Trial Outcomes & Findings for A Study to Assess the Safety, Efficacy and Tolerability of AZD8233 Treatment in Participants With Hyperlipidaemia (NCT NCT04964557)
NCT ID: NCT04964557
Last Updated: 2023-12-15
Results Overview
Percentage change in Low-density Lipoprotein Cholesterol (LDL-C) from baseline to Day 197.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
411 participants
Primary outcome timeframe
From baseline to Day 197
Results posted on
2023-12-15
Participant Flow
This study was conducted at a total of 66 study centres in 8 countries: Czech Republic (10 centres), Denmark (8 centres), Hungary (4 centres), Netherlands (6 centres), Poland (8 centres), Slovakia (7 centres), Spain (7 centres), and United States (16 centres). First subject enrolled: 07 July 2021 and Last subject last visit: 15 July 2022.
Participant milestones
| Measure |
AZD8233
AZD8233 for subcutaneous use.
|
Placebo
Matching placebo solution for subcutaneous injection.
|
|---|---|---|
|
Overall Study
STARTED
|
206
|
205
|
|
Overall Study
COMPLETED
|
196
|
201
|
|
Overall Study
NOT COMPLETED
|
10
|
4
|
Reasons for withdrawal
| Measure |
AZD8233
AZD8233 for subcutaneous use.
|
Placebo
Matching placebo solution for subcutaneous injection.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
2
|
|
Overall Study
Lost to Follow-up
|
1
|
2
|
|
Overall Study
Physician Decision
|
2
|
0
|
|
Overall Study
Death
|
3
|
0
|
|
Overall Study
Reported by investigator as completed but did not fulfil the Completed study definition.
|
1
|
0
|
Baseline Characteristics
The table contains all subjects randomized (Full analysis set)
Baseline characteristics by cohort
| Measure |
AZD8233
n=206 Participants
AZD8233 for subcutaneous use.
|
Placebo
n=205 Participants
Matching placebo solution for subcutaneous injection.
|
Total
n=411 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62.4 Years
STANDARD_DEVIATION 8.1 • n=5 Participants
|
62.2 Years
STANDARD_DEVIATION 7.7 • n=7 Participants
|
62.3 Years
STANDARD_DEVIATION 7.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
101 Participants
n=5 Participants
|
94 Participants
n=7 Participants
|
195 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
105 Participants
n=5 Participants
|
111 Participants
n=7 Participants
|
216 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
9 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
194 Participants
n=5 Participants
|
199 Participants
n=7 Participants
|
393 Participants
n=5 Participants
|
|
Region of Enrollment
USA
|
48 Participants
n=5 Participants • The table contains all subjects randomized (Full analysis set)
|
39 Participants
n=7 Participants • The table contains all subjects randomized (Full analysis set)
|
87 Participants
n=5 Participants • The table contains all subjects randomized (Full analysis set)
|
|
Region of Enrollment
Czech Republic
|
45 Participants
n=5 Participants • The table contains all subjects randomized (Full analysis set)
|
44 Participants
n=7 Participants • The table contains all subjects randomized (Full analysis set)
|
89 Participants
n=5 Participants • The table contains all subjects randomized (Full analysis set)
|
|
Region of Enrollment
Denmark
|
31 Participants
n=5 Participants • The table contains all subjects randomized (Full analysis set)
|
21 Participants
n=7 Participants • The table contains all subjects randomized (Full analysis set)
|
52 Participants
n=5 Participants • The table contains all subjects randomized (Full analysis set)
|
|
Region of Enrollment
Hungary
|
15 Participants
n=5 Participants • The table contains all subjects randomized (Full analysis set)
|
14 Participants
n=7 Participants • The table contains all subjects randomized (Full analysis set)
|
29 Participants
n=5 Participants • The table contains all subjects randomized (Full analysis set)
|
|
Region of Enrollment
Netherlands
|
12 Participants
n=5 Participants • The table contains all subjects randomized (Full analysis set)
|
7 Participants
n=7 Participants • The table contains all subjects randomized (Full analysis set)
|
19 Participants
n=5 Participants • The table contains all subjects randomized (Full analysis set)
|
|
Region of Enrollment
Poland
|
4 Participants
n=5 Participants • The table contains all subjects randomized (Full analysis set)
|
10 Participants
n=7 Participants • The table contains all subjects randomized (Full analysis set)
|
14 Participants
n=5 Participants • The table contains all subjects randomized (Full analysis set)
|
|
Region of Enrollment
Slovakia
|
35 Participants
n=5 Participants • The table contains all subjects randomized (Full analysis set)
|
43 Participants
n=7 Participants • The table contains all subjects randomized (Full analysis set)
|
78 Participants
n=5 Participants • The table contains all subjects randomized (Full analysis set)
|
|
Region of Enrollment
Spain
|
16 Participants
n=5 Participants • The table contains all subjects randomized (Full analysis set)
|
27 Participants
n=7 Participants • The table contains all subjects randomized (Full analysis set)
|
43 Participants
n=5 Participants • The table contains all subjects randomized (Full analysis set)
|
|
LDL-C
|
103 mg/dL
STANDARD_DEVIATION 31.8 • n=5 Participants
|
107.4 mg/dL
STANDARD_DEVIATION 31.9 • n=7 Participants
|
105.2 mg/dL
STANDARD_DEVIATION 31.9 • n=5 Participants
|
PRIMARY outcome
Timeframe: From baseline to Day 197Population: Full analysis set includes all subjects who were randomly assigned to study intervention. Subjects were analysed according to their randomised study medication assignment, irrespective of the treatment actually received.
Percentage change in Low-density Lipoprotein Cholesterol (LDL-C) from baseline to Day 197.
Outcome measures
| Measure |
AZD8233
n=206 Participants
AZD8233 for subcutaneous use.
|
Placebo
n=205 Participants
Matching placebo solution for subcutaneous injection.
|
|---|---|---|
|
Percentage Change From Baseline on Serum LDL-C
|
-56.7 percent change
Interval -60.8 to -52.7
|
5.6 percent change
Interval 1.5 to 9.6
|
PRIMARY outcome
Timeframe: On-study includes adverse events with an onset date on or after the date of first dose of IP through study competition, planned visit date Day 281.Population: The safety analysis set consists of all subjects who have received at least one dose of investigational product. Erroneously treated subjects (e.g., those randomised to treatment A but actually given treatment B) are accounted for in the treatment group of the treatment they actually received.
Please refer to the adverse event module for specifics.
Outcome measures
| Measure |
AZD8233
n=207 Participants
AZD8233 for subcutaneous use.
|
Placebo
n=203 Participants
Matching placebo solution for subcutaneous injection.
|
|---|---|---|
|
Number of Subjects With Adverse Events (AEs)
|
141 Participants
|
127 Participants
|
PRIMARY outcome
Timeframe: Baseline, Days 15, 29, 57, 85, 113, 141, 169, 197, 225, and 281.Population: Safety analysis set, the number analyzed represents the number of participants with available temperature data at that time point.
Mean and standard deviation of Temperature at each scheduled visit by treatment.
Outcome measures
| Measure |
AZD8233
n=207 Participants
AZD8233 for subcutaneous use.
|
Placebo
n=203 Participants
Matching placebo solution for subcutaneous injection.
|
|---|---|---|
|
Vital Signs - Temperature
Baseline
|
36.434 Celsius
Standard Deviation 0.437
|
36.369 Celsius
Standard Deviation 0.389
|
|
Vital Signs - Temperature
Day 15
|
36.344 Celsius
Standard Deviation 0.404
|
36.387 Celsius
Standard Deviation 0.378
|
|
Vital Signs - Temperature
Day 29
|
36.360 Celsius
Standard Deviation 0.422
|
36.361 Celsius
Standard Deviation 0.386
|
|
Vital Signs - Temperature
Day 57
|
36.340 Celsius
Standard Deviation 0.420
|
36.396 Celsius
Standard Deviation 0.368
|
|
Vital Signs - Temperature
Day 225
|
36.327 Celsius
Standard Deviation 0.472
|
36.365 Celsius
Standard Deviation 0.37
|
|
Vital Signs - Temperature
Day 85
|
36.360 Celsius
Standard Deviation 0.416
|
36.362 Celsius
Standard Deviation 0.363
|
|
Vital Signs - Temperature
Day 113
|
36.359 Celsius
Standard Deviation 0.391
|
36.399 Celsius
Standard Deviation 0.348
|
|
Vital Signs - Temperature
Day 141
|
36.335 Celsius
Standard Deviation 0.398
|
36.373 Celsius
Standard Deviation 0.341
|
|
Vital Signs - Temperature
Day 169
|
36.304 Celsius
Standard Deviation 0.454
|
36.353 Celsius
Standard Deviation 0.411
|
|
Vital Signs - Temperature
Day 197
|
36.299 Celsius
Standard Deviation 0.477
|
36.352 Celsius
Standard Deviation 0.316
|
|
Vital Signs - Temperature
Day 281
|
36.353 Celsius
Standard Deviation 0.396
|
36.391 Celsius
Standard Deviation 0.363
|
PRIMARY outcome
Timeframe: Baseline and Day 281.Population: Safety analysis set, the number analyzed represents the number of participants with available weight data at that time point.
Mean and standard deviation of Weight at each scheduled visit by treatment.
Outcome measures
| Measure |
AZD8233
n=207 Participants
AZD8233 for subcutaneous use.
|
Placebo
n=203 Participants
Matching placebo solution for subcutaneous injection.
|
|---|---|---|
|
Vital Sign - Weight
Baseline
|
86.642 kg
Standard Deviation 17.054
|
88.750 kg
Standard Deviation 17.566
|
|
Vital Sign - Weight
Day 281
|
85.493 kg
Standard Deviation 16.561
|
88.759 kg
Standard Deviation 18.110
|
PRIMARY outcome
Timeframe: Baseline, Days 85, 169, 225, and 281.Population: Safety analysis set, the number analyzed represents the number of participants with available ECG data at that time point.
Number of participants With an ECG Determined to be Abnormal and Clinically Significant at each scheduled visit by treatment
Outcome measures
| Measure |
AZD8233
n=207 Participants
AZD8233 for subcutaneous use.
|
Placebo
n=203 Participants
Matching placebo solution for subcutaneous injection.
|
|---|---|---|
|
Number of Participants With an ECG Determined to be Abnormal and Clinically Significant
Day 225
|
0 Participants
|
0 Participants
|
|
Number of Participants With an ECG Determined to be Abnormal and Clinically Significant
Day 281
|
0 Participants
|
0 Participants
|
|
Number of Participants With an ECG Determined to be Abnormal and Clinically Significant
Baseline
|
0 Participants
|
0 Participants
|
|
Number of Participants With an ECG Determined to be Abnormal and Clinically Significant
Day 85
|
1 Participants
|
1 Participants
|
|
Number of Participants With an ECG Determined to be Abnormal and Clinically Significant
Day 169
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Baseline, Days 15, 29, 57, 85, 113, 141, 169, 197, 225, and 281.Population: Safety analysis set, the number analyzed represents the number of participants with available systolic blood pressure data at that time point.
Mean and standard deviation of Systolic Blood Pressure at each scheduled visit by treatment.
Outcome measures
| Measure |
AZD8233
n=207 Participants
AZD8233 for subcutaneous use.
|
Placebo
n=203 Participants
Matching placebo solution for subcutaneous injection.
|
|---|---|---|
|
Vital Sign - Systolic Blood Pressure
Day 169
|
130.959 mmHg
Standard Deviation 11.874
|
132.706 mmHg
Standard Deviation 12.481
|
|
Vital Sign - Systolic Blood Pressure
Day 197
|
129.351 mmHg
Standard Deviation 14.236
|
133.149 mmHg
Standard Deviation 11.838
|
|
Vital Sign - Systolic Blood Pressure
Day 85
|
131.913 mmHg
Standard Deviation 12.083
|
132.111 mmHg
Standard Deviation 12.238
|
|
Vital Sign - Systolic Blood Pressure
Day 113
|
131.974 mmHg
Standard Deviation 12.622
|
132.493 mmHg
Standard Deviation 12.022
|
|
Vital Sign - Systolic Blood Pressure
Day 141
|
131.386 mmHg
Standard Deviation 14.246
|
132.041 mmHg
Standard Deviation 14.081
|
|
Vital Sign - Systolic Blood Pressure
Day 225
|
131.188 mmHg
Standard Deviation 14.578
|
133.165 mmHg
Standard Deviation 12.746
|
|
Vital Sign - Systolic Blood Pressure
Day 281
|
130.048 mmHg
Standard Deviation 13.288
|
131.043 mmHg
Standard Deviation 13.069
|
|
Vital Sign - Systolic Blood Pressure
Baseline
|
130.918 mmHg
Standard Deviation 13.284
|
131.325 mmHg
Standard Deviation 11.281
|
|
Vital Sign - Systolic Blood Pressure
Day 15
|
130.438 mmHg
Standard Deviation 13.541
|
131.198 mmHg
Standard Deviation 12.711
|
|
Vital Sign - Systolic Blood Pressure
Day 29
|
130.741 mmHg
Standard Deviation 13.363
|
133.152 mmHg
Standard Deviation 11.881
|
|
Vital Sign - Systolic Blood Pressure
Day 57
|
130.754 mmHg
Standard Deviation 12.536
|
131.465 mmHg
Standard Deviation 14.073
|
PRIMARY outcome
Timeframe: Baseline, Days 15, 29, 57, 85, 113, 141, 169, 197, 225, and 281.Population: Safety analysis set, the number analyzed represents the number of participants with available diastolic blood pressure data at that time point.
Mean and standard deviation of Diastolic Blood Pressure at each scheduled visit by treatment.
Outcome measures
| Measure |
AZD8233
n=207 Participants
AZD8233 for subcutaneous use.
|
Placebo
n=203 Participants
Matching placebo solution for subcutaneous injection.
|
|---|---|---|
|
Vital Sign - Diastolic Blood Pressure
Day 225
|
78.582 mmHg
Standard Deviation 8.313
|
78.988 mmHg
Standard Deviation 7.254
|
|
Vital Sign - Diastolic Blood Pressure
Day 281
|
78.812 mmHg
Standard Deviation 8.484
|
78.601 mmHg
Standard Deviation 7.249
|
|
Vital Sign - Diastolic Blood Pressure
Baseline
|
78.937 mmHg
Standard Deviation 7.608
|
78.562 mmHg
Standard Deviation 6.134
|
|
Vital Sign - Diastolic Blood Pressure
Day 15
|
78.318 mmHg
Standard Deviation 8.060
|
78.559 mmHg
Standard Deviation 6.946
|
|
Vital Sign - Diastolic Blood Pressure
Day 29
|
78.408 mmHg
Standard Deviation 8.157
|
79.611 mmHg
Standard Deviation 6.779
|
|
Vital Sign - Diastolic Blood Pressure
Day 57
|
78.714 mmHg
Standard Deviation 7.799
|
79.369 mmHg
Standard Deviation 7.120
|
|
Vital Sign - Diastolic Blood Pressure
Day 85
|
78.867 mmHg
Standard Deviation 8.053
|
79.081 mmHg
Standard Deviation 7.575
|
|
Vital Sign - Diastolic Blood Pressure
Day 113
|
79.164 mmHg
Standard Deviation 8.393
|
79.584 mmHg
Standard Deviation 7.152
|
|
Vital Sign - Diastolic Blood Pressure
Day 141
|
78.698 mmHg
Standard Deviation 8.505
|
78.836 mmHg
Standard Deviation 7.758
|
|
Vital Sign - Diastolic Blood Pressure
Day 169
|
78.139 mmHg
Standard Deviation 8.489
|
78.402 mmHg
Standard Deviation 7.359
|
|
Vital Sign - Diastolic Blood Pressure
Day 197
|
78.382 mmHg
Standard Deviation 7.736
|
78.615 mmHg
Standard Deviation 7.432
|
PRIMARY outcome
Timeframe: Baseline, Days 15, 29, 57, 85, 113, 141, 169, 197, 225, and 281.Population: Safety analysis set, the number analyzed represents the number of participants with available pulse rate data at that time point.
Mean and standard deviation of Pulse rate at each scheduled visit by treatment.
Outcome measures
| Measure |
AZD8233
n=207 Participants
AZD8233 for subcutaneous use.
|
Placebo
n=203 Participants
Matching placebo solution for subcutaneous injection.
|
|---|---|---|
|
Vital Sign - Pulse Rate
Baseline
|
68.93 beats/min
Standard Deviation 11.52
|
67.88 beats/min
Standard Deviation 10.47
|
|
Vital Sign - Pulse Rate
Day 85
|
68.90 beats/min
Standard Deviation 9.87
|
69.53 beats/min
Standard Deviation 11.10
|
|
Vital Sign - Pulse Rate
Day 113
|
70.77 beats/min
Standard Deviation 10.58
|
70.03 beats/min
Standard Deviation 10.48
|
|
Vital Sign - Pulse Rate
Day 15
|
70.63 beats/min
Standard Deviation 10.07
|
69.48 beats/min
Standard Deviation 10.42
|
|
Vital Sign - Pulse Rate
Day 29
|
68.52 beats/min
Standard Deviation 9.91
|
68.90 beats/min
Standard Deviation 10.05
|
|
Vital Sign - Pulse Rate
Day 57
|
69.58 beats/min
Standard Deviation 10.59
|
69.90 beats/min
Standard Deviation 11.56
|
|
Vital Sign - Pulse Rate
Day 141
|
70.85 beats/min
Standard Deviation 11.10
|
70.00 beats/min
Standard Deviation 10.84
|
|
Vital Sign - Pulse Rate
Day 169
|
69.35 beats/min
Standard Deviation 10.44
|
68.38 beats/min
Standard Deviation 10.31
|
|
Vital Sign - Pulse Rate
Day 197
|
70.69 beats/min
Standard Deviation 12.26
|
69.43 beats/min
Standard Deviation 8.94
|
|
Vital Sign - Pulse Rate
Day 225
|
69.56 beats/min
Standard Deviation 10.17
|
68.79 beats/min
Standard Deviation 10.48
|
|
Vital Sign - Pulse Rate
Day 281
|
68.39 beats/min
Standard Deviation 9.99
|
69.31 beats/min
Standard Deviation 10.90
|
PRIMARY outcome
Timeframe: Treatment emergent includes results after the first dose of IP through study competition, planned visit date Day 281.Population: Safety analysis set
Treatment emergent platelet count abnormalities by pre-specified criteria by treatment.
Outcome measures
| Measure |
AZD8233
n=207 Participants
AZD8233 for subcutaneous use.
|
Placebo
n=203 Participants
Matching placebo solution for subcutaneous injection.
|
|---|---|---|
|
Treatment Emergent Platelet Count Abnormalities
Platelet count < 50 x 10^9/L
|
0 Participants
|
0 Participants
|
|
Treatment Emergent Platelet Count Abnormalities
Platelet count < 75 x 10^9/L
|
1 Participants
|
1 Participants
|
|
Treatment Emergent Platelet Count Abnormalities
Platelet count < 100 x 10^9/L
|
2 Participants
|
2 Participants
|
|
Treatment Emergent Platelet Count Abnormalities
Platelet count < LLN
|
9 Participants
|
11 Participants
|
|
Treatment Emergent Platelet Count Abnormalities
Platelet count > ULN
|
26 Participants
|
20 Participants
|
|
Treatment Emergent Platelet Count Abnormalities
Platelet count < 150 x 10^9/L
|
19 Participants
|
21 Participants
|
|
Treatment Emergent Platelet Count Abnormalities
>30% decrease from baseline
|
14 Participants
|
14 Participants
|
|
Treatment Emergent Platelet Count Abnormalities
<150 x 10^9/L or >30% decrease from baseline
|
28 Participants
|
26 Participants
|
|
Treatment Emergent Platelet Count Abnormalities
<150 x 10^9/L and >30% decrease from baseline
|
5 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: From baseline to Day 197Population: Full analysis set includes all subjects who were randomly assigned to study intervention. Subjects will be analysed according to their randomised study medication assignment, irrespective of the treatment actually received.
Percentage change in Proprotein convertase subtilisin/kexin type-9 (PCSK9) from baseline to Day 197.
Outcome measures
| Measure |
AZD8233
n=206 Participants
AZD8233 for subcutaneous use.
|
Placebo
n=205 Participants
Matching placebo solution for subcutaneous injection.
|
|---|---|---|
|
Percentage Change From Baseline on Serum PCSK9
|
-77.5 percent change
Interval -81.1 to -74.0
|
-0.8 percent change
Interval -4.3 to 2.6
|
SECONDARY outcome
Timeframe: Pre-dose of Day 29, Day 85, Day 141, Day 183, Day 197Population: The PK analysis set consists of all subjects who receive at least 1 dose of AZD8233, for whom at least 1 post-dose PK concentration assessment is available. Subjects were allocated to the actual treatment received. The number analyzed represents the number of participants with available PK data at that time point, including lower limit of quantification (LLoQ) observations, but not included in the calculation of summary statistics of Geometric Mean and Geometric Coefficient of Variation.
AZD8233 full length ASO concentrations in plasma were summarised by descriptive statistics by sampling time point and listed on individual level based on the PK analysis set.
Outcome measures
| Measure |
AZD8233
n=200 Participants
AZD8233 for subcutaneous use.
|
Placebo
Matching placebo solution for subcutaneous injection.
|
|---|---|---|
|
Plasma Concentration of AZD8233
Day 29
|
0.2648 ng/mL
Geometric Coefficient of Variation 82.8352
|
—
|
|
Plasma Concentration of AZD8233
Day 85
|
0.3927 ng/mL
Geometric Coefficient of Variation 84.9378
|
—
|
|
Plasma Concentration of AZD8233
Day 141
|
0.5749 ng/mL
Geometric Coefficient of Variation 161.9301
|
—
|
|
Plasma Concentration of AZD8233
Day 183
|
1.0441 ng/mL
Geometric Coefficient of Variation 178.5196
|
—
|
|
Plasma Concentration of AZD8233
Day 197
|
0.6975 ng/mL
Geometric Coefficient of Variation 208.2431
|
—
|
SECONDARY outcome
Timeframe: Pre-dose of Day 1, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 197, Day 281Population: The safety analysis set consists of all subjects who have received at least one dose of investigational product. Erroneously treated subjects (e.g., those randomised to treatment A but actually given treatment B) are accounted for in the treatment group of the treatment they actually received. The number analyzed represents the number of participants with available ADA data at that time point.
Number of ADA positive subjects at each time point during the treatment period and follow-up period.
Outcome measures
| Measure |
AZD8233
n=207 Participants
AZD8233 for subcutaneous use.
|
Placebo
n=203 Participants
Matching placebo solution for subcutaneous injection.
|
|---|---|---|
|
Anti-drug Antibodies (ADAs) During the Treatment Period and Follow-up Period
Day 113
|
21 Participants
|
3 Participants
|
|
Anti-drug Antibodies (ADAs) During the Treatment Period and Follow-up Period
Day 1
|
6 Participants
|
4 Participants
|
|
Anti-drug Antibodies (ADAs) During the Treatment Period and Follow-up Period
Day 29
|
15 Participants
|
3 Participants
|
|
Anti-drug Antibodies (ADAs) During the Treatment Period and Follow-up Period
Day 57
|
16 Participants
|
3 Participants
|
|
Anti-drug Antibodies (ADAs) During the Treatment Period and Follow-up Period
Day 85
|
18 Participants
|
3 Participants
|
|
Anti-drug Antibodies (ADAs) During the Treatment Period and Follow-up Period
Day 141
|
25 Participants
|
2 Participants
|
|
Anti-drug Antibodies (ADAs) During the Treatment Period and Follow-up Period
Day 169
|
31 Participants
|
2 Participants
|
|
Anti-drug Antibodies (ADAs) During the Treatment Period and Follow-up Period
Day 197
|
37 Participants
|
3 Participants
|
|
Anti-drug Antibodies (ADAs) During the Treatment Period and Follow-up Period
Day 281
|
40 Participants
|
3 Participants
|
Adverse Events
AZD8233
Serious events: 18 serious events
Other events: 69 other events
Deaths: 3 deaths
Placebo
Serious events: 12 serious events
Other events: 62 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
AZD8233
n=207 participants at risk
AZD8233 for subcutaneous use.
|
Placebo
n=203 participants at risk
Matching placebo solution for subcutaneous injection.
|
|---|---|---|
|
Eye disorders
Amaurosis fugax
|
0.48%
1/207 • Number of events 1 • On-study includes adverse events with an onset date on or after the date of first dose of IP through study competition, planned visit date Day 281.
The safety analysis set consists of all subjects who have received at least one dose of investigational product. Erroneously treated subjects (e.g., those randomised to treatment A but actually given treatment B) are accounted for in the treatment group of the treatment they actually received.
|
0.00%
0/203 • On-study includes adverse events with an onset date on or after the date of first dose of IP through study competition, planned visit date Day 281.
The safety analysis set consists of all subjects who have received at least one dose of investigational product. Erroneously treated subjects (e.g., those randomised to treatment A but actually given treatment B) are accounted for in the treatment group of the treatment they actually received.
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.00%
0/207 • On-study includes adverse events with an onset date on or after the date of first dose of IP through study competition, planned visit date Day 281.
The safety analysis set consists of all subjects who have received at least one dose of investigational product. Erroneously treated subjects (e.g., those randomised to treatment A but actually given treatment B) are accounted for in the treatment group of the treatment they actually received.
|
0.49%
1/203 • Number of events 1 • On-study includes adverse events with an onset date on or after the date of first dose of IP through study competition, planned visit date Day 281.
The safety analysis set consists of all subjects who have received at least one dose of investigational product. Erroneously treated subjects (e.g., those randomised to treatment A but actually given treatment B) are accounted for in the treatment group of the treatment they actually received.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.48%
1/207 • Number of events 1 • On-study includes adverse events with an onset date on or after the date of first dose of IP through study competition, planned visit date Day 281.
The safety analysis set consists of all subjects who have received at least one dose of investigational product. Erroneously treated subjects (e.g., those randomised to treatment A but actually given treatment B) are accounted for in the treatment group of the treatment they actually received.
|
0.00%
0/203 • On-study includes adverse events with an onset date on or after the date of first dose of IP through study competition, planned visit date Day 281.
The safety analysis set consists of all subjects who have received at least one dose of investigational product. Erroneously treated subjects (e.g., those randomised to treatment A but actually given treatment B) are accounted for in the treatment group of the treatment they actually received.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/207 • On-study includes adverse events with an onset date on or after the date of first dose of IP through study competition, planned visit date Day 281.
The safety analysis set consists of all subjects who have received at least one dose of investigational product. Erroneously treated subjects (e.g., those randomised to treatment A but actually given treatment B) are accounted for in the treatment group of the treatment they actually received.
|
0.99%
2/203 • Number of events 2 • On-study includes adverse events with an onset date on or after the date of first dose of IP through study competition, planned visit date Day 281.
The safety analysis set consists of all subjects who have received at least one dose of investigational product. Erroneously treated subjects (e.g., those randomised to treatment A but actually given treatment B) are accounted for in the treatment group of the treatment they actually received.
|
|
General disorders
Sudden death
|
0.48%
1/207 • Number of events 1 • On-study includes adverse events with an onset date on or after the date of first dose of IP through study competition, planned visit date Day 281.
The safety analysis set consists of all subjects who have received at least one dose of investigational product. Erroneously treated subjects (e.g., those randomised to treatment A but actually given treatment B) are accounted for in the treatment group of the treatment they actually received.
|
0.00%
0/203 • On-study includes adverse events with an onset date on or after the date of first dose of IP through study competition, planned visit date Day 281.
The safety analysis set consists of all subjects who have received at least one dose of investigational product. Erroneously treated subjects (e.g., those randomised to treatment A but actually given treatment B) are accounted for in the treatment group of the treatment they actually received.
|
|
Infections and infestations
Covid-19 pneumonia
|
0.48%
1/207 • Number of events 1 • On-study includes adverse events with an onset date on or after the date of first dose of IP through study competition, planned visit date Day 281.
The safety analysis set consists of all subjects who have received at least one dose of investigational product. Erroneously treated subjects (e.g., those randomised to treatment A but actually given treatment B) are accounted for in the treatment group of the treatment they actually received.
|
0.00%
0/203 • On-study includes adverse events with an onset date on or after the date of first dose of IP through study competition, planned visit date Day 281.
The safety analysis set consists of all subjects who have received at least one dose of investigational product. Erroneously treated subjects (e.g., those randomised to treatment A but actually given treatment B) are accounted for in the treatment group of the treatment they actually received.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/207 • On-study includes adverse events with an onset date on or after the date of first dose of IP through study competition, planned visit date Day 281.
The safety analysis set consists of all subjects who have received at least one dose of investigational product. Erroneously treated subjects (e.g., those randomised to treatment A but actually given treatment B) are accounted for in the treatment group of the treatment they actually received.
|
0.49%
1/203 • Number of events 1 • On-study includes adverse events with an onset date on or after the date of first dose of IP through study competition, planned visit date Day 281.
The safety analysis set consists of all subjects who have received at least one dose of investigational product. Erroneously treated subjects (e.g., those randomised to treatment A but actually given treatment B) are accounted for in the treatment group of the treatment they actually received.
|
|
Infections and infestations
Diverticulitis
|
0.48%
1/207 • Number of events 1 • On-study includes adverse events with an onset date on or after the date of first dose of IP through study competition, planned visit date Day 281.
The safety analysis set consists of all subjects who have received at least one dose of investigational product. Erroneously treated subjects (e.g., those randomised to treatment A but actually given treatment B) are accounted for in the treatment group of the treatment they actually received.
|
0.00%
0/203 • On-study includes adverse events with an onset date on or after the date of first dose of IP through study competition, planned visit date Day 281.
The safety analysis set consists of all subjects who have received at least one dose of investigational product. Erroneously treated subjects (e.g., those randomised to treatment A but actually given treatment B) are accounted for in the treatment group of the treatment they actually received.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.48%
1/207 • Number of events 1 • On-study includes adverse events with an onset date on or after the date of first dose of IP through study competition, planned visit date Day 281.
The safety analysis set consists of all subjects who have received at least one dose of investigational product. Erroneously treated subjects (e.g., those randomised to treatment A but actually given treatment B) are accounted for in the treatment group of the treatment they actually received.
|
0.00%
0/203 • On-study includes adverse events with an onset date on or after the date of first dose of IP through study competition, planned visit date Day 281.
The safety analysis set consists of all subjects who have received at least one dose of investigational product. Erroneously treated subjects (e.g., those randomised to treatment A but actually given treatment B) are accounted for in the treatment group of the treatment they actually received.
|
|
Infections and infestations
Gangrene
|
0.00%
0/207 • On-study includes adverse events with an onset date on or after the date of first dose of IP through study competition, planned visit date Day 281.
The safety analysis set consists of all subjects who have received at least one dose of investigational product. Erroneously treated subjects (e.g., those randomised to treatment A but actually given treatment B) are accounted for in the treatment group of the treatment they actually received.
|
0.49%
1/203 • Number of events 1 • On-study includes adverse events with an onset date on or after the date of first dose of IP through study competition, planned visit date Day 281.
The safety analysis set consists of all subjects who have received at least one dose of investigational product. Erroneously treated subjects (e.g., those randomised to treatment A but actually given treatment B) are accounted for in the treatment group of the treatment they actually received.
|
|
Infections and infestations
Urosepsis
|
0.48%
1/207 • Number of events 1 • On-study includes adverse events with an onset date on or after the date of first dose of IP through study competition, planned visit date Day 281.
The safety analysis set consists of all subjects who have received at least one dose of investigational product. Erroneously treated subjects (e.g., those randomised to treatment A but actually given treatment B) are accounted for in the treatment group of the treatment they actually received.
|
0.00%
0/203 • On-study includes adverse events with an onset date on or after the date of first dose of IP through study competition, planned visit date Day 281.
The safety analysis set consists of all subjects who have received at least one dose of investigational product. Erroneously treated subjects (e.g., those randomised to treatment A but actually given treatment B) are accounted for in the treatment group of the treatment they actually received.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/207 • On-study includes adverse events with an onset date on or after the date of first dose of IP through study competition, planned visit date Day 281.
The safety analysis set consists of all subjects who have received at least one dose of investigational product. Erroneously treated subjects (e.g., those randomised to treatment A but actually given treatment B) are accounted for in the treatment group of the treatment they actually received.
|
0.49%
1/203 • Number of events 1 • On-study includes adverse events with an onset date on or after the date of first dose of IP through study competition, planned visit date Day 281.
The safety analysis set consists of all subjects who have received at least one dose of investigational product. Erroneously treated subjects (e.g., those randomised to treatment A but actually given treatment B) are accounted for in the treatment group of the treatment they actually received.
|
|
Investigations
Blood creatinine increased
|
0.48%
1/207 • Number of events 1 • On-study includes adverse events with an onset date on or after the date of first dose of IP through study competition, planned visit date Day 281.
The safety analysis set consists of all subjects who have received at least one dose of investigational product. Erroneously treated subjects (e.g., those randomised to treatment A but actually given treatment B) are accounted for in the treatment group of the treatment they actually received.
|
0.00%
0/203 • On-study includes adverse events with an onset date on or after the date of first dose of IP through study competition, planned visit date Day 281.
The safety analysis set consists of all subjects who have received at least one dose of investigational product. Erroneously treated subjects (e.g., those randomised to treatment A but actually given treatment B) are accounted for in the treatment group of the treatment they actually received.
|
|
Investigations
Coagulation time prolonged
|
0.48%
1/207 • Number of events 1 • On-study includes adverse events with an onset date on or after the date of first dose of IP through study competition, planned visit date Day 281.
The safety analysis set consists of all subjects who have received at least one dose of investigational product. Erroneously treated subjects (e.g., those randomised to treatment A but actually given treatment B) are accounted for in the treatment group of the treatment they actually received.
|
0.00%
0/203 • On-study includes adverse events with an onset date on or after the date of first dose of IP through study competition, planned visit date Day 281.
The safety analysis set consists of all subjects who have received at least one dose of investigational product. Erroneously treated subjects (e.g., those randomised to treatment A but actually given treatment B) are accounted for in the treatment group of the treatment they actually received.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.48%
1/207 • Number of events 1 • On-study includes adverse events with an onset date on or after the date of first dose of IP through study competition, planned visit date Day 281.
The safety analysis set consists of all subjects who have received at least one dose of investigational product. Erroneously treated subjects (e.g., those randomised to treatment A but actually given treatment B) are accounted for in the treatment group of the treatment they actually received.
|
0.00%
0/203 • On-study includes adverse events with an onset date on or after the date of first dose of IP through study competition, planned visit date Day 281.
The safety analysis set consists of all subjects who have received at least one dose of investigational product. Erroneously treated subjects (e.g., those randomised to treatment A but actually given treatment B) are accounted for in the treatment group of the treatment they actually received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder transitional cell carcinoma
|
0.48%
1/207 • Number of events 1 • On-study includes adverse events with an onset date on or after the date of first dose of IP through study competition, planned visit date Day 281.
The safety analysis set consists of all subjects who have received at least one dose of investigational product. Erroneously treated subjects (e.g., those randomised to treatment A but actually given treatment B) are accounted for in the treatment group of the treatment they actually received.
|
0.00%
0/203 • On-study includes adverse events with an onset date on or after the date of first dose of IP through study competition, planned visit date Day 281.
The safety analysis set consists of all subjects who have received at least one dose of investigational product. Erroneously treated subjects (e.g., those randomised to treatment A but actually given treatment B) are accounted for in the treatment group of the treatment they actually received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.48%
1/207 • Number of events 1 • On-study includes adverse events with an onset date on or after the date of first dose of IP through study competition, planned visit date Day 281.
The safety analysis set consists of all subjects who have received at least one dose of investigational product. Erroneously treated subjects (e.g., those randomised to treatment A but actually given treatment B) are accounted for in the treatment group of the treatment they actually received.
|
0.00%
0/203 • On-study includes adverse events with an onset date on or after the date of first dose of IP through study competition, planned visit date Day 281.
The safety analysis set consists of all subjects who have received at least one dose of investigational product. Erroneously treated subjects (e.g., those randomised to treatment A but actually given treatment B) are accounted for in the treatment group of the treatment they actually received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic malignant melanoma
|
0.48%
1/207 • Number of events 1 • On-study includes adverse events with an onset date on or after the date of first dose of IP through study competition, planned visit date Day 281.
The safety analysis set consists of all subjects who have received at least one dose of investigational product. Erroneously treated subjects (e.g., those randomised to treatment A but actually given treatment B) are accounted for in the treatment group of the treatment they actually received.
|
0.00%
0/203 • On-study includes adverse events with an onset date on or after the date of first dose of IP through study competition, planned visit date Day 281.
The safety analysis set consists of all subjects who have received at least one dose of investigational product. Erroneously treated subjects (e.g., those randomised to treatment A but actually given treatment B) are accounted for in the treatment group of the treatment they actually received.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.48%
1/207 • Number of events 1 • On-study includes adverse events with an onset date on or after the date of first dose of IP through study competition, planned visit date Day 281.
The safety analysis set consists of all subjects who have received at least one dose of investigational product. Erroneously treated subjects (e.g., those randomised to treatment A but actually given treatment B) are accounted for in the treatment group of the treatment they actually received.
|
0.49%
1/203 • Number of events 1 • On-study includes adverse events with an onset date on or after the date of first dose of IP through study competition, planned visit date Day 281.
The safety analysis set consists of all subjects who have received at least one dose of investigational product. Erroneously treated subjects (e.g., those randomised to treatment A but actually given treatment B) are accounted for in the treatment group of the treatment they actually received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of lung
|
0.48%
1/207 • Number of events 1 • On-study includes adverse events with an onset date on or after the date of first dose of IP through study competition, planned visit date Day 281.
The safety analysis set consists of all subjects who have received at least one dose of investigational product. Erroneously treated subjects (e.g., those randomised to treatment A but actually given treatment B) are accounted for in the treatment group of the treatment they actually received.
|
0.00%
0/203 • On-study includes adverse events with an onset date on or after the date of first dose of IP through study competition, planned visit date Day 281.
The safety analysis set consists of all subjects who have received at least one dose of investigational product. Erroneously treated subjects (e.g., those randomised to treatment A but actually given treatment B) are accounted for in the treatment group of the treatment they actually received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional cell carcinoma
|
0.00%
0/207 • On-study includes adverse events with an onset date on or after the date of first dose of IP through study competition, planned visit date Day 281.
The safety analysis set consists of all subjects who have received at least one dose of investigational product. Erroneously treated subjects (e.g., those randomised to treatment A but actually given treatment B) are accounted for in the treatment group of the treatment they actually received.
|
0.49%
1/203 • Number of events 1 • On-study includes adverse events with an onset date on or after the date of first dose of IP through study competition, planned visit date Day 281.
The safety analysis set consists of all subjects who have received at least one dose of investigational product. Erroneously treated subjects (e.g., those randomised to treatment A but actually given treatment B) are accounted for in the treatment group of the treatment they actually received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional cell carcinoma urethra
|
0.48%
1/207 • Number of events 1 • On-study includes adverse events with an onset date on or after the date of first dose of IP through study competition, planned visit date Day 281.
The safety analysis set consists of all subjects who have received at least one dose of investigational product. Erroneously treated subjects (e.g., those randomised to treatment A but actually given treatment B) are accounted for in the treatment group of the treatment they actually received.
|
0.00%
0/203 • On-study includes adverse events with an onset date on or after the date of first dose of IP through study competition, planned visit date Day 281.
The safety analysis set consists of all subjects who have received at least one dose of investigational product. Erroneously treated subjects (e.g., those randomised to treatment A but actually given treatment B) are accounted for in the treatment group of the treatment they actually received.
|
|
Nervous system disorders
Carotid artery stenosis
|
0.00%
0/207 • On-study includes adverse events with an onset date on or after the date of first dose of IP through study competition, planned visit date Day 281.
The safety analysis set consists of all subjects who have received at least one dose of investigational product. Erroneously treated subjects (e.g., those randomised to treatment A but actually given treatment B) are accounted for in the treatment group of the treatment they actually received.
|
0.49%
1/203 • Number of events 1 • On-study includes adverse events with an onset date on or after the date of first dose of IP through study competition, planned visit date Day 281.
The safety analysis set consists of all subjects who have received at least one dose of investigational product. Erroneously treated subjects (e.g., those randomised to treatment A but actually given treatment B) are accounted for in the treatment group of the treatment they actually received.
|
|
Psychiatric disorders
Bipolar i disorder
|
0.48%
1/207 • Number of events 1 • On-study includes adverse events with an onset date on or after the date of first dose of IP through study competition, planned visit date Day 281.
The safety analysis set consists of all subjects who have received at least one dose of investigational product. Erroneously treated subjects (e.g., those randomised to treatment A but actually given treatment B) are accounted for in the treatment group of the treatment they actually received.
|
0.00%
0/203 • On-study includes adverse events with an onset date on or after the date of first dose of IP through study competition, planned visit date Day 281.
The safety analysis set consists of all subjects who have received at least one dose of investigational product. Erroneously treated subjects (e.g., those randomised to treatment A but actually given treatment B) are accounted for in the treatment group of the treatment they actually received.
|
|
Psychiatric disorders
Mental disorder
|
0.00%
0/207 • On-study includes adverse events with an onset date on or after the date of first dose of IP through study competition, planned visit date Day 281.
The safety analysis set consists of all subjects who have received at least one dose of investigational product. Erroneously treated subjects (e.g., those randomised to treatment A but actually given treatment B) are accounted for in the treatment group of the treatment they actually received.
|
0.49%
1/203 • Number of events 1 • On-study includes adverse events with an onset date on or after the date of first dose of IP through study competition, planned visit date Day 281.
The safety analysis set consists of all subjects who have received at least one dose of investigational product. Erroneously treated subjects (e.g., those randomised to treatment A but actually given treatment B) are accounted for in the treatment group of the treatment they actually received.
|
|
Respiratory, thoracic and mediastinal disorders
Haemothorax
|
0.48%
1/207 • Number of events 1 • On-study includes adverse events with an onset date on or after the date of first dose of IP through study competition, planned visit date Day 281.
The safety analysis set consists of all subjects who have received at least one dose of investigational product. Erroneously treated subjects (e.g., those randomised to treatment A but actually given treatment B) are accounted for in the treatment group of the treatment they actually received.
|
0.00%
0/203 • On-study includes adverse events with an onset date on or after the date of first dose of IP through study competition, planned visit date Day 281.
The safety analysis set consists of all subjects who have received at least one dose of investigational product. Erroneously treated subjects (e.g., those randomised to treatment A but actually given treatment B) are accounted for in the treatment group of the treatment they actually received.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.48%
1/207 • Number of events 1 • On-study includes adverse events with an onset date on or after the date of first dose of IP through study competition, planned visit date Day 281.
The safety analysis set consists of all subjects who have received at least one dose of investigational product. Erroneously treated subjects (e.g., those randomised to treatment A but actually given treatment B) are accounted for in the treatment group of the treatment they actually received.
|
0.00%
0/203 • On-study includes adverse events with an onset date on or after the date of first dose of IP through study competition, planned visit date Day 281.
The safety analysis set consists of all subjects who have received at least one dose of investigational product. Erroneously treated subjects (e.g., those randomised to treatment A but actually given treatment B) are accounted for in the treatment group of the treatment they actually received.
|
|
Vascular disorders
Hypovolaemic shock
|
0.00%
0/207 • On-study includes adverse events with an onset date on or after the date of first dose of IP through study competition, planned visit date Day 281.
The safety analysis set consists of all subjects who have received at least one dose of investigational product. Erroneously treated subjects (e.g., those randomised to treatment A but actually given treatment B) are accounted for in the treatment group of the treatment they actually received.
|
0.49%
1/203 • Number of events 1 • On-study includes adverse events with an onset date on or after the date of first dose of IP through study competition, planned visit date Day 281.
The safety analysis set consists of all subjects who have received at least one dose of investigational product. Erroneously treated subjects (e.g., those randomised to treatment A but actually given treatment B) are accounted for in the treatment group of the treatment they actually received.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/207 • On-study includes adverse events with an onset date on or after the date of first dose of IP through study competition, planned visit date Day 281.
The safety analysis set consists of all subjects who have received at least one dose of investigational product. Erroneously treated subjects (e.g., those randomised to treatment A but actually given treatment B) are accounted for in the treatment group of the treatment they actually received.
|
0.49%
1/203 • Number of events 1 • On-study includes adverse events with an onset date on or after the date of first dose of IP through study competition, planned visit date Day 281.
The safety analysis set consists of all subjects who have received at least one dose of investigational product. Erroneously treated subjects (e.g., those randomised to treatment A but actually given treatment B) are accounted for in the treatment group of the treatment they actually received.
|
|
Vascular disorders
Iliac artery stenosis
|
0.00%
0/207 • On-study includes adverse events with an onset date on or after the date of first dose of IP through study competition, planned visit date Day 281.
The safety analysis set consists of all subjects who have received at least one dose of investigational product. Erroneously treated subjects (e.g., those randomised to treatment A but actually given treatment B) are accounted for in the treatment group of the treatment they actually received.
|
0.49%
1/203 • Number of events 1 • On-study includes adverse events with an onset date on or after the date of first dose of IP through study competition, planned visit date Day 281.
The safety analysis set consists of all subjects who have received at least one dose of investigational product. Erroneously treated subjects (e.g., those randomised to treatment A but actually given treatment B) are accounted for in the treatment group of the treatment they actually received.
|
|
Cardiac disorders
Atrial flutter
|
0.48%
1/207 • Number of events 1 • On-study includes adverse events with an onset date on or after the date of first dose of IP through study competition, planned visit date Day 281.
The safety analysis set consists of all subjects who have received at least one dose of investigational product. Erroneously treated subjects (e.g., those randomised to treatment A but actually given treatment B) are accounted for in the treatment group of the treatment they actually received.
|
0.49%
1/203 • Number of events 1 • On-study includes adverse events with an onset date on or after the date of first dose of IP through study competition, planned visit date Day 281.
The safety analysis set consists of all subjects who have received at least one dose of investigational product. Erroneously treated subjects (e.g., those randomised to treatment A but actually given treatment B) are accounted for in the treatment group of the treatment they actually received.
|
|
Cardiac disorders
Atrioventricular block second degree
|
0.48%
1/207 • Number of events 1 • On-study includes adverse events with an onset date on or after the date of first dose of IP through study competition, planned visit date Day 281.
The safety analysis set consists of all subjects who have received at least one dose of investigational product. Erroneously treated subjects (e.g., those randomised to treatment A but actually given treatment B) are accounted for in the treatment group of the treatment they actually received.
|
0.00%
0/203 • On-study includes adverse events with an onset date on or after the date of first dose of IP through study competition, planned visit date Day 281.
The safety analysis set consists of all subjects who have received at least one dose of investigational product. Erroneously treated subjects (e.g., those randomised to treatment A but actually given treatment B) are accounted for in the treatment group of the treatment they actually received.
|
|
Cardiac disorders
Ventricular tachycardia
|
0.48%
1/207 • Number of events 1 • On-study includes adverse events with an onset date on or after the date of first dose of IP through study competition, planned visit date Day 281.
The safety analysis set consists of all subjects who have received at least one dose of investigational product. Erroneously treated subjects (e.g., those randomised to treatment A but actually given treatment B) are accounted for in the treatment group of the treatment they actually received.
|
0.00%
0/203 • On-study includes adverse events with an onset date on or after the date of first dose of IP through study competition, planned visit date Day 281.
The safety analysis set consists of all subjects who have received at least one dose of investigational product. Erroneously treated subjects (e.g., those randomised to treatment A but actually given treatment B) are accounted for in the treatment group of the treatment they actually received.
|
|
Ear and labyrinth disorders
Acute vestibular syndrome
|
0.00%
0/207 • On-study includes adverse events with an onset date on or after the date of first dose of IP through study competition, planned visit date Day 281.
The safety analysis set consists of all subjects who have received at least one dose of investigational product. Erroneously treated subjects (e.g., those randomised to treatment A but actually given treatment B) are accounted for in the treatment group of the treatment they actually received.
|
0.49%
1/203 • Number of events 1 • On-study includes adverse events with an onset date on or after the date of first dose of IP through study competition, planned visit date Day 281.
The safety analysis set consists of all subjects who have received at least one dose of investigational product. Erroneously treated subjects (e.g., those randomised to treatment A but actually given treatment B) are accounted for in the treatment group of the treatment they actually received.
|
|
Ear and labyrinth disorders
Vertigo
|
0.48%
1/207 • Number of events 1 • On-study includes adverse events with an onset date on or after the date of first dose of IP through study competition, planned visit date Day 281.
The safety analysis set consists of all subjects who have received at least one dose of investigational product. Erroneously treated subjects (e.g., those randomised to treatment A but actually given treatment B) are accounted for in the treatment group of the treatment they actually received.
|
0.00%
0/203 • On-study includes adverse events with an onset date on or after the date of first dose of IP through study competition, planned visit date Day 281.
The safety analysis set consists of all subjects who have received at least one dose of investigational product. Erroneously treated subjects (e.g., those randomised to treatment A but actually given treatment B) are accounted for in the treatment group of the treatment they actually received.
|
Other adverse events
| Measure |
AZD8233
n=207 participants at risk
AZD8233 for subcutaneous use.
|
Placebo
n=203 participants at risk
Matching placebo solution for subcutaneous injection.
|
|---|---|---|
|
General disorders
Injection site reaction
|
10.6%
22/207 • Number of events 56 • On-study includes adverse events with an onset date on or after the date of first dose of IP through study competition, planned visit date Day 281.
The safety analysis set consists of all subjects who have received at least one dose of investigational product. Erroneously treated subjects (e.g., those randomised to treatment A but actually given treatment B) are accounted for in the treatment group of the treatment they actually received.
|
2.5%
5/203 • Number of events 7 • On-study includes adverse events with an onset date on or after the date of first dose of IP through study competition, planned visit date Day 281.
The safety analysis set consists of all subjects who have received at least one dose of investigational product. Erroneously treated subjects (e.g., those randomised to treatment A but actually given treatment B) are accounted for in the treatment group of the treatment they actually received.
|
|
Infections and infestations
Covid-19
|
15.9%
33/207 • Number of events 33 • On-study includes adverse events with an onset date on or after the date of first dose of IP through study competition, planned visit date Day 281.
The safety analysis set consists of all subjects who have received at least one dose of investigational product. Erroneously treated subjects (e.g., those randomised to treatment A but actually given treatment B) are accounted for in the treatment group of the treatment they actually received.
|
17.7%
36/203 • Number of events 37 • On-study includes adverse events with an onset date on or after the date of first dose of IP through study competition, planned visit date Day 281.
The safety analysis set consists of all subjects who have received at least one dose of investigational product. Erroneously treated subjects (e.g., those randomised to treatment A but actually given treatment B) are accounted for in the treatment group of the treatment they actually received.
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
8.7%
18/207 • Number of events 19 • On-study includes adverse events with an onset date on or after the date of first dose of IP through study competition, planned visit date Day 281.
The safety analysis set consists of all subjects who have received at least one dose of investigational product. Erroneously treated subjects (e.g., those randomised to treatment A but actually given treatment B) are accounted for in the treatment group of the treatment they actually received.
|
6.9%
14/203 • Number of events 14 • On-study includes adverse events with an onset date on or after the date of first dose of IP through study competition, planned visit date Day 281.
The safety analysis set consists of all subjects who have received at least one dose of investigational product. Erroneously treated subjects (e.g., those randomised to treatment A but actually given treatment B) are accounted for in the treatment group of the treatment they actually received.
|
|
Vascular disorders
Hypertension
|
5.3%
11/207 • Number of events 11 • On-study includes adverse events with an onset date on or after the date of first dose of IP through study competition, planned visit date Day 281.
The safety analysis set consists of all subjects who have received at least one dose of investigational product. Erroneously treated subjects (e.g., those randomised to treatment A but actually given treatment B) are accounted for in the treatment group of the treatment they actually received.
|
6.4%
13/203 • Number of events 16 • On-study includes adverse events with an onset date on or after the date of first dose of IP through study competition, planned visit date Day 281.
The safety analysis set consists of all subjects who have received at least one dose of investigational product. Erroneously treated subjects (e.g., those randomised to treatment A but actually given treatment B) are accounted for in the treatment group of the treatment they actually received.
|
Additional Information
AstraZeneca Clinical Study Information Center
AstraZeneca
Phone: +1-877-240-9479
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place