Trial Outcomes & Findings for AZD8848 Single Ascending Dose Study (NCT NCT01560234)
NCT ID: NCT01560234
Last Updated: 2016-06-06
Results Overview
Summary of number of subjects who had at least one adverse event
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
47 participants
Primary outcome timeframe
Screening up to Day 13
Results posted on
2016-06-06
Participant Flow
There were 47 male and female subjects (6 cohorts with additional 2 cohorts) were randomized in the study.There were 6 subjects per cohort (4 subjects received AZD8848 and 2 subjects received placebo), with the exception of Cohort 3 (1.5 μg), where 3 subjects received AZD8848 and 2 subjects received placebo.
Participant milestones
| Measure |
Placebo
Commercial 0.9% sodium chloride solution.
|
Cohort 1
AZD8848 0.15 μg
|
Cohort 2
AZD8848 0.5 ug
|
Cohort 3
AZD8848 1.5 μg
|
Cohort 4
AZD8848 5 μg
|
Cohort 5
AZD8848 15 μg
|
Cohort 7
AZD8848 15 μg (Multiple Inhalation)
|
Cohort 6 and 8
AZD8848 30 μg (similar investigational product administration conditions)
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
16
|
4
|
4
|
3
|
4
|
4
|
4
|
8
|
|
Overall Study
COMPLETED
|
13
|
4
|
3
|
3
|
4
|
2
|
4
|
6
|
|
Overall Study
NOT COMPLETED
|
3
|
0
|
1
|
0
|
0
|
2
|
0
|
2
|
Reasons for withdrawal
| Measure |
Placebo
Commercial 0.9% sodium chloride solution.
|
Cohort 1
AZD8848 0.15 μg
|
Cohort 2
AZD8848 0.5 ug
|
Cohort 3
AZD8848 1.5 μg
|
Cohort 4
AZD8848 5 μg
|
Cohort 5
AZD8848 15 μg
|
Cohort 7
AZD8848 15 μg (Multiple Inhalation)
|
Cohort 6 and 8
AZD8848 30 μg (similar investigational product administration conditions)
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
3
|
0
|
1
|
0
|
0
|
2
|
0
|
2
|
Baseline Characteristics
AZD8848 Single Ascending Dose Study
Baseline characteristics by cohort
| Measure |
Placebo
n=16 Participants
Commercial 0.9% sodium chloride solution.
|
Cohort 1
n=4 Participants
AZD8848 0.15 μg
|
Cohort 2
n=4 Participants
AZD8848 0.5 ug
|
Cohort 3
n=3 Participants
AZD8848 1.5 μg
|
Cohort 4
n=4 Participants
AZD8848 5 μg
|
Cohort 5
n=4 Participants
AZD8848 15 μg
|
Cohort 7
n=4 Participants
AZD8848 15 μg (Multiple Inhalation)
|
Cohort 6 and 8
n=8 Participants
AZD8848 30 μg (similar investigational product administration conditions)
|
Total
n=47 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
27 Years
STANDARD_DEVIATION 6 • n=5 Participants
|
29 Years
STANDARD_DEVIATION 10 • n=7 Participants
|
23 Years
STANDARD_DEVIATION 3 • n=5 Participants
|
24 Years
STANDARD_DEVIATION 5 • n=4 Participants
|
31 Years
STANDARD_DEVIATION 4 • n=21 Participants
|
27 Years
STANDARD_DEVIATION 6 • n=10 Participants
|
30 Years
STANDARD_DEVIATION 9 • n=115 Participants
|
31 Years
STANDARD_DEVIATION 9 • n=24 Participants
|
28 Years
STANDARD_DEVIATION 7 • n=42 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
1 Participants
n=24 Participants
|
23 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
7 Participants
n=24 Participants
|
24 Participants
n=42 Participants
|
|
Subject characteristics (Height)
|
170.1 cm
STANDARD_DEVIATION 7.1 • n=5 Participants
|
168.6 cm
STANDARD_DEVIATION 1.7 • n=7 Participants
|
170.5 cm
STANDARD_DEVIATION 8.5 • n=5 Participants
|
167.7 cm
STANDARD_DEVIATION 15.5 • n=4 Participants
|
166.0 cm
STANDARD_DEVIATION 5.0 • n=21 Participants
|
175.0 cm
STANDARD_DEVIATION 8.3 • n=10 Participants
|
169.3 cm
STANDARD_DEVIATION 11.1 • n=115 Participants
|
176.9 cm
STANDARD_DEVIATION 8.6 • n=24 Participants
|
170.9 cm
STANDARD_DEVIATION 8.3 • n=42 Participants
|
|
Subject characteristics (Weight)
|
72.1 kg
STANDARD_DEVIATION 11.2 • n=5 Participants
|
76.9 kg
STANDARD_DEVIATION 6.7 • n=7 Participants
|
68.2 kg
STANDARD_DEVIATION 12.2 • n=5 Participants
|
71.4 kg
STANDARD_DEVIATION 5.0 • n=4 Participants
|
67.7 kg
STANDARD_DEVIATION 14.2 • n=21 Participants
|
78.1 kg
STANDARD_DEVIATION 16.3 • n=10 Participants
|
69.4 kg
STANDARD_DEVIATION 10.5 • n=115 Participants
|
79.3 kg
STANDARD_DEVIATION 8.0 • n=24 Participants
|
73.3 kg
STANDARD_DEVIATION 10.9 • n=42 Participants
|
|
Subject characteristics (BMI)
|
24.81 kg/m²
STANDARD_DEVIATION 2.71 • n=5 Participants
|
27.02 kg/m²
STANDARD_DEVIATION 1.94 • n=7 Participants
|
23.41 kg/m²
STANDARD_DEVIATION 3.50 • n=5 Participants
|
25.63 kg/m²
STANDARD_DEVIATION 3.16 • n=4 Participants
|
24.48 kg/m²
STANDARD_DEVIATION 4.46 • n=21 Participants
|
25.31 kg/m²
STANDARD_DEVIATION 3.47 • n=10 Participants
|
24.41 kg/m²
STANDARD_DEVIATION 4.87 • n=115 Participants
|
25.40 kg/m²
STANDARD_DEVIATION 2.37 • n=24 Participants
|
25.01 kg/m²
STANDARD_DEVIATION 3.00 • n=42 Participants
|
PRIMARY outcome
Timeframe: Screening up to Day 13Population: Safety Analysis Set
Summary of number of subjects who had at least one adverse event
Outcome measures
| Measure |
Placebo
n=16 Participants
Commercial 0.9% sodium chloride solution.
|
Cohort 1
n=4 Participants
AZD8848 0.15 μg
|
Cohort 2
n=4 Participants
AZD8848 0.5 ug
|
Cohort 3
n=3 Participants
AZD8848 1.5 μg
|
Cohort 4
n=4 Participants
AZD8848 5 μg
|
Cohort 5
n=4 Participants
AZD8848 15 μg
|
Cohort 7
n=4 Participants
AZD8848 15 μg (Multiple Inhalation)
|
Cohort 6 and 8
n=8 Participants
AZD8848 30 μg (similar investigational product administration conditions)
|
|---|---|---|---|---|---|---|---|---|
|
Adverse Events
|
6 participants
|
2 participants
|
1 participants
|
0 participants
|
3 participants
|
1 participants
|
2 participants
|
4 participants
|
PRIMARY outcome
Timeframe: Baseline, Day 1, Day 2, Day 3, and Follow up (up to Day 13)Population: Safety Analysis Set
Outcome measures
| Measure |
Placebo
n=16 Participants
Commercial 0.9% sodium chloride solution.
|
Cohort 1
n=4 Participants
AZD8848 0.15 μg
|
Cohort 2
n=4 Participants
AZD8848 0.5 ug
|
Cohort 3
n=3 Participants
AZD8848 1.5 μg
|
Cohort 4
n=4 Participants
AZD8848 5 μg
|
Cohort 5
n=4 Participants
AZD8848 15 μg
|
Cohort 7
n=4 Participants
AZD8848 15 μg (Multiple Inhalation)
|
Cohort 6 and 8
n=8 Participants
AZD8848 30 μg (similar investigational product administration conditions)
|
|---|---|---|---|---|---|---|---|---|
|
Summary for Lymphocytes Laboratory Results
Day 1
|
2.3 cells*10^9/L
Standard Deviation 0.5
|
2.1 cells*10^9/L
Standard Deviation 0.7
|
2.7 cells*10^9/L
Standard Deviation 0.7
|
2.2 cells*10^9/L
Standard Deviation 0.3
|
2.4 cells*10^9/L
Standard Deviation 0.6
|
2.4 cells*10^9/L
Standard Deviation 0.6
|
2.0 cells*10^9/L
Standard Deviation 0.4
|
1.4 cells*10^9/L
Standard Deviation 0.6
|
|
Summary for Lymphocytes Laboratory Results
Baseline
|
1.6 cells*10^9/L
Standard Deviation 0.3
|
1.7 cells*10^9/L
Standard Deviation 0.5
|
2.0 cells*10^9/L
Standard Deviation 0.6
|
2.1 cells*10^9/L
Standard Deviation 0.5
|
2.3 cells*10^9/L
Standard Deviation 0.7
|
2.1 cells*10^9/L
Standard Deviation 0.3
|
1.9 cells*10^9/L
Standard Deviation 0.3
|
1.6 cells*10^9/L
Standard Deviation 0.3
|
|
Summary for Lymphocytes Laboratory Results
Day 2
|
1.6 cells*10^9/L
Standard Deviation 0.4
|
2.0 cells*10^9/L
Standard Deviation 0.6
|
1.9 cells*10^9/L
Standard Deviation 0.3
|
2.0 cells*10^9/L
Standard Deviation 1.5
|
2.2 cells*10^9/L
Standard Deviation 0.7
|
2.0 cells*10^9/L
Standard Deviation 0.3
|
1.4 cells*10^9/L
Standard Deviation 0.3
|
0.9 cells*10^9/L
Standard Deviation 0.2
|
|
Summary for Lymphocytes Laboratory Results
Day 3
|
1.8 cells*10^9/L
Standard Deviation 0.5
|
2.0 cells*10^9/L
Standard Deviation 0.6
|
2.1 cells*10^9/L
Standard Deviation 0.2
|
2.0 cells*10^9/L
Standard Deviation 0.6
|
2.3 cells*10^9/L
Standard Deviation 1.0
|
2.0 cells*10^9/L
Standard Deviation 0.1
|
1.7 cells*10^9/L
Standard Deviation 0.1
|
1.4 cells*10^9/L
Standard Deviation 0.2
|
|
Summary for Lymphocytes Laboratory Results
Follow up (up to Day 13)
|
1.7 cells*10^9/L
Standard Deviation 0.4
|
2.0 cells*10^9/L
Standard Deviation 0.5
|
2.1 cells*10^9/L
Standard Deviation 0.5
|
1.8 cells*10^9/L
Standard Deviation 0.3
|
2.1 cells*10^9/L
Standard Deviation 0.8
|
1.9 cells*10^9/L
Standard Deviation 0.2
|
1.7 cells*10^9/L
Standard Deviation 0.3
|
1.5 cells*10^9/L
Standard Deviation 0.4
|
SECONDARY outcome
Timeframe: On Day 1 at 0min, 2min, 5min, 10min, 20min, 30min, 45min, 60min, 90min, 2h, 4h, 6h, 8h, 12h, 24h and 48hPopulation: Pharmacokinetic Population
Outcome measures
| Measure |
Placebo
Commercial 0.9% sodium chloride solution.
|
Cohort 1
AZD8848 0.15 μg
|
Cohort 2
AZD8848 0.5 ug
|
Cohort 3
AZD8848 1.5 μg
|
Cohort 4
n=4 Participants
AZD8848 5 μg
|
Cohort 5
n=4 Participants
AZD8848 15 μg
|
Cohort 7
n=4 Participants
AZD8848 15 μg (Multiple Inhalation)
|
Cohort 6 and 8
n=5 Participants
AZD8848 30 μg (similar investigational product administration conditions)
|
|---|---|---|---|---|---|---|---|---|
|
Summary (Geometric Mean and GCV%) of Pharmacokinetic Parameters of Total AZ12432045 - AUC (Nmol*h/L)
|
—
|
—
|
—
|
—
|
0.149 nmol*h/L
Geometric Coefficient of Variation 22.9
|
0.360 nmol*h/L
Geometric Coefficient of Variation 43.4
|
0.312 nmol*h/L
Geometric Coefficient of Variation 26.2
|
0.642 nmol*h/L
Geometric Coefficient of Variation 21.9
|
SECONDARY outcome
Timeframe: On Day 1 at 0min, 2min, 5min, 10min, 20min, 30min, 45min, 60min, 90min, 2h, 4h, 6h, 8h, 12h, 24h and 48hPopulation: Pharmacokinetic Population
Outcome measures
| Measure |
Placebo
Commercial 0.9% sodium chloride solution.
|
Cohort 1
AZD8848 0.15 μg
|
Cohort 2
AZD8848 0.5 ug
|
Cohort 3
AZD8848 1.5 μg
|
Cohort 4
n=4 Participants
AZD8848 5 μg
|
Cohort 5
n=4 Participants
AZD8848 15 μg
|
Cohort 7
n=4 Participants
AZD8848 15 μg (Multiple Inhalation)
|
Cohort 6 and 8
n=5 Participants
AZD8848 30 μg (similar investigational product administration conditions)
|
|---|---|---|---|---|---|---|---|---|
|
Summary (Geometric Mean and GCV%) of Pharmacokinetic Parameters of Total AZ12432045 - AUC(0-t) (Nmol*h/L)
|
—
|
—
|
—
|
—
|
0.131 nmol*h/L
Geometric Coefficient of Variation 22.1
|
0.328 nmol*h/L
Geometric Coefficient of Variation 46.2
|
0.279 nmol*h/L
Geometric Coefficient of Variation 26.6
|
0.591 nmol*h/L
Geometric Coefficient of Variation 22.3
|
SECONDARY outcome
Timeframe: On Day 1 at 0min, 2min, 5min, 10min, 20min, 30min, 45min, 60min, 90min, 2h, 4h, 6h, 8h, 12h, 24h and 48hPopulation: Pharmacokinetic Population
Outcome measures
| Measure |
Placebo
Commercial 0.9% sodium chloride solution.
|
Cohort 1
AZD8848 0.15 μg
|
Cohort 2
n=4 Participants
AZD8848 0.5 ug
|
Cohort 3
n=3 Participants
AZD8848 1.5 μg
|
Cohort 4
n=4 Participants
AZD8848 5 μg
|
Cohort 5
n=4 Participants
AZD8848 15 μg
|
Cohort 7
n=4 Participants
AZD8848 15 μg (Multiple Inhalation)
|
Cohort 6 and 8
n=5 Participants
AZD8848 30 μg (similar investigational product administration conditions)
|
|---|---|---|---|---|---|---|---|---|
|
Summary (Geometric Mean and GCV%) of Pharmacokinetic Parameters of Total AZ12432045 - Cmax (Nmol/L)
|
—
|
—
|
0.0362 nmol/L
Geometric Coefficient of Variation 10.3
|
0.0903 nmol/L
Geometric Coefficient of Variation 40.8
|
0.473 nmol/L
Geometric Coefficient of Variation 36.1
|
0.963 nmol/L
Geometric Coefficient of Variation 47.0
|
0.629 nmol/L
Geometric Coefficient of Variation 13.6
|
1.67 nmol/L
Geometric Coefficient of Variation 18.6
|
SECONDARY outcome
Timeframe: Baseline, 24 Hours.Population: Pharmacodynamic Population Set
Smmarizes the statistical assessment comparing active CXCL10 ratio to baseline to placebo at each dose level, sampling time, and matrix
Outcome measures
| Measure |
Placebo
n=16 Participants
Commercial 0.9% sodium chloride solution.
|
Cohort 1
n=4 Participants
AZD8848 0.15 μg
|
Cohort 2
n=4 Participants
AZD8848 0.5 ug
|
Cohort 3
n=3 Participants
AZD8848 1.5 μg
|
Cohort 4
n=4 Participants
AZD8848 5 μg
|
Cohort 5
n=4 Participants
AZD8848 15 μg
|
Cohort 7
n=4 Participants
AZD8848 15 μg (Multiple Inhalation)
|
Cohort 6 and 8
n=8 Participants
AZD8848 30 μg (similar investigational product administration conditions)
|
|---|---|---|---|---|---|---|---|---|
|
Statistical Assessment of CXCL10 Ratio-to-baseline - Plasma
|
0.9290 ratio
95% Confidence Interval 10.4 • Interval 0.7703 to 1.12
|
0.9267 ratio
95% Confidence Interval 107.7 • Interval 0.6381 to 1.346
|
0.8638 ratio
Interval 0.5949 to 1.254
|
0.9869 ratio
Interval 0.6417 to 1.518
|
1.355 ratio
Interval 0.9332 to 1.967
|
2.079 ratio
Interval 1.412 to 3.059
|
2.120 ratio
Interval 1.46 to 3.078
|
6.354 ratio
Interval 4.88 to 8.274
|
SECONDARY outcome
Timeframe: Baseline, 48 HoursPopulation: Pharmacodynamic Population Set
Smmarize the statistical assessment comparing active CXCL10 ratio to baseline to placebo at each dose level, sampling time, and matrix
Outcome measures
| Measure |
Placebo
n=16 Participants
Commercial 0.9% sodium chloride solution.
|
Cohort 1
n=4 Participants
AZD8848 0.15 μg
|
Cohort 2
n=4 Participants
AZD8848 0.5 ug
|
Cohort 3
n=3 Participants
AZD8848 1.5 μg
|
Cohort 4
n=4 Participants
AZD8848 5 μg
|
Cohort 5
n=4 Participants
AZD8848 15 μg
|
Cohort 7
n=4 Participants
AZD8848 15 μg (Multiple Inhalation)
|
Cohort 6 and 8
n=8 Participants
AZD8848 30 μg (similar investigational product administration conditions)
|
|---|---|---|---|---|---|---|---|---|
|
Statistical Assessment of CXCL10 Ratio-to-baseline - Plasma
|
1.009 ratio
95% Confidence Interval 10.4 • Interval 0.8914 to 1.142
|
0.9669 ratio
95% Confidence Interval 107.7 • Interval 0.7552 to 1.238
|
0.9256 ratio
Interval 0.7229 to 1.185
|
1.134 ratio
Interval 0.8524 to 1.508
|
1.211 ratio
Interval 0.946 to 1.55
|
1.036 ratio
Interval 0.802 to 1.338
|
1.482 ratio
Interval 1.158 to 1.897
|
2.422 ratio
Interval 2.034 to 2.885
|
SECONDARY outcome
Timeframe: Baseline, 24 Hours.Population: Pharmacodynamic Population Set
Summarize the statistical assessment comparing active CXCL10 ratio to baseline to placebo at each dose level, sampling time, and matrix
Outcome measures
| Measure |
Placebo
n=16 Participants
Commercial 0.9% sodium chloride solution.
|
Cohort 1
n=4 Participants
AZD8848 0.15 μg
|
Cohort 2
n=4 Participants
AZD8848 0.5 ug
|
Cohort 3
n=3 Participants
AZD8848 1.5 μg
|
Cohort 4
n=4 Participants
AZD8848 5 μg
|
Cohort 5
n=4 Participants
AZD8848 15 μg
|
Cohort 7
n=4 Participants
AZD8848 15 μg (Multiple Inhalation)
|
Cohort 6 and 8
n=8 Participants
AZD8848 30 μg (similar investigational product administration conditions)
|
|---|---|---|---|---|---|---|---|---|
|
Statistical Assessment of CXCL10 Ratio-to-baseline- Sputum
|
1.038 ratio
95% Confidence Interval 10.4 • Interval 0.5929 to 1.818
|
1.192 ratio
95% Confidence Interval 107.7 • Interval 0.4145 to 3.43
|
0.8500 ratio
Interval 0.2976 to 2.428
|
0.8465 ratio
Interval 0.2396 to 2.991
|
3.160 ratio
Interval 0.9011 to 11.08
|
2.012 ratio
Interval 0.7055 to 5.737
|
4.858 ratio
Interval 1.704 to 13.85
|
11.29 ratio
Interval 3.792 to 33.6
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Cohort 1
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Cohort 2
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Cohort 3
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Cohort 4
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Cohort 5
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Cohort 7
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Cohort 6 and 8
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=16 participants at risk
Commercial 0.9% sodium chloride solution.
|
Cohort 1
n=4 participants at risk
AZD8848 0.15 μg
|
Cohort 2
n=4 participants at risk
AZD8848 0.5 ug
|
Cohort 3
n=3 participants at risk
AZD8848 1.5 μg
|
Cohort 4
n=4 participants at risk
AZD8848 5 μg
|
Cohort 5
n=4 participants at risk
AZD8848 15 μg
|
Cohort 7
n=4 participants at risk
AZD8848 15 μg (Multiple Inhalation)
|
Cohort 6 and 8
n=8 participants at risk；n=4 participants at risk
AZD8848 30 μg (similar investigational product administration conditions)
|
|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
Pelvic Inflammatory disease
|
0.00%
0/16 • Screening up to 11 - 13 Months
|
0.00%
0/4 • Screening up to 11 - 13 Months
|
0.00%
0/4 • Screening up to 11 - 13 Months
|
0.00%
0/3 • Screening up to 11 - 13 Months
|
25.0%
1/4 • Number of events 1 • Screening up to 11 - 13 Months
|
0.00%
0/4 • Screening up to 11 - 13 Months
|
0.00%
0/4 • Screening up to 11 - 13 Months
|
0.00%
0/4 • Screening up to 11 - 13 Months
|
Other adverse events
| Measure |
Placebo
n=16 participants at risk
Commercial 0.9% sodium chloride solution.
|
Cohort 1
n=4 participants at risk
AZD8848 0.15 μg
|
Cohort 2
n=4 participants at risk
AZD8848 0.5 ug
|
Cohort 3
n=3 participants at risk
AZD8848 1.5 μg
|
Cohort 4
n=4 participants at risk
AZD8848 5 μg
|
Cohort 5
n=4 participants at risk
AZD8848 15 μg
|
Cohort 7
n=4 participants at risk
AZD8848 15 μg (Multiple Inhalation)
|
Cohort 6 and 8
n=8 participants at risk；n=4 participants at risk
AZD8848 30 μg (similar investigational product administration conditions)
|
|---|---|---|---|---|---|---|---|---|
|
Ear and labyrinth disorders
Ear Pain
|
0.00%
0/16 • Screening up to 11 - 13 Months
|
0.00%
0/4 • Screening up to 11 - 13 Months
|
0.00%
0/4 • Screening up to 11 - 13 Months
|
0.00%
0/3 • Screening up to 11 - 13 Months
|
0.00%
0/4 • Screening up to 11 - 13 Months
|
0.00%
0/4 • Screening up to 11 - 13 Months
|
0.00%
0/4 • Screening up to 11 - 13 Months
|
12.5%
1/8 • Number of events 1 • Screening up to 11 - 13 Months
|
|
Eye disorders
dry eye
|
0.00%
0/16 • Screening up to 11 - 13 Months
|
0.00%
0/4 • Screening up to 11 - 13 Months
|
0.00%
0/4 • Screening up to 11 - 13 Months
|
0.00%
0/3 • Screening up to 11 - 13 Months
|
0.00%
0/4 • Screening up to 11 - 13 Months
|
0.00%
0/4 • Screening up to 11 - 13 Months
|
25.0%
1/4 • Number of events 1 • Screening up to 11 - 13 Months
|
0.00%
0/8 • Screening up to 11 - 13 Months
|
|
Gastrointestinal disorders
dry mouth
|
0.00%
0/16 • Screening up to 11 - 13 Months
|
0.00%
0/4 • Screening up to 11 - 13 Months
|
0.00%
0/4 • Screening up to 11 - 13 Months
|
0.00%
0/3 • Screening up to 11 - 13 Months
|
0.00%
0/4 • Screening up to 11 - 13 Months
|
0.00%
0/4 • Screening up to 11 - 13 Months
|
25.0%
1/4 • Number of events 1 • Screening up to 11 - 13 Months
|
0.00%
0/8 • Screening up to 11 - 13 Months
|
|
Gastrointestinal disorders
nausea
|
0.00%
0/16 • Screening up to 11 - 13 Months
|
0.00%
0/4 • Screening up to 11 - 13 Months
|
0.00%
0/4 • Screening up to 11 - 13 Months
|
0.00%
0/3 • Screening up to 11 - 13 Months
|
25.0%
1/4 • Number of events 1 • Screening up to 11 - 13 Months
|
0.00%
0/4 • Screening up to 11 - 13 Months
|
0.00%
0/4 • Screening up to 11 - 13 Months
|
0.00%
0/4 • Screening up to 11 - 13 Months
|
|
General disorders
chills
|
0.00%
0/16 • Screening up to 11 - 13 Months
|
0.00%
0/4 • Screening up to 11 - 13 Months
|
0.00%
0/4 • Screening up to 11 - 13 Months
|
0.00%
0/3 • Screening up to 11 - 13 Months
|
0.00%
0/4 • Screening up to 11 - 13 Months
|
0.00%
0/4 • Screening up to 11 - 13 Months
|
0.00%
0/4 • Screening up to 11 - 13 Months
|
12.5%
1/8 • Number of events 1 • Screening up to 11 - 13 Months
|
|
General disorders
feeling hot
|
0.00%
0/16 • Screening up to 11 - 13 Months
|
0.00%
0/4 • Screening up to 11 - 13 Months
|
0.00%
0/4 • Screening up to 11 - 13 Months
|
0.00%
0/3 • Screening up to 11 - 13 Months
|
0.00%
0/4 • Screening up to 11 - 13 Months
|
0.00%
0/4 • Screening up to 11 - 13 Months
|
25.0%
1/4 • Number of events 1 • Screening up to 11 - 13 Months
|
0.00%
0/8 • Screening up to 11 - 13 Months
|
|
General disorders
Influenza like illness
|
0.00%
0/16 • Screening up to 11 - 13 Months
|
25.0%
1/4 • Number of events 1 • Screening up to 11 - 13 Months
|
0.00%
0/4 • Screening up to 11 - 13 Months
|
0.00%
0/3 • Screening up to 11 - 13 Months
|
0.00%
0/4 • Screening up to 11 - 13 Months
|
0.00%
0/4 • Screening up to 11 - 13 Months
|
0.00%
0/4 • Screening up to 11 - 13 Months
|
0.00%
0/8 • Screening up to 11 - 13 Months
|
|
General disorders
Chest pain
|
6.2%
1/16 • Number of events 1 • Screening up to 11 - 13 Months
|
0.00%
0/4 • Screening up to 11 - 13 Months
|
0.00%
0/4 • Screening up to 11 - 13 Months
|
0.00%
0/3 • Screening up to 11 - 13 Months
|
0.00%
0/4 • Screening up to 11 - 13 Months
|
0.00%
0/4 • Screening up to 11 - 13 Months
|
0.00%
0/4 • Screening up to 11 - 13 Months
|
0.00%
0/8 • Screening up to 11 - 13 Months
|
|
Infections and infestations
Upper respiratory tract infections
|
6.2%
1/16 • Number of events 1 • Screening up to 11 - 13 Months
|
0.00%
0/4 • Screening up to 11 - 13 Months
|
25.0%
1/4 • Number of events 1 • Screening up to 11 - 13 Months
|
0.00%
0/3 • Screening up to 11 - 13 Months
|
0.00%
0/4 • Screening up to 11 - 13 Months
|
0.00%
0/4 • Screening up to 11 - 13 Months
|
0.00%
0/4 • Screening up to 11 - 13 Months
|
0.00%
0/8 • Screening up to 11 - 13 Months
|
|
Infections and infestations
Urinary tract infection
|
6.2%
1/16 • Number of events 1 • Screening up to 11 - 13 Months
|
0.00%
0/4 • Screening up to 11 - 13 Months
|
0.00%
0/4 • Screening up to 11 - 13 Months
|
0.00%
0/3 • Screening up to 11 - 13 Months
|
0.00%
0/4 • Screening up to 11 - 13 Months
|
0.00%
0/4 • Screening up to 11 - 13 Months
|
0.00%
0/4 • Screening up to 11 - 13 Months
|
0.00%
0/8 • Screening up to 11 - 13 Months
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/16 • Screening up to 11 - 13 Months
|
25.0%
1/4 • Number of events 1 • Screening up to 11 - 13 Months
|
0.00%
0/4 • Screening up to 11 - 13 Months
|
0.00%
0/3 • Screening up to 11 - 13 Months
|
0.00%
0/4 • Screening up to 11 - 13 Months
|
0.00%
0/4 • Screening up to 11 - 13 Months
|
0.00%
0/4 • Screening up to 11 - 13 Months
|
0.00%
0/8 • Screening up to 11 - 13 Months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/16 • Screening up to 11 - 13 Months
|
0.00%
0/4 • Screening up to 11 - 13 Months
|
0.00%
0/4 • Screening up to 11 - 13 Months
|
0.00%
0/3 • Screening up to 11 - 13 Months
|
0.00%
0/4 • Screening up to 11 - 13 Months
|
0.00%
0/4 • Screening up to 11 - 13 Months
|
25.0%
1/4 • Number of events 1 • Screening up to 11 - 13 Months
|
12.5%
1/8 • Number of events 1 • Screening up to 11 - 13 Months
|
|
Nervous system disorders
Headache
|
18.8%
3/16 • Number of events 3 • Screening up to 11 - 13 Months
|
0.00%
0/4 • Screening up to 11 - 13 Months
|
0.00%
0/4 • Screening up to 11 - 13 Months
|
0.00%
0/3 • Screening up to 11 - 13 Months
|
25.0%
1/4 • Number of events 1 • Screening up to 11 - 13 Months
|
25.0%
1/4 • Number of events 1 • Screening up to 11 - 13 Months
|
0.00%
0/4 • Screening up to 11 - 13 Months
|
25.0%
2/8 • Number of events 2 • Screening up to 11 - 13 Months
|
|
Nervous system disorders
Dizziness
|
6.2%
1/16 • Number of events 1 • Screening up to 11 - 13 Months
|
0.00%
0/4 • Screening up to 11 - 13 Months
|
0.00%
0/4 • Screening up to 11 - 13 Months
|
0.00%
0/3 • Screening up to 11 - 13 Months
|
25.0%
1/4 • Number of events 1 • Screening up to 11 - 13 Months
|
0.00%
0/4 • Screening up to 11 - 13 Months
|
0.00%
0/4 • Screening up to 11 - 13 Months
|
0.00%
0/8 • Screening up to 11 - 13 Months
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/16 • Screening up to 11 - 13 Months
|
0.00%
0/4 • Screening up to 11 - 13 Months
|
0.00%
0/4 • Screening up to 11 - 13 Months
|
0.00%
0/3 • Screening up to 11 - 13 Months
|
0.00%
0/4 • Screening up to 11 - 13 Months
|
0.00%
0/4 • Screening up to 11 - 13 Months
|
25.0%
1/4 • Number of events 1 • Screening up to 11 - 13 Months
|
0.00%
0/8 • Screening up to 11 - 13 Months
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
6.2%
1/16 • Number of events 1 • Screening up to 11 - 13 Months
|
0.00%
0/4 • Screening up to 11 - 13 Months
|
0.00%
0/4 • Screening up to 11 - 13 Months
|
0.00%
0/3 • Screening up to 11 - 13 Months
|
0.00%
0/4 • Screening up to 11 - 13 Months
|
0.00%
0/4 • Screening up to 11 - 13 Months
|
0.00%
0/4 • Screening up to 11 - 13 Months
|
0.00%
0/8 • Screening up to 11 - 13 Months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee If a publication (e.g., in a scientific journal) based on the results of this study is envisaged, approval from AstraZeneca will be obtained and a draft manuscript will be submitted to AstraZeneca for scrutiny and comment. The choice of conduit will be mutually agreed on by the Principal Investigator and AstraZeneca.
- Publication restrictions are in place
Restriction type: OTHER