec
Standard Deviation 17.988
|
422.94 msec
Standard Deviation 18.036
|
NA msec
Standard Deviation NA
Mean and standard deviation were not calculated because there were \< 3 participants in this arm.
|
414.99 msec
Standard Deviation 17.250
|
424.00 msec
Standard Deviation 22.528
|
418.60 msec
Standard Deviation 15.144
|
|
QTcF Over 24 Hours
6 Hours Postdose
|
419.14 msec
Standard Deviation 21.269
|
421.50 msec
Standard Deviation 15.453
|
411.85 msec
Standard Deviation 13.387
|
414.74 msec
Standard Deviation 16.413
|
418.34 msec
Standard Deviation 13.781
|
NA msec
Standard Deviation NA
Mean and standard deviation were not calculated because there were \< 3 participants in this arm.
|
412.80 msec
Standard Deviation 17.342
|
417.00 msec
Standard Deviation 20.421
|
422.94 msec
Standard Deviation 18.577
|
|
QTcF Over 24 Hours
8 Hours Postdose
|
420.16 msec
Standard Deviation 20.437
|
424.86 msec
Standard Deviation 12.688
|
411.16 msec
Standard Deviation 15.587
|
413.56 msec
Standard Deviation 15.072
|
425.54 msec
Standard Deviation 12.246
|
NA msec
Standard Deviation NA
Mean and standard deviation were not calculated because there were \< 3 participants in this arm.
|
414.17 msec
Standard Deviation 18.533
|
419.90 msec
Standard Deviation 22.274
|
416.80 msec
Standard Deviation 15.144
|
|
QTcF Over 24 Hours
12 Hours Postdose
|
425.46 msec
Standard Deviation 21.533
|
427.74 msec
Standard Deviation 15.157
|
409.67 msec
Standard Deviation 19.176
|
414.59 msec
Standard Deviation 15.760
|
432.46 msec
Standard Deviation 16.503
|
NA msec
Standard Deviation NA
Mean and standard deviation were not calculated because there were \< 3 participants in this arm.
|
414.09 msec
Standard Deviation 18.188
|
431.70 msec
Standard Deviation 16.896
|
420.66 msec
Standard Deviation 10.462
|
|
QTcF Over 24 Hours
24 Hours Postdose
|
421.45 msec
Standard Deviation 16.339
|
425.54 msec
Standard Deviation 10.519
|
409.33 msec
Standard Deviation 16.313
|
415.29 msec
Standard Deviation 16.968
|
NA msec
Standard Deviation NA
Data not collected
|
NA msec
Standard Deviation NA
Mean and standard deviation were not calculated because there were \< 3 participants in this arm.
|
422.73 msec
Standard Deviation 17.900
|
426.77 msec
Standard Deviation 16.591
|
NA msec
Standard Deviation NA
Data not collected
|
PRIMARY outcome
Timeframe: 28 DaysPopulation: The analysis population consisted of all participants who received at least one dose of AZD2014.
Outcome measures
| Measure |
50 mg BID Continuous
n=13 Participants
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.
|
35 mg BID Continuous
n=6 Participants
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.
|
75 mg
n=14 Participants
Participants received a single dose of 75 mg of AZD2014 in fasted condition.
|
100 mg
n=10 Participants
Participants received a single dose of 100 mg of AZD2014 in fasted condition.
|
170 mg BID Intermittent Days 1 and 2 (Fed)
n=5 Participants
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.
|
125 mg BID Intermittent Days 1 and 4 (Fasted)
n=2 Participants
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.
|
125 mg BID Intermittent Days 1 and 2 (Fasted)
n=37 Participants
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.
|
125 mg BID Intermittent Days 1 and 2 (Fed)
n=4 Participants
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.
|
170 mg BID Intermittent Days 1 and 2 (Fasted)
n=8 Participants
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.
|
|---|---|---|---|---|---|---|---|---|---|
|
Post-Baseline Glucose Elevation
Participants with ≥ 1 post-baseline elevation
|
6 Participants
|
3 Participants
|
7 Participants
|
5 Participants
|
5 Participants
|
0 Participants
|
29 Participants
|
3 Participants
|
6 Participants
|
|
Post-Baseline Glucose Elevation
Subjects with Max Post-Baseline CTCAE Grade ≥ 1
|
5 Participants
|
2 Participants
|
5 Participants
|
3 Participants
|
4 Participants
|
0 Participants
|
17 Participants
|
2 Participants
|
2 Participants
|
|
Post-Baseline Glucose Elevation
Subjects with Max Post-Baseline CTCAE Grade ≥ 2
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
7 Participants
|
1 Participants
|
1 Participants
|
|
Post-Baseline Glucose Elevation
Subjects with Max Post-Baseline CTCAE Grade ≥ 3
|
1 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
5 Participants
|
0 Participants
|
3 Participants
|
|
Post-Baseline Glucose Elevation
Subjects with Max Post-Baseline CTCAE Grade ≥ 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 28 DaysPopulation: The analysis population consisted of all participants who received at least one dose of AZD2014.
Outcome measures
| Measure |
50 mg BID Continuous
n=13 Participants
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.
|
35 mg BID Continuous
n=6 Participants
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.
|
75 mg
n=14 Participants
Participants received a single dose of 75 mg of AZD2014 in fasted condition.
|
100 mg
n=10 Participants
Participants received a single dose of 100 mg of AZD2014 in fasted condition.
|
170 mg BID Intermittent Days 1 and 2 (Fed)
n=5 Participants
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.
|
125 mg BID Intermittent Days 1 and 4 (Fasted)
n=2 Participants
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.
|
125 mg BID Intermittent Days 1 and 2 (Fasted)
n=37 Participants
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.
|
125 mg BID Intermittent Days 1 and 2 (Fed)
n=4 Participants
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.
|
170 mg BID Intermittent Days 1 and 2 (Fasted)
n=8 Participants
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.
|
|---|---|---|---|---|---|---|---|---|---|
|
Sitting Diastolic Blood Pressure
Baseline
|
75.4 mmHg
Standard Deviation 10.43
|
72.8 mmHg
Standard Deviation 7.31
|
77.4 mmHg
Standard Deviation 7.71
|
74.9 mmHg
Standard Deviation 8.36
|
76.6 mmHg
Standard Deviation 8.59
|
NA mmHg
Standard Deviation NA
Mean and standard deviation were not calculated because there were \< 3 participants in this arm.
|
74.4 mmHg
Standard Deviation 11.68
|
73.8 mmHg
Standard Deviation 8.62
|
75.5 mmHg
Standard Deviation 13.32
|
|
Sitting Diastolic Blood Pressure
Cycle 1, Day 1
|
77.4 mmHg
Standard Deviation 9.82
|
74.8 mmHg
Standard Deviation 9.43
|
75.4 mmHg
Standard Deviation 6.91
|
76.5 mmHg
Standard Deviation 8.03
|
76.6 mmHg
Standard Deviation 8.59
|
NA mmHg
Standard Deviation NA
Mean and standard deviation were not calculated because there were \< 3 participants in this arm.
|
74.4 mmHg
Standard Deviation 11.68
|
73.8 mmHg
Standard Deviation 8.62
|
75.5 mmHg
Standard Deviation 12.32
|
|
Sitting Diastolic Blood Pressure
Cycle 1, Day 8
|
74.3 mmHg
Standard Deviation 8.58
|
74.5 mmHg
Standard Deviation 5.96
|
75.3 mmHg
Standard Deviation 8.84
|
72.6 mmHg
Standard Deviation 12.68
|
75.8 mmHg
Standard Deviation 7.63
|
NA mmHg
Standard Deviation NA
Mean and standard deviation were not calculated because there were \< 3 participants in this arm.
|
72.4 mmHg
Standard Deviation 11.77
|
70.8 mmHg
Standard Deviation 5.38
|
78.3 mmHg
Standard Deviation 10.64
|
|
Sitting Diastolic Blood Pressure
Cycle 1, Day 15
|
72.8 mmHg
Standard Deviation 8.64
|
74.7 mmHg
Standard Deviation 2.16
|
75.4 mmHg
Standard Deviation 7.86
|
68.7 mmHg
Standard Deviation 7.12
|
69.0 mmHg
Standard Deviation 9.59
|
NA mmHg
Standard Deviation NA
Mean and standard deviation were not calculated because there were \< 3 participants in this arm.
|
73.1 mmHg
Standard Deviation 11.09
|
70.0 mmHg
Standard Deviation 7.87
|
74.2 mmHg
Standard Deviation 14.11
|
|
Sitting Diastolic Blood Pressure
Cycle 1, Day 22
|
73.9 mmHg
Standard Deviation 9.37
|
72.5 mmHg
Standard Deviation 7.48
|
76.2 mmHg
Standard Deviation 6.20
|
77.0 mmHg
Standard Deviation 5.40
|
73.2 mmHg
Standard Deviation 13.10
|
NA mmHg
Standard Deviation NA
Mean and standard deviation were not calculated because there were \< 3 participants in this arm.
|
70.9 mmHg
Standard Deviation 11.76
|
74.8 mmHg
Standard Deviation 10.24
|
75.0 mmHg
Standard Deviation 12.40
|
|
Sitting Diastolic Blood Pressure
Cycle 2, Day 1
|
73.3 mmHg
Standard Deviation 10.49
|
72.0 mmHg
Standard Deviation 8.00
|
72.7 mmHg
Standard Deviation 8.91
|
74.1 mmHg
Standard Deviation 7.36
|
68.0 mmHg
Standard Deviation 5.29
|
NA mmHg
Standard Deviation NA
Mean and standard deviation were not calculated because there were \< 3 participants in this arm.
|
71.4 mmHg
Standard Deviation 10.43
|
73.3 mmHg
Standard Deviation 4.57
|
72.5 mmHg
Standard Deviation 12.42
|
PRIMARY outcome
Timeframe: 28 DaysPopulation: The analysis population consisted of all participants who received at least one dose of AZD2014.
Outcome measures
| Measure |
50 mg BID Continuous
n=13 Participants
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.
|
35 mg BID Continuous
n=6 Participants
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.
|
75 mg
n=14 Participants
Participants received a single dose of 75 mg of AZD2014 in fasted condition.
|
100 mg
n=10 Participants
Participants received a single dose of 100 mg of AZD2014 in fasted condition.
|
170 mg BID Intermittent Days 1 and 2 (Fed)
n=5 Participants
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.
|
125 mg BID Intermittent Days 1 and 4 (Fasted)
n=2 Participants
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.
|
125 mg BID Intermittent Days 1 and 2 (Fasted)
n=37 Participants
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.
|
125 mg BID Intermittent Days 1 and 2 (Fed)
n=4 Participants
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.
|
170 mg BID Intermittent Days 1 and 2 (Fasted)
n=8 Participants
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.
|
|---|---|---|---|---|---|---|---|---|---|
|
Sitting Systolic Blood Pressure
Cycle 2, Day 1
|
119.7 mmHg
Standard Deviation 17.59
|
111.7 mmHg
Standard Deviation 17.83
|
123.6 mmHg
Standard Deviation 24.89
|
116.6 mmHg
Standard Deviation 10.31
|
117.0 mmHg
Standard Deviation 9.06
|
NA mmHg
Standard Deviation NA
Mean and standard deviation were not calculated because there were \< 3 participants in this arm.
|
119.3 mmHg
Standard Deviation 17.81
|
112.5 mmHg
Standard Deviation 9.00
|
113.2 mmHg
Standard Deviation 18.54
|
|
Sitting Systolic Blood Pressure
Baseline
|
126.3 mmHg
Standard Deviation 14.65
|
114.2 mmHg
Standard Deviation 9.13
|
127.4 mmHg
Standard Deviation 14.09
|
125.2 mmHg
Standard Deviation 20.82
|
137.8 mmHg
Standard Deviation 19.18
|
NA mmHg
Standard Deviation NA
Mean and standard deviation were not calculated because there were \< 3 participants in this arm.
|
124.4 mmHg
Standard Deviation 19.04
|
122.3 mmHg
Standard Deviation 14.31
|
120.8 mmHg
Standard Deviation 17.65
|
|
Sitting Systolic Blood Pressure
Cycle 1, Day 1
|
125.1 mmHg
Standard Deviation 15.68
|
113.5 mmHg
Standard Deviation 17.02
|
122.6 mmHg
Standard Deviation 18.05
|
124.7 mmHg
Standard Deviation 14.51
|
137.8 mmHg
Standard Deviation 19.18
|
NA mmHg
Standard Deviation NA
Mean and standard deviation were not calculated because there were \< 3 participants in this arm.
|
124.4 mmHg
Standard Deviation 19.04
|
122.3 mmHg
Standard Deviation 14.31
|
120.8 mmHg
Standard Deviation 17.65
|
|
Sitting Systolic Blood Pressure
Cycle 1, Day 8
|
120.4 mmHg
Standard Deviation 9.12
|
124.0 mmHg
Standard Deviation 5.93
|
123.7 mmHg
Standard Deviation 16.41
|
122.2 mmHg
Standard Deviation 20.67
|
124.8 mmHg
Standard Deviation 21.56
|
NA mmHg
Standard Deviation NA
Mean and standard deviation were not calculated because there were \< 3 participants in this arm.
|
122.2 mmHg
Standard Deviation 13.88
|
115.3 mmHg
Standard Deviation 13.30
|
127.9 mmHg
Standard Deviation 17.59
|
|
Sitting Systolic Blood Pressure
Cycle 1, Day 15
|
115.5 mmHg
Standard Deviation 17.50
|
119.7 mmHg
Standard Deviation 6.59
|
121.6 mmHg
Standard Deviation 17.68
|
115.2 mmHg
Standard Deviation 9.17
|
126.6 mmHg
Standard Deviation 10.97
|
NA mmHg
Standard Deviation NA
Mean and standard deviation were not calculated because there were \< 3 participants in this arm.
|
122.8 mmHg
Standard Deviation 14.96
|
112.8 mmHg
Standard Deviation 13.10
|
128.3 mmHg
Standard Deviation 15.87
|
|
Sitting Systolic Blood Pressure
Cycle 1, Day 22
|
124.7 mmHg
Standard Deviation 16.92
|
116.7 mmHg
Standard Deviation 12.09
|
123.5 mmHg
Standard Deviation 21.17
|
125.4 mmHg
Standard Deviation 16.67
|
109.2 mmHg
Standard Deviation 8.32
|
NA mmHg
Standard Deviation NA
Mean and standard deviation were not calculated because there were \< 3 participants in this arm.
|
116.6 mmHg
Standard Deviation 16.62
|
115.5 mmHg
Standard Deviation 15.50
|
119.9 mmHg
Standard Deviation 19.18
|
PRIMARY outcome
Timeframe: 28 DaysPopulation: The analysis population consisted of all participants who received at least one dose of AZD2014.
Outcome measures
| Measure |
50 mg BID Continuous
n=13 Participants
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.
|
35 mg BID Continuous
n=6 Participants
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.
|
75 mg
n=14 Participants
Participants received a single dose of 75 mg of AZD2014 in fasted condition.
|
100 mg
n=10 Participants
Participants received a single dose of 100 mg of AZD2014 in fasted condition.
|
170 mg BID Intermittent Days 1 and 2 (Fed)
n=5 Participants
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.
|
125 mg BID Intermittent Days 1 and 4 (Fasted)
n=2 Participants
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.
|
125 mg BID Intermittent Days 1 and 2 (Fasted)
n=37 Participants
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.
|
125 mg BID Intermittent Days 1 and 2 (Fed)
n=4 Participants
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.
|
170 mg BID Intermittent Days 1 and 2 (Fasted)
n=8 Participants
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.
|
|---|---|---|---|---|---|---|---|---|---|
|
Respiratory Rate
Cycle 1, Day 1
|
16.6 breaths/min
Standard Deviation 1.43
|
16.0 breaths/min
Standard Deviation 1.63
|
17.7 breaths/min
Standard Deviation 1.33
|
17.3 breaths/min
Standard Deviation 1.34
|
17.6 breaths/min
Standard Deviation 0.89
|
NA breaths/min
Standard Deviation NA
Mean and standard deviation were not calculated because there were \< 3 participants in this arm.
|
17.5 breaths/min
Standard Deviation 0.96
|
17.5 breaths/min
Standard Deviation 0.58
|
18.1 breaths/min
Standard Deviation 0.83
|
|
Respiratory Rate
Cycle 1, Day 8
|
16.4 breaths/min
Standard Deviation 1.89
|
17.3 breaths/min
Standard Deviation 1.63
|
17.6 breaths/min
Standard Deviation 1.34
|
17.5 breaths/min
Standard Deviation 0.85
|
18.0 breaths/min
Standard Deviation 0.00
|
NA breaths/min
Standard Deviation NA
Mean and standard deviation were not calculated because there were \< 3 participants in this arm.
|
17.2 breaths/min
Standard Deviation 1.47
|
16.8 breaths/min
Standard Deviation 0.96
|
17.3 breaths/min
Standard Deviation 1.89
|
|
Respiratory Rate
Cycle 1, Day 15
|
17.1 breaths/min
Standard Deviation 1.38
|
17.2 breaths/min
Standard Deviation 0.98
|
18.5 breaths/min
Standard Deviation 1.20
|
17.9 breaths/min
Standard Deviation 1.66
|
17.4 breaths/min
Standard Deviation 0.89
|
NA breaths/min
Standard Deviation NA
Mean and standard deviation were not calculated because there were \< 3 participants in this arm.
|
17.6 breaths/min
Standard Deviation 1.03
|
17.0 breaths/min
Standard Deviation 0.82
|
17.7 breaths/min
Standard Deviation 0.82
|
|
Respiratory Rate
Cycle 1, Day 22
|
17.8 breaths/min
Standard Deviation 1.03
|
17.3 breaths/min
Standard Deviation 2.07
|
18.0 breaths/min
Standard Deviation 1.15
|
17.1 breaths/min
Standard Deviation 1.07
|
18.0 breaths/min
Standard Deviation 0.00
|
NA breaths/min
Standard Deviation NA
Mean and standard deviation were not calculated because there were \< 3 participants in this arm.
|
17.6 breaths/min
Standard Deviation 1.54
|
17.8 breaths/min
Standard Deviation 1.26
|
17.6 breaths/min
Standard Deviation 0.79
|
|
Respiratory Rate
Cycle 2, Day 1
|
17.6 breaths/min
Standard Deviation 1.16
|
17.3 breaths/min
Standard Deviation 1.63
|
17.8 breaths/min
Standard Deviation 0.99
|
18.3 breaths/min
Standard Deviation 1.28
|
17.5 breaths/min
Standard Deviation 1.00
|
NA breaths/min
Standard Deviation NA
Mean and standard deviation were not calculated because there were \< 3 participants in this arm.
|
17.3 breaths/min
Standard Deviation 2.11
|
17.8 breaths/min
Standard Deviation 1.26
|
17.3 breaths/min
Standard Deviation 1.03
|
|
Respiratory Rate
Baseline
|
17.5 breaths/min
Standard Deviation 1.85
|
18.3 breaths/min
Standard Deviation 2.66
|
18.3 breaths/min
Standard Deviation 1.33
|
17.8 breaths/min
Standard Deviation 2.39
|
17.6 breaths/min
Standard Deviation 0.89
|
NA breaths/min
Standard Deviation NA
Mean and standard deviation were not calculated because there were \< 3 participants in this arm.
|
17.5 breaths/min
Standard Deviation 0.96
|
17.5 breaths/min
Standard Deviation 0.58
|
18.1 breaths/min
Standard Deviation 0.83
|
PRIMARY outcome
Timeframe: 28 DaysPopulation: The analysis population consisted of all participants who received at least one dose of AZD2014.
Outcome measures
| Measure |
50 mg BID Continuous
n=13 Participants
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.
|
35 mg BID Continuous
n=6 Participants
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.
|
75 mg
n=14 Participants
Participants received a single dose of 75 mg of AZD2014 in fasted condition.
|
100 mg
n=10 Participants
Participants received a single dose of 100 mg of AZD2014 in fasted condition.
|
170 mg BID Intermittent Days 1 and 2 (Fed)
n=5 Participants
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.
|
125 mg BID Intermittent Days 1 and 4 (Fasted)
n=2 Participants
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.
|
125 mg BID Intermittent Days 1 and 2 (Fasted)
n=37 Participants
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.
|
125 mg BID Intermittent Days 1 and 2 (Fed)
n=4 Participants
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.
|
170 mg BID Intermittent Days 1 and 2 (Fasted)
n=8 Participants
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.
|
|---|---|---|---|---|---|---|---|---|---|
|
Heart Rate
Baseline
|
84.5 beats/min
Standard Deviation 13.31
|
87.5 beats/min
Standard Deviation 11.36
|
82.7 beats/min
Standard Deviation 14.14
|
81.0 beats/min
Standard Deviation 13.11
|
79.6 beats/min
Standard Deviation 5.32
|
NA beats/min
Standard Deviation NA
Mean and standard deviation were not calculated because there were \< 3 participants in this arm.
|
83.5 beats/min
Standard Deviation 15.32
|
73.5 beats/min
Standard Deviation 10.75
|
86.1 beats/min
Standard Deviation 21.40
|
|
Heart Rate
Cycle 1, Day 1
|
77.7 beats/min
Standard Deviation 14.28
|
87.3 beats/min
Standard Deviation 4.92
|
87.3 beats/min
Standard Deviation 19.53
|
86.8 beats/min
Standard Deviation 12.90
|
79.6 beats/min
Standard Deviation 5.32
|
NA beats/min
Standard Deviation NA
Mean and standard deviation were not calculated because there were \< 3 participants in this arm.
|
83.5 beats/min
Standard Deviation 15.32
|
73.5 beats/min
Standard Deviation 10.75
|
86.1 beats/min
Standard Deviation 21.40
|
|
Heart Rate
Cycle 1, Day 22
|
87.8 beats/min
Standard Deviation 16.95
|
82.4 beats/min
Standard Deviation 13.58
|
85.3 beats/min
Standard Deviation 20.23
|
86.1 beats/min
Standard Deviation 11.18
|
88.8 beats/min
Standard Deviation 11.43
|
NA beats/min
Standard Deviation NA
Mean and standard deviation were not calculated because there were \< 3 participants in this arm.
|
84.6 beats/min
Standard Deviation 17.27
|
77.8 beats/min
Standard Deviation 7.80
|
87.4 beats/min
Standard Deviation 25.97
|
|
Heart Rate
Cycle 1, Day 8
|
81.2 beats/min
Standard Deviation 15.93
|
80.8 beats/min
Standard Deviation 11.39
|
85.4 beats/min
Standard Deviation 19.97
|
92.6 beats/min
Standard Deviation 12.47
|
75.5 beats/min
Standard Deviation 12.01
|
NA beats/min
Standard Deviation NA
Mean and standard deviation were not calculated because there were \< 3 participants in this arm.
|
84.4 beats/min
Standard Deviation 15.61
|
71.5 beats/min
Standard Deviation 6.61
|
79.4 beats/min
Standard Deviation 15.78
|
|
Heart Rate
Cycle 1, Day 15
|
89.3 beats/min
Standard Deviation 16.83
|
80.2 beats/min
Standard Deviation 9.97
|
86.7 beats/min
Standard Deviation 18.48
|
82.8 beats/min
Standard Deviation 8.60
|
77.4 beats/min
Standard Deviation 7.92
|
NA beats/min
Standard Deviation NA
Mean and standard deviation were not calculated because there were \< 3 participants in this arm.
|
81.3 beats/min
Standard Deviation 14.79
|
83.3 beats/min
Standard Deviation 15.33
|
82.5 beats/min
Standard Deviation 17.65
|
|
Heart Rate
Cycle 2, Day 1
|
89.7 beats/min
Standard Deviation 11.63
|
83.5 beats/min
Standard Deviation 11.81
|
84.0 beats/min
Standard Deviation 16.39
|
87.9 beats/min
Standard Deviation 12.45
|
85.0 beats/min
Standard Deviation 12.68
|
NA beats/min
Standard Deviation NA
Mean and standard deviation were not calculated because there were \< 3 participants in this arm.
|
85.7 beats/min
Standard Deviation 15.53
|
78.0 beats/min
Standard Deviation 15.75
|
83.0 beats/min
Standard Deviation 13.94
|
PRIMARY outcome
Timeframe: 28 DaysPopulation: The analysis population consisted of all participants who received at least one dose of AZD2014.
Outcome measures
| Measure |
50 mg BID Continuous
n=13 Participants
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.
|
35 mg BID Continuous
n=6 Participants
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.
|
75 mg
n=14 Participants
Participants received a single dose of 75 mg of AZD2014 in fasted condition.
|
100 mg
n=10 Participants
Participants received a single dose of 100 mg of AZD2014 in fasted condition.
|
170 mg BID Intermittent Days 1 and 2 (Fed)
n=5 Participants
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.
|
125 mg BID Intermittent Days 1 and 4 (Fasted)
n=2 Participants
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.
|
125 mg BID Intermittent Days 1 and 2 (Fasted)
n=37 Participants
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.
|
125 mg BID Intermittent Days 1 and 2 (Fed)
n=4 Participants
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.
|
170 mg BID Intermittent Days 1 and 2 (Fasted)
n=8 Participants
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.
|
|---|---|---|---|---|---|---|---|---|---|
|
Body Temperature
Baseline
|
36.44 °C
Standard Deviation 0.399
|
36.35 °C
Standard Deviation 0.327
|
36.46 °C
Standard Deviation 0.303
|
36.48 °C
Standard Deviation 0.297
|
36.40 °C
Standard Deviation 0.394
|
NA °C
Standard Deviation NA
Mean and standard deviation were not calculated because there were \< 3 participants in this arm
|
36.57 °C
Standard Deviation 0.320
|
36.60 °C
Standard Deviation 0.183
|
36.39 °C
Standard Deviation 0.482
|
|
Body Temperature
Cycle 1, Day 1
|
36.57 °C
Standard Deviation 0.465
|
36.33 °C
Standard Deviation 0.189
|
36.34 °C
Standard Deviation 0.318
|
36.46 °C
Standard Deviation 0.306
|
36.40 °C
Standard Deviation 0.394
|
NA °C
Standard Deviation NA
Mean and standard deviation were not calculated because there were \< 3 participants in this arm
|
36.57 °C
Standard Deviation 0.320
|
36.60 °C
Standard Deviation 0.183
|
36.39 °C
Standard Deviation 0.482
|
|
Body Temperature
Cycle 1, Day 8
|
36.42 °C
Standard Deviation 0.217
|
36.33 °C
Standard Deviation 0.308
|
36.59 °C
Standard Deviation 0.493
|
36.35 °C
Standard Deviation 0.372
|
36.88 °C
Standard Deviation 0.359
|
NA °C
Standard Deviation NA
Mean and standard deviation were not calculated because there were \< 3 participants in this arm
|
36.51 °C
Standard Deviation 0.370
|
36.25 °C
Standard Deviation 0.129
|
36.36 °C
Standard Deviation 0.276
|
|
Body Temperature
Cycle 1, Day 15
|
36.74 °C
Standard Deviation 0.323
|
36.48 °C
Standard Deviation 0.313
|
36.45 °C
Standard Deviation 0.333
|
36.35 °C
Standard Deviation 0.299
|
36.42 °C
Standard Deviation 0.130
|
NA °C
Standard Deviation NA
Mean and standard deviation were not calculated because there were \< 3 participants in this arm
|
36.50 °C
Standard Deviation 0.400
|
36.30 °C
Standard Deviation 0.216
|
36.77 °C
Standard Deviation 0.489
|
|
Body Temperature
Cycle 1, Day 22
|
36.38 °C
Standard Deviation 0.360
|
36.13 °C
Standard Deviation 0.403
|
36.38 °C
Standard Deviation 0.414
|
36.26 °C
Standard Deviation 0.450
|
36.88 °C
Standard Deviation 0.319
|
NA °C
Standard Deviation NA
Mean and standard deviation were not calculated because there were \< 3 participants in this arm
|
36.54 °C
Standard Deviation 0.550
|
36.65 °C
Standard Deviation 0.465
|
36.66 °C
Standard Deviation 0.341
|
|
Body Temperature
Cycle 2, Day 1
|
36.55 °C
Standard Deviation 0.238
|
36.25 °C
Standard Deviation 0.315
|
36.57 °C
Standard Deviation 0.312
|
36.54 °C
Standard Deviation 0.444
|
36.54 °C
Standard Deviation 0.152
|
NA °C
Standard Deviation NA
Mean and standard deviation were not calculated because there were \< 3 participants in this arm
|
36.56 °C
Standard Deviation 0.292
|
36.90 °C
Standard Deviation 0.294
|
36.50 °C
Standard Deviation 0.456
|
PRIMARY outcome
Timeframe: 28 DaysPopulation: The analysis population consisted of all participants who received at least one dose of AZD2014.
Outcome measures
| Measure |
50 mg BID Continuous
n=13 Participants
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.
|
35 mg BID Continuous
n=6 Participants
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.
|
75 mg
n=14 Participants
Participants received a single dose of 75 mg of AZD2014 in fasted condition.
|
100 mg
n=10 Participants
Participants received a single dose of 100 mg of AZD2014 in fasted condition.
|
170 mg BID Intermittent Days 1 and 2 (Fed)
n=5 Participants
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.
|
125 mg BID Intermittent Days 1 and 4 (Fasted)
n=2 Participants
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.
|
125 mg BID Intermittent Days 1 and 2 (Fasted)
n=37 Participants
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.
|
125 mg BID Intermittent Days 1 and 2 (Fed)
n=4 Participants
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.
|
170 mg BID Intermittent Days 1 and 2 (Fasted)
n=8 Participants
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.
|
|---|---|---|---|---|---|---|---|---|---|
|
Oxygen Saturation
Baseline
|
97.2 % Arterial Oxygen Saturation
Standard Deviation 1.59
|
97.0 % Arterial Oxygen Saturation
Standard Deviation 0.89
|
96.8 % Arterial Oxygen Saturation
Standard Deviation 1.85
|
96.7 % Arterial Oxygen Saturation
Standard Deviation 2.41
|
97.6 % Arterial Oxygen Saturation
Standard Deviation 1.14
|
NA % Arterial Oxygen Saturation
Standard Deviation NA
Mean and standard deviation were not calculated because there were \< 3 participants in this arm
|
97.8 % Arterial Oxygen Saturation
Standard Deviation 1.49
|
97.0 % Arterial Oxygen Saturation
Standard Deviation 1.83
|
97.0 % Arterial Oxygen Saturation
Standard Deviation 0.93
|
|
Oxygen Saturation
Cycle 1, Day 1
|
97.7 % Arterial Oxygen Saturation
Standard Deviation 1.90
|
97.5 % Arterial Oxygen Saturation
Standard Deviation 1.00
|
97.4 % Arterial Oxygen Saturation
Standard Deviation 1.16
|
96.9 % Arterial Oxygen Saturation
Standard Deviation 1.90
|
97.6 % Arterial Oxygen Saturation
Standard Deviation 1.14
|
NA % Arterial Oxygen Saturation
Standard Deviation NA
Mean and standard deviation were not calculated because there were \< 3 participants in this arm
|
97.8 % Arterial Oxygen Saturation
Standard Deviation 1.49
|
97.0 % Arterial Oxygen Saturation
Standard Deviation 1.83
|
97.0 % Arterial Oxygen Saturation
Standard Deviation 0.93
|
|
Oxygen Saturation
Cycle 1, Day 8
|
97.5 % Arterial Oxygen Saturation
Standard Deviation 1.98
|
98.3 % Arterial Oxygen Saturation
Standard Deviation 1.21
|
97.1 % Arterial Oxygen Saturation
Standard Deviation 1.66
|
97.1 % Arterial Oxygen Saturation
Standard Deviation 1.37
|
98.3 % Arterial Oxygen Saturation
Standard Deviation 2.06
|
NA % Arterial Oxygen Saturation
Standard Deviation NA
Mean and standard deviation were not calculated because there were \< 3 participants in this arm
|
97.8 % Arterial Oxygen Saturation
Standard Deviation 1.70
|
97.0 % Arterial Oxygen Saturation
Standard Deviation 2.16
|
97.7 % Arterial Oxygen Saturation
Standard Deviation 1.50
|
|
Oxygen Saturation
Cycle 1, Day 15
|
96.5 % Arterial Oxygen Saturation
Standard Deviation 1.94
|
97.7 % Arterial Oxygen Saturation
Standard Deviation 0.82
|
97.3 % Arterial Oxygen Saturation
Standard Deviation 1.50
|
97.1 % Arterial Oxygen Saturation
Standard Deviation 1.17
|
96.8 % Arterial Oxygen Saturation
Standard Deviation 1.48
|
NA % Arterial Oxygen Saturation
Standard Deviation NA
Mean and standard deviation were not calculated because there were \< 3 participants in this arm
|
98.0 % Arterial Oxygen Saturation
Standard Deviation 1.34
|
97.0 % Arterial Oxygen Saturation
Standard Deviation 1.41
|
97.0 % Arterial Oxygen Saturation
Standard Deviation 1.26
|
|
Oxygen Saturation
Cycle 1, Day 22
|
97.3 % Arterial Oxygen Saturation
Standard Deviation 1.82
|
96.8 % Arterial Oxygen Saturation
Standard Deviation 1.72
|
96.8 % Arterial Oxygen Saturation
Standard Deviation 1.77
|
97.6 % Arterial Oxygen Saturation
Standard Deviation 1.51
|
98.0 % Arterial Oxygen Saturation
Standard Deviation 1.63
|
NA % Arterial Oxygen Saturation
Standard Deviation NA
Mean and standard deviation were not calculated because there were \< 3 participants in this arm
|
98.1 % Arterial Oxygen Saturation
Standard Deviation 1.63
|
97.5 % Arterial Oxygen Saturation
Standard Deviation 3.11
|
97.9 % Arterial Oxygen Saturation
Standard Deviation 1.57
|
|
Oxygen Saturation
Cycle 2, Day 1
|
97.3 % Arterial Oxygen Saturation
Standard Deviation 2.09
|
97.5 % Arterial Oxygen Saturation
Standard Deviation 0.55
|
96.9 % Arterial Oxygen Saturation
Standard Deviation 1.26
|
97.3 % Arterial Oxygen Saturation
Standard Deviation 1.04
|
97.0 % Arterial Oxygen Saturation
Standard Deviation 2.16
|
NA % Arterial Oxygen Saturation
Standard Deviation NA
Mean and standard deviation were not calculated because there were \< 3 participants in this arm
|
98.2 % Arterial Oxygen Saturation
Standard Deviation 1.39
|
96.5 % Arterial Oxygen Saturation
Standard Deviation 2.52
|
96.2 % Arterial Oxygen Saturation
Standard Deviation 3.31
|
PRIMARY outcome
Timeframe: 5 DaysOutcome measures
| Measure |
50 mg BID Continuous
n=13 Participants
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.
|
35 mg BID Continuous
n=5 Participants
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.
|
75 mg
n=14 Participants
Participants received a single dose of 75 mg of AZD2014 in fasted condition.
|
100 mg
n=10 Participants
Participants received a single dose of 100 mg of AZD2014 in fasted condition.
|
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.
|
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.
|
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.
|
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.
|
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.
|
|---|---|---|---|---|---|---|---|---|---|
|
AZD2014 Peak Plasma Concentration at Steady State (Cmax,ss) on Cycle 0 Days -5 to -1, Continuous Dosing, no Fulvestrant
|
1023 ng/mL
Standard Deviation 339.4
|
971.2 ng/mL
Standard Deviation 413.6
|
1895 ng/mL
Standard Deviation 965.6
|
2166 ng/mL
Standard Deviation 964.3
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 5 DaysOutcome measures
| Measure |
50 mg BID Continuous
n=13 Participants
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.
|
35 mg BID Continuous
n=5 Participants
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.
|
75 mg
n=14 Participants
Participants received a single dose of 75 mg of AZD2014 in fasted condition.
|
100 mg
n=10 Participants
Participants received a single dose of 100 mg of AZD2014 in fasted condition.
|
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.
|
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.
|
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.
|
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.
|
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.
|
|---|---|---|---|---|---|---|---|---|---|
|
AZD2014 Area Under the Plasma Concentration Time Curve (AUC 0-12) Cycle 0 Days -5 to -1, Continuous Dosing, no Fulvestrant
|
5080 h*ng/mL
Standard Deviation 1985
|
3478 h*ng/mL
Standard Deviation 1398
|
9723 h*ng/mL
Standard Deviation 6408
|
12590 h*ng/mL
Standard Deviation 4900
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 5 DaysOutcome measures
| Measure |
50 mg BID Continuous
n=13 Participants
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.
|
35 mg BID Continuous
n=5 Participants
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.
|
75 mg
n=14 Participants
Participants received a single dose of 75 mg of AZD2014 in fasted condition.
|
100 mg
n=10 Participants
Participants received a single dose of 100 mg of AZD2014 in fasted condition.
|
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.
|
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.
|
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.
|
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.
|
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.
|
|---|---|---|---|---|---|---|---|---|---|
|
AZD2014 Area Under the Plasma Concentration Time Curve (AUC 0-24) Cycle 0 Days -5 to -1, Continuous Dosing, no Fulvestrant
|
6006 h*ng/mL
Standard Deviation 2838
|
3697 h*ng/mL
Standard Deviation 1426
|
11650 h*ng/mL
Standard Deviation 8685
|
15790 h*ng/mL
Standard Deviation 7286
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 5 DaysOutcome measures
| Measure |
50 mg BID Continuous
n=13 Participants
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.
|
35 mg BID Continuous
n=5 Participants
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.
|
75 mg
n=14 Participants
Participants received a single dose of 75 mg of AZD2014 in fasted condition.
|
100 mg
n=10 Participants
Participants received a single dose of 100 mg of AZD2014 in fasted condition.
|
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.
|
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.
|
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.
|
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.
|
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.
|
|---|---|---|---|---|---|---|---|---|---|
|
AZD2014 Area Under the Plasma Concentration Time Curve (AUC 0-t) Cycle 0 Days -5 to -1, Continuous Dosing, no Fulvestrant
|
5832 h*ng/mL
Standard Deviation 2926
|
3458 h*ng/mL
Standard Deviation 1433
|
11500 h*ng/mL
Standard Deviation 8761
|
15660 h*ng/mL
Standard Deviation 7345
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 5 DaysOutcome measures
| Measure |
50 mg BID Continuous
n=13 Participants
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.
|
35 mg BID Continuous
n=5 Participants
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.
|
75 mg
n=14 Participants
Participants received a single dose of 75 mg of AZD2014 in fasted condition.
|
100 mg
n=10 Participants
Participants received a single dose of 100 mg of AZD2014 in fasted condition.
|
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.
|
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.
|
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.
|
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.
|
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.
|
|---|---|---|---|---|---|---|---|---|---|
|
AZD2014 Area Under the Plasma Concentration Time Curve (AUC 0-∞) Cycle 0 Days -5 to -1, Continuous Dosing, no Fulvestrant
|
6392 h*ng/mL
Standard Deviation 3350
|
3731 h*ng/mL
Standard Deviation 1412
|
12360 h*ng/mL
Standard Deviation 9950
|
17360 h*ng/mL
Standard Deviation 9479
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 15 DaysOutcome measures
| Measure |
50 mg BID Continuous
n=3 Participants
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.
|
35 mg BID Continuous
n=33 Participants
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.
|
75 mg
n=6 Participants
Participants received a single dose of 75 mg of AZD2014 in fasted condition.
|
100 mg
n=5 Participants
Participants received a single dose of 100 mg of AZD2014 in fasted condition.
|
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.
|
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.
|
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.
|
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.
|
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.
|
|---|---|---|---|---|---|---|---|---|---|
|
AZD2014 Peak Plasma Concentration at Steady State (Cmax,ss) on Cycle 1 Day 15, BID Intermittent Dosing, With Fulvestrant
|
1933 ng/mL
Standard Deviation 793.9
|
3165 ng/mL
Standard Deviation 1052
|
4238 ng/mL
Standard Deviation 1440
|
2454 ng/mL
Standard Deviation 838.4
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 15 DaysOutcome measures
| Measure |
50 mg BID Continuous
n=3 Participants
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.
|
35 mg BID Continuous
n=33 Participants
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.
|
75 mg
n=6 Participants
Participants received a single dose of 75 mg of AZD2014 in fasted condition.
|
100 mg
n=5 Participants
Participants received a single dose of 100 mg of AZD2014 in fasted condition.
|
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.
|
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.
|
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.
|
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.
|
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.
|
|---|---|---|---|---|---|---|---|---|---|
|
Time to AZD2014 Peak Plasma Concentration at Steady State (Tmax,ss) on Cycle 1 Day 15, BID Intermittent Dosing, With Fulvestrant
|
2.0 hours
Full Range 793.9 • Interval 1.07 to 6.15
|
1.1 hours
Full Range 1052 • Interval 0.5 to 4.0
|
1.5 hours
Full Range 1440 • Interval 0.5 to 8.0
|
3.0 hours
Full Range 838.4 • Interval 1.0 to 4.0
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 15 DaysOutcome measures
| Measure |
50 mg BID Continuous
n=13 Participants
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.
|
35 mg BID Continuous
n=5 Participants
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.
|
75 mg
n=14 Participants
Participants received a single dose of 75 mg of AZD2014 in fasted condition.
|
100 mg
n=10 Participants
Participants received a single dose of 100 mg of AZD2014 in fasted condition.
|
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.
|
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.
|
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.
|
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.
|
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.
|
|---|---|---|---|---|---|---|---|---|---|
|
AZD2014 Area Under the Plasma Concentration Time Curve (AUC 0-12) Cycle 1 Day 15 Intermittent Dosing, With Fulvestrant
|
13760 h*ng/mL
Standard Deviation 5737
|
19810 h*ng/mL
Standard Deviation 6562
|
26570 h*ng/mL
Standard Deviation 8600
|
16150 h*ng/mL
Standard Deviation 5591
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 22 DaysOutcome measures
| Measure |
50 mg BID Continuous
n=10 Participants
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.
|
35 mg BID Continuous
n=6 Participants
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.
|
75 mg
n=11 Participants
Participants received a single dose of 75 mg of AZD2014 in fasted condition.
|
100 mg
n=6 Participants
Participants received a single dose of 100 mg of AZD2014 in fasted condition.
|
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.
|
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.
|
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.
|
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.
|
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.
|
|---|---|---|---|---|---|---|---|---|---|
|
AZD2014 Peak Plasma Concentration at Steady State (Cmax,ss) on Cycle 1 Day 22, Continuous Dosing, With Fulvestrant
|
1785 ng/mL
Standard Deviation 866
|
1374 ng/mL
Standard Deviation 447.9
|
2409 ng/mL
Standard Deviation 1305
|
2327 ng/mL
Standard Deviation 1257
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 22 DaysOutcome measures
| Measure |
50 mg BID Continuous
n=10 Participants
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.
|
35 mg BID Continuous
n=6 Participants
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.
|
75 mg
n=11 Participants
Participants received a single dose of 75 mg of AZD2014 in fasted condition.
|
100 mg
n=6 Participants
Participants received a single dose of 100 mg of AZD2014 in fasted condition.
|
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.
|
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.
|
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.
|
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.
|
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.
|
|---|---|---|---|---|---|---|---|---|---|
|
Time to AZD2014 Peak Plasma Concentration at Steady State (Tmax,ss) on Cycle 1 Day 22, Continuous Dosing, With Fulvestrant
|
1.0 hours
Full Range 866 • Interval 0.5 to 2.0
|
1.3 hours
Full Range 447.9 • Interval 0.5 to 4.0
|
1.5 hours
Full Range 1305 • Interval 0.5 to 6.12
|
1.5 hours
Full Range 1257 • Interval 0.5 to 6.0
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 15 DaysOutcome measures
| Measure |
50 mg BID Continuous
n=10 Participants
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.
|
35 mg BID Continuous
n=6 Participants
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.
|
75 mg
n=11 Participants
Participants received a single dose of 75 mg of AZD2014 in fasted condition.
|
100 mg
n=6 Participants
Participants received a single dose of 100 mg of AZD2014 in fasted condition.
|
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.
|
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.
|
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.
|
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.
|
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.
|
|---|---|---|---|---|---|---|---|---|---|
|
AZD2014 Area Under the Plasma Concentration Time Curve (AUC 0-12) Cycle 1 Day 22 Continuous Dosing, With Fulvestrant
|
11810 h*ng/mL
Standard Deviation 7107
|
8611 h*ng/mL
Standard Deviation 3864
|
13510 h*ng/mL
Standard Deviation 8937
|
15580 h*ng/mL
Standard Deviation 6024
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 1 DayOutcome measures
| Measure |
50 mg BID Continuous
n=13 Participants
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.
|
35 mg BID Continuous
n=5 Participants
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.
|
75 mg
n=14 Participants
Participants received a single dose of 75 mg of AZD2014 in fasted condition.
|
100 mg
n=10 Participants
Participants received a single dose of 100 mg of AZD2014 in fasted condition.
|
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.
|
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.
|
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.
|
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.
|
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.
|
|---|---|---|---|---|---|---|---|---|---|
|
AZD2014 Peak Plasma Concentration (Cmax) Following Single Dose, Fasted, no Fulvestrant.
|
968.5 ng/mL
Geometric Coefficient of Variation 36.45
|
889.4 ng/mL
Geometric Coefficient of Variation 52.72
|
1678 ng/mL
Geometric Coefficient of Variation 55.72
|
1942 ng/mL
Geometric Coefficient of Variation 56.46
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 1 DayOutcome measures
| Measure |
50 mg BID Continuous
n=13 Participants
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.
|
35 mg BID Continuous
n=5 Participants
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.
|
75 mg
n=14 Participants
Participants received a single dose of 75 mg of AZD2014 in fasted condition.
|
100 mg
n=10 Participants
Participants received a single dose of 100 mg of AZD2014 in fasted condition.
|
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.
|
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.
|
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.
|
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.
|
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.
|
|---|---|---|---|---|---|---|---|---|---|
|
Time to AZD2014 Peak Plasma Concentration (Tmax) Following Single Dose, Fasted, no Fulvestrant.
|
1.00 hour
Full Range 36.45 • Interval 0.45 to 4.0
|
1.00 hour
Full Range 52.72 • Interval 0.5 to 1.5
|
1.10 hour
Full Range 55.72 • Interval 0.5 to 4.0
|
1.80 hour
Full Range 56.46 • Interval 0.5 to 4.02
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 1 DayOutcome measures
| Measure |
50 mg BID Continuous
n=13 Participants
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.
|
35 mg BID Continuous
n=5 Participants
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.
|
75 mg
n=14 Participants
Participants received a single dose of 75 mg of AZD2014 in fasted condition.
|
100 mg
n=10 Participants
Participants received a single dose of 100 mg of AZD2014 in fasted condition.
|
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.
|
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.
|
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.
|
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.
|
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.
|
|---|---|---|---|---|---|---|---|---|---|
|
Area Under the Plasma Concentration-time Curve for AZD2014 From 0 to 12 Hours (AUC 0-12) Following Single Dose, Fasted, no Fulvestrant.
|
4666 h*ng/mL
Geometric Coefficient of Variation 48.2 • Interval 0.45 to 4.0
|
3233 h*ng/mL
Geometric Coefficient of Variation 46.26 • Interval 0.5 to 1.5
|
8185 h*ng/mL
Geometric Coefficient of Variation 65.21 • Interval 0.5 to 4.0
|
11470 h*ng/mL
Geometric Coefficient of Variation 53.45 • Interval 0.5 to 4.02
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 1 DayOutcome measures
| Measure |
50 mg BID Continuous
n=13 Participants
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.
|
35 mg BID Continuous
n=5 Participants
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.
|
75 mg
n=14 Participants
Participants received a single dose of 75 mg of AZD2014 in fasted condition.
|
100 mg
n=10 Participants
Participants received a single dose of 100 mg of AZD2014 in fasted condition.
|
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.
|
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.
|
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.
|
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.
|
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.
|
|---|---|---|---|---|---|---|---|---|---|
|
Area Under the Plasma Concentration-time Curve for AZD2014 From 0 to Infinity (AUC 0-∞) Following Single Dose, Fasted, no Fulvestrant.
|
5543 h*ng/mL
Geometric Coefficient of Variation 63.41 • Interval 0.45 to 4.0
|
3494 h*ng/mL
Geometric Coefficient of Variation 43.96 • Interval 0.5 to 1.5
|
9843 h*ng/mL
Geometric Coefficient of Variation 75.43 • Interval 0.5 to 4.0
|
15110 h*ng/mL
Geometric Coefficient of Variation 63.32 • Interval 0.5 to 4.02
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 12 monthsPopulation: 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.
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).
Outcome measures
| Measure |
50 mg BID Continuous
n=11 Participants
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.
|
35 mg BID Continuous
n=2 Participants
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.
|
75 mg
n=13 Participants
Participants received a single dose of 75 mg of AZD2014 in fasted condition.
|
100 mg
n=4 Participants
Participants received a single dose of 100 mg of AZD2014 in fasted condition.
|
170 mg BID Intermittent Days 1 and 2 (Fed)
n=3 Participants
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.
|
125 mg BID Intermittent Days 1 and 4 (Fasted)
n=1 Participants
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.
|
125 mg BID Intermittent Days 1 and 2 (Fasted)
n=27 Participants
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.
|
125 mg BID Intermittent Days 1 and 2 (Fed)
n=3 Participants
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.
|
170 mg BID Intermittent Days 1 and 2 (Fasted)
n=5 Participants
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.
|
|---|---|---|---|---|---|---|---|---|---|
|
Objective Response Rate
|
2 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to 12 monthsPopulation: 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.
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.
Outcome measures
| Measure |
50 mg BID Continuous
n=11 Participants
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.
|
35 mg BID Continuous
n=2 Participants
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.
|
75 mg
n=13 Participants
Participants received a single dose of 75 mg of AZD2014 in fasted condition.
|
100 mg
n=4 Participants
Participants received a single dose of 100 mg of AZD2014 in fasted condition.
|
170 mg BID Intermittent Days 1 and 2 (Fed)
n=3 Participants
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.
|
125 mg BID Intermittent Days 1 and 4 (Fasted)
n=1 Participants
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.
|
125 mg BID Intermittent Days 1 and 2 (Fasted)
n=27 Participants
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.
|
125 mg BID Intermittent Days 1 and 2 (Fed)
n=3 Participants
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.
|
170 mg BID Intermittent Days 1 and 2 (Fasted)
n=5 Participants
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.
|
|---|---|---|---|---|---|---|---|---|---|
|
Best Objective Response (BOR)
Complete Response
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Best Objective Response (BOR)
Partial Response
|
2 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
|
Best Objective Response (BOR)
Stable Disease ≥ 8 weeks
|
4 Participants
|
1 Participants
|
7 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
17 Participants
|
2 Participants
|
3 Participants
|
|
Best Objective Response (BOR)
Progression
|
2 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
7 Participants
|
0 Participants
|
0 Participants
|
|
Best Objective Response (BOR)
Not Evaluable
|
3 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to 12 monthsPopulation: The number of participants analyzed for Duration of Response is zero in cohorts which had no responders \[35 mg BID Continuous and 170 mg BID Intermittent Days 1 and 2 (fed)\]
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.
Outcome measures
| Measure |
50 mg BID Continuous
n=2 Participants
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.
|
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.
|
75 mg
n=2 Participants
Participants received a single dose of 75 mg of AZD2014 in fasted condition.
|
100 mg
n=1 Participants
Participants received a single dose of 100 mg of AZD2014 in fasted condition.
|
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.
|
125 mg BID Intermittent Days 1 and 4 (Fasted)
n=1 Participants
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.
|
125 mg BID Intermittent Days 1 and 2 (Fasted)
n=2 Participants
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.
|
125 mg BID Intermittent Days 1 and 2 (Fed)
n=1 Participants
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.
|
170 mg BID Intermittent Days 1 and 2 (Fasted)
n=1 Participants
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.
|
|---|---|---|---|---|---|---|---|---|---|
|
Duration of Response (DoR)
|
5.1 Months
Interval 3.9 to 6.3
|
—
|
9.7 Months
Interval 3.3 to 16.0
|
NA Months
Median and interquartile range can not be calculated because there was only one participant in the cohort.
|
—
|
10.4 Months
Median and interquartile range can not be calculated because there was only one participant in the cohort.
|
NA Months
Interval 3.6 to
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.
|
NA Months
Median and interquartile range can not be calculated because there was only one participant in the cohort.
|
NA Months
Median and interquartile range can not be calculated because there was only one participant in the cohort.
|
SECONDARY outcome
Timeframe: Up to 12 monthsPopulation: 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.
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.
Outcome measures
| Measure |
50 mg BID Continuous
n=13 Participants
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.
|
35 mg BID Continuous
n=6 Participants
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.
|
75 mg
n=14 Participants
Participants received a single dose of 75 mg of AZD2014 in fasted condition.
|
100 mg
n=10 Participants
Participants received a single dose of 100 mg of AZD2014 in fasted condition.
|
170 mg BID Intermittent Days 1 and 2 (Fed)
n=5 Participants
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.
|
125 mg BID Intermittent Days 1 and 4 (Fasted)
n=2 Participants
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.
|
125 mg BID Intermittent Days 1 and 2 (Fasted)
n=37 Participants
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.
|
125 mg BID Intermittent Days 1 and 2 (Fed)
n=8 Participants
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.
|
170 mg BID Intermittent Days 1 and 2 (Fasted)
n=5 Participants
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.
|
|---|---|---|---|---|---|---|---|---|---|
|
Clinical Benefit Rate (CBR) at 24 Weeks
Yes
|
6 Participants
Interval 3.6 to 6.3
|
2 Participants
|
4 Participants
Interval 3.3 to 16.0
|
7 Participants
Interval 39.1 to 39.1
|
2 Participants
|
2 Participants
Interval 10.4 to 10.4
|
11 Participants
Interval 3.6 to
|
2 Participants
Interval 6.4 to 6.4
|
3 Participants
Interval 12.0 to 12.0
|
|
Clinical Benefit Rate (CBR) at 24 Weeks
No
|
7 Participants
|
4 Participants
|
10 Participants
|
3 Participants
|
3 Participants
|
0 Participants
|
26 Participants
|
2 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Up to 12 monthsPopulation: 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.
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.
Outcome measures
| Measure |
50 mg BID Continuous
n=10 Participants
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.
|
35 mg BID Continuous
n=2 Participants
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.
|
75 mg
n=12 Participants
Participants received a single dose of 75 mg of AZD2014 in fasted condition.
|
100 mg
n=2 Participants
Participants received a single dose of 100 mg of AZD2014 in fasted condition.
|
170 mg BID Intermittent Days 1 and 2 (Fed)
n=2 Participants
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.
|
125 mg BID Intermittent Days 1 and 4 (Fasted)
n=1 Participants
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.
|
125 mg BID Intermittent Days 1 and 2 (Fasted)
n=26 Participants
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.
|
125 mg BID Intermittent Days 1 and 2 (Fed)
n=3 Participants
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.
|
170 mg BID Intermittent Days 1 and 2 (Fasted)
n=5 Participants
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.
|
|---|---|---|---|---|---|---|---|---|---|
|
Percentage Change From Baseline at 16 Weeks in Target Lesion (TL) Size.
|
-9.37 Percentage Change
Standard Deviation 39.544
|
NA Percentage Change
Standard Deviation NA
Mean change in tumour size and standard deviation are not reported when data are available for less than 3 patients.
|
-5.83 Percentage Change
Standard Deviation 52.781
|
NA Percentage Change
Standard Deviation NA
Mean change in tumour size and standard deviation are not reported when data are available for less than 3 patients.
|
NA Percentage Change
Standard Deviation NA
Mean change in tumour size and standard deviation are not reported when data are available for less than 3 patients.
|
NA Percentage Change
Standard Deviation NA
Mean change in tumour size and standard deviation are not reported when data are available for less than 3 patients.
|
-0.46 Percentage Change
Standard Deviation 28.208
|
-3.57 Percentage Change
Standard Deviation 28.476
|
-10.96 Percentage Change
Standard Deviation 19.012
|
SECONDARY outcome
Timeframe: Up to 12 monthsPopulation: 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.
Outcome measures
| Measure |
50 mg BID Continuous
n=13 Participants
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.
|
35 mg BID Continuous
n=6 Participants
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.
|
75 mg
n=14 Participants
Participants received a single dose of 75 mg of AZD2014 in fasted condition.
|
100 mg
n=10 Participants
Participants received a single dose of 100 mg of AZD2014 in fasted condition.
|
170 mg BID Intermittent Days 1 and 2 (Fed)
n=5 Participants
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.
|
125 mg BID Intermittent Days 1 and 4 (Fasted)
n=2 Participants
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.
|
125 mg BID Intermittent Days 1 and 2 (Fasted)
n=37 Participants
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.
|
125 mg BID Intermittent Days 1 and 2 (Fed)
n=4 Participants
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.
|
170 mg BID Intermittent Days 1 and 2 (Fasted)
n=8 Participants
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.
|
|---|---|---|---|---|---|---|---|---|---|
|
Progression Free Survival
|
35.6 Weeks
80% Confidence Interval 39.544 • Interval 25.57 to 44.43
|
49.4 Weeks
80% Confidence Interval NA • Interval 8.14 to 82.86
|
17.3 Weeks
80% Confidence Interval 52.781 • Interval 16.0 to 21.0
|
78.3 Weeks
80% Confidence Interval NA • Interval 57.0 to 178.14
|
83.4 Weeks
80% Confidence Interval NA • Interval 7.14 to 83.43
|
NA Weeks
80% Confidence Interval NA • Interval 61.86 to
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
|
22.6 Weeks
80% Confidence Interval 28.208 • Interval 16.14 to 25.14
|
33.9 Weeks
80% Confidence Interval 28.476 • Interval 17.14 to
The upper bound of the 80% C.I. was not a finite number
|
60.1 Weeks
80% Confidence Interval 19.012 • Interval 16.0 to
The upper bound of the 80% C.I. was not a finite number
|
SECONDARY outcome
Timeframe: Up to 12 monthsPopulation: 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.
Outcome measures
| Measure |
50 mg BID Continuous
n=13 Participants
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.
|
35 mg BID Continuous
n=6 Participants
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.
|
75 mg
n=14 Participants
Participants received a single dose of 75 mg of AZD2014 in fasted condition.
|
100 mg
n=10 Participants
Participants received a single dose of 100 mg of AZD2014 in fasted condition.
|
170 mg BID Intermittent Days 1 and 2 (Fed)
n=5 Participants
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.
|
125 mg BID Intermittent Days 1 and 4 (Fasted)
n=2 Participants
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.
|
125 mg BID Intermittent Days 1 and 2 (Fasted)
n=37 Participants
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.
|
125 mg BID Intermittent Days 1 and 2 (Fed)
n=4 Participants
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.
|
170 mg BID Intermittent Days 1 and 2 (Fasted)
n=8 Participants
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.
|
|---|---|---|---|---|---|---|---|---|---|
|
Progression Free Survival at 26 Weeks
|
38 Percentage
80% Confidence Interval 39.544 • Interval 20.1 to 59.8
|
33 Percentage
80% Confidence Interval NA • Interval 9.3 to 66.7
|
21 Percentage
80% Confidence Interval 52.781 • Interval 8.1 to 41.7
|
60 Percentage
80% Confidence Interval NA • Interval 35.4 to 81.2
|
40 Percentage
80% Confidence Interval NA • Interval 11.2 to 75.3
|
100 Percentage
80% Confidence Interval NA • Interval 31.6 to 100.0
|
35 Percentage
80% Confidence Interval 28.208 • Interval 24.6 to 47.0
|
50 Percentage
80% Confidence Interval 28.476 • Interval 14.3 to 85.7
|
38 Percentage
80% Confidence Interval 19.012 • Interval 14.7 to 65.5
|
Adverse Events
35 mg BID Continuous
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
50 mg BID Continuous
Serious events: 1 serious events
Other events: 13 other events
Deaths: 0 deaths
75 mg QD Continuous
Serious events: 3 serious events
Other events: 14 other events
Deaths: 0 deaths
100 mg QD Continuous
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
125 mg BID Intermittent Days 1 and 2 (Fasted)
Serious events: 7 serious events
Other events: 37 other events
Deaths: 0 deaths
125 mg BID Intermittent Days 1 and 2 (Fed)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
170 mg BID Intermittent Days 1 and 2 (Fasted)
Serious events: 3 serious events
Other events: 8 other events
Deaths: 0 deaths
170 mg BID Intermittent Days 1 and 2 (Fed)
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
125 mg BID Intermittent Days 1 and 4 (Fasted)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
35 mg BID Continuous
n=6 participants at risk
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.
|
50 mg BID Continuous
n=13 participants at risk
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.
|
75 mg QD Continuous
n=14 participants at risk
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.
|
100 mg QD Continuous
n=10 participants at risk
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.
|
125 mg BID Intermittent Days 1 and 2 (Fasted)
n=37 participants at risk
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.
|
125 mg BID Intermittent Days 1 and 2 (Fed)
n=4 participants at risk
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.
|
170 mg BID Intermittent Days 1 and 2 (Fasted)
n=8 participants at risk
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.
|
170 mg BID Intermittent Days 1 and 2 (Fed)
n=5 participants at risk
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.
|
125 mg BID Intermittent Days 1 and 4 (Fasted)
n=2 participants at risk
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.
|
|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Evans Syndrome
|
0.00%
0/6 • Up to 1 year
|
0.00%
0/13 • Up to 1 year
|
0.00%
0/14 • Up to 1 year
|
0.00%
0/10 • Up to 1 year
|
0.00%
0/37 • Up to 1 year
|
0.00%
0/4 • Up to 1 year
|
12.5%
1/8 • Number of events 1 • Up to 1 year
|
0.00%
0/5 • Up to 1 year
|
0.00%
0/2 • Up to 1 year
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
0.00%
0/6 • Up to 1 year
|
0.00%
0/13 • Up to 1 year
|
7.1%
1/14 • Number of events 1 • Up to 1 year
|
0.00%
0/10 • Up to 1 year
|
0.00%
0/37 • Up to 1 year
|
0.00%
0/4 • Up to 1 year
|
0.00%
0/8 • Up to 1 year
|
0.00%
0/5 • Up to 1 year
|
0.00%
0/2 • Up to 1 year
|
|
Gastrointestinal disorders
Ascities
|
0.00%
0/6 • Up to 1 year
|
0.00%
0/13 • Up to 1 year
|
0.00%
0/14 • Up to 1 year
|
0.00%
0/10 • Up to 1 year
|
2.7%
1/37 • Number of events 1 • Up to 1 year
|
0.00%
0/4 • Up to 1 year
|
0.00%
0/8 • Up to 1 year
|
0.00%
0/5 • Up to 1 year
|
0.00%
0/2 • Up to 1 year
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/6 • Up to 1 year
|
0.00%
0/13 • Up to 1 year
|
0.00%
0/14 • Up to 1 year
|
0.00%
0/10 • Up to 1 year
|
2.7%
1/37 • Number of events 1 • Up to 1 year
|
0.00%
0/4 • Up to 1 year
|
0.00%
0/8 • Up to 1 year
|
0.00%
0/5 • Up to 1 year
|
0.00%
0/2 • Up to 1 year
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/6 • Up to 1 year
|
0.00%
0/13 • Up to 1 year
|
0.00%
0/14 • Up to 1 year
|
0.00%
0/10 • Up to 1 year
|
2.7%
1/37 • Number of events 1 • Up to 1 year
|
0.00%
0/4 • Up to 1 year
|
0.00%
0/8 • Up to 1 year
|
0.00%
0/5 • Up to 1 year
|
0.00%
0/2 • Up to 1 year
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/6 • Up to 1 year
|
0.00%
0/13 • Up to 1 year
|
0.00%
0/14 • Up to 1 year
|
0.00%
0/10 • Up to 1 year
|
0.00%
0/37 • Up to 1 year
|
0.00%
0/4 • Up to 1 year
|
12.5%
1/8 • Number of events 1 • Up to 1 year
|
0.00%
0/5 • Up to 1 year
|
0.00%
0/2 • Up to 1 year
|
|
Gastrointestinal disorders
Enteritis
|
0.00%
0/6 • Up to 1 year
|
0.00%
0/13 • Up to 1 year
|
0.00%
0/14 • Up to 1 year
|
0.00%
0/10 • Up to 1 year
|
2.7%
1/37 • Number of events 1 • Up to 1 year
|
0.00%
0/4 • Up to 1 year
|
0.00%
0/8 • Up to 1 year
|
0.00%
0/5 • Up to 1 year
|
0.00%
0/2 • Up to 1 year
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/6 • Up to 1 year
|
0.00%
0/13 • Up to 1 year
|
0.00%
0/14 • Up to 1 year
|
0.00%
0/10 • Up to 1 year
|
2.7%
1/37 • Number of events 2 • Up to 1 year
|
0.00%
0/4 • Up to 1 year
|
0.00%
0/8 • Up to 1 year
|
0.00%
0/5 • Up to 1 year
|
0.00%
0/2 • Up to 1 year
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/6 • Up to 1 year
|
0.00%
0/13 • Up to 1 year
|
0.00%
0/14 • Up to 1 year
|
0.00%
0/10 • Up to 1 year
|
2.7%
1/37 • Number of events 2 • Up to 1 year
|
0.00%
0/4 • Up to 1 year
|
0.00%
0/8 • Up to 1 year
|
0.00%
0/5 • Up to 1 year
|
0.00%
0/2 • Up to 1 year
|
|
General disorders
Fatigue
|
0.00%
0/6 • Up to 1 year
|
0.00%
0/13 • Up to 1 year
|
0.00%
0/14 • Up to 1 year
|
0.00%
0/10 • Up to 1 year
|
0.00%
0/37 • Up to 1 year
|
0.00%
0/4 • Up to 1 year
|
12.5%
1/8 • Number of events 1 • Up to 1 year
|
0.00%
0/5 • Up to 1 year
|
0.00%
0/2 • Up to 1 year
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/6 • Up to 1 year
|
0.00%
0/13 • Up to 1 year
|
0.00%
0/14 • Up to 1 year
|
0.00%
0/10 • Up to 1 year
|
2.7%
1/37 • Number of events 1 • Up to 1 year
|
0.00%
0/4 • Up to 1 year
|
0.00%
0/8 • Up to 1 year
|
0.00%
0/5 • Up to 1 year
|
0.00%
0/2 • Up to 1 year
|
|
Infections and infestations
Pneumonia
|
0.00%
0/6 • Up to 1 year
|
7.7%
1/13 • Number of events 2 • Up to 1 year
|
0.00%
0/14 • Up to 1 year
|
0.00%
0/10 • Up to 1 year
|
0.00%
0/37 • Up to 1 year
|
0.00%
0/4 • Up to 1 year
|
12.5%
1/8 • Number of events 1 • Up to 1 year
|
0.00%
0/5 • Up to 1 year
|
0.00%
0/2 • Up to 1 year
|
|
Infections and infestations
Sepsis
|
0.00%
0/6 • Up to 1 year
|
0.00%
0/13 • Up to 1 year
|
7.1%
1/14 • Number of events 1 • Up to 1 year
|
0.00%
0/10 • Up to 1 year
|
0.00%
0/37 • Up to 1 year
|
0.00%
0/4 • Up to 1 year
|
0.00%
0/8 • Up to 1 year
|
0.00%
0/5 • Up to 1 year
|
0.00%
0/2 • Up to 1 year
|
|
Injury, poisoning and procedural complications
Spinal Compression Fracture
|
0.00%
0/6 • Up to 1 year
|
0.00%
0/13 • Up to 1 year
|
7.1%
1/14 • Number of events 1 • Up to 1 year
|
0.00%
0/10 • Up to 1 year
|
0.00%
0/37 • Up to 1 year
|
0.00%
0/4 • Up to 1 year
|
0.00%
0/8 • Up to 1 year
|
0.00%
0/5 • Up to 1 year
|
0.00%
0/2 • Up to 1 year
|
|
Injury, poisoning and procedural complications
Subdural Haematoma
|
0.00%
0/6 • Up to 1 year
|
0.00%
0/13 • Up to 1 year
|
0.00%
0/14 • Up to 1 year
|
0.00%
0/10 • Up to 1 year
|
2.7%
1/37 • Number of events 1 • Up to 1 year
|
0.00%
0/4 • Up to 1 year
|
0.00%
0/8 • Up to 1 year
|
0.00%
0/5 • Up to 1 year
|
0.00%
0/2 • Up to 1 year
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/6 • Up to 1 year
|
0.00%
0/13 • Up to 1 year
|
0.00%
0/14 • Up to 1 year
|
0.00%
0/10 • Up to 1 year
|
0.00%
0/37 • Up to 1 year
|
0.00%
0/4 • Up to 1 year
|
12.5%
1/8 • Number of events 2 • Up to 1 year
|
0.00%
0/5 • Up to 1 year
|
0.00%
0/2 • Up to 1 year
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/6 • Up to 1 year
|
0.00%
0/13 • Up to 1 year
|
0.00%
0/14 • Up to 1 year
|
0.00%
0/10 • Up to 1 year
|
2.7%
1/37 • Number of events 1 • Up to 1 year
|
0.00%
0/4 • Up to 1 year
|
0.00%
0/8 • Up to 1 year
|
0.00%
0/5 • Up to 1 year
|
0.00%
0/2 • Up to 1 year
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/6 • Up to 1 year
|
0.00%
0/13 • Up to 1 year
|
0.00%
0/14 • Up to 1 year
|
0.00%
0/10 • Up to 1 year
|
0.00%
0/37 • Up to 1 year
|
0.00%
0/4 • Up to 1 year
|
12.5%
1/8 • Number of events 1 • Up to 1 year
|
0.00%
0/5 • Up to 1 year
|
0.00%
0/2 • Up to 1 year
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Chest Pain
|
0.00%
0/6 • Up to 1 year
|
0.00%
0/13 • Up to 1 year
|
0.00%
0/14 • Up to 1 year
|
0.00%
0/10 • Up to 1 year
|
0.00%
0/37 • Up to 1 year
|
0.00%
0/4 • Up to 1 year
|
0.00%
0/8 • Up to 1 year
|
20.0%
1/5 • Number of events 1 • Up to 1 year
|
0.00%
0/2 • Up to 1 year
|
|
Renal and urinary disorders
Acute Kidney Injury
|
0.00%
0/6 • Up to 1 year
|
0.00%
0/13 • Up to 1 year
|
7.1%
1/14 • Number of events 1 • Up to 1 year
|
0.00%
0/10 • Up to 1 year
|
0.00%
0/37 • Up to 1 year
|
0.00%
0/4 • Up to 1 year
|
0.00%
0/8 • Up to 1 year
|
0.00%
0/5 • Up to 1 year
|
0.00%
0/2 • Up to 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/6 • Up to 1 year
|
0.00%
0/13 • Up to 1 year
|
0.00%
0/14 • Up to 1 year
|
10.0%
1/10 • Number of events 1 • Up to 1 year
|
0.00%
0/37 • Up to 1 year
|
0.00%
0/4 • Up to 1 year
|
0.00%
0/8 • Up to 1 year
|
0.00%
0/5 • Up to 1 year
|
0.00%
0/2 • Up to 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
0.00%
0/6 • Up to 1 year
|
7.7%
1/13 • Number of events 1 • Up to 1 year
|
0.00%
0/14 • Up to 1 year
|
0.00%
0/10 • Up to 1 year
|
0.00%
0/37 • Up to 1 year
|
0.00%
0/4 • Up to 1 year
|
0.00%
0/8 • Up to 1 year
|
0.00%
0/5 • Up to 1 year
|
0.00%
0/2 • Up to 1 year
|
Other adverse events
| Measure |
35 mg BID Continuous
n=6 participants at risk
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.
|
50 mg BID Continuous
n=13 participants at risk
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.
|
75 mg QD Continuous
n=14 participants at risk
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.
|
100 mg QD Continuous
n=10 participants at risk
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.
|
125 mg BID Intermittent Days 1 and 2 (Fasted)
n=37 participants at risk
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.
|
125 mg BID Intermittent Days 1 and 2 (Fed)
n=4 participants at risk
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.
|
170 mg BID Intermittent Days 1 and 2 (Fasted)
n=8 participants at risk
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.
|
170 mg BID Intermittent Days 1 and 2 (Fed)
n=5 participants at risk
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.
|
125 mg BID Intermittent Days 1 and 4 (Fasted)
n=2 participants at risk
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.
|
|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
16.7%
1/6 • Number of events 1 • Up to 1 year
|
23.1%
3/13 • Number of events 3 • Up to 1 year
|
21.4%
3/14 • Number of events 4 • Up to 1 year
|
10.0%
1/10 • Number of events 1 • Up to 1 year
|
8.1%
3/37 • Number of events 4 • Up to 1 year
|
0.00%
0/4 • Up to 1 year
|
25.0%
2/8 • Number of events 2 • Up to 1 year
|
0.00%
0/5 • Up to 1 year
|
50.0%
1/2 • Number of events 2 • Up to 1 year
|
|
Blood and lymphatic system disorders
Anaemia of Malignant Disease
|
0.00%
0/6 • Up to 1 year
|
0.00%
0/13 • Up to 1 year
|
0.00%
0/14 • Up to 1 year
|
0.00%
0/10 • Up to 1 year
|
10.8%
4/37 • Number of events 4 • Up to 1 year
|
0.00%
0/4 • Up to 1 year
|
0.00%
0/8 • Up to 1 year
|
20.0%
1/5 • Number of events 1 • Up to 1 year
|
0.00%
0/2 • Up to 1 year
|
|
Blood and lymphatic system disorders
Neutropenia
|
16.7%
1/6 • Number of events 1 • Up to 1 year
|
7.7%
1/13 • Number of events 2 • Up to 1 year
|
0.00%
0/14 • Up to 1 year
|
0.00%
0/10 • Up to 1 year
|
10.8%
4/37 • Number of events 4 • Up to 1 year
|
0.00%
0/4 • Up to 1 year
|
0.00%
0/8 • Up to 1 year
|
20.0%
1/5 • Number of events 1 • Up to 1 year
|
0.00%
0/2 • Up to 1 year
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/6 • Up to 1 year
|
7.7%
1/13 • Number of events 1 • Up to 1 year
|
0.00%
0/14 • Up to 1 year
|
0.00%
0/10 • Up to 1 year
|
8.1%
3/37 • Number of events 3 • Up to 1 year
|
25.0%
1/4 • Number of events 1 • Up to 1 year
|
12.5%
1/8 • Number of events 1 • Up to 1 year
|
0.00%
0/5 • Up to 1 year
|
0.00%
0/2 • Up to 1 year
|
|
Eye disorders
Vision Blurred
|
0.00%
0/6 • Up to 1 year
|
0.00%
0/13 • Up to 1 year
|
7.1%
1/14 • Number of events 1 • Up to 1 year
|
10.0%
1/10 • Number of events 1 • Up to 1 year
|
0.00%
0/37 • Up to 1 year
|
0.00%
0/4 • Up to 1 year
|
25.0%
2/8 • Number of events 2 • Up to 1 year
|
20.0%
1/5 • Number of events 1 • Up to 1 year
|
0.00%
0/2 • Up to 1 year
|
|
Gastrointestinal disorders
Abdominal Distension
|
0.00%
0/6 • Up to 1 year
|
0.00%
0/13 • Up to 1 year
|
0.00%
0/14 • Up to 1 year
|
0.00%
0/10 • Up to 1 year
|
10.8%
4/37 • Number of events 5 • Up to 1 year
|
0.00%
0/4 • Up to 1 year
|
12.5%
1/8 • Number of events 1 • Up to 1 year
|
0.00%
0/5 • Up to 1 year
|
0.00%
0/2 • Up to 1 year
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/6 • Up to 1 year
|
0.00%
0/13 • Up to 1 year
|
0.00%
0/14 • Up to 1 year
|
0.00%
0/10 • Up to 1 year
|
18.9%
7/37 • Number of events 8 • Up to 1 year
|
0.00%
0/4 • Up to 1 year
|
12.5%
1/8 • Number of events 1 • Up to 1 year
|
0.00%
0/5 • Up to 1 year
|
0.00%
0/2 • Up to 1 year
|
|
Gastrointestinal disorders
Abdominal Pain, Upper
|
0.00%
0/6 • Up to 1 year
|
7.7%
1/13 • Number of events 1 • Up to 1 year
|
14.3%
2/14 • Number of events 3 • Up to 1 year
|
0.00%
0/10 • Up to 1 year
|
13.5%
5/37 • Number of events 5 • Up to 1 year
|
0.00%
0/4 • Up to 1 year
|
0.00%
0/8 • Up to 1 year
|
0.00%
0/5 • Up to 1 year
|
0.00%
0/2 • Up to 1 year
|
|
Gastrointestinal disorders
Constipation
|
16.7%
1/6 • Number of events 1 • Up to 1 year
|
15.4%
2/13 • Number of events 2 • Up to 1 year
|
14.3%
2/14 • Number of events 3 • Up to 1 year
|
10.0%
1/10 • Number of events 1 • Up to 1 year
|
29.7%
11/37 • Number of events 11 • Up to 1 year
|
0.00%
0/4 • Up to 1 year
|
12.5%
1/8 • Number of events 1 • Up to 1 year
|
0.00%
0/5 • Up to 1 year
|
50.0%
1/2 • Number of events 1 • Up to 1 year
|
|
Gastrointestinal disorders
Diarrhoea
|
33.3%
2/6 • Number of events 2 • Up to 1 year
|
61.5%
8/13 • Number of events 8 • Up to 1 year
|
50.0%
7/14 • Number of events 10 • Up to 1 year
|
50.0%
5/10 • Number of events 8 • Up to 1 year
|
51.4%
19/37 • Number of events 26 • Up to 1 year
|
0.00%
0/4 • Up to 1 year
|
87.5%
7/8 • Number of events 12 • Up to 1 year
|
20.0%
1/5 • Number of events 1 • Up to 1 year
|
100.0%
2/2 • Number of events 2 • Up to 1 year
|
|
Gastrointestinal disorders
Dry Mouth
|
16.7%
1/6 • Number of events 1 • Up to 1 year
|
15.4%
2/13 • Number of events 2 • Up to 1 year
|
7.1%
1/14 • Number of events 1 • Up to 1 year
|
20.0%
2/10 • Number of events 3 • Up to 1 year
|
13.5%
5/37 • Number of events 5 • Up to 1 year
|
0.00%
0/4 • Up to 1 year
|
0.00%
0/8 • Up to 1 year
|
40.0%
2/5 • Number of events 3 • Up to 1 year
|
0.00%
0/2 • Up to 1 year
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/6 • Up to 1 year
|
7.7%
1/13 • Number of events 1 • Up to 1 year
|
7.1%
1/14 • Number of events 1 • Up to 1 year
|
10.0%
1/10 • Number of events 1 • Up to 1 year
|
8.1%
3/37 • Number of events 4 • Up to 1 year
|
0.00%
0/4 • Up to 1 year
|
0.00%
0/8 • Up to 1 year
|
20.0%
1/5 • Number of events 1 • Up to 1 year
|
50.0%
1/2 • Number of events 1 • Up to 1 year
|
|
Gastrointestinal disorders
Gastrooesophageal Reflux Disease
|
0.00%
0/6 • Up to 1 year
|
0.00%
0/13 • Up to 1 year
|
7.1%
1/14 • Number of events 1 • Up to 1 year
|
20.0%
2/10 • Number of events 2 • Up to 1 year
|
16.2%
6/37 • Number of events 7 • Up to 1 year
|
25.0%
1/4 • Number of events 1 • Up to 1 year
|
12.5%
1/8 • Number of events 1 • Up to 1 year
|
0.00%
0/5 • Up to 1 year
|
0.00%
0/2 • Up to 1 year
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/6 • Up to 1 year
|
53.8%
7/13 • Number of events 9 • Up to 1 year
|
50.0%
7/14 • Number of events 8 • Up to 1 year
|
90.0%
9/10 • Number of events 15 • Up to 1 year
|
75.7%
28/37 • Number of events 39 • Up to 1 year
|
75.0%
3/4 • Number of events 3 • Up to 1 year
|
100.0%
8/8 • Number of events 15 • Up to 1 year
|
60.0%
3/5 • Number of events 4 • Up to 1 year
|
100.0%
2/2 • Number of events 2 • Up to 1 year
|
|
Gastrointestinal disorders
Oral Pain
|
0.00%
0/6 • Up to 1 year
|
0.00%
0/13 • Up to 1 year
|
14.3%
2/14 • Number of events 2 • Up to 1 year
|
10.0%
1/10 • Number of events 2 • Up to 1 year
|
21.6%
8/37 • Number of events 11 • Up to 1 year
|
0.00%
0/4 • Up to 1 year
|
12.5%
1/8 • Number of events 1 • Up to 1 year
|
0.00%
0/5 • Up to 1 year
|
0.00%
0/2 • Up to 1 year
|
|
Gastrointestinal disorders
Stomatitis
|
50.0%
3/6 • Number of events 4 • Up to 1 year
|
69.2%
9/13 • Number of events 12 • Up to 1 year
|
42.9%
6/14 • Number of events 6 • Up to 1 year
|
70.0%
7/10 • Number of events 10 • Up to 1 year
|
35.1%
13/37 • Number of events 16 • Up to 1 year
|
25.0%
1/4 • Number of events 1 • Up to 1 year
|
50.0%
4/8 • Number of events 6 • Up to 1 year
|
40.0%
2/5 • Number of events 6 • Up to 1 year
|
100.0%
2/2 • Number of events 2 • Up to 1 year
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/6 • Up to 1 year
|
30.8%
4/13 • Number of events 5 • Up to 1 year
|
28.6%
4/14 • Number of events 5 • Up to 1 year
|
30.0%
3/10 • Number of events 4 • Up to 1 year
|
51.4%
19/37 • Number of events 29 • Up to 1 year
|
75.0%
3/4 • Number of events 5 • Up to 1 year
|
100.0%
8/8 • Number of events 18 • Up to 1 year
|
60.0%
3/5 • Number of events 4 • Up to 1 year
|
50.0%
1/2 • Number of events 1 • Up to 1 year
|
|
General disorders
Asthenia
|
0.00%
0/6 • Up to 1 year
|
15.4%
2/13 • Number of events 2 • Up to 1 year
|
21.4%
3/14 • Number of events 3 • Up to 1 year
|
20.0%
2/10 • Number of events 3 • Up to 1 year
|
27.0%
10/37 • Number of events 10 • Up to 1 year
|
25.0%
1/4 • Number of events 1 • Up to 1 year
|
50.0%
4/8 • Number of events 4 • Up to 1 year
|
20.0%
1/5 • Number of events 1 • Up to 1 year
|
0.00%
0/2 • Up to 1 year
|
|
General disorders
Fatigue
|
100.0%
3/3 • Number of events 3 • Up to 1 year
|
53.8%
7/13 • Number of events 13 • Up to 1 year
|
64.3%
9/14 • Number of events 10 • Up to 1 year
|
70.0%
7/10 • Number of events 10 • Up to 1 year
|
62.2%
23/37 • Number of events 24 • Up to 1 year
|
75.0%
3/4 • Number of events 4 • Up to 1 year
|
62.5%
5/8 • Number of events 6 • Up to 1 year
|
80.0%
4/5 • Number of events 5 • Up to 1 year
|
100.0%
2/2 • Number of events 2 • Up to 1 year
|
|
General disorders
Oedema Peripheral
|
16.7%
1/6 • Number of events 1 • Up to 1 year
|
23.1%
3/13 • Number of events 5 • Up to 1 year
|
42.9%
6/14 • Number of events 8 • Up to 1 year
|
0.00%
0/10 • Up to 1 year
|
18.9%
7/37 • Number of events 7 • Up to 1 year
|
0.00%
0/4 • Up to 1 year
|
37.5%
3/8 • Number of events 3 • Up to 1 year
|
0.00%
0/5 • Up to 1 year
|
0.00%
0/2 • Up to 1 year
|
|
General disorders
Pain
|
16.7%
1/6 • Number of events 1 • Up to 1 year
|
23.1%
3/13 • Number of events 3 • Up to 1 year
|
0.00%
0/14 • Up to 1 year
|
0.00%
0/10 • Up to 1 year
|
8.1%
3/37 • Number of events 3 • Up to 1 year
|
0.00%
0/4 • Up to 1 year
|
0.00%
0/8 • Up to 1 year
|
0.00%
0/5 • Up to 1 year
|
0.00%
0/2 • Up to 1 year
|
|
General disorders
Pyrexia
|
0.00%
0/6 • Up to 1 year
|
7.7%
1/13 • Number of events 4 • Up to 1 year
|
21.4%
3/14 • Number of events 3 • Up to 1 year
|
40.0%
4/10 • Number of events 4 • Up to 1 year
|
16.2%
6/37 • Number of events 8 • Up to 1 year
|
0.00%
0/4 • Up to 1 year
|
25.0%
2/8 • Number of events 2 • Up to 1 year
|
0.00%
0/5 • Up to 1 year
|
0.00%
0/2 • Up to 1 year
|
|
Infections and infestations
Sinusitis
|
0.00%
0/6 • Up to 1 year
|
7.7%
1/13 • Number of events 1 • Up to 1 year
|
0.00%
0/14 • Up to 1 year
|
10.0%
1/10 • Number of events 1 • Up to 1 year
|
2.7%
1/37 • Number of events 1 • Up to 1 year
|
0.00%
0/4 • Up to 1 year
|
37.5%
3/8 • Number of events 4 • Up to 1 year
|
0.00%
0/5 • Up to 1 year
|
0.00%
0/2 • Up to 1 year
|
|
Infections and infestations
Urinary Tract Infection
|
33.3%
2/6 • Number of events 2 • Up to 1 year
|
0.00%
0/13 • Up to 1 year
|
14.3%
2/14 • Number of events 2 • Up to 1 year
|
20.0%
2/10 • Number of events 3 • Up to 1 year
|
21.6%
8/37 • Number of events 10 • Up to 1 year
|
0.00%
0/4 • Up to 1 year
|
25.0%
2/8 • Number of events 2 • Up to 1 year
|
40.0%
2/5 • Number of events 2 • Up to 1 year
|
0.00%
0/2 • Up to 1 year
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/6 • Up to 1 year
|
7.7%
1/13 • Number of events 2 • Up to 1 year
|
7.1%
1/14 • Number of events 1 • Up to 1 year
|
0.00%
0/10 • Up to 1 year
|
5.4%
2/37 • Number of events 2 • Up to 1 year
|
0.00%
0/4 • Up to 1 year
|
25.0%
2/8 • Number of events 4 • Up to 1 year
|
0.00%
0/5 • Up to 1 year
|
50.0%
1/2 • Number of events 1 • Up to 1 year
|
|
Investigations
Alanine Aminotransferase Increased
|
0.00%
0/6 • Up to 1 year
|
0.00%
0/13 • Up to 1 year
|
7.1%
1/14 • Number of events 1 • Up to 1 year
|
20.0%
2/10 • Number of events 3 • Up to 1 year
|
13.5%
5/37 • Number of events 5 • Up to 1 year
|
0.00%
0/4 • Up to 1 year
|
0.00%
0/8 • Up to 1 year
|
20.0%
1/5 • Number of events 1 • Up to 1 year
|
50.0%
1/2 • Number of events 1 • Up to 1 year
|
|
Investigations
Aspartate Aminotransferase Increased
|
0.00%
0/6 • Up to 1 year
|
0.00%
0/13 • Up to 1 year
|
14.3%
2/14 • Number of events 2 • Up to 1 year
|
20.0%
2/10 • Number of events 2 • Up to 1 year
|
21.6%
8/37 • Number of events 9 • Up to 1 year
|
0.00%
0/4 • Up to 1 year
|
0.00%
0/8 • Up to 1 year
|
20.0%
1/5 • Number of events 1 • Up to 1 year
|
50.0%
1/2 • Number of events 1 • Up to 1 year
|
|
Investigations
Blood Creatinine Increased
|
0.00%
0/6 • Up to 1 year
|
7.7%
1/13 • Number of events 1 • Up to 1 year
|
14.3%
2/14 • Number of events 2 • Up to 1 year
|
10.0%
1/10 • Number of events 1 • Up to 1 year
|
16.2%
6/37 • Number of events 6 • Up to 1 year
|
25.0%
1/4 • Number of events 1 • Up to 1 year
|
0.00%
0/8 • Up to 1 year
|
0.00%
0/5 • Up to 1 year
|
0.00%
0/2 • Up to 1 year
|
|
Investigations
Breath Sounds Abnormal
|
0.00%
0/6 • Up to 1 year
|
7.7%
1/13 • Number of events 1 • Up to 1 year
|
0.00%
0/14 • Up to 1 year
|
10.0%
1/10 • Number of events 1 • Up to 1 year
|
2.7%
1/37 • Number of events 1 • Up to 1 year
|
0.00%
0/4 • Up to 1 year
|
50.0%
4/8 • Number of events 5 • Up to 1 year
|
0.00%
0/5 • Up to 1 year
|
0.00%
0/2 • Up to 1 year
|
|
Investigations
Transaminases Increased
|
0.00%
0/6 • Up to 1 year
|
0.00%
0/13 • Up to 1 year
|
7.1%
1/14 • Number of events 1 • Up to 1 year
|
10.0%
1/10 • Number of events 1 • Up to 1 year
|
2.7%
1/37 • Number of events 2 • Up to 1 year
|
0.00%
0/4 • Up to 1 year
|
0.00%
0/8 • Up to 1 year
|
40.0%
2/5 • Number of events 2 • Up to 1 year
|
0.00%
0/2 • Up to 1 year
|
|
Investigations
Weight Decreased
|
33.3%
2/6 • Number of events 2 • Up to 1 year
|
15.4%
2/13 • Number of events 2 • Up to 1 year
|
7.1%
1/14 • Number of events 1 • Up to 1 year
|
10.0%
1/10 • Number of events 1 • Up to 1 year
|
27.0%
10/37 • Number of events 10 • Up to 1 year
|
50.0%
2/4 • Number of events 2 • Up to 1 year
|
25.0%
2/8 • Number of events 2 • Up to 1 year
|
60.0%
3/5 • Number of events 3 • Up to 1 year
|
0.00%
0/2 • Up to 1 year
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
16.7%
1/6 • Number of events 1 • Up to 1 year
|
38.5%
5/13 • Number of events 5 • Up to 1 year
|
21.4%
3/14 • Number of events 3 • Up to 1 year
|
40.0%
4/10 • Number of events 4 • Up to 1 year
|
40.5%
15/37 • Number of events 16 • Up to 1 year
|
25.0%
1/4 • Number of events 1 • Up to 1 year
|
37.5%
3/8 • Number of events 4 • Up to 1 year
|
60.0%
3/5 • Number of events 3 • Up to 1 year
|
0.00%
0/2 • Up to 1 year
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/6 • Up to 1 year
|
30.8%
4/13 • Number of events 5 • Up to 1 year
|
14.3%
2/14 • Number of events 2 • Up to 1 year
|
10.0%
1/10 • Number of events 1 • Up to 1 year
|
16.2%
6/37 • Number of events 6 • Up to 1 year
|
0.00%
0/4 • Up to 1 year
|
12.5%
1/8 • Number of events 1 • Up to 1 year
|
20.0%
1/5 • Number of events 1 • Up to 1 year
|
0.00%
0/2 • Up to 1 year
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/6 • Up to 1 year
|
23.1%
3/13 • Number of events 5 • Up to 1 year
|
14.3%
2/14 • Number of events 4 • Up to 1 year
|
20.0%
2/10 • Number of events 4 • Up to 1 year
|
13.5%
5/37 • Number of events 9 • Up to 1 year
|
0.00%
0/4 • Up to 1 year
|
50.0%
4/8 • Number of events 8 • Up to 1 year
|
0.00%
0/5 • Up to 1 year
|
0.00%
0/2 • Up to 1 year
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/6 • Up to 1 year
|
0.00%
0/13 • Up to 1 year
|
0.00%
0/14 • Up to 1 year
|
20.0%
2/10 • Number of events 4 • Up to 1 year
|
13.5%
5/37 • Number of events 5 • Up to 1 year
|
25.0%
1/4 • Number of events 1 • Up to 1 year
|
12.5%
1/8 • Number of events 1 • Up to 1 year
|
0.00%
0/5 • Up to 1 year
|
0.00%
0/2 • Up to 1 year
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/6 • Up to 1 year
|
7.7%
1/13 • Number of events 1 • Up to 1 year
|
14.3%
2/14 • Number of events 2 • Up to 1 year
|
10.0%
1/10 • Number of events 3 • Up to 1 year
|
18.9%
7/37 • Number of events 11 • Up to 1 year
|
25.0%
1/4 • Number of events 1 • Up to 1 year
|
12.5%
1/8 • Number of events 1 • Up to 1 year
|
40.0%
2/5 • Number of events 3 • Up to 1 year
|
0.00%
0/2 • Up to 1 year
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/6 • Up to 1 year
|
7.7%
1/13 • Number of events 1 • Up to 1 year
|
7.1%
1/14 • Number of events 1 • Up to 1 year
|
0.00%
0/10 • Up to 1 year
|
5.4%
2/37 • Number of events 2 • Up to 1 year
|
0.00%
0/4 • Up to 1 year
|
37.5%
3/8 • Number of events 4 • Up to 1 year
|
20.0%
1/5 • Number of events 2 • Up to 1 year
|
0.00%
0/2 • Up to 1 year
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/6 • Up to 1 year
|
0.00%
0/13 • Up to 1 year
|
0.00%
0/14 • Up to 1 year
|
10.0%
1/10 • Number of events 1 • Up to 1 year
|
13.5%
5/37 • Number of events 7 • Up to 1 year
|
0.00%
0/4 • Up to 1 year
|
0.00%
0/8 • Up to 1 year
|
0.00%
0/5 • Up to 1 year
|
0.00%
0/2 • Up to 1 year
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
16.7%
1/6 • Number of events 1 • Up to 1 year
|
0.00%
0/13 • Up to 1 year
|
21.4%
3/14 • Number of events 5 • Up to 1 year
|
40.0%
4/10 • Number of events 9 • Up to 1 year
|
16.2%
6/37 • Number of events 6 • Up to 1 year
|
0.00%
0/4 • Up to 1 year
|
25.0%
2/8 • Number of events 2 • Up to 1 year
|
40.0%
2/5 • Number of events 2 • Up to 1 year
|
50.0%
1/2 • Number of events 1 • Up to 1 year
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
33.3%
2/6 • Number of events 2 • Up to 1 year
|
15.4%
2/13 • Number of events 2 • Up to 1 year
|
14.3%
2/14 • Number of events 2 • Up to 1 year
|
20.0%
2/10 • Number of events 2 • Up to 1 year
|
18.9%
7/37 • Number of events 8 • Up to 1 year
|
0.00%
0/4 • Up to 1 year
|
12.5%
1/8 • Number of events 1 • Up to 1 year
|
20.0%
1/5 • Number of events 1 • Up to 1 year
|
0.00%
0/2 • Up to 1 year
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
16.7%
1/6 • Number of events 2 • Up to 1 year
|
0.00%
0/13 • Up to 1 year
|
7.1%
1/14 • Number of events 1 • Up to 1 year
|
10.0%
1/10 • Number of events 1 • Up to 1 year
|
2.7%
1/37 • Number of events 1 • Up to 1 year
|
0.00%
0/4 • Up to 1 year
|
12.5%
1/8 • Number of events 1 • Up to 1 year
|
0.00%
0/5 • Up to 1 year
|
50.0%
1/2 • Number of events 1 • Up to 1 year
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
16.7%
1/6 • Number of events 1 • Up to 1 year
|
7.7%
1/13 • Number of events 1 • Up to 1 year
|
14.3%
2/14 • Number of events 3 • Up to 1 year
|
10.0%
1/10 • Number of events 1 • Up to 1 year
|
8.1%
3/37 • Number of events 3 • Up to 1 year
|
0.00%
0/4 • Up to 1 year
|
37.5%
3/8 • Number of events 3 • Up to 1 year
|
0.00%
0/5 • Up to 1 year
|
0.00%
0/2 • Up to 1 year
|
|
Musculoskeletal and connective tissue disorders
Muscular Weakness
|
0.00%
0/6 • Up to 1 year
|
7.7%
1/13 • Number of events 2 • Up to 1 year
|
0.00%
0/14 • Up to 1 year
|
10.0%
1/10 • Number of events 2 • Up to 1 year
|
5.4%
2/37 • Number of events 3 • Up to 1 year
|
25.0%
1/4 • Number of events 1 • Up to 1 year
|
0.00%
0/8 • Up to 1 year
|
0.00%
0/5 • Up to 1 year
|
0.00%
0/2 • Up to 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea, Exertional
|
16.7%
1/6 • Number of events 1 • Up to 1 year
|
15.4%
2/13 • Number of events 2 • Up to 1 year
|
21.4%
3/14 • Number of events 3 • Up to 1 year
|
20.0%
2/10 • Number of events 2 • Up to 1 year
|
18.9%
7/37 • Number of events 7 • Up to 1 year
|
25.0%
1/4 • Number of events 1 • Up to 1 year
|
12.5%
1/8 • Number of events 1 • Up to 1 year
|
0.00%
0/5 • Up to 1 year
|
50.0%
1/2 • Number of events 1 • Up to 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
0.00%
0/6 • Up to 1 year
|
15.4%
2/13 • Number of events 2 • Up to 1 year
|
0.00%
0/14 • Up to 1 year
|
10.0%
1/10 • Number of events 1 • Up to 1 year
|
13.5%
5/37 • Number of events 5 • Up to 1 year
|
0.00%
0/4 • Up to 1 year
|
12.5%
1/8 • Number of events 1 • Up to 1 year
|
0.00%
0/5 • Up to 1 year
|
0.00%
0/2 • Up to 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Productive Cough
|
16.7%
1/6 • Number of events 1 • Up to 1 year
|
7.7%
1/13 • Number of events 1 • Up to 1 year
|
0.00%
0/14 • Up to 1 year
|
10.0%
1/10 • Number of events 1 • Up to 1 year
|
2.7%
1/37 • Number of events 1 • Up to 1 year
|
25.0%
1/4 • Number of events 1 • Up to 1 year
|
12.5%
1/8 • Number of events 1 • Up to 1 year
|
20.0%
1/5 • Number of events 1 • Up to 1 year
|
0.00%
0/2 • Up to 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/6 • Up to 1 year
|
0.00%
0/13 • Up to 1 year
|
0.00%
0/14 • Up to 1 year
|
0.00%
0/10 • Up to 1 year
|
8.1%
3/37 • Number of events 3 • Up to 1 year
|
25.0%
1/4 • Number of events 1 • Up to 1 year
|
37.5%
3/8 • Number of events 3 • Up to 1 year
|
0.00%
0/5 • Up to 1 year
|
0.00%
0/2 • Up to 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Sinus Congestion
|
0.00%
0/6 • Up to 1 year
|
0.00%
0/13 • Up to 1 year
|
7.1%
1/14 • Number of events 1 • Up to 1 year
|
10.0%
1/10 • Number of events 1 • Up to 1 year
|
5.4%
2/37 • Number of events 2 • Up to 1 year
|
25.0%
1/4 • Number of events 1 • Up to 1 year
|
12.5%
1/8 • Number of events 1 • Up to 1 year
|
20.0%
1/5 • Number of events 1 • Up to 1 year
|
0.00%
0/2 • Up to 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
16.7%
1/6 • Number of events 1 • Up to 1 year
|
0.00%
0/13 • Up to 1 year
|
7.1%
1/14 • Number of events 1 • Up to 1 year
|
0.00%
0/10 • Up to 1 year
|
5.4%
2/37 • Number of events 2 • Up to 1 year
|
0.00%
0/4 • Up to 1 year
|
12.5%
1/8 • Number of events 1 • Up to 1 year
|
0.00%
0/5 • Up to 1 year
|
0.00%
0/2 • Up to 1 year
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
16.7%
1/6 • Number of events 1 • Up to 1 year
|
7.7%
1/13 • Number of events 1 • Up to 1 year
|
14.3%
2/14 • Number of events 3 • Up to 1 year
|
0.00%
0/10 • Up to 1 year
|
10.8%
4/37 • Number of events 4 • Up to 1 year
|
0.00%
0/4 • Up to 1 year
|
25.0%
2/8 • Number of events 2 • Up to 1 year
|
0.00%
0/5 • Up to 1 year
|
0.00%
0/2 • Up to 1 year
|
|
Skin and subcutaneous tissue disorders
Dermatitis Acneiform
|
0.00%
0/6 • Up to 1 year
|
23.1%
3/13 • Number of events 3 • Up to 1 year
|
7.1%
1/14 • Number of events 2 • Up to 1 year
|
0.00%
0/10 • Up to 1 year
|
5.4%
2/37 • Number of events 2 • Up to 1 year
|
0.00%
0/4 • Up to 1 year
|
12.5%
1/8 • Number of events 2 • Up to 1 year
|
0.00%
0/5 • Up to 1 year
|
0.00%
0/2 • Up to 1 year
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
50.0%
3/6 • Number of events 3 • Up to 1 year
|
38.5%
5/13 • Number of events 5 • Up to 1 year
|
28.6%
4/14 • Number of events 6 • Up to 1 year
|
10.0%
1/10 • Number of events 1 • Up to 1 year
|
5.4%
2/37 • Number of events 2 • Up to 1 year
|
25.0%
1/4 • Number of events 1 • Up to 1 year
|
25.0%
2/8 • Number of events 2 • Up to 1 year
|
20.0%
1/5 • Number of events 1 • Up to 1 year
|
100.0%
2/2 • Number of events 3 • Up to 1 year
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
66.7%
4/6 • Number of events 6 • Up to 1 year
|
46.2%
6/13 • Number of events 9 • Up to 1 year
|
14.3%
2/14 • Number of events 2 • Up to 1 year
|
20.0%
2/10 • Number of events 2 • Up to 1 year
|
16.2%
6/37 • Number of events 6 • Up to 1 year
|
0.00%
0/4 • Up to 1 year
|
25.0%
2/8 • Number of events 3 • Up to 1 year
|
20.0%
1/5 • Number of events 1 • Up to 1 year
|
100.0%
2/2 • Number of events 2 • Up to 1 year
|
|
Skin and subcutaneous tissue disorders
Pruritus Generalised
|
0.00%
0/6 • Up to 1 year
|
23.1%
3/13 • Number of events 3 • Up to 1 year
|
0.00%
0/14 • Up to 1 year
|
20.0%
2/10 • Number of events 2 • Up to 1 year
|
2.7%
1/37 • Number of events 1 • Up to 1 year
|
25.0%
1/4 • Number of events 1 • Up to 1 year
|
12.5%
1/8 • Number of events 1 • Up to 1 year
|
0.00%
0/5 • Up to 1 year
|
0.00%
0/2 • Up to 1 year
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/6 • Up to 1 year
|
23.1%
3/13 • Number of events 5 • Up to 1 year
|
7.1%
1/14 • Number of events 1 • Up to 1 year
|
0.00%
0/10 • Up to 1 year
|
5.4%
2/37 • Number of events 2 • Up to 1 year
|
25.0%
1/4 • Number of events 1 • Up to 1 year
|
0.00%
0/8 • Up to 1 year
|
0.00%
0/5 • Up to 1 year
|
50.0%
1/2 • Number of events 1 • Up to 1 year
|
|
Skin and subcutaneous tissue disorders
Rash Erythematous
|
0.00%
0/6 • Up to 1 year
|
23.1%
3/13 • Number of events 4 • Up to 1 year
|
7.1%
1/14 • Number of events 1 • Up to 1 year
|
20.0%
2/10 • Number of events 3 • Up to 1 year
|
2.7%
1/37 • Number of events 1 • Up to 1 year
|
0.00%
0/4 • Up to 1 year
|
12.5%
1/8 • Number of events 1 • Up to 1 year
|
0.00%
0/5 • Up to 1 year
|
50.0%
1/2 • Number of events 1 • Up to 1 year
|
|
Skin and subcutaneous tissue disorders
Rash, Maculo-Papular
|
33.3%
2/6 • Number of events 2 • Up to 1 year
|
46.2%
6/13 • Number of events 8 • Up to 1 year
|
28.6%
4/14 • Number of events 5 • Up to 1 year
|
20.0%
2/10 • Number of events 2 • Up to 1 year
|
10.8%
4/37 • Number of events 4 • Up to 1 year
|
0.00%
0/4 • Up to 1 year
|
25.0%
2/8 • Number of events 3 • Up to 1 year
|
0.00%
0/5 • Up to 1 year
|
100.0%
2/2 • Number of events 2 • Up to 1 year
|
|
Vascular disorders
Deep Vein Thrombosis
|
0.00%
0/6 • Up to 1 year
|
0.00%
0/13 • Up to 1 year
|
7.1%
1/14 • Number of events 1 • Up to 1 year
|
0.00%
0/10 • Up to 1 year
|
5.4%
2/37 • Number of events 2 • Up to 1 year
|
0.00%
0/4 • Up to 1 year
|
12.5%
1/8 • Number of events 1 • Up to 1 year
|
20.0%
1/5 • Number of events 1 • Up to 1 year
|
0.00%
0/2 • Up to 1 year
|
|
Vascular disorders
Hypotension
|
0.00%
0/6 • Up to 1 year
|
0.00%
0/13 • Up to 1 year
|
7.1%
1/14 • Number of events 1 • Up to 1 year
|
0.00%
0/10 • Up to 1 year
|
16.2%
6/37 • Number of events 7 • Up to 1 year
|
0.00%
0/4 • Up to 1 year
|
0.00%
0/8 • Up to 1 year
|
0.00%
0/5 • Up to 1 year
|
0.00%
0/2 • Up to 1 year
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
0.00%
0/6 • Up to 1 year
|
7.7%
1/13 • Number of events 1 • Up to 1 year
|
0.00%
0/14 • Up to 1 year
|
10.0%
1/10 • Number of events 1 • Up to 1 year
|
8.1%
3/37 • Number of events 3 • Up to 1 year
|
0.00%
0/4 • Up to 1 year
|
0.00%
0/8 • Up to 1 year
|
0.00%
0/5 • Up to 1 year
|
0.00%
0/2 • Up to 1 year
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
0.00%
0/6 • Up to 1 year
|
7.7%
1/13 • Number of events 1 • Up to 1 year
|
21.4%
3/14 • Number of events 4 • Up to 1 year
|
20.0%
2/10 • Number of events 3 • Up to 1 year
|
16.2%
6/37 • Number of events 7 • Up to 1 year
|
0.00%
0/4 • Up to 1 year
|
25.0%
2/8 • Number of events 3 • Up to 1 year
|
20.0%
1/5 • Number of events 1 • Up to 1 year
|
50.0%
1/2 • Number of events 2 • Up to 1 year
|
|
Nervous system disorders
Dizziness
|
0.00%
0/6 • Up to 1 year
|
15.4%
2/13 • Number of events 2 • Up to 1 year
|
7.1%
1/14 • Number of events 1 • Up to 1 year
|
30.0%
3/10 • Number of events 4 • Up to 1 year
|
21.6%
8/37 • Number of events 10 • Up to 1 year
|
25.0%
1/4 • Number of events 1 • Up to 1 year
|
37.5%
3/8 • Number of events 4 • Up to 1 year
|
0.00%
0/5 • Up to 1 year
|
0.00%
0/2 • Up to 1 year
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/6 • Up to 1 year
|
7.7%
1/13 • Number of events 1 • Up to 1 year
|
0.00%
0/14 • Up to 1 year
|
10.0%
1/10 • Number of events 1 • Up to 1 year
|
18.9%
7/37 • Number of events 7 • Up to 1 year
|
50.0%
2/4 • Number of events 2 • Up to 1 year
|
0.00%
0/8 • Up to 1 year
|
20.0%
1/5 • Number of events 2 • Up to 1 year
|
0.00%
0/2 • Up to 1 year
|
|
Nervous system disorders
Headache
|
0.00%
0/6 • Up to 1 year
|
23.1%
3/13 • Number of events 3 • Up to 1 year
|
14.3%
2/14 • Number of events 2 • Up to 1 year
|
30.0%
3/10 • Number of events 3 • Up to 1 year
|
32.4%
12/37 • Number of events 13 • Up to 1 year
|
0.00%
0/4 • Up to 1 year
|
50.0%
4/8 • Number of events 9 • Up to 1 year
|
0.00%
0/5 • Up to 1 year
|
50.0%
1/2 • Number of events 1 • Up to 1 year
|
|
Nervous system disorders
Peripheral Neuropathy
|
0.00%
0/6 • Up to 1 year
|
0.00%
0/13 • Up to 1 year
|
14.3%
2/14 • Number of events 2 • Up to 1 year
|
10.0%
1/10 • Number of events 1 • Up to 1 year
|
5.4%
2/37 • Number of events 2 • Up to 1 year
|
0.00%
0/4 • Up to 1 year
|
12.5%
1/8 • Number of events 1 • Up to 1 year
|
0.00%
0/5 • Up to 1 year
|
0.00%
0/2 • Up to 1 year
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/6 • Up to 1 year
|
0.00%
0/13 • Up to 1 year
|
14.3%
2/14 • Number of events 2 • Up to 1 year
|
10.0%
1/10 • Number of events 1 • Up to 1 year
|
8.1%
3/37 • Number of events 3 • Up to 1 year
|
0.00%
0/4 • Up to 1 year
|
12.5%
1/8 • Number of events 1 • Up to 1 year
|
0.00%
0/5 • Up to 1 year
|
0.00%
0/2 • Up to 1 year
|
|
Psychiatric disorders
Confusional State
|
0.00%
0/6 • Up to 1 year
|
7.7%
1/13 • Number of events 1 • Up to 1 year
|
0.00%
0/14 • Up to 1 year
|
0.00%
0/10 • Up to 1 year
|
10.8%
4/37 • Number of events 4 • Up to 1 year
|
25.0%
1/4 • Number of events 1 • Up to 1 year
|
0.00%
0/8 • Up to 1 year
|
0.00%
0/5 • Up to 1 year
|
0.00%
0/2 • Up to 1 year
|
|
Psychiatric disorders
Depression
|
16.7%
1/6 • Number of events 1 • Up to 1 year
|
0.00%
0/13 • Up to 1 year
|
0.00%
0/14 • Up to 1 year
|
0.00%
0/10 • Up to 1 year
|
8.1%
3/37 • Number of events 3 • Up to 1 year
|
0.00%
0/4 • Up to 1 year
|
25.0%
2/8 • Number of events 2 • Up to 1 year
|
20.0%
1/5 • Number of events 1 • Up to 1 year
|
0.00%
0/2 • Up to 1 year
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/6 • Up to 1 year
|
15.4%
2/13 • Number of events 2 • Up to 1 year
|
0.00%
0/14 • Up to 1 year
|
0.00%
0/10 • Up to 1 year
|
10.8%
4/37 • Number of events 4 • Up to 1 year
|
25.0%
1/4 • Number of events 1 • Up to 1 year
|
12.5%
1/8 • Number of events 1 • Up to 1 year
|
0.00%
0/5 • Up to 1 year
|
50.0%
1/2 • Number of events 1 • Up to 1 year
|
|
Renal and urinary disorders
Dysuria
|
16.7%
1/6 • Number of events 1 • Up to 1 year
|
0.00%
0/13 • Up to 1 year
|
7.1%
1/14 • Number of events 1 • Up to 1 year
|
0.00%
0/10 • Up to 1 year
|
8.1%
3/37 • Number of events 4 • Up to 1 year
|
0.00%
0/4 • Up to 1 year
|
12.5%
1/8 • Number of events 1 • Up to 1 year
|
20.0%
1/5 • Number of events 1 • Up to 1 year
|
0.00%
0/2 • Up to 1 year
|
|
Reproductive system and breast disorders
Pelvic Pain
|
33.3%
2/6 • Number of events 2 • Up to 1 year
|
0.00%
0/13 • Up to 1 year
|
7.1%
1/14 • Number of events 1 • Up to 1 year
|
0.00%
0/10 • Up to 1 year
|
5.4%
2/37 • Number of events 2 • Up to 1 year
|
0.00%
0/4 • Up to 1 year
|
0.00%
0/8 • Up to 1 year
|
0.00%
0/5 • Up to 1 year
|
50.0%
1/2 • Number of events 1 • Up to 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
16.7%
1/6 • Number of events 1 • Up to 1 year
|
0.00%
0/13 • Up to 1 year
|
14.3%
2/14 • Number of events 3 • Up to 1 year
|
40.0%
4/10 • Number of events 8 • Up to 1 year
|
10.8%
4/37 • Number of events 4 • Up to 1 year
|
0.00%
0/4 • Up to 1 year
|
50.0%
4/8 • Number of events 4 • Up to 1 year
|
20.0%
1/5 • Number of events 1 • Up to 1 year
|
50.0%
1/2 • Number of events 1 • Up to 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
16.7%
1/6 • Number of events 1 • Up to 1 year
|
0.00%
0/13 • Up to 1 year
|
0.00%
0/14 • Up to 1 year
|
0.00%
0/10 • Up to 1 year
|
5.4%
2/37 • Number of events 2 • Up to 1 year
|
0.00%
0/4 • Up to 1 year
|
12.5%
1/8 • Number of events 1 • Up to 1 year
|
20.0%
1/5 • Number of events 1 • Up to 1 year
|
0.00%
0/2 • Up to 1 year
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place