Trial Outcomes & Findings for AZD7442 - a Potential Combination Therapy for the Prevention and Treatment of COVID-19 (NCT NCT04507256)
NCT ID: NCT04507256
Last Updated: 2024-10-18
Results Overview
The safety and tolerability of AZD7442 administered IV or IM to healthy adult participants 18 to 55 years of age was evaluated.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
60 participants
Primary outcome timeframe
From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
Results posted on
2024-10-18
Participant Flow
A total of 60 healthy participants were enrolled at a single study center in the United Kingdom (UK) from 18 August 2020 to 19 0ctober 2021.
Participants who met the inclusion and none of the exclusion criteria were enrolled to the study. A washout period was not included in this study.
Participant milestones
| Measure |
Pooled Placebo
Participants received single intravenous infusion (IV) or intramuscular injection (IM) of placebo.
|
AZD7442 300 mg, IM
Participants received 300 mg of AZD7442 (AZD8895 + AZD1061) via intramuscular injection (IM) administered in 2 sequential injections, starting with 150 mg AZD8895 and followed by 150 mg AZD1061.
|
AZD7442 300 mg, IV
Participants received 300 mg of AZD7442 (AZD8895 + AZD1061) via intravenous infusion (IV) administered in 2 sequential infusions, starting with 150 mg AZD8895 and followed by 150 mg AZD1061.
|
AZD7442 1000 mg, IV
Participants received 1000 mg of AZD7442 (AZD8895 + AZD1061) via IV infusion administered in 2 sequential infusions, starting with 500 mg AZD8895 and followed by 500 mg AZD1061.
|
AZD7442 3000 mg, IV
Participants received 3000 mg of AZD7442 (AZD8895 + AZD1061) via IV infusion administered in 2 sequential infusions, starting with 1500 mg AZD8895 and followed by 1500 mg AZD1061.
|
AZD7442 3000 mg, IV Co-administered
Participants received 3000 mg of AZD7442 (AZD8895 + AZD1061) via IV infusion, the investigational medicinal product (IMP) was co-administered as a single IV infusion containing both (1500 mg of AZD8895 and 1500 mg of AZD1061).
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
10
|
10
|
10
|
10
|
|
Overall Study
COMPLETED
|
9
|
10
|
10
|
9
|
10
|
10
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
0
|
1
|
0
|
0
|
Reasons for withdrawal
| Measure |
Pooled Placebo
Participants received single intravenous infusion (IV) or intramuscular injection (IM) of placebo.
|
AZD7442 300 mg, IM
Participants received 300 mg of AZD7442 (AZD8895 + AZD1061) via intramuscular injection (IM) administered in 2 sequential injections, starting with 150 mg AZD8895 and followed by 150 mg AZD1061.
|
AZD7442 300 mg, IV
Participants received 300 mg of AZD7442 (AZD8895 + AZD1061) via intravenous infusion (IV) administered in 2 sequential infusions, starting with 150 mg AZD8895 and followed by 150 mg AZD1061.
|
AZD7442 1000 mg, IV
Participants received 1000 mg of AZD7442 (AZD8895 + AZD1061) via IV infusion administered in 2 sequential infusions, starting with 500 mg AZD8895 and followed by 500 mg AZD1061.
|
AZD7442 3000 mg, IV
Participants received 3000 mg of AZD7442 (AZD8895 + AZD1061) via IV infusion administered in 2 sequential infusions, starting with 1500 mg AZD8895 and followed by 1500 mg AZD1061.
|
AZD7442 3000 mg, IV Co-administered
Participants received 3000 mg of AZD7442 (AZD8895 + AZD1061) via IV infusion, the investigational medicinal product (IMP) was co-administered as a single IV infusion containing both (1500 mg of AZD8895 and 1500 mg of AZD1061).
|
|---|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
0
|
1
|
0
|
0
|
Baseline Characteristics
AZD7442 - a Potential Combination Therapy for the Prevention and Treatment of COVID-19
Baseline characteristics by cohort
| Measure |
Pooled Placebo
n=10 Participants
Participants received single intravenous infusion (IV) or intramuscular injection (IM) of placebo.
|
AZD7442 300 mg, IM
n=10 Participants
Participants received 300 mg of AZD7442 (AZD8895 + AZD1061) via intramuscular injection (IM) administered in 2 sequential injections, starting with 150 mg AZD8895 and followed by 150 mg AZD1061.
|
AZD7442 300 mg, IV
n=10 Participants
Participants received 300 mg of AZD7442 (AZD8895 + AZD1061) via intravenous infusion (IV) administered in 2 sequential infusions, starting with 150 mg AZD8895 and followed by 150 mg AZD1061.
|
AZD7442 1000 mg, IV
n=10 Participants
Participants received 1000 mg of AZD7442 (AZD8895 + AZD1061) via IV infusion administered in 2 sequential infusions, starting with 500 mg AZD8895 and followed by 500 mg AZD1061.
|
AZD7442 3000 mg, IV
n=10 Participants
Participants received 3000 mg of AZD7442 (AZD8895 + AZD1061) via IV infusion administered in 2 sequential infusions, starting with 1500 mg AZD8895 and followed by 1500 mg AZD1061.
|
AZD7442 3000 mg, IV Co-administered
n=10 Participants
Participants received 3000 mg of AZD7442 (AZD8895 + AZD1061) via IV infusion, the investigational medicinal product (IMP) was co-administered as a single IV infusion containing both (1500 mg of AZD8895 and 1500 mg of AZD1061).
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
38.1 Years
STANDARD_DEVIATION 11.45 • n=5 Participants
|
41.9 Years
STANDARD_DEVIATION 6.51 • n=7 Participants
|
40.7 Years
STANDARD_DEVIATION 7.83 • n=5 Participants
|
38.9 Years
STANDARD_DEVIATION 8.86 • n=4 Participants
|
35.8 Years
STANDARD_DEVIATION 9.44 • n=21 Participants
|
39.6 Years
STANDARD_DEVIATION 9.30 • n=10 Participants
|
39.17 Years
STANDARD_DEVIATION 8.86 • n=115 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
4 Participants
n=10 Participants
|
23 Participants
n=115 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
6 Participants
n=10 Participants
|
37 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
10 Participants
n=10 Participants
|
59 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
9 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
5 Participants
n=115 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
7 Participants
n=10 Participants
|
40 Participants
n=115 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
6 Participants
n=115 Participants
|
PRIMARY outcome
Timeframe: From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)Population: Safety analysis set included all participants who were randomized and received any amount of AZD7442.
The safety and tolerability of AZD7442 administered IV or IM to healthy adult participants 18 to 55 years of age was evaluated.
Outcome measures
| Measure |
Pooled Placebo
n=10 Participants
Participants received single intravenous infusion (IV) or intramuscular injection (IM) of placebo.
|
AZD7442 300 mg, IM
n=10 Participants
Participants received 300 mg of AZD7442 (AZD8895 + AZD1061) via intramuscular injection (IM) administered in 2 sequential injections, starting with 150 mg AZD8895 and followed by 150 mg AZD1061.
|
AZD7442 300 mg, IV
n=10 Participants
Participants received 300 mg of AZD7442 (AZD8895 + AZD1061) via intravenous infusion (IV) administered in 2 sequential infusions, starting with 150 mg AZD8895 and followed by 150 mg AZD1061.
|
AZD7442 1000 mg, IV
n=10 Participants
Participants received 1000 mg of AZD7442 (AZD8895 + AZD1061) via IV infusion administered in 2 sequential infusions, starting with 500 mg AZD8895 and followed by 500 mg AZD1061.
|
AZD7442 3000 mg, IV
n=10 Participants
Participants received 3000 mg of AZD7442 (AZD8895 + AZD1061) via IV infusion administered in 2 sequential infusions, starting with 1500 mg AZD8895 and followed by 1500 mg AZD1061.
|
AZD7442 3000 mg, IV Co-administered
n=10 Participants
Participants received 3000 mg of AZD7442 (AZD8895 + AZD1061) via IV infusion, the investigational medicinal product (IMP) was co-administered as a single IV infusion containing both (1500 mg of AZD8895 and 1500 mg of AZD1061).
|
|---|---|---|---|---|---|---|
|
Number of Participants With Adverse Events (AEs) and Serious AEs
Any AE
|
8 Participants
|
2 Participants
|
5 Participants
|
6 Participants
|
7 Participants
|
6 Participants
|
|
Number of Participants With Adverse Events (AEs) and Serious AEs
Any AE with outcome of death
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events (AEs) and Serious AEs
Any SAE (including events with outcome of death)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events (AEs) and Serious AEs
Any AE leading to discontinuation of Investigational Medicinal Product (IMP)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events (AEs) and Serious AEs
Any AE leading to dose interruption
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events (AEs) and Serious AEs
Ant AE leading to dose reduction
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events (AEs) and Serious AEs
Any AE leading to withdrawal from the study
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 1 (pre-dose, 8 h), Day 2 (24 h), Day 4 (72 h), Day 6 (120 h), Day 8 (168), Day 15 (336 h), Day 31 (720 h), Day 61 (1440 h), Day 91 (2160 h), Day 151 (3600 h), Day 211 (5040), Day 271 (6480 h), and Day 361 (8640 h)Population: The Pharmacokinetic (PK) analysis set consisted of all participants in the safety analysis set who received AZD7442 and who had evaluable serum PK data, with no important protocol deviations thought to impact on the analysis of the PK data.
The single dose Cmax of AZD7442 and of the individual monoclonal antibodies (mAbs) in serum were evaluated.
Outcome measures
| Measure |
Pooled Placebo
n=10 Participants
Participants received single intravenous infusion (IV) or intramuscular injection (IM) of placebo.
|
AZD7442 300 mg, IM
n=9 Participants
Participants received 300 mg of AZD7442 (AZD8895 + AZD1061) via intramuscular injection (IM) administered in 2 sequential injections, starting with 150 mg AZD8895 and followed by 150 mg AZD1061.
|
AZD7442 300 mg, IV
n=10 Participants
Participants received 300 mg of AZD7442 (AZD8895 + AZD1061) via intravenous infusion (IV) administered in 2 sequential infusions, starting with 150 mg AZD8895 and followed by 150 mg AZD1061.
|
AZD7442 1000 mg, IV
n=10 Participants
Participants received 1000 mg of AZD7442 (AZD8895 + AZD1061) via IV infusion administered in 2 sequential infusions, starting with 500 mg AZD8895 and followed by 500 mg AZD1061.
|
AZD7442 3000 mg, IV
n=10 Participants
Participants received 3000 mg of AZD7442 (AZD8895 + AZD1061) via IV infusion administered in 2 sequential infusions, starting with 1500 mg AZD8895 and followed by 1500 mg AZD1061.
|
AZD7442 3000 mg, IV Co-administered
Participants received 3000 mg of AZD7442 (AZD8895 + AZD1061) via IV infusion, the investigational medicinal product (IMP) was co-administered as a single IV infusion containing both (1500 mg of AZD8895 and 1500 mg of AZD1061).
|
|---|---|---|---|---|---|---|
|
Maximum Serum Concentration (Cmax) of AZD7442
AZD8895
|
16.52 μg/mL (microgram per milliliter)
Geometric Coefficient of Variation 35.56
|
53.71 μg/mL (microgram per milliliter)
Geometric Coefficient of Variation 10.24
|
162.2 μg/mL (microgram per milliliter)
Geometric Coefficient of Variation 11.31
|
505.8 μg/mL (microgram per milliliter)
Geometric Coefficient of Variation 10.54
|
447.8 μg/mL (microgram per milliliter)
Geometric Coefficient of Variation 8.980
|
—
|
|
Maximum Serum Concentration (Cmax) of AZD7442
AZD1061
|
15.27 μg/mL (microgram per milliliter)
Geometric Coefficient of Variation 38.53
|
51.69 μg/mL (microgram per milliliter)
Geometric Coefficient of Variation 12.31
|
154.3 μg/mL (microgram per milliliter)
Geometric Coefficient of Variation 14.66
|
465.5 μg/mL (microgram per milliliter)
Geometric Coefficient of Variation 11.09
|
419.3 μg/mL (microgram per milliliter)
Geometric Coefficient of Variation 11.62
|
—
|
SECONDARY outcome
Timeframe: Day 1 (pre-dose, 8 h), Day 2 (24 h), Day 4 (72 h), Day 6 (120 h), Day 8 (168), Day 15 (336 h), Day 31 (720 h), Day 61 (1440 h), Day 91 (2160 h), Day 151 (3600 h), Day 211 (5040), Day 271 (6480 h), and Day 361 (8640 h)Population: The PK analysis set consisted of all participants in the safety analysis set who received AZD7442 and who had evaluable serum PK data, with no important protocol deviations thought to impact on the analysis of the PK data.
The single dose tmax of AZD7442 and of the individual mAbs in serum was evaluated
Outcome measures
| Measure |
Pooled Placebo
n=10 Participants
Participants received single intravenous infusion (IV) or intramuscular injection (IM) of placebo.
|
AZD7442 300 mg, IM
n=10 Participants
Participants received 300 mg of AZD7442 (AZD8895 + AZD1061) via intramuscular injection (IM) administered in 2 sequential injections, starting with 150 mg AZD8895 and followed by 150 mg AZD1061.
|
AZD7442 300 mg, IV
n=10 Participants
Participants received 300 mg of AZD7442 (AZD8895 + AZD1061) via intravenous infusion (IV) administered in 2 sequential infusions, starting with 150 mg AZD8895 and followed by 150 mg AZD1061.
|
AZD7442 1000 mg, IV
n=10 Participants
Participants received 1000 mg of AZD7442 (AZD8895 + AZD1061) via IV infusion administered in 2 sequential infusions, starting with 500 mg AZD8895 and followed by 500 mg AZD1061.
|
AZD7442 3000 mg, IV
n=10 Participants
Participants received 3000 mg of AZD7442 (AZD8895 + AZD1061) via IV infusion administered in 2 sequential infusions, starting with 1500 mg AZD8895 and followed by 1500 mg AZD1061.
|
AZD7442 3000 mg, IV Co-administered
Participants received 3000 mg of AZD7442 (AZD8895 + AZD1061) via IV infusion, the investigational medicinal product (IMP) was co-administered as a single IV infusion containing both (1500 mg of AZD8895 and 1500 mg of AZD1061).
|
|---|---|---|---|---|---|---|
|
Time to Reach Maximum Serum Concentration (Tmax) of AZD7442
AZD8895
|
13.96 Day
Interval 3.05 to 29.99
|
0.04 Day
Interval 0.02 to 0.33
|
0.04 Day
Interval 0.02 to 0.05
|
0.10 Day
Interval 0.06 to 0.13
|
0.05 Day
Interval 0.05 to 0.05
|
—
|
|
Time to Reach Maximum Serum Concentration (Tmax) of AZD7442
AZD1061
|
13.98 Day
Interval 3.05 to 60.23
|
0.02 Day
Interval 0.02 to 0.96
|
0.02 Day
Interval 0.02 to 0.34
|
0.06 Day
Interval 0.06 to 0.33
|
0.05 Day
Interval 0.05 to 0.33
|
—
|
SECONDARY outcome
Timeframe: Day 1 (pre-dose, 8 h), Day 2 (24 h), Day 4 (72 h), Day 6 (120 h), Day 8 (168), Day 15 (336 h), Day 31 (720 h), Day 61 (1440 h), Day 91 (2160 h), Day 151 (3600 h), Day 211 (5040), Day 271 (6480 h), and Day 361 (8640 h)Population: The PK analysis set consisted of all participants in the safety analysis set who received AZD7442 and who had evaluable serum PK data, with no important protocol deviations thought to impact on the analysis of the PK data.
The single dose t½λz of AZD7442 and of the individual mAbs in serum was evaluated.
Outcome measures
| Measure |
Pooled Placebo
n=10 Participants
Participants received single intravenous infusion (IV) or intramuscular injection (IM) of placebo.
|
AZD7442 300 mg, IM
n=9 Participants
Participants received 300 mg of AZD7442 (AZD8895 + AZD1061) via intramuscular injection (IM) administered in 2 sequential injections, starting with 150 mg AZD8895 and followed by 150 mg AZD1061.
|
AZD7442 300 mg, IV
n=9 Participants
Participants received 300 mg of AZD7442 (AZD8895 + AZD1061) via intravenous infusion (IV) administered in 2 sequential infusions, starting with 150 mg AZD8895 and followed by 150 mg AZD1061.
|
AZD7442 1000 mg, IV
n=10 Participants
Participants received 1000 mg of AZD7442 (AZD8895 + AZD1061) via IV infusion administered in 2 sequential infusions, starting with 500 mg AZD8895 and followed by 500 mg AZD1061.
|
AZD7442 3000 mg, IV
n=10 Participants
Participants received 3000 mg of AZD7442 (AZD8895 + AZD1061) via IV infusion administered in 2 sequential infusions, starting with 1500 mg AZD8895 and followed by 1500 mg AZD1061.
|
AZD7442 3000 mg, IV Co-administered
Participants received 3000 mg of AZD7442 (AZD8895 + AZD1061) via IV infusion, the investigational medicinal product (IMP) was co-administered as a single IV infusion containing both (1500 mg of AZD8895 and 1500 mg of AZD1061).
|
|---|---|---|---|---|---|---|
|
Terminal Elimination Half-life (t½λz) of AZD7442
AZD8895
|
87.76 Day
Geometric Coefficient of Variation 14.56
|
86.97 Day
Geometric Coefficient of Variation 5.195
|
92.38 Day
Geometric Coefficient of Variation 17.23
|
91.27 Day
Geometric Coefficient of Variation 7.827
|
95.33 Day
Geometric Coefficient of Variation 11.06
|
—
|
|
Terminal Elimination Half-life (t½λz) of AZD7442
AZD1061
|
79.78 Day
Geometric Coefficient of Variation 9.649
|
91.08 Day
Geometric Coefficient of Variation 9.152
|
83.05 Day
Geometric Coefficient of Variation 16.22
|
88.52 Day
Geometric Coefficient of Variation 9.086
|
87.17 Day
Geometric Coefficient of Variation 10.78
|
—
|
SECONDARY outcome
Timeframe: Day 1 (pre-dose, 8 h), Day 2 (24 h), Day 4 (72 h), Day 6 (120 h), Day 8 (168), Day 15 (336 h), Day 31 (720 h), Day 61 (1440 h), Day 91 (2160 h), Day 151 (3600 h), Day 211 (5040), Day 271 (6480 h), and Day 361 (8640 h)Population: The PK analysis set consisted of all participants in the safety analysis set who received AZD7442 and who had evaluable serum PK data, with no important protocol deviations thought to impact on the analysis of the PK data.
The single dose AUClast of AZD7442 and of the individual mAbs in serum was evaluated.
Outcome measures
| Measure |
Pooled Placebo
n=10 Participants
Participants received single intravenous infusion (IV) or intramuscular injection (IM) of placebo.
|
AZD7442 300 mg, IM
n=9 Participants
Participants received 300 mg of AZD7442 (AZD8895 + AZD1061) via intramuscular injection (IM) administered in 2 sequential injections, starting with 150 mg AZD8895 and followed by 150 mg AZD1061.
|
AZD7442 300 mg, IV
n=9 Participants
Participants received 300 mg of AZD7442 (AZD8895 + AZD1061) via intravenous infusion (IV) administered in 2 sequential infusions, starting with 150 mg AZD8895 and followed by 150 mg AZD1061.
|
AZD7442 1000 mg, IV
n=10 Participants
Participants received 1000 mg of AZD7442 (AZD8895 + AZD1061) via IV infusion administered in 2 sequential infusions, starting with 500 mg AZD8895 and followed by 500 mg AZD1061.
|
AZD7442 3000 mg, IV
n=10 Participants
Participants received 3000 mg of AZD7442 (AZD8895 + AZD1061) via IV infusion administered in 2 sequential infusions, starting with 1500 mg AZD8895 and followed by 1500 mg AZD1061.
|
AZD7442 3000 mg, IV Co-administered
Participants received 3000 mg of AZD7442 (AZD8895 + AZD1061) via IV infusion, the investigational medicinal product (IMP) was co-administered as a single IV infusion containing both (1500 mg of AZD8895 and 1500 mg of AZD1061).
|
|---|---|---|---|---|---|---|
|
Area Under the Concentration Curve From Time Zero to the Time of Last Quantifiable Concentration (AUClast) of AZD7442
AZD8895
|
2367 day*μg/mL (microgram per milliliter)
Geometric Coefficient of Variation 28.92
|
3467 day*μg/mL (microgram per milliliter)
Geometric Coefficient of Variation 13.20
|
9237 day*μg/mL (microgram per milliliter)
Geometric Coefficient of Variation 11.75
|
29800 day*μg/mL (microgram per milliliter)
Geometric Coefficient of Variation 9.799
|
29380 day*μg/mL (microgram per milliliter)
Geometric Coefficient of Variation 10.81
|
—
|
|
Area Under the Concentration Curve From Time Zero to the Time of Last Quantifiable Concentration (AUClast) of AZD7442
AZD1061
|
2018 day*μg/mL (microgram per milliliter)
Geometric Coefficient of Variation 30.98
|
3085 day*μg/mL (microgram per milliliter)
Geometric Coefficient of Variation 13.01
|
9245 day*μg/mL (microgram per milliliter)
Geometric Coefficient of Variation 11.22
|
28160 day*μg/mL (microgram per milliliter)
Geometric Coefficient of Variation 10.85
|
28210 day*μg/mL (microgram per milliliter)
Geometric Coefficient of Variation 11.21
|
—
|
SECONDARY outcome
Timeframe: Day 1 (pre-dose, 8 h), Day 2 (24 h), Day 4 (72 h), Day 6 (120 h), Day 8 (168), Day 15 (336 h), Day 31 (720 h), Day 61 (1440 h), Day 91 (2160 h), Day 151 (3600 h), Day 211 (5040), Day 271 (6480 h), and Day 361 (8640 h)Population: The PK analysis set consisted of all participants in the safety analysis set who received AZD7442 and who had evaluable serum PK data, with no important protocol deviations thought to impact on the analysis of the PK data.
The single dose AUCinf of AZD7442 and of the individual mAbs in serum was evaluated. The bioavailability (F) of AZD7442 Dose 1 administered by IM was calculated as the ratio of geometric mean AUCinf after IM to IV, for mAb AZD8895 and mAb AZD1061 is also presented.
Outcome measures
| Measure |
Pooled Placebo
n=10 Participants
Participants received single intravenous infusion (IV) or intramuscular injection (IM) of placebo.
|
AZD7442 300 mg, IM
n=9 Participants
Participants received 300 mg of AZD7442 (AZD8895 + AZD1061) via intramuscular injection (IM) administered in 2 sequential injections, starting with 150 mg AZD8895 and followed by 150 mg AZD1061.
|
AZD7442 300 mg, IV
n=9 Participants
Participants received 300 mg of AZD7442 (AZD8895 + AZD1061) via intravenous infusion (IV) administered in 2 sequential infusions, starting with 150 mg AZD8895 and followed by 150 mg AZD1061.
|
AZD7442 1000 mg, IV
n=10 Participants
Participants received 1000 mg of AZD7442 (AZD8895 + AZD1061) via IV infusion administered in 2 sequential infusions, starting with 500 mg AZD8895 and followed by 500 mg AZD1061.
|
AZD7442 3000 mg, IV
n=10 Participants
Participants received 3000 mg of AZD7442 (AZD8895 + AZD1061) via IV infusion administered in 2 sequential infusions, starting with 1500 mg AZD8895 and followed by 1500 mg AZD1061.
|
AZD7442 3000 mg, IV Co-administered
Participants received 3000 mg of AZD7442 (AZD8895 + AZD1061) via IV infusion, the investigational medicinal product (IMP) was co-administered as a single IV infusion containing both (1500 mg of AZD8895 and 1500 mg of AZD1061).
|
|---|---|---|---|---|---|---|
|
Area Under the Serum Concentration Versus Time Curve Extrapolated to Infinity (AUCinf) of AZD7442
AZD8895
|
2526 day*ug/mL (microgram per milliliter)
Geometric Coefficient of Variation 29.75
|
3677 day*ug/mL (microgram per milliliter)
Geometric Coefficient of Variation 13.75
|
9893 day*ug/mL (microgram per milliliter)
Geometric Coefficient of Variation 12.58
|
31850 day*ug/mL (microgram per milliliter)
Geometric Coefficient of Variation 10.85
|
31850 day*ug/mL (microgram per milliliter)
Geometric Coefficient of Variation 11.89
|
—
|
|
Area Under the Serum Concentration Versus Time Curve Extrapolated to Infinity (AUCinf) of AZD7442
AZD1061
|
2130 day*ug/mL (microgram per milliliter)
Geometric Coefficient of Variation 31.25
|
3276 day*ug/mL (microgram per milliliter)
Geometric Coefficient of Variation 14.17
|
9712 day*ug/mL (microgram per milliliter)
Geometric Coefficient of Variation 11.69
|
29860 day*ug/mL (microgram per milliliter)
Geometric Coefficient of Variation 11.71
|
30030 day*ug/mL (microgram per milliliter)
Geometric Coefficient of Variation 11.82
|
—
|
SECONDARY outcome
Timeframe: Day 1 (pre-dose, 8 h), Day 2 (24 h), Day 4 (72 h), Day 6 (120 h), Day 8 (168), Day 15 (336 h), Day 31 (720 h), Day 61 (1440 h), Day 91 (2160 h), Day 151 (3600 h), Day 211 (5040), Day 271 (6480 h), and Day 361 (8640 h)Population: The PK analysis set consisted of all participants in the safety analysis set who received AZD7442 and who had evaluable serum PK data, with no important protocol deviations thought to impact on the analysis of the PK data. It was pre-specified in the statistical analysis plan (SAP) and clinical study protocol (CSP) to report CL for only arms receiving IV infusion.
The single dose CL of AZD7442 and of the individual mAbs in serum was evaluated.
Outcome measures
| Measure |
Pooled Placebo
n=9 Participants
Participants received single intravenous infusion (IV) or intramuscular injection (IM) of placebo.
|
AZD7442 300 mg, IM
n=9 Participants
Participants received 300 mg of AZD7442 (AZD8895 + AZD1061) via intramuscular injection (IM) administered in 2 sequential injections, starting with 150 mg AZD8895 and followed by 150 mg AZD1061.
|
AZD7442 300 mg, IV
n=10 Participants
Participants received 300 mg of AZD7442 (AZD8895 + AZD1061) via intravenous infusion (IV) administered in 2 sequential infusions, starting with 150 mg AZD8895 and followed by 150 mg AZD1061.
|
AZD7442 1000 mg, IV
n=10 Participants
Participants received 1000 mg of AZD7442 (AZD8895 + AZD1061) via IV infusion administered in 2 sequential infusions, starting with 500 mg AZD8895 and followed by 500 mg AZD1061.
|
AZD7442 3000 mg, IV
Participants received 3000 mg of AZD7442 (AZD8895 + AZD1061) via IV infusion administered in 2 sequential infusions, starting with 1500 mg AZD8895 and followed by 1500 mg AZD1061.
|
AZD7442 3000 mg, IV Co-administered
Participants received 3000 mg of AZD7442 (AZD8895 + AZD1061) via IV infusion, the investigational medicinal product (IMP) was co-administered as a single IV infusion containing both (1500 mg of AZD8895 and 1500 mg of AZD1061).
|
|---|---|---|---|---|---|---|
|
Systemic Clearance (CL) of AZD7442 IV Infusion
AZD8895
|
0.04113 L (Litre)/day
Standard Deviation 0.005411
|
0.05090 L (Litre)/day
Standard Deviation 0.006510
|
0.04736 L (Litre)/day
Standard Deviation 0.005317
|
0.04740 L (Litre)/day
Standard Deviation 0.005661
|
—
|
—
|
|
Systemic Clearance (CL) of AZD7442 IV Infusion
AZD1061
|
0.04618 L (Litre)/day
Standard Deviation 0.006162
|
0.05180 L (Litre)/day
Standard Deviation 0.006260
|
0.05055 L (Litre)/day
Standard Deviation 0.006086
|
0.05026 L (Litre)/day
Standard Deviation 0.006036
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 (pre-dose, 8 h), Day 2 (24 h), Day 4 (72 h), Day 6 (120 h), Day 8 (168), Day 15 (336 h), Day 31 (720 h), Day 61 (1440 h), Day 91 (2160 h), Day 151 (3600 h), Day 211 (5040), Day 271 (6480 h), and Day 361 (8640 h)Population: The PK analysis set consisted of all participants in the safety analysis set who received AZD7442 and who had evaluable serum PK data, with no important protocol deviations thought to impact on the analysis of the PK data. It was pre-specified in the SAP and CSP to report CL/F for only arm receiving IM injection.
The single dose CL/F of AZD7442 and of the individual mAbs in serum was evaluated.
Outcome measures
| Measure |
Pooled Placebo
n=10 Participants
Participants received single intravenous infusion (IV) or intramuscular injection (IM) of placebo.
|
AZD7442 300 mg, IM
Participants received 300 mg of AZD7442 (AZD8895 + AZD1061) via intramuscular injection (IM) administered in 2 sequential injections, starting with 150 mg AZD8895 and followed by 150 mg AZD1061.
|
AZD7442 300 mg, IV
Participants received 300 mg of AZD7442 (AZD8895 + AZD1061) via intravenous infusion (IV) administered in 2 sequential infusions, starting with 150 mg AZD8895 and followed by 150 mg AZD1061.
|
AZD7442 1000 mg, IV
Participants received 1000 mg of AZD7442 (AZD8895 + AZD1061) via IV infusion administered in 2 sequential infusions, starting with 500 mg AZD8895 and followed by 500 mg AZD1061.
|
AZD7442 3000 mg, IV
Participants received 3000 mg of AZD7442 (AZD8895 + AZD1061) via IV infusion administered in 2 sequential infusions, starting with 1500 mg AZD8895 and followed by 1500 mg AZD1061.
|
AZD7442 3000 mg, IV Co-administered
Participants received 3000 mg of AZD7442 (AZD8895 + AZD1061) via IV infusion, the investigational medicinal product (IMP) was co-administered as a single IV infusion containing both (1500 mg of AZD8895 and 1500 mg of AZD1061).
|
|---|---|---|---|---|---|---|
|
Apparent Total Clearance (CL/F) of AZD7442 IM Injection
AZD8895
|
0.06174 L (Litre)/day
Standard Deviation 0.01857
|
—
|
—
|
—
|
—
|
—
|
|
Apparent Total Clearance (CL/F) of AZD7442 IM Injection
AZD1061
|
0.07383 L (Litre)/day
Standard Deviation 0.02733
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 (pre-dose, 8 h), Day 2 (24 h), Day 4 (72 h), Day 6 (120 h), Day 8 (168), Day 15 (336 h), Day 31 (720 h), Day 61 (1440 h), Day 91 (2160 h), Day 151 (3600 h), Day 211 (5040), Day 271 (6480 h), and Day 361 (8640 h)Population: The PK analysis set consisted of all participants in the safety analysis set who received AZD7442 and who had evaluable serum PK data, with no important protocol deviations thought to impact on the analysis of the PK data.
The single dose Vz/F of AZD7442 and of the individual mAbs in serum was evaluated.
Outcome measures
| Measure |
Pooled Placebo
n=10 Participants
Participants received single intravenous infusion (IV) or intramuscular injection (IM) of placebo.
|
AZD7442 300 mg, IM
n=9 Participants
Participants received 300 mg of AZD7442 (AZD8895 + AZD1061) via intramuscular injection (IM) administered in 2 sequential injections, starting with 150 mg AZD8895 and followed by 150 mg AZD1061.
|
AZD7442 300 mg, IV
n=9 Participants
Participants received 300 mg of AZD7442 (AZD8895 + AZD1061) via intravenous infusion (IV) administered in 2 sequential infusions, starting with 150 mg AZD8895 and followed by 150 mg AZD1061.
|
AZD7442 1000 mg, IV
n=10 Participants
Participants received 1000 mg of AZD7442 (AZD8895 + AZD1061) via IV infusion administered in 2 sequential infusions, starting with 500 mg AZD8895 and followed by 500 mg AZD1061.
|
AZD7442 3000 mg, IV
n=10 Participants
Participants received 3000 mg of AZD7442 (AZD8895 + AZD1061) via IV infusion administered in 2 sequential infusions, starting with 1500 mg AZD8895 and followed by 1500 mg AZD1061.
|
AZD7442 3000 mg, IV Co-administered
Participants received 3000 mg of AZD7442 (AZD8895 + AZD1061) via IV infusion, the investigational medicinal product (IMP) was co-administered as a single IV infusion containing both (1500 mg of AZD8895 and 1500 mg of AZD1061).
|
|---|---|---|---|---|---|---|
|
Apparent Volume of Distribution at Terminal Phase (Vz/F) of AZD7442
AZD8895
|
7.771 L (Litre)
Standard Deviation 2.152
|
5.150 L (Litre)
Standard Deviation 0.5804
|
6.814 L (Litre)
Standard Deviation 1.065
|
6.227 L (Litre)
Standard Deviation 0.5926
|
6.514 L (Litre)
Standard Deviation 0.7232
|
—
|
|
Apparent Volume of Distribution at Terminal Phase (Vz/F) of AZD7442
AZD1061
|
8.471 L (Litre)
Standard Deviation 2.832
|
6.042 L (Litre)
Standard Deviation 0.5914
|
6.241 L (Litre)
Standard Deviation 0.9723
|
6.449 L (Litre)
Standard Deviation 0.6920
|
6.324 L (Litre)
Standard Deviation 0.7784
|
—
|
SECONDARY outcome
Timeframe: Day 1 (pre-dose, 8 h), Day 2 (24 h), Day 4 (72 h), Day 6 (120 h), Day 8 (168), Day 15 (336 h), Day 31 (720 h), Day 61 (1440 h), Day 91 (2160 h), Day 151 (3600 h), Day 211 (5040), Day 271 (6480 h), and Day 361 (8640 h)Population: The PK analysis set consisted of all participants in the safety analysis set who received AZD7442 and who had evaluable serum PK data, with no important protocol deviations thought to impact on the analysis of the PK data. It was pre-specified in the SAP and CSP to report Vss for only arms receiving IV infusion.
The single dose Vss of AZD7442 and of the individual mAbs in serum was evaluated.
Outcome measures
| Measure |
Pooled Placebo
n=9 Participants
Participants received single intravenous infusion (IV) or intramuscular injection (IM) of placebo.
|
AZD7442 300 mg, IM
n=9 Participants
Participants received 300 mg of AZD7442 (AZD8895 + AZD1061) via intramuscular injection (IM) administered in 2 sequential injections, starting with 150 mg AZD8895 and followed by 150 mg AZD1061.
|
AZD7442 300 mg, IV
n=10 Participants
Participants received 300 mg of AZD7442 (AZD8895 + AZD1061) via intravenous infusion (IV) administered in 2 sequential infusions, starting with 150 mg AZD8895 and followed by 150 mg AZD1061.
|
AZD7442 1000 mg, IV
n=10 Participants
Participants received 1000 mg of AZD7442 (AZD8895 + AZD1061) via IV infusion administered in 2 sequential infusions, starting with 500 mg AZD8895 and followed by 500 mg AZD1061.
|
AZD7442 3000 mg, IV
Participants received 3000 mg of AZD7442 (AZD8895 + AZD1061) via IV infusion administered in 2 sequential infusions, starting with 1500 mg AZD8895 and followed by 1500 mg AZD1061.
|
AZD7442 3000 mg, IV Co-administered
Participants received 3000 mg of AZD7442 (AZD8895 + AZD1061) via IV infusion, the investigational medicinal product (IMP) was co-administered as a single IV infusion containing both (1500 mg of AZD8895 and 1500 mg of AZD1061).
|
|---|---|---|---|---|---|---|
|
Volume of Distribution at Steady State (Vss) of AZD7442 IV Infusion
AZD8895
|
5.074 L (Litre)
Standard Deviation 0.4766
|
6.520 L (Litre)
Standard Deviation 0.9739
|
6.118 L (Litre)
Standard Deviation 0.5983
|
6.373 L (Litre)
Standard Deviation 0.6854
|
—
|
—
|
|
Volume of Distribution at Steady State (Vss) of AZD7442 IV Infusion
AZD1061
|
5.687 L (Litre)
Standard Deviation 0.4691
|
6.020 L (Litre)
Standard Deviation 0.8755
|
6.311 L (Litre)
Standard Deviation 0.6722
|
6.286 L (Litre)
Standard Deviation 0.7465
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 361 (Post dose)Population: Safety analysis set included all participants who were randomized and received any amount of AZD7442.
The ADA response to AZD7442 in serum was evaluated.
Outcome measures
| Measure |
Pooled Placebo
n=10 Participants
Participants received single intravenous infusion (IV) or intramuscular injection (IM) of placebo.
|
AZD7442 300 mg, IM
n=10 Participants
Participants received 300 mg of AZD7442 (AZD8895 + AZD1061) via intramuscular injection (IM) administered in 2 sequential injections, starting with 150 mg AZD8895 and followed by 150 mg AZD1061.
|
AZD7442 300 mg, IV
n=10 Participants
Participants received 300 mg of AZD7442 (AZD8895 + AZD1061) via intravenous infusion (IV) administered in 2 sequential infusions, starting with 150 mg AZD8895 and followed by 150 mg AZD1061.
|
AZD7442 1000 mg, IV
n=10 Participants
Participants received 1000 mg of AZD7442 (AZD8895 + AZD1061) via IV infusion administered in 2 sequential infusions, starting with 500 mg AZD8895 and followed by 500 mg AZD1061.
|
AZD7442 3000 mg, IV
n=10 Participants
Participants received 3000 mg of AZD7442 (AZD8895 + AZD1061) via IV infusion administered in 2 sequential infusions, starting with 1500 mg AZD8895 and followed by 1500 mg AZD1061.
|
AZD7442 3000 mg, IV Co-administered
n=10 Participants
Participants received 3000 mg of AZD7442 (AZD8895 + AZD1061) via IV infusion, the investigational medicinal product (IMP) was co-administered as a single IV infusion containing both (1500 mg of AZD8895 and 1500 mg of AZD1061).
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Who Have Positive Antidrug Antibodies (ADA) of AZD8895 and AZD1061
AZD8895
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Percentage of Participants Who Have Positive Antidrug Antibodies (ADA) of AZD8895 and AZD1061
AZD1061
|
0 Participants
|
4 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Pooled Placebo
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
AZD7442 300 mg, IM
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
AZD7442 300 mg, IV
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
AZD7442 1000 mg, IV
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
AZD7442 3000 mg, IV
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
AZD7442 3000 mg, IV Co-administered
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Pooled Placebo
n=10 participants at risk
Participants received single intravenous infusion (IV) or intramuscular injection (IM) of placebo.
|
AZD7442 300 mg, IM
n=10 participants at risk
Participants received 300 mg of AZD7442 (AZD8895 + AZD1061) via intramuscular injection (IM) administered in 2 sequential injections, starting with 150 mg AZD8895 and followed by 150 mg AZD1061.
|
AZD7442 300 mg, IV
n=10 participants at risk
Participants received 300 mg of AZD7442 (AZD8895 + AZD1061) via intravenous infusion (IV) administered in 2 sequential infusions, starting with 150 mg AZD8895 and followed by 150 mg AZD1061.
|
AZD7442 1000 mg, IV
n=10 participants at risk
Participants received 1000 mg of AZD7442 (AZD8895 + AZD1061) via IV infusion administered in 2 sequential infusions, starting with 500 mg AZD8895 and followed by 500 mg AZD1061.
|
AZD7442 3000 mg, IV
n=10 participants at risk
Participants received 3000 mg of AZD7442 (AZD8895 + AZD1061) via IV infusion administered in 2 sequential infusions, starting with 1500 mg AZD8895 and followed by 1500 mg AZD1061.
|
AZD7442 3000 mg, IV Co-administered
n=10 participants at risk
Participants received 3000 mg of AZD7442 (AZD8895 + AZD1061) via IV infusion, the investigational medicinal product (IMP) was co-administered as a single IV infusion containing both (1500 mg of AZD8895 and 1500 mg of AZD1061).
|
|---|---|---|---|---|---|---|
|
Nervous system disorders
Headache
|
20.0%
2/10 • Number of events 2 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
0.00%
0/10 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
20.0%
2/10 • Number of events 2 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
20.0%
2/10 • Number of events 2 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
30.0%
3/10 • Number of events 3 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
0.00%
0/10 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
|
Nervous system disorders
Dizziness
|
0.00%
0/10 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
0.00%
0/10 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
0.00%
0/10 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
0.00%
0/10 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
0.00%
0/10 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
10.0%
1/10 • Number of events 1 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/10 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
0.00%
0/10 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
0.00%
0/10 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
0.00%
0/10 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
0.00%
0/10 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
10.0%
1/10 • Number of events 1 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/10 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
10.0%
1/10 • Number of events 1 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
0.00%
0/10 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
0.00%
0/10 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
0.00%
0/10 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
0.00%
0/10 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
|
Nervous system disorders
Tremor
|
0.00%
0/10 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
0.00%
0/10 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
10.0%
1/10 • Number of events 1 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
0.00%
0/10 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
0.00%
0/10 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
0.00%
0/10 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
|
Nervous system disorders
Paraesthesia
|
10.0%
1/10 • Number of events 1 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
0.00%
0/10 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
0.00%
0/10 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
0.00%
0/10 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
0.00%
0/10 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
0.00%
0/10 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/10 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
0.00%
0/10 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
10.0%
1/10 • Number of events 1 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
10.0%
1/10 • Number of events 1 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
0.00%
0/10 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
10.0%
1/10 • Number of events 1 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/10 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
0.00%
0/10 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
20.0%
2/10 • Number of events 2 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
0.00%
0/10 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
0.00%
0/10 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
0.00%
0/10 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/10 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
0.00%
0/10 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
20.0%
2/10 • Number of events 2 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
0.00%
0/10 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
0.00%
0/10 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
0.00%
0/10 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/10 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
0.00%
0/10 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
0.00%
0/10 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
20.0%
2/10 • Number of events 3 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
0.00%
0/10 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
0.00%
0/10 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/10 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
0.00%
0/10 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
0.00%
0/10 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
10.0%
1/10 • Number of events 1 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
0.00%
0/10 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
0.00%
0/10 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/10 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
0.00%
0/10 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
0.00%
0/10 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
0.00%
0/10 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
10.0%
1/10 • Number of events 1 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
0.00%
0/10 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/10 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
0.00%
0/10 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
10.0%
1/10 • Number of events 1 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
0.00%
0/10 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
0.00%
0/10 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
0.00%
0/10 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/10 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
10.0%
1/10 • Number of events 1 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
0.00%
0/10 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
10.0%
1/10 • Number of events 1 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
0.00%
0/10 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
0.00%
0/10 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
|
Infections and infestations
COVID-19
|
0.00%
0/10 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
0.00%
0/10 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
0.00%
0/10 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
0.00%
0/10 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
0.00%
0/10 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
10.0%
1/10 • Number of events 1 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
|
Infections and infestations
Coronavirus infection
|
0.00%
0/10 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
10.0%
1/10 • Number of events 1 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
0.00%
0/10 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
0.00%
0/10 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
0.00%
0/10 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
0.00%
0/10 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
|
Infections and infestations
Nail infection
|
0.00%
0/10 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
0.00%
0/10 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
10.0%
1/10 • Number of events 1 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
0.00%
0/10 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
0.00%
0/10 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
0.00%
0/10 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
|
Infections and infestations
Oral herpes
|
0.00%
0/10 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
0.00%
0/10 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
0.00%
0/10 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
0.00%
0/10 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
10.0%
1/10 • Number of events 1 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
0.00%
0/10 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
|
Infections and infestations
Tooth infection
|
0.00%
0/10 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
0.00%
0/10 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
0.00%
0/10 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
0.00%
0/10 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
10.0%
1/10 • Number of events 1 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
0.00%
0/10 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
|
Infections and infestations
Urinary tract infection
|
10.0%
1/10 • Number of events 1 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
0.00%
0/10 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
10.0%
1/10 • Number of events 1 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
0.00%
0/10 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
0.00%
0/10 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
0.00%
0/10 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
|
Infections and infestations
Vulvovaginal candidiasis
|
10.0%
1/10 • Number of events 1 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
0.00%
0/10 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
0.00%
0/10 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
0.00%
0/10 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
0.00%
0/10 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
0.00%
0/10 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
10.0%
1/10 • Number of events 1 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
0.00%
0/10 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
0.00%
0/10 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
10.0%
1/10 • Number of events 1 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
10.0%
1/10 • Number of events 3 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
10.0%
1/10 • Number of events 1 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/10 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
0.00%
0/10 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
0.00%
0/10 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
10.0%
1/10 • Number of events 1 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
10.0%
1/10 • Number of events 1 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
0.00%
0/10 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/10 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
0.00%
0/10 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
0.00%
0/10 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
0.00%
0/10 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
10.0%
1/10 • Number of events 1 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
0.00%
0/10 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
0.00%
0/10 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
0.00%
0/10 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
0.00%
0/10 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
0.00%
0/10 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
0.00%
0/10 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
10.0%
1/10 • Number of events 1 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/10 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
0.00%
0/10 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
10.0%
1/10 • Number of events 1 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
0.00%
0/10 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
0.00%
0/10 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
0.00%
0/10 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.00%
0/10 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
0.00%
0/10 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
0.00%
0/10 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
0.00%
0/10 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
10.0%
1/10 • Number of events 1 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
0.00%
0/10 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
|
General disorders
Fatigue
|
0.00%
0/10 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
0.00%
0/10 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
0.00%
0/10 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
10.0%
1/10 • Number of events 1 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
0.00%
0/10 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
20.0%
2/10 • Number of events 2 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
|
General disorders
Application site irritation
|
0.00%
0/10 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
0.00%
0/10 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
0.00%
0/10 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
10.0%
1/10 • Number of events 1 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
0.00%
0/10 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
0.00%
0/10 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
|
General disorders
Energy increased
|
0.00%
0/10 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
0.00%
0/10 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
10.0%
1/10 • Number of events 1 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
0.00%
0/10 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
0.00%
0/10 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
0.00%
0/10 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
|
General disorders
Malaise
|
0.00%
0/10 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
0.00%
0/10 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
10.0%
1/10 • Number of events 1 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
0.00%
0/10 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
0.00%
0/10 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
0.00%
0/10 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
|
General disorders
Vessel puncture site pain
|
10.0%
1/10 • Number of events 1 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
0.00%
0/10 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
0.00%
0/10 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
0.00%
0/10 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
0.00%
0/10 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
0.00%
0/10 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/10 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
0.00%
0/10 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
0.00%
0/10 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
10.0%
1/10 • Number of events 1 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
0.00%
0/10 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
0.00%
0/10 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/10 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
0.00%
0/10 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
0.00%
0/10 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
0.00%
0/10 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
0.00%
0/10 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
10.0%
1/10 • Number of events 1 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
|
Injury, poisoning and procedural complications
Injury
|
10.0%
1/10 • Number of events 1 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
0.00%
0/10 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
0.00%
0/10 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
0.00%
0/10 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
0.00%
0/10 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
0.00%
0/10 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
10.0%
1/10 • Number of events 1 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
0.00%
0/10 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
0.00%
0/10 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
0.00%
0/10 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
10.0%
1/10 • Number of events 1 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
0.00%
0/10 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/10 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
0.00%
0/10 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
0.00%
0/10 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
0.00%
0/10 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
10.0%
1/10 • Number of events 1 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
0.00%
0/10 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
20.0%
2/10 • Number of events 2 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
0.00%
0/10 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
0.00%
0/10 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
0.00%
0/10 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
0.00%
0/10 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
0.00%
0/10 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
|
Blood and lymphatic system disorders
Lymphadenitis
|
0.00%
0/10 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
0.00%
0/10 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
10.0%
1/10 • Number of events 1 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
0.00%
0/10 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
0.00%
0/10 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
0.00%
0/10 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/10 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
0.00%
0/10 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
0.00%
0/10 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
0.00%
0/10 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
10.0%
1/10 • Number of events 1 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
0.00%
0/10 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
|
Reproductive system and breast disorders
Heavy menstrual bleeding
|
0.00%
0/10 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
0.00%
0/10 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
0.00%
0/10 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
0.00%
0/10 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
10.0%
1/10 • Number of events 1 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
0.00%
0/10 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
10.0%
1/10 • Number of events 1 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
0.00%
0/10 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
0.00%
0/10 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
0.00%
0/10 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
0.00%
0/10 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
0.00%
0/10 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
|
Skin and subcutaneous tissue disorders
Myxoid cyst
|
0.00%
0/10 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
0.00%
0/10 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
0.00%
0/10 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
0.00%
0/10 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
0.00%
0/10 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
10.0%
1/10 • Number of events 1 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
|
Surgical and medical procedures
Tooth repair
|
0.00%
0/10 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
0.00%
0/10 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
0.00%
0/10 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
10.0%
1/10 • Number of events 1 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
0.00%
0/10 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
0.00%
0/10 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
|
Cardiac disorders
Palpitations
|
10.0%
1/10 • Number of events 1 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
0.00%
0/10 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
0.00%
0/10 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
0.00%
0/10 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
0.00%
0/10 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
0.00%
0/10 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
|
Eye disorders
Vitreous floaters
|
10.0%
1/10 • Number of events 1 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
0.00%
0/10 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
0.00%
0/10 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
0.00%
0/10 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
0.00%
0/10 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
0.00%
0/10 • From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee This document contains trade secrets and confidential commercial information, disclosure of which is prohibited without providing advance notice to AstraZeneca and opportunity to object.
- Publication restrictions are in place
Restriction type: OTHER